Biologics Safety Testing Market Outline:

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.


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.


Market Scope:

Biologics safety testing market is segmented on the basis of product type, test type, application, and end user

Based on the product type,

  • Reagents and Kits
  • Instruments
  • Services

Based on the test type,

  • Sterility Tests
  • Bioburden Tests
  • Endotoxin Tests
  • Residual Host Contamination detection Tests
  • Cell Line Authentication and Characterization Tests
  • Others

Based on the application,

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

Based on end-user,

  • Pharmaceutical Companies
  • Biotechnology Companies


Market Summary: 

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 biologics safety testing 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.


Regional Analysis: 

Geographically, global biologics safety testing market segmented into North America, Europe, Asia Pacific, Latin America, and Middle East and Africa. North America biologics safety testing market expected to hold dominant share owing to increase in R&D activities by the market players, presence of huge number of market players, and well-developed healthcare infrastructure. Europe biologics safety testing market has a significant share owing to adoption of newer technologies, expansion of business by market players in Germany and UK, and increase in funding for R&D activities for the development of newer biologics. For instance, in 2013, European Research Council awarded $830 Mn for life sciences research in Europe. Asia Pacific biologics safety testing market is projected to grow due to rise in awareness about biologics safety testing, favorable regulatory policies, and increase in healthcare expenditure.


Competition Assessment:

  • 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.)


Notable Market Developments:

  • In October 2017, Sterigenics International LLC acquired Toxikon’s European laboratory business including biologics testing business


Key Features of the Report:

  • The report provides granular level information about the market size, regional market share, historic market (2015 – 2019) and Forecast (2020 – 2026)
  • 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



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