USD 161.18 million
Sterility Testing Market Size, Share, Growth Analysis, By Product & Services(Kits & Reagents, Services, Instruments ), By Test Type(Membrane Filtration, Direct Inoculation, Other Tests), By Application(Pharmaceuticals and Biologicals, Medical Devices, Other Applications), By End User(Pharmaceutical Companies, Biotechnology Companies, and Others), By Region - Industry Forecast 2025-2032
Report ID:
SQMIG35A2169 |
Region:
Global |
Published Date: September, 2024
Pages:
219
|Tables:
86
|Figures:
76
Sterility Testing Market Insights
Sterility Testing Market size was valued at USD 1.2 Billion in 2023 and is poised to grow from USD 1.33 Billion in 2024 to USD 2.98 Billion by 2032, growing at a CAGR of 10.5% during the forecast period (2025-2032).
Rapidly increasing biopharmaceutical and pharmaceutical production around the world is forecasted to drive up the demand for sterility testing solutions and services. Imposition of strict regulations regarding sterility testing from governments and regulatory authorities will also present new opportunities for sterility testing companies in the long run. The growing popularity of outsourcing in the healthcare industry is also expected to present new revenue generation opportunities as per this sterility testing market outlook. High emphasis on improving quality assurance in the food and beverages industry will also increase the demand for sterility testing in the future. Advancements in sterility testing technologies and rising adoption of rapid sterility testing solutions and services are also estimated to create an opportune setting for market players across the study period and beyond. However, complex and time-consuming procedures, absence of skilled workforce, and variations in regulatory framework around the world are slated to slow down the demand for sterility testing in the future.
US Sterility Testing Market is poised to grow at a sustainable CAGR for the next forecast year.
Market snapshot - 2024–2031
Global Market Size
Largest Segment
Membrane filtration sterility
Fastest Growth
Membrane filtration sterility
Growth Rate
12.6% CAGR
Global Sterility Testing Market ($ Bn)
Country Share for North America Region (%)
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Sterility Testing Market Segmental Analysis
Global Sterility Testing Market is segmented by Product & Services, Test Type, Application, End User, and region. Based on Product & Services, the market is segmented into Kits & Reagents, Services, Instruments. Based on Test type, the market is segmented into Membrane Filtration, Direct Inoculation, Other Tests. Based on Application, the market is segmented into Pharmaceuticals and Biologicals, Medical Devices, Other Applications. Based on End User, the market is segmented into Pharmaceutical Companies, Biotechnology Companies, and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & and Africa.
Sterility Testing Market Analysis by Product & Services
Kits and reagents are forecasted to account for a substantial chunk of the global sterility testing market share. Repetitive purchase and use of kits and reagents in sterility testing applications is allowing this segment to account for a dominant stance in the global sterility testing industry. Surging demand for sterility testing and the need for better reagents and fresh kits for every sterility testing procedure are also expected to generate more revenue for market players than other segments. Growing use of advanced reagents for better results in different types of products are also expected to help bolster the sales of kits and reagents in the long run.
Meanwhile, the demand for services is forecasted to increase at a rapid pace as per this sterility testing market outlook. Increasing popularity of outsourcing in the healthcare industry and growing emphasis on improving efficiency of sterility testing operations are projected to help this segment emerge as a highly opportune one in the global sterility testing market analysis. Providing sterility testing services to companies who lack the resources and time to do it themselves will boost market development potential and generate new business scope in the future. Increasing emphasis on reducing time to market for different healthcare products will also create new opportunities for sterility testing companies going forward.
Sterility Testing Market Analysis by End User
Pharmaceutical companies are predicted to spearhead the global sterility testing demand outlook across the study period. Growing demand for pharmaceutical manufacturing and increasing prevalence of chronic diseases are forecasted to help this segment maintain its dominance. Increasing investments in drug discovery and development are also estimated to aid sterility testing demand in this segment going forward. Imposition of stringent regulatory mandates to ensure sterility of pharmaceuticals will also create new opportunities for sterility testing providers focusing on this segment in the long run. Establishment of pharmaceutical manufacturing facilities and expansion of existing ones will also boost sterility testing demand through 2031.
On the other hand, the use of sterility testing in medical device companies is forecasted to rise at an impressive CAGR across the study period and beyond. Growing emphasis on ensuring proper sterility of medical devices to prevent the risk of cross contamination and hospital acquired infections (HAIs) will primarily help this segment bolster sterility testing adoption in the future. Advancements in medical device technologies and continual launches of new products are expected to provide sustained growth for sterility testing companies focusing on this segment in the long run.
Global Sterility Testing Market By Products & Services
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Sterility Testing Market Regional Insights
North America is predicted to spearhead the demand for sterility testing in the world. Growing healthcare research activity, presence of a strict regulatory framework mandating use of sterility testing, and the presence of key sterility testing companies are helping North America lead the global sterility testing market growth. Targeting the United States and Canada will offer good returns on investment for almost all sterility testing providers operating in this region. Rising incidence of infectious diseases in this region is also expected to create new opportunities for sterility testing providers going forward. Supportive government initiatives to promote safety in healthcare will also benefit sterility testing market forecast in North America.
The Asia Pacific region is slated to emerge as the fastest expanding market for sterility testing companies in the world. Growing investments in healthcare infrastructure development, rising pharmaceutical manufacturing activities, and changing regulatory landscape are some key factors that could offer a new business scope for market players in the long run. The presence of multiple contract research and manufacturing organizations in this region will also bolster the demand for sterility testing services going forward. China, Japan, and India are slated to be the most rewarding markets for sterility testing providers in the Asia Pacific region.
Global Sterility Testing Market By Region
- Largest
- Fastest
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Sterility Testing Market Dynamics
Sterility Testing Market Drivers
Imposition of Strict Mandates for Sterility
- Increasing emphasis on keeping healthcare products free from contamination is pushing governments and regulatory bodies such as the U.S. FDA and the European Medicines Agency (EMA) to impose strict regulations for sterility testing. Maintaining compliance with these regulations is essential and thereby promotes adoption of sterility testing around the world.
Rise in Biopharmaceutical and Pharmaceutical Production Activity
- Surging prevalence of chronic diseases and increasing spending on healthcare has bolstered the demand for pharmaceuticals and biopharmaceuticals. This has resulted in increasing manufacturing activity in the pharmaceutical industry and is forecasted to also favor the adoption of sterility testing to ensure products are free from contaminants and contamination.
Sterility Testing Market Restraints
Absence of Skilled Professionals
- Sterility testing requires individuals that have certain skills and knowledge to ensure proper handling of advanced techniques and equipment. However, the world is facing a shortage of skilled professionals and this is expected to impede the adoption of sterility testing in the long run. This restraint will be highly prominent in developing and underdeveloped countries going forward.
Complex and Time-consuming Processes
- Sterility testing procedures are often termed as quite complex and time-consuming with some techniques requiring incubation periods of up to 14 days. High reliance on these time-consuming sterility testing procedures slows down the time to market for products and further impedes the global sterility testing industry as well.
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Sterility Testing Market Competitive Landscape
Developing sterility testing procedures that take less time and provide accurate results will be the prime focus of all sterility testing companies. Targeting developing and underdeveloped countries could help sterility testing providers maximize their revenue generation and global sterility testing market share as well. Market players should also launch training programs to address the issue of absence of skilled professionals to perform sterility testing.
Sterility Testing Market Top Player’s Company Profiles
- Merck KGaA
- Charles river laboratories
- bioMérieux SA
- Sgs s.a.
- Sartorius ag
- Thermo fisher scientific inc.
- Wuxi apptec
- Samsung biologics
- Genscript
- Pacific biolabs
- Nelson laboratories, llc
- Pace analytical
- Rapid micro biosystems, inc.
- Tentamus
- Singota solutions
- Neopharm labs inc.
- Lexamed
- Astell scientific ltd
- Himedia laboratories
- Pall corporation (part of danaher corporation)
- Boston analytical
- Solvias ag
- BD
Sterility Testing Market Recent Developments
- In October 2024, LGM Pharma, leading service provider for drug development lifecycle added endotoxin and rapid sterility testing capabilities to its Analytical Testing Services (ATS) offering. LGM made these new services available at its Irving facility after installing new equipment for sterility testing.
- In May 2024, Sartorius, a renowned developer and supplier of life science and analytical tools and instruments announced the launch of its new pump for sterility testing use. The novel 4th generation Sterisart® Universal pump is designed to comply with modern safety standards and redefine sterility testing in this connected era of healthcare.
- In January 2024, Rapid Micro Biosystems, a leading name in the quality control space announced its plans to launch its new Growth Direct® Rapid Sterility System in mid 2024. The new system is capable of delivering sterility testing results in as little as 1 to 3 days' time.
Sterility Testing Key Market Trends
- Use of Automation: Sterility testing companies should focus on developing automated solutions and services to streamline the sterility testing workflow and improve accuracy and efficiency as well. Integration of artificial intelligence and machine learning could help sterility testing companies achieve the desired automation and also help them stand out in the global sterility testing industry landscape going forward.
- Development of Sterility Testing for Gene and Cell Therapy: Gene and cell therapy manufacturing requires specialized sterility testing solutions and services. Companies can leverage this sterility testing market trend to maximize their business scope and demand for gene and cell therapies is rising rapidly around the world. Growing commercialization of cell and gene therapies will further offer more opportunities for sterility testing providers in the long run.
Sterility Testing Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
As per SkyQuest analysis, growing pharmaceutical manufacturing activity around the world and the imposition of stringent mandates to ensure sterility are projected to drive up the demand for sterility testing. However, a lack of skilled professionals for sterility testing and the time-consuming nature of sterility testing procedures are slated to impede sterility testing market development going forward. The Asia Pacific region is forecasted to emerge as the fastest-expanding regional market in the world owing to rising pharmaceutical manufacturing and healthcare infrastructure development activities. Integration of artificial intelligence to automate sterility testing procedures is expected to be a key opportunity for market players in the long run. The need for fresh kits and reagents for every sterility testing procedure allows them to dominate the sterility testing market outlook.
| Report Metric | Details |
|---|---|
| Market size value in 2022 | USD 1.1 billion |
| Market size value in 2031 | USD 2.7 billion |
| Growth Rate | 10.5% |
| Base year | 2023 |
| Forecast period | 2024–2031 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
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| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
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| Customization scope | Free report customization with purchase. Customization includes:-
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Sterility Testing Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Sterility Testing Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Sterility Testing Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Sterility Testing Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Sterility Testing Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Sterility Testing Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
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