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COMPETITIVE ASSESSMENT AND MARKET ENTRY STUDY OF DEVIL’S CLAW

IN THE U.S. NUTRACEUTICAL / HERBAL SUPPLEMENT MARKET

Agribusiness, Food, and Consumer Economics Research Center (AFCERC) report. Final report
on Cooperative Agreement No. 58-3148-2-014 with the U.S. Department of Agriculture, Foreign
Agricultural Service, July 2012. Submitted by Dr. Victoria Salin, Dr. Desmond Ng, Dr. Gary W.
Williams, Dr. Eluned Jones, and Dr. Ariun Ishdorj.
ABSTRACT
Devil’s Claw is a plant indigenous to a number of countries in southern Africa that is used as an
herbal remedy for pain and inflammation of the joints. Stakeholders in the Namibian supply
regions are considering whether to develop capacity to market dietary supplements in the United
States. As a preliminary step in the development of commercial ventures using this indigenous
traditional product, a market assessment has been undertaken and is reported in this study. The
competitive environment in the U.S. market for nutraceutical and herbal supplements is assessed
with Porter’s Five Forces framework. In both human and animal markets, a set of natural and
non-natural substitutes to Devil’s Claw are marketed, around half of them sold via the Internet.
Natural substitutes present a significant threat to the market potential of Devil’s Claw in the
United States. The threat of rivalry is high because barriers to entry to the markets are limited.
Value chain analysis indicates that the Namibian stakeholders have a presence in the harvest and
primary production stages. In order to extend the business along the market channel, it is
possible to work with brokers and the ingredient buyers at the major processing companies. This
includes the potential to leverage the distributional and logistical efficiencies of companies
situated in China and India as a means of entry into the United States. Those companies market
a variety of botanicals (not significant quantities of Devil’s Claw) but they might expand product
lines using existing operations and logistics / trade flows. Alternatively, a U.S. market entry
plan would be to ship Devil’s Claw root in raw form to serve a niche market of consumers
interested in ecologically oriented or traditional remedies. Finally, to facilitate entry into
markets for animal health products or pet foods that contain health supplements, research on the
toxicity of Devil’s Claw to animals should be considered.

ACKNOWLEDGEMENTS
Funding for this research was provided under Cooperative Agreement No. 58-3148-2-014 from
the U.S. Department of Agriculture, Foreign Agricultural Service.

The Agribusiness, Food, and Consumer Economics Research Center (AFCERC) provides analyses, strategic planning, and
forecasts of the market conditions impacting domestic and global agricultural, agribusiness, and food industries. Our high-
quality, objective, and timely research supports strategic decision-making at all levels of the supply chain from producers to
processors, wholesalers, retailers, and consumers. Through research efforts, outreach programs, and industry collaboration,
AFCERC has become a leading source of knowledge on how food reaches consumers efficiently and contributes to safe and
healthy lives. AFCERC is a research and outreach service of Texas AgriLife Research and Extension and resides within the
Department of Agricultural Economics at Texas A&M University. Online at http://afcerc.tamu.edu/

Contact the authors at 979.845.8013 or v-salin@tamu.edu


COMPETITIVE ASSESSMENT AND MARKET ENTRY STUDY OF DEVIL’S CLAW
IN THE U.S. NUTRACEUTICAL / HERBAL SUPPLEMENT MARKET

EXECUTIVE SUMMARY

This summary provides the findings of an analysis of the competitive environment for a producer
of Devil's Claw products intended for distribution in the United States (U.S.). We provide
industry level perspectives that result in an assessment of the competitiveness of the target
market. Following, there is a value chain analysis that identifies the specific business partners,
product lines, and/or geographic markets that are most promising avenues for market entry. This
summary is organized as follows:

1. Briefing on the analytical approach,


2. Market size summary,
3. Substitutes for Devil’s Claw products,
4. Threats from rival companies and potential entrants,
5. Market access considerations, and
6. Preliminary recommendations to mitigate the threats identified.
The full report contains the following chapters:
1. Introduction and Background
2. Competitive Landscape Analysis with Porter’s Five Forces
3. Conclusions on Competitive Landscape
4. Value Chain Analysis and Market Entry Study

Analytical Approach

Porter’s Five Forces framework was used to assess the competitive landscape and form the
preliminary value chain analysis of Devil's Claw for the human and animal nutraceutical / herbal
supplement markets. Porter’s approach underscores that the attractiveness or profitability of an
industry is determined by five sets of unique factors that might independently reduce industry
profitability. The Porter’s Five Forces framework is thus suited to not only assessing the
competitive landscape and value chain of Devil's Claw, but it is also useful in determining the
attractiveness of eventual entry into the U.S. human and animal nutraceutical / herbal supplement
markets.

Of course, the prediction of success of any entry event faces significant uncertainties. The
identification of these key threats / factors in the five forces analysis serves to identify the nature
of such uncertainties. As a result, the stakeholders of Namibian Devil's Claw will be better able
to mitigate uncertainties of entry and thus improve on the potential to profit from the
introduction of Devil's Claw products in the U.S. human and animal nutraceutical / herbal
supplement markets.

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Market Size and Boundaries

The U.S. herbal supplement market in 2009 was estimated to be $5.03 billion (sales value) and
has risen by 4.8% over the previous year, according to industry sources. Retail sales for pet
supplements is estimated at just below $1 billion for 2007. Within the supplement category,
growth rates for joint health remedies are expected to exceed the rate of overall industry growth.
Basic improvement in the quality of life and advances in health care have resulted in more active
lifestyles and improvements in life expectancy, which are likely to further advance the future
demand and growth for joint health products in the human market in the U.S. According to U.S.
Census Bureau projections, the U.S. population is projected to increase to 392 million by 2050.
The age group of 65 and older is projected to increase to 88.5 million in 2050, more than double
the number in 2008 (38.7 million). About 80 percent of seniors have at least one chronic health
condition and the number of people diagnosed with arthritis is projected to increase to 67 million
in 2030 compared to 50 million today.

The animal nutraceutical / herbal market is in large part an extension of the health and wellness
preferences of the pet owners. Hence, the growth of the animal market is influenced by similar
growth dynamics to the human nutraceutical / herbal supplement market.

While certain important distinctions between the human and animal nutraceutical / herbal
supplement markets exist, the threats facing both markets are closely intertwined. This is
because both markets draw on a common therapeutic property of Devil's Claw. In the
human nutraceutical / herbal supplement market, Devil's Claw has been found to reduce pain
from muscular skeletal problems (i.e. back pain), as well as to reduce the inflammation of joints
that is associated with arthritis. These therapeutic findings for humans have subsequently been
used to justify the inclusion of Devil's Claw in the nutraceutical / herbal supplement market for
animal populations. Because both markets draw on these therapeutic properties, the human and
animal markets share similar threats. The important distinctions between opportunities in the
human and animal markets are outlined in this report but, in terms of the recommendations,
similarities dominate and thus we largely discuss the two markets together.

Substitutes for Devil's Claw Products

In terms of Devil's Claw’s therapeutic properties (i.e. an anti-inflammatory and pain relief agent),
human and animal markets face natural as well as non-natural substitutes. Natural substitutes are
Glucosamine, Chondroitin Sulfate, Boswellia, and / or Methylsulfonylmethane (MSM). With
respect to non-natural substitutes, these include anti-arthritic agents, Nonsteroidal Drugs
(NSAIDs), and Steroidal drugs. However, NSAIDs are the most commonly used non-natural
substitute.

In our judgment, there is a significant threat of substitutes not only because there are a great
number of natural and non-natural items that exhibit similar therapeutic benefits to Devil's Claw,
but also because they are competitively priced. There are at least 7,500 product listings on the
Internet that draw on these active ingredients either individually or in combination--in capsule,

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powder, liquid or juice forms. Because of the great number of natural substitutes as well as
variation in product forms and prices, the threat of substitutes in acting as a “price ceiling” poses
a significant challenge to Devil's Claw.

Threats from Rivals and Potential Entrants

Both human and animal markets have direct rivals involved in the manufacture of Devil's Claw
products. However, unlike the European markets, Devil's Claw in the U.S. market is relatively
immature. Thus, the number of manufacturers, especially in the animal market, is limited.
Furthermore, because the market for joint health care products is an emerging segment of growth
-- in both human and animal markets -- direct rivalry amongst manufacturers is mitigated. That
is, several rivals can co-exist successfully in the growing market that is anticipated for joint
health remedies. Hence, direct competition or rivalry in the human and animal markets is not a
significant threat.

In addition to the rivals in business today, the outlook for new entrants to the sector must be
considered, and in this regard we identify a significant threat. The same growth outlook that
reduces concern about rivals raises the prospect that new competitors will arise, driven by the
expected growth in the market for anti-inflammatory supplements. Moreover, as nutritional /
herbal supplement providers face less government regulation than pharmaceutical products, entry
barriers due to regulation are not a major deterrent to new entrants. In terms of production,
through “contract” manufacturing, entry into the manufacturing of herbal supplements can be
achieved in ways that not only abide by current regulations but can also be achieved with
relatively low costs. The contract manufacturing option is available to parties from the United
States and from overseas, most notably China, so that the universe of potential entrants is wide.
Hence, while there are few manufacturers or rivals that are currently involved in the production
of Devil's Claw products, the projected growth in the human and animal market coupled with
relatively low entry barriers presents a significant threat of new or potential entrants. Thus,
while a Devil’s Claw product can feasibly enter the U.S. market, so can other competitors.

Market Access Considerations

While the threat of entry, rivalry, and substitutes underscore the close and potential rivals to
Devil's Claw, the Namibian stakeholders will need to operate in a global, multi-level supply
chain in which the influences of customers or suppliers can also compromise the profitability or
attractiveness of an industry. We consider the immediate customer to be both online and mass
market retailers, and the power of those buyers relative to the Namibian stakeholders is a
pending concern. Online retailers operate in a generally competitive environment, especially for
human dietary supplements. Online distributors carry multiple Devil's Claw products from
different manufacturers. This increases the threat of buyer power because online retailers can
source from multiple manufacturers to compete on price and thus reduce manufacturer profits.
There is also an increasing trend toward consolidation, especially in the mass retail market. The
large retailers have the buyers' influence with respect to manufacturers, which face fewer

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alternatives to distributing their products and a Namibian supplier may well be captive to the
price demands of these retailers.

With respect to upstream threats to manufacturers of Devil's Claw, there does not appear to be
any significant distinction in the quality of raw supplies of Devil's Claw for either human or
animal markets. Specifically, there appears to be limited differentiation by suppliers in terms of
the level of the active ingredient, harpagoside, or its dosage. This lack of differentiation may be
due to the emergent or immature nature of these markets and thus buyers do not require suppliers
to develop specialized raw ingredients that match the demands of each of these markets. In the
absence of any significant distinction in this “quality” aspect of Devil's Claw, the supplier market
appears to be competitive. In particular, while there are sixteen listed suppliers of Devil's Claw
from southern Africa, we have also found that according to supplier procurement sources, there
are 450 supplier/distributors from China. There potentially are multiple options for procurement
of extracts and raw materials and thus there is a highly competitive supplier market.
Furthermore, given that businesses in Namibia are likely to source their raw supplies of Devil's
Claw from their local partners, who comprise a fragmented group of harvesters, supplier power
is currently not likely to be a significant concern in the manufacturing of Devil's Claw products.
That is, while there are current efforts by MCA to coordinate the production of at least 21
Devil’s Claw groups that harvest in Namibia, their contributions constitute 10-20% of the market
(communications with David Cole) and thus do not hold a strong supplier position.

Regulatory Issues

Devil’s Claw products marketed to human or animal markets will be within the purview of the
Food and Drug Administration. Human dietary supplements do not require pre-market approval,
although informational communications with FDA and strict adherence to labeling rules are
important. Products destined for animals must be marketed as food additives or drugs. Overall,
regulatory uncertainty is a modest risk.

Value Chain Analysis and Market Entry Study

In addition to the industry analysis of the five forces competitive framework, the conceptual
framework of value chain is taken from the resource-based view of the firm, where the business
analyst considers the available resources and capabilities of a company at a finer level of detail.
According to this firm level view, value chains involve both primary and support activities that
are used by a firm to efficiently deploy the available resources in a manner that creates durable
competitive advantage. The various functional areas of the value chain include technology,
regulatory and legal support, infrastructure for distribution support, and sales marketing or
merchandising.
The Namibian stakeholders have strength in the harvest and primary production activities of the
value chain. In the United States, the buyers of ingredients for dietary supplements may be
found in specialized broker businesses or the procurement staff of manufacturing firms. Much of
the trade accepts imported goods only where manufacturing quality standards are assured. Thus,
while supplies of Devil’s Claw from China and India remain limited today, those foreign

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suppliers have strong scale and distributional advantages that can pose a significant challenge to
Namibian suppliers who seek further value added processing. That is, because Namibian
suppliers of Devil’s Claw may also provide post-harvesting activities involving drying, slicing
and other value added processing and distribution activities, Namibian suppliers thereby need to
also contend with Chinese or Indian manufacturing/trading companies as another potential
source of supply for the U.S. market. Thus, strength of scale and distribution support from
China and India implies a significant challenge to stakeholders interested in marketing directly
from southern Africa to the United States.
With regard to marketing and merchandising support, the U.S. market for dietary supplements is
very active and dynamic. Current trends point to the use of food ingredients in addition to
herbal supplements and an emphasis on anti-inflammatory mechanisms. The market for pain
remedies is considered mature and no longer a leader within supplements. The ecologically-
oriented market niche is very small and retails through the fragmented specialty store channel.
These highly quality sensitive buyers prefer to receive raw, unprocessed product to allow them to
have complete control of the processing to their own specifications.
If the Namibian stakeholders desire to enter the USA market, they will need to find reliable
business partners and to be prepared for those business partners to capture a large share of the
returns from value-adding business. We believe that the identification of business partners and
the execution of contracts for transactions involving raw materials and primary processing can be
pursued by a Namibian stakeholder. When it comes to formulation, the scientific expertise and
ability to show credible results are not likely to be organized in Namibia. Thus the avenue to the
market must be to identify research partners at the level of product formulation.

Recommendations

As one of the goals of this study is to determine a course of action that would enable entry into
the U.S. human and animal nutraceutical / herbal supplement markets, the following
recommendations are offered to mitigate key threats and thus alleviate some of the uncertainties
of entry into these markets.

Differentiation to Reduce the Threat of Substitutes

While the therapeutic benefits of Devil’s Claw are generally well documented in scientific
literature and known to customers in Europe, such benefits are less well established in the U.S.
market. In particular, the therapeutic benefits of Devil's Claw remain generally unclear within the
animal market and thus differentiation through investments in clinical studies is one means to
mitigate the threats from both natural and non-natural substitutes. Since natural substitutes reflect
the most immediate threat to Devil's Claw, clinical studies that compare the therapeutic benefits
of Devil's Claw to that of Glucosamine, Chondroitin and /or MSM in either of the human and
animal markets are suggested. While such studies will benefit producers of Devil’s Claw, they
are nevertheless expensive and would involve a highly specialized research study.

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Such investments in clinical studies can be an important source of differentiation, but as
explained shortly, can also yield other indirect benefits. To date, we have found no clinical
studies that compare substitute products (the natural supplements for joint health) directly to
Devil’s Claw. Investments in research and development, such as clinical trials on the therapeutic
properties of Devil's Claw, serve a double purpose in raising a barrier to entry by potential rivals
to the extent that a differentiating trait is identified and can be capitalized on through
manufacturing.

We suggest research to address at least the following:

1. Efficacy and/or toxicity tests in combinations with Boswellia and other natural supplements.
2. Effects on pregnancy under recommended dosages (human and animal).
3. Feasibility to incorporate in soft gel pill form which is easy to swallow and is an increasingly
popular form of delivery.
4. Anti-inflammatory effects compared with existing natural substitutes such as resveratrol.
5. Toxicity studies for the veterinary channel with a focus on the canine and feline market.

Phased Entry to Test Market Access and Acceptance with U.S. Buyers.

To limit the risks associated with capital investments in R&D and possibly plant and equipment,
a staged entry strategy is recommended. In the first stage, “contract manufacturing” is to be
undertaken while technical and market uncertainties are being resolved. Contract manufacturing
can leverage the Namibian stakeholder’s advantages in its raw ingredient production of Devil's
Claw. Production through certified means in Namibia is likely to be more feasible after a period
of experience with outsourcing manufacturing to an agent certified by industry-accepted
agencies, to assure Good Manufacturing Practices (GMP). Certification will be minimally
necessary to meet the specifications of buyers in any retail channel. Indeed, the buyers at
smaller specialty firms that manufacture in-house prefer the product to enter the country un-
refined in order to have maximum control over the processing.

With respect to value-added opportunities, a vertically coordinated value chain with a contract
manufacturer under the brand name of a Namibian stakeholder may be developed through
alliance with the following companies:

• in the USA (Pharmachem, SoftGel Technologies, Novagroup),


• in China (Jiaherb) with headquarters in New Jersey, USA
• and in India (Advantage Botanical).

The products would bear a Namibian company’s own label without the need for investment in
the entire processing technology. The Namibian company will need to invest in the expertise
about formulation so that its specifications can be delivered to the contract manufacturer.

During the period of contract manufacturing, studies to identify costs of transportation and
distribution as well as quality assurance for GMP status should be undertaken. The cost analysis
will establish the feasibility of competing as a low-cost entrant using powder, extracts or other
products manufactured in Namibia at some point in the future.

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TABLE OF CONTENTS
EXECUTIVE SUMMARY ............................................................................................................ ii 
Analytical Approach ....................................................................................................................... ii 
Market Size and Boundaries .......................................................................................................... iii 
Substitutes for Devil's Claw Products ............................................................................................ iii 
Threats from Rivals and Potential Entrants ................................................................................... iv 
INTRODUCTION AND BACKGROUND ................................................................................... 1 
Description of the Product Market ............................................................................................................ 1 
Market Size ............................................................................................................................................... 2 
Regulatory Environment ........................................................................................................................... 2 
Special Considerations for the Animal Nutraceutical / Herbal Supplement Market ................................ 5 
Equine ................................................................................................................................................... 5 
Canine and Feline ................................................................................................................................. 5 
COMPETITIVE LANDSCAPE ANALYSIS WITH PORTERS FIVE FORCES......................... 6 
Overview of Porter’s Five Forces ............................................................................................................. 7 
Human Nutraceutical / Herbal Supplement Market Forces ................................................................. 8 
Threat of Rivalry ................................................................................................................. 8 
Threat of Entry .................................................................................................................... 9 
Threat of Substitutes ......................................................................................................... 10 
Threat of Supplier Power .................................................................................................. 12 
Threat of Buyer Power ...................................................................................................... 13 
Animal Nutraceutical / Herbal Supplement Market Forces ............................................................... 14 
Threat of Rivalry ............................................................................................................... 15 
Threat of Entry .................................................................................................................. 16 
Equine ............................................................................................................................... 16 
Canine and Feline ............................................................................................................. 17 
Threat of Substitutes ......................................................................................................... 17 
Threat of Supplier Power .................................................................................................. 18 
Threat of Buyer Power ...................................................................................................... 19 
CONCLUSION on COMPETITIVE LANDSCAPE.................................................................... 20 
Threat of Substitutes ............................................................................................................................... 20 
Threat of Rivalry ..................................................................................................................................... 21 
Threat of Entry ........................................................................................................................................ 21 
Threat of Buyer Power ............................................................................................................................ 21 
Threat of Supplier Power ........................................................................................................................ 22 
Recommendations / Implications ............................................................... Error! Bookmark not defined. 
Mitigating Key Threats ........................................................................................................................... 22 
Threat of Substitutes ........................................................................................................................... 22 
Threat of Entry .................................................................................................................................... 23 
Threat of Buyer Power ........................................................................................................................ 23

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VALUE CHAIN ANALYSIS AND MARKET ENTRY STUDY .............................................. 25 
Primary Activities: Harvest and Processing ............................................................................................ 26 
Harvest ................................................................................................................................................ 26 
Primary processing ............................................................................................................................. 26 
Further processing .............................................................................................................................. 27 
Distribution support activities ................................................................................................................. 31 
Retail distribution and marketing activities ............................................................................................ 31 
Recommendations for Market Entry ....................................................................................................... 32 
Cost Estimates for Performing Clinical Studies on Efficacy of Devil’s Claw  ....................................... 33 
Human Markets –Efficacy as a Dietary Supplement .......................................................................... 33 
Veterinary drug status......................................................................................................................... 34 
FIGURES ...................................................................................................................................... 37 
TABLES ....................................................................................................................................... 40 
APPENDIX- FDA LETTERS ...................................................................................................... 63 
REFERENCES ............................................................................................................................. 76 

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COMPETITIVE ASSESSMENT AND MARKET ENTRY STUDY OF DEVIL’S CLAW
IN THE U.S. NUTRACEUTICAL / HERBAL SUPPLEMENT MARKET

INTRODUCTION AND BACKGROUND

As Devil’s Claw is primarily used as a nutraceutical / herbal supplement, an assessment of


Devil’s Claw competitive landscape is contingent on first defining the nature of the nutraceutical
/ herbal supplement market and its associated therapeutic properties. The nutraceutical / herbal
supplement market is defined by “any substance that may be considered a food or part of a food
and provides medical and health benefits, including the prevention and treatment of diseases”
(Williams, 2009, p. 87).

While there appears to be some overlap between the human and animal nutraceutical / herbal
supplement markets, each market nevertheless faces a number of notable distinctions. In
outlining these distinctions, the following discussion elaborates on the therapeutic and market
specific considerations for the human and animal markets.

Description of the Product Market

In the context of Devil’s Claw, there is a growing body of clinical literature that supports the
therapeutic benefits of Devil’s Claw (Harpagophytum procumens). The active ingredients of
interest consist of Iridroid glycosides –that include four categories of harpagoside, harpagide,
procumbide and procumboside, acetylated phenolic glycosides, and terpenoid (Fiebich et al.,
2001; Hsun-Wei Huang et al., 2006). Studies have indicated that Devil’s Claw exhibits pain
killing and anti-inflammatory properties (Williams, 2009; Fiebich et al., 2001; Hsun-Wei Huang
et al., 2006). In the human nutraceutical / herbal supplement market, Devil’s Claw has been
found to not only reduce pain from muscular skeletal problems, but also reduce the inflammation
of joints from osteo and rheumatic arthritis (Fiebich et al., 2001; Katerere and Naidoo, 2010;
Chrubasik et al., 1996; Chrubasik et al., 2006; McGregor et al., 2005) 1 . For instance, in
Williams’ (2009) review of studies of Devil’s Claw, Williams finds that “most of the clinical
studies in humans, some of which were blinded, revealed decreased pain intensity and increased
flexibility in patients taking Devil’s Claw extract (p. 90).” With respect to the relief of pain from
musculoskeletal problems involving the treatment of back pain, human subjects who were
treated with Devil’s Claw who reported “pain free” in greater number than did a placebo group
(Chrubasik et al., 1996; McGregor et al., 2005; Hsun-Wei Huang et al., 2006). Furthermore,
other studies have confirmed the anti-inflammatory properties of Devil’s Claw (Fiebich et al.
2001; Ernst and Chrubasik etal., 2000; McGregor et al., 2005; Hsun-Wei Huang et al., 2006).

In the human market, there is a body of research that supports the use of Devil’s Claw in the
treatment of back pain (e.g. Chrubasik et al, 1996; Chrubasik et al., 2007; Brien et al., 2006) and
also as a potential treatment for osteoarthritis (see also Chrubasik et al., 2007; Brien et al., 2006;
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For studies that do not support such therapeutic benefits, please see Whitehouse et al. (1983) and McLeod et al,
(1979).
McGregor et al., 2005). As McGregor et al. (2005) notes, “the data indicate that Devils’ Claw
relieves pain, and has anti-inflammatory properties and is, therefore, a potential treatment for
alleviating the systems of osteoarthritis of the knee and other large joints” (p. 52). Furthermore,
because pain relief and osteoarthritis are treated by using analgesics and / or NSAID medication,
these alternatives have serious side effects including, heartburn, nausea, dyspepsia, vomiting,
abdomen pain, perforated ulcers and gastro intestinal bleeding. In the UK alone, NSAID have
contributed to 12,000 hospitalizations and 2,000 deaths (Brien et al., 2006). As an alternative to
NSAID, human studies have been conducted on the safety and toxicity of Devil’s Claw to which
some have suggested that Devil’s Claw can be viewed as a possibly safer alternative to NSAID
(Brien et al., 2006). Human studies have found that Devil’s Claw can be an effective replacement
to the use of NSAID because it does not exhibit such adverse health effects (see in human studies
Chrubasik et al., 2007; Brien et al., 2006).
These studies however tend to be hampered by small population samples to which Brien et al.
(2006) contend that “Devil’s Claw appears to be associated with minor risk (relative to
NSAIDs); however, no firm conclusion regarding the herb’s safety can be made. Further
assessment of safety risk is needed” (p. 981). There are also other concerns that surround the
therapeutic benefits of Devil’s Claw. The available studies are based on methodologies that
prevent a full clinical assessment of the therapeutic value of Devil’s Claw (McGregor et al.,
2005). As a result, many researchers contend that the therapeutic value of Devil’s Claw requires
further research attention (McGregor et al., 2005; Chrubasik et al., 2007; Brien et al., 2006).
Because findings from human clinical trials are often used to justify the use of Devil’s Claw in
the animal market (e.g. Williams, 2009; Cavaliere et al., 2009), there is greater uncertainty about
the therapeutic benefits in the animal nutraceutical / herbal supplement market than in the dietary
supplements market for humans.

Market Size

The total estimated sales for U.S. herbal supplements in 2009 was $5.03 billion and rose by 4.8%
over the previous year (Cavaliere et al., 2010; ABC, 2010; various NBJ sources). Of that figure,
an estimated $1 billion was spent on treatments for pets. The category of joint health
supplements in particular is significant: glucosamine and chondroitin sales constitute 21% of the
U.S. supplement market or around $803 million in sales in 2009 (NBJ, 2010e).

Regulatory Environment

Foods and drugs marketed for human or animal use are regulated by the FDA. The Federal
Food, Drug and Cosmetic Act is the legislative authority by which FDA distinguishes the
regulatory status of food and drugs. Drugs are “substances intended for use in diagnosis, cure,
mitigation of disease…” The Act also defines drugs as: "articles (other than food) intended to
affect structure or function of the body of man or other animals."

Food additives are a separate type of substance under U.S. regulation. The 1996 Food Quality
Protection Act is intended to implement science-based risk assessment with respect to the safety
of an additive. Additives must show that there is “reasonable certainty of no harm.” The list of

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approved additives is known as the GRAS list (Generally Recognized as Safe). Separate GRAS
lists are maintained for additives used in human foods and those destined for the animal market.
The FDA undertakes enforcement actions for two issues: misbranded goods or adulterated
goods. Misbranding actions are classified as fraudulent or misleading labeling, or the failure to
label. Adulteration arises when the product includes ingredients that are not legally marketable,
or if there is contamination by filth, pests, or pathogens.

Dietary supplements are distinct from food or drugs in regulatory status as a result of the 1994
legislation entitled the Dietary Supplement Health and Education Act (DSHEA). The dietary
supplements category includes essential nutrients (vitamins, minerals) and herbs or botanicals.
Dietary supplements marketed to humans under DSHEA are exempt from the pre-market
approvals required of new foods and drugs. To be covered under DSHEA, items may not make
claims as to disease or the structure or function of the body. Further, products must be labeled as
dietary supplements and there must be a supplement facts label disclosing the ingredients. Thus,
the regulatory burden for dietary supplements is clearly less than the premarket proofs for drugs
that are marketed for human use.
Enforcement actions on dietary supplements highlight FDA’s concern that supplements may not
make health claims. For example, three products marketed for human use that contain Devil’s
Claw were involved in enforcement action by FDA due to mislabeling. Two product labels
made health claims for the supplement that went beyond the type of statements that are
acceptable under DSHEA. In addition, the topical gel was an unapproved new use of the
ingredient as well as having medical claims. See Appendix for FDA enforcement letters.
For animal products, there is no legal approved market in dietary supplements (FDA, 1995).
Products sold for use by animals therefore will be categorized as either a food additive or a drug
(AAFCO). Animal feed labels may not bear claims that products can be used for mitigation of
disease or to alter structure or function of the body. This type of claim triggers regulation as a
veterinary drug.
Foods and drugs administered to animals concern the FDA because of the risk to the production
animal sector and the risk that residue from an ingredient could remain in the foods and
subsequently harm consumers. The companion animals market is segmented from the
production animal market in important ways, however both are regulated. FDA exercises
discretion in pursuing its oversight over products intended for companion animals and thus some

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observers feel that there is room for supplement-type products to enter the US market. Indeed,
such products are sold today. However the legal status is ambiguous. Well-known incidents
have blemished the quality record of animal feed ingredients, particularly with respect to
imported ingredients. In 2007, deliberate contamination of pet food with melamine affected
goods imported from China (FDA, 2010a). The deaths of companion animals in the USA caused
a public reaction and a large product recall. Herbal and botanical ingredients in particular have a
questioned reputation in the USA. In 1998, contamination was found in a number of herbal
ingredients imported from Asia (Machado and Benz, 2000).
The rationale for opening up the dietary supplement market to herbs and botanicals is that these
supplements had a long history of use in human communities and therefore, concerns about
toxicity are low. Toxicity in animals is different than in humans, and there is no historical record
of supplement use in animals. Less information is available on safe dosages in animals. And
because animal populations are more heterogeneous than humans, there are specific gaps in
information.
Devil's Claw products are marketed to companion animals in the USA, in spite of the fact that
they have not been approved (Machado and Benz, 2000). FDA provides comments on its intent
and the conditions for acceptable marketing of herbal / botanicals for pets. These conditions will
be elaborated in value chain studies in the next phase of this project.
In addition to the issues described above that relate primarily to mislabeling, the oversight by
FDA extends to safety and quality. Problems in this regard are referred to as “adulteration” and
FDA takes measures to prevent entry or remove products from the market that are adulterated.
Pet food products have been recalled from the market after several foodborne illness outbreaks
among pets and pet owners. Further, FDA is currently pursuing a national testing program
regarding salmonella contamination in dog and cat food (FDA, 2010b). Hence, the sensitivity of
the U.S. market to contamination of herbal and imported ingredients is high in both human and
animal product markets.
Proof of sanitary conditions in production (and distribution) is needed to avoid the imported
product being deemed adulterated. Quality for herbal and botanical ingredients has at least three
aspects: (1) free of contamination with heavy metals or pesticide residue, (2) production in a
certified facility using Current Good Manufacturing Practices, and (3) testing and documentation
of the levels of active ingredients.
Sanitary and quality concerns can be raised by government agencies or the private sector. While
the FDA has primary responsibility, attention can arise from legislative agencies or state-level
officials. In 2010, the GAO, under the direction of Congress, investigated supplements. The
focus of that investigation was on false or misleading promotional activities. At virtually any
moment, an investigative body might focus on the content of the product in terms of cleanliness,
pathogens, or control over the chain of custody from harvest through manufacture. Any
number of non-governmental organizations also might undertake testing and then disclose
failings of a product.

4
Special Considerations for the Animal Nutraceutical / Herbal Supplement Market

With respect to the animal nutraceutical / herbal supplement market, Devil’s Claw has some
notable therapeutic and market specific considerations. This body of therapeutic evidence on
humans has been subsequently used in justifying the use of Devil’s Claw in the animal
nutraceutical / herbal supplement market (e.g. Cavaliere, 2009; Katerere and Naidoo, 2010). As
Katerere and Naidoo (2010) note, “most of the human clinical studies reported reduced pain
intensity and increased joint flexibility, and these studies have been used to justify the use of
Devil’s Claw preparations in animals, particularly horses [in which] Pearson, McKee and Clarke
(1999) reported an anti-inflammatory effect in horses due to a reduction of the prostaglandin E2
(PGE2) synovial fluid content” (p. 395). The use of Devil’s Claw in the animal market is largely
confined to equine, canine, and feline sub-animal species.

Equine

In terms of the equine sub-animal market, there are few, if any, clinical studies that examine the
anti-inflammatory and pain relief properties of Devil’s Claw. Most animal studies have been
conducted on rats (Whitehouse et al., 1983; McLeod et al, 1979) which did not find any anti-
inflammatory and pain reducing effects. There are nevertheless various marketing claims that
contend Devil’s Claw not only exhibits anti-inflammatory and pain relief properties, but they
also suggest that Devil’s Claw is effective in weaning horses from non-steroidal anti-
inflammatories (NSAID), such as phenylbutazone (“bute”). Commonly used as an anti-
inflammatory in the horse market, phenylbutazone can lead to gastric ulcer diseases.
Furthermore, while Devil’s Claw has been viewed as a safer alternative to NSAIDs and as a
supplement that aids in joint health, the use of Devil’s Claw is banned for competitive and racing
purposes (Williams). As Williams (2009) notes,

“In the United States, most breeds and competition operate under U.S. Equestrian Equine
Drug testing rules…The following excerpt is from the U.S. Equestrian Federation
(USEF) Drugs and Mediations Guidelines (2006) [which states]… Just of the examples
of the hundreds and perhaps thousands of examples of herbal / natural or plant
ingredients that would cause a product to be classified as forbidden are Valerian, Kava
Kava, Passion flower….Devil’s Claw…”(p. 87)

This indicates Devil’s Claw will be strictly limited to horses used for recreational purposes only,
which, as indicated in our subsequent competitive analysis, will significantly constrain the
commercial potential of this product in the animal nutraceutical / herbal supplement market.

Canine and Feline

There are few if any clinical trials that have examined the therapeutic benefits of Devil’s Claw in
the canine and feline sub-animal market. This is because, like the equine market, the
development of Devil’s Claw products is based on the presumption that the therapeutical
properties observed in human can be extrapolated to the animal market (Cavaliere, 2009). For
instance, pet supplement manufacturers, such as Natural Remedy, extended their human dietary
supplement products to the animal market largely on the premise that the therapeutical properties

5
observed in humans can be transcended to the animal market (Cavaliere, 2009). Yet, as noted in
Cavaliere (2009), pet supplement manufacturers do not typically conduct clinical trials on the
efficacy of their products because they are considered “natural.” Hence the current practice of
domestic industry is to not provide a research base to differentiate pet products in terms of higher
quality.

COMPETITIVE LANDSCAPE ANALYSIS WITH PORTERS FIVE FORCES

As competition is defined by the extent to which products exhibit similar valued traits (Porter,
1980), the clinical studies used in assessing Devil’s Claw’s therapeutic properties are used to
define such valued traits. Specifically, there appears to be a general clinical consensus on the
anti-inflammatory properties of Devil’s Claw in its treatment of joint related problems that
involve the reduction of pain and the alleviation of arthritis. As a result, competition in the
human and animal nutraceutical / herbal supplement market is defined by manufacturing firms
that produce Devil’s Claw products that draw on these anti-inflammatory properties.
Furthermore, as competition also includes firms that produce substitute products (Porter, 1980),
Glucosamine, Chondroitin sulfate, and to a lesser extent, Methylsulfonylmethane (MSM), are
considered as natural substitutes to Devil’s Claw. That is, since the competition facing Devil’s
Claw is based on its anti-inflammatory properties, clinical studies have indicated that
Glucosamine / Chondroitin sulfate exhibit “mild anti-inflammatory effects” (Plumb, 2011, p.
473) and appear to have the minimal adverse effects as that of Devil’s Claw (Plumb, 2011, p.
475). Namely, like Devil’s Claw, Glucosamine / Chondroitin sulfate appear not to have the
serious side effects of NSAID and appear to be well tolerated in horses, dogs and cats (Plumb,
2011, p. 474; see also PFI, 2011c; See also Brien et al., 2006). This is because like Devil’s Claw,
they are derived from “natural sources” (Plumb, 2011, p. 474) and thereby reflect a “natural
substitute” to Devil’s Claw. Although there are other natural substitutes to Devil’s Claw that
exhibit such anti-inflammatory properties, such as bee pollen, Echinacea, flaxseed, ginger,
ginseng, yucca, these natural substitutes are not included because they either lack clinical
evidence in support of anti-inflammatory properties or they do not possess the minimal adverse
effects of Devil’s’ Claw (see Williams, 2009). These other natural remedies are thereby not
included as legitimate substitutes for Devil's Claw.

A further set of substitutes are the non-natural pharmaceutical preparations. There is a variety of
clinically supported “non-natural” anti-inflammatory products, in three main classes of drugs:
anti-arthritic agents, Non-steroidal Anti-arthritic drugs (NSAID) and Steroid drugs (Bayer,
2009).
Given this clinically based definition of competition, Porter’s (1980) five forces is used to assess
the competitive landscape of Devil’s Claw and its associated value chain in the human and
animal nutraceutical / herbal supplement markets. Porter’s (1980) five forces is a well-
established framework to conduct an industry analysis of their competitors (Sanburn, 2011). In
the context of the objectives of this study, Porter’s five forces is suited to not only assessing
Devil’s Claw’s competitive landscape and its associated value chain, but also useful in
determining the attractiveness of entry into the U.S. human and animal nutraceutical / herbal
supplement markets. In fact, marketing studies have utilized Porter’s five forces to assess the

6
attractiveness of foreign market entry (e.g. Cavusgil and Zou, 1994; Dian and Burrell, 1995).
The prediction of success of any entry event is often marred with significant uncertainties. While
five forces analysis is typically used to assess the competitive structure of a value chain system,
the identification of such threats serves to also identify the nature of those uncertainties involved
in the entry to the U.S. human and animal nutraceutical / herbal supplement markets. Identifying
such key threats and their associated factors will serve to not only better manage the
uncertainties of this entry but if they can be mitigated, can improve the potential profitability of
Devil’s Claw products in these markets.

Overview of Porter’s Five Forces

Porter’s framework underscores that the attractiveness or profitability of an industry is


determined by five threats: the threat of entry, rivalry, substitutes, buyer and supplier power
(Figure 1). While increases to all of these threats reduce industry profitability and thus entry
attractiveness, there are nevertheless numerous underlying factors that can contribute to each
threat. Figure 1 summarizes all factors pertaining to each of these threats. As different industries
emphasize different threats and factors, we will analyze only those threats and factors that are
most pertinent to the Devil’s Claw nutraceutical / herbal supplement market.

Such an analysis draws from a rich collection of sources provided by The Texas A&M Vet-
Medical and business libraries. In fact, while the assessment of new markets will undoubtedly
require obtaining varied and often difficult to acquire market and medical based information,
Texas A&M has one of largest and most extensive business, veterinarian and medical collections
in the country. To complement these library sources, this study also draws on internet sources,
such as Google product search.

Google product search when used in conjunction with our referenced resources is an important
tool to assessing Devil’s Claw competition. Namely, according to the Nutrition Business Journal,
internet sales of nutraceutical supplements lead direct mainstream channel sales (i.e. retail store
sales). In 2009, internet sales of dietary supplement constitute a little over 50% of the total $5.03
billion in the U.S. herbal supplement market (Cavaliere et al. 2010) and is also supported more
recently in the Nutrition Business Journal (NBJ, 2010c). As a result, since a significant portion
of sales in the natural herbal supplement is conducted through the internet and that online
purchases are driven by online user reviews, Google product search in conjunction with our
library resources seems to be well suited to conducting a five forces assessment of the
competition facing Devil’s Claw. Specifically, product searches in Google are ordered in
descending sequence of the most to least popular products. Such rankings are largely influenced
by seller rating and user reviewers and thus a Google product search will serve to reflect the
space of the most popular products being searched by users, and will indicate those products that
are most likely to be in competition.

7
Human Nutraceutical / Herbal Supplement Market Forces

Threat of Rivalry

Threat of rivalry refers to the degree of direct competition by producers of the same or identical
product (Barney, 2003; Porter, 1980). In the context of human nutraceutical / herbal supplement
market, rivals are defined as the manufacturing firms that produce products that directly employ
Devil’s Claw as an anti-inflammatory in the treatment of joint problems. Specifically, as this
definition of rivalry is rooted in the therapeutic properties of Devil’s Claw, we search for rivals
through the aforementioned Google product search. To ensure that we have a robust sample of
direct rivals, the term Devil’s Claw along with its therapeutic properties were used as search
terms in the Google product search. For instance, the search term Devil’s Claw was combined
with search terms: anti-inflammatory, pain relief, joint health, arthritis etc. This search process
was iterated until there was convergence of re-occurring product-firm pairings. Table 1 shows
the competitive characteristics of Devil’s Claw’s direct rivals.

The number of direct rivals positively influences the threat of rivalry (Barney, 2003; Porter,
1980). At least 13 distinct rival manufacturers employ Devil’s Claw as an active ingredient in
products that treat joint related problems. There is, however, no clear benchmark in determining
the “number” of firms that constitutes a high threat of rivalry.
Analysis of rivalry takes into account the concentration levels, trends for consolidation, and
growth in a market segment. Concentration of herbal supplement manufacturers must be
considered in light of the diversity of other herbal supplements. Concentration is defined broadly
as the number of companies sharing market presence.

Industries that face a less concentrated - meaning a large number of smaller players - market tend
to have greater threat of rivalry. Muth et al., (1999) finds that the concentration ratio - CR4 and
CR8- for the top four and eight dietary supplement manufacturers is 23% and 39% respectively.
The dietary manufacturer industry also has a reported Herfindahl Index (HHI) of 250. According
to the U.S. Department of Justice’s Horizontal merger guidelines, industries with HHI below
1000 are not considered concentrated (Muth et al., 1999). Both these measures suggest low
concentration. As a result, in the absence of significant concentration, there appears to be a high
degree of rivalry which includes those members shown in Table 1.

However, this needs to be tempered by the fact that the overall dietary supplement market is
facing an increasing trend towards consolidation (Muth et al., 1999). Furthermore, the threat of
rivalry is positively influenced by a slow rate of industry growth whereby threat of rivalry
increases when a large number of rivals compete for a slow or declining market (Barney, 2003;
Porter, 1980).

The herbal supplement market, however, does not appear to be experiencing slow growth. In
fact, according to Nutrition Business Journal (NBJ, 2010c), the total estimated sales for U.S.
herbal supplements in 2009 was $5.03 Billion and rose by 4.8% over the previous year
(Cavaliere et al, 2010; ABC, 2010; various NBJ sources).

8
Within herbal supplements, the growth in anti-inflammatory products in the treatment of joint
health is likely to increase (Cavaliere et al., 2010; Muth et al., 1999). This is because the U.S. not
only faces an aging population, but due to rising health care costs, there has been an increasing
awareness to seek alternative medicinal remedies in the treatment of joint related illnesses
(Cavaliere et al., 2010; Muth et al., 1999). As a result, due to the increasing rate of market
growth for joint related products, the market for Devil’s Claw is likely to be in an immature stage
of market development in which its potential for growth will likely mitigate the threat of direct
rivals for Devil’s Claw. Relative to other threats, threat of rivalry is not likely to be a key threat.

Threat of Entry

Threat of entry refers to the potential for new competitors to gain access to the market. Closely
related to the threat of rivalry, threat of entry deals with “potential” rivals who enter an industry
at a later date. Threats of new entrants are driven by the expected profits of an industry, which
are often determined by projected growth in the market (Barney, 2003; Porter, 1980). As a result,
the threat of rivalry and threat of entry are highly intertwined. Namely, the rate of industry
growth (i.e. threat of rivalry) in the nutraceutical / herbal supplement market is determined by the
expected profits that accrue from projected growth in the market (i.e. threat of entry).

Various industry reports have projected a growth in the herbal supplement market (Heller, 2011;
DaVanzo et al., 2009; Muth et al., various NBJ sources; Cavaliere et al., 2010). While such
growth is driven by various factors, Cavaliere et al., (2010) contends that “an article published in
Newsweek in Oct. 2009 noted that some stores selling vitamins, minerals, and supplements
benefitted from the recession due to some Americans exchanging bad and / or expensive habits
for healthier ones and from some Americans losing their health insurance and choosing
supplements over costly prescriptions” (see also Muth et al., 1999). Other studies (Davanzo et al.
2009) find that the herbal supplement market has been able to maintain itself at more than 1% of
total U.S. health expenditures. As health expenditures grow, the herbal supplement industry is
thereby likely to also grow.

Furthermore, while the U.S. – as well as other developed countries – faces a growing retirement
population, their quality of life and life expectancy has increased over prior generations.
According to the U.S. Census Bureau projections, the U.S. population is projected to increase to
392 million by 2050. A substantial increase in the number of older people will occur during the
2010 and 2030 period, after the first Baby Boomers turn 65 in 2011. In 2030, when all the baby
boomers will be 65 and older, nearly one in five U.S. residents is expected to be 65 and older.
This age group is projected to increase to 88.5 million in 2050, more than double the number in
2008 (38.7 million) (U.S. Census Bureau, 2008 National Population Projections). About 80
percent of seniors have at least one chronic health condition and 50 percent have at least two.
Arthritis is one of the leading causes of activity limitations among older people. As the U.S.
population ages, the number of people diagnosed with arthritis is projected to increase to 67
million in 2030 compared to 50 million now (CDC, 2011).

Basic improvement in the quality of life and advances in health care have resulted in more active
lifestyles (i.e. such as gardening, golfing, hiking etc.) and thus likely to further advance the
future demand for joint health products (Katz and Marshall, 2003; NBJ, 2011). Such problems of

9
joint health have been reported as an increasingly important health concern in developed
countries by the U.N. and WHO, and especially amongst an aging population (Woolf, 2000). The
demand for herbal supplements in their treatment of joint problem is thus likely to drive the
growth of this market. Given recessionary influences, an aging demographic and rising health
care costs, there is a general trend by consumers who, in their efforts to avoid costly doctor visits
and prescription drugs, seek natural alternatives (NBJ, 2009, 2010e).

While the projected growth in the market for nutraceutical / herbal supplements is a key driver of
this threat of entry, the relatively lower barriers to entry or low costs of entry reinforces this
threat. Because nutraceutical / herbal supplements face less stringent FDA regulations than that
of prescription drugs, potential manufacturers of herbal supplements do not have to incur the
additional costs associated with clinical trials. For instance, as a basis for comparison, the cost
associated with clinical trials in the FDA approval averages $800 million per drug (Powell et al.,
1996). Hence, potential entrants into the nutraceutical / herbal supplement market are thus not
likely to incur a high cost of entry. This is consistent with industry observations that contend
that, aside from manufacturing costs, most dietary supplement manufacturers do not incur
significant additional R&D outlays (see Muth et al, 1999). Furthermore, according to Muth et al.
(1999) there are over 1,000 supplement manufacturers, of which 16 have annual sales greater
than $100 million in sales, 38 have sales of $20-100 million and 996 supplement manufacturers
have less than $20 million in sales. This indicates dietary supplement manufacturing is not a
capital and scale intensive production process (Muth et al., 1999) and thus capital investments
are also not likely to be a barrier to entry.

Lastly, there are “contract” manufacturers, such as Nutricaps (www.nutricaplabs.com), who can
provide for such manufacturing services on a for-hire basis. Contract manufacturers circumvent
requirements for capital investments and thus overcome any remaining barriers to entering the
nutraceutical / herbal supplement market.
As the threat of entry is driven by the potential profits that accrue from projected market
growths, growth in the demand for nutraceutical / herbal supplements in the treatment of joint
related problems is likely to attract entry (see also Muth et al., 1999; see also NBJ, 2009) and can
subsequently increase the degree of rivalry in the Devil’s Claw market. For instance, if past
projections are any indications of future growth, the U.S. nutrition industry has grown at an
annual rate of approximately 7-9% between periods 2008 at a total market value of $101.8
billion (NBJ, 2009). Note that this is the nutrition industry broadly defined. As a result, while
the threat of direct rivalry does not reflect an “immediate” threat, the threat of potential entrants
can be a key threat to the future attractiveness of Devil’s Claw.

Threat of Substitutes

Threat of substitutes involves products that “approximately” serve the needs of consumers but in
way that slightly differs from that of direct rivals (Barney, 2003; Porter, 1980). Because
substitutes are closely related to the products produced by rivals, substitutes have the effect of
placing a “price ceiling” on what rivals can charge for their products and thus limit their profit
potential (Barney, 2003). Specifically, “relative price differences” between the pricing of the
rival product and that of the substitute product directly impact the threat of substitutes (Barney,
2003; Porter, 1980). Devil’s Claw products shown in Table 1 face two classes of substitutes. As

10
noted earlier, in the treatment of joint problems, the threat of substitutes consists of natural and
non-natural anti-inflammatory products. As glucosamine and chondroitin sulfate exhibit very
similar therapeutic properties to that of Devil’s Claw, joint products that employ these natural
ingredients reflect the closest natural substitute to Devil’s Claw.

In order to identify these natural substitutes, a Google product search was conducted to search
for products in the treatment of joint related problems that contain Glucosamine, Chondroitin
Sulfate and / or combinations thereof –which may also include anti-inflammatory ingredients
such as MSM. Through this search, there are at least 7,500 product listings that draw on these
active ingredients either individually or in their combination in capsule, powder, liquid or juice
forms. To confine this space of natural substitutes, we limited substitutes to only the “most
popular brands” found in Google product search. The listing of companies and the number of
natural substitute products that contain Glucosamine, Chondroitin Sulfate and or combinations is
in Table 2. Although these do not reflect an exhaustive list, they are nevertheless ranked by
Google as the most popular.

Table 2 shows that there is much variation in the form (i.e. capsule, power, liquid or juice, or
creams) and prices of these natural substitutes. Because of the great number of natural substitutes
as well as variation in product forms and prices, the threat of substitutes in acting as a “price
ceiling” is difficult to assess. Nevertheless, due to the great number of substitutes and their
associated price ranges, it is very likely that the natural substitute market poses a significant
threat to Devil’s Claw. For instance, in comparing products, the price of Glucosamine products
from a retailer called Now Foods (60 capsules of Glucosamine at 1000 mg for $6.15), while a
Devil’s Claw product sold by the same retailer is 100 capsules for $6.99 at retail. While there is
further work that might be done to make the comparison more direct, by factoring in differences
in dosage requirements, the price differences between natural substitutes and Devil’s Claw
products do not appear to be large. Thus, the natural substitutes are likely placing a very
significant limit on a rival firm’s ability to exert price increases in Devil’s Claw products.
Furthermore, although the total demand for Devil’s Claw supplements is not known, the
percentage of consumers using Glucosamine / Chondroitin constitutes 21% of the U.S.
supplement market or $803 million in sales for 2009 (NBJ, 2010e). This size of the market
supports many natural substitute products in the treatment of joint health (see table 2) which
increases the likelihood that any one of these products might place a price ceiling on the charges
by rival producers of Devil’s Claw.
Moreover, NSAIDs are the most commonly used anti-inflammatory in the treatment of joint and
arthritic pain. Table 3 shows the threat of this class of non-natural substitutes to Devil’s Claw
products. Table 3 shows a listing (not a complete listing) of Over the Counter and Prescription
based Non-steroidal Anti-inflammatory drugs.
As NSAID can yield adverse health effects, such as gastric bleeding, these non-natural drugs are
secondary or more distant substitutes to Devil's Claw, relative to the natural counterparts.
Nevertheless, as non-prescription based NSAID tends to be competitively priced, especially
generic brands of aspirin, there is not likely to be a large relative price difference between
Devil’s Claw and aspirin or other generic analgesics. For instance, Wal-Mart’s house brand,
Equate, retails a 300 count bottle of generic aspirin for $3.94. While in comparison (table 1), the
lowest price product for Devil’s Claw from Puritan’s Pride retails for $3.99 for 50 capsules. In

11
conjunction with the other NSAIDs, these substitutes are likely to exert a strong price ceiling on
Devil’s Claw products and thus present a high threat of substitutes.

Threat of Supplier Power

Threat of supplier power refers to the ability of suppliers in a value chain to raise prices and / or
reduce the quality of raw materials provided to input purchasing firms (Barney, 2003; Porter
1980). Threat of supplier power is commonly an issue in concentrated markets in which a small
number of suppliers can raise input prices to (manufacturers) and thus reduce the profits
available to the manufacturer. In the nutraceutical / herbal supplement market, supplier
concentration is not a significant threat. According to the Nutrition Business Journal, agents in
the nutraceutical / herbal supplement market consist of over 300+ suppliers, 100+ brokers /
distributors and 1000+ growers, harvesters, refiners and extractors2 (see DaVanzo et al. 2009).
This lack of concentration in the supplier market is also consistent with Muth et al. earlier study
(1999) where the supplying stages of the nutraceutical / herbal supplement market is
characterized as highly fragmented. For instance, Muth et al. (1999) study found that there were
over 150 herb and botanical suppliers in which 127 had less than $5 million in sales, 15 with $5-
20 million in sales, and 8 with sales of greater than $20 million. Although these studies do not
provide a direct indication of the degree of supplier concentration in the U.S. supply chain of
Devil’s Claw, it nevertheless characterizes a structure that likely is typical in the U.S. today.

Further, many foreign suppliers of Devil’s Claw exist. For instance, according to an online raw
ingredient sourcing site (www.alibaba.com), there are 447 Chinese Manufacturing / trading
companies involved in the raw supply of Devil’s Claw, such as, Shaanxi Undersun Biomedtech
Co., followed by 15 in South Africa, such as Global Fusion Trading CC. Thus, while supplies of
Devil’s Claw from China – and also India- remain generally limited, they have strong scale and
distributional advantages that can pose a significant challenge to those Namibia suppliers who
seek further value add processing. That is, because Namibian suppliers of Devil’s Claw may also
include post harvesting activities involving drying, slicing and other value added processing and
distribution activities (see section on Value Chain Analysis and Market Entry), Namibian
suppliers thereby need to also contend with Chinese manufactures/ trading companies as another
potential source of supply for the U.S. market As there are a great number of suppliers available
from these exporting countries, supplier prices tend to be highly competitive (see
www.alibaba.com). For instance, according to www.alibaba.com, suppliers appear to market
their supplies of Devil’s Claw largely in terms of their competitive pricing as well as a minimum
order purchase. This suggests scale economies are driving pricing and thus such competitive
pricing is not likely to limit the performance of purchasers that rely on procurement of Devil’s
Claw for processing operations. Furthermore, with respect to Namibia market, supplier
production remains generally fragmented. While there are current efforts to organize suppliers
(24 organized producer groups), they constitute 10-20% of the total market. This suggests while
efforts to organize production will eventually lead to a greater supplier power, suppliers currently
face a generally fragmented market.

2
Total combined sales of these suppliers amount to $2.8 billion.

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However, in light of such competitive conditions, there appear to be some suppliers who have
differentiated their Devil’s Claw supply in terms of quality by the percentage of harpagoside.
Specifically, the therapeutic properties of Devil’s Claw stem from Iridroid glycosides – that
include four categories of harpagoside, harpagide, procumbide and procumboside (Hsun-Wei
Huang et al, 2006) –, acetylated phenolic glycosides, and terpenoid (Fiebich et al., 2001; Hsun-
Wei Huang et al., 2006). The anti-inflammatory and pain relief properties of Devil’s Claw have
been specifically attributed to the percentage of harposide. Hence, while there is not generally a
threat of supplier power, suppliers that differentiate on this therapeutic attribute can command a
greater raw ingredient price and as a result can negatively impact a company that procures
Devil’s Claw raw materials.
In the United States, there is another plant known as Devil’s Claw (proboscidea parviflora
[Woot.] Woot. & Standl). It is found in southwestern United States and northern Mexico. It
shares the common name, Devil’s Claw, with the Namibian variety (harpogophytum
procumbens DeCandolle [Pedaliaceae]), but little else. The Claws of the U.S. variety are split
and used by southwestern Native Americans in basket designs. There is limited small market
distribution of the Claws. The seeds are available at sites such as Native Seeds in Tucson, AZ.
The seeds and the pods are eaten occasionally within some Native American communities. Some
health stores in the southwest sell the African variety as a natural product, so it appears that
consumers can differentiate between the two plants and thus there is not a threat from the US-
grown variety which is mainly known for its use in basketry.

Threat of Buyer Power

Threat of buyer power refers to customers who purchase a rival firm’s products and services
(Barney, 2003). Buyers can be end consumers or adjacent consumers in a value chain, such as
retailers. Like the threat of supplier power, the threat of buyer power is impacted by the degree
of market concentration. The threat of buyer power stems from the buyer / retailer’s ability to
reduce a selling firm’s product price. In the context of Devil’s Claw, buyers consist of online and
mainstream retailers (see distributors listed in Table 1). These buyers operate in a competitive
market. For instance, in the U.S., there are over 1,800 direct distributors that not only include
internet retailers, but also include direct marketers selling via television and mail order channels
(DaVanzo et al., 2009).

Since Devil’s Claw does not require any specialized form of distribution, there are many possible
retail outlets and thus sellers face a variety of options in the online retail market. This reduces the
threat of buyer power. However in terms of mass market modes of retail distribution (i.e.
Walmart, Walgreens, GNC), there is a trend towards increasing consolidation and thus
concentration (Muth et al., 1999 who sources from the Nutrition Business Journal, see also NBJ,
2010c). This concentration yields a greater ability by these retailers / buyers to leverage their
volume purchasing in depressing prices that can be charged by Devil’s Claw manufacturers. This
suggests that the distribution of Devil’s Claw to mass market retailers will likely need to contend
with the price pressures of an increasingly concentrated buyer / retail supply stage (see also Muth
et al., 1999).

Furthermore, the threat of buyer power also stems from a lack of product differentiation (Barney,
2003; Porter, 1980). Namely, when buyers / retailers face products that are highly standardized,

13
buyers face a greater number of alternatives which forces selling firms to reduce their prices and
profits. In the case of the human nutraceutical / dietary market, Muth et al., (1999) finds that
many supplements “are more commodity like and there is little variation among different
manufacturers of the product” (p. 5-16). This appears to be also the case for Devil’s Claw. For
instance, Table 1 shows that Devil’s Claw is not marketed with any discernible traits and pricing
appears generally to be competitive. Yet, clinical studies have shown that Devil’s Claw’s anti-
inflammatory and pain relieving (analgesic) properties stem from the key active ingredients:
harpagoside and harpagide (Hsun-Wei Huang et al., 2006). Close examination of the branding of
products produced by those rivals in Table 1 show that none of these products are differentiated
on any of these active components. As a result, while both the online and mainstream retail
segments appear to be generally competitive, this lack of product differentiation and an
upcoming trend towards consolidation, especially in mainstream retailing, suggests these factors
can pose a pending threat of buyer power.

Animal Nutraceutical / Herbal Supplement Market Forces

In addition to human nutraceutical / herbal supplement market, Porter’s five forces is also used to
examine the competitive landscape and value chain for Devil’s Claw in the animal market that is
comprised of equine, canine and feline. A five forces analysis is conducted on these three pet
groups as a whole because some of these pet groups, such as feline, are too small to merit a
separate analysis. Furthermore, industry trade reports have defined the animal nutritional / herbal
supplement industry to consist of these three types of pets, thus justifying their aggregation. In
describing this animal market, the Packaged Facts industry report indicates that the U.S. retail
sales of pet supplements and nutraceutical treats amounts to $2.1 billion in 2007 of which
supplements accounted for 45% of sales (Cavaliere, 2009). The majority of pet supplements
(51%) are purchased for horses, while dog supplements represent 38% of the market and cat
supplements at 6% (Cavaliere, 2009). Although we do not conduct a five forces analysis for each
pet group, the five forces analysis will point out features salient to each of these animal sub
markets.

It is important to note that the competitive landscape of this market bears many strong parallels
to the human nutrition / herbal supplement market. This is because the demands for pet
supplements, especially that pertaining to joint health, mimic that of the human nutraceutical /
herbal supplement market (PFI, 2010; PFI, 2011e, PFI, 2011d). In fact, according to the Pet Food
Industry report, the demand for pet supplements is only 3 months behind that of human
nutraceutical food trends (PFI, 2011e) and “the cycle keeps getting shorter as pets are treated
more and more like human family members” (PFI, 2011e). Namely, as pets are increasingly
treated as an extended family member, especially amongst an aging demographic, pet owners are
treating their pet’s joint health in ways similar to their own (PFI, 2010b).
Furthermore, much like the rising health care costs faced in the human nutraceutical / herbal
supplement market, rising veterinarian health care costs have prompted greater interest in
seeking natural and holistic alternatives (PFI, 2011b; PFI, 2010). Lastly, there is an increasing
perception amongst pet owners that natural ingredients are viewed as safer alternatives to
pharmaceutical drugs, especially that of NSAID (PFI, 2011b, PFI, 2010; PFI, 2011c; McGregor
et al., 2005).

14
Threat of Rivalry

Threat of Rivalry is defined by veterinary manufacturing firms who produce an anti-


inflammatory product that directly employs Devil’s Claw as an active ingredient for the
treatment of joint related problems (i.e. reduction of inflammation of joints and pain relief) in
animals. In following the Google product search procedure described earlier, this definition was
used to search for rival manufacturing firms of Devil’s Claw. Like the human nutrition / herbal
supplement market, the use of this Google Product search procedure is justified by industry
survey data. Packaged Facts survey data indicate that internet sales of pet supplement products
continue to outpace pet market growth whereby close to half of pet owners use the internet to
research products on line (PFI, 2011c). Hence, as Google product search serves to identify the
most popular Devil’s Claw products, this search will also indicate those products that are most
likely to be in direct competition. Hence, in adapting our Google search procedure for the animal
nutraceutical / herbal supplement market, Table 5 shows a listing of veterinarian manufacturers
that satisfy this study’s definition of rivalry. Specifically, when conducting this search for each
animal category, we only include unique brand product-company listings in which brands that
have multiple SKU involving different size formulations or different products forms (i.e.
powders, liquid forms) are not included. Much like the human nutraceutical / herbal supplement
market, this was done to focus on rivalry that is based on brand-company pairings rather than
rivalry from SKU basis. Table 5 outlines the competitive characteristics of direct rivals for
veterinarian manufacturers of Devil’s Claws products by animal subclass.

Similar to the human nutraceutical / herbal supplement market, there are a number of direct
rivals that offer Devil’s Claw products in the treatment of joint related problems for animals.
With respect to the sub-animal markets, there is significantly greater rivalry in the use of Devil’s
Claw in the horse sub market than that of the canine and feline market. This is not surprising as
51% of the animal supplement market is consumed by horses.
Yet, as the threat of rivalry would be intensified under a slow-growth environment, the animal
nutraceutical / herbal supplement market as a whole is growing fairly well. For instance,
according to the Nutritional Business Journal, although the animal nutrition industry only makes
up about 6% of the entire US $ 45 billion pet industry, within that small nutrition sector, pet
supplements make up 50% of all products (PFI, 2010). This amounts to a $1.35 billion market in
2008 that is projected to grow to under $2 billion by 2013 (PFI, 2010). Despite recessional
influences, there has been a steady 5% growth in sales in the pet segment from 2007 to 2011.
The “top segments are “joint / senior and skin /coat with weight related products are also picking
up steam” (PFI, 2010, PFI, 2011d). A 5% annual sales growth is also expected from the period
2011-2013 (PFI, 2010).
As joint related health problems reflect important segments of growth in the pet supplement
market, such growth is likely to mitigate the greater degree of rivalry in the horse sub segment.
Furthermore, given the limited number of direct rivals in the canine and feline sub markets, the
overall growth in this market for joint care products will further reduce any threat of direct rivals
in these sub markets. Hence, like the threat of rivalry in the human nutraceutical / herbal
supplement market, the growth in this industry segment, especially on animal products relating
to joint health, renders the threat of direct rivals to be limited.

15
Threat of Entry

The threat of entry is, however, a significant threat. Like the human nutraceutical / herbal
supplement market, the threat of entry into the animal market is dependent upon its expected
profits. Specifically, as the growth of the animal nutraceutical / herbal market is in part an
extension of the health and wellness preferences of pet owners, the expected profits of this
industry are influenced by the growth dynamics of the human nutraceutical / dietary supplement
market (see PFI, 2010; PFI, 2011a). Taylor notes, “nutritional supplements for pets have become
a fast growth business, as pet owners seek out health products for the cute companions that
mimic those they use for themselves” (PFI, 2010). Within the pet supplement market, the
majority of pet supplements (51%) are purchased for horse, while dog supplements represent
38% of the market and cat supplements at 6% (Cavaliere, 2009). Pet supplements as whole are
expected to grow at an annual sales rate of 5% for the period 2011-2013 (PFI, 2010). In
particular as the top segments for growth in the animal nutrition / herbal supplements market is
involved with “joint / senior” related products (PFI, 2011a), such potential growth is likely to
motivate future entry. Although generally speaking there is a threat of new entry in the animal
nutraceutical / herbal supplement market, there are nevertheless some animal specific
considerations.

Equine

The projected growth in the equine market has been reported at 2.2% for periods between 2011-
16 (McBee, 2011). The equine market thereby faces an overall lower rate of growth than the
overall pet supplement market (5%) (PFI, 2010; see also Heller, 2010) and thus faces a smaller
threat of entry. Specifically, although racing horse and the closely associated thoroughbred breed
markets constitute less than 20% of the overall equine market, revenue in this market is primarily
driven by the demand for race horses (McBee, 2011). As gambling for racehorses is projected to
recover from recessionary periods, the demand for race horses is expected to grow (McBee,
2011) and as a consequence the demand for the treatment of joint related problems is likely to
improve. However, since Devil’s Claw is a banned substance in horse racing (Williams, 2009),
the use of Devil’s Claw to capture such growth opportunities in racing horses that include
breeding mares, and thoroughbred foals and stallions and show horses will not be possible. This
legal restraint suggests that there are high barriers to entry.
Horses used for recreational and utility (i.e. farming) purposes are generally owned by a large
number of small family owned operations (McBee, 2011). They face considerably smaller
returns than that of their racing counterparts and thus the rate of market growth for the treatment
of joint related problems in this equine market is likely to be smaller than that of the racing
market. In particular, as the manufacture of Devil’s Claw products does not appear to involve
capital intensive technologies and face relatively few regulatory restrictions, these factors lower
the barriers to entry in this market. When coupling the lower barriers to entry with the relatively
limited growth opportunities of the recreational and utility market for horses, these entry
conditions can only support a few entrants. Hence, the threat of entry by just a few players can
lead to over supply conditions that can significantly reduce the expected profitability of the
Devil’s Claw market for horses.

16
Canine and Feline

With respect to the threat of entry in the canine / feline animal submarkets, the opportunities are
closely tied to pet ownership rates (PFI, 2011e). Historically, dog and cat ownership in the USA
had experienced significant growth and has impacted the growth of the herbal supplement
market, especially the types of products for joint health (PFI, 2011a). Approximately 50% of
U.S. households in 2010 have owned a dog or cat. Ownership rates for dogs or cats tend to vary
by age and race. For instance, ownership rates for 35-54 age group is 59%, while seniors (65+)
have a lower ownership rate of 46% (PFI, 2011f). In terms of race, white non-Hispanic
households have an ownership rate of 58% where as it is 40% for Hispanics, 20% for Blacks and
23% for Asians (PFI, 2011f). Growth in minority pet ownership, especially Hispanics, has been
argued as an untapped source of market opportunity. This is because according to the U.S.
Census Bureau, Hispanics are expected to account for 52% of U.S. population growth from 2010
to 2015 and by 2050 will likely account for one third of the US population (PFI, 2011f). Based
on these demographic projections, the threat of entry is likely to increase because increases in pet
ownership by the growing Hispanic population will place greater demand for joint health
products, such as that of Devil’s Claw.

Furthermore, there are generally low barriers to entry in the manufacture of herbal supplements
not only because the manufacture of supplements does not require capital intensive technologies
but also because there are options to coordinate with “contract” manufacturers (e.g. Nutricaps).
Contract manufacturers can process and package raw ingredients, such as Devil’s Claw, into
various forms – tablet compression, tablet coating, powder blending, encapsulation, bottling,
powder filling and blister packaging that meet certain safety requirements. Out sourcing to
companies, such as Nutricaps (www.nutricaplabs.com), in the production of Devil’s Claw can be
achieved for the various animal sub categories as well as that of the human market (Personal
communications to Andrew at Nutricaps). Such outsourcing activities can thereby lower the
barriers to entry in these markets, while also meeting Good Manufacturing Practices (GMP)
certification requirements (Nutricaps is GMP certified).

Outsourcing to such certified manufacturers is an important means to overcoming the entry


barrier that results from the ambiguous regulation of supplements for pets. Namely, due to the
general ambiguity involved in FDA regulation of pet supplements, the industry established a
National Animal Supplement Council (NASC) to ensure that pet supplement manufacturers
conform to strict quality standards; standards that are often higher than their human counterparts
(Cavaliere, 2009). NASC certification requires that manufacturers produce pet dietary
supplements in accordance to good manufacturing practices (GMPs) that involve high quality
control standards (Cavaliere, 2009). Hence, sourcing from contract manufacturers such as
Nutricap not only overcomes the capital investments required in the manufacture of Devil’s
Claw products but also regulatory based barriers to entry. As a result, there is a significant threat
of new entry to the pet market for Devil's Claw.

Threat of Substitutes

The threat of substitutes in the animal market for Devil’s Claw also involves both natural and
non-natural substitutes. Similar to that of the human nutraceutical / herbal supplement market,

17
Glucosamine and Chondroitin Sulfate and MSM or their combination are the most popular
natural substitutes in the treatment of joint related problems in the animal market (PFI, 2010; PFI
2011a). As online sales of animal supplement tend to lead mainstream retailing (PFI, 2011c), a
listing of searched products from Google product search was used to identify natural substitutes
to Devil’s Claw. The search terms “Glucosamine, Chondroitin Sulfate and / or MSM” and “joint
health” are search with the descriptors equine, canine, and / or feline. By animal sub category,
Table 6 a, b and c identifies the threat of substitutes facing Devil’s Claw. Although this is not a
comprehensive listing of all available natural substitutes, there are nevertheless a great number of
substitute products for animal joint health care, especially when compared with that of threat of
rivalry.

Furthermore, as pet food manufacturers address the all-important issue of palatability,


nutraceutical and functional ingredients are appearing in toppers, gravies, foods and treats (PFI,
2010). There are some recent indications that the development of these products is likely to
further the threat of substitutes to Devil’s Claw. For instance, MARS, a leading manufacturer of
pet food, in 2010 introduced “Pedigree Healthy Joints” that contain Glucosamine and
Chondroitin (PFI, 2011a). Similarly, Del Monte’s “Every Day Health Snacks” has been extended
to include “Hip and Joint Crunchy Bits” that include Glucosamine and Chondroitin (PFI, 2011a).
While it is difficult to accurately assess the price ceiling effects of these varied substitutes, there
are an overall great number of natural substitutes in all animal submarkets. Some of these natural
substitutes shown in Table 6 a, b, and c appear to be competitively priced to those Devil’s Claw
product prices shown in Table 5. Hence, like the human nutraceutical / herbal supplement
market, the great number of natural substitutes on the market can exert a significant price
constraint on manufacturer’s ability to raise prices for their Devil’s Claw products.
Threat of non-natural substitutes is also an additional challenge to veterinarian manufacturers of
Devil’s Claw. Non-natural substitutes consist of anti-arthritic agents, Nonsteroidal Drugs
(NSAID), and Steroidal drugs. Table 7 a, b, and c 3 provides a listing of these non-natural
substitute products by animal sub-class. There are a great number of such non-natural substitutes,
especially NSAIDs--there are 180 NSAID products (Bayer, 2009). Because of this great number
of substitutes, we did not list the prices for these varied products. Table 8 however summarizes
this listing of products by animal sub class. Hence, although prices are not listed by the non-
natural substitutes, the great number of these non-natural substitutes especially NSAIDs in the
equine market are likely to further the threat of substitutes to manufacturers of Devil’s Claw.

Threat of Supplier Power

The threat of supplier power in the animal nutraceutical / herbal supplement market parallels the
situation in the human market. Namely, there does not appear to be any significant distinction
made as to the concentration, form, or other attributes of the raw root. This is because both are
largely emergent or immature markets and thus buyers do not require suppliers to develop inputs
that are specialized to the demands in each of these markets. Manufacturers of Devil’s Claw
containing products for animals are likely to face a minimal supplier threat. However, as the
animal nutraceutical / herbal supplement market can be perceived as receiving less enforcement
of regulations, there has been increasing concern by consumers about misleading claims in the

3
Compendium of Veterinary Products handbook (11th edition)

18
pet supplement market (Cavaliere, 2009). For instance according to the Nutrition Business
journal survey, 74% of respondents identified that current regulation of pet supplements needed
improvement and that pet supplement products have been marketed with misleading claims or
claims that lack scientific merit (PFI, 2010). Hence, as a means to signaling quality attributes that
are not governed by FDA, suppliers of Devil’s Claw for animal feeds or pet supplements which
are able to differentiate on the active ingredient (percentage of harpagoside) may attain some
advantages.

Threat of Buyer Power

Threat of buyer power is similar to that of the human market in which it is primarily influenced
by online retailers and mass merchandisers. Like the human nutritional / herbal market, animal
supplements are primarily sold online through a number of internet based distributors (see Table
5 for list of buyers / online retailers). Based on our Google’ product search, Table 5 shows the
list of buyer/ distributors. Furthermore, in conducting a separate search of Devil’s Claw products
listed by most popular brand, the most commonly listed animal supplement retailers of Devil’s
Claw products by Google Product search also include the following buyers / online retailers:
Valley Vet Supply, Horse.com, and Equestrian collections, Ranch Division, KV Supply,
Ablackhorse, All American Saddles and Smart Pak4. While some of these online retailers clearly
have a specific focus to the equine supplement market, such as Equine Collections, there are
other online retailers that also focus on herbal supplements for dogs and cats, such as Valley Vet
and KV Supply. Overall there appears to be generally large numbers of retail buyers / retailers of
Devil’s Claw for the horse market. Furthermore, online retailers tend to source from multiple
manufacturers. For instance, one of the more popular online distributors is Valley Vet which
retails three Equine Devil’s Claw product brands: DC-Y, FM Solution, and B-L. Hence, while
there are generally a number of buyer / retailers, buyers can source products from multiple
manufacturers. This increases the threat of buyer power because manufactures not only have
fewer alternatives to retailing their products, but also the buyers can engage manufacturers to
compete on price and thus reducing their profits.
Furthermore, unlike the human nutraceutical / herbal supplement market, pet supplements are
sold through veterinarians (McBee, 2011). Although the number of veterinarian providers in the
U.S. can be generalized as competitive, veterinarians are likely to exert considerable buyer
power over manufacturers because veterinarians tend to develop long-term relationships with pet
owners (equine, canine and feline). These relationships build a pet owner’s trust in the medical
expertise of the veterinarian and thus are likely to be highly influenced by veterinarian
recommendations. Such relationships not only yield a power or influence over their owners but
subsequently that of the manufacturers of the Devil’s Claw product. In particular, as the clinical
studies in the treatment of joint health by Devil’s Claw remains generally uncertain, a
veterinarian’s experience and subsequent recommendation of Devil’s Claw can have a
significant influence on pet owners’ decision to purchase these products. Thus in the absence of

4
Readers should note that Devil’s Claw products are also retailed by non-animal retailers such as Amazon, Newegg,
and Sears. We however did not include them because these retailers distribute Devil’s Claw product through third
party distributors and thus are not direct distributors of the product. These retailers would thus not directly affect the
threat of buyer power.

19
further clinical studies in this area, veterinarians are likely to exert significant buyer power over
Devil’s Claw manufacturers.

CONCLUSION on COMPETITIVE LANDSCAPE

As one of the objectives of this study is to conduct an analysis of the competitive landscape and
value chain of Devil’s Claw, the major highlights and implications of this analysis are
summarized. Porter’s five forces framework was used to assess the competitive landscape and
value chain of Devil’s Claw for the human and animal nutraceutical / herbal supplement market.
Porter’s five forces (see Figure 1), underscores that the attractiveness or profitability of an
industry is determined by five threats in which each of these threats have unique factors that
reduce industry profitability. Porter five forces are suited to not only assessing the competitive
landscape and value chain of Devil’s Claw, but it is also useful in determining the attractiveness
of entry into human and animal nutraceutical / herbal supplement markets in the U.S. While
there are important distinctions between these markets, a general conclusion from this five forces
analysis is that the threats facing both human and animal markets are closely intertwined. This is
because the use of Devil’s Claw in both markets draws on a common set of therapeutic benefits.
In particular, various clinical studies indicated that Devil’s Claw exhibits pain killing and anti-
inflammatory properties (Williams, 2009; Fiebich et al., 2001; Hsun-Wei Huang et al., 2006). In
the human nutraceutical / herbal supplement market, Devil’s Claw has been found to not only
reduce pain from muscular skeletal problems, but also reduce the inflammation of joints from
osteo and rheumatic arthritis (Fiebich et al., 2001; Williams, 2009; Katerere and Naidoo, 2010;
Chrubasik et al., 1996; McGregor et al., 2005). These therapeutic findings have been
subsequently used in justifying the use of Devil’s Claw in the animal nutraceutical / herbal
supplement market, such as equine, canine and feline animal populations (e.g. Cavaliere, 2009;
Katerere and Naidoo, 2010). Because both markets draw on these therapeutic properties, both the
human and animal market shares similar threats.

Threat of Substitutes

Both markets not only leverage the therapeutic properties of Devil’s Claw, but these markets also
face a common set of substitute products that offer similar therapeutic benefits. Namely, while,
Devil’s Claw has been found to exhibit anti-inflammatory properties and also suggested as a
potential treatment to joint related problems (i.e. arthritis), both human and animal markets face
a similar set of natural as well as non-natural substitutes. Natural substitutes involve anti-
inflammatory / joint care products that use Glucosamine / Chondroitin Sulfate / and MSM. These
natural products present a significant threat of substitutes. There is large number of available
substitutes that utilize these active ingredients in various forms, such as capsules, power, and
liquid and or juices. While, the large number of such natural substitutes is not a sufficient
indicator of a substitute threat, they nevertheless increase the likelihood that each of these
substitute products can be competitively priced to that of a comparable Devil’s Claw product.
Similar observations were also made of the animal nutraceutical / herbal supplement market.
With respect to non-natural substitutes that include anti-arthritic agents, Nonsteroidal Drugs

20
(NSAID), and Steroidal drugs, NSAID are the most common non-natural substitute (see also
PFI, 2011c; McGregor et al., 2005). Although NSAID are generally an effective anti-
inflammatory as well as a pain reducer, it has adverse health effects that involve gastric bleeding.
Nevertheless in spite of such adverse health effects, there are also a greater number of substitutes
that are competitive priced to Devil’s Claw products. As a result, the threat of substitutes is likely
to significantly constrain the ability to command premium prices for a Devil’s Claw product.

Threat of Rivalry

Both human and animal markets also share a similar competitive structure of direct rivals.
Namely, the number of companies that directly manufacture Devil’s Claw for the treatment of
joint health problems in the U.S. human and animal markets remain generally limited. This is
because unlike European markets, Devil’s Claw in the U.S. market is immature and thus, there is
generally a limited number of manufacturers of Devil’s Claw, especially that of the animal
market. Hence, direct competition or rivalry in the human and animal markets is not a significant
immediate threat. Furthermore, because the demand for joint related health care products reflect
an emerging segment of growth, growth in demand for such products – in both human and
animal markets- (e.g. NBJ, 2010e, PFI, 2011b, PFI, 2011d) further mitigates the direct rivalry of
Devil’s Claw products.

Threat of Entry

The threat of entry, while closely related to the threat of rivalry, is however a significant threat.
The threat of entry is driven by expected profits from producing anti-inflammatory supplements
that aid in joint health. Specifically, the growth of the animal nutraceutical / herbal industry is in
part an extension of the health and wellness preferences of and has similar growth dynamics as
that of the human nutraceutical / herbal supplement market (see PFI, 2010; PFI, Feb, 2011a;
Woolf, 2000; NBJ, 2011). For instance, in the human market, problems of joint health have been
reported as an increasingly important health concern in developed countries and especially
amongst an aging population. Such health concerns appear to be translated to the animal
nutraceutical / herbal supplement market. Moreover, as both human and animal nutritional /
herbal supplement markets face less FDA regulation – relative to that of drugs- there are
relatively few regulatory barriers. The costs of entering the industry in the manufacture of
Devil’s Claw products are not significant because they can be outsourced contract
manufacturers. Hence, with growth in the human and animal market and coupled with low entry
costs, risk of entry is a significant threat to the profitability of Devil’s Claw products in these
markets.

Threat of Buyer Power

The analysis of the threat of buyer power in both markets is a pending concern. Specifically, a
significant amount of the sales – upwards of 50% – of human and animal nutraceutical / herbal
supplements is distributed through online retail sites. Buyers, as online retailers, operate in a

21
highly competitive market environment, especially that of the human market. For instance, there
are 1800 direct distributors that include internet retailers and direct mail order that are involved
in sale of nutraceutical related products (DaVanzo et al. 2009). In the absence of a concentrated
buyer market, Devil’s Claw manufactures are less vulnerable to buyer demands in reducing their
pricing. While the human market generally faces a greater degree of competition, the animal
market faces significantly fewer distributors (10+ online distributors). Furthermore, in both
human and animal markets, online distributors tend to carry multiple Devil’s Claw products from
different manufacturers. For instance, one of the more popular online distributors is Valley Vet
who retails three Equine Devil’s Claw product brands: DC-Y, FM Solution, and B-L. This
increases the threat of buyer power because online retailers can engage multiple manufacturers to
compete on price and thus reduce manufacturer profits. There also appears to be an increasing
trend toward consolidation which increases buyer power because manufacturers face fewer
alternatives and thus can be captive to the price demands of their retailers.

Threat of Supplier Power

With respect to upstream threats to the manufacture of Devil’s Claw products, the threat of
supplier power in the animal nutraceutical / dietary supplement market parallels that of the
supplier power in the human market. Namely, there does not appear to be any significant
distinction in the quality of raw supplies of Devil’s Claw for either of these markets. This is
because both are largely emergent or immature markets and thus do not require suppliers that are
specialized to the demands to each of these markets. In that, there does not appear to be any
significant distinction in terms of the active ingredient -% of harpagoside- in the sourcing of raw
/ unprocessed suppliers Devil’s Claw (see www.alibaba.com) for either of these markets. In the
absence of any significant distinction in this “quality” aspect of Devil’s Claw, the supplier
market appears to be competitive. Hence, as a manufacturer of Devil’s Claw, the competitive
nature of this supplier market is not likely to be a source of threat as supplies can be sourced at
competitive prices. Furthermore, given that MCC Namibia is likely to source from their local
sources in the manufacture of a Devil’s Claw product, such threats of supplier power are not
likely to be a significant concern in either the human or animal markets.

Mitigating Key Threats

As one of the goals of this study is to determine a course of action that would enable successful
entry into the U.S. nutraceutical / herbal supplement market, success depends on mitigating the
identified threats outlined by the five forces analysis.

Threat of Substitutes

Differentiation is a common means to mitigate the threat of substitutes (Barney, 2003; Porter,
1980). As the therapeutic benefits of Devil’s Claw remains generally unclear, especially in the
animal market, differentiation through investments in clinical studies on Devil’s Claw’s
therapeutic properties is one means to mitigate threats from natural and non-natural substitutes.

22
Such investment should focus on clinical trials that examine the relative effectiveness of Devil’s
Claw as an anti-inflammatory to the treatment of joint health problems, compared directly to its
natural and non-natural substitutes. To our knowledge there remain few if any clinical studies
that have conducted such clinical comparisons. While the threat of rivalry was not identified as a
significant threat, differentiating efforts to neutralize the threat of substitutes will also serve to
develop a unique position relative to existing and potential rivals in this market.

Threat of Entry

Due to the potential growth in the market for joint care products and given relatively low entry
barriers, threat of entry is a significant factor that can affect the future returns in the Devil’s Claw
product-market. Such threats of entry are typically mitigated by creating entry barriers through
various means (Barney, 2003; Porter 1980). Investments in research and development, such as
investments in clinical trials on the therapeutic effectiveness of Devil’s Claw, is one means
because such investments serve to not only develop a differentiating trait that mitigates threats of
substitutes and to a lesser extent rivalry. But such investments can subsequently yield a greater
ability to exert a price premium over new entrants who do not commit to such investments.

Yet, since natural products face considerable legal challenges in the protection of property rights,
such investments in research need to account for this fact. Other means of creating an entry
barrier may thus require early entrant strategies. Early entry strategies are particularly suited for
entry into emergent markets in which early entry yields an accumulation of learning experiences
that reduce costs. For instance, early entry into the manufacturing of Devil’s Claw products – as
opposed to contract manufacturing- can yield learning curve economies that enable market
penetration through a low margin-high volume strategy. Currently, the market of manufacturers
(i.e. direct rivals) appears to be fragmented which suggests possibilities to exploiting untapped
scale and related learning curve advantages. However, such an entry strategy would require
significant capital investments. To limit the risky investments an alternative is a staged entry
strategy in which “contract manufacturing” is first sought. After uncertainties in the therapeutic
benefits of Devil’s Claw and market acceptance by distributors have been resolved, investment
in a manufacturing facility should then be considered.

Threat of Buyer Power

Threat of buyer power is the remaining threat to the viability of a Devil’s Claw product.
Although online distribution of nutraceutical / herbal supplements is generally competitive,
online vendors possess considerable market power, because they source from multiple
manufacturers. One means to mitigate such market power is to leverage strategies used in
mitigating the threat of substitutes. Efforts to differentiate Devil’s Claw through either clinical
trials and / or production through certified means, such as contracting to manufacturers that are
NASC certified, can serve to mitigate such buyer power. Such differentiation efforts reduce
Devil’s Claw’s “commodity like” status and thus provide Devil’s Claw manufacturers an
improved bargaining position.

While both the human and animal nutraceutical / herbal supplement markets have their own
distinctions, they nevertheless share these common threats and thus the above strategies can be

23
applied to either of these markets. However, decisions in regards to entry in either of these
markets depend on the extent to which these mitigating strategies can be implemented.
Nevertheless, when all factors are considered equal, we recommend that if entry is pursued, the
following pattern of entry be considered:

1) Although each of the above threats tends to be more acute in the human nutraceutical /
herbal supplement market than that of the animal market, growing and aging
demographic and basic changes in health care are likely to yield greater growth prospects
for humans relative to the animal market. Hence, entry into the human market that
emphasizes any one or all of the above mitigating strategies would be recommended.
Specifically, a differentiating focus that clinically supports the anti-inflammatory and
joint health properties of Devil’s Claw to a senior demographic should be considered.
Marketing of such clinical claims through product labels as well as through internet
advertisements is important because internet sales constitute a significant share of the
market. Subsequently, the development of positive online user rating and reviews is
important to receiving higher Google product search rankings and thus can provide an
important means of differentiation.

2) Because many of the clinical claims in the human market are used as a basis to justify the
development of Devil’s Claw products for animals, entry into the human market is not
only conducive to capitalizing on an emerging market for joint health, but the
differentiating efforts made in this market can be leveraged into the entry of animal
market. With respect to the animal market, the horse market does not appear to be an
attractive mode of market entry. Furthermore, there are currently a number of rival
products that are available in that market. The remaining markets would thus favor the
entry into the Canine and Feline market not only because there are considerably fewer
rivals (see table 5), but pet ownership rates are projected to increase, especially that of the
Hispanic population.
To conclude, while the prediction of success of any entry event is often marred with significant
uncertainties, the identification of these key threats in the five forces analysis serve to identifies
the nature of such uncertainties facing a U.S. entry of Devil’s Claw products. Identifying such
key threats will serve to not only better manage the uncertainties of this entry but if they can be
mitigated, can improve the profitability of Devil’s Claw products in the U.S. human and animal
nutraceutical / herbal supplement market.

24
VALUE CHAIN ANALYSIS AND MARKET ENTRY STUDY

The business processes, organizational forms, and inter-firm relationships that enable raw
materials be transformed into a consumer - ready form comprise the value chain for Devil’s
Claw. The conceptual framework that we use in analyzing this chain is taken from the resource-
based view of the firm, where the business analyst considers the available resources and
capabilities of a company at a fine level of detail (Barney, 2003; Porter, 1980). Value chains
involve both primary and support activities that are used by a firm to efficiently deploy the
available resources in a manner that creates durable competitive advantage. These resources are
characterized by various functional areas of the value chain that involve technology, regulatory
and legal support, infrastructure for distribution support, and sales marketing or merchandising.
While, value chain analysis is most often conducted within a company or by researchers in
consulting firms who have access to a great deal of information about the internal functional
areas of the firm, this study extends this firm level focus to that of the system of relationships
involved in the commercialization of Devil’s Claw. Such an effort serves to identify the potential
parties and functional responsibilities of those involved in the commercialization of Devil’s
Claw. As part of the background to this study, we conducted one interview with the principal of
a company in Namibia and the value chain analysis is focused around the capabilities and current
positioning of that business.
The value chain conceptual framework is used as an organizing method to fix ideas on the
current status of Devil’s Claw and identify the near-term prospects for entry into the United
States market. Although the initial research plan was to analyze the value chains separately for
veterinary products and human dietary supplements, our competitive analysis, as well as our
discussions with industry members, indicates that the two markets share much in common. The
primary and value added production levels are nearly the same for human and animal markets.
Indeed, the major brokers and manufacturer's requirements for ingredients are quite similar. The
separation of the two channels largely begins with the manufacturing level in which there needs
to be different preparation for the legal and regulatory support activities for products destined for
human or animal products.
The market opportunity for Devil's Claw can be seen within the structure of a series of primary
and infrastructure functional responsibilities that are shared by many firms, each responsible for
a fairly limited phase of the market channel (figure 3). The market channel in the figure is
divided into primary activities, distribution activities, and retailing activities arranged vertically
down the figure. The current Namibian stakeholders occupy the harvest level of primary
activities and provide a limited degree of processing.
The perspective on the U.S. market in figure 3 is similar to the traditional market channel in
which a product is transformed in form or location as it moves from raw material to consumer-
ready form. We expand into several chains horizontally because there are multiple product
options that can be produced with the same raw material. For example, from the manufacturing
level, either human or animal products can be produced. At the manufacturing level, there are
scope and scale opportunities to diversifying the use of the firm’s processing assets to these two
markets. Further, there are niches within the human or animal lines that represent distinct market

25
segments—for example, formulations sold only through veterinarians are produced by different
companies than those that market to mass channels.
At the retail level on figure 3, moving left to right, the divisions of the consumer market are
illustrated. The animal market accessed through the veterinarian channel or (separately) the
mass market channels is on the left, and, on the right, the human market accessed through
specialty "health food store" retailers or mass market channels. Within the animal market, there
are further divisions (not shown) between dogs and horses. The internet distribution option is
included within the mass market channel in both human and animal markets.
In the boxes denoted by dotted lines, we list the names of selected key firms involved at that
level of the market channel. Contact information for those firms, as well as others indicated
from our research and field experience, is provided in a database as a supplement to this report.

Primary Activities: Harvest and Processing

Harvest

At the present time, Devil's Claw is harvested mainly in Namibia but some sources in Botswana,
Zambia, and Angola are potential competition to the Namibian business. The ability to source
and to document a sustainable method of harvest is a key advantage to Namibian stakeholders.
Harvesting is done by agents of the firm who are not directly employed by the company, do not
have voting equity, but they do have a formal equity stake in the business, according to
management (personal communication). The harvesters maintain adherence to a unique
sustainable harvest system affiliated with the Sandveld Conservancy (http://www.sandveld.com/)
and with MCA-Namibia. This harvesting system is a form of Good Agricultural Practice (GAP).
Considerable organization and coordination has been invested in developing the supply
relationships and as a result, the Namibian stakeholder Dynamics has a strong position in the
harvest activities.

Primary processing

The first stage in processing, cleaning, slicing, and drying the roots, is done by small scale
farmers. There is no certification of GMP (good manufacturing practice) offered for these
processing activities. The value proposition for the entire chain will be significantly enhanced
by obtaining GMP status for the primary processing. There are important buyers in the USA that
strictly control quality of the ingredients they use, therefore they will only purchase whole or
sliced root and would not import an extract or powder or other processed form of Devil's Claw.
In order to gain their business, a credible quality assurance system is needed. A supervisor who
is knowledgeable about contamination risks and has credentials in GMP is a key starting point.
GMP-type training for food ingredient suppliers is available at many international trade shows or
direct certification of the company’s procedures can begin with one of several third party
providers.

26
The Namibian supplier buys minimally processed Devil's Claw root from a group of harvesters
who have substantive ties with the firm, therefore the buyer is in a position to direct and motivate
the use of GMP at the processing stage. GMP expertise can thereby be leveraged by Namibia
producers as a point of market entry. Further, the GMP process may be leveraged in the future to
assure even higher quality standards with regard to concentration of the active ingredient so that
lots are consistent, or those that vary can be priced according to content and quality. Given that
the Namibian entity appears to have, or will be developing, a reputation for such quality
standards, the ability to leverage on such quality differentiating efforts would be an additional
advantage to the Namibia group. At a minimum, close attention to first handling and storage
conditions will assure that product shipped to distant markets has not deteriorated in
concentration or activation. Temperature, humidity, and time in storage are likely factors in the
precision with which raw materials are converted to supplement dosages under exacting
standards.
Further, without assurances as to quality from the field, the further processing undertaken by a
stakeholder in Namibia or elsewhere will need to include higher levels of sanitation or control in
order to yield outputs that are of suitable quality for consumption by pets and humans. To the
extent that processing will eventually become part of the value chain, it is important to initiate
controls at the primary processor to reduce burdens on further processing and thus increasing
Namibia’s position to commanding greater premiums.
However, in spite of the advantages of the stakeholder interviewed for this study, there is no
Namibian firm that currently has the critical resources to successfully place products directly into
the U.S. market. The subject company lacks a brand and the healthful product image that will be
necessary to compete in the specialty product niche in the U.S. market. Clearly the market entry
strategy for the near term must be to develop relationships with a business partner to provide
services of distribution, further processing, and delivery.
GMP certification of supplies is feasible given that there are existing business connections with
the harvesters. It will be possible for the supplier to develop procedures to document training of
workers in safety during the cleaning and cutting processes. Of particular concern is that any
water used for cleaning follows standard sanitation procedures and that workers have protective
equipment when using cutting surfaces. The product must be covered in storage and processing
in order to protect it from contamination that might be introduced by birds or other wildlife.
These standards may not be common practice in the field or village today but the components are
well understood in food production systems. Because risks from pathogen contamination are not
high in the primary production process, it is our assessment that an elevation to GMP standards
is feasible for processing in very small scale settings. As a result of this enhanced production
system, Namibian stakeholders will be able to deliver products to buyers in the USA to be
further processed into goods in the form that US consumers desire.

Further processing

The trends in product forms for dietary supplements in the USA include soft gel pills and liquids
in single-serve bottles. These product forms appeal particularly to senior citizens in the USA
because they are easier to swallow than traditional tablets or capsules. In order to apply soft gel
technology to Devil's Claw ingredients, laboratory studies of the formulation will be necessary.

27
These tests will investigate whether the Devil’s Claw material is compatible with the gel medium
and not so dry that it will cause the casing to harden. The resources needed to conduct this sort
of technical research are available through contract manufacturers.

Sabinsa5 is a major ingredient supplier and a business arrangement with a company of this scale
and focus may provide an opportunity in the joint pain relief category. Boswellia (sourced from
India) is currently among the fastest growing of the natural supplements for joint pain. Sabinsa
contracts growers in India in a closely controlled production system. Devil’s Claw might be
complementary to the active ingredients in Boswellia, and there may be an opening for Devil's
Claw in a new formulation.
Jarrow6 is a large volume manufacturer of dietary supplements. The company representatives we
interviewed suggested that joint pain remedies were not a major emphasis in their business at this
time.
There is potential for Devil’s Claw to be marketed in traditional powdered forms that do not
require advanced processing. There was one brand with an ecological theme that was sold in
large jars of powder (Health Force Nutritionals7) and that company expressed interest in hearing
more about Devil's Claw. Health Force Nutritional's product along with most other dietary
supplements is a blend of several botanicals. Thus, we see an opportunity for Devil's Claw to be
added to an existing product line. In order to capitalize on this opportunity, Namibian companies
will need to sponsor scientific testing to assure that the active ingredients in those blends are
complementary to Devil's Claw rather than interfering or interacting in a way to generate toxicity
or reduce effectiveness.
As an alternative to marketing minimally processed material (sliced dry roots), the Namibian
stakeholder we interviewed currently has vertical linkages to manufacture consumer-ready
products by contract with a South African custom manufacturer. There is no operating
processing facility within Namibia at this time. Thus, a vertically integrated further processing
option is not available to any Namibian harvesting entity. A vertically coordinated value chain
with contract manufacture under a Namibian brand may be developed in the near future through
alliance with the following companies:

 in the USA (Pharmachem8, SoftGel Technologies9, Novagroup10),


 in China (Jiaherb11) with headquarters in New Jersey, USA
 and in India (Advantage Botanical12).

The products would bear the Namibian brand without the need to invest in systems for complex
formulations, for assurances of regulatory compliance, and for packaging in the forms

5
Sabinsa Corporation. Pande, Anurag. (732)-777-1111 anurag@sabinsa.com
6
Jarrow Formulas. (310)-204-6936 info@jarrow.com
7
Health Force Nutritionals. Phillips, Fred. (800)-357-2717
8
Pharmachem Laboratories Inc. (201)-246-1000 info@pharmachemlabs.com
9
Soft Gel Technologies. Bouskila, Roy. (972)-524-8569-34 royb@soft-gel.com
10
Nova Group. Williams, Natalie. (801)-261-2252 n.williams@novagroup.net
11
Jiaherb Inc. 1-888-542-4372 www.jiaherbinc.com/
12
Advantage Botanical LLC. (845)-610-3673 www.advantagebotanicals.com/

28
demanded by U.S. consumers. The Namibian firm will need to invest in the expertise about
formulation so that its specifications can be delivered to the contract manufacturer.
Formulation is the key stage in leveraging the further-processing activities into a profitable
dietary supplement for the US market. Products are marketed based on therapeutic properties.
Even where companies are not making health claims per se, they offer high standards for safety
and efficacy. For example, the leading companies advertise GRAS status (Generally Recognized
as Safe, a status that requires FDA oversight). Further, companies have obtained patents on the
extraction process (ethicalnaturals.com, advertising of resveratrol) similar to the technology that
is used to produce Doloteffin (Ardeypharm GmbH), the high quality Devil’s Claw extract
produced in Germany. These levels of quality are for the premium ingredients niche and have the
potential to yield price advantages.
The competition to a Namibian entrant is providing proof that products are not toxic, are not
working against other ingredients in a blend, and have efficacy in the intended use. Information
about therapeutic benefits cannot legally be conveyed on labels of the consumer-ready package,
but it will be raised as an important issue in discussions with business customers who are
considering Devil’s Claw as a new ingredient complementary to its existing lines. Hence we
stress that it is crucial for Devil's Claw stakeholders to understand and to convey all information
about its therapeutic properties and any possible interactions and side effects. For instance, now
that the USA market has been exposed to Devil’s Claw product labels with health warnings
about use by pregnant women, there have been contradictory messages about therapeutic value,
which, in our opinion, clouds the prospects for Devil's Claw.
Additionally, the company should consider changing to a new name more appealing to
consumers in the U.S. than the current Devil’s Claw. There is some confusion in the market
about products sourced in Arizona carrying the same name.
Recent presentations on the cutting edge issues in the dietary supplements field highlighted the
importance of anti-inflammatory properties of botanicals and foods (Marks, 2009 and 2012). For
example, resveratrol (made from grape seeds) is in vogue. There is apparently a body of
evidence on Devil's Claw supporting its anti-inflammatory attributes as well as its role as a
remedy for pain and natural healing. To our knowledge, customers in the USA do not associate
these attributes with Devil’s Claw. Industry contacts who knew of Devil’s Claw classified it in
the joint pain remedy product line, which is not as popular currently as the anti-inflammatories.
Effectiveness of Devil’s Claw toward inflammation rather than merely pain relief is an area for
scientific clarification and might be completed without new research if it is placed in the
appropriate context for business development. That is, part of the market entry strategy must be
to generate credible scientific testimonials in an industry outreach format.
An avenue for outreach would be the Nutracon conferences or in the trade journals and blogs
associated with New Hope media company. A Namibian stakeholder might seek a speaking
engagement on the program or offer an interview to the media firm. In this way, the Namibian
stakeholders would build an evidence-based strategy for market entry that will facilitate
placement in high-value market niches. Information on the therapeutic properties and the
efficacy of Devil’s Claw can best be conveyed to the sophisticated buyers and related value
chain members in the USA market if it is backed by credible research.

29
This information exchange is quite different from the FDA-regulated information that needs to
be conveyed on consumer-ready packages. Buyers of ingredients for dietary supplements have a
high level of sophistication about the health and wellness effects of certain compounds, and the
research base to support benefits must be well documented and explained before a buyer will
consider purchasing the product. Major ingredient companies supplying to the dietary
supplements products include XTO, Sabinsa and DSM, and they are staffed by individuals with
food science and biological expertise.
Both the dietary supplements industry and the US federal regulators at the FDA have a renewed
emphasis on enhancing the safety and credibility of the dietary supplements industry. Industry
leaders are motivated to a higher level of quality following some scandals in the media recently
about companies that have deliberately misled consumers concerning the ingredients in their
products (FDA, 2012; Schultz, 2012)13.
As a specific example of the higher emphasis on credibility, please note the draft guidance to
industry of July 2011 regarding compliance with the New Dietary Ingredient regulation (NDI).
The NDI has been in place for several years, but FDA signaled a new emphasis when it released
a draft guidance to industry about a change in focus (FDA, 2011a)14. The NDI requires pre-
market notification to FDA (not approval) to assure that a "new dietary ingredient will
reasonably be expected to be safe under the conditions of use recommended or suggested in the
labeling" (FDA, 2011b and 2011c)15.
Many botanical products are among those that have notified FDA under this regulation,
including: stevia, white zapote, bark extract of Pao, fenugreek, periwinkle, resveratrol, and
many root crops. Clearly several of these items are like Devil's Claw in that they are natural,
traditionally known among certain populations, and have been used for some time. The
submissions to the FDA are new uses or new formulations of the well-known ingredients. Thus
the submission to FDA will be fairly routine. Nevertheless, the new dietary ingredient
notification is likely to be requested by trade partners in the USA. Such a request would be an
action consistent with a cautious approach as the industry seeks to understand the intentions of
the nonbinding recommendations that the FDA published in July 2011. Thus, Devil's Claw
stakeholders should be prepared to assist with or to complete a premarket notification under the
NDI regulation.
For animal products to be distributed in the veterinarian office sales channel rather than chain
stores or internet, the opportunities for higher margins are attractive. The burden on safety is
correspondingly higher. At a minimum, the ingredient supplier must document research to

13
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm274599.htm
http://newhope360.com/supply-chain-management/dry-labbing-dirty-secret-dietary-supplements-industry
14
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/
ucm257563.htm
15
http://www.fda.gov/Food/DietarySupplements/ucm109764.htm
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/uc
m257563.htm#topents/DietarySupplements/UCM260199.pdf

30
determine the toxicity level of the active ingredient. Research is needed to understand the
dosages that are contraindicated for pregnancy and to determine if there are milder symptoms
that are also detrimental to market acceptance. Sources from the vet market report that there is a
perception that Devil’s Claw is dangerous to mares and breeding dogs. This information has not
completely excluded Devil’s Claw from the pet market, according to our source. Within the dog
market, Devil’s Claw might be acceptable for the product line specifically targeted to senior pets
that would not be breeding. However, if a warning label is necessary, it is likely to be a major
limiting factor to consumer acceptance. Research is clearly needed to understand the doses that
threaten pregnancy or fertility and whether those risks are different for various species.

Distribution support activities

A Namibia-based company manages its export of raw materials from Africa through a spot order
of a 20-foot shipping container. With this arrangement, occasional shipments are feasible but
there is no ability to mix loads for cost-effectiveness in ocean freight. No detailed data on cost
were provided for use in this study. In order for a larger volume to be accommodated for direct
exports to the USA, the Namibian value chain will need to be supported with leased or owned
storage facilities under temperature and humidity control so that the product quality remains
acceptable when stored for longer periods.

Our interviews with industry did not identify any U.S. company currently involved in trade of
dietary supplement ingredients from Africa; therefore, we lack precise detail on the costs of
transportation and logistics. Brokers from Maypro, Inc. 16 are knowledgeable advisors about
shipping costs.

There is a possible low-cost strategy in logistics to align with firms that are producing in India or
China. The preponderance of trade in dietary supplement ingredients is from India or China due
to the low cost and adequate infrastructure for research and certification. There are large
companies processing ingredients and finished goods across several product lines that can
constitute a full container load and be handled under effective controls for a traceable
distribution system. The cost to distribute directly from Namibia must be contrasted with the
alternative of exporting from India or China to the USA, suggesting that the avenue for entry to
the USA may be through China.

Retail distribution and marketing activities

Namibian stakeholders do not currently work in a value chain that extends to retail. Companies
that might provide retailing support on behalf of a Namibian stakeholder are those in the eco-
environmentally conscious niche. While there has been growth in this market in the USA (Soref,
2011) the average consumer and even buyers in the natural foods specialty stores are not
associating fair trade or environmental attributes with dietary supplements and herbs.

16
Maypro Industries LLC. Alimonti, Denis (914)251-0701 ext 126 denis.alimonti@maypro.com

31
The Fair Trade category is a relevant segment for marketing products that are harvested in an
environmentally sustainable manner. The companies that operate in this area are: Guyaki17—
marketing the South American product yerba mate; Josef Brinckmann at Traditional
Medicinals 18 from Sebastopol, CA, Gaia Herbs in North Carolina, and Organic India. The
Institute for Marketecology is an international agency for certification of eco-friendly (Soref,
2011).

Recommendations for Market Entry

We suggest research to address at least the following:

1. Efficacy and/or toxicity tests in combinations with Boswellia and other natural supplements
appears to be a promising avenue as few if any research has tried such combinations.
2. Effects on pregnancy under recommended dosages (human and animal).
3. Feasibility to incorporate in soft gel product form
4. Anti-inflammatory effects compared with existing natural substitutes such as resveratrol.
5. Toxicity studies for the veterinary channel with a focus on the canine and feline market.

If the Namibian stakeholders desire to enter the USA market, they will need to find reliable
business partners and to be prepared for those business partners to capture a large share of the
returns from value-adding business. We believe that the identification of business partners and
finalizing contracts for transactions involving raw materials and primary processing can be
executed from a remote location, in large part. When it comes to formulation, the scientific
expertise and ability to show credible results are not likely to be organized in Namibia.

Other issues

In light of these recommendations, it is also prudent to outline any other considerations that can
impact Devil’s Claw’s U.S. market entry. Although primary production of Devil’s Claw is
predominantly in Namibia, the post processing requirements of Devil’s Claw suggests that
companies in China and India can fulfill some of these post harvesting activities at a potentially
lower cost than Namibian suppliers. Therefore, while China and India are currently not
significant suppliers of Devil’s Claw, their low cost position in post manufacturing and
distribution and, most importantly, existing market access to U.S. dietary supplements market,
are a major source of supplier threat to Namibian producers. Hence, from the standpoint of
suppliers, one means of neutralizing this potential supplier threat is for Namibian producers to
coordinate rather than compete on the post harvesting requirements of Devil’s Claw with
Chinese and Indian manufacturers. Hence, under such a coordinated arrangement, entry may
occur through Chinese and Indian exports into the U.S.
Another related supplier consideration is that while the current assessment of the threat of
supplier remains relatively low, there is potential to increase the supplier position of Namibia

17
Guyaki. (888)-482-9254 http://guayaki.com/
18
Traditional Medicinals. 1-800-543-4372 www.traditionalmedicinals.com/

32
producers. That is, while there are current efforts by MCA to coordinate the production of at
least 21 Devil’s Claw harvester groups, their contributions constitute only 10-20% of the raw
material supply (communications with David Cole) and thus do not hold a strong supplier
position. This suggests that there are significant opportunities for MCA to continue their efforts
to coordinate production amongst Namibian producers. We expect that such coordination will be
in close alignment between harvesters and the first handlers in Namibia and is not a significant
threat to a Namibian stakeholder. Instead, there is potential to position the Namibian producers
in a marginally improved position with respect to foreign buyers, in which higher prices can be
charged to U.S. and Chinese / Indian manufacturers.

Cost Estimates for Performing Clinical Studies on Efficacy of Devil’s Claw for Joint Health
in Humans and Animals

This section is a compilation of information on the costs of clinical and laboratory research that
is suggested to assist in market entry. If there is interest in claiming Devil’s Claw as a drug
which would be recognized by the FDA, all regulatory considerations would be satisfied but the
expense of the research is daunting. Studies must first be conducted on animals and then
followed up with studies of the effects on humans. Outlined are the total financial estimates to
conduct studies on the efficacy of Devil’s Claw and the cost to evaluate the safety of Devil’s
Claw on horses and dogs. As there is no dietary supplement category for pet food, the research
cost estimate is for full FDA approval of a veterinary drug.

Human Markets –Efficacy as a Dietary Supplement

According to Dr. Heather Boon, from the Faculty of Pharmacy of University of Toronto, the cost
of clinical trials for natural medicine products is usually calculated as an amount per patient.
Drug trials range from several hundred dollars per patient to $1000/patient enrolled. Factors that
impact the estimates were identified by Dr. Boon as: payment reception permitted or restricted to
recruitment centers for patient recruitment; whether or not participants in the trial are paid for
their participation (or just receive free product for example), how many visits to the study center
are required, and what kind of data are being collected (amount and invasiveness -- for example
are the participants filling our pre- and post-surveys or are physical assessments and blood draws
necessary). Clinical trials (if undertaken by Dr. Boon’s laboratory in Canada) need to be pre-
approved by Natural Health Products Directorate of Health Canada which regulates clinical trials
with natural health products. The review process takes approximately 30-60 days.

For Dr. Sandra P. Welch from Virginia Commonwealth University, inflammation/pain studies
require testing multiple compounds. The first step in the process requires testing animals. A
rough estimate for animal testing includes 50 rats in 100 days, a housing rate of $1 per day and a
principal investigator salary for six months. Following the conclusion of the animal testing, the
next step in the process is testing humans. A major portion of clinical trials in pharmacology
require funding for the physician, statisticians, and staff to work with patients.

33
Veterinary drug status

Attempting to make a drug claim for Devil’s Claw could result in a significant regulatory burden,
with oversight by the FDA Center for Veterinary Medicine. The Federal Food Drug and
Cosmetic Act defines a drug as:

“(A) articles recognized in the official United States Pharmacopoeia, official


Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or
any supplement to any of them; and (B) articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or other animals; and (C) articles
(other than food) intended to affect the structure or any function of the body of man or
other animals; and (D) articles intended for use as a component of any article specified in
clause (A), (B), or (C).”

Therefore, claims for Devil’s Claw such as for “treatment of osteoarthritis” or “alleviation of
pain” would likely result in requirements for studies to be conduct under GLP/GCP conditions,
approval of manufacturing processes, and so on. Note that the studies outlined below would
require significantly more time and financial resources if they were to be performed in
accordance with the legal standards. In order to comply with personnel and facility requirements
and provide for quality assurance, an increase of 5-10 times the original cost may arise.

All estimates below are approximations and should not be considered as actual budgets. Studies
comparing Devil’s Claw to placebo, and studies comparing Devil’s Claw to another product
depict that smaller expected differences in variability between Devil’s Claw and similar products
will require larger sample sizes in order to show a statistically significant differences; or show
that a lack of difference is not due to a lack of power to detect that difference. In addition, the
estimates below do not reflect any indirect costs. If these studies were to be conducted by Texas
A&M University, indirect costs would add approximately 46% to each study (Dr. Virginia Fajt,
Personal communication, April 20, 2012).

Horses
1. Efficacy
a. Purported efficacy in protecting joint health suggests that changes in joint fluid
and changes in indicators of pain in the joint should be evaluated. Horses with
naturally occurring joint disease should be identified and randomly selected for
treatment or placebo. One possible pool of animals at Texas A&M is client-
owned horses that visit the Veterinary Medical Teaching Hospital. (Horses would
need to be NSAID-free for at least 2 weeks and glucocorticoid-free for at least 3
weeks prior to the beginning of the study.) Lameness can be assessed on a 5-
point scale (American Association of Equine Practitioners, 1999) prior to the
beginning of the study. In addition to comparing attenuation of lameness with
Devil’s Claw, glycosaminoglycan, hyaluronic acid, prostaglandin E, and tumor-
necrosis-factor (TNF) levels could be evaluated in blood and synovial fluid.
b. Financial consideration would include lump-sum payments to clients for use of
client-owned animals ($200/animal x 10-20 animals if comparing to placebo or
50-100 animals if comparing to NSAID or other product), outpatient fees for 4-5

34
visits ($50/visit), fees for collecting blood and joint fluid samples ($50/sample),
study personnel (technician and clinical veterinarian for developing the Animal
Use Protocol and for collecting samples – 25% time over 3 months - $2000 +
$6000), and sample analysis ($50/sample type x 4 sampling times x 4-5 sample
types).
i. Total estimates
1. Placebo-controlled study: $81,000
2. Comparator study: $377,000

2. Safety
a. As an adjunct to assessing efficacy, safety could also be evaluated. Given that the
mechanism of action is still being worked out, several parameters might be
evaluated to detect any adverse effects of Devil’s Claw. For example: blood
chemistries, levels of glycosaminoglycans and hyaluronic acid in serum and
synovial fluid, and prostaglandin E and TNF levels in synovial fluid. Each of
these measurements would likely add $50 to each sampling point.
b. Financial consideration would include: purchase of horses ($1000/animal x 10
animals), per diem charges for animals boarded by Comparative Medicine
($7/day x 42 days), study personnel (technician and clinical veterinarian for
developing the Animal Use Protocol and for collecting samples – 25% time over
3 months = $2000 + $6000 for 20-animal study), and sample analysis ($50/sample
type x 4 sample times x 4-5 sample types).
1. Total estimate = $31,000

Dogs
1. Efficacy
a. Purported efficacy in protecting joint health suggests that changes in joint fluid
and changes in indicators of pain in the joint should be evaluated. Dogs with
naturally occurring joint disease could be identified and randomly selected for
treatment or placebo. One possible pool of animals here at Texas A&M is client-
owned horses that visit the Veterinary Medical Teaching Hospital. (Dogs would
need to be NSAID-free for at least 2 weeks and glucocorticoid-free for at least 3
weeks prior to the beginning of the study.) Lameness can be assessed using a
multi-factor lameness scale such as the one used in Reymond et al., 2012.
Glycosaminoglycan, hyaluronic acid, prostaglandin E, and TNF levels could be
evaluated in blood and synovial fluid.
b. Financial consideration would include lump-sum payments to clients for use of
client-owned animals ($200/animal x 10-20 animals if comparing to placebo or
50-100 animals if comparing to NSAID), outpatient fees for 4-5 visits ($55/visit),
fees for collecting blood and joint fluid samples ($50/sample), study personnel
(technician and clinical veterinarian for developing the Animal Use Protocol and
for collecting samples – 25% time over 3 months = $2000 + $6000 for 20-animal
study; $12,000 for 100-animal study), and sample analysis ($50/sample type x 4
sampling times x 4-5 sample types).
i. Total estimates
1. Placebo-controlled: $82,000

35
2. Comparator: $380,000

2. Safety
a. As an adjunct to assessing efficacy, safety could also be evaluated. Given that the
mechanism of action is still being worked out, several parameters might be
evaluated to detect any adverse effects of Devil’s Claw. For example, blood
chemistries, levels of polysulfated glycosaminoglycans and hyaluronic acid in
serum and synovial fluid, and prostaglandin E and TNF levels in synovial fluid.
Each of these measurements would likely add $50 to each sampling point.
b. Financial consideration would include purchase of horses ($650/animal x 10
animals), per diem charges for animals boarded by Comparative Medicine
($5/day x 42 days), study personnel (technician and clinical veterinarian for
developing the Animal Use Protocol and for collecting samples – 25% time over
3 months - $2000 + $6000), and sample analysis ($50/sample type x 4 sample
times x 4-5 sample types).
i. Total estimate = $27,000

Breathitt Veterinary Center from Murray State University has been recommended as the leading
laboratory for pain efficacy research for all animal species. The laboratory’s testing capabilities
include clinical pathology, histopathology/necropsy, microbiology, molecular diagnostics,
serology, toxicology and virology. The laboratory webpage
(https://breathitt.murraystate.edu/handbook/) contains information about the test fees per
turnaround times and required specimens for each type of procedure. Also, the laboratory
charges a higher fee if the specimen is from outside of Kentucky. For example, a toxicology test
for calcium will require a specimen of 200 g ground feed or 500 mL water, a turnaround time of
2 days and a KY fee of $ 26.50 or Non KY fee of $40.00.
According to other industry sources, the toxicity test is crucial for entry into the animal market
and should be performed with a histology test. The cost of such test will be $150,000 or less. A
toxicity test performed with a small sample of rats can be completed in 28 days for $10,000.

36
Figure 1: Human & Animal Nutraceutical / Herb Supplement Market

Porter’s Five Forces


A Model for Industry Analysis

37
Figure 2: Example of Disclaimer on Advertisement of Dietary Supplement

38
Figure 3. Devil’s Claw Value Chain

Harvest (Africa)

ECOSO
Wholesale/Export

Animal Market Manufacturing Human Market

Specialty Broker Contract


Brands Manufacturer
Specialty Traditional
Brands Brands  Maypro
 XTO
 Soft Gel Tech
 Aumed  Pharmachem
 Gaia Major  Navagroup
Garmon Del Monte  Geromatrix  Paragon
Corp. Manufacturer
Corp.  Reservage

 Sabinsa
 Jarrow

Veterinarian Internet National


Channel Chain Specialty Internet National Chain
Stores

Consumers Consumers

39
Table 1: Threat of Rivalry: Competitive Characteristics of Rivals
Price
(based on
Company Name Product Name Distributed by (Buyer)
lowest
retail price)
Devil’s Claw Root 500 4All Vitamins
Now Foods $4.58
(100mg)
Nature’s Way Devil’s Claw extract 90 $5.73 Nutrasource
Nature’s Answer Devil’s Claw Extract (1oz) $6.25 The Vitamin Shoppe
Swansons
Swanson’s Devil’s Claw $7.98 Swanson Health products
Premium
Douglas Labs Devil’s
Douglas Lab Claw Max-V (200 mg 60 $14.70 Natural health concepts
c)
Devil’s Claw 90c –
Davinci $12.47 Pure formulas
Davinci
Seroyal /
Devil’s Claw Cream 56 g $23.45 Health Remedies
Genestra
Puritan’s Pride Puritan Pride Devil’s Claw $3.99 Puritan’s Pride
Solaray –Devil’s Claw,
Solaray $9.77 Best Price Nutrition
525 mg, 100 cap.
Devil’s Claw Extract, 100
Vitamin Shoppe $6.99 Vitamin Shoppe
cap.
Alternative Health and
Alternative
Herb Remedies Yucca
Health and Herb $16.20 Amazon
Devil’s Claw Vegetarian
Remedies
Capsule, 450 mg, 60 count
Food Science of Food Science of Vermont,
$12.97 Health designs.com
Vermont Devil’s Claw 90 cap
Eclective Institute- Devil’s
Eclectic Institute $6.38 Herbspro
Claw extract, 1 oz.

40
Table 2: Threat of “Natural” Substitutes: Dietary supplements containing Glucosamine /
Chondroitin Sulfate / and or MSM by most popular brand
Number of
Natural Distributors based on
Company/
Substitute Price range Google product / company
Brand
Product relevance rankings
Offered
Dymatize 2 $11-12.36 1) The healthier.com
1) Health superstore
Dynamic
10 $13-16.99 2) Bulk Nutrition
Health
3) Cheapvitamins
Elations 10 $5-8.99 1) Drugstore
2) Walgreens
Joint Juice 3) CBS
10 $6.29-26.27
Supplement 4) BJ’s Wholesale club
5) Sam’s Club
6) Amazon
7) Sears
8) Newegg
9) The Vitamin
Nature’s Plus 9 $10-45
Shoppes
10) Swanson Health
Products
11) Vitacost
1) vitacost
2) Cheap vitamins
Natrol 10 $6.77-7.41 3) Bulk Nutrition
4) Affordable
supplements
1) Herbal remedies
2) Tao of herbs
3) Newegg
Now Foods 10 $6.15-9.74
4) Swanson health
products
5) Takeherb

41
Table 3: Threat of Non-Natural Substitutes: NSAID OTC

Brand Name Generic Name


Advil, Nuprin, Motrin ibuprofen
Aleve naproxen sodium
Ascriptin, Bayer,
aspirin
Ecotrin
Source:: http://www.webmd.com/osteoarthritis/guide/anti-inflammatory-drugs

Table 4: Threat of Non-Natural Substitutes: Prescription NSAID19

Brand Name Generic Name


Anaprox naproxen sodium
Celebrex* celecoxib
Clinoril sulindac
Daypro oxaprozin
Disalcid salsalate
Feldene piroxicam
Indocin indomethacin
Lodine etodolac
Mobic meloxicam
Naprelan naproxen sodium
Naprosyn naproxen
Orudis ketoprofen
Relafen nabumetone
Ketorolac
Toradol
tromethamin
2
Source: http://www.webmd.com/osteoarthritis/guide/anti-
inflammatory-drugs

19
Source: http://www.webmd.com/osteoarthritis/guide/anti-inflammatory-drugs

42
Table 5: Threat of Rivals for Devil’s Claw in the Animal Nutraceutical / Herbal Supplement
market
Company Price
Pet Class Product Name Distributor
/Manufacturers ($)
Med-Vet DC-Y 15 lb Joint Met-Vet
Horses 167.99 horse.com
Support Pharmaceuticals
Wendals Herbs Liquid Devil’s equestrian
Horses Wendals 45.95
Claw collections
Yucca, Devil’s Claw and Myrrh -
Horses Herbs of the World 48.95 KV Supply
2 pounds
All American All American
Horses #18 Joint Support 75
Saddles Saddles
Wendals Herbs Devil’s equestrian
Horses Wendals 69.95
Claw Root collections
Horses FM Solution - 32 oz (32 days) Select The Best® 14.79 Valley vet
equestrian
Horses Equilite Ani-Motion equilite 47.95
collections
Su-Per SuBstitUTE Liquid -
Horses Gateway products 32.47 KV Equine
Gallon
Su-Per SuBstitUTE Liquid - 32
Horses Gateway products 23.95 KV Equine
ounces
Uckele Health and
Horses Devil’s Claw Plus 17.95 SmartPak
Nutrition
Horses Smart TLC Pellets Smart Pak 27.95 SmartPak
Horses B-L Pellets 5bl Equine America 43.34 ABlackhorse
Equine Conectin 600 mg 20
Horses In Clover 48.95 KV Equine
ounces
Dogs and Muscle and Joint Support,
Native remedies 39.95 gaeastore
Cats PetAlive
Wendals Herbs Dog Devil’s Equestrian
Dogs Wendals 29.95
Claw Liquid collections
Dogs and
Devil’s Claw ZPNCH-007 Zurispridenaturals 16 ecrater
Cats
Dogs and Chudleys Devil’s Claw Root Dodson & Horrell
13.65 UK company
Cats Tincture 250ml Ltd
Dogs and
DEVIL’S CLAW PLUS - 2 LB Uckele Health 34.95 SmartPak
Cats

43
Table 6a: Threat of Natural Substitutes: Equine
Price
Product Name Company/Manufactures
($)
32oz Fluidflex/Horse Joints 29.39 Farnam
AHC Products, Inc.-
Animed Aniflex GL - Glucosamine for Horses 11.25
Animed™
AHC Products, Inc.-
Animed Aniflex Complete Equine 16oz 27.14
Animed™
AHC Products, Inc.-
AniMed Glucosamine 5000 Powder 5 lb Joint Support 29.95
Animed™
Bci Best Quality Gluco-flex / Size 4 Pound By Equine
60.42 Equine America
America
Bci Best Quality Super-Flx Glucosamine Solution / Size
34 Equine America
Quart by Equine America
Central Life Sciences 3001032 - 1lb MSM Ultra
10 Central Life Sciences
Pure/Horse Suplm
Chondroitin Plus by Horse Guard Inc 216.06 Horse Guard Inc
Cosequin Animal Care Cosequin equine optimized formula
114.89 Nutramax Laboratories. Inc
joint supplements with MSM for horse - 1400 grm
Cosequin ASU for Horses (1300 gm) 157.94 Nutramax Laboratories. Inc
Cosequin ASU Plus Equine Powder (1050 grams) 189.99 Nutramax Laboratories. Inc
Cosequin Equine - 700 gram 154.99 Nutramax Laboratories. Inc
Cosequin Equine Horse Powder- MAXIMA 500gm 180 Nutramax Laboratories. Inc
Cosequin Equine Joint Supplements 1400 grams, 3 lbs (up
154.99 Nutramax Laboratories. Inc
to 140 ...
Cosequin Equine Joint Supplements Optimized; 800
81 Nutramax Laboratories. Inc
Grams, 1.7 lbs
Cosequin Equine Optimized (800 Grams) 100.04 Nutramax Laboratories. Inc
Cosequin equine optimized formula joint supplements with
114.89 Nutramax Laboratories. Inc
MSM for horse
Cosequin Equine Optimized with MSM 1400 gram 114.89 Nutramax Laboratories. Inc
Cosequin Equine Optimized With Msm, 1400 Gram
127.99 Nutramax Laboratories. Inc
Container
Cosequin® Equine Joint Supplements 114.99 Nutramax Laboratories. Inc
Cosequin® Equine Powder 35.95 Nutramax Laboratories. Inc
Veterinary Products
Duralactin equine joint plus, 3.75 lbs bucket 67.57
Laboratories
Equine America MSM 32oz Liquid Joint Support 19.99 Equine America
Equine America Quart 770A Super-Flx Glucosamine
17 Equine America
Solution
Equine Bone & Joint MSM Powder - 1lb Jar 8 Rich's
Equinyl Glucosamine for horses 51.95 Vita-Flex
Equinyl Glucosamine for horses with HA 58.1 Vita-Flex
Equinyl Liquid Glucosamine with Hyaluronic Acid 60 Day 99 Vita-Flex
Farnam Equinyl Glucosamine For Horses 158.21 Farnam

44
Table 6a: Threat of Natural Substitutes: Equine
Price
Product Name Company/Manufactures
($)
Farnam Equinyl Glucosamine For Horses With Ha 68.09 Farnam
Finish Line Horse Products - MSM 10 Lb 63.35 Finish Line Horse Products
Finish Line MSM 1 Lb 6 Finish Line Horse Products
Finish Line® Horse Products MSM 26.99 Finish Line Horse Products
Flex-Force Chondroitin Sulfate - Gallon (64-256 days) 34.95 Corta-flx
(continued on the next page)
Flex-Force Chondroitin Sulfate Pellets - 12 lb (192-384
59.95 Corta-flx
days)
Flex-Force Glucosamine 5000 Pellets - 12 lb (96-384 days) 46.95 Corta-flx
Flex-Force Glucosamine 5000 Solution 128 oz Joint
35 Corta-flx
Support
Gluco-Flex Feed Supplement For Horses, 4 Lb 47.23 Equine America
Horses Prefer HP-MSM (1 lb Granules) 10.88 Vets Plus, Inc.
Joint Combo 3.5 Lb 34 Farnam
Joint Combo Hoof and Coat for Horses / Size (8 lbs.) 97.19 Farnam
Joint Max Triple Strength Horse Health Supplement (Pack
145.99 Farnam
of 2)
Legacy Horse Pellets 10 Lb 59.19 Select the Best
Liquid Health Equine 4 in 1 Joint Formula -- 32 fl oz 21.12 Liquid health.Inc
Liquid Health Equine Level 5000 Super Concentrated Hip
39.62 Liquid health.Inc
and Joint
MaxFlex Chondroitin Pellets for Horses - 3.75 lb. 72 Farnam
MaxFlex Glucosamine Pellets for Horses 3.75 lbs 54 Farnam
MaxFlex Maximum Relief 8 Lb 105 Farnam
MaxFlex Maximum Relief Glucosamine Pellets 33.95 Farnam
Med-Vet Glucosamine XL Plus MSM 10 Lb Joint Support 115 Med Vet pharmaceuticals
Med-Vet Glucosamine XL Plus MSM 15 Lb Joint Support 167 Med Vet pharmaceuticals
Med-Vet Glucosamine XL Plus MSM 25 Lb Joint Support 241 Med Vet pharmaceuticals
Med-Vet Glucosamine XL Plus MSM 5 Lb Joint Support 60 Med Vet pharmaceuticals
Missing Link Plus with Glucosamine - Equine Formula - 5
33 Designing Health
Pounds
MSM Pellets by SmartPak (formerly SmartMSM® Pellets) 10.95 SmartPak
AHC Products, Inc.-
MSM Powder 2.5 Pound Package 10
Animed™
AHC Products, Inc.-
MSM Powder Horse Supplement 1Lb 21.5
Animed™
Nimble Supreme - Equine - 3.75 lbs 89.99 Adeptus Nutrition, Inc
Probios Treats Hip and Joint w/Glucosamine Flavor: Apple 7 Probios®
Pure Encapsulations - Glucosamine Complex 500G (Vet
206 Pure Encapsulations, Inc
Equine Pwd)
Pure MSM by AniMed(up to 1600 servings) 15.99 AHC Products, Inc.-

45
Table 6a: Threat of Natural Substitutes: Equine
Price
Product Name Company/Manufactures
($)
Animed™
Regenex Equine Joint Supplements - Glucosamine -
33 Nusentia Horse Supplements
Regenex for Horses - 32oz Liquid
Richdel Inc 20 Pound MSM Powder 89 Richdel Inc
Richdel Legacy Horse Pellets 20 Lb 113.52 Richdel Inc
Select MSM for Horses / Size (10 lbs) 46 Horse.com
Sogeval MSM Equine Pellets, 10 lbs. 105.99 Sogeval Laboratories
Springtime J-Flex Concentrate Horse Joint Supplement 48.48 Springtime Inc
The Missing Link Plus with Glucosamine 1 lb 14 Designing Health
Vita Flex MSM 4 Lb 22 Vita-Flex
Vita Flex Ultra Pure MSM Horse Supplement 7.5 Vita-Flex
Vita-Flexreg MSM Horse Joint Supplement 99.9 Vita-Flex

46
Table 6b: Threat of Natural Substitutes: Equine
Product Name Prices Company/Manufacturer
($)
1 Alaska Naturals Salmon Oil with Glucosamine, Chondroitin, and MSM for 15 Alaska Naturals
2 Arthogen Plus for Dogs, 360 Tabs 57 PetLabs360
3 Arthrisoothe Gold - Liquid: 16 Ounces 20 NaturVet
4 Bellyrubs Organic 16-ounce Liquid Dog Supplement, Glucosamine HCL W... 15 Bellyrubs Organic
5 Bellyrubs Organic 32-ounce Liquid Dog Supplement, Glucosamine HCL W... 26 Bellyrubs Organic
6 Cosequin Cosequin DS Plus MSM for Dogs -- 60 Chewable Tablets 21.14 Nutramax Laboratories, Inc
7 Cosequin Double Strength Plus MSM Joint Health Dog Supplement 27.99 Nutramax Laboratories, Inc
8 Cosequin DS Plus MSM Joint Health Supplement for Dogs - 180 Chewable Tablets 50 Nutramax Laboratories, Inc
9 Cosequin DS Plus MSM, Joint Health Supplement for Dogs 60 ea. 14.91 Nutramax Laboratories, Inc
10 Cosequin Ds Plus Msm, Joint Health Supplement For Dogs, 60 Scored 21.01 Nutramax Laboratories, Inc
11 Cosequin Soft Chews Glucosamine Chondroitin for Dogs 60ct Nutramax Pet 25.53 Nutramax Laboratories, Inc
12 Cosequin Soft Chews, Glucosamine Chondroitin For Dogs, 60 Soft Chews, 29.36 Nutramax Laboratories, Inc
13 Dasuquin Chew MSM Large Dogs 84ct 54.38 Nutramax Laboratories, Inc
14 Dasuquin with MSM for Large Dogs Over 60lbs 150ct Bottle 52 Nutramax Laboratories, Inc
15 Dasuquin with MSM for Large Dogs Over 60lbs 84ct Bottle 33 Nutramax Laboratories, Inc
16 Dasuquin with MSM for Small to Medium Dogs - 150 Ct 47 Nutramax Laboratories, Inc
17 Dasuquin with MSM for Small to Medium Dogs Under 60lbs 84ct Bottle 38 Nutramax Laboratories, Inc
18 GLC Direct GLC 1000 Canine Glucosamine Powder for Dogs - 12.4 oz 32 Glc Direct Inc
19 Glucosamine Chondroitin for Dogs - 90 + 30 Free - 120 Total Chewable Tablets 25 Dog Glucosamine
20 Glucosamine DS Liquid with MSM: 8 Ounces 9 NaturVet
21 Glucosamine for Dogs w/ Chondroitin & MSM - Regenex for Dogs - 192 Doses 39.95 Nusentia
22 Greens + Paws for Dogs for Healthy Joints Beef -120 Wafers 15 Greens Plus
(continued on the next
page)
23 Healthy Baker Glucosamine Treats Dog Treat Size: 1 Lb Jar 21 Healthy Baker
24 Hip & Joint Peanut Butter Flavor Wafers - 6lb Bag 11 Nutri Vet
25 Hip and Joint Support Plus Chewable Tablets for Dogs, Liver Flavored 20 Nutri Vet
I Love Dogs Glucosamine and Chondroitin with Green Tea and Reishi - Medium Dogs
26 23 I love dogs
(30 tablets)
27 I Love Dogs Large- 30 Glucosamine and Chondroitin with Green Tea and Reishi 28 I love dogs

47
Table 6b: Threat of Natural Substitutes: Equine
Product Name Prices Company/Manufacturer
($)
28 Kala Health Comfort MSM Plus for Dogs (90 Chews) 41 NaturVet
29 Mendota Glucosamine 2x Dog Supplement 14 Mendota.Inc
30 Motion Ade Msm For Dogs, 60 Soft Chews, Pet Naturals Of Vermont 9.38 NaturVet
31 NaturVet Glucosamine DS Liquid for Dogs and Cats - 8 oz. 7 NaturVet
32 NaturVet Glucosamine DS Liquid with MSM & Chondroitin for Dogs and Cats, 32oz 28.62 NaturVet
33 NaturVet Glucosamine DS with MSM 120 Tabs for Dogs 18 NaturVet
34 NaturVet Glucosamine DS with MSM and Chondroitin - tablets: 60 Tablets 10 NaturVet
35 Nutri Vet Nutritionals 80404 Large Hip and Joint Wafers 6 Nutri Vet
36 Nutri-Vet Hip & Joint Chewables for Dogs, 90 ct 19.99 Nutri Vet
37 Osteo pet glucosamine chondroitin for dogs 16.95 Nutra paws
38 Osteo pet glucosamine chondroitin for dogs - 720 ct value size 120 Nutra paws
Regenex for dogs, glucosamine chondroitin for dogs plus msm - 192 Doses, 32oz
39 39.95 Nusentia
Liquid
40 Single Source Glucosamine for Dogs & Cats: 120 Count 15 Veri-Science
41 Single Source Glucosamine for Dogs & Cats: 60 Count 7 Veri-Science
42 Veterinarian's Best Dog Care Hip & Joint Formula 90-count 20 Nutri Vet
43 Vetri-Science Multi-Source Glucosamine for Dogs (120 capsules) 25 Veri-Science
44 Zukes's Hip Action Beef Glucosamine and Chondroitin Dog Treats 6.36 Zukes

48
Table 6c: Threat of Natural Substitutes: Feline
Product Name Price ($) Manufacturer/Company
1 100% Pure Msm Powder For Dogs And Cats, 16 Oz, Flying Basset Organics 21.06 Flying Basset Organics
2 8in1 Glucosamine Paste 2.5oz 5 8in1
3 Ark Naturals Joint "Rescue", Super Strength Chewable, 500mg 19.59 Ark Naturals
4 Blooming Pets Dog & Cat MSM Cream 100g 7.92 Blooming
Catswell Happy Hips for Cats, Chicken Breast, Glucosamine & Chondroitin,
5 17.94 Catswell
2-Ounce Pouches (Pack of 10)
6 Cosequin For Cats 80 Capsules 19.99 Nutramax Laboratories, Inc.
7 Cosequin for Cats with Glucosamine 55 CT. 8 Nutramax Laboratories, Inc.
8 Cosequin Glucosamine Chondroitin Supplement for Cats 50count 17.72 Nutramax Laboratories, Inc.
9 Cosequin Joint Supplement for Cats 19.99 Nutramax Laboratories, Inc.
10 Flying Basset, Organics, 100% MSM, Methyl Sulfonyl Methane for Dogs An 18 Flying Basset Organics
11 Glucosamine & Chondroitin for Cats 18.99 Kala Health, Inc
12 Glucosamine DS Liquid with MSM: 8 Ounces 9 NaturVet
13 Glucosamine Ds, Chondroitin Hip/joint 60 Tablets 11.99 NaturVet
14 Glucosamine for Cats Regenex Liquid Feline Joint Supplement 24.95 Nusentia
15 Glucosamine, chondroitin & msm supplements for cats - 90 tablets 15.99 KALA Health, Inc
16 Hartz Glucosamine Joint Maintennce for Cats 4 Hartz
17 Iams Senior Premium Protection Cat Food, 5.5 lb 12.77 Iams
18 Joint Care 2 with MSM 100 Tablets 47.99 Foster & Smith, Inc
19 Joint Complete For Dogs & Cats, Beef Flavor, 32 oz (960 ml) 19.52 Tropical Oasis
20 Joint MAX Cat Ganules 60 Doses (Pack of 2) 30.99 Joint Max
21 Methylsulfonylmethane (MSM) For Cats and Dogs, 250 mg, 120 Capsules 6.78 Vetri-Science
22 Motionade Msm Softchews Dogs & Cats 60 Chews 6.97 Pet Naturals
NaturVet - Glucosamine DS with Chondroitin Hip & Joint for Cats & Dogs -
23 12.72 NaturVet
60 Chewable Tablets

(continued on the next page)

49
Table 6c: Threat of Natural Substitutes: Feline
Product Name Price ($) Manufacturer/Company
NaturVet - Glucosamine DS with MSM and Chondroitin For Cats & Dogs - 60
24 14.99 NaturVet
Chewable Tablets
25 NaturVet Cat Joint Support Gel 10.39 NaturVet
26 NaturVet Glucosamine DS Liquid for Dogs and Cats - 8 oz. 7 NaturVet
NaturVet Glucosamine DS with Chondroitin Chewable Tablets For Dogs and
27 23.19 NaturVet
Cats
28 NaturVet Glucosamine DS with Chondroitin Liquid For Dogs and Cats 8-oz 14.25 NaturVet
29 NaturVet Glucosamine DS with MSM Liquid For Dogs and Cats 8-oz 18.45 NaturVet
30 NaturVet Glucosamine DS with MSM Tablets for Dogs and Cats - 60 ct. 16.99 NaturVet
31 NaturVet Joint Support Gel for Cats (3 oz) 5.99 NaturVet
32 Nutramax Cosequin DS PLUS MSM Chewable Tablets - 132 Count 132 ... 49.99 NaturVet
33 Pet Naturals Hip + Joint Cat Soft Chews, 2.22 oz. 4.79 Pet Naturals
Pet Naturals of Vermont MotionAde MSM Softchews For Dogs & Cats Dogs
34 6.58 Pet Naturals
& Cats 60 Chews by Pet Na
35 PetLabs360 Arthogen for Cats - 2 pk. - 90 ct. each - Health Care 17.39 Pet Labs
36 Single Source Glucosamine for Dogs & Cats: 120 Count 15 Vetri-Science
37 Single Source Glucosamine for Dogs & Cats: 60 Count 7 Vetri-Science
38 Single-Source Glucosamine Caps for Dogs & Cats 120ct 18 Vetri-Science
39 Sogeval msm crystals for dogs and cats, 1 lb 16.91 Sogeval Laboratories
40 Sogeval msm crystals for dogs and cats, 4 lbs. 56.88 Sogeval Laboratories
41 Ultra Flex Plus Glucosamine For Cats - 80 count 17.95 Ultra Flex
42 Ultraflex plus glucosamine for cats - 80 ct 17.95 Ultra Flex
43 Zukes Hip Action Glucosamine & Chondroitin Cat Chicken 2.2lb (12x3oz) 35 Zukes
44 Zukes Hip Action Glucosamine & Chondroitin Cat Salmon 2.2lb (12x3oz) 3 Zukes
45 Zukes HipAction Glucosamine & Chondroiton Chicken Treats for Cats: ... 2.94 Zukes

50
Table 7a: Non-natural substitute products for Equine
Animal
Sub Product Name Company Name Drug Class
Market
Equine Legend® Injection Bayer Animal Health Antiarthritic Agent
Legend ® Injectable Solution
Equine Bayer Animal Health Antiarthritic Agent
(20mg)
Legend ® Injectable Solution
Equine Bayer Animal Health Antiarthritic Agent
(40mg)
Legend Multi Dose Injectable
Equine Bayer Animal Health Antiarthritic Agent
Solution
Equine Hy-50® Bexco Antiarthritic Agent
Binoniche Animal
Equine Hyalovet® 20 Antiarthritic Agent
Health
Equine Hyvisc ® Boehringer Ingelheim Antiarthritic Agent
Equine Hyalovet® Fort Dodge Antiarthritic Agent
Equine Adequan ® I. A Luitpold Antiarthritic Agent
Equine Adequan ®I.M Luitpold Antiarthritic Agent
Equine Adequan® I.A luitpold Antiarthritic Agent
Equine Adequan® I.M luitpold Antiarthritic Agent
Equine Hylarti® Vet Pfizer Antiarthritic Agent
Equine Hylartin® V Pharmacia &Upjohn Antiarthritic Agent
Equine Aspirin Bolus-240 Agrilabs Nonsteroidal Drug(NSAID)
Equine Aspirin Powder Agrilabs Nonsteroidal Drug(NSAID)
Equine Flu-Nix™ D (IVX) Agrilabs Nonsteroidal Drug(NSAID)
Equine Flu-Nix™ D(Norborook) Agrilabs Nonsteroidal Drug(NSAID)
Equine Aspirin Bolus-480 AgriPharm Nonsteroidal Drug(NSAID)
Equine Aspirin Powder AgriPharm Nonsteroidal Drug(NSAID)
Equine AniPrin EZ AHC Nonsteroidal Drug(NSAID)
Equine AniPrin F AHC Nonsteroidal Drug(NSAID)
Equine AniPrin P AHC Nonsteroidal Drug(NSAID)
Equine Bupactin™ Apical Nonsteroidal Drug(NSAID)
Equine Phenylbutazone Injection 20% Aspen Nonsteroidal Drug(NSAID)
Equine VetaMeg™ 50mg/ml Aspen Nonsteroidal Drug(NSAID)
Equine Aspirin Bolus Bimeda Nonsteroidal Drug(NSAID)
Flunazine™ Injectable
Equine Bimeda Nonsteroidal Drug(NSAID)
Solution
Equine Aspirin Powder Bimeda Nonsteroidal Drug(NSAID)
Equine Butatron® Tablets Bimeda Nonsteroidal Drug(NSAID)
Equine Flunazine™ Bimeda-MTC Nonsteroidal Drug(NSAID)
Binoniche Animal
Equine Butequine® Nonsteroidal Drug(NSAID)
Health
(continued on the next page)

51
Table 7a: Non-natural substitute products for Equine
Animal
Sub Product Name Company Name Drug Class
Market
Binoniche Animal
Equine Cronyxin™ Nonsteroidal Drug(NSAID)
Health
Equine Aspirin 60 Grain Butler Nonsteroidal Drug(NSAID)
Equine Aspirin Powder Butler Nonsteroidal Drug(NSAID)
Aspirin Powder Molasses
Equine Butler Nonsteroidal Drug(NSAID)
Flavored
Equine ButaJect Butler Nonsteroidal Drug(NSAID)
Equine Buta Paste Butler Nonsteroidal Drug(NSAID)
Equine Buta Tabs Butler Nonsteroidal Drug(NSAID)
Equine DMSO 90% Butler Nonsteroidal Drug(NSAID)
Equine DMSO 99% Butler Nonsteroidal Drug(NSAID)
Equine DMSO Gel 90% Butler Nonsteroidal Drug(NSAID)
Equine FlunixiJect Butler Nonsteroidal Drug(NSAID)
Equine Phenylbutazone Injection Dominion Nonsteroidal Drug(NSAID)
Equine Phenylbutazone Tabs Dominion Nonsteroidal Drug(NSAID)
Equine Arthri- Eze Aspirin Granules Durvet Nonsteroidal Drug(NSAID)
Equine AspirEze Aspirin Gel Durvet Nonsteroidal Drug(NSAID)
Equine Aspirin Bolus-240 Durvet Nonsteroidal Drug(NSAID)
Equine Equi-Spirin Granules First Companion Nonsteroidal Drug(NSAID)
Equine Equi-Spirin Pain Relief Gel First Companion Nonsteroidal Drug(NSAID)
Equine Aspirin Bolus-480 Grains First Priority Nonsteroidal Drug(NSAID)
Equine Aspirin Powder First Priority Nonsteroidal Drug(NSAID)
Equine Flavored Aspirin Powder First Priority Nonsteroidal Drug(NSAID)
Equine Pributazone® Tablets First Priority Nonsteroidal Drug(NSAID)
Equine Domoso® Gel Fort Dodge Nonsteroidal Drug(NSAID)
Equine Domoso® Solution Fort Dodge Nonsteroidal Drug(NSAID)
Equine Ketofen® Fort Dodge Nonsteroidal Drug(NSAID)
Equine Cool-cast® Hawthorne Nonsteroidal Drug(NSAID)
Equine Surpass® Tropical Cream Idexx Pharm Nonsteroidal Drug(NSAID)
Equine Quadrisol ® 100 Intervet Canada Ltd Nonsteroidal Drug(NSAID)
Equine Quadrisol ® i.v.50 Intervet Canada Ltd Nonsteroidal Drug(NSAID)
Equine Amtech® Asprin Bolus IVX Animal Health Nonsteroidal Drug(NSAID)
Amtech® Phenylbutazone
Equine IVX Animal Health Nonsteroidal Drug(NSAID)
20% Injection
Amtech® Phenylbutazone
Equine IVX Animal Health Nonsteroidal Drug(NSAID)
20% Tablet, USP 1 Gram
Equine Flunixin Meglumine Injection IVX Animal Health Nonsteroidal Drug(NSAID)
Equine Asen 240 Bolus Jaapharm Nonsteroidal Drug(NSAID)
(continued on the next page)

52
Table 7a: Non-natural substitute products for Equine
Animal
Sub Product Name Company Name Drug Class
Market
Equine Asen P Powder Jaapharm Nonsteroidal Drug(NSAID)
Equine Butasone 400 Jaapharm Nonsteroidal Drug(NSAID)
Equine Butasone 1000 Jaapharm Nonsteroidal Drug(NSAID)
(continued)
Equine Butasone Conc Jaapharm Nonsteroidal Drug(NSAID)
Equine Suppressor Kane Nonsteroidal Drug(NSAID)
Equine Equinphen® Paste luitpold Nonsteroidal Drug(NSAID)
Equine EQUIOXX ® Oral Paste Merial Nonsteroidal Drug(NSAID)
Equine Anafen® Injection 100mg/ml Merial Nonsteroidal Drug(NSAID)
Equine Aspirin U.S.P Powder Neogen Nonsteroidal Drug(NSAID)
Aspirin USP With Apple
Equine Neogen Nonsteroidal Drug(NSAID)
Flavoring
Equine Dipyrone 50% P.V.L Nonsteroidal Drug(NSAID)
Equine Phenylbutazone Injection P.V.L Nonsteroidal Drug(NSAID)
Equine Phenylbutazone Tablets P.V.L Nonsteroidal Drug(NSAID)
Phoenix
Equine Aspirin Bolus-240 Nonsteroidal Drug(NSAID)
Pharmaceutical
Phoenix
Equine FluMeglumine® (IVX) Nonsteroidal Drug(NSAID)
Pharmaceutical
Phoenix
Equine FluMeglumine®(Norbrook) Nonsteroidal Drug(NSAID)
Pharmaceutical
Phoenix
Equine Ketoprofen Sterile Solution Nonsteroidal Drug(NSAID)
Pharmaceutical
Phenylbute® Injection 20% Phoenix
Equine Nonsteroidal Drug(NSAID)
(IVX) Pharmaceutical
Phenylbute® Injection 20% Phoenix
Equine Nonsteroidal Drug(NSAID)
(Sparhawk) Pharmaceutical
Phoenix
Equine Phenylbute® Paste Nonsteroidal Drug(NSAID)
Pharmaceutical
Phoenix
Equine Phenylbute® Powder Nonsteroidal Drug(NSAID)
Pharmaceutical
Phenylbute® Tablets 1 Phoenix
Equine Nonsteroidal Drug(NSAID)
gram(first priority) Pharmaceutical
Phenylbute® Tablets 1 Phoenix
Equine Nonsteroidal Drug(NSAID)
gram(IVX) Pharmaceutical
Equine Pro-bute™ Injection Prolabs Nonsteroidal Drug(NSAID)
Equine Pro-bute™ Tablets 1 gram Prolabs Nonsteroidal Drug(NSAID)
Equine Suppressor® RVX Nonsteroidal Drug(NSAID)
Equine Suppressor®-Dairy RVX Nonsteroidal Drug(NSAID)
(continued on the next page)

53
Table 7a: Non-natural substitute products for Equine
Animal
Sub Product Name Company Name Drug Class
Market
Equine Phenylbutazone Tablets RVX Nonsteroidal Drug(NSAID)
Banamine®Sterile Solution Schering- Plough
Equine Nonsteroidal Drug(NSAID)
Injectable Canada Inc
Equine Banamine® Granules Schering-Plough Nonsteroidal Drug(NSAID)
Banamine® Injectable
Equine Schering-Plough Nonsteroidal Drug(NSAID)
Solution
Equine Banamine® Paste Schering-Plough Nonsteroidal Drug(NSAID)
Equine Phenylzone® Paste Schering-Plough Nonsteroidal Drug(NSAID)
Equine Phenylbutazone 20% Injection Sparhawk Nonsteroidal Drug(NSAID)
Equine Phenylbutazone Injection Univet Nonsteroidal Drug(NSAID)
Equine Aspirin 240 Grain Boluses Vedco Nonsteroidal Drug(NSAID)
Equine Aspirin 480 Grain Boluses Vedco Nonsteroidal Drug(NSAID)
Equine Aspirin Powder Vedco Nonsteroidal Drug(NSAID)
Equine Bute Tabs Vedco Nonsteroidal Drug(NSAID)
Equine Equi-Phar ButePaste Vedco Nonsteroidal Drug(NSAID)
Equi-Phar™ Phenylbutazone
Equine Vedco Nonsteroidal Drug(NSAID)
Injection 20%
Equine VedaGesic™ Vedco Nonsteroidal Drug(NSAID)
Equine Flunixin Meglumine Injection Vet tek Nonsteroidal Drug(NSAID)
Equine Phenylbutazone 20% Injection Vet tek Nonsteroidal Drug(NSAID)
Equine Phenylbutazone Tablets UPS Vet tek Nonsteroidal Drug(NSAID)
Equine Aspirin Bolus VetOne Nonsteroidal Drug(NSAID)
Equine Phenylbutazone Tablets Vetone Nonsteroidal Drug(NSAID)
Prevail ™ Flunixin Meglumine
Equine VetOne Nonsteroidal Drug(NSAID)
Injection
Equine Acetylsalicylic Acid Boluses Vetoquinol Nonsteroidal Drug(NSAID)
Equine Buzone Conc Vetoquinol Nonsteroidal Drug(NSAID)
Equine Dipyrone 50% Vetoquinol Nonsteroidal Drug(NSAID)
Equine Phenylbutazone Vetoquinol Nonsteroidal Drug(NSAID)
Equine Phenylbutazone Powder Vetoquinol Nonsteroidal Drug(NSAID)
Equine Domoso® Gel Wyeth Animal Health Nonsteroidal Drug(NSAID)
Equine Domoso ® Solution Wyeth Animal Health Nonsteroidal Drug(NSAID)
Equine Fluxin Injection Wyeth Animal Health Nonsteroidal Drug(NSAID)
Equine Dexamethasone Solution Agrilabs Steroid
Equine Dexamethasone Solution Aspen Steroid
Equine Dexium™ Injection Bimeda Steroid
Equine Dexium-SP ™ Bimeda Steroid
Equine DexaJect Butler Steroid
(continued on the next page)

54
Table 7a: Non-natural substitute products for Equine
Animal
Sub Product Name Company Name Drug Class
Market
Equine DexaJect SP Butler Steroid
Dexamethasone 21 Phosphate
Equine Dominion Steroid
Injection
Equine Dexamethasone Powder Dominion Steroid
Equine Prednisolone Acetate Dominion Steroid
Equine Flucort® Solution Fort Dodge Steroid
Equine Vetalog® Parental Veterinary Fort Dodge Steroid
Amtech® Dexamethasone
Equine IVX Animal Health Steroid
Sodium Phosphate Injection
Amtech® Dexamethasone
Equine IVX Animal Health Steroid
Solution
Equine Dexone Jaapharm Steroid
Equine Dexamethasone Injection P.V.L Steroid
Equine Prednisolone Acetate P.V.L Steroid
Depo-Medrok ® Sterile
Equine Pfizer Steroid
Aqueous Suspension
Predef® 2x Sterile Aqueous
Equine Pfizer Steroid
Suspension
Solu-Delta-Cortef®Sterile
Equine Pfizer Steroid
Solution
Equine Depo-Medrol® Pharmacia &Upjohn Steroid
Equine Solu-Delta-Cortef ® Pharmacia &Upjohn Steroid
Dexamethasone Injection 2 Phoenix
Equine Steroid
mg/ml(sparhawk) Pharmaceutical
Dexamethasone Sodium Phoenix
Equine Steroid
Phosphate Pharmaceutical
Phoenix
Equine Dexamethasone Solution(IVX) Steroid
Pharmaceutical
Equine Dexacort 5 Rafter 8 Steroid
Equine Rafer Dex Rafter 8 Steroid
Equine Dexasone RVX Steroid
Equine Dexasone 4 mg RVX Steroid
Equine Azium® Powder Schering-Plough Steroid
Equine Azium® Solution Schering-Plough Steroid
Dexamethasone Injection 2
Equine Sparhawk Steroid
mg/ml
Prednisolone Sodium
Equine Univet Steroid
Succinate
Equine Uni-cort Univet Steroid
(continued on the next page)

55
Table 7a: Non-natural substitute products for Equine
Animal
Sub Product Name Company Name Drug Class
Market
Equine Uni-Dex Univet Steroid
Equine Uni-Med Univet Steroid
Equine Uni-Pred 50 Univet Steroid
Dexamethasone 2.0 mg
Equine Vedco Steroid
Injection
Dexamethasone Sodium
Equine Vedco Steroid
Phosphate Injection
Equine Dexamethasone Solution 2 mg Vet tek Steroid
Equine Dexamethasone 2 mg Injection VetOne Steroid
Dexamethasone- SP 4 mg
Equine Vetone Steroid
Injection
Equine Dexamethasone 2 Vetoquinol Steroid
Equine Dexamethasone 5 Vetoquinol Steroid
Equine Prednisolone Injection Vetoquinol Steroid
Equine Vetacortyl® Vetoquinol Steroid
Equine Flucort® Injection Wyeth Animal Health Steroid

56
Table 7b: Non-natural substitute products for Feline
Animal
Sub Product Name Company Name Drug Class
Market
Feline Aspirin Powder Agripharm Nonsteroidal Drug
Feline Metacam® 0.5% Injection Boehringer Ingelheim Nonsteroidal Drug
Feline Metacan Injection for Cats Boehringer Ingelheim Nonsteroidal Drug
Feline Aspirin Powder Butler Nonsteroidal Drug
Feline Anafen ® 5mg Tablets Merial Nonsteroidal Drug
Feline Anafen ® injection 10mg/ml Merial Nonsteroidal Drug
Feline (nv)Ketoprofen Tablets(5mg) Novopharm Nonsteroidal Drug
Feline Aspirin Powder Vedco Nonsteroidal Drug
Feline Tolfedine® 6mg Tablets Vetoquinol Nonsteroidal Drug
Feline Dexamethasone Solutions Aspen Steroid
Feline Dexium® Tablets Bimeda Steroid
Triamcinolone Acetonide
Feline Boehringer Ingelheim Steroid
Tablets
Feline Triam Tabs Butler Steroid
Feline Flucort® Solution Fort Dodge Steroid
Vetalog® Parenteral
Feline Fort Dodge Steroid
Veterinary
Feline Dexamethasone Injection P.V.L Steroid
Depo-Medrol ® Sterile
Feline Pfizer Steroid
Aquenous Suspension
Solu-Delata-Cortef®Sterile
Feline Pfizer Steroid
Solution
Feline Depo-Medrol® Pharmacia&Upjohn Steroid
Feline Medrol® Pharmacia&Upjohn Steroid
Feline Solu-Delta-Cortel Pharmacia&Upjohn Steroid
Phoenix
Feline TriAcet® Tablets Steroid
Pharmacautical
Feline Dexacort 5 Rafter 8 Steroid
Feline Prednisolone 5 mg Tablets Rafter 8 Steroid
Feline Rafter Dex Rafter 8 Steroid
Prednisolone Sodium
Feline Univet Steroid
Succinate
Feline Cortalone Tablets Vedco Steroid
Feline Dexamethasone 2 Vetoquinol Steroid
Feline Dexamethasone 5 Vetoquinol Steroid
Feline Dextab Vetoquinol Steroid
Feline Vetacortyl Vetoquinol Steroid
Feline Flucort® Injection Wyeth Animal Health Steroid

57
Table 7c: Non-natural substitute products for Canine
Animal
Sub Product Name Company Name Drug Class
Market
Canine Adequan® Canine Luitpold Antiarthritic agent
Canine Cartrophen Vet Arthropharm Antiarthritic agent
Canine Adequan® Canine Luitpold Antiarthritic agent
Canine Asprin Powder Agrilabs Nonsteroidal Drug
Canine Asprin Powder Agripharm Nonsteroidal Drug
Canine Asprin Powder Bimeda Nonsteroidal Drug
Canine Butatron® Tablets Bimeda Nonsteroidal Drug
Canine Metacam® 0.5% Injection Boehringer Nonsteroidal Drug
Metacam® 1.0 mg Chewable
Canine Boehringer Nonsteroidal Drug
Tablets
Metacam® 2.5 mg Chewable
Canine Boehringer Nonsteroidal Drug
Tablets
Canine Metacam® Oral Suspension Boehringer Nonsteroidal Drug
Canine Metacam® Injection for Dogs Boehringer Ingelheim Nonsteroidal Drug
Canine Metacam® Oral Suspension Boehringer Ingelheim Nonsteroidal Drug
Canine Asprin Powder Butler Nonsteroidal Drug
Canine Buta Tabs D Butler Nonsteroidal Drug
Canine DMSO 90% Butler Nonsteroidal Drug
Canine DMSO 99% Butler Nonsteroidal Drug
Canine DMSO Gel 90% Butler Nonsteroidal Drug
Canine Phenyltutazone Injection Dominion Nonsteroidal Drug
Aspir-Flex ™ Aspirin Gel for
Canine Durvet Nonsteroidal Drug
Large Dogs
Aspir-Flex ™ Aspirin Gel for
Canine Durvet Nonsteroidal Drug
small and medium Dogs
Vetrin™ Canine Pain Relief
Canine Farnam Nonsteroidal Drug
Tablets
Canine Asprin Powder First Priority Nonsteroidal Drug
Canine Flavored Aspirin Powder First Priority Nonsteroidal Drug
Canine Domoso® Gel Fort Dodge Nonsteroidal Drug
Canine Domoso® Solution Fort Dodge Nonsteroidal Drug
Canine EtoGesic® Injectable Fort Dodge Nonsteroidal Drug
Canine EtoGesic® Tablets Fort Dodge Nonsteroidal Drug
Hartx® Advanced Care™
Canine Harz Mountain Nonsteroidal Drug
Enteric-Coated Asprin for dogs
AmTech® Phenylbutazone
Canine Ivx animal Health Nonsteroidal Drug
Tablets, UPS 100mg
Canine Anafen® 5 mg Tablets Merial Nonsteroidal Drug
(continued on the next page)

58
Table 7c: Non-natural substitute products for Canine
Animal
Sub Product Name Company Name Drug Class
Market
Canine Anafen® 20 mg Tablets Merial Nonsteroidal Drug
Canine Anafen Injection 10mg/ml Merial Nonsteroidal Drug
Previcox™ Chewable Tablets
Canine Merial Nonsteroidal Drug
(57 mg)
Previcox™ Chewable Tablets
Canine Merial Nonsteroidal Drug
(227 mg)
Canine Previcox Chewable Tablets Merial Nonsteroidal Drug
Asprin UPS with Apple
Canine Neogen Nonsteroidal Drug
Flavoring
Deramaxx ® Flavor Tabs™
Canine Novartis Nonsteroidal Drug
(25mg)
Deramaxx ® Flavor Tabs™
Canine Novartis Nonsteroidal Drug
(100mg)
Canine Deramax® Chewable Tablets Novartis Nonsteroidal Drug
Canine (nv)Ketoprofen Tablets(5mg) Novopharm Nonsteroidal Drug
Canine (nv)Ketoprofen Tablets(20mg) Novopharm Nonsteroidal Drug
Canine Dipyrone 50% P.V.L Nonsteroidal Drug
Canine Phenyltutazone Injection P.V.L Nonsteroidal Drug
Canine Aspirin Chewable
Canine Pala-Tech Nonsteroidal Drug
Tablets for Large Dogs
Canine Aspirin Chewable
Canine Tablets for Small and Medium Pala-Tech Nonsteroidal Drug
Dogs
Rimadyl® Chewable
Canine Pfizer Nonsteroidal Drug
Tablets(25mg)
Rimadyl® Chewable
Canine Pfizer Nonsteroidal Drug
Tablet(75mg)
Rimadyl® Chewable
Canine Pfizer Nonsteroidal Drug
Tablet(100mg)
Canine Rimadyl Injectable Solution Pfizer Nonsteroidal Drug
Canine Rimadyl® Caplets Pfizer Animal Health Nonsteroidal Drug
Canine Rimadyl® Chewable Tablets Pfizer Animal Health Nonsteroidal Drug
Canine Rimadyl® Injectable Pfizer Animal Health Nonsteroidal Drug
Phoenix
Canine Phenylbute® Tablets 100mg Nonsteroidal Drug
Pharmacautical
Phoenix
Canine Phenylbute® Tablets 200mg Nonsteroidal Drug
Pharmacautical
Canine Zubrin® Tablets Schering-Plough Nonsteroidal Drug
Canine Asprin Powder Vedco Nonsteroidal Drug
(continued on the next page)

59
Table 7c: Non-natural substitute products for Canine
Animal
Sub Product Name Company Name Drug Class
Market
Canine Novox® Caplets Vedco Nonsteroidal Drug
Canine Dipyrone 50% Vetoquinol Nonsteroidal Drug
Canine Phenyltutazone Vetoquinol Nonsteroidal Drug
Canine Tolfedine®4% Injection Vetoquinol Nonsteroidal Drug
Canine Tolfedine® 6 mg Tablets Vetoquinol Nonsteroidal Drug
Canine Tolfedine® 20 mg Tablets Vetoquinol Nonsteroidal Drug
Canine Tolfedine® 60 mg Tablets Vetoquinol Nonsteroidal Drug
Canine Vetprofen™ Caplets Vetoquinol USA Nonsteroidal Drug
Canine Domoso (R) Solution Wyeth Animal Health Nonsteroidal Drug
Canine Dexamethasone Solutions Aspen Steroid
Canine Dexium® Tablets Bimeda Steroid
Triamcinolone Acetonide
Canine Boehringer Ingelheim Steroid
Tablets
Canine DexaJect SP Butler Steroid
Canine Prednis Tab® Butler Steroid
Canine Triam Tabs Butler Steroid
Canine Prednisolone Acetate Dominion Steroid
Canine Flucort® Solution Fort Dodge Steroid
Vetalog® Parenteral
Canine Fort Dodge Steroid
Veterinary
AmTech® Dexamethasone
Canine IVX animal health Steroid
Sodium Phosphate
Canine Dexamethasone Injection P.V.L Steroid
Canine Prednisolone Acetate P.V.L Steroid
Depo-Medrol® Sterile
Canine Pfizer Steroid
Aqueous Suspension
SOlu-Delata-Cortef® Sterile
Canine Pfizer Steroid
Solution
Canine Depo-Medrol® Pharmacia&Upjohn Steroid
Canine Metrol Pharmacia&Upjohn Steroid
Canine Solu-Delta-Cortel Pharmacia&Upjohn Steroid
Dexamethasone Sodium Phoenix
Canine Steroid
Phosphate Pharmacautical
Phoenix
Canine Prednis Tab® Steroid
Pharmacautical
Phoenix
Canine TriAcet® Tablets Steroid
Pharmacautical
Canine Dexacort 5 Rafter 8 Steroid
(continued on the next page)

60
Table 7c: Non-natural substitute products for Canine
Animal
Sub Product Name Company Name Drug Class
Market
Canine Prednisolone 5mg Tablets Rafter 8 Steroid
Canine Rafter Dex Rafter 8 Steroid
Canine Dexasone 4mg RXV Steroid
Prednisolone Sodium
Canine Univet Steroid
Succcinate
Canine Uni-Med Univet Steroid
Canine Uni-Pred 50 Univet Steroid
Canine Cortalone Tablets Vedco Steroid
Dexamethasone Sodium
Canine Vedco Steroid
Phosphate Injection
Canine Prednis Tab® Vedco Steroid
Canine Prednis Tab® Vet-A- Mix Steroid
Canine Dexamethasone 2 Vetoquinol Steroid

Canine Dexamethasone 5 Vetoquinol Steroid


Canine Dextab Vetoquinol Steroid
Canine Prednisolone Injection Vetoquinol Steroid
Canine Vetacortyl® Vetoquinol Steroid
Canine Genesis® Tropical Spray Virbac Steroid
Canine Flucort® Injection Wyeth Animal Health Steroid

61
Table 8: Summary of number substitute non-natural substitutes by Animal Sub class
(create a table)
Animal Sub Class Anti-Arthritic Agent NSAID Steroidal Drugs
Equine 14 (8 Companies) 108 (34 companies) 46 (22 companies)
Canine 3 (2 companies) 63 (25 companies) 38 (19 companies)
Feline 9 (7 companies) 23 (15 companies)
Total 17 180 107

62
APPENDIX- FDA LETTERS

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