Biological Safety Testing Market Size, Share & Trends Report

Biological Safety Testing Market Size, Share & Trends Analysis Report By Product, By Application (Vaccines & Therapeutics, Gene Therapy, Stem Cell), By Test, By Region, And Segment Forecasts, 2018 - 2024

  • Published Date: May, 2018
  • Base Year for Estimate: 2015
  • Report ID: GVR-1-68038-140-5
  • Format: Electronic (PDF)
  • Historical Data: 2013 - 2015
  • Number of Pages: 109

Industry Insights

The global biological safety testing market size was valued at USD 2.20 billion in 2016 and is anticipated to exhibit a CAGR of 12.2% during the forecast period. The market is primarily driven by increasing production of new generation biologics by major pharmaceutical and biotechnology companies. High global prevalence of target diseases has triggered companies to increase production of advanced biologics.

U.S. biological safety testing market

Rising need for biologics has resulted in unprecedented growth in number of biopharmaceutical companies. This increasing competition to develop therapeutically advanced drugs on a large scale has compelled manufacturers to improve on aspects such as productivity, cost efficiency, and deviations. Companies are thus implementing good manufacturing practices involving thorough biological testing at various levels of production cycles, thereby contributing toward market growth.

Rising number of government initiatives to promote biological safety testing products is anticipated to drive overall market growth over the coming years. High microbial contamination rates and bioburden during pharmaceutical and biologics manufacturing are expected to drive government and private organizations to improve underlying biological safety practices.

Moreover, presence of regulatory authorities to enforce significant safety standards is anticipated to provide boost adoption of testing tools. Stringent guidelines and recommendations laid down by these authorities increases incorporation of these tools by quality assurance technicians, thus providing a significant boost to the overall industry.

Product Insights

Reagents and kits accounted for the largest share by product in 2015. Reagents are a major component in biological safety testing and hence are extensively used in research and clinical laboratories. These reagents are antibiotics, attachments and matrix factors, biological buffers, freezing and dissociation reagents, and miscellaneous reagents. Increasing advancements and modifications in formulation of reagents and kits will drive laboratory technicians in incorporating these products, specifically in toxicology assessment.

The instruments segment is expected to witness an upward shift during the forecast period due to rising demand from biological safety testing laboratories. Demand for the same has been increasing due to rising pressure from regulatory bodies on biopharma companies to implement safety guidelines. Instruments are used to perform biological assays to perform toxicology and bioburden tests, among others.

Application Insights

Vaccine and therapeutics held the dominant share based on application in 2015. Clearly defined guidelines ensuring safety of developed vaccines with unaltered therapeutic value and reduced toxicity are presumed to be responsible for heightened demand of this segment.

Global biological safety testing market

This segment is also anticipated to exhibit a strong CAGR during the forecast period, which can be attributed to significant increase in disease outbreaks over the years. This is consequently promoting usage of vaccines for disease prevention, thus widening growth potential for adoption of biological safety tools. Several guidelines and recommendations issued by regulatory authorities such as U.S. FDA pertaining to characterization and qualification of materials used in the production of vaccines for infectious disease indications are predicted to broaden segment growth.

Test Insights

Endotoxin tests dominated the global biological safety testing market in terms of revenue in 2015 at 24.3%. The substantial share can be attributed to rising incorporation of these tests in a wide range of areas of drug manufacturing and production to reduce threat of endotoxins during the manufacturing of biopharmaceuticals. In addition, availability of numerous types of endotoxin tests, such as gel clot endotoxin testing, turbidimetric method, and USP chromogenic endotoxin testing, which are designed to suit different requirements, are likely to boost the potential of this segment.

The bioburden tests segment is expected to grow at a lucrative rate throughout the forecast period. This is attributable to high adoption rate to determine bioburden limits in wide-ranging biologics and medical devices. Moreover, integration of advanced colorimetric method and computation has enabled rapid generation of results and precise bioburden quantification. Consistent advancements in this segment are further expected to provide high growth potential.

Regional Insights

North America captured a share of over 36.0% in the global market in 2015. The dominant share is attributed to high investments in biotechnology and increasing adoption in cancer research and development of new biologics, vaccines, and drugs. Moreover, increasing number of R&D investments initiated by companies is one of the potential growth factors.

The regional market is also fueled by presence of prominent market players undertaking extensive expansion strategies. Moreover, increasing burden of chronic diseases in this region is anticipated to drive the inclination of researchers and healthcare professionals toward advanced technologies. This is further anticipated to widen the scope for growth.

The Asia Pacific market is anticipated to exhibit a lucrative CAGR of over 13.0% throughout the forecast period. This is believed to be an outcome of rising healthcare spending and increasing awareness levels pertaining to benefits of these tools.

Biological Safety Testing Market Share Insights

The industry is highly competitive in nature and a considerable number of players enjoy a dominant share of the overall revenue. Some of the notable market participants are Charles River Laboratories, Lonza Group, Merck Millipore, and Wuxi PharmaTech and they account for a considerable share in the market owing to their product offerings.

Market leaders are involved in extensive research for development of cost-efficient and technologically advanced testing products. In addition, strategies to improve market presence, such as mergers and acquisitions, undertaken by these companies are expected to provide the market with lucrative growth opportunities throughout the forecast period. For instance, in June 2016, Charles River acquired Blue Stream Laboratories, Inc., an analytical contract research organization. This acquisition was carried out to enhance the former’s existing capabilities in safety assessment and biologics development.

Report Scope



Base year for estimation


Actual estimates/Historical data

2013 - 2015

Forecast period

2016 - 2024

Market representation

Revenue in USD Million & CAGR from 2013 to 2024

Regional scope

North America, Europe, Asia Pacific, Latin America, MEA

Report coverage        

Revenue forecast, company share, competitive landscape, growth factors and trends

Country Scope

U.S., Canada, U.K., Germany, China, Japan, India, Mexico, Brazil, South Africa

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Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of latest industry trends in each of the sub-segments from 2016 to 2024. For the purpose of this study, Grand View Research has segmented the global biological safety testing market report on the basis of product, application, test, and region:

  • Product Outlook (Revenue, USD Million, 2013 - 2024)

    • Reagents & kits

    • Instruments

    • Services

  • Application Outlook (Revenue, USD Million, 2013 - 2024)

    • Stem cell

    • Tissue & tissue-based products

    • Gene therapy

    • Blood & blood-based therapy

    • Vaccines & therapeutics

  • Test Outlook (Revenue, USD Million, 2013 - 2024)

    • Sterility tests

    • Cell line authentication and characterization tests

    • Bioburden tests

    • Endotoxin tests

    • Adventitious agent detection tests

    • Residual host contamination detection tests

    • Others

  • Regional Outlook (Revenue, USD Million, 2013 - 2024)

    • North America

      • U.S.

      • Canada

    • Europe

      • U.K.

      • Germany

    • Asia Pacific

      • Japan

      • China

      • India

    • Latin America

      • Mexico

      • Brazil

    • MEA

      • South Africa

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