Professional Documents
Culture Documents
BIOCIDES IN STERILANTS
AND HIGH LEVEL
DISINFECANTS
2017
1.2 METHODOLOGY....................................................................................................................................................5
1.4 DEFINITIONS...........................................................................................................................................................5
6 DISTRIBUTION ...............................................................................................................34
7 VALUE CHAIN ANALYSIS .............................................................................................36
9 TRENDS ..........................................................................................................................39
10 FUTURE ......................................................................................................................41
2) To identify and analyse the trends taking place within the Biocides used.
1.2 METHODOLOGY
The report is based on 10 interviews conducted throughout the globe. In each industry
analysis, BI contacted Sterilant manufacturers, biocide manufacturers, formulators, suppliers,
distributors and trade associations by telephone and conducted unstructured interviews
typical of the type used in industrial market research. In addition to interviews, the report also
summarises suppliers' product literature, data from trade associations, BI databases, and our
Monthly Information Report.
1.4 DEFINITIONS
Biocide manufacturers are defined as companies who manufacture biocide active ingredients
in-house. For example BASF, Dow, DSM, Evonik, PeroxyChem and Solvay.
Disinfectant and Steriliser Formulators are defined as companies whose majority of sales
comes from purchasing biocides which they incorporate into their own products. For example
Bioquell, Ecolab, Johnson & Johnson (Advanced Sterilisation Products), Metrex, and
Minntech etc.
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Distributors act as agents for both active manufacturers and biocide blenders. They are the
most popular choice of supplier for small end-users. Distributors sell a range of additives and
so will be making deliveries to end users and therefore biocides tend to be combined with
other products which allow the distributor to be competitive.
Prices are in U.S. dollars and are at active manufacturer level unless stated. The exchange
rates used are as in the following table:.
$ Currency
1 0.94 EUR
1 6.94 CNY
1 116.95JPY
1 0.81 GBP
Source: www.xe.com
Volumes are reported in tonnes based on a 100% active biocide basis. In the case of
formulated products, the data is reported with a typical percentage of the formulated product.
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Machines and reusable instruments are divided into three classes for the purpose of
determining the level of disinfection required: critical, semicritical, and noncritical.
Critical instruments are those that penetrate normally sterile tissue, including blood vessels.
Examples, in addition to surgical instruments and implants, include arthroscopes,
laparoscopes, and endoscopic biopsy forceps.
Semicritical instruments contact mucous membranes or non-intact skin, but are not
intended to penetrate sterile tissue. Examples include gastrointestinal endoscopes,
cystoscopes, bronchoscopes, anesthesia and respiratory therapy equipment, vaginal probes
used in diagnostic radiology, fitting diaphrams and laryngoscopes. Items directly attached to
instruments that contact mucous membranes, such as the handles of rigid laryngoscopes,
should be considered semicritical instruments. Tonometers (used to measure ocular
pressure) are also often not appropriately disinfected, resulting in outbreaks of epidemic
keratoconjunctivitis.
Noncritical items are those that come in contact with only intact skin, and include blood
pressure cuffs, linens and general use equipment, furnishings, and environmental surfaces.
Critical instruments should be sterilized before reuse and semicritical instruments should be
subjected to at least high level disinfection or sterilization, while non-critical items require only
low or intermediate level disinfection prior to use. This report focuses on the consumption of
Biocides in critical and semicritical instruments.
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This report focuses on the consumption of Biocides in high level Disinfecants and Sterilants.
Such products are used to sterilize surgical instruments and equipment when autoclaving or
gas sterilization is unsuitable due to heat sensitivity such as in small surgeries or day care
centres. In liquid sterilisation, surgical instruments are soaked. The most popular biocides are
Glutaraldehyde, Hydrogen Peroxide, o-phthalaldehyde and Peracetic acid. The leading
suppliers of high level Disinfectants and Sterilants are Johnson & Johnson and Minntech. The
high level Disinfectants and Sterilants must be able to destroy microorganisms on the surface
of equipment without damaging the equipment.
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For sterilization to be effective, items being processed require exposure to direct steam contact at
the required temperature and pressure for the specified time. Pressure serves as the means to obtain
the high temperatures needed to kill microorganisms.
High temperature of the steam, 121 to 132°C (250 to 270°F) kills microorganisms in 3 to 20
minutes, depending on the type of sterilizer and wrapping.
ADVANTAGES DISADVANTAGES
- effective against most spore forming organisms - causes rust and corrosion in unprotected carbon
steel instruments (anti-rust agents helps reduce
this)
- quick and easy to use - may damage heat sensitive materials
- penetrates fabric and paper wrapping - dulls unprotected cutting edges
- reliable, can be monitored - Bacillus stearothermophilus
B. Dry Heat
Dry heat sterilizes less efficiently than moist heat because as proteins dehydrate and dry, their
resistance to denaturation increases. A higher temperature is required for a dry heat unit than for a
steam processor. In order for sterilization to occur, the cycle must be brought to correct temperature
and then maintained at that temperature.
Actual time needed to sterilize instruments will depend on the size and arrangement of the load, the
type of wrapping material and unit efficiency. A typical dry heat cycle is 1 hour at 170°C. or 2
hours at 160°.
ADVANTAGES DISADVANTAGES
- reliable - longer processing times
- no rust or corrosion of previously dried - damages some plastics
instruments
- little maintenance - scorches paper of cloth wrappings
- has monitoring capabilities - can destroy the temper of metal instruments and
melt solder joints
- cycle must be uninterrupted - start complete
cycle over if unit door is opened to add forgotten
items
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Chemical vapor sterilizers use a specific mixture of formaldehyde, alcohols, ketone, acetone and
water under pressure at 132°C (270°F) to achieve sterilization. Sterilization requires 20 - 40
minutes and the chemical solution must only be used once.
ADVANTAGES DISADVANTAGES
- relatively quick; no drying time - produces offensive odor
- minimal rusting or corrosion - won't penetrate fabric wrapping
- reliable - damages plastics
- works with paper packaged articles - high cost of special solutions
- has monitoring capabilities
These sterilizers use extremely hot rapid airflow to achieve sterilization in approximately six
minutes.
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End-Use %
Medical 40
Other 10
TOTAL $ 2.2 Bn
The global market for medical device sterilant products is estimated at $ 880 million.
Endoscope sterilants is the biggest sector within the medical device market with estimated
sales of $ 500 million.
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REGION % SALES
America 40%
Europe 28%
TOTAL $2.2 Bn
The Americas is the leading geographical region for Sterilant products with consumption of $
880 million. European sales of Sterilants are estimated at $600 million with Germany being
the leading market as it has the highest number of hospitals in Europe giving it a substantial
end user base.
The main growth for Sterilant products in the future will be in developing regions, particularly
in Asia/Pacific, Eastern Europe and Latin America.
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STERILANT TRADENAME
% BIOCIDES
FORMULATOR
Omnicare 1 Step,
Allergan hydrogen peroxide
Oxysept, Ultracare
Steranios 20 %
SCJ Concentrate 20 % glutaraldehyde
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19.7 g.
Bode alkyldimethylammoniumchlorides
1.0 g,
didecyldimethylammoniumchlorid
es 1.0 g.
Sterilant
Sinopec hydrogen peroxide
Sporicidin
1.12 % glutaraldehyde, 1.93 %
Sporicidin Disinfecting and
phenol phenate
Sterilizing
Resert XL
Steris 2 % hydrogen peroxide
Steris S-20
Steris 0.2 % peracetic acid
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2.5 AMERICA
STERILANT TRADENAME
% BIOCIDES
FORMULATOR
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Resert XL
Steris 2 % hydrogen peroxide
Steris S-20
Steris 0.2 % peracetic acid
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STERILANT TRADENAME
% BIOCIDES
FORMULATOR
Steriliser
Sinopec Baling Hydrogen peroxide
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2.7 EUROPE
STERILANT TRADENAME
BIOCIDES
FORMULATOR
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Resert XL
Steris 2 % hydrogen peroxide
Steris S-20
Steris 0.2 % peracetic acid
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In general terms, prices tend to be highest in highly regulated markets e.g. USA and lowest in
unregulated markets. The most popular Biocides used in liquid sterilisation are listed in the
following table with supplier, trade names, active ingredient and price.
As seen in the above table, Glutaraldehyde sells for $ 10 per kg (50 % active ingredient).
There is a 50 % difference in pricing across all regions of the World. For example, ortho-
phthalaldehyde can be purchased from Chinese / Indian Suppliers for as low as $ 40 per kg
whereas the leading supplier is DSM who charge $ 80 per KG. This is a similar trend for all
Biocides with Chinese / Indian pricing up to 50 % lower than the price for Biocides in the west.
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If the biocides have regulatory approvals and are formulated for immediate usage, the price of
the biocide will increase by 100 %. This would mean the cost of treating sterilants with
registered biocides would amount to 6 % and 10 % respectively.
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Biocide application levels vary with production conditions, desired shelf life, susceptibility of
raw materials to microbial contamination, end user application and the biocides strength. The
typical usage for 2 sterilants containing 2.4 % glutaraldehyde and 0.55 % ortho-phthaldehyde
are compared in a hospital setting.
Glutaraldehyde ($ 5 per 1 pint bottle). 20 minutes per cycle (automated) = 24 cycles per 8-
hour shift.
There was 14 days maximum reuse contact conditions. (If a lot of contamination within the
instruments, the active ingredients may be used up sooner. This can be measured via test
strips such as cidex test strips)
The benefits of increased process time are (1) Increased availability of instruments and
medical devices (2) Decreased inventory needed on hand (3) Increased personnel
availability to care for patients.
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3 BIOCIDE CONSUMPTION
Glutaraldehyde is a popular Sterilant with sales of $38 million at active manufacture level.
Glutaraldehyde is used primarily for the sterilisation of medical instruments such as
endoscopes. It has a wide range of bactericidal, fungicidal and virucidal activity. In the
Johnson & Johnson Cidex product, glutaraldehyde is formulated as a single active at a
concentration of 2%. In other products, it is frequently combined with other aldehydes or
actives. The leading manufacturers of glutaraldehyde are BASF and Dow where it is sold
under the tradenames of Protectol GDA and Ucarcide 250. Recently Glutaraldehyde has
been substituted by another Aldehyde called Ortho-phthalaldehyde (OPA). Glutaraldehyde
can be unpopular due to its unpleasant odour.
Peracetic acid is a popular sterilant with sales of $36 million at active manufacture level.
Peracetic acid is an oxidizing agent and is very effective with a broad spectrum of activity; it
covers Gram-positive and Gram-negative bacteria, yeasts, fungi, spores and viruses. The
product is used for liquid sterilisation of medical appliances and equipment. In liquid
sterilisation, the instruments are soaked in Peracetic acid to prevent the development of
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growth and risk of spread of infection. A major advantage of Peracetic acid is that it is non
foaming water soluble liquids which are fast acting and break down to environmentally
acceptable decomposition products. Solvay, Peroxychem, Evonik, Mitsubishi Chemical,
Nippon Peroxide and Seeler are the leading manufacturers of Peracetic acid for the Medical
industry. A leading formulator of Peracetic acid is Fresenius who markets Puristeril which
contains 3.5% active solution and is widely used for dialysis equipment sterilization.
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The value of biocides in the Sterilants and high level Disinfectants market at the end user
level is estimated at $ 2,636 million or some 20 times the sales at manufacture level. Active
ingredient manufacturers supply sterilant formulators with biocides, which are formulated for
ready to use applications. Sterilant formulators supply directly or via distributors and service
companies to hospitals. As can be seen in the following table, there is a very high percentage
of value added between the manufacturer of biocides and the end user of biocides.
Table 16: Consumption of Biocides within Sterilants at Manufacture and End User level
SALES OF BIOCIDES AT MANUFACTURE LEVEL AND END USER LEVEL FOR
FORMULATED STERILANTS INDUSTRY IN $ M
Sales at Distribution % Mark-Up Sales at end-
manufacture route to end- user level ($m)
level ($m) user in %
A. I. Manufacturer 110
Sterilant 70 1800 * 1,877.0
Formulators
Distributor & 30 2200 ** 759.0
Service
Companies
Total 110 100 2,636.0
* Sterilant formulator mark-up includes mark-up for all additives, formulating, packaging,
marketing, regulatory costs associated with supplying high level disinfectants and sterilant
formulations.
** Distributor mark-up includes mark-up for all additives, formulating, packaging, marketing
regulatory costs and distribution margin associated with supplying sterilant formulations via a
distributor and service company.
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5 BIOCIDE MANUFACTURERS
BASF manufactures glutaraldehyde and glyoxal for the Sterilants industry and supplies under
the Protectol tradename with estimated sales of $9 million. The biocides supplied by BASF
are listed in the following table:.
Dow has sales of $ 21 million to the Sterilants industry. The company manufactures
glutaraldehyde and phenolic biocides. Dow is the dominant supplier of glutaraldehyde and
OPP phenolics to the Sterilants products industry.
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Ecolab is a leading supplier of Hydrogen Peroxide and Peracetic acid with sales of $ 10
million to the high level Disinfectants and Sterilants industry. Ecolab’s products are toll
manufacturered using Seeler in the USA and Henkel in Europe.
Evonik is a manufacturer of Hydrogen Peroxide and Peracetic acid with sales of $ 8 million to
the Sterilants industry. Sales are mainly to specialist formulators who resell sterilants.
Solvay is the leading European producer of Hydrogen Peroxide and Peracetic acid. The
company had sales of $ 11 million to the Sterilants industry. The company manufactures
Peracetic acid sold under the tradename of Proxitane which is primarily used for sterilisation
of medical instruments. Solvay supplies direct to large endusers and also via distributors and
formulators.
The other sector has sales of $ 37 million. This group of companies include DSM (Europe),
Envirotech (US), Fresenius (Europe) and Nippon Peroxide (Japan). Also included in the other
sector are tollers and generic suppliers. The leading tollers are Burlington (www.burco.com)
and Seeler (www.seeler.com) in the US.
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6 DISTRIBUTION
Biocide Active Ingredient Manufacturers supply Biocides to distributors and via Sterilant
formulators. The single most important route is to formulators of Sterilants and high level
Disinfectants who purchase biocides directly from Biocide active ingredient manufacturers. It
is estimated that 70 % of the total biocide consumption within the Sterilants and high level
Disinfectants industry goes via this route as illustrated in the chart below:
DISTRIBUTION OF BIOCIDES
Active Ingredient
Manufacturer
(2)
(1)
Sterilant Distributor
Formulator
Distributor and
Service Company
70 %
Typically for each active ingredient, a Sterilant products formulator will qualify one biocide
manufacturer as a primary supplier and another as a back-up source. The leading
manufacturers are BASF, Dow, DSM, Evonik, Peroxychem and Solvay.
The typical scenario for Sterilant formulators, would involve the addition of the biocide to other
additives with good characteristics of storage, ease of use and performance. Some additives
will improve the antimicrobial activity of the biocide. Special attention is being devoted to the
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ease and safety of application. Liquid formulations, either solutions or dispersions with low
viscosity, are the easiest to handle and can be added automatically by pumps.
The sterilant formulators play a very important role in the distribution of biocides with an
estimated 70% of the total biocide purchases. Sterilant formulators tend to concentrate on
specific market segments where they provide technical service and regulatory approval as
well as taking the best of different actives and combining them together to increase
effectiveness. The chemical manufacturers of biocide actives invariably provide data giving
the effectiveness of their product against a variety of target microorganisms. This information
is used by the sterilant formulators to provide blended products for their target market and
also to gain registration for their blended products.
As well as supplying sterilant formulations direct, Sterilant formulators will also supply
distributors and service companies. Service companies have grown by offering a complete
cleaning and sterilisation service.
Distributors and service companies tend to handle the orders of the smaller end-users and in
remote geographical regions. They are many types of distributors who will range from
suppliers of the biocide active ingredients used in the Sterilant to suppliers of the complete
sterilant formulation. The leading distributors for biocide active ingredients are Ashland,
Azelis, Brenntag and Univar while smaller regional distributors tend to dominate the supply of
sterilants.
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Active Manufacturer
Value Added up to 200 %
Distributor / Service
Value Added up to 200 %
As can be seen in the above table, value added is maximised at the sterilants formulator level
for biocides within the Sterilants industry.
Biocide manufacturers sell active ingredients for sterilants directly to the formulators and
distributors. The Biocide manufacturers could receive value added of up to 200% if they
supply registered formulated biocides via a frame formulation to Sterilant formulators. In most
situations, the biocide manufacturer does not provide frame formulations and so their value
added is much reduced.
The Sterilant formulators achieve value added of between 1000 % and 3000 % based on the
purchase price of the biocide when they supply sterilant formulations to end users such as
Hospital, Medical and Retail Centres. The higher value added of 3000 % would only be
achieved with a new active ingredient which is patented and where they have all the
formulation and regulatory expertise for the biocide. This high value added was achieved by
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Johnson & Johnson when they introduced Cidex OPA to the market. The high value added
reflects the costs of distribution, formulating, marketing, packaging, technical and regulatory
support which they have incurred while developing the formulation .
Distributors and Service companies receive a value added of up to 200% when they supply
sterilants to hospitals and medical centres. The higher value added would reflect the high
costs incurred in servicing smaller hospitals in remote areas.
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8 REGULATORY ANALYSIS
1) In Europe, Biocides used in Sterilants are covered by the directive on medical Devices
93/42/EEC. In addition, CEN, the European standards body sets standards for high
level Disinfectants and Sterilants.
2) The FDA and EPA have agreed to give the FDA greater involvement in the
implementation of disinfectant and germicide approvals. The FDA has increased the
stringency of its regulations regarding high level disinfectant products. Part of these
regulations include the categorisation of products into "safe and effective" (Category I),
"unsafe and /or ineffective", (Category II) and "insufficient data", Category III.
3) In other countries throughout the globe, biocides used in sterilants are classified and
labelled in accordance with respective national laws or using FDA approvals where
national laws do not exist.
4) Once a Biocide is on the approved list, suppliers will use approval bodies via standards
to endorse their usage. For example, sporicidal testing (B Subtilis) according to
Standard NF T 72231 or NFT 72230. Virucidal testing (Polio virus) according to
Standard NFT 72180 or EN 14476. Tuberculocidal testing (M. tuberculois) to standard
NFT 7230 or EN 14348. Bactericidal testing according to NFT 72190 or EN 13727.
Fungicidal testing (C albicans) according to NF EN 1275 or EN 13624.
Mycobactericidal Effects according to standard EN 14348.
In Europe, The Biocidal Products Regulation (BPR) is responsible for Biocides regulation and
the European Chemicals Agency (ECHA) is responsible for coordinating the approval
processes for Biocides and the authorisation of Biocides at EU level. A Biocidal Products
Committee, consisting of representatives from each of the EU Member States will give its
opinion on Biocidal products, supported by technical and scientific support from ECHA. A
Biocidal product cannot be supplied on the EU market after 1st September 2015 unless the
Biocide is included in the Article 95 list of the approved Biocides. See the list on
http://echa.europa.eu/information-on-chemicals/active-substance-suppliers
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9 TRENDS
1) All biocides used within the Sterilants industry, have had their patents expired and as a
result, generic competitors have entered the market. Generic products will continue to
grow in popularity as hospitals and other health care institutions are facing declining
budgets and in many cases there is an incentive from the Government for doctors to
use generic products.
6) There is a current trend towards rationalisation and globalisation via the large
multinationals. This trend is set to continue. One such company is STERIS who is a
global leader in infection prevention, contamination control, surgical and critical care
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7) There has been a trend towards the increased use of endoscopic surgery procedures
driven by the increased popularity of minimal invasive surgical operations and the
increasing age of the population. This trend will be a major positive influence on the
use of all Sterilants.
3. Fast kill
4. Cost effective
6. Low toxicity
7. Biodegradable
8. Relevant Approvals
9. Low Ecotoxicity
10. High dirt resistance
Most of the current biocides used within the Sterilants industry have limitations. There is an
opportunity in the Sterilants industry for a new active which provides broad spectrum efficacy
against microorganisms. Furthermore products must have a benign toxicological profile, non-
irritating and rated “risk free” from cancer and other chronic effects.
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10 FUTURE
The consumption of biocides in Sterilants is forecasted to increase 3% per year for the next
five years as outlined in the following table:.
Biocides used in Sterilants will grow to $ 128 million at manufacture level in 2023. The
following factors will affect future consumption of biocides used in Sterilants:
MARKET
The Sterilants industry will continue to grow at 3% per year due to increasing surgery and
increased healthcare spending in the under developed world and the switch to higher value
biocides.
BIOCIDES
The most popular sterilant is Glutaraldehyde but has been under pressure as it is viewed as
an irritant which may cause asthma and respiratory sensitization. It is also a Skin sensitizer.
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(2) Efficacy
(3) Price
The global consumption of Sterilants is forecasted to grow 3% per year for the next five years.
At the raw material level, environmental and regulatory considerations are the principal
factors driving technological development and changes in the industry. Consequently,
products that present the greatest challenges in terms of environmental and workplace safety
will register below average growth. This trend is best illustrated in the movement from
glutaraldehyde to alternative products such as OPA and hydrogen peroxide and Peracetic
Acid based Sterilants.
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