Report Description Table of Contents Industry Report and Statistics (Facts & Figures) - Number of Tests Conducted & Demand by Product, Test Type & Application The global sterility testing market will witness a robust CAGR of 12.6%, valued at $181.49 million in 2022, expected to appreciate and reach $469 million by 2030, confirms Strategic Market Research. North America dominates the sector with increased investments in R&D, government initiatives, and advancements in pharmaceutical and biotechnology. Before being released and administered to patients, sterile products must pass sterility testing, and it is necessary for all pharmaceuticals, tissue materials, medical devices, and other items claiming to be sterile or contamination-free. Sterility testing maintains the safety and efficacy of the products, and this fuels the growth of the sterility testing market. By 2030, the need for sterile pharmaceuticals is anticipated to grow by 50%, according to McKinsey. The rise in drug development and the adoption of new technology, including cell and gene therapies, create a need for sterility testing. Growth is spearheaded by various factors like the increasing number of chronic diseases, increasing demand for biopharmaceuticals, and the stringent regulatory framework for product safety. The pharmaceutical industry is witnessing advancements in sterility testing technologies, enabling more accurate and efficient testing. The recent trend of sterility testing services provided by companies like BioMerieux, Charles River Laboratories, Inc., Merck KGaA, and Sartorius AG proliferates the market because of their high service quality. Charles River developed a rapid sterility testing method that shows results by saving time by 50% from the compendial method and is regulated as per USP<1223> and shows results in 6 days. Drivers – Government Regulation, Expansion of Pharmaceutical R&D, and Out-Sourcing of Testing Services There are stringent regulations for sterility testing from authorities like the FDA and EMA to ensure the safety and quality of the devices. Most countries have their sterility testing standards. For example, in the USA, USP chapter <71> outlines the requirements for sterility testing. Stringent rules of sterility testing involve validation, methodology, environmental monitoring, sampling technique, and test methods. Not following sterility testing regulations can result in product recalls, regulatory actions, and damage to the reputation. This raises the process standard for sterility testing hence driving the market. The pharmaceutical and biotechnology industries are experiencing significant growth globally. In 2022 the market share of the global pharmaceutical sector was $1.5 trillion, stated by International Trade Organisation. The rise in drug development and the adoption of new technology, including cell and gene therapies, create a need for sterility testing. The pharmaceutical industry is witnessing advancements in sterility testing technologies, enabling more accurate and efficient testing. Traditional methods, such as membrane filtration and direct inoculation, are being complemented or replaced by rapid microbial detection methods, such as automated growth-based systems, nucleic acid amplification techniques, and optical-based methods. These technologies offer faster results, improved sensitivity, and increased throughput thereby propelling the market further. Technological advancements have improved sterility testing methods, making them more efficient and accurate. Technological advances in testing methods like the next generation sequencing (NGS) and polymerase chain reaction (PCR) have increased the accuracy by reducing testing time. The introduction of automated systems, such as the Vitek and BacT/ALERT systems, has further streamlined the sterility testing process. Many companies outsource their sterility testing needs to specialized laboratories and contract testing organizations. Outsourcing provides flexibility and scalability in sterility testing. Outsourcing sterility testing can offer cost and efficiency advantages, risk mitigation, and focus on core competencies. In conclusion, the market drivers for sterility testing include government regulations, the growth of the pharmaceutical industries, technological advancements, and outsourcing sterility testing services, contributing to the growing importance and market demand for sterility testing. Restraints - Stringent Government Regulations A rise in the sterility testing unit price and the scarcity of qualified sterility test professionals due to strict government rules are highly obstructing the market growth. High levels of consolidation, as well as rigid regulatory frameworks and lengthy licensing processes, are significant barriers to new market entrants. Trends and Opportunities - Emerging Markets and Increasing Pharmaceutical Outsourcing Industry players in the pharmaceutical and biopharmaceutical industries are ensuring that environmental monitoring (EM) program is implemented to avoid sterility test failures in the future. The sterilization of the product assures safety and detects early concerns quickly. This aids the firms in maximizing their market position in the service industry. According to India Brand Equity Foundation, Biopharmaceuticals, Bio Services, Bio-agriculture, Bioindustry, and Bioinformatics makeup India's biotechnology industry. In 2020, the Indian biotechnology industry was valued at $70.2 billion; by 2025, it is predicted to be worth $150 billion. Further, the governmental bodies are spending a hefty amount of money on the improvisation of the testing procedure. Apart from that, they have also introduced some of the notable FDA guidelines for sterility testing, which is expected to cater to ample growth opportunities for the market in due course of time. According to India Brand Equity Foundation, in FY20, India's medical device market was valued at US$ 10.36 billion. From 2020 to 2025, the industry is predicted to grow at a CAGR of 37%, reaching US$ 50 billion. Moreover, scientists from all across the globe are toiling hard in their field of research. They have successfully developed some of the critical sterility testing methods in microbiology, which is expected to extensively fuel market growth. Market Analysis Of Different Segments Covered in the Report Based on Product Kits and Reagents Instruments Services Based on Test Membrane Filtration Direct Inoculation Other Sterility Tests Based on Application Pharmaceutical and Biological Manufacturing Medical devises Manufacturing Others Applications Regional Coverage Analysis North America U.S. Canada Europe Germany France U.K. Italy Spain Rest of Europe (RoE) Asia China Japan India Rest of Asia (RoA) Product Analysis & Insights Based on product type, sterility testing is segmented as Kits and Reagents, Instruments, and Services. Kits and Reagents dominate the segment with a 65% market share. According to WHO, sterility testing is mandatory for every pharmaceutical and medical device, so they need a new kit each time. This increases the demand for the kits and reagents. Kits and reagents are expected to dominate the segment due to repetitive kit purchases, easy-to-use, and affordability. According to Milliflex, with advancements in the medical field, the kits give results in 5 days as compared to instruments and services, which provide results in 14 days. The service segment of sterility testing is growing at a constant CAGR of 13% because of testing facilities around the USA. Several companies offer sterility testing services, like BioMerieux, Charles River Laboratories, Inc., Merck KGaA, and Sartorius AG. These testing facilities are known for their high service quality. Type Analysis & Insights Membrane filtration dominated the market, owing to technological advancements in membrane filtration design and operations, which increases the filtration efficiency and allows the filtration processes to operate at low temperatures with less energy consumption. According to Bit Rebels, Over the next few years, 47% of businesses is anticipated to increase their usage of connected health solutions. Personal sensor technologies such as wearable gadgets are expected to have a favorable impact on health, according to 71% of physicians. Application Analysis & Insights Based on application type, Pharmaceutical and Biological manufacturing is dominating the market with 77% of the market share and is expected to hold that position. This dominates the market due to proliferating demand for drugs and vaccines, high pharma industry growth, and increased regulatory interventions like mandatory sterility testing for equipment. Sterility testing is performed to manufacture pharma products to reduce the risk of contamination. With the growth in medicine, the frequency of sterility testing is also growing, boosting the market for sterility testing. According to a report, $248 billion is spent on pharmaceutical R&D. Therefore, these increasing R&D expenditures are expected to proliferate the market growth over the period. Region Analysis & Insights Based on Region, North America dominates the sector with increased investments in R&D, government initiatives, and advancements in pharmaceutical and biotechnology. The establishment of sterility testing facilities by companies like BioMerieux, Charles River Laboratories, Inc., Merck KGaA, and Sartorius AG fuels the growth of the sterility testing market in the North-America. North America has 41% of global spending on the pharmaceutical industry, which fuels the expansion of sterility testing with a growing approval rate of new drugs. Asia Pacific is the fastest-growing market for sterility testing due to medical advancements from leading countries like China and India, and outsourcing medicines and vaccines gave rise to the sterility testing market. Sterility Testing Market Report Coverage Report Attribute Details Forecast Period 2020-2027 The market size value in 2021 USD 161.18 Million Revenue Forecast in 2030 USD 469.0 million Growth Rate CAGR of Approximately 12.6% The base year for estimation 2021 Historical Data 2017 - 2020 Unit USD Million, CAGR (2021-2030) Segmentation By Product, By Test, By Application, By Region By Product Kits and Reagents, Instruments, and Services By Test Membrane Filtration, Direct Inoculation, and Other Sterility Tests By Application Pharmaceutical and biological manufacturing, Medical Devices Manufacturing, and Other Applications. By Region North America, Europe, and Asia Country Space US, Canada, Germany, France, UK, Japan, China, India, etc. Company Usability Profiles BioMérieux, Charles River Laboratories, Inc., Merck KGaA, Sartorius AG, SGS S.A., Sotera Health LLC, and Thermo Fisher Scientific Global Sterility Testing Market Competitive Landscape Analysis The competitive landscape analysis provides information about the crucial competitors prevailing in the global environment. The comparison is performed based on overall revenue generation, market initiatives, company overview, investment in R&D, company financials, company strengths and weaknesses, global presence, production capacity, production sites and facilities, market potential, etc. Merck KGaA Baxter Healthcare Corporation Boston Analytical Neopharm Labs Inc. 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 Rapid Micro Biosystems, Inc. Recent Developments On April 2023, Milliflex announced the Rapid System 2.0, an automated sterility testing kit that can calibrate the test result in 5 days compared to the traditional 14 days. Milliflex uses technologies like membrane filtration, ATP bioluminescence, and image analysis. These automated results can be viewed in 2D and 3D with a detailed analysis within 90 seconds. On April 2023, STEMart, a U.S. based service provider, introduced sterility testing services for all medical devices under the guidance of the ISO 11731 method. Bioburden Testing estimates the number of microorganisms on the surface of medical devices, while Sterility Testing reveals whether medical devices are sterile. Sterility Testing is a strategy used to avoid false negatives in sterility tests by determining the growth of bacteria and fungi. ISO 11731 specifies the method to analyze the sterilization of medical devices. Various Devices that the Market Leaders are Manufacturing Name of the product Function Key Players Filter Paper Filter papers are often used in quantitative and qualitative analysis. Sigma-Aldrich Co. LLC. QuantStudio Real-Time PCR systems Changes in gene expression as little as 1.5-fold can be detected with QuantStudio Real-Time PCR equipment. Thermo Fisher Scientific Inc. ProClin Preservatives ProClinTM preservatives are water-soluble biocide formulations among the most effective biocides in the IVD sector and are utilized in over 1,000 FDA-approved IVD kits from leading diagnostic companies. Sigma-Aldrich Co. LLC. KingFisher Apex System The KingFisher Apex of Thermo Scientific is the pinnacle of automated DNA, RNA, protein, and cell purification. Thermo Fisher Scientific Inc. Frequently Asked Question About This Report What is the sterility testing market growth? The global sterility testing market is expected to grow at a compound annual growth rate (CAGR) of 12.6% from 2021 to 2030 to reach USD 469.0 billion by 2030. How big is the global sterility testing market? The global sterility testing market size was $161.18 Mn in 2021 and is predicted to reach $469.0 Mn by 2030, representing a CAGR of 12.6% during 2021 - 2030. List the essential players in the market. BioMerieux, Charles River Laboratories, Inc., Merck KGaA, Sartorius AG, SGS S.A., Sotera Health LLC, and Thermo Fisher Scientific, among others, are some of the markets key competitors. What is a sterility test? What are the sterility testing types? Sterility testing is a GMP microbiological testing requirement that ensures the presence of sterile items before being released and administered to patients. Membrane filtration, Direct Transfer and Product Flush are the various types of sterility tests. Which media is used for sterility testing? Fluid thioglycolate medium (FTM) is used for sterility testing. Why sterility testing is performed for 14 days? Sterility testing usually requires two weeks of long incubation time as there exists some bacteria which are very slow in terms of growth, such as Propionibacterium acnes. P. acne is gram-positive, rod-shaped, slow-growing bacteria which is found in the acne of homosapians. What is the predicted size of the market? The global market is predicted to reach USD 469.0 million by 2030. Sources https://www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/the-next-wave-of-healthcare-innovation-the-evolution-of-ecosystems https://economictimes.indiatimes.com/news/science/union-budget-2022-23-ministry-of-science-and-technology-allocated-rs-14217-crore/articleshow/89280245.cms?from=mdr https://www.ibef.org/blogs/india-a-global-biotech-market https://www.ibef.org/download/Medical-Devices-March-2021.pdf https://ised-isde.canada.ca/site/industrial-technological-benefits/en https://www.clinicalresearchnewsonline.com/news/2023/04/13/stemart-launches-bioburden-and-sterility-testing-for-medical-devices https://www.merckmillipore.com/IN/en/product/Milliflex-Rapid-System-2.0,MM_NF-C10711 https://www.cphi-online.com/regions/north-america/ https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/sterility-testing https://www.criver.com/products-services/biologics-testing-solutions/contamination-and-impurity-testing/sterility-testing https://www.rapidmicrobiology.com/news/why-is-bact-alert-the-method-of-choice-for-rapid-sterility-testing https://www.sartorius.com/en/knowledge/science-snippets/regulatory-standards-for-sterility-testing-693916 https://www.sigmaaldrich.com/IN/en/applications/microbiological-testing/sterility-testing https://www.mckinsey.com/industries/life-sciences/our-insights/how-sterile-pharma-manufacturers-can-grow-capacity-without-capital-investment https://www.sigmaaldrich.com/ES/en/applications/microbiological-testing/sterility-testing https://www.criver.com/products-services/biologics-testing-solutions/contamination-and-impurity-testing/sterility-testing?region=3701 1. Introduction 1.1. Study Objective 1.2. Market Definition 1.3. Study Scope 1.3.1. Markets Covered 1.3.2. Geographic Scope 1.3.3. Years Considered 1.3.4. Stakeholders 2. Research Methodology 2.1. Data Procurement 2.2. Paid Database 2.2.1. Secondary Data 2.2.1.1. Key Secondary sources 2.2.2. Primary Data 2.2.2.1 Primary sources 2.2.2.2. Key industry insights 2.2.2.3. Primary interviews with experts 2.2.2.4. Key primary respondent list 2.3. Market Size Estimation 2.4. Bottom-Up and Top-Down Approaches 2.4.1. Bottom-Up Approach 2.4.1.1. Approach for arriving at market size by bottom-up analysis 2.4.2. Top-Down Approach 2.4.2.1. Approach for Capturing Market Size by Top-Down Analysis 2.5. Market Breakdown and Data Triangulation 2.6. Research Methodology 2.7. Risk Assessment 3. Executive Summary 3.1 Sterility Testing Market: Post-Covid-19 3.1.1 Actual Scenario 3.1.2 Pessimistic Scenario 3.1.3 Optimistic Scenario 3.1.4 Market Summary 4. Industry Outlook 4.1 Market Snapshot 4.2 Regional Analysis 4.2.1 market, by region, 2021-2030 (USD Million) 4.3 By Product Analysis 4.3.1 market, By Product, 2021-2030 (USD Million) 4.4 By Test Analysis 4.4.1 market, By Test, 2021-2030 (USD Million) 4.5 Application Analysis 4.5.1 market, By Application, 2021-2030 (USD Million) 4.6 Value Chain Analysis 4.7 Market Variable Analysis 4.7.1 Market Drivers Analysis 4.7.2 Market Restraints Analysis 4.8 Environment Analysis Tool 4.8.1 PEST analysis 4.8.2 Porter’s analysis 4.9 Penetration & Growth Prospect Mapping 5. Market Dynamics 5.1. Introduction 5.2. Market Dynamics 5.2.1. Drivers 5.2.2. Restraints 5.2.3. Opportunities 5.2.4. Challenges 5.3. Impact of Covid-19 On Market 5.4. Value Chain Analysis 5.5. Ecosystem 5.6. Patent Analysis 5.7. Trade Analysis 5.8. Tariff Analysis 5.9. Case Study Analysis 5.10. Porter’s Five Forces Analysis 5.10.1 Threat of New Entrants 5.10.2 Threat of Substitutes 5.10.3 Bargaining Power of Buyers 5.10.4 Bargaining Power of Suppliers 5.10.5 Degree of Competition 5.11. Application Analysis 5.11.1. Trends in Application (2014-2020) 5.11.2. Trends in Application (2021-2028) 5.12. Pricing Analysis 5.12.1. Average Price Trend Analysis (By region, By Countries) 6. Competitive & Vendor Landscape 6.1. Company Market Share Analysis 6.2. Manufacturing Sites, Area Served, Product Product 6.3. Market Competitive Situation and Trends 6.4. Manufacturers Mergers & Acquisitions, Expansion Plans 7. Global Market: By Product Segment Analysis 7.1. Introduction 7.2. Sales Volume & Revenue Analysis (2021-2030) 7.3. Kits and Reagents 7.3.1. Kits and Reagents market, 2021-2030 (USD Million) 7.4. Instruments 7.4.1. Instruments market, 2021-2030 (USD Million) 7.5. Services 7.5.1. Services market, 2021-2030 (USD Million) 8. Global Market: By Test Segment Analysis 8.1. Introduction 8.2. Sales Volume & Revenue Analysis (2021-2030) 8.3. Membrane Filtration 8.3.1. Membrane Filtration market, 2021-2030 (USD Million) 8.4. Direct Inoculation 8.4.1. Direct Inoculation market, 2021-2030 (USD Million) 8.5. Others 8.5.1. Others market, 2021-2030 (USD Million) 9. Global Market: By Application Segment Analysis 9.1. Introduction 9.2. Sales Volume & Revenue Analysis (2021-2030) 9.3. Pharmaceutical and Biological Manufacturing 9.3.1. Pharmaceutical and Biological Manufacturing market, 2021-2030 (USD Million) 9.4. Medical Devices Manufacturing 9.4.1. Medical Devices Manufacturing market, 2021-2030 (USD Million) 9.5. Others Applications 9.5.1. Others Applications market, 2021-2030 (USD Million) 10. Global Market: Regional Outlook 10.1 North America 10.1.1. North America market, by By Product, 2021-2030 (USD Million) 10.1.2. North America market, by By Test, 2021-2030 (USD Million) 10.1.3. North America market, by Application, 2021-2030 (USD Million) 10.1.4. North America market, by Country, 2021-2030 (USD Million) 10.1.4.1. U.S. 10.1.4.1.1. U.S. market, by By Product, 2021-2030 (USD Million) 10.1.4.1.2. U.S. market, by By Test, 2021-2030 (USD Million) 10.1.4.1.3. U.S. market, by Application, 2021-2030 (USD Million) 10.1.4.2. Canada 10.1.4.2.1. Canada market, by By Product, 2021-2030 (USD Million) 10.1.4.2.2. Canada market, by By Test, 2021-2030 (USD Million) 10.1.4.2.3. Canada market, by Application, 2021-2030 (USD Million) 10.2. Europe 10.2.1. Europe market, by By Product, 2021-2030 (USD Million) 10.2.2. Europe market, by By Test, 2021-2030 (USD Million) 10.2.3. Europe market, by Application, 2021-2030 (USD Million) 10.2.4. Europe market, by country, 2021-2030 (USD Million) 10.2.4.1 U.K. 10.2.4.1.1. U.K. market, by By Product, 2021-2030 (USD Million) 10.2.4.1.2. U.K. market, by By Test, 2021-2030 (USD Million) 10.2.4.1.3. U.K. market, by Application, 2021-2030 (USD Million) 10.2.4.2. Germany 10.2.4.2.1. Germany market, by By Product, 2021-2030 (USD Million) 10.2.4.2.2. Germany market, by By Test, 2021-2030 (USD Million) 10.2.4.2.3. Germany market, by Application, 2021-2030 (USD Million) 10.2.4.3. France 10.2.4.3.1. France market, by By Product, 2021-2030 (USD Million) 10.2.4.3.2. France market, by By Test, 2021-2030 (USD Million) 10.2.4.3.3. France market, by Application, 2021-2030 (USD Million) 10.2.4.4. Rest of Europe 10.2.4.4.1. Rest of Europe market, by By Product, 2021-2030 (USD Million) 10.2.4.4.2. Rest of Europe market, by By Test, 2021-2030 (USD Million) 10.2.4.4.3. Rest of Europe market, by Application, 2021-2030 (USD Million) 10.3. Asia Pacific 10.3.1. Asia Pacific market, by By Product, 2021-2030 (USD Million) 10.3.2. Asia Pacific market, by By Test, 2021-2030 (USD Million) 10.3.3. Asia Pacific market, by Application, 2021-2030 (USD Million) 10.3.4. Asia Pacific market, by country, 2021-2030 (USD Million) 10.3.4.1. China 10.3.4.1.1. China market, by By Product, 2021-2030 (USD Million) 10.3.4.1.2. China market, by By Test, 2021-2030 (USD Million) 10.3.4.1.3. China market, by Application, 2021-2030 (USD Million) 10.3.4.2. India 10.3.4.2.1. India market, by By Product, 2021-2030 (USD Million) 10.3.4.2.2. India market, by By Test, 2021-2030 (USD Million) 10.3.4.2.3. India market, by Application, 2021-2030 (USD Million) 10.3.4.3. Japan 10.3.4.3.1. Japan market, by By Product, 2021-2030 (USD Million) 10.3.4.3.2. Japan market, by By Test, 2021-2030 (USD Million) 10.3.4.3.3. Japan market, by Application, 2021-2030 (USD Million) 10.3.4.4. South Korea 10.3.4.4.1. South Korea market, by By Product, 2021-2030 (USD Million) 10.3.4.4.2. South Korea market, by By Test, 2021-2030 (USD Million) 10.3.4.4.3. South Korea market, by Application, 2021-2030 (USD Million) 10.3.4.5. Rest of ASIA PACIFIC 10.3.4.5.1. Rest of ASIA PACIFIC market, by By Product, 2021-2030 (USD Million) 10.3.4.5.2. Rest of ASIA PACIFIC market, by By Test, 2021-2030 (USD Million) 10.3.4.5.3. Rest of ASIA PACIFIC market, by Application, 2021-2030 (USD Million) 10.4. Latin America 10.4.1. Latin America market, by By Product, 2021-2030 (USD Million) 10.4.2. Latin America market, by By Test, 2021-2030 (USD Million) 10.4.3. Latin America market, by Application, 2021-2030 (USD Million) 10.4.4. Latin America market, by country, 2021-2030 (USD Million) 10.4.4.1. Brazil 10.4.4.1.1. Brazil market, by By Product, 2021-2030 (USD Million) 10.4.4.1.2. Brazil market, by By Test, 2021-2030 (USD Million) 10.4.4.1.3. Brazil market, by Application, 2021-2030 (USD Million) 10.4.4.2. Mexico 10.4.4.2.1. Mexico market, by By Product, 2021-2030 (USD Million) 10.4.4.2.2. Mexico market, by By Test, 2021-2030 (USD Million) 10.4.4.2.3. Mexico market, by Application, 2021-2030 (USD Million) 10.4.4.3. Rest of the Latin America 10.4.4.3.1. Rest of the Latin America market, by By Product, 2021-2030 (USD Million) 10.4.4.3.2. Rest of the Latin America market, by By Test, 2021-2030 (USD Million) 10.4.4.3.3. Rest of the Latin America market, by Application, 2021-2030 (USD Million) 10.5. MEA 10.5.1. MEA market, by By Product, 2021-2030 (USD Million) 10.5.2. MEA market, by By Test, 2021-2030 (USD Million) 10.5.3. MEA market, by Application, 2021-2030 (USD Million) 10.5.4. MEA market, by Region, 2021-2030 (USD Million) 11. Competitive Landscape 11.1 Merck KGaA 11.1.1. Company overview 11.1.2. Financial performance 11.1.3. Product Portfolio Analysis 11.1.4. Strategy & Recent Development 11.2. BAXTER HEALTHCARE CORPORATION 11.2.1. Company overview 11.2.2. Financial performance 11.2.3. Product Portfolio Analysis 11.2.4. Strategy & Recent Development 11.3. BOSTON ANALYTICAL 11.3.1. Company overview 11.3.2. Financial performance 11.3.3. Product Portfolio Analysis 11.3.4. Strategy & Recent Development 11.4. NEOPHARM LABS INC. 11.4.1. Company overview 11.4.2. Financial performance 11.4.3. Product Portfolio Analysis 11.4.4. Strategy & Recent Development 11.5. LEXAMED LTD 11.5.1. Company overview 11.5.2. Financial performance 11.5.3. Product Portfolio Analysis 11.5.4. Strategy & Recent Development 11.6. Danaher Corporation 11.6.1. Company overview 11.6.2. Financial performance 11.6.3. Product Portfolio Analysis 11.6.4. Strategy & Recent Development 11.7. Sartorius AG 11.7.1. Company overview 11.7.2. Financial performance 11.7.3. Product Portfolio Analysis 11.7.4. Strategy & Recent Development 11.8. Gibraltar Laboratories 11.8.1. Company overview 11.8.2. Financial performance 11.8.3. Product Portfolio Analysis 11.8.4. Strategy & Recent Development 11.9. Pace Analytical Services, Inc 11.9.1. Company overview 11.9.2. Financial performance 11.9.3. Product Portfolio Analysis 11.9.4. Strategy & Recent Development 11.10. Sigma-Aldrich Co. LLC 11.10.1. Company overview 11.10.2. Financial performance 11.10.3. Product Portfolio Analysis 11.10.4. Strategy & Recent Development 11.11. Nelson Laboratories 11.11.1. Company overview 11.11.2. Financial performance 11.11.3. Product Portfolio Analysis 11.11.4. Strategy & Recent Development 11.12. Pacific Biolabs. 11.12.1. Company overview 11.12.2. Financial performance 11.12.3. Product Portfolio Analysis 11.12.4. Strategy & Recent Development 11.13. BioConvergence LLC 11.13.1. Company overview 11.13.2. Financial performance 11.13.3. Product Portfolio Analysis 11.13.4. Strategy & Recent Development 11.14. Thermo Fisher Scientific Inc 11.14.1. Company overview 11.14.2. Financial performance 11.14.3. Product Portfolio Analysis 11.14.4. Strategy & Recent Development 11.15. Toxikon Corporation 11.15.1. Company overview 11.15.2. Financial performance 11.15.3. Product Portfolio Analysis 11.15.4. Strategy & Recent Development 11.16. Wuxi Apptec 11.16.1. Company overview 11.16.2. Financial performance 11.16.3. Product Portfolio Analysis 11.16.4. Strategy & Recent Development 11.17. Rapid Micro Biosystems, Inc. 11.17.1. Company overview 11.17.2. Financial performance 11.17.3. Product Portfolio Analysis 11.17.4. Strategy & Recent Development List of Tables (63 Tables) TABLE 1. MARKET, By Product, 2021-2030 (USD Million) TABLE 2. MARKET FOR Kits and Reagents, BY REGION, 2021-2030 (USD Million) TABLE 3. MARKET FOR Instruments, BY REGION, 2021-2030 (USD Million) TABLE 4. MARKET FOR Services, BY REGION, 2021-2030 (USD Million) TABLE 5. MARKET, By Test, 2021-2030 (USD Million) TABLE 6. MARKET FOR Membrane Filtration, BY REGION, 2021-2030 (USD Million) TABLE 7. MARKET FOR Direct Inoculation, BY REGION, 2021-2030 (USD Million) TABLE 8. MARKET FOR Others Sterility Tests, BY REGION, 2021-2030 (USD Million) TABLE 9. MARKET, BY APPLICATION, 2021-2030 (USD Million) TABLE 10. MARKET FOR Pharmaceutical and Biological Manufacturing, BY REGION, 2021-2030 (USD Million) TABLE 11. MARKET FOR Medical Devices Manufacturing, BY REGION, 2021-2030 (USD Million) TABLE 12. MARKET FOR Others Applications, BY REGION, 2021-2030 (USD Million) TABLE 13. MARKET, BY REGION, 2021-2030 (USD Million) TABLE 14. NORTH AMERICA MARKET, BY COUNTRY, 2021-2030 (USD Million) TABLE 15. NORTH AMERICA MARKET, By Product, 2021-2030 (USD Million) TABLE 16. NORTH AMERICA MARKET, By Test, 2021-2030 (USD Million) TABLE 17. NORTH AMERICA MARKET, BY APPLICATION, 2021-2030 (USD Million) TABLE 18. EUROPE MARKET, BY COUNTRY, 2021-2030 (USD Million) TABLE 19. EUROPE MARKET, By Product, 2021-2030 (USD Million) TABLE 20. EUROPE MARKET, By Test, 2021-2030 (USD Million) TABLE 21. EUROPE MARKET, BY APPLICATION, 2021-2030 (USD Million) TABLE 22. ASIA-PACIFIC MARKET, BY COUNTRY, 2021-2030 (USD Million) TABLE 23. ASIA-PACIFIC MARKET, By Product, 2021-2030 (USD Million) TABLE 24. ASIA-PACIFIC MARKET, By Test, 2021-2030 (USD Million) TABLE 25. ASIA-PACIFIC MARKET, BY APPLICATION, 2021-2030 (USD Million) TABLE 26. LAMEA MARKET, BY COUNTRY, 2021-2030 (USD Million) TABLE 27. LAMEA MARKET, By Product, 2021-2030 (USD Million) TABLE 28. LAMEA MARKET, By Test, 2021-2030 (USD Million) TABLE 29. LAMEA MARKET, BY APPLICATION, 2021-2030 (USD Million) TABLE 30. Merck KGaA: COMPANY SNAPSHOT TABLE 31. Merck KGaA: OPERATING SEGMENTS TABLE 32. BAXTER HEALTHCARE CORPORATION: COMPANY SNAPSHOT TABLE 33. BAXTER HEALTHCARE CORPORATION: OPERATING SEGMENTS TABLE 34. BOSTON ANALYTICAL: COMPANY SNAPSHOT TABLE 35. BOSTON ANALYTICAL: OPERATING SEGMENTS TABLE 36. NEOPHARM LABS INC. : COMPANY SNAPSHOT TABLE 37. NEOPHARM LABS INC. : OPERATING SEGMENTS TABLE 38. LEXAMED LTD: COMPANY SNAPSHOT TABLE 39. LEXAMED LTD: OPERATING SEGMENTS TABLE 40. Danaher Corporation: COMPANY SNAPSHOT TABLE 41. Danaher Corporation: OPERATING SEGMENTS TABLE 42. Sartorius AG: COMPANY SNAPSHOT TABLE 43. Sartorius AG: OPERATING SEGMENTS TABLE 44. Gibraltar Laboratories: COMPANY SNAPSHOT TABLE 45. Gibraltar Laboratories: OPERATING SEGMENTS TABLE 46. Pace Analytical Services, Inc: COMPANY SNAPSHOT TABLE 47. Pace Analytical Services, Inc: OPERATING SEGMENTS TABLE 48. Sigma-Aldrich Co. LLC: COMPANY SNAPSHOT TABLE 49. Sigma-Aldrich Co. LLC: OPERATING SEGMENTS TABLE 50. Nelson Laboratories: COMPANY SNAPSHOT TABLE 51. Nelson Laboratories: OPERATING SEGMENTS TABLE 52. Pacific Biolabs: COMPANY SNAPSHOT TABLE 53. Pacific Biolabs: OPERATING SEGMENTS TABLE 54. BioConvergence LLC: COMPANY SNAPSHOT TABLE 55. BioConvergence LLC: OPERATING SEGMENTS TABLE 56. Thermo Fisher Scientific Inc: COMPANY SNAPSHOT TABLE 57. Thermo Fisher Scientific Inc: OPERATING SEGMENTS TABLE 58. Toxikon Corporation: COMPANY SNAPSHOT TABLE 59. Toxikon Corporation: OPERATING SEGMENTS TABLE 60. Wuxi Apptec: COMPANY SNAPSHOT TABLE 61. Wuxi Apptec: OPERATING SEGMENTS TABLE 62. Rapid Micro Biosystems, Inc.: COMPANY SNAPSHOT TABLE 63. Rapid Micro Biosystems, Inc.: OPERATING SEGMENTS List of Figures (22 Figures) Figure 1 Research Methodology Steps Figure 2 Research Design Figure 3 Breakdown of Primaries Figure 4 Research Methodology: Hypothesis Building Figure 5 Product-Based Estimation Figure 6 Top 17 Companies with Highest No. Of Patent in Last 9 Years Figure 7 No. Of Patents Granted Per Year, 2019–2020 Figure 8 Import Data for Sterility Testing, By Country, 2016–2020 (USD Thousand) Figure 9 Export Data for Sterility Testing, By Country, 2016–2020 (USD Thousand) Figure 10 Data Triangulation Methodology Figure 11 Market, By Test, 2019 vs. 2025 (USD Million) Figure 12 Market Share, By Application, 2019 vs. 2025 (USD Million) Figure 13 Market Share, By Product, 2019 vs. 2025 (USD Million) Figure 14 Geographical Snapshot of the Market Figure 15 Kits and Reagents to Witness Higher CAGR in Market for Product Segment during Forecast Period. Figure 16 Pharmaceutical and Biological Manufacturing to Witness Higher CAGR in Market for Application Segment during Forecast Period. Figure 17 Membrane Filtration to Witness Higher CAGR in Market for Test Segment during Forecast Period. Figure 18 North American region Accounted for the Largest Share of the Market, By Regional Basis, in 2019 Figure 19 Drivers, Restraints, Opportunities, and Challenges Figure 20 North America: Market Snapshot Figure 21 Asia Pacific: Market Snapshot Figure 22 Vendor Dive: Evaluation Overview