Global Biologics Safety Testing Market is Estimated to Value Over USD 5.9 Billion by 2026 End

  • 07 Oct 2019

Global Biologics Safety Testing Market is estimated to value over USD 5.9 billion by 2026 end and record a CAGR of over 10.9% during the forecast period 2019 to 2026. 


Rise in biotechnology and pharmaceutical industry, huge research investments by major players in life sciences and rise in the number of new drug announcements in the past few years steer the global biologics safety testing market growth. Although, strict regulations from the government for approving high drug development costs and biosimilars impedes the market proliferation. Additionally, support from the government towards offering funds for developing biologics is predicted to provide profitable opportunities for market augmentation.

The endotoxin tests are predicted to hold over 1/3rd global biologics safety testing market share of overall revenue is predicted to incur over USD 1,200 million. The endotoxin test segment will register the largest share of the revenue coupled with the rapid growth of revenue in the total market.

Residual contamination of host tests and sterility tests will record substantial growth with similar growth rates over the forecast period. The insistence for cell line characterization and authentication tests is predicted to gain market traction. Conversely, the bioburden test segment is projected to pose a lucrative opportunity of approximately USD 90 million between 2018 and 2023. Comparatively, the detection tests for adventitious agents will witness a low CAGR, thus restricting demand in the upcoming years.


The global market is segmented based on test type, application and product & services. Based on the application, the market is categorized into vaccine development, stem cell research, gene and cellular therapy, tissue-related products testing and testing of blood products. Based on the services and products, the market is categorized into instruments, services and kits and reagents. Based on region, it is analysed across Latin America, Middle East & Africa, Asia-Pacific, North America and Europe.


Key market players included in the global biologics safety testing market are Charles River Laboratories International, Inc., Merck KGaA, Lonza Group Ltd., SGS S.A., Thermo Fisher Scientific Inc., Wuxi Apptec, Sartorius AG, Cytovance Biologics, Inc., Pace Analytical Services Inc., Toxikon Corporation, Eurofins Scientific Se, Avance Biosciences Inc., Source Bioscience 


Global Biologics Safety Testing Market Segmentation:

By Product and Service

  • Kits & Reagents
  • Services
  • Instruments

By Test Type

  • Endotoxin Tests
  • Sterility Tests
  • Cell Line Authentication and Characterization Tests
  • Bioburden Tests
  • Residual Host Contaminant Detection Tests
  • Adventitious Agent Detection Tests
  • Other Tests

By Application

  • Vaccine & Therapeutics Development
  • Blood and Blood-Related Products Testing
  • Cellular and Gene Therapy
  • Tissue and Tissue-Related Products Testing
  • Stem Cell Research

By Region


FutureWise Key Takeaways:

  • Growth prospects
  • SWOT analysis
  • Key trends
  • Key data-points affecting market growth


Objectives of the Study:

  • To provide with an exhaustive analysis on the global biologics safety testing market by product and service, by test type, by application and by region
  • To cater comprehensive information on factors impacting market growth (drivers, restraints, opportunities, and industry-specific restraints)
  • To evaluate and forecast micro-markets and the overall market
  • To predict the market size, in key regions (along with countries)— North America, Europe, Asia Pacific and the rest of the world
  • To record evaluate and competitive landscape mapping- product launches, technological advancements, mergers and expansions
  • Profiling of companies to evaluate their market shares, strategies, financials and core competencies


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