USD 161.18 million
Global Sterility Testing Market Size, Share, Growth Analysis, By Test(Membrane filtration sterility testing and direct inoculation sterility testing), By End user(Pharmaceutical & biotechnology and medical devices), By Product(Instruments, Services) - Industry Forecast 2024-2031
Report ID:
SQMIG35A2169 |
Region:
Global |
Published Date: February, 2024
Pages:
219
|
Tables:
86 |
Figures:
76
Global Sterility Testing Market Insights
Sterility Testing Market size was valued at USD 161.18 million in 2019 and is poised to grow from USD 181.36 million in 2023 to USD 469 million by 2031, growing at a CAGR of 12.6% in the forecast period (2024-2031).
Growth in research and development activities in the education sector, microbiological and pathological laboratories, and the pharmaceutical sector is an important factor driving the market. Advanced research and development, as well as beneficial government policies drive global sterility testing market. A microbiological laboratory deals with activities like culture, examination, and identification of microorganisms including bacteria, fungi, yeast, etc. A water bath is used to heat chemicals, melt substrates, and incubate cell cultures. An increase in the number of chronic diseases along with increasing awareness about healthcare is driving the global sterility testing market. Heart disease, cancer, and diabetes are examples of chronic diseases that persist for a year or more and require ongoing medical care. The development of chronic diseases is mainly due to changes in human lifestyle, including poor nutrition, physical inactivity, increased consumption of fast food, and excessive alcohol consumption. Sterility testing is performed at every stage of production in the pharmaceutical and biotechnology sector to reduce the risk of product contamination. As a result, the overall consumption of sterility testing will increase significantly as this end-use sector grows during the forecast period. The first step in determining the quality of pharmaceutical drugs is sterility testing. However, stringent regulatory rules, regulations, and time-consuming procedures in many countries may hamper the growth of global sterility testing market.
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($Bn)
Country Share for North America Region (%)
Global Sterility Testing Market size by test ($Bn)
Global Sterility Testing Market size by test($Bn)
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Global Sterility Testing Market Segmental Analysis
Global sterility testing market is segmented on the basis of product, tests, end-user, and region. By product, Sterility Testing Market is segmented into instruments, services, and kits & reagents. By tests, Sterility Testing Market is segmented into membrane filtration sterility testing and direct inoculation sterility testing. By end user, Sterility Testing Market is segmented into pharmaceutical & biotechnology and medical devices. By region, Sterility Testing Market is segmented into North America, Europe, Asia Pacific and MEA.
Sterility Testing Market Analysis by Test
By tests, market is segmented into membrane filtration sterility testing and direct inoculation sterility testing. The membrane filtration sterility testing segment held the largest share of the market and is expected to grow at a significant CAGR during the forecast period. Testing for sterility by membrane filtration involves running test samples over conventional membranes that can capture bacteria. Membrane filtration sterility testing is usually performed for samples containing adjuvant gels and other general-purpose items such as vaccines. When using membrane filtration the microorganisms are retained using a 0.45 m pore size filter and all interfering substances are removed using a suitable rinsing solution. It can handle numerous solutions up to 500 ml and removes inhibitory compounds that inhibit bacterial growth by rinsing the membrane filter with the appropriate reagent. This test is most popular in the pharmaceutical industry and is gaining more attention. So, this major factor will drive the growth of the membrane filtration sterility testing segment in global sterility testing during the forecast period. Direct Inoculation Sterility Testing held the 2nd largest market share.
Sterility Testing Market Analysis by End User
By end user, market is segmented into pharmaceutical & biotechnology and medical devices. The pharmaceutical & biotechnology segment held the largest market share. As sterility testing is done to find pyrogenic compounds or any foreign material that affects the quality of the final product. Parenteral products must specifically undergo sterility testing to ensure that they are pyrogen-free. One essential GMP (Good Manufacturing Practices) microbial testing requirement for sterile pharmaceutical products is sterility testing. A rod-shaped, gram-positive bacteria is called Propionibacterium acnes. These slow growing bacteria are found in human acne. Due to some bacteria's extremely slow growth rates, such as propionibacterium acne, sterility testing is conducted over a 14-day incubation period.
Global sterility market size by test, 2023 (%)
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Global Sterility Testing Market Regional Insights
By region, market is segmented into North America, Europe, Asia Pacific and MEA. In 2021, North America accounted for the largest market share of 49.6%. This may be due to the growing number of pharmaceutical industries in the US and Canada. The presence of numerous major market players in this sector is expected to have a significant impact on the expansion of the market. The global sterility testing market in this region is expanding as a result of stringent regulatory requirements for sterility testing of drugs and medical devices. The United States is currently the largest sterility testing market in North America and is expected to continue its dominance during the forecast period. The United States holds a major market share for sterility testing due to the presence of various global pharmaceutical and biopharmaceutical companies as well as significant funding for R&D from both the public and commercial sectors in the country. For example, in 2019, Canadian businesses spent a record USD 21.7 billion on in-house R&D, according to the Government of Canada, Industrial Research and Development, 2019 (Actual), 2020 (Intended), and 2021 (Intended) reports. , which is an increase of 3.8% compared to the expenditure in 2018. The Government of Canada's Pharmaceutical Industry Profile shows that from 2011 to 2020, pharmaceutical exports and imports to Canada and the rest of the world increased by 143% and 58%, respectively.
Asia Pacific is expected to grow the fastest during the forecast period. This is a result of emerging countries harmonizing their regulatory regimes with ICH standards. In addition, many growing economies in the region are taking various steps to expand their domestic pharmaceutical industry and are encouraging global companies to set up facilities (collaborations that support outsourcing activities) there. Such activities will help regional development.
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Global Sterility Testing Market Dynamics
Sterility Testing Market Drivers
New emerging technologies
- The demand for sterility tests will increase with the improvement in the pharmaceutical and medical sectors. Global biotechnology industry growth is one factor that will support the expansion of the sterility testing market in the coming years. Concerns about the safety of biological pharmaceutical products are also increasing. In the coming years, these factors will drive the market for sterility testing. Sterility testing has benefited from the advancement of new technologies that have increased the efficiency of the process, thereby fueling market expansion. For filterable pharmaceutical items, the method of choice for sterility testing is membrane filtration.
- According to USP <71>, in this sterility testing procedure, the products are filtered through a 0.45 or 0.2 micron membrane filter. After washing with suitable USP fluid to remove inhibitors, the filtrate is placed in a fluid thioglycollate medium (FTM) and soybean casein digest medium (SCDM). Each day during the 14-day incubation period, both media were examined for the presence of microbial growth in accordance with USP <71>. To promote the growth of both anaerobic and aerobic microbes, the sterilization test recommends the use of a fluid thioglycollate medium (FTM) and Soybean casein digest media (SCDM). These types of practices drive market growth.
Expansion of the pharmaceutical industry
- The global pharmaceutical market was valued at USD 934.8 billion in 2017 and will grow by 5.8% to reach USD 1170 billion in 2021. Sterility testing is performed at every stage of production in the pharmaceutical and biopharmaceutical sector to minimize the possibility of product contamination. Therefore, the expansion of this end-use industry will significantly increase the overall consumption of sterility testing in the coming years. Strict regulatory controls ensure process monitoring and quality control throughout the production chain of pharmaceutical and biopharmaceutical products. Sterilization testing is done during this process for raw material, bulk lot release testing, and final product release testing. By application, the pharmaceutical and biotechnology industries have experienced significant expansion in recent years; As a result, the pharmaceutical and biological product market has grown significantly and is a major driver of the market.
Sterility Testing Market Restraints
Stringent government regulations
- Increased sterility testing unit costs as a result of stringent regulatory norms and an acute shortage of skilled sterility testing experts are severely hampering the market expansion. High levels of integration, stringent regulatory frameworks, and lengthy licensing processes are all significant barriers to new market players.
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Global Sterility Testing Market Competitive Landscape
The global sterility testing market is fragmented and highly competitive with the presence of local as well as global companies. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of global sterility testing market.
For example, in September 2021, Nelson Labs and Sterigenics Germany GmbH launched an expanded Center of Excellence for increased sterilization capacity and microbiological laboratory testing at their Wiesbaden facilities. This expansion is expected to meet the significantly increased demand for these services by the pharmaceutical and medical device industries.
Sterility Testing Market Top Player’s Company Profiles
- Merck KGaA
- Charles River Laboratories International, Inc.
- SGS S.A.
- WuXi AppTec Inc.
- Thermo Fisher Scientific Inc.
- bioMérieux SA
- Sartorius AG
- Pacific Biolabs
- Nelson Laboratories, LLC
- Bio-Rad Laboratories, Inc.
- Becton, Dickinson and Company
- Sigma-Aldrich Corporation
- Pace Analytical Services LLC
- Eurofins Scientific SE
- ATS Labs, Inc.
- MilliporeSigma
- Cytovance Biologics, Inc.
- North American Science Associates, Inc. (NAMSA)
- Toxikon Corporation
- Nelson Laboratories (Europe) B.V.
Sterility Testing Market Recent Developments
- In July 2022, the West Virginia Press reported that US scientists had developed the USP71> sterility test, a novel, and rapid sterility testing (RMT) technique. For sterility tests, it is known as the "gold standard". Together, the EU Pharmacopoeia (EP-2.6.1-Sterility) and the Japanese Pharmacopoeia (JP-4.06-Sterility Test) account for (90+) % of the standardized test procedures used to determine sterility for a specific product.
- In May 2021, Charles River Laboratories International, Inc. announced that it has acquired Vigene Biosciences, Inc., a leading gene therapy contract development and manufacturing organization (CDMO) in the United States specializing in viral vectors. A definitive agreement has been entered into to acquire these company-based gene delivery solutions.
Global Sterility Testing Key Market Trends
- Players in the pharmaceutical and biopharmaceutical industry are ensuring that environmental monitoring (EM) programs are in place to prevent future sterility test failures. The product is sterilized to ensure safety and identify any problems at the earliest. It helps businesses position themselves in the service sector as effectively as possible.
- Government agencies are heavily funding changes to the testing process. In addition, they have issued some key FDA standards for sterility testing, which is expected to provide the market with various opportunities for future expansion. Also, scientists all over the world are working hard in their research fields. They have successfully developed some of the critical sterility testing methods in microbiology, which is expected to drive massive growth in the market.
Global Sterility Testing Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Co-relates and Analyses the Data collected by means of Primary Exploratory Research backed by the robust Secondary Desk research.
According to our global sterility testing market analysis, by test segmentation, the membrane filtration sterility testing segment accounted for the largest market share and is expected to grow at a significant CAGR during the forecast period. By region, in 2021, North America accounted for the largest market share of 49.6%. The presence of a number of major market players in this sector is expected to have a significant impact on the expansion of the market. The increased unit cost of sterility testing due to stringent regulatory norms and the acute shortage of qualified sterility testing professionals are severely hampering the market expansion.
| Report Metric | Details |
|---|---|
| Market size value in 2023 | USD 161.18 million |
| Market size value in 2031 | USD 469 million |
| Growth Rate | 12.6% |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Million |
| Segments covered |
|
| 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 |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
| Historical Year | 2019 |
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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 Global 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 Global 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 Global 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 Global 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 Global Sterility Testing Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Global 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.
Global Sterility Testing Market Report Snapshots
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