According to the new market research report "Biologics Safety Testing Market by Product Service (Consumables, Instrument, Services), Application (Vaccine, Monoclonal Antibodies, Blood products, Cell Gene Therapy Products), Test Type (Endotoxin, Myoplasm, Sterility Test) - Global Forecast to 2027", published by MarketsandMarkets™. Biologics Safety Testing Market is projected to reach USD 6.8 billion by 2027 from USD 3.6 billion in 2022, at a CAGR of 13.3% during the forecast period. 

The growth of the global biologics safety testing market is driven by factors such as companies investing heavily in the development of biologics and biosimilars, strict regulatory concerns over growing cell culture contamination, and increased demand for various drugs, cell therapies, diagnostics, and active biological products.

Biologics safety testing services are used to detect and monitor potential adverse events associated with biologics, as well as to monitor the safety of biologics during the manufacturing process.

The increasing number of clinical trials and the rising prevalence of chronic diseases are the major factors driving the growth of the biologics safety testing market. The increasing number of clinical trials, particularly in the United States, is expected to increase the demand for biologics safety testing services. The rising prevalence of chronic diseases such as diabetes, cancer, infectious diseases, and cardiovascular diseases is also expected to drive the demand for biologics safety testing services.

The increasing global demand for biopharmaceuticals, such as recombinant proteins, vaccines, and monoclonal antibodies, is also expected to drive the growth of the biologics safety testing market. Additionally, the increasing adoption of immunoassay and PCR-based technologies for biologics safety testing is expected to support market growth.

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Top Lading Players: Charles River Laboratories, Inc. (US), Lonza (Switzerland), Thermo Fisher Scientific, Inc. (US), Merck KGaA (Germany), SGS SA (Switzerland), WuXi AppTec (China), Labcorp (US) and Eurofins Scientific (Luxembourg)

Some Key Highlights from the Report:

  • The global biologics safety testing market size was valued at USD 3.6 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 13.3% from 2022 to 2027.
  • The increasing demand for biologics safety testing is due to the growing prevalence of chronic diseases and the need to evaluate the safety of biosimilars. The growing focus on biologics safety testing services is due to the increasing government spending on healthcare, which has created a need for safety evaluation of biosimilars.
  • The increasing demand for biologics safety testing is expected to drive the market in the coming years. The growing prevalence of chronic diseases and the need to evaluate the safety of biosimilars are major factors driving the growth of the market.
  • The market is segmented based on application, end user, and region. On the basis of application, the market is divided into safety assessment, product quality control, and process optimization. Safety assessment is expected to hold the largest share of the market during the forecast period.
  • On the basis of end user, the market is divided into pharmaceutical and biotechnology companies, CROs, and academic and research institutes. The pharmaceutical and biotechnology companies segment is expected to hold the largest share of the market during the forecast period.
  • The Asia Pacific region is the fastest growing region of the Biologics safety testing market

Segments covered in the report:

Biologics Safety Testing Market, by Product Services
  • Consumables
  • Instrument
  • Services
Biologics Safety Testing Market, by Application 
  • Vaccine Development and Manufacturing
  • Monoclonal Antibodies Development and Manufacturing
  • Cellular Gene Therapy Products Development and Manufacturing
  • Blood and Blood Products Development and Manufacturing
  • Other Application
Biologics Safety Testing Market, by Test Type
  • Endotoxin Test
  • Sterility Test
  • Mycoplasma Tests
  • Bioburden Tests
  • Residual Host-cell Proteins DNA Detection Tests
  • Virus safety Test
  • Other Biologics safety Tests

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Regional Outlook:

  • North America (U.S.A., Canada, Mexico)
  • Europe (Italy, U.K., Germany, France, Rest of Europe)
  • Asia Pacific (China, India, Japan, South Korea, Australia, Rest of APAC)
  • Latin America (Chile, Brazil, Argentina, Peru, Rest of Latin America)
  • Middle East Africa (Saudi Arabia, U.A.E., South Africa, Rest of MEA)

Key Questions Addressed in the Report:

  1. What are the dominating factors that are influencing the growth of the industry?
  2. In the forecast period, which market segment is expected to rise the most?
  3. What are the risks and challenges that the industry is facing?
  4. In the coming years, which area is projected to dominate the market?
  5. Who are the major players in the market?
  6. What kind of strategic business plans have they made?

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