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Global biologics safety testing market registered USD 3,701.1 Million in 2022. The global industry is projected to register an incremental spend of about USD 6,830 Million during the forecast period with a Compounded Annual Growth Rate (CAGR) of 9.20% during 2022-2030.

A biologics product refers to the added product derivative from biological sources. They are used in animals and humans as medical devices. The rising demand for biologics to deal with a load of several chronic diseases is increasing the requirements for the biologics safety testing market. Also, the quick development in fresh product launches, the larger investment in life science and research & development, expansion in pharmaceutical and biopharmaceutical research, and growing incidence of chronic diseases are propelling the global market growth and will continue to grow over the forecast period.
Various key industrial players are highly investing in the advancement of biosimilar and biologic drugs production. It is found recently that the majority of the drug candidates in the discovery stage are biologics like peptides, proteins, and monoclonal antibodies where biologic drugs are projected to provide a large market share produced by the top pharmaceutical products during the forecast period.

Growth Factors

Furthermore, other factors like the increase in concerns in the cell culture contamination, augmentation in biosimilars and the biologics market, and the escalation in biopharmaceuticals research and development programs and investments. However, the ever-increasing biopharmaceutical outsourcing and promising markets are anticipated to for lucrative opportunities for the industrial players in the biologics safety testing market all over the globe.
Owing to the rising figure of COVID-19 patients, the vaccine production is projected to enhance the market of biologics safety testing having an essential quality assurance measure to make sure the patient safety. In addition, the rising implementation of endotoxin testing for drug development and COVID-19 research will be having a positive effect on market growth at a global level.

Regional Analysis

In terms of revenue, North America is contributing to the largest market growth across the world in the biologics safety testing market and will continue to grow in the future. This is due to the quick expansion in the biopharmaceutical production companies in the region. Also, other factors like the increasing awareness among consumers about product safety, rising demand for high-quality research tools for data reproducibility, Growing academic and government investments, and the presence of major market players are responsible for fueling the market of biologics safety testing in the North American region.

Top Market Players

The numerous initiatives by the market players and the use of biologics safety testing products and services in COVID-19 research widely have positively influenced the biologics safety testing market. This, in turn, is expected to grow the market revenue all over the world. Pace Analytical Services Inc., Merck KGaA, Charles River Laboratories, Cytovance Biologics Inc., Toxikon Corporation, Sartorius AG, WuXi Apptec, Thermo Fisher Scientific Inc., Lonza Group LTD, and SGS SA are key market players in the global biologics safety testing market.

Report Attribute Details
The market size value in 2022 USD 3,701.1 million
The revenue forecast in 2030 USD 6,830 million
Growth Rate CAGR of 9.20% from 2020 to 2028
The base year for estimation 2021
Historical data 2018 – 2020
Forecast period 2022 – 2030
Top Manufacturers Xilinx (US), United Microelectronics (Taiwan), Microchip Technology, Intel (US), Microchip (US), Lattice Semiconductor (US), Achronix (US), TSMC (Taiwan), QuickLogic (US), GLOBALFOUNDRIES (US), S2C Inc (US)
By Product Services, Instruments and Reagents, Kits
By Test Type Bioburden Tests, Adventitious Agent Detection Tests, Residual Host Contamination Detection Tests, Cell Line Authentication and Characterization Tests, Sterility Tests, Endotoxin Tests, Other Test Types
By Application
Tissue and Tissue-Related Products Testing, Cellular and Gene Therapy, Blood and Blood-Related Products Testing, Vaccine and Therapeutics Development, Stem Cell Research
Regional Scope North America, Europe, Asia Pacific, Latin America, Middle East and Africa

This report segments the global biologics safety testing market as follows:

Global Biologics Safety Testing Market: By Product

  • Services
  • Instruments and Reagents
  • Kits

Global Biologics Safety Testing Market: By Test Type

  • Bioburden Tests
  • Adventitious Agent Detection Tests
  • Residual Host Contamination Detection Tests
  • Cell Line Authentication and Characterization Tests
  • Sterility Tests
  • Endotoxin Tests
  • Other Test Types

Global Biologics Safety Testing Market: By Application

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

Global Biologics Safety Testing Market: Regional Segmentation Analysis

  • North America
    • The U.S.
    • Canada
  • Europe
    • France
    • The UK
    • Spain
    • Germany
    • Italy
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Southeast Asia
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa

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