Biological Safety Testing Market Size, Industry Analysis Report, Regional Outlook (U.S., Canada, Germany, UK, France, Spain, Italy, Russia, Japan, China, India, Australia, Argentina, Brazil, Mexico, South Africa, Saudi Arabia, UAE), Application Potential, Price Trends, Competitive Market Share & Forecast, 2019 – 2025

Report ID: GMI4278

Summary Methodology

Biological Safety Testing Market size is projected to experience significant growth from 2019 to 2025.

Increasing focus by companies on development of novel biological products and drugs to treat a wide array of diseases will boost the global biological safety testing market growth over the forthcoming years. Several companies across the U.S. have their new entities in pipeline, targeting more than 100 diseases, thereby escalating the need for safety testing of these entities. For instance, in 2018, the U.S. FDA approved over 55 new drugs. In addition, growing prevalence of chronic and infectious diseases worldwide will further stimulate the demand for biological safety testing services in the upcoming period.

Growing number of pharmaceutical and biotechnology firms will offer lucrative growth potential for biological safety testing business growth. Several companies across emerging countries such as India and China are investing in innovating pharmaceuticals and biotechnological products. Numerous start-ups in the healthcare sector have evolved including Roivant Sciences, Inflazome and Ayala Pharmaceuticals among various others. Additionally, government and private organizations across the globe are funding such companies for research activities. Thus, with rising advancements and progress in new drug discoveries, the adoption of biological safety testing services will significantly accelerate in the future.

However, consumption of significant amount of time for product testing and approval may restraint biological safety market growth in the coming years.

Bioburden testing market will hold considerable revenue size in the forecast timeframe. Manufacturers of medical devices require bioburden testing to determine the concentration of total microbes. Similarly, the test is required to ensure proper sterilization of medical devices, further validating its safety for use. Moreover, stringent regulations for approval of medical devices, pharmaceutical and biotechnology products will expand the segmental growth over the foreseeable years.

Vaccines & therapeutics market is projected to grow at robust pace over the analysis period. There is growing burden of diseases including various cancer forms, animal-originated infections as well as autoimmune diseases. Therefore, leading drug manufacturers are developing new therapies and vaccines to decrease the disease burden across the globe, thereby augmenting the segmental growth.

U.S. biological safety testing market will hold considerable revenue size over the estimation period. High market size can be attributed to large number of established and start-up healthcare firms developing novel therapies and medical devices. Growth of diagnostic laboratories in the nation will further support the market growth. Moreover, rising need to reduce the risk of disease outbreak coupled with growing stringency by the regulatory authorities will expand the U.S. biological safety testing market growth over the estimation period.    

India biological safety testing market is projected to grow at a momentous pace in the coming years due to expansion of healthcare facilities coupled with growing government investment in healthcare sector. New product development and manufacturing in India is favorable for numerous international companies due to cost-advantage. In addition, expanding number of firms providing biosafety testing services will offer lucrative opportunities to India biological safety testing business growth over the foreseeable future.

Some of the major market players involved in the global biological safety testing market are Sartorius, Eurofins Scientific, Merck, Charles River among few other players. Strategic initiatives such as launch of novel tests for biological safety testing, acquisitions and expansion of testing facilities are being adopted by these firms to fortify their business growth. For instance, in May 2015, Eurofins announced about its acquisition with Experchem Laboratories, involved in analytical testing services. The strategy will assist the company to broaden its testing capacities for nutraceuticals and biopharmaceutical product quality control.

Biological Safety Testing Market, by Test Type, 2014-2025 (USD Million)

  • Sterility tests
  • Cell Line Authentication & Characterization Tests
  • Bioburden Tests
  • Adventitious Agent Detection Tests
  • Others

Biological Safety Testing Market, by Application, 2014-2025 (USD Million)

  • Blood & Blood-based Products
  • Vaccines & Therapeutics
  • Stem Cell
  • Others

The above information is provided for the following regions and countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Russia
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia
  • Latin America
    • Argentina
    • Mexico
    • Brazil
  • Middle East and Africa
    • South Africa
    • Saudi Arabia
    • UAE

Company Profiles:

  • Avance Biosciences
  • BioOutsource
  • Charles River
  • Eurofins Scientific
  • Merck KGaA
  • PharmaBio Corporation
  • Sartorius AG
  • SGS SA
  • Toxikon
  • WuXi Biologics


What Information does this report contain?

Historical data coverage: 2014 to 2018; Growth Projections: 2019 to 2025.
Expert analysis: industry, governing, innovation and technological trends; factors impacting development; drawbacks, SWOT.
6-7 year performance forecasts: major segments covering applications, top products and geographies.
Competitive landscape reporting: market leaders and important players, competencies and capacities of these companies in terms of production as well as sustainability and prospects.

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