Summary

The global sterilization services market is valued at an estimated 3.6 billion in 2024 and is projected to reach USD 5.2 billion by 2029, at a CAGR of 7.7% during the forecast period. The increasing number of surgeries performed has led to a growing need sterilization services. The demand for sterilization services is therefore expected to increase as prevalence of hospital-acquired infection is growing. The sterilization services market observes lucrative opportunity area due to the potential of E-beam sterilization.
“The gamma sterilization segment is projected to witness highest growth rate in the sterilization services market, by method, during the forecast period”
Based on method, the global sterilization services market is segmented into ethylene oxide sterilization, gamma sterilization, e-beam sterilization, x-ray sterilization, steam sterilization, hydrogen peroxide sterilization and other methods. . Gamma sterilization is ideal for high-throughput environments and packaged goods, effectively sterilizing items such as syringes, surgical gloves, and packaging components without altering the product, contributes to their extensive usage and market demand during the forecast period. Gamma sterilization has observed increasing demand from pharmaceutical, medical and packaging sctors due to bulk item sterilization and minimal residuals.
“The contract sterilization services segment is projected to witness the highest growth rate in the sterilization services market, by type, during the forecast period.”
Based on type, the sterilization services marketis segmented contract sterilization services and sterilization validation services. Contract sterilization services include off-site and on-site services for sterilizing several products and medical devices. These services are considered a good choice for most products, especially medical devices, owing to their suitability for large and small companies. These factors are contributing to growth of this segment. The growing preference of contract sterilization by medical device company is driven by focus on reducing surgical site infection.
“The off-site sterilization service segment is projected to witness the highest growth rate in the sterilization services market, in 2023, by mode of delivery”
Based on shape, the sterilization services market is segmented into off-site sterilization service and on-site sterilization service. Off-site sterilization/contract sterilization allows for higher output with less financial risk while ensuring the efficiency & quality of the product. Off-site sterilization services allow healthcare facilities, especially hospitals and ambulatory care facilities, to focus more on their core competencies, such as R&D and other healthcare provisions. Which is contributing to their extensive adoption and market demand during the forecast period.
“The medical device companies segment is projected to witness the highest growth rate in the sterilization services market in 2023, by end user”.
Based on end user, the sterilization services market is segmented into medical device companies, hospitals & clinics, pharmaceutical & biotechnology companies and other end users. The expansion of healthcare facilities, particularly in emerging markets, has led to an increase in number of medical device companies, driving demand for sterilization services among these end users during the forecasted period. Medical device companies recommend sterilization for products such as endoscopes, laproscopes, arthroscopes, mouth pieces and spirometry tubing.
“The Asia Pacific region is projected to witness highest growth rate in the sterilization services market during the forecast period”
The global sterilization services market is segmented into six regions - North America, Europe, Asia Pacific, the Middle East & Africa, Latin America, and the GCC Countries. Over the span of the forecast period, the sterilization services market is expected to grow at the fastest rate in the Asia Pacific region. Over the projected period, the Asia Pacific market is expected to develop at the greatest rate due to factors such government initiatives to raise awareness about infection control and the growing number of hospitals and clinics in China and India.

The primary interviews conducted for this report can be categorized as follows:

• By Company Type: Tier 1 - 42%, Tier 2 - 30%, and Tier 3 - 28%
• By Designation: C-level - 46%, Director-level - 23%, and Others - 31%
• By Region: North America – 23%, Europe – 44%, Asia Pacific – 28%, Latin America – 3%, Middle East & Africa – 1%, and the GCC Countries – 1%
Lists of Companies Profiled in the Report:
STERIS plc (Ireland), Sotera Health (US), Servizi Italia S.p.A (Italy), E-BEAM Services, Inc. (US), BGS Beta-Gamma-Service GmbH & co. KG (Germany), Medistri SA (Switzerland), H.W.Andersen Products Ltd. (UK), Cretex Companies (US),Life Science Outsourcing, Inc. (US), Microtrol Sterilisation Services Pvt Ltd. (India), Avantti Medi Clear (Mexico), SteriPack Group (Ireland), Europlaz (UK), Prince Sterilization Services, LLC (US), Steripure (France), SteriTek Inc. (US), Centerpiece (US), Sterilization Services (US), NextBeam (US), Meridian Medical (UK), C.G. Laboratories, Inc. (US), Pro-Tech Design and Manufacturing Inc. (US), ClorDiSys Solutions Inc. (US), Blue Line Sterilization Services, LLC (US) and Midwest Sterilization Corporation (US).
Research Coverage:
In this report, the sterilization services market has been categorized based on method ( ethylene oxide sterilization, gamma sterilization, electron beam sterilization, x-ray irradiation sterilization, steam sterilization and hydrogen peroxide sterilization), type (contract sterilization services and sterilization validation services), mode of delivery (off-site sterilization services and on-site sterilization services), end user (medical device companies, hospitals & clinics, pharmaceutical & biotechnology companies and other end users), and region (North America, Europe, Asia Pacific, Latin America, Middle East & Africa, and the GCC Countries).
Comprehensive information regarding the main drivers, restraints, opportunities, and challenges influencing the sterilization services market's expansion is included in detail in this study. A study of the key players in the sterilization services market has been done to provide insights into their business overview, service offered, strategies, acquisitions, expansions, and other deals made relevant to the market. This study is done for the competitive landscape of the emerging sterilization services startups.
Reasons to buy this report:
The report will help the market leaders/new entrants in this market with information on the closest approximations of the revenue numbers for the overall sterilization services market and the subsegments. This report will help stakeholders understand the competitive landscape and gain more insights to position their businesses better and to plan suitable go-to-market strategies. The report also helps stakeholders understand the pulse of the market and provides them with information on key market drivers, challenges, opportunities, and restaints.
The report provides insights on the following pointers:
• Analysis of key drivers: (Growing prevalence of hospital-acquired infections, increasing number of surgical pocedures, growing focus o food sterilization due to foodborne diseases and rising trend of outsourcing sterilization services to third party vendors), opportunities (Potential of E-beam sterilization and growth potential of healthcare industry in emerging economies), and trends (Advancement of hydrogen peroxide sterilization service) influencing the growth of the in sterilization services market.
• Market Development: Comprehensive information about lucrative markets – the report analyses the sterilization services market across varied regions.
• Market Diversification: Exhaustive information about untapped geographies, and investments in the sterilization services market
• Competitive Assessment: In-depth assessment of market shares, growth strategies, and product offerings of leading players like STERIS plc (Ireland), Sotera Health (US) and Servizi Italia S.p.A (Italy) are among others, in the sterilization services market strategies.
• Product Development/Innovation: Detailed insights on upcoming technologies, research & development activities, and new product launches in the sterilization services market.

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Table of Contents

1 INTRODUCTION 26
1.1 STUDY OBJECTIVES 26
1.2 MARKET DEFINITION 27
1.3 INCLUSIONS & EXCLUSIONS 27
1.4 MARKET SCOPE 28
1.4.1 MARKETS COVERED 28
1.4.2 YEARS CONSIDERED 29
1.4.3 CURRENCY CONSIDERED 29
1.5 STAKEHOLDERS 29
1.6 SUMMARY OF CHANGES 30
2 RESEARCH METHODOLOGY 31
2.1 RESEARCH DATA 31
2.1.1 SECONDARY DATA 32
2.1.1.1 Key data from secondary sources 33
2.1.2 PRIMARY DATA 34
2.1.2.1 Primary sources 34
2.1.2.2 Key industry insights 35
2.1.2.3 Key data from primary sources 35
2.1.2.4 Breakdown of primary interviews 36
2.2 MARKET SIZE ESTIMATION 37
2.2.1 BOTTOM-UP APPROACH 37
2.2.1.1 Approach 1: Company revenue estimation approach 37
2.2.1.2 Approach 2: Presentations of companies and primary interviews 38
2.2.1.3 Approach 3: Primary interviews 38
2.2.1.4 Growth forecast 38
2.2.1.5 CAGR projections 38
2.2.2 TOP-DOWN APPROACH 39
2.3 MARKET BREAKDOWN & DATA TRIANGULATION 40
2.4 MARKET SHARE 41
2.5 STUDY ASSUMPTIONS 41
2.6 RESEARCH LIMITATIONS 42
2.7 RISK ASSESSMENT 42
3 EXECUTIVE SUMMARY 43
 
4 PREMIUM INSIGHTS 47
4.1 STERILIZATION SERVICES MARKET OVERVIEW 47
4.2 STERILIZATION SERVICES MARKET, BY METHOD, 2024 VS. 2029 (USD MILLION) 48
4.3 NORTH AMERICA: STERILIZATION SERVICES MARKET, BY METHOD
AND COUNTRY (2023) 49
4.4 GEOGRAPHIC GROWTH OPPORTUNITIES 50
5 MARKET OVERVIEW 51
5.1 INTRODUCTION 51
5.2 MARKET DYNAMICS 51
5.2.1 DRIVERS 52
5.2.1.1 Growing prevalence of hospital-acquired infections (HAIs) 52
5.2.1.2 Increasing number of surgical procedures 53
5.2.1.3 Growing focus on food sterilization due to foodborne diseases 53
5.2.1.4 Rising trend of outsourcing sterilization services to
third-party vendors 54
5.2.2 RESTRAINTS 54
5.2.2.1 Concerns associated with safety of reprocessed instruments 54
5.2.3 OPPORTUNITIES 55
5.2.3.1 Increasing expansion of pharmaceutical & medical device companies in emerging markets 55
5.2.3.2 Potential of E-beam sterilization 56
5.2.3.3 Reintroduction of ethylene oxide sterilization 56
5.2.3.4 Growth potential of healthcare industry in emerging economies 57
5.2.4 CHALLENGES 57
5.2.4.1 Sterilization of advanced medical instruments 57
5.2.4.2 Non-compliance with sterilization guidelines 58
5.3 PORTER’S FIVE FORCES ANALYSIS 59
5.3.1 DEGREE OF COMPETITION 60
5.3.2 BARGAINING POWER OF SUPPLIERS 60
5.3.3 BARGAINING POWER OF BUYERS 60
5.3.4 THREAT OF SUBSTITUTES 60
5.3.5 THREAT OF NEW ENTRANTS 60
5.4 ECOSYSTEM ANALYSIS 61
5.4.1 ROLE IN ECOSYSTEM 62
5.5 KEY STAKEHOLDERS AND BUYING CRITERIA 62
5.5.1 KEY STAKEHOLDERS ON BUYING PROCESS 62
5.5.2 KEY BUYING CRITERIA 63
5.6 REGULATORY ANALYSIS 64
5.6.1 REGULATORY LANDSCAPE 64
5.6.1.1 North America 64
5.6.1.1.1 US 64
5.6.1.1.2 Canada 65
5.6.1.2 Europe 65
5.6.1.3 Asia Pacific 66
5.6.1.3.1 South Korea 66
5.6.1.3.2 Australia 67
5.6.1.4 Latin America 68
5.6.1.4.1 Brazil 68
5.6.2 LIST OF REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 69
5.7 TECHNOLOGY ANALYSIS 71
5.7.1 KEY TECHNOLOGIES 71
5.7.1.1 Ethylene oxide (ETO) sterilization 71
5.7.2 ADJACENT TECHNOLOGIES 71
5.7.2.1 Plasma sterilization 71
5.8 KEY CONFERENCES & EVENTS, 2024−2025 72
5.9 VALUE CHAIN ANALYSIS 73
5.10 TRENDS/DISRUPTIONS IMPACTING CUSTOMERS’ BUSINESSES 74
5.10.1 REVENUE SHIFT FOR STERILIZATION SERVICE PROVIDERS 74
5.11 INVESTMENT & FUNDING SCENARIO 75
5.12 IMPACT OF GENERATIVE AI ON STERILIZATION SERVICES MARKET 75
6 STERILIZATION SERVICES MARKET, BY METHOD 76
6.1 INTRODUCTION 77
6.2 HYDROGEN PEROXIDE STERILIZATION 77
6.2.1 REGULATORY APPROVAL FOR VHP TESTING OF HEALTHCARE EQUIPMENT
TO PROPEL MARKET 77
6.3 ELECTRON-BEAM RADIATION STERILIZATION 80
6.3.1 RAPID PROCESSING AND HIGH PRECISION CAPABILITIES TO BOOST DEMAND 80
6.4 GAMMA STERILIZATION 83
6.4.1 ABILITY TO STERILIZE BULK PACKAGING MATERIALS WITH MINIMAL RESIDUAL TO DRIVE MARKET 83
6.5 ETHYLENE OXIDE (ETO) STERILIZATION 87
6.5.1 BROAD APPLICATIONS OF ETO AND HIGH PENETRATIVE CAPABILITIES
TO PROPEL MARKET 87
6.6 X-RAY IRRADIATION 90
6.6.1 NON-RADIOACTIVE PROPERTIES AND ADAPTABILITY TO COMPLEX CONFIGURATIONS TO SUPPORT MARKET GROWTH 90
6.7 STEAM STERILIZATION 94
6.7.1 RISING PREFERENCE IN FOOD & MEDICAL INDUSTRIES TO FUEL UPTAKE 94
6.8 OTHER STERILIZATION METHODS 97
 
7 STERILIZATION SERVICES MARKET, BY TYPE 102
7.1 INTRODUCTION 103
7.2 CONTRACT STERILIZATION SERVICES 103
7.2.1 RISING OUTSOURCING OF STERILIZATION PROCESSES TO THIRD-PARTY PROVIDERS FOR COST EFFICIENCY TO DRIVE MARKET 103
7.3 STERILIZATION VALIDATION SERVICES 107
7.3.1 RISING REGULATORY COMPLIANCE REQUIREMENTS TO SUPPORT
MARKET GROWTH 107
8 STERILIZATION SERVICES MARKET, BY MODE OF DELIVERY 110
8.1 INTRODUCTION 111
8.2 OFF-SITE STERILIZATION SERVICES 111
8.2.1 TREND OF OUTSOURCING STERILIZATION SERVICES DUE
TO HIGHER OUTPUTS TO PROPEL MARKET 111
8.3 ON-SITE STERILIZATION SERVICES 114
8.3.1 LOW OPERATIONAL COSTS AND LESSER TURNAROUND TIME
TO BOOST DEMAND 114
9 STERILIZATION SERVICES MARKET, BY END USER 118
9.1 INTRODUCTION 119
9.2 MEDICAL DEVICE COMPANIES 119
9.2.1 HIGH UPTAKE OF ETO AND E-BEAM STERILIZATION METHODS FOR ENDOSCOPES AND LAPAROSCOPES TO DRIVE MARKET 119
9.3 HOSPITALS & CLINICS 124
9.3.1 HIGH INCIDENCE OF HAIS TO BOOST DEMAND 124
9.4 PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES 128
9.4.1 GROWING NEED FOR PRODUCT SAFETY TO FUEL UPTAKE 128
9.5 OTHER END USERS 131
10 STERILIZATION SERVICES MARKET, BY REGION 135
10.1 INTRODUCTION 136
10.2 NORTH AMERICA 136
10.2.1 MACROECONOMIC OUTLOOK FOR NORTH AMERICA 137
10.2.2 US 140
10.2.2.1 Stringent regulatory guidelines for sterilized medical devices
to propel market 140
10.2.3 CANADA 142
10.2.3.1 Growing number of surgical procedures and rising incidence
of HAIs to drive market 142
10.3 EUROPE 144
10.3.1 MACROECONOMIC OUTLOOK FOR EUROPE 145
10.3.2 GERMANY 147
10.3.2.1 Rising demand for precision medical instruments to drive market 147
 
10.3.3 UK 149
10.3.3.1 Rising incidence of HAIs and STIs to fuel uptake 149
10.3.4 FRANCE 151
10.3.4.1 Supportive government initiatives for surgical equipment manufacturers to drive market 151
10.3.5 ITALY 153
10.3.5.1 Adoption of gamma sterilization methods in biotechnology industry to drive market 153
10.3.6 SPAIN 155
10.3.6.1 Growing awareness of HAIs to boost demand 155
10.3.7 SWITZERLAND 157
10.3.7.1 Implementation of inspection machines by pharmaceutical companies to boost demand 157
10.3.8 REST OF EUROPE 160
10.4 ASIA PACIFIC 162
10.4.1 MACROECONOMIC OUTLOOK FOR ASIA PACIFIC 162
10.4.2 CHINA 166
10.4.2.1 Rising incidence of infectious diseases to boost demand 166
10.4.3 JAPAN 168
10.4.3.1 Increasing prevalence of antimicrobial-resistant infections
to boost demand 168
10.4.4 INDIA 170
10.4.4.1 Growth in medical devices & pharmaceutical industry to
propel market 170
10.4.5 AUSTRALIA 172
10.4.5.1 Growing demand for sterile medical devices to fuel uptake 172
10.4.6 SOUTH KOREA 174
10.4.6.1 Rising number of cosmetic surgeries to support market growth 174
10.4.7 REST OF ASIA PACIFIC 175
10.5 LATIN AMERICA 177
10.5.1 MACROECONOMIC OUTLOOK FOR LATIN AMERICA 178
10.5.2 BRAZIL 180
10.5.2.1 High rate of nosocomial infections to drive market 180
10.5.3 MEXICO 182
10.5.3.1 Expansion of leading pharmaceutical companies in the country to drive market 182
10.5.4 REST OF LATIN AMERICA 184
10.6 MIDDLE EAST & AFRICA 186
10.6.1 IMPROVEMENTS IN HEALTHCARE INFRASTRUCTURE TO DRIVE MARKET 186
10.6.2 MACROECONOMIC OUTLOOK FOR MIDDLE EAST & AFRICA 187
10.7 GCC COUNTRIES 189
10.7.1 MACROECONOMIC OUTLOOK FOR GCC COUNTRIES 189
10.7.2 KINGDOM OF SAUDI ARABIA 191
10.7.2.1 Increasing expenditure on healthcare infrastructure to fuel uptake 191
10.7.3 UAE 193
10.7.3.1 Hub for medical-grade logistics to boost demand 193
10.7.4 OTHER GCC COUNTRIES 195
11 COMPETITIVE LANDSCAPE 197
11.1 INTRODUCTION 197
11.2 KEY PLAYER STRATEGY/RIGHT TO WIN 197
11.2.1 OVERVIEW OF STRATEGIES ADOPTED BY KEY PLAYERS IN STERILIZATION SERVICES MARKET 197
11.3 REVENUE ANALYSIS 199
11.4 MARKET SHARE ANALYSIS 200
11.4.1 RANKING OF KEY MARKET PLAYERS 201
11.5 COMPANY EVALUATION MATRIX: KEY PLAYERS, 2023 202
11.5.1 STARS 202
11.5.2 EMERGING LEADERS 202
11.5.3 PERVASIVE PLAYERS 202
11.5.4 PARTICIPANTS 202
11.5.5 COMPANY FOOTPRINT: KEY PLAYERS, 2023 204
11.5.5.1 Company footprint 204
11.5.5.2 Method footprint 205
11.5.5.3 Mode of delivery footprint 205
11.5.5.4 Type footprint 206
11.5.5.5 Region footprint 206
11.6 COMPANY EVALUATION MATRIX: STARTUPS/SMES, 2023 207
11.6.1 PROGRESSIVE COMPANIES 207
11.6.2 RESPONSIVE COMPANIES 207
11.6.3 DYNAMIC COMPANIES 207
11.6.4 STARTING BLOCKS 207
11.6.5 COMPETITIVE BENCHMARKING: STARTUPS/SMES, 2023 209
11.7 VALUATION & FINANCIAL METRICS 210
11.7.1 FINANCIAL METRICS 210
11.7.2 COMPANY VALUATION 210
11.8 BRAND/PRODUCT COMPARISON 211
11.9 COMPETITIVE SCENARIO 212
11.9.1 DEALS 212
11.9.2 EXPANSIONS 213
12 COMPANY PROFILES 214
12.1 KEY PLAYERS 214
12.1.1 STERIS PLC 214
12.1.1.1 Business overview 214
12.1.1.2 Services offered 215
12.1.1.3 Recent developments 216
12.1.1.3.1 Deals 216
12.1.1.3.2 Expansions 216
12.1.1.4 MnM view 217
12.1.1.4.1 Key strengths 217
12.1.1.4.2 Strategic choices 217
12.1.1.4.3 Weaknesses & competitive threats 217
12.1.2 SOTERA HEALTH 218
12.1.2.1 Business overview 218
12.1.2.2 Services offered 219
12.1.2.3 Recent developments 220
12.1.2.3.1 Expansions 220
12.1.2.4 MnM view 220
12.1.2.4.1 Key strengths 220
12.1.2.4.2 Strategic choices 220
12.1.2.4.3 Weaknesses & competitive threats 221
12.1.3 SERVIZI ITALIA S.P.A 222
12.1.3.1 Business overview 222
12.1.3.2 Services offered 223
12.1.3.3 Recent developments 224
12.1.3.3.1 Deals 224
12.1.3.3.2 Expansions 224
12.1.3.4 MnM view 224
12.1.3.4.1 Key strengths 224
12.1.3.4.2 Strategic choices 225
12.1.3.4.3 Weaknesses & competitive threats 225
12.1.4 E-BEAM SERVICES, INC. 226
12.1.4.1 Business overview 226
12.1.4.2 Services offered 226
12.1.5 BGS BETA-GAMMA-SERVICE GMBH & CO.KG 227
12.1.5.1 Business overview 227
12.1.5.2 Services offered 227
12.1.6 MEDISTRI SA 228
12.1.6.1 Business overview 228
12.1.6.2 Services offered 228
12.1.7 H.W. ANDERSEN PRODUCTS LTD. 229
12.1.7.1 Business overview 229
12.1.7.2 Services offered 229
12.1.8 CRETEX COMPANIES 230
12.1.8.1 Business overview 230
12.1.8.2 Services offered 230
 
12.1.9 LIFE SCIENCE OUTSOURCING, INC. 231
12.1.9.1 Business overview 231
12.1.9.2 Services offered 231
12.1.10 MICROTROL STERILISATION SERVICES PVT. LTD. 232
12.1.10.1 Business overview 232
12.1.10.2 Services offered 232
12.2 OTHER PLAYERS 233
12.2.1 AVANTTI MEDI CLEAR 233
12.2.2 STERIPURE 234
12.2.3 EUROPLAZ 235
12.2.4 CENTERPIECE 235
12.2.5 MIDWEST STERILIZATION CORPORATION 236
12.2.6 BLUE LINE STERILIZATION SERVICES, LLC 236
12.2.7 STERIPACK GROUP 237
12.2.8 STERITEK INC. 238
12.2.9 STERILIZATION SERVICES 238
12.2.10 NEXTBEAM 239
12.2.11 MERIDIAN MEDICAL 239
12.2.12 PRINCE STERILIZATION SERVICES, LLC 240
12.2.13 C.G. LABORATORIES, INC. 240
12.2.14 PRO-TECH DESIGN AND MANUFACTURING INC. 241
12.2.15 CLORDISYS SOLUTIONS INC. 241
13 APPENDIX 242
13.1 DISCUSSION GUIDE 242
13.2 KNOWLEDGESTORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 246
13.3 CUSTOMIZATION OPTIONS 248
13.4 RELATED REPORTS 248
13.5 AUTHOR DETAILS 249