The global Biological Safety Testing Market was valued at USD 4.32 billion in 2022, with a projected CAGR of 13% during the forecast period to reach USD 12.98 billion in 2032. The growth of the biologics and biosimilars market in the pharmaceutical and biotechnology sectors is the major factor driving revenue growth. Rising incidences of chronic diseases, including cancer and autoimmune disorders, are creating high demand for biological safety testing. Biological safety testing is an essential step in the medication development process to assure the safety and efficacy of biologics and biosimilars before they are put on the market.

The market expansion is also being driven by the rising need for innovative technology for biological safety testing. Manufacturers are constantly developing innovative technologies to improve the sensitivity and accuracy of biological safety testing, including real-time Polymerase Chain Reaction (PCR), Enzyme-Linked Immunosorbent Assay (ELISA), and flow cytometry, among others. Additionally, strict regulatory requirements for biological safety testing set by regulatory agencies such as the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), the European Medicines Agency (EMA), and the U.S. Food and Drug Administration (FDA) are driving demand for biological safety testing at every stage of drug development, from research and development to commercialization.

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The rising demand for cell and gene therapies is also driving the revenue growth of the biological safety testing market. However, the high price of biological safety testing due to the employment of innovative technologies and strict regulatory requirements could restrain revenue growth of the market. A scarcity of qualified individuals in the field of biological safety testing could also hamper revenue growth to some extent.

The market is segmented into three product categories: instruments, kits and reagents, and services. While the services segment is anticipated to experience the greatest revenue increase over the projected period, the kits and reagents segment had the largest revenue share in 2021. Due to the growing use of cutting-edge technologies in biological safety testing, the instruments market is also expanding significantly.

North America dominated the market for biological safety testing in 2021, with Asia Pacific expected to experience the greatest revenue growth over the forecast period. The Occupational Safety and Health Administration (OSHA), U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), International Organization for Standardization (ISO), and U.S. Department of Agriculture (USDA) are among the government agencies that regulate biological safety testing.

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Companies considered and profiled in this market study

  • Merck KGaA
  • Thermo Fisher Scientific Inc.
  • Charles River Laboratories International, Inc.
  • Lonza Group AG
  • SGS SA
  • WuXi AppTec
  • Eurofins Scientific SE
  • Cytiva
  • bioMérieux SA
  • Sartorius AG

Segments covered in the report

This report forecasts revenue growth at a global, regional & country level, and provides an analysis of the market trends in each of the sub-segments from 2020 to 2028. The scope of the report can be defined as: For the purpose of this report, Reports and Data have segmented the global Biological Safety Testing Market on the basis of Product, Application, Test Type, and region:

Product Outlook

  • Reagents & kits
  • Instruments
  • Services

Application Outlook

  • Vaccines & therapeutics
  • Stem cell
  • Tissue & tissue-based products
  • Gene therapy
  • Blood & blood-based therapy

Test type Outlook

  • Endotoxin tests
  • Bioburden tests
  • Adventitious agent detection tests
  • Residual host contamination detection tests
  • Sterility tests
  • Cell line authentication and characterization tests
  • Others

Regional Outlook

  • North America
    • U.S
    • Canada
  • Europe
    • Germany
    • France
    • Benelux
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
  • MEA
    • Saudi Arabia
    • UAE
    • Turkey
  • Latin America
    • Brazil

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In conclusion, the growth of the biologics and biosimilars market, strict regulatory requirements for biological safety testing, and the need for innovative technology for biological safety testing are the major factors driving the expansion of the biological safety testing market. The rising demand for cell and gene therapies is also contributing to the growth of the market. The high cost of biological safety testing and the scarcity of qualified personnel in the field could hinder the growth of the market to some extent.

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