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Sterility Testing Market Research Report - Forecast till 2027

Sterility Testing Market Research Report:  Product Type (Instruments, Services), Test Type (Membrane Filtration, Direct Transfer) End-User (Pharmaceutical Companies, Hospitals & Clinics, Academic & Research Laboratories) – Forecast Till 2027

ID: MRFR/LS/0104-CR | June 2018 | Region: Global | 115 pages

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Sterility Testing Market Overview 

The sterility testing market was expected to cover an area worth USD 1245.2 million and projected at a CAGR of 11.7% during the forecast period of 2018 to 2023. Sterility testing is performed to know the presence of microorganisms that develop in favorable situations. Sterility testing is carried out in pharma companies, biotechnological sectors, and companies manufacturing raw materials for detection of quality on the initial materials, for controlling the process, and for validation of the manufactured products. It is used for bulk and end products of drugs, cell banks, and the raw materials used. 2015 is considered as the base year for studying and for good sterility testing market analysis where the market forecast period is expected to be between the period of 2018 to 2023.


The outbreak of the pandemic has severely affected the industry. Due to the outbreak, the production unit faced many difficulties and experienced a shutdown for many days. Manufacturing of many sterility products was hindered. COVID has hindered the research work of scientists and many other experts. The supply chain along with consumer behavior was hampered.

 The government has taken steps against this outbreak. Anyone found violating such was punished.


  • Drivers- rise in growth of pharma companies and rise in growth in biotechnological units acts as a driving factor for the expansion of sterility testing market size. Launching new and innovative drugs in the pharmaceutical sterility testing market and covering the major market share leading to the rise in growth of the sterility testing industry. The state government has also started taking large initiatives for the manufacturing of new products which will be highly beneficial for the nationwide people. He is also contributing some funds to the pharma companies and the biotechnological unit. Contributing R and D investments in life sciences increasing the production of sterility products thus leading to the rise of sterility testing market size.

  • Opportunities- arise in the growth of key players in the developing countries who are covering a large area of sterility testing market share. The Rise in pharma products outsourcing provides large opportunities for the growth of the U.S. pharmaceutical sterility testing market.

  • Challenges- lack of skilled and highly trained professionals and experts act as a challenging factor for growth. Sterility products if available at high prices act as a challenging factor for size expansion.

  • Cumulative Growth- in pharma and biotech units stability manufacturing is carried out at all the levels of manufacturing to decrease the risk of contamination of end products. The rise in this end-users industry is leading to the expansion of the sterility testing industry. Along with strict regulatory control in place, estimating and control of quality are being carried out for the availability of raw materials and for its entire production which pushes up the growth.

  • Restraints- increase in the rate of consolidation and the creation of new barriers for the entry of new key players to the market becomes the most hampering factor for growth. Strict laws and regulations imposed by the government against the regulatory framework and even for time-consuming approval processes become the restraining factor for growth and rise of sterility testing market size.


  • By type- the pharmaceutical sterility testing market is classified based on product, test, application, and region. Based on product, the market is classified into kits and reagents, services, and instruments. Based on tests, the sterility testing industry is classified into membrane filtration sterility testing, product flush sterility testing, Direct transfer sterility testing, etc. Based on product, the pharmaceutical sterility testing market is classified into consumables, instruments, and services. Based on end-users, the industry is divided into pharma companies, research along with academic laboratories, clinics, and hospitals, etc. The rise in treatment for chronic disorders like cardiovascular diseases, cancer, etc. Have risen the demand of sterility testing market.

  • By technology- advanced technology led to the innovation of new sterility products. It gives the opportunity of launching new products, for staple sourcing, launched high-quality effective products. Technology helped in reducing the risk of a combination of products. Technology helped to undergo endotoxin testing. It gave a good utilization of the growing pharma industry. With the help of technology, it was marked that it was being used in cell banks, as raw materials, and for the launching of final products of drugs.


Geographically and regionally, the sterility market is divided into four regions which include the American region, Asia-Pacific, European region, and the Middle East and African region. The pharma industry of the United States covers a dominant sterility testing market share. U. S. has adopted the new technology and has discovered and launched some new products. High expenses on research and development have been marked to be the driving factors of the sterility testing market. Some of the Asia Pacific regions have shown fast growth during the market forecast period. This is due to technological advancement, and the growth in the areas of the healthcare sector, and the rise in health facilities are the driving force of the market. The rise in investment and increase in expenses on research and development plays a main role in the enhancement of the revenue. European regions cover the largest area where the rise in competitors in pharma and biotech units play a major role in the research and launching of new products due to its rise in availability of hospitals and medical units which steers up the market growth. In the Middle East and African region, the industry has shown a little slow growth due to lack of healthcare units, types of equipment and presence of less specialized consultants are some of the reasons inhibiting the growth.


These market players track and analyze well the competitive developments like building partnerships, acquisition, merging with other companies, launching new products, and expanding well in the market ground, they also carry out the developmental activities which will help for the growth of the sterility testing industry. They have carried out top-down and bottom down research for determining the sterility testing market size. Some of them are BioMerieux SA of France, Thermo Fisher Scientific, Inc of United States, Merck kGaA of Germany, Sartorius Ag of Germany, WuXi Apptec of China, Astell  Scientific of United Kingdom, Sa, Pacific BioLabs Inc. of the United States, Bioquell U.K. Ltd of the United Kingdom and many more.


  • Merck kGaA in September 2016, developed Steritest Symbio Pump Systems accessories. They are helpful as they provide easy sterility testing in any setting.

  • Merck kGaA in August 2014, has developed the same Steritest Symbio Pump. This is quite accessible, easier, and more reliable to carry out sterility testing of pharma and biotech products in laminar flow hoods, isolators, and many more.

  • Nelson Laboratories in June 2014, expanded its company by taking the help of the Technical Consulting Services group for the Medtech companies which comprises the development of products and validation of the products, testing the products, and providing regulatory support.

  • Merck kGaA in November 2014, made a partnership with Sigma Aldrich Corporation of the United States. This deal was made at a market value of USD 17 billion. Their merging helped the company expand its business to a large area and cover major sterility testing market share and helped in the expansion of product portfolio.

  • Danaher in August 2015, merged with the renounceable company of the United States named Pall Corporation. Their partnership helped Danaher to add Pall's so manufactured sterility filtered products to their existing product portfolio.


The report provides a good sterility testing market analysis about the major factors that act as a driving force for the market. It gives a good analysis about the micromarkets1 concerning the growing sterility testing market trends, future growth and this contributes to the overall market growth. The report gives a good analysis of the market opportunities for the market players and gives detailed information about the competitive benchmarking of the gives a comprehensive analysis of the competitors holding major market share and core competencies of the key players who will help in growth and development.

Report Scope:
Report Attribute/Metric Details
  Market Size

  • 2023: USD 1245.2 Million
  • 2027: Significant Value
  •   CAGR   11.7% (2017-2023)
      Base Year   2019
      Forecast Period   2020-2027
      Historical Data   2018
      Forecast Units   Value (USD Million)
      Report Coverage   Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
      Segments Covered   Product Type, Test Type, End-User
      Geographies Covered   North America, Europe, Asia-Pacific, and Rest of the World (RoW)
      Key Vendors   BioMérieux SA (France), Thermo Fisher Scientific, Inc. (U.S.), Merck KGaA (Germany), Sartorius AG (Germany), Charles River Laboratories International, Inc. (U.S.), WuXi AppTec (China), Astell Scientific (U.K.), Becton, Dickinson and Company (U.S.), SA, Pacific BioLabs Inc. (U.S.),Belimed Deutschland GmbH (Massachusetts), Bioquell U.K. Ltd (U.K.)
      Key Market Opportunities   FDA Centre for Drug Evaluation and Research has approved drugs
      Key Market Drivers

  • Increasing cases of patients suffering from cardiovascular diseases
  • Support by the government for research and investments
  • Rising healthcare centers and research institutes

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    Frequently Asked Questions (FAQ) :

    Sterility Testing Market size can reach USD 1,245.2 million by 2023.

    Sterility Testing Market is expected to fetch high returns at a CAGR of 11.7% from 2020 to 2027.

    High prevalence of chronic diseases and testing of brand new drugs are major drivers of the Global Sterility Testing Market.

    Pharmaceutical companies are the end-users which can contribute the most to the Global Sterility Testing Market.

    The Americas held the largest share in the global sterility testing market owing to advances in pharmaceutical formulations and presence of various top-end manufacturers.

    The APAC region can display a CAGR of 12.4% from 2020 to 2027 in the Global Sterility Testing Market.

    Merck KGaA, SGS SA, Charles River Laboratories Inc., Thermo Fisher Scientific Inc., Astell Scientific, Pacific BioLabs Inc., Boston Scientific Corporation, bioMérieux SA, Baxter BioPharma Solutions, WuXi AppTec, Becton, Dickinson and Company, Belimed Deutschland GmbH, Bioquell U.K. Ltd., and Sartorius AG are the key players in the global sterility testing market.

    Market Players have adopted the strategy of acquisitions, product launches, and partnerships for the development of the market

    Merck KGaA is the market leader in the global sterility testing market with a market share of 18.7% in 2016. The company has a well-developed market, strong product portfolio, and effective distribution network around the globe. In the last three years, Merck KGaA has adopted the organic strategy of product launches and acquisitions to cement their position in the global sterility testing market. Moreover, the company has also increased investments in various R&D activities. This enabled them to launch innovative products in the market, thereby, expanding their market reach.

    Charles River Laboratories Inc. assumed the second position in the global sterility testing market with a share of 12.4% in 2016. The company showed positive growth regarding revenue from 2015 to 2016 owing to strong sales in high potential emerging markets. Further, to sustain its place in the sterility testing market, the company follows strategic business strategies such as partnerships, collaborations, and acquisitions to expand their product portfolio and geographical reach. For instance, in July 2015, the company acquired Celsis International Ltd, which helped it in quality control testing of biopharmaceutical and consumer products industries.

    BioMérieux SA was third in the global sterility testing market with a share of 9.3% in 2016. The company adopted the strategy of product launches to expand its market share and keep the sterility testing market updated. In addition, the company has a huge product portfolio and good brand identity.

    Other prominent players in the market include Thermo Fisher Scientific Inc., Becton, Dickinson and Company (BD), SGS SA, and Baxter BioPharma Solutions. Other players accounted for a share of 48.2% in the market in 2016. Majority of the companies have adopted the strategy of acquisitions and product launches for market development. For instance, in September 2016, the company announced the acquisition of the laboratory products and services segment of Alfa Aesar, a company based in the U.K., forUSD 392 million. This acquisition would help in expanding the company’s existing portfolio of chemicals, solvents, and reagents.