The biologics safety testing market is projected to reach USD 7.2 billion by 2029 from an estimated USD 4.2 billion in 2024, at a CAGR of 11.1% from 2024 to 2029. The growth of this market can be attributed to the increasing focus on the development and manufacturing of novel biologics. The rising demand for advanced therapies such as cell and gene therapies due to the growing rate of chronic diseases is propelling the growth of biologics safety testing. This trend is expected to drive the growth of the biologics safety testing market in the coming years.

“The monoclonal antibodies development and manufacturing segment accounted for the largest share of by application segment in 2023.”
In 2023, the monoclonal antibodies development and manufacturing segment accounted for the largest share of the global biologics safety testing market by application. Growing investments and funding in the development of novel biotherapeutics and rising demand for biological therapies for the treatment of chronic diseases are promoting the segment’s growth in the biologics safety testing market.

“The US has continued to dominate the biologics safety testing market from 2024 to 2029.”
The US dominated the biologics safety testing market in North America in 2023. The US is the world’s largest biopharmaceutical market and a leader in biopharmaceutical research/investments. Also, US has strong healthcare infrastructure which drives the research and development in life sciences sector. Additionally, US has large number of biopharmaceutical companies; thus, increasing number of biopharmaceutical companies and growing research activities in biotechnology sector are propelling the market growth in US. Moreover, increasing approvals for biosimilars are also driving the growth of biologics safety testing market.

The primary interviews conducted for this report can be categorized as follows:

  • By Respondent: Supply Side- 60% and Demand Side 40%
  • By Designation: Managers - 45%, CXO & Directors - 30%, and Executives - 25%
  • By Region: North America - 40%, Europe -25%, Asia-Pacific -25%, Latin America -5% and Middle East & Africa- 5%

Research Coverage:
This research report categorizes the biologics safety testing market by product & service (services (mycoplasma testing services, sterility testing services, endotoxin testing services, virus safety testing services, bioburden testing services, and other testing services), consumables, and instrument), test type (residual host-cell proteins & DNA detection tests, mycoplasma tests, sterility tests, endotoxin tests, virus safety tests, bioburden tests, other biologics safety tests), application (monoclonal antibodies development and manufacturing, vaccine development and manufacturing, cellular & gene therapy products development and manufacturing, blood & blood products development and manufacturing, other applications), end user (pharmaceutical & biotechnology companies, CROs and CDMOs, and academic & research institutes), and by region (North America, Europe, Asia Pacific, Latin America, Middle East, and Africa). The scope of the report covers detailed information regarding the major factors, such as drivers, restraints, challenges, and opportunities, influencing the growth of the biologics safety testing market. A thorough analysis of the key industry players has been done to provide insights into their business overview, products, services, solutions, key strategies, collaborations, partnerships, and agreements. Also, it includes new product launches, collaborations and acquisitions, and recent developments associated with the biologics safety testing market.

Key Benefits of Buying the Report:
The report will help market leaders/new entrants by providing the closest approximations of the revenue numbers for the overall biologics safety testing market and its subsegments. It will also help stakeholders better understand the competitive landscape and gain more insights to position their business better and make suitable go-to-market strategies. This report will enable stakeholders to understand the market’s pulse and provide them with information on the key market drivers, restraints, opportunities, and challenges.

The report provides insights on the following pointers:

  • Analysis of key drivers (growing development of mAbs and biosimilars, rising investments and fundings in biopharmaceutical industry, and stringent regulatory guidelines for biologics safety), restraints (ethical concern regarding animal testing), opportunities (growing opportunities in emerging economies, increasing focus on next generation therapeutics), and Challenges (high cost of biologics) influencing the growth of the market.
  • Product Development/Innovation: Detailed insights on newly launched products of the biologics safety testing market
  • Market Development: Comprehensive information about lucrative markets - the report analyses the market across varied regions.
  • Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the biologics safety testing market
  • Competitive Assessment: Thermo Fisher Scientific Inc. (US), Merck KGaA (Germany), Lonza (Switzerland), FUJIFILM Corporation (Japan), Sartorius AG (Germany), F. Hoffmann-La Roche Ltd (Switzerland), Charles River Laboratories (US), BIOM?RIEUX (France), Maravai LifeSciences (US), WuXi AppTec (China), SGS Soci?t? G?n?rale de Surveillance SA. (Switzerland), Sotera Health (Nelson Laboratories, LLC) (US), Samsung Biologics (South Korea), GenScript (US), Agilent Technologies, Inc. (US), Syngene International Limited (India), Eurofins Scientific (Luxembourg), Laboratory Corporation of America Holdings (US), Bio-Rad Laboratories, Inc. (US), QIAGEN (Netherlands), Promega Corporation (US), Catalent, Inc (US), ASSOCIATES OF CAPE COD, INC. (US), Pacific BioLabs (US), Clean Biologics (France), PathoQuest (France), ARL Bio Pharma, Inc. (US), Frontage Labs (US), Creative Biogene (US), Advaxia Biologics (Italy), among others in the market.