Biologics Safety Testing Market Size Worth $11,949.49 Million By 2032 | CAGR: 12.41%

Biologics Safety Testing Market Size Worth $11,949.49 Million By 2032 | CAGR: 12.41%

The global biologics safety testing market size is expected to reach USD 11,949.49 million by 2032, according to a new study by Polaris Market Research. The report “Biologics Safety Testing Market Share, Size, Trends, Industry Analysis Report, By Product & Service (Consumable, Instrument, Services); By Application; By Test Type; By Region; Segment Forecast, 2023-2032” gives a detailed insight into current market dynamics and provides analysis on future market growth.

The market for biologics safety testing requires stringent regulatory requirements, and agencies like (EMA) and the (FDA) demand that biologics undergo extensive effectiveness and safety testing before receiving marketing authorization, positively influencing the market growth. The FDA has issued guidelines for various processes in biologics development like administrative guidelines, adverse effects, product derivation guidelines, application submission guidelines, clinical trials guidelines, CMC and GMP guidelines, Devices guidelines, and Labeling and Promotion guidelines.

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New biologics are being developed due to increased investment in R&D in the pharmaceutical and healthcare sectors, which has augmented market growth. For instance, in December 2022, Global pharma companies GSK, Takeda, and Sanofi announced their collaboration with the agency for the National University of Singapore; Nanyang Technological University, & the Singapore Institute of Technology to expand country's capacity for producing biologics.

The increasing trend towards personalized medicine and targeted therapies has led to the development of biologics tailored to specific patient populations, increasing the demand for biologics safety testing. The global biologics market is growing rapidly, which is expected to continue in the coming years, augmenting biologics safety testing. In November 2022, Abzena launched a new biologics testing facility in California. The facility enables stricter control over schedules and a thorough review of each integrated program to give appropriate biosafety data de-risking and their partners' activities and assist with regulatory filings.

Biologics Safety Testing Market Report Highlights

  • Consumables segment is leading the global market owing to the growing use of biologics drugs due to growing prevalence of the chronic diseases.
  • Vaccine development segment is expected to grow at a high CAGR during the forecast period. The rising demand for the vaccines due to Covid-19 and other diseases is bolstering market growth.
  • Endotoxin test segment accounted for the largest market share in 2022 due to an increase in demand for innovative medical equipment, medicinal medicines, and biologics to perform many tests.
  • North America is the largest market due to the presence of many small and large players in the region.
  • Key players include Charles River Laboratories, Thermo Fisher Scientific, SGS and Bioservice Scientific Laboratories.

Polaris Market Research has segmented the Biologics Safety Testing market report according to test type, product & services, application, and region:

Biologics Safety Testing, Test Type Outlook (Revenue - USD Million, 2019 - 2032)

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

Biologics Safety Testing, Product & Services Outlook (Revenue - USD Million, 2019 - 2032)

  • Consumables
  • Instrument
  • Services

Biologics Safety Testing, Application Outlook (Revenue - USD Million, 2019 - 2032)

  • Vaccine Development & Manufacturing
  • Monoclonal Antibodies Development & Manufacturing
  • Cellular & Gene Therapy
  • Blood & Blood related Products Development and Manufacturing
  • Others

Biologics Safety Testing, Regional Outlook (Revenue - USD Million, 2019 - 2032)

  • North America
  • U.S.
  • Canada
  • Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Russia
  • Netherlands
  • Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Indonesia
  • Malaysia
  • Latin America
  • Argentina
  • Brazil
  • Mexico
  • Middle East & Africa
  • UAE
  • Saudi Arabia
  • Israel
  • South Africa