Biologics Safety Testing Market is Expected to Reach USD 6.9 Billion by 2027


Global Biologics Safety Testing Market is forecasted to grow due to rising biosimilars and biologics markets, cross-contamination in cell culture, increasing biopharmaceuticals research and development investments. The Global Biologics Safety Testing Market size was valued at USD 3.0 Bn in 2020 and is expected to reach USD 6.9 Bn by 2027, with a growing CAGR of 12.4% during the forecast period.

The increase in the adoption of biologics safety testing consumables drives the market. The increasing biopharmaceutical outsourcing and emerging markets, increasing biopharmaceuticals research and development, cross-contamination in the cell culture are the major factors driving the biologics safety testing market. The growth in biologics and biosimilars also helps in propelling the global market.

The increasing number of acquisitions of players favor the biologics safety testing market growth. For instance, in 2021, Charles River Laboratories, Inc. acquired Cognate BioServices for expanding its product offerings in gene and cell therapy development resulting in basic research and discovery in current good manufacturing practices.

The biologics safety testing market is segmented into product & services, application, test type, and regions. Product & services are segregated into consumables, instruments, and services. Application is segregated into monoclonal antibodies manufacturing, vaccines manufacturing, blood and blood products manufacturing, cellular and gene therapy products manufacturing, and others. The test type segment in the biologics safety testing market is segregated into residual host-cell proteins and DNA detection tests, endotoxin tests, sterility tests, mycoplasma tests, bioburden tests, and virus safety tests.

The factors such as increasing drugs pipeline, rise in number of clinical trials, increasing investment for manufacturing of biologics contribute to accelerate the market. The monoclonal antibodies market is rising due to the increasing number of diseases and their diagnosis. The increasing DNA-based testing profile favor the biologics safety testing market growth.

Global Biologics Safety Testing Market by Region Outlook (Revenue, USD Million, 2021-2027)

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

Based on region, North America dominated the biologics safety testing market in 2020 and is expected to maintain the same dominance throughout the forecast period. This is due to the increasing recognition among consumers about product safety, the demand for high-quality research tools for data reproducibility, rising government investments, and academic fundings, and the fast growth in the biopharmaceutical market in the region. The new company acquisitions and launches to expand the product portfolio accelerate the biologics safety testing market in North America.

For instance, in 2021, Lonza launched a new product named PyroTec PRO Automated Robotic Solution for endotoxin testing. The product is designed with the PyroGene Recombinant Factor C (rFC) Assay. The key players have a strong presence and easy product sales due to the high demand ultimately leading to drive the biologics safety testing market in the region. The prominent players are focused on mergers & acquisitions and strategic expansions to expand their presence and product profile in the biologics safety testing market.

The Asia Pacific is projected to observe the strong growth during the forecast period due to the rising life science research activities, growing biopharmaceutical industries.

The Global Biologics Safety Testing Market Segmentation:

Global Biologics Safety Testing Market by Product & Services Outlook (Revenue, USD Million, 2021-2027)

  • Consumables
  • Instrument
  • Services

Global Biologics Safety Testing Market by Application Outlook (Revenue, USD Million, 2021-2027)

  • Vaccine Manufacturing
  • Monoclonal Antibodies Manufacturing
  • Cellular & Gene Therapy Products Manufacturing
  • Blood and Blood Products Manufacturing
  • Other

Global Biologics Safety Testing Market by Test Type Outlook (Revenue, USD Million, 2021-2027)

  • Endotoxin Test
  • Sterility Test
  • Mycoplasma Tests
  • Bioburden Tests
  • Residual Host-cell Proteins & DNA Detection Tests
  • Virus safety Test

Key Findings:

  • Based on product & services, the service segment held the largest market shares in 2020. And the consumables segment witnessed the fastest growing during the forecast period.
  • Based on application, the monoclonal antibodies manufacturing segment held the highest market shares in 2020
  • Based on test type, the residual host-cell proteins and DNA detection tests segment accounted for highest market share in 2020
  • Geographically, in North America accounted the maximum share of the market, however, Asia Pacific is anticipated to grow at the fastest growth during the forecast period.

Company Profiles and Competitive Intelligence

The key players operating in the market are:

  • Thermo Fisher Scientific
  • Merck KGaA
  • Maravai Lifesciences
  • Associates of Cape Cod, Inc.
  • bioMérieux SA
  • Sartorius AG
  • F. Hoffmann-La Roche Ltd
  • Nelson Laboratories, LLC
  • Bio-Rad Laboratories, Inc.
  • QIAGEN
  • Agilent Technologies, Inc.
  • Pacific BioLabs
  • Microcoat Biotechnologie GmbH
  • PromoCell GmbH
  • FUJIFILM Wako Pure Chemical Corporation
  • Almac Group
  • Charles River Laboratories
  • Lonza
  • SGS SA
  • WuXi AppTec
  • Eurofins Scientific

Recent News:

  • In September 2019 Charles River Laboratories, Inc. launched EndoScan-V, for generating report and quantitative test data. The detection toll had a software to calculate and produce test reports as digital signature approved report.
  • In January 2021, Charles River Laboratories, Inc. made an agreement of partnership with JADE Biomedical to expand its biological testing solutions capabilities region wise by increasing the demand for biologics therapeutics. These favoured the biologics safety testing market

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