Biologics Safety Testing Market: By Product Type (Reagents and Kits, Instruments, Services), By Test Type (Sterility Tests, Bioburden Tests, Endotoxin Tests, Residual Host Contamination detection Tests, Cell Line Authentication and Characterization Tests, Others), By Application (Cellular and Gene Therapy, Vaccine and Therapeutics Development, Tissue and Tissue-Related Products Testing, Blood and Blood-Related Products Testing, Stem Cell Research), By End-User (Pharmaceutical Companies, Biotechnology Companies), and Geography


Purchase Option

$ 3000
$ 4400
$ 6600
$ 8900

The global biologics safety testing market size valued USD 3.15 billion in 2020 and expected to reach USD 7.28 billion by 2027, at a CAGR of 12.18% during forecast period 2021 to 2027. Biologics are the large and complex molecules derived from the genes of living organisms by advanced DNA technologies. Biologics are commonly used in the treatment of chronic diseases such as rheumatoid arthritis, cancer, and other chronic diseases. These biologics are complex molecules such as recombinant proteins and monoclonal antibodies among others. Biologics safety testing is carried to ensure the patient safety. Biological safety testing is carried by using various tests such as sterility tests, endotoxins test, residual host contamination detection tests, and bioburden tests among others. Biologics safety testing market exhibiting lucrative growth, which is attributed to increase in the R&D for the development of newer biologics by pharmaceutical and biopharmaceutical companies for the treatment of chronic diseases such as diabetes, cancer and innovation of newer biologics safety tests. Moreover, rise in funding from the government, and increase in the prevalence of chronic diseases are anticipated to fuel the market over the forecast period. Furthermore, acquisitions and mergers, collaborations, and launching of newer tests by market players also immensely boost to the biologics safety testing market. For instance, in June 2016, Charles River Laboratories acquired Blue Stream laboratories to strengthen its capabilities in biologics development and safety assessments. In addition in March 2016, Abreos Biosciences collaborated with True Diagnostics to develop the point-of-care tests for biologics.

Biologics Safety Testing Market Summary

Study Period


Base Year




Largest Market


Fastest Growing Market

North America
Biologics Safety Testing Market Dynamics

Growing biologic products launches, rise R&D activities by pharmaceutical and biotechnology companies, technological advancements of biologics safety testing methods, stringent regulatory guidelines for product approval, and rise in funding from public and private sectors for the development of newer biologics are exepcted to boost the biologics safety testing market over the forecast period. However, high cost of biologics safety testing, and lack of well-developed healthcare in underdeveloped countries are hamper the growth of biologics safety testing market.

Key Features of the Reports

  • The report provides granular level information about the market size, regional market share, historic market (2018 to 2022) and forecast (2023 to 2029)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments and startup’s details that are actively working in the market
  • The report provides plethora of information about market entry strategies, regulatory framework and reimbursement scenario
  • The report analyses the impact of socio-political environment through PESTLE Analysis and competition through Porter’s Five Force Analysis in addition to recent technology advancements and innovations in the market

Biologics Safety Testing Market Segmentation

By Product Type
  • Reagents and Kits
  • Instruments
  • Services
By Test
  • Sterility Tests
  • Bioburden Tests
  • Endotoxin Tests
  • Residual Host Contamination detection Tests
  • Cell Line Authentication and Characterization Tests
  • Others
By Application
  • Cellular and Gene Therapy
  • Vaccine and Therapeutics Development
  • Tissue and Tissue-related Products Testing
  • Blood and Blood-related Products Testing
  • Stem Cell Research
By End User
  • Pharmaceutical Companies
  • Biotechnology Companies

Frequently Asked Questions

2021 is the base year and 2028 is the forecast year.

The report covers the five regions and 15+ countries market data: North America (United States, Canada), Europe (Germany, France, Italy, Spain, and United Kingdom (UK), Asia Pacific (China, India, Japan, Australia & New Zealand), Latin America (Brazil, Mexico, Argentina) and Middle East and Africa (Saudi Arabia, United Arab Emirates, South Africa).

In our report, we provide 12-15 market players’ information into the report. However, based on the client’s request we will provide additional country and regional market players information as well.

[urltag url='request-table-of-content']
  • Charles River Laboratories (U.S.),
  • Pace Analytical Services Inc. (U.S.)
  • Thermo Fisher Scientific Inc. (U.S.)
  • WuXi Apptec (China)
  • Sartorius AG (Germany)
  • Toxikon Corporation (U.S.)
  • Cytovance Biologics, Inc. (U.S.)
  • SGS SA (Switzerland)
  • Merck KGaA (Germany)
  • Sterigenics International, LLC (U.S.)
  • Abreos Biosciences (U.S.)
  • True Diagnostics, Inc. (U.S.)