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Global Sterility Testing Market Size, Share, Trends, Growth: By Products and Services: Kits And Reagents, Services, Instruments; By Test Type: Membrane Filtration, Direct Inoculation; By Application: Pharmaceutical and Biological Manufacturing, Others; By End User; Regional Analysis; Market Dynamics; Supplier Landscape; 2024-2032
Global Sterility Testing Market Outlook
The global sterility testing market size was valued at USD 1.23 billion in 2023, driven by the rising research and development activities in healthcare and life sciences domain across the globe. The market is expected to grow at a CAGR of 11.90% during the forecast period of 2024-2032, with the values likely to rise from USD 1.38 billion in 2024 to USD 3.38 billion by 2032.
Global Sterility Testing Market Overview
Sterility testing is a mandatory step in the manufacturing process of pharmaceuticals and medical devices. It minimizes the risk of product contamination by verifying the absence of viable microorganisms. Such tests are crucial to ensure the quality, safety, and efficacy of pharmaceutical preparations and medical devices, among others. The healthcare and life science industries have experienced significant growth in production capacity in recent years. This growth is anticipated to contribute to the growing sterility testing market demand in the forecast period.
The key players in the market are heavily investing in research and development activities which is positively influencing the market growth. In December 2023, Symbiosis Pharmaceutical Services, a United Kingdom-based contract development and manufacturing organization (CDMO), invested USD 1.25 million to build in-house analytical and microbiological testing capabilities. The new testing laboratories (spanning 3600 square feet) and quality control function are approved by the United Kingdom regulatory body Medicines and Healthcare products Regulatory Agency (MHRA). The project aims to offer sterility, bioburden, and endotoxin testing, among others, to accelerate drug development timelines. Such strategic investment initiatives will significantly aid in the sterility testing market growth.
The rising prevalence and incidence of chronic diseases are also pushing the demand for therapeutics and medical devices that have undergone strict sterility testing. In addition, the rising healthcare expenditure is expected to fuel the market growth.
Global Sterility Testing Market Segmentation
Market Breakup by Products & Services
- Kits And Reagents
- Services
- Instruments
The market is segmented by products and services into kits and reagents, services, and instruments. These segments offer the necessary tools, reagents, and services to ensure the safety and quality of pharmaceutical and healthcare products.
Market Breakup by Test Type
- Membrane Filtration
- Direct Inoculation
The sterility testing market is segmented by test type into membrane filtration and direct inoculation methods. These test methods help validate the sterility of pharmaceutical products, medical devices, and other healthcare products. The choice of method depends on the type of product and the associated regulatory guidelines.
Market Breakup by Application
- Pharmaceutical and Biological Manufacturing
- Medical Devices Manufacturing
- Others
Based on the application, the market is divided into pharmaceutical and biological manufacturing, medical devices manufacturing, and others. The increasing application of sterility testing procedures is expected to boost the sterility testing market share in the coming years.
Market Breakup by End User
- Pharmaceutical Companies
- Biotechnological Companies
- Others
The market for sterility testing is segmented by end users into pharmaceutical companies, biotechnological companies, and others. This market segment reflects the diverse industries that depend on sterility testing to ensure the safety, quality, and efficacy of their products.
Market Breakup by Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East and Africa
The market report offers deep insights into different regions including North America, Europe, Asia Pacific, Latin America, the Middle East, and Africa. North America is anticipated to hold a substantial market share, which can be attributed to the presence of several pioneering pharmaceutical and biotechnology companies and research facilities relying on sterility testing methods.
Global Sterility Testing Market: Competitor Landscape
The key features of the market report include patent analysis, grants analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:
- Merck KGaA
- BAXTER HEALTHCARE CORPORATION
- BOSTON ANALYTICAL
- LEXAMED LTD
- Danaher Corporation
- Sartorius AG
- Gibraltar Laboratories
- Pace Analytical Services, Inc
- Sigma-Aldrich Co. LLC
- Nelson Laboratories
- Pacific Biolabs.
- BioConvergence LLC
- Thermo Fisher Scientific Inc
- Toxikon Corporation
- Wuxi Apptec
Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.
Key Highlights of the Report
| REPORT FEATURES | DETAILS |
| Base Year | 2023 |
| Historical Period | 2017-2023 |
| Forecast Period | 2024-2032 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
|
| Breakup by Products & Services |
|
| Breakup by Test Type |
|
| Breakup by Application |
|
| Breakup by End User |
|
| Breakup by Region |
|
| Market Dynamics |
|
| Competitive Landscape |
|
| Companies Covered |
|
Key Queries Solved in the Global Sterility Testing Market Report
- How will the market landscape evolve in the coming years?
- What are the major market trends influencing the market?
- What are the major drivers, opportunities, and restraints in the market?
- What will be the effect of each driver, challenge, and opportunity on the market?
- Which country is poised to lead the market share in the forecast period?
- Which country is expected to experience expedited growth during the forecast period?
- Which product is anticipated to lead the market share in the forecast period?
- What type of sterility testing services are expected to dominate the respective market segment?
- Which applications are expected to significantly impact the growth of the market?
- What are the key research initiatives expected to boost the sterility testing market value during the forecast period?
- What are the potential risks and challenges associated with the market?
- What are the regulatory requirements governing sterility testing, and how do they influence market dynamics?
- Which segment has the most significant impact on the market size?
- What major mergers and collaborations are poised to impact the market in the forecast period?
*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Global Sterility Testing Market Overview
3.1 Global Sterility Testing Market Historical Value (2017-2023)
3.2 Global Sterility Testing Market Forecast Value (2024-2032)
4 Global Sterility Testing Market Landscape*
4.1 Global Cardiac Pacemaker: Developers Landscape
4.1.1 Analysis by Year of Establishment
4.1.2 Analysis by Company Size
4.1.3 Analysis by Region
4.2 Global Cardiac Pacemaker: Product Landscape
4.2.1 Analysis by Products & Services
4.2.2 Analysis by Test Type
4.2.3 Analysis by End User
5 Global Sterility Testing Market Dynamics
5.1 Market Drivers and Constraints
5.2 SWOT Analysis
5.2.1 Strengths
5.2.2 Weaknesses
5.2.3 Opportunities
5.2.4 Threats
5.3 Porter’s Five Forces Model
5.3.1 Bargaining Power of Suppliers
5.3.2 Bargaining Power of Buyers
5.3.3 Threat of New Entrants
5.3.4 Threat of Substitutes
5.3.5 Degree of Rivalry
5.4 Key Demand Indicators
5.5 Key Price Indicators
5.6 Industry Events, Initiatives, and Trends
5.7 Value Chain Analysis
6 Global Sterility Testing Market Segmentation (2017-2032)
6.1 Global Sterility Testing Market (2017-2032) by Products & Services
6.1.1 Market Overview
6.1.2 Kits And Reagents
6.1.3 Services
6.1.4 Instruments
6.2 Global Sterility Testing Market (2017-2032) by Test Type
6.2.1 Market Overview
6.2.2 Membrane Filtration
6.2.3 Direct Inoculation
6.3 Others Global Sterility Testing Market (2017-2032) by Application
6.3.1 Market Overview
6.3.2 Pharmaceutical and Biological Manufacturing
6.3.3 Medical Devices Manufacturing
6.3.4 Others
6.4 Global Sterility Testing Market (2017-2032) by End User
6.4.1 Market Overview
6.4.2 Pharmaceutical Companies
6.4.3 Biotechnological Companies
6.4.4 Others
6.5 Global Sterility Testing Market (2017-2032) by Region
6.5.1 Market Overview
6.5.2 North America
6.5.3 Europe
6.5.4 Asia Pacific
6.5.5 Latin America
6.5.6 Middle East and Africa
7 North America Sterility testing market (2017-2032)
7.1 North America Sterility testing market (2017-2032) by Products & Services
7.1.1 Market Overview
7.1.2 Kits & Reagents
7.1.3 Services
7.1.4 Instruments
7.2 North America Sterility testing market (2017-2032) by Test Type
7.2.1 Market Overview
7.2.2 Membrane Filtration
7.2.3 Direct Inoculation
7.2.4 Others
7.3 North America Sterility testing market (2017-2032) by Country
7.3.1 United States of America
7.3.2 Canada
8 Europe Sterility testing market (2017-2032)
8.1 Europe Sterility testing market (2017-2032) by Products & Services
8.1.1 Market Overview
8.1.2 Kits & Reagents
8.1.3 Services
8.1.4 Instruments
8.2 Europe Sterility testing market (2017-2032) by Test Type
8.2.1 Market Overview
8.2.2 Membrane Filtration
8.2.3 Direct Inoculation
8.2.4 Others
8.3 Europe Sterility testing market (2017-2032) by Country
8.3.1 United Kingdom
8.3.2 Germany
8.3.3 France
8.3.4 Italy
8.3.5 Others
9 Asia Pacific Sterility testing market (2017-2032)
9.1 Asia Pacific Sterility testing market (2017-2032) by Products & Services
9.1.1 Market Overview
9.1.2 Kits & Reagents
9.1.3 Services
9.1.4 Instruments
9.2 Asia Pacific Sterility testing market (2017-2032) by Test Type
9.2.1 Market Overview
9.2.2 Membrane Filtration
9.2.3 Direct Inoculation
9.2.4 Others
9.3 Asia Pacific Sterility testing market (2017-2032) by Country
9.3.1 China
9.3.2 Japan
9.3.3 India
9.3.4 ASEAN
9.3.5 Australia
9.3.6 Others
10 Latin America Sterility testing market (2017-2032)
10.1 Latin America Sterility testing market (2017-2032) by Products & Services
10.1.1 Market Overview
10.1.2 Kits & Reagents
10.1.3 Services
10.1.4 Instruments
10.2 Latin America Sterility testing market (2017-2032) by Test Type
10.2.1 Market Overview
10.2.2 Membrane Filtration
10.2.3 Direct Inoculation
10.2.4 Others
10.3 Latin America Sterility testing market (2017-2032) by Country
10.3.1 Brazil
10.3.2 Argentina
10.3.3 Mexico
10.3.4 Others
11 Middle East and Africa Sterility testing market (2017-2032)
11.1 Middle East and Africa Sterility testing market (2017-2032) by Products & Services
11.1.1 Market Overview
11.1.2 Kits & Reagents
11.1.3 Services
11.1.4 Instruments
11.2 Middle East and Africa Sterility testing market (2017-2032) by Test Type
11.2.1 Market Overview
11.2.2 Membrane Filtration
11.2.3 Direct Inoculation
11.2.4 Others
11.3 Middle East and Africa Sterility testing market (2017-2032) by Country
11.3.1 Saudi Arabia
11.3.2 United Arab Emirates
11.3.3 Nigeria
11.3.4 South Africa
11.3.5 Others
12 Regulatory Framework
12.1 Regulatory Overview
12.1.1 US FDA
12.1.2 EU EMA
12.1.3 INDIA CDSCO
12.1.4 JAPAN PMDA
12.1.5 Others
13 Patent Analysis
13.1 Analysis by Type of Patent
13.2 Analysis by Publication year
13.3 Analysis by Issuing Authority
13.4 Analysis by Patent Age
13.5 Analysis by CPC Analysis
13.6 Analysis by Patent Valuation
13.7 Analysis by Key Players
14 Grants Analysis
14.1 Analysis by Year
14.2 Analysis by Amount Awarded
14.3 Analysis by Issuing Authority
14.4 Analysis by Grant Type
14.5 Analysis by Funding Institute
14.6 Analysis by Departments
14.7 Analysis by Recipient Organization
15 Funding and Investment Analysis
15.1 Analysis by Funding Instances
15.2 Analysis by Type of Funding
15.3 Analysis by Funding Amount
15.4 Analysis by Leading Players
15.5 Analysis by Leading Investors
15.6 Analysis by Geography
16 Partnership and Collaborations Analysis
16.1 Analysis by Partnership Instances
16.2 Analysis by Type of Partnership
16.3 Analysis by Leading Players
16.4 Analysis by Geography
17 Supplier Landscape
17.1 Merck KGaA
17.1.1 Financial Analysis
17.1.2 Product Portfolio
17.1.3 Demographic Reach and Achievements
17.1.4 Mergers and Acquisitions
17.1.5 Certifications
17.2 BAXTER HEALTHCARE CORPORATION
17.2.1 Financial Analysis
17.2.2 Product Portfolio
17.2.3 Demographic Reach and Achievements
17.2.4 Mergers and Acquisitions
17.2.5 Certifications
17.3 BOSTON ANALYTICAL
17.3.1 Financial Analysis
17.3.2 Product Portfolio
17.3.3 Demographic Reach and Achievements
17.3.4 Mergers and Acquisitions
17.3.5 Certifications
17.4 LEXAMED LTD
17.4.1 Financial Analysis
17.4.2 Product Portfolio
17.4.3 Demographic Reach and Achievements
17.4.4 Mergers and Acquisitions
17.4.5 Certifications
17.5 Danaher Corporation
17.5.1 Financial Analysis
17.5.2 Product Portfolio
17.5.3 Demographic Reach and Achievements
17.5.4 Mergers and Acquisitions
17.5.5 Certifications
17.6 Sartorius AG
17.6.1 Financial Analysis
17.6.2 Product Portfolio
17.6.3 Demographic Reach and Achievements
17.6.4 Mergers and Acquisitions
17.6.5 Certifications
17.7 Gibraltar Laboratories
17.7.1 Financial Analysis
17.7.2 Product Portfolio
17.7.3 Demographic Reach and Achievements
17.7.4 Mergers and Acquisitions
17.7.5 Certifications
17.8 Pace Analytical Services, Inc
17.8.1 Financial Analysis
17.8.2 Product Portfolio
17.8.3 Demographic Reach and Achievements
17.8.4 Mergers and Acquisitions
17.8.5 Certifications
17.9 Sigma-Aldrich Co. LLC
17.9.1 Financial Analysis
17.9.2 Product Portfolio
17.9.3 Demographic Reach and Achievements
17.9.4 Mergers and Acquisitions
17.9.5 Certifications
17.10 Nelson Laboratories
17.10.1 Financial Analysis
17.10.2 Product Portfolio
17.10.3 Demographic Reach and Achievements
17.10.4 Mergers and Acquisitions
17.10.5 Certifications
17.11 Pacific Biolabs.
17.11.1 Financial Analysis
17.11.2 Product Portfolio
17.11.3 Demographic Reach and Achievements
17.11.4 Mergers and Acquisitions
17.11.5 Certifications
17.12 BioConvergence LLC
17.12.1 Financial Analysis
17.12.2 Product Portfolio
17.12.3 Demographic Reach and Achievements
17.12.4 Mergers and Acquisitions
17.12.5 Certifications
17.13 Thermo Fisher Scientific Inc
17.13.1 Financial Analysis
17.13.2 Product Portfolio
17.13.3 Demographic Reach and Achievements
17.13.4 Mergers and Acquisitions
17.13.5 Certifications
17.14 Toxikon Corporation
17.14.1 Financial Analysis
17.14.2 Product Portfolio
17.14.3 Demographic Reach and Achievements
17.14.4 Mergers and Acquisitions
17.14.5 Certifications
17.15 Wuxi Apptec
17.15.1 Financial Analysis
17.15.2 Product Portfolio
17.15.3 Demographic Reach and Achievements
17.15.4 Mergers and Acquisitions
17.15.5 Certifications
List not exhaustive!
18 Global Sterility Testing Market – Distribution Model (Additional Insight)
18.1 Overview
18.2 Potential Distributors
18.3 Key Parameters for Distribution Partner Assessment
19 Key Opinion Leaders (KOL) Insights (Additional Insight)
20 Company Competitiveness Analysis (Additional Insight)
20.1 Very Small Companies
20.2 Small Companies
20.3 Mid-Sized Companies
20.4 Large Companies
20.5 Very Large Companies
21 Payment Methods (Additional Insight)
21.1 Government Funded
21.2 Private Insurance
21.3 Out-of-Pocket
*Additional insights provided are customisable as per client requirements.
* The coverage of the Market Landscape section depends on the data availability and may cover a minimum of 80% of the total market. The EMR team strives to make this section as comprehensive as possible.
Key Questions Answered in the Report
The market attained a value of about USD 1.23 billion in 2023 driven by the rising research and development activities in healthcare and life sciences sectors across the globe.
The market is anticipated to grow at a CAGR of 11.90% during the forecast period of 2024-2032, likely to reach a market value of USD 3.38 billion by 2032.
The increasing prevalence of chronic diseases necessitates effective therapeutics and medical devices that have undergone rigorous sterility testing. This is expected to drive demand for sterility testing products and services.
One of the significant market trends is the expansion of sterility testing capacities by the key market players. In December 2023, United Kingdom based Symbiosis Pharmaceutical Services, invested USD 1.25 million to build in-house analytical and microbiological testing capabilities to offer sterility, bioburden, and endotoxin testing, among others.
The market is segmented by products and services into kits and reagents, services, and instruments.
The sterility testing market is segmented by test type into membrane filtration and direct inoculation methods.
The market for sterility testing is segmented by end users into pharmaceutical companies, biotechnological companies, and others.
Based on the application, the market is divided into pharmaceutical and biological manufacturing, medical devices manufacturing, and others.
The major regions of the market include North America, Europe, Asia Pacific, Latin America, Middle East, and Africa.
Key players involved in the market are Merck KGaA, BAXTER HEALTHCARE CORPORATION, BOSTON ANALYTICAL, LEXAMED LTD, Danaher Corporation, Sartorius AG, Gibraltar Laboratories, Pace Analytical Services, Inc, Sigma-Aldrich Co. LLC, Nelson Laboratories, Pacific Biolabs., BioConvergence LLC, Thermo Fisher Scientific Inc, Toxikon Corporation, and Wuxi Apptec.
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