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Sterility Testing Market - Growth, Trends, and Forecast (2020 - 2025)

  • ID: 4591914
  • Report
  • February 2020
  • Region: Global
  • 120 pages
  • Mordor Intelligence
1 of 4


  • BioMerieux
  • Merck KGaA
  • Sartorius AG
  • SGS S.A.
  • Sotera Health LLC
  • Steris PLC
  • MORE
The number of drug approvals and new drug launches is increasing over the years. In 2018, the United States FDA Center for Drug Evaluation and Research has approved around 59 novel drugs as new molecular entities under the New Drug Applications (NDAs). The statistics shows that the number of the new drug launches is increasing over the years, which is likely to impact positively on the growth of sterility testing market. Furthermore, certain potential safety concerns are associated with the products, which generally arise from the manufacturing processes and complex biological and structural characteristics of the products.

The other factors such as increasing R&D in life science research and rise in demand for sterilized products are expected to fuel the market growth in the forecast period.

Key Market Trends

Pharmaceutical and Biological Manufacturing Segment is Expected to Register a Significant Growth in the Forecast Years

Based on application, it is segmented into pharmaceutical and biological manufacturing, medical devices manufacturing and other applications. Sterility testing is carried out at all levels of manufacturing to minimize the risk of product contamination. The high growth of pharmaceutical and biological industries will considerably boost the overall use of sterility testing. In this process, sterility testing is carried out for raw materials, bulk and final product release testing. Additionally, growing approvals from the regulatory bodies are surging the launch of new drugs and several products, which is expected to fuel the market in the coming years.

North America holds the Largest Share in the Sterility Testing Market

The sterility testing market holds the largest share in the North America region. This is mainly attributed to the growing biotechnology and pharmaceutical industries in the region. The high growth of these industries is further attributable to factors, such as innovative technologies and the presence of favorable government initiatives. Additionally, the advanced healthcare infrastructure and rising R&D spending are expected to influence the growth of the sterility testing market over the forecast period.

Competitive Landscape

The global players into the sterility testing market are BioMérieux, Charles River Laboratories, Inc., Merck KGaA, Sartorius AG, SGS S.A., Sotera Health LLC, Steris PLC, Thermo Fisher Scientific, Toxikon Corporation and WuXi AppTec.

Reasons to Purchase this report:
  • The market estimate (ME) sheet in Excel format.
  • Report customization as per the client's requirements.
  • 3 months of analyst support.
Note: Product cover images may vary from those shown
2 of 4


  • BioMerieux
  • Merck KGaA
  • Sartorius AG
  • SGS S.A.
  • Sotera Health LLC
  • Steris PLC
  • MORE
1.1 Study Deliverables
1.2 Study Assumptions
1.3 Scope of the Study




4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing R&D in Life Science Research
4.2.2 Increasing Number of Drug Launches
4.2.3 Rise in Demand for Sterilized Products
4.3 Market Restraints
4.3.1 Stringent Regulatory Framework
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry


5.1 By Product Type
5.1.1 Instruments
5.1.2 Kits and Reagents
5.1.3 Services
5.2 By Test Type
5.2.1 Membrane Filtration
5.2.2 Direct Inoculation
5.2.3 Other Sterility Tests
5.3 By Application
5.3.1 Pharmaceutical and Biological Manufacturing
5.3.2 Medical Devices Manufacturing
5.3.3 Other Applications
5.4 Geography
5.4.1 North America United States Canada Mexico
5.4.2 Europe Germany United Kingdom France Italy Spain Rest of Europe
5.4.3 Asia-Pacific China Japan India Australia South Korea Rest of Asia-Pacific
5.4.4 Middle-East and Africa GCC South Africa Rest of Middle-East and Africa
5.4.5 South America Brazil Argentina Rest of South America


6.1 Company Profiles
6.1.1 BioMerieux
6.1.2 Charles River Laboratories, Inc.
6.1.3 Merck KGaA
6.1.4 Sartorius AG
6.1.5 SGS S.A.
6.1.6 Sotera Health LLC
6.1.7 Steris PLC
6.1.8 Thermo Fisher Scientific
6.1.9 Toxikon Corporation
6.1.10 WuXi AppTec

Note: Product cover images may vary from those shown
3 of 4


4 of 4
  • BioMerieux
  • Charles River Laboratories, Inc.
  • Merck KGaA
  • Sartorius AG
  • SGS S.A.
  • Sotera Health LLC
  • Steris PLC
  • Thermo Fisher Scientific
  • Toxikon Corporation
  • WuXi AppTec
Note: Product cover images may vary from those shown