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REPORT

BIOCIDES IN STERILANTS
AND HIGH LEVEL
DISINFECANTS

2017

Prepared by: Biocide Information Limited


Email: info@biocide-information.com
More about us on www.biocide-information.com
GLOBAL SUMMARY – BIOCIDES IN STERILANTS

Market Size 2017: Active Ingredient


$ 110 million

BIOCIDE SALES BY REGION:


Table 1: Biocide Sales by Region for Sterilants
REGION SALES ($M)
AMERICAS 34
ASIA PACIFIC 37
EUROPE 39

BIOCIDE SALES BY LEADING ACTIVE INGREDIENT:


Table 2: Biocide Sales by Type
BIOCIDES SALES ($M)
Glutaraldehyde 38
Peracetic acid 36

BIOCIDE SALES BY LEADING ACTIVE INGREDIENT SUPPLIER:


Table 3: Biocide Sales by Manufacturer
COMPANY SALES ($M)
BASF 9
Dow 21
Solvay 11

Outlook for the future:


• The market for Biocides in Sterilants and high level Disinfectants is expected to
show an increase of 3% per year. The most popular Sterilant Ethylene oxide will
continue to be replaced by biocides due to health (carcinogen) and safety reasons
(extremely reactive). Safety, indoor air quality and environmental impact via the
waste generation and disposal are the main factors governing the use of biocides.
TABLE OF CONTENTS

1 INTRODUCTION & METHODOLGY .................................................................................5


1.1 OBJECTIVES............................................................................................................................................................5

1.2 METHODOLOGY....................................................................................................................................................5

1.3 ACCURACY OF THE INFORMATION ...............................................................................................................5

1.4 DEFINITIONS...........................................................................................................................................................5

2 END USER ANALYSIS .....................................................................................................7


2.1 TARGET MARKET – TYPE OF MACHINE / INSTRUMENT .........................................................................7

2.2 TYPE OF DISINFECTANTS...................................................................................................................................8

2.3 NON CHEMICALS TYPE OF DISINFECTANTS ...............................................................................................9

2.4 GLOBAL ANALYSIS.............................................................................................................................................11


2.4.1 Global Sterilants by Suppliers ..............................................................................................................................11
2.4.2 Global Sterilants by Geography............................................................................................................................12
2.4.3 Biocides used by leading Sterilant Formulators ...................................................................................................13

2.5 AMERICA ...............................................................................................................................................................18


2.5.1 Biocides used by Sterilant Formulators in America .............................................................................................18

2.6 ASIA PACIFIC........................................................................................................................................................20


2.6.1 Biocides used by Sterilant Formulators in Asia Pacific........................................................................................20

2.7 EUROPE ..................................................................................................................................................................21


2.7.1 Biocides used by Sterilant Formulators in Europe................................................................................................21

2.8 BIOCIDE COMPARISON .....................................................................................................................................23

2.9 PRICING OF BIOCIDES.......................................................................................................................................25


2.9.1 Pricing at Active Ingredient Level........................................................................................................................25
2.9.2 Pricing at Formulated Products Level ..................................................................................................................26

2.10 ANTI-MICROBIAL COSTS IN SYSTEM ...........................................................................................................27


2.10.1 Cost of Biocides in a Sterilant..........................................................................................................................27
2.10.2 Comparison of 2 Sterilants in U.S.A................................................................................................................28

3 BIOCIDE CONSUMPTION ..............................................................................................29


3.1 GLOBAL ANALYSIS.............................................................................................................................................29

4 BIOCIDE CONSUMPTION AT END-USER LEVEL ........................................................31

5 BIOCIDE MANUFACTURERS ........................................................................................32

5.1 GLOBAL MARKET SHARE BY MANUFACTURER ......................................................................................32

6 DISTRIBUTION ...............................................................................................................34
7 VALUE CHAIN ANALYSIS .............................................................................................36

8 REGULATORY ANALYSIS ............................................................................................38

9 TRENDS ..........................................................................................................................39

10 FUTURE ......................................................................................................................41

10.1 BIOCIDE GROWTH..............................................................................................................................................42


BIOCIDES IN STERILANTS AND HIGH LEVEL DISINFECTANTS – 2017

1 INTRODUCTION & METHODOLGY


1.1 OBJECTIVES
The key objectives of this study were:
1) To provide marketing data on Biocides, major Sterilant and high level disinfectant
products using Biocides, suppliers and customers.

2) To identify and analyse the trends taking place within the Biocides used.

3) To define the distribution channels in the industry

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.

1.3 ACCURACY OF THE INFORMATION


BI believes our estimates to be within 20% of the actual value. The accuracy of the
information is dependent on many factors such as the number of interviews conducted per
application, industry concentration and industry usage patterns. In order to increase our
accuracy, BI increases the number of end-user interviews where an industry is fragmented
and continues to interview until there is similarity in responses. Also all conclusions and data
per industry were confirmed with the key manufacturers of Biocides.

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:.

Table 4: Currency Conversion Rates

$ 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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2 END USER ANALYSIS

2.1 TARGET MARKET – TYPE OF MACHINE / INSTRUMENT

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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2.2 TYPE OF DISINFECTANTS


Levels of Disinfectants

Sterilants destroy all microorganisms, including bacterial endospores. Examples of sterilants


include pressurized steam, ethylene oxide gas, and hydrogen peroxide plasma.
High level disinfectants destroy all pathogenic microorganisms, including some bacterial
endospores during short exposure times, and can destroy high numbers of bacterial
endospores during long exposures times. Examples include 2% glutaraldehyde, 7.5%
hydrogen peroxide, and 0.2% peracetic acid.

Intermediate-level disinfectants, labelled as tuberculocidal, destroy many types of


microorganisms including Mycobacteria, but not endospores. Examples include bleach,
phenolic compounds, alcohols, and concentrated quaternary ammonium compounds. These
are also commonly used for disinfection of environmental surfaces, including blood spills.

Low-level disinfectants destroy some types of microorganisms, but not endospores or


Mycobacteria. Examples include alcohols and diluted quaternary ammonium compounds.
Intermediate and low level disinfectants are not licensed for use in reprocessing critical or
semicritical patient care equipment.

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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2.3 NON CHEMICALS TYPE OF DISINFECTANTS

The following is a brief overview of heat sterilization.

A. Steam, Vapor Under Pressure (AUTOCLAVE)

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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C. Chemical Vapor (CHEMICLAVE)

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

D. Heat Transfer (Bead Type)

These sterilizers use extremely hot rapid airflow to achieve sterilization in approximately six
minutes.

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2.4 GLOBAL ANALYSIS


The Global demand for the formulated Sterilants markets is estimated at $ 2.2 Billion in 2015.
The market is boosted by growing global healthcare spending especially within Asia Pacific
and an aging population. The global Sterilants products market can be broken down by
enduse as shown in the following table:.

Table 5: Global Demand for Sterilants products by End Use

End-Use %

Medical 40

Dental & Optical 50

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.

2.4.1 Global Sterilants by Suppliers


There are many companies manufacturing Sterilants products across the globe. One major
development is the consolidation at each level of the distribution chain and the smaller
players are becoming more and more marginalized. For the future, there is expected to be 20
large suppliers well positioned to grow.

On a global level, the market is dominated by STERIS Corporation, Fresenius, Getinge


Group, Advanced Sterilization Products (J&J), 3M and Belimed. These companies together
accounted for around 70 percent of the total market revenue. Some other important players
operating in the market include Cantel (Minntech), Nordion, Synergy Health, SAKURA, CISA
and TSO3.

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2.4.2 Global Sterilants by Geography


The global consumption of Sterilants is $2.2 billion. The leading regions for Sterilants
products are the Americas as illustrated in the following table:.

Table 6: Global Demand for Sterilants by geography

REGION % SALES

America 40%

Europe 28%

Asia Pacific 32%

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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2.4.3 Biocides used by leading Sterilant Formulators


The main biocides used by Sterilant formulators throughout the globe are illustrated in the
following table:.

Table 7: Biocides used by Sterilant Formulators

STERILANT TRADENAME
% BIOCIDES
FORMULATOR

Alcon Septicon hydrogen peroxide for lenses

Omnicare 1 Step,
Allergan hydrogen peroxide
Oxysept, Ultracare

SCJ Aniosept Activ Peracetic acid

SCJ Anioxy-Twin Peracetic acid

Chlorispray glutaraldehyde, alcohol,


chlorhexidine gluconate, didecyl
SCJ (Anios)
dimethyl ammonium chloride,
formaldehyde

SCJ Steranios 2 % 2 % glutaraldehyde

Steranios 20 %
SCJ Concentrate 20 % glutaraldehyde

Delegol Glutaraldehyde, chlorocresol, o-


Bayer
phenylphenol

Demykosan Glutaraldehyde, didecyl dimethyl


Bayrol
ammonium chloride,
Chemische
formaldehyde, glyoxal

B. Braun Helimatic 20g glutaraldehyde per 100g soln

B. Braun Helipur H Plus glutaraldehyde, glyoxal

B. Braun Helix Ultra 0.16 % peracetic acid

Korsolex Basic Glutaral 15.2 g,


Bode
(ethylendioxy)dimethanol

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19.7 g.

Korsolex Extra (Ethylendioxy)dimethanol 15.3 g,

glutaral 7.5 g, benzyl-C12-18-

Bode alkyldimethylammoniumchlorides
1.0 g,
didecyldimethylammoniumchlorid
es 1.0 g.

Borer Deconex 53 100 gram contains 2.8 g


Instruments Didecyldimethyl ammonium
chloride, 9.9 gram N-(3-
aminopropyl)-N-dodecylpropane-
1,3-diamine

Borer Deconex 53 Plus 100 gram contains 3.8 g


cocospropylenediamine-1.5-bis
guanidium acetate, 5.6 g N,N-
didecyl-N-methylpoly(oxethyl)
ammonium propionate

Borer Deconex HLD PA 1200 – 1600 PPM peracetic acid

Borer Deconex 54 Sporicide 100 gram contains 2.5 g


glutaraldehyde

Cetylite Cetylcide-G 3.2 % glutaraldehyde

Ciden Opaciden 0.6 % OPA


Technologies

CID Lines Vorocid glutaraldehyde, benzalkonium


chloride,

didecyl dimethyl ammonium


chloride

Cottrell EndoSpor 7.35 % hydrogen peroxide, 0.23


% peracetic acid

Cottrell Omnicide / Procide 2.4 % glutaraldehyde

Pro Sep glutaraldehyde, didecyl


SealedAirDiversey
dimethyl ammonium chloride
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Dolorgiet Indulfan Plus glutaraldehyde, benzalkonium


chloride, formaldehyde, glyoxal

Sekumatic glutaraldehyde, acetone,


Ecolab
alcohol, chloroform

Fresenius Ultrasol-F / S glutaraldehyde, benzalkonium


chloride, formaldehyde,
glyoxal

Fresenius Puristeril Peracetic acid

Johnson & Cidex Activated 2.4 % glutaraldehyde


Johnson Dialdehyde Solution

Johnson & Cidex Formula 7 2.5 % glutaraldehyde


Johnson Long Life Activated
Dialdehyde Solution

Johnson & Cidex Plus 28 day 3.4 % glutaraldehyde


Johnson solution

Johnson & Cidex OPA ortho-phthalaldehyde 5.75%


Johnson Concentrate

Johnson & Nu-Cidex Peracetic acid


Johnson

Kawamoto Steriliser Alcohol, peracetic acid

Maruishi Sterihyde Glutaraldehyde

Medivators Rapidcide 2.5 % glutaraldehyde

MedSci Inc Medsci 3 % glutaraldehyde

Metrex Metricide OPA Plus 0.6 % OPA

Minntech Minncare hydrogen peroxide 22%;


peracetic acid 4.5%

Minntech Peract 1 % hydrogen peroxide, 0.08


% peracetic acid

Paragerm Incidine glutaraldehyde, formaldehyde,


Laboratoires glyoxal

Peters Surfalyse glutaraldehyde, formaldehyde,


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Laboratoires glyoxal, quaternary ammonium


compounds

Reckitt Benckiser Sporox 7.5 % hydrogen peroxide

Schulke & Mayr Gigasept Formaldehyde and


succindialdehyde

Schulke & Mayr Gigasept Autogen 750 ppm peracetic acid

Schulke & Mayr Gigasept ISIS 750 ppm peracetic acid

Schulke & Mayr Gigasept Once 750 ppm peracetic acid

Schulke & Mayr Gigasept PA Peracetic acid

Schulke & Mayr Kodan hydrogen peroxide; acetic


acid; peracetic acid

Schulke & Mayr Thermodept PAA Peracetic acid

Sterilant
Sinopec hydrogen peroxide

Instrunet Liquid glutaraldehyde, didecyl


Smith & Nephew dimethyl ammonium chloride,
formaldehyde, glyoxal

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

Denoglutar 2.5 % glutaraldehyde, 3.5 %


Sutter
alcohol

Wave Energy Wavicide-01


2.5% glutaraldehyde
Systems

Whiteley Aidal Plus


2 % glutaraldehyde
Industries

Yamanouchi Oxoferin hydrogen peroxide, potassium


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chlorate, sodium carbonate,


sodium chlorite, sodium
hypochlorite, sodium peroxide,
sulfuric acid

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2.5 AMERICA

2.5.1 Biocides used by Sterilant Formulators in America


The main suppliers of Sterilants to the American market together with biocides used are listed
in the following table:.

Table 8: Leading brands of Sterilants in the Americas

STERILANT TRADENAME
% BIOCIDES
FORMULATOR

Cetylite Cetylcide-G 3.2 % glutaraldehyde

Ciden Opaciden 0.6 % OPA


Technologies

Cottrell EndoSpor 7.35 % hydrogen peroxide,


0.23 % peracetic acid

Cottrell Omnicide / Procide 2.4 % glutaraldehyde

Johnson & Cidex Formula 7 2.5 % glutaraldehyde


Johnson

Johnson & Cidex OPA ortho-phthalaldehyde 5.75%


Johnson Concentrate

Johnson & Nu-Cidex Peracetic acid


Johnson

Medivators Rapidcide 2.5 % glutaraldehyde

MedSci Inc Medsci 3 % glutaraldehyde

Metrex Metricide OPA Plus 0.6 % OPA

Minntech Minncare hydrogen peroxide 22%;


peracetic acid 4.5%

Minntech Peract 1 % hydrogen peroxide, 0.08 %


peracetic acid

Reckitt Sporox 7.5 % hydrogen peroxide


Benckiser

Sporicidin Disinfecting 1.12 % glutaraldehyde, 1.93 %


Sporicidin
and Sterilizing phenol phenate

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Resert XL
Steris 2 % hydrogen peroxide

Steris S-20
Steris 0.2 % peracetic acid

Wave Energy Wavicide-01


2.5% glutaraldehyde
Systems

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2.6 ASIA PACIFIC

2.6.1 Biocides used by Sterilant Formulators in Asia Pacific


The main suppliers of Sterilants to the Asian market together with Biocides used are listed in
the following table:.

Table 9: Leading suppliers of Sterilants in Asia Pacific and Biocides used

STERILANT TRADENAME
% BIOCIDES
FORMULATOR

Fresenius Ultrasol-F / S glutaraldehyde, benzalkonium


chloride, formaldehyde, glyoxal

Fresenius Puristeril Peracetic acid

Johnson & Cidex OPA ortho-phthalaldehyde 5.75%


Johnson Concentrate

Johnson & Nu-Cidex Peracetic acid


Johnson

Kawamoto Steriliser Alcohol, peracetic acid

Maruishi Sterihyde Glutaraldehyde

Steriliser
Sinopec Baling Hydrogen peroxide

Whiteley Aidal Plus


2 % glutaraldehyde
Industries

Yamanouchi Oxoferin hydrogen peroxide, potassium


chlorate, sodium carbonate,
sodium chlorite, sodium
hypochlorite, sodium peroxide,
sulfuric acid

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2.7 EUROPE

2.7.1 Biocides used by Sterilant Formulators in Europe


The main suppliers of Sterilants to the European market together with biocides used are listed
in the following table:.

Table 10: Leading suppliers of Sterilants in Europe and Biocides used

STERILANT TRADENAME
BIOCIDES
FORMULATOR

Chlorispray glutaraldehyde, alcohol,


chlorhexidine gluconate, didecyl
Anios (Ecolab)
dimethyl ammonium chloride,
formaldehyde

Delegol Glutaraldehyde, chlorocresol, o-


Bayer
phenylphenol

Demykosan Glutaraldehyde, didecyl dimethyl


Bayrol
ammonium chloride,
Chemische
formaldehyde, glyoxal

Melsept SF glutaraldehyde, didecyl dimethyl


B. Braun
ammonium chloride, glyoxal

B. Braun Melsitt Glutaraldehyde, didecy dimethyl


ammonium chloride,
formaldehyde

B. Braun Helipur H Plus glutaraldehyde, glyoxal

Bode Chemie Aseptisol glutaraldehyde,


gidecylmethyloxethylammonium
propionate, formaldehyde

Borer Deconex 50FF glutaraldehyde, didecyl dimethyl


ammonium chloride, glyoxal

CID Lines Vorocid glutaraldehyde, benzalkonium


chloride,
didecyl dimethyl ammonium
chloride

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Pro Sep glutaraldehyde, didecyl dimethyl


Diversey
ammonium chloride

Dolorgiet Indulfan Plus glutaraldehyde, benzalkonium


chloride, formaldehyde, glyoxal

Sekumatic glutaraldehyde, acetone,


Ecolab
alcohol, chloroform

Fresenius Ultrasol-F / S glutaraldehyde, benzalkonium


chloride, formaldehyde, glyoxal

Fresenius Puristeril Peracetic acid

Johnson & Cidex OPA ortho-phthalaldehyde 5.75%


Johnson Concentrate

Johnson & Nu-Cidex Peracetic acid


Johnson

Schulke & Mayr Kodan hydrogen peroxide; acetic acid;


peracetic acid

Instrunet Liquid glutaraldehyde, didecyl dimethyl


Smith &
ammonium chloride,
Nephew
formaldehyde, glyoxal

Resert XL
Steris 2 % hydrogen peroxide

Steris S-20
Steris 0.2 % peracetic acid

Denoglutar 2.5 % glutaraldehyde, 3.5 %


Sutter
alcohol

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2.8 BIOCIDE COMPARISON


The most popular Biocides used in sterilisation are compared in the following table with
advantages and disadvantages.
Table 11: Comparison of major Biocides used in Sterilants
TYPE LEVEL MAJOR MAJOR
ADVANTAGES DISADVANTAGES
Glutaraldehyde Sterilant/High - Good materials - Slow mycobactericidal
level compatibility activity (up to 10 hours)
- Active in - Coagulates blood and fixes
presence of tissue to surfaces
organic material
- Prolonged
activated life
Hydrogen peroxide Sterilant/High - Environmentally - Poor metal compatibility for
level compatible brass, zinc, copper, and
- Compatible with nickel/silver plating
plastics and - Serious eye damage if
elastomers contacted
- Does not - Needs temperature to
coagulate blood activate it.
and fix tissue to - Mainly used as a bleacher
surfaces
Orthophthaldehyde Sterilant/High - Fast acting - Stains proteins gray
level - Good materials - Disposal can be problematic
compatibility (should not be poured into
- Does not sewer)
coagulate blood
and fix tissue to
surfaces
Peracetic acid Sterilant/High - Fast acting - Low temperature immersion
level - Good materials system (not just a chemical)
compatibility - Concentrated solution can
- Does not cause serious eye and skin
coagulate blood damage
and fix tissue to
surfaces
Superoxidized High level - Environmentally - Equipment required
Water compatible (additional cost)
- Rapidly effective - Does not work well in
presence of organic material
Chlorine releasing Intermediate - Inexpensive - Requires daily mixing
compounds- level/low level - Rapidly effective - Not compatible with metals
hypochlorite and can also damage plastics,
vinyls, fabrics

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Chlorine dioxide Sterilant/high - 6 hours for - Requires daily mixing


level/intermediate sterilization - Not compatible with
- 3 minutes for aluminum
disinfection - Adequate ventilation
required
Iodophors Intermediate level - Biocidal activity - Requires daily mixing
within 5-10 - Corrosive
minutes - Stains
- Irritation of tissues
- Allergenicity
Phenolics Intermediate level - Useful on metal, - Skin and eye irritation
glass, rubber, and - Degrades some plastics and
plastic etch glass over prolonged use
Alcohols (Ethyl and Not recommended - Exposure to alcohol
isopropyl) denatures and dehydrates
proteins making them
insoluble and adherent to
most surfaces which can
protect them from
disinfectant property of
alcohol or other chemical
Quaternary Low level Not recommended - Inactivated by organic
ammonium matter
compounds
Quats/alcohols Intermediate Tuberculocidal - Sanitization step has to be
activity done with a water based
cleaner

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2.9 PRICING OF BIOCIDES

2.9.1 Pricing at Active Ingredient Level


Pricing is determined by regulatory approval, quantities purchased and geographical region.
The following table compares biocide prices at active manufacture level observed in the field
for the Sterilants industry by each of the main geographical countries.

Table 12: Comparison of Prices in $/kg (99% AI unless otherwise stated)


Biocide Asia Pacific America Europe
Glutaraldehyde China 3 (50 %) Germany 7 (50 %)
India 4 (50 %)
Ortho-phthalaldehyde China 20, 30. Austria 80 (99 %)
India 38
Peracetic Acid China 1 (5 %). Brazil 1 (5
India 1 (5%). %),
Japan 3 (15%), USA 2
(5 %)

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2.9.2 Pricing at Formulated Products Level

The prices of biocides are governed by;


(1) Quantities purchased

(2) Regulatory approval

(3) Formulation of Biocides


(4) Technical and Laboratory Support

(5) Geographical Region

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.

Table 13: Comparison of major Biocides used in Sterilants


% A. I. in Formulated
Chemistry Trade name Supplier
formulation Price $/Kg
Glutaraldehyde Ucarcide 250 Dow 50% 10

Ortho-phthalaldehyde OPA DSM 99 % 80

Flowcide 375 FMC


Renalin Evonik
Peroxyacetic acid Peraclean L’Air Liquide 0.2-5% 2.5
Dialox Solvay

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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2.10 ANTI-MICROBIAL COSTS IN SYSTEM

2.10.1 Cost of Biocides in a Sterilant


The price of two popular sterilants (Cidex Plus and Cidex OPA solution) at supplier level was
$ 17 and $ 74 per gallon. The cost of biocides used in Cidex Plus and Cidex OPA was $ 175
and $ 440 per tonne of Sterilant. This is for biocides at the active ingredient level with no
registrations provided. The following table compares the cost of using Glutaraldehyde and
Ortho-phthaldehyde:.

Table 14: Cost of Treating Sterilants with a Biocide


Sales
Amount of Percentage of
Price of Price of
% Biocide in the Biocides per the Sterilant
the Sterilant ($
Sterilant Tonne of Sterilant Selling Price
Biocide per Gallon
in kg (in $) (%)
($/Kg)
Cidex Plus
Glutaraldehyde 3.4 % 7 17 34 (175) 5
Cidex OPA Solution
Ortho-phthaldehyde 0.55
80 74 5.5 (440) 3
%

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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2.10.2 Comparison of 2 Sterilants in U.S.A.

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.

Cidex OPA ($ 25 per 1 pint bottle)

12 minutes per cycle (manual) = 40 cycles per 8-hour shift.


5 minutes per cycle (automated) = 96 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

3.1 GLOBAL ANALYSIS


The global consumption of biocides used in Sterilant products is estimated at $ 110 million at
manufacture level. The leading biocides consumed in the global Sterilant products market is
Glutaraldehyde as shown in the following table which shows the breakdown by region of the
leading biocides used in the Sterilants market.

Table 15: Biocide Sales by Type within Sterilants at Manufacture level


AMERICAS ASIA PACIFIC EUROPE GLOBAL
BIOCIDE
($M) ($M) ($M) ($M)
Amines 2.0 2.0
Formaldehyde 3.0 4.0 2.0 9.0
Glutaraldehyde 11.0 12.0 15.0 38.0
Organic Acids 1.0 1.0
Ortho-phthalaldehyde 2.0 3.0 2.0 7.0
Peracetic Acid 8.0 14.0 14.0 36.0
Phenolics 1.0 1.0 2.0
Quats 1.0 2 2 5.0
Other (e.g.chlorine
dioxide, glyoxal,
5.0 2.0 3 10.0
hydrogen peroxide,
succindialdehyde)
TOTAL 34.0 37.0 39.0 110.0

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.

Ortho-phthalaldehyde (OPA) is a relatively new sterilant having received clearance by FDA


in October 1999. The product has sales of $ 7 million at active manufacture level. OPA has
several advantages compared with glutaraldehyde. It requires no activation, has excellent
stability over a wide range of pH (pH 3-9) and has a barely perceptible odor. Like
glutaraldehyde, OPA has excellent material compatibility. The leading brand of Sterilants with
OPA is Cidex OPA (0.55% ortho-phthalaldehyde) which is marketed as a safer alternative to
2% glutaraldehyde for endoscope decontamination. Cidex® OPA ortho-phthalaldehyde high
level disinfectant solution is manufactured by Advanced Sterilization. Products (ASP) a
Johnson & Johnson company. OPA is manufactured by DSM in Austria along with some
small Chinese and Indian producers. DSM do not have biocidal or medical device approval for
OPA. Lianyungang Jinyang Chemical Co., Ltd. (Jintan Jinfeng Chemical Co.,Ltd.) is the
leading Chinese producer of OPA.

Other Biocides used in Sterilants


Other biocides used in Sterilants include amines such as N-(3-aminopropyl)-n-dodecylpropan-
1,3-diamine, chlorine dioxide, formaldehyde, glyoxal, hydrogen peroxide and
succindialdehyde. The most popular Biocide in the ‘Other’ sector is Hydrogen Peroxide.
Hydrogen Peroxide is effective as a biocide and it decomposes to water and oxygen which is
responsible for the antimicrobial action. It is typically used in formulations of 3-6% A.I. for
sterilization. The pH for optimum efficiency is in the acidic range as in alkaline media
hydrogen peroxide decomposes too quickly. It also requires a high concentration to be
effective and this can make it hazardous.

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4 BIOCIDE CONSUMPTION AT END-USER LEVEL

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

5.1 GLOBAL MARKET SHARE BY MANUFACTURER


Dow is the leading manufacturer of biocides used in Sterilants with sales of $ 21 million. The
sales of biocides at active ingredient manufacture (a.i.) level for the leading manufacturers are
illustrated in the following table:.

Table 17: Biocide Sales by Manufacturer in $ Million - Global and Regional


AMERICAS ASIA PACIFIC EUROPE GLOBAL
MANUFACTURER
SALES ($M) SALES ($M) SALES ($M) SALES ($M)
Akzo Nobel 1.0 1
BASF 3 2 4.0 9
Dow 10 5 6.0 21
Ecolab 4 3 3.0 10
Evonik 2 2 4.0 8
Lanxess 2 1.0 3
Lonza 2 2
PeroxyChem 3 2 3.0 8
Solvay 3 4 4.0 11
Other 5 19 13.0 37
TOTAL 34 37 39.0 110

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:.

Table 18: Biocides supplied by BASF


Active Ingredient Trade Name
Glutaraldehyde Protectol GDA
Glyoxal Protectol GL40
BASF is the second largest supplier of glutaraldehyde which is the preferred antimicrobial
agent in Sterilants. The company sells its biocides via its speciality chemical division directly
to large users and via distributors for smaller formulators.

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.

PeroxyChem (formerly FMC) is a manufacturer of Hydrogen Peroxide and Peracetic acid


with sales of $ 8 million to the global Sterilants industry. Both products are primarily used for
sterilisation of equipment within the medical industry. Peroxychem is the leading manufacturer
of Hydrogen Peroxide and Peracetic acid within the Americas.

Mitsubishi is a manufacturer of Hydrogen Peroxide and Peracetic acid with sales of $ 1


million to the high level Disinfectants and Sterilants industry. Sales are mainly to specialist
formulators who resell sterilants in Asia Pacific.

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 %

END- USER e.g. hospital

Route 1 - 30 % of total sales


Route 2 - 70 % of total sales

Figure 1: Distribution Channels for Sterilants

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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7 VALUE CHAIN ANALYSIS


The value added analysis in Figure 2 illustrates the value added achieved for Biocides used
within the Sterilants industry.

VALUE ADDED FOR BIOCIDES ALONG THE SUPPLY CHAIN

Active Manufacturer
Value Added up to 200 %

Distributor Sterilant Formulator


Value Added up to 20 % Value Added 1000 % - 3000 %

Distributor / Service
Value Added up to 200 %

End – User of Sterilant e.g. Hospital

Figure 2: Value Added Analysis for Biocides the Sterilants Industry

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.

2) There are numerous manufacturers of medical devices with most companies


specialising in selected devices. For endoscopes, the market is dominated by
Olympus, Pentax and Fujinon with an estimated market shares of 50 %, 20 % and 10
% respectively. There is a trend among regulatory authorities to make original
equipment manufacturers responsible for ensuring their devices are able to be
effectively sterilized and disinfected.

3) Currently glutaraldehyde is to be replaced in endoscope formulations due to corrosion


and sensitivity carried over due to residues. Johnson & Johnson is the leading
formulator of glutaraldehyde for this application and it has recently launched alternative
formulations based on orthoparaformaldehyde and peracetic acid. Johnson & Johnson
also introduced Nucidex based on peracetic acid which will compete with other
sterilants. It is a fast acting formulation, requiring only ten minutes for a sporicidal
effect.
4) There is a movement to more biodegradable actives. This is best illustrated by the
recent announcement by the Royal Liverpool University Hospital who has appointed
Advanced Sterilization Products (ASP) to perform a deep clean decontamination
service using its ASP Glosair technology. Glosair technology uses a low concentration
hydrogen peroxide dry-mist technology, which operates at room temperature to
decontaminate a ward or patient room within three hours of operation time. Its proven
efficacy ensures that the safest possible environment is created for patients and
healthcare professionals, says ASP.

5) There is a trend towards combining biocides to maximise synergistic effects. Alcohol,


Quats and phenolics are often mixed with the traditional sterilants and this blend
combines the advantages of both classes of active ingredient e.g. good antimicrobial
ability.

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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technologies, and more. Through a series of strategic acquisitions and continual


innovation of new products, STERIS holds one of the broadest portfolios of products in
the industry. Another company active in the consolidation field is Contec who acquired
Sporicidin® International in 2008. The company is based in Rockville, Maryland as a
manufacturer of disinfectants and cold sterilants for the medical, dental, hospital,
critical environments, and mold remediation markets. Contec has manufacturing
facilities in Spartanburg, South Carolina and Suzhou China.

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.

8) The essential features of a biocide used in Sterilants are:


1. Gentle to skin

2. Broad spectrum of activity

3. Fast kill
4. Cost effective

5. Compatible with other ingredients e.g. surfactants

6. Low toxicity
7. Biodegradable

8. Relevant Approvals

9. Low Ecotoxicity
10. High dirt resistance

11. Easy to formulate

12. Halogen free


13. Be effective for a reasonable length of time

14. Have a license to sell

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:.

Table 19: Projected Sales of Biocides in Sterilants market


YEARS SALES ($M)
2018 113
2019 116
2020 119
2021 122
2022 125
2023 128

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.

Glutaraldehyde is being substituted by ortho-Phthalaldehyde, Hydrogen Peroxide and


Peracetic acid. OPA is more effective than Glutaraldehyde but 4 times the cost.

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10.1 BIOCIDE GROWTH


Future growth for Sterilants
The growth rate for biocides will depend on the following factors:

(1) Country Market Growth

(2) Efficacy
(3) Price

(4) Economic Circumstances

(5) Regulatory Status


(6) Adoption by major sterilant formulators

(7) External Approvals

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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