Biologics Safety Testing Market is Expected to Reach $7.2 billion | MarketsandMarkets™

Chicago, May 30, 2024 (GLOBE NEWSWIRE) — Biologics Safety Testing market in terms of revenue was estimated to be worth $4.2 billion in 2024 and is poised to reach $7.2 billion by 2029, growing at a CAGR of 11.1% from 2024 to 2029 according to a latest report published by MarketsandMarkets™.

Factors like stringent regulatory requirements and growing concern over cell culture contamination are driving the growth of biologics safety testing market.

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Biologics Safety Testing Market Scope:

Report Coverage Details
Market Revenue in 2024 $4.2 billion
Estimated Value by 2029 $7.2 billion
Growth Rate Poised to grow at a CAGR of 11.1%
Market Size Available for 2022–2029
Forecast Period 2024–2029
Forecast Units Value (USD Billion)
Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments Covered Product & Service, Test Type, Application, and End User
Geographies Covered North America, Europe, Asia Pacific, Latin America, Middle East, and Africa
Report Highlights Updated financial information / product portfolio of players
Key Market Opportunity Increasing focus on next generation therapeutics
Key Market Driver Increasing development of mAbs and biosimilars

Technological advancements are playing a transformative role in reshaping the business landscape of the biologics safety testing market. Advanced robotics and automation technologies have enabled significant improvements in biologics safety testing processes. Automated systems can handle large volumes of samples, increasing efficiency and reducing human error. Additionally, Next-Generation Sequencing technologies have revolutionized genetic analysis in biologics safety testing. They allow for comprehensive assessment of genetic stability, purity, and identity of biologics products, leading to more accurate safety assessments.

Based on product & service, the biologics safety testing market is segmented into services, consumables, and instruments. Services segment is further categorized into mycoplasma testing services, sterility testing services, endotoxin testing services, virus safety testing services, bioburden testing services, and other testing services. In 2023, services accounted for the largest share of the global biologics safety testing market. The large share of this segment can primarily be attributed to the increasing development of biologics. Additionally, increasing research activities for the development and manufacturing of advanced biotherapeutics is anticipated to drive the segment growth.

Based on test type, the global biologics safety testing market is segmented into residual host-cell proteins & DNA detection tests, mycoplasma tests, sterility tests, endotoxin tests, virus safety tests, bioburden tests, and other biologics safety tests. In 2023, residual host-cell proteins & DNA detection tests segment accounted for the largest share of the biologics safety testing market. The large share of this segment can be attributed to the increasing demand for monoclonal antibodies and vaccine manufacturing. Additionally, the sterility tests segment is expected to register the highest CAGR during the forecast period.

Based on application, the biologics safety testing market has been segmented into monoclonal antibodies development and manufacturing, vaccine development and manufacturing, cellular and gene therapy products development and manufacturing, blood and blood products development and manufacturing, and other applications. In 2023, monoclonal antibodies development and manufacturing accounted for the largest share of biologics safety testing market. The highest share of the segment is attributed to various factors such as the increasing number of regulatory approvals for monoclonal antibodies.

Based on end user, the biologics safety testing market has been segmented into pharmaceutical and biotechnology companies, CROs and CDMOs, and academic and research institutes. In 2023, pharmaceutical and biotechnology companies accounted for the largest share of the biologics safety testing market. The large share of this segment can be attributed to the rising demand for advanced therapies. Additionally, the growing focus of pharmaceutical and biotechnology companies for development of novel biologics and biosimilars is anticipated to boost the segment growth.

The key regional markets for the global biologics safety testing market are North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. In 2023, North America accounted for the largest share of the market. The large share of this region can be attributed to the increasing development of biosimilars and rising focus on advancement of healthcare infrastructure. However, the Asia Pacific region is expected to be the fastest-growing regional market during the forecast period. Factors such as the increasing research practices in the field of biotechnology and life sciences are driving growth in these markets. Moreover, growing focus on advancement of biopharmaceutical industry is boosting the growth of biologics safety testing market in Asia Pacific region.

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Prominent Players of Biologics Safety Testing Market

  • 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)
  • BIOMÉRIEUX (France)
  • Maravai LifeSciences (US)
  • WuXi AppTec (China)
  • SGS Société Générale 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)
  • Pacific BioLabs (US)
  • Clean Biologics (France)
  • PathoQuest (France)
  • ARL Bio Pharma, Inc. (US)
  • Frontage Labs (US)
  • Creative Biogene (US)
  • Advaxia Biologics (Italy)
  • and Among others

This report categorizes the biologics safety testing market into the following segments:

Biologics Safety Testing Market, by Product & Service

  • Services
    • Mycoplasma Testing Services
    • Sterility Testing Services
    • Endotoxin Testing Services
    • Virus safety Testing Services
    • Bioburden Testing Services
    • Other Testing Services
  • Consumables 
  • Instrument

Biologics Safety Testing Product Market, by Test Type

  • Residual host-cell proteins & DNA detection Tests
  • Mycoplasma Tests
  • Sterility Tests
  • Endotoxin Tests
  • Virus Safety Tests
  • Bioburden Tests
  • Other Biologics Safety Tests  

Biologics Safety Testing Market, by 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

Biologics Safety Testing Market, by End User

  • Pharmaceutical & Biotechnology Companies
  • CROs and CDMOs
  • Academic and Research Institutes

Biologics Safety Testing Market, by region

  • North America
    • US
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Rest of Europe (RoE)
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of Asia Pacific (RoAPAC)
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America (RoLATAM)
  • Middle East
    • GCC Countries
      • Saudi Arabia (KSA)
      • United Arab Emirates (UAE)
      • Rest of GCC Countries (RoGCC)
    • Rest of Middle East (RoME)
  • Africa

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Key Market Stakeholders:

  • Biologics Safety Testing Product Manufacturers, Vendors, and Distributors
  • Biologics Safety Testing Service Providers
  • Academic and Research Institutes
  • Pharmaceutical and Biotechnology Companies
  • Venture Capitalists and Investors
  • Government Organizations
  • Private Research Firms
  • Contract Research Organizations (CROs)
  • Contract Development and Manufacturing Organizations (CDMOs)

Report Objectives:

  • To define, describe, and forecast the global biologics safety testing market based on the product & service, test type, application, end user, and region
  • To provide detailed information regarding the major factors influencing the growth of the market (such as drivers, restraints, opportunities and challenges)
  • To strategically analyze micro-markets with respect to individual growth trends, future prospects, and contributions to the overall biologics safety testing market
  • To analyze opportunities in the market for stakeholders and provide details of the competitive landscape for market leaders
  • To forecast the size of the market segments with respect to six main regions, namely, North America, Europe, Asia Pacific, Latin America, Middle East, and Africa
  • To strategically profile the key players and comprehensively analyze their product and service portfolios, market positions, and core competencies
  • To track and analyze competitive developments such as acquisitions, product launches, expansions, and R&D activities in the biologics safety testing market.

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