Biologics Safety Testing Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global biologics safety testing market growth forecasted to transform from USD 4.2 billion in 2024 to USD 7.2 billion by 2029, driven by a CAGR of 11.1%. Growth of the market can be attributed to factors such as the rising need for novel biotherapeutics and increasing focus on advancement of biopharmaceutical industry. However, ethical concern about animal testing may hamper the growth of the market.

Biologics Safety Testing Market- Global Forecast to 2029

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Attractive Opportunities in the Biologics Safety Testing Market

Global Biologics Safety Testing Market Dynamics

DRIVER: Increasing development of mAbs and biosimilars

The growing development of monoclonal antibodies (mAbs) and biosimilars has significantly impacted the biologics safety testing market. With the rise in mAb therapeutics, especially for oncology and autoimmune diseases, there is an increased demand for stringent safety testing to ensure product quality and patient safety. The rising development of mAbs and biosimilars is propelling the growth of market. For instance, in 2024, FDA approved various biosimilars such as Tyenne (tocilizumab-aazg), Jubbonti and Wyost (denosumab-bbdz), and Simlandi (adalimumab-ryvk). Furthermore, the rising number of approvals for antibody therapeutics is propelling the growth of market. For instance, according to the Antibody Society, during 2023, 10 antibody therapeutics were granted first approvals in either the US or EU. Thus, increasing development of mAbs and biosimilars is driving the growth of market.

RESTRAINT: Ethical concern related to animal testing

One of the significant ethical concerns related to biologics safety testing, especially in pharmaceutical and biotechnology industries, is the use of animals in testing procedures. Animal studies or in vivo tests are conducted to evaluate the safety profile of biologics, including potential toxicities, immunogenicity, and adverse effects. However, growing ethical concerns about animal welfare and rights have prompted efforts to minimize animal use in testing. Entities engaged in biomedical research must strictly adhere to ethical guidelines, prioritizing the humane care and welfare of animals involved in experiments Ethical problems arise from issues such as insufficient housing, painful procedures, and a lack of enrichment activities, prompting critical reflections on the ethical treatment of animals. Thus, ethical concerns related to animal testing might hamper the growth of market.

OPPORTUNITY: Increasing focus on next generation therapeutics

Next-generation therapeutics encompass innovative approaches and advanced technologies that offer improved efficacy, precision, and safety profiles compared to traditional biopharmaceuticals. Next-generation therapeutics, such as gene therapies, cell-based therapies, RNA therapeutics, immunotherapy, and personalized medicines, are often more complex than conventional small molecule drugs. They may involve genetic manipulation, cell engineering, or targeted delivery systems. This complexity increases the need for thorough safety testing to ensure product quality and patient safety. Thus, increasing focus on next generation therapeutics is driving the growth of biologics safety testing market.

CHALLENGE: Challenges related to biologics complexity and heterogenicity

Biologics encompass a wide range of products such as monoclonal antibodies, vaccines, gene therapies, and cell-based therapies. Each of these has unique structures, mechanisms of action, and potential safety concerns. Biologics often undergo complex post-translational modifications (PTMs) such as glycosylation, phosphorylation, and acetylation. These modifications can impact the safety profile by affecting efficacy, immunogenicity, and stability. Additionally, manufacturing of biologics involves complex processes that can result in batch-to-batch variability. Variations in product quality, purity, and potency can affect safety outcomes. Thus, complexity and heterogeneity of the process make it challenging to manufacture, screen and develop the biologics. Hence, the challenges related to complexities and heterogenicity of biologics are anticipated to hamper the growth of market.

Global Biologics Safety Testing Industry Ecosystem Analysis

The market ecosystem comprises raw material suppliers, biologics safety testing product manufacturers, biologics safety testing service providers, and end users such as pharmaceutical and biotechnology companies, CROs and CDMOs, and academic and research institutes. Biologics safety testing product products manufacturers provide consumables and instruments whereas, biologics safety testing service providers offers wide range of services including endotoxin testing services, mycoplasma testing services, bioburden testing services, virus safety testing services, and sterility testing services.

The residual host cell proteins & DNA detection tests segment dominated biologics safety testing industry in 2023.

Based on test type, the 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 tests. In 2023, residual host cell proteins & dna detection tests segment dominated the market owing to rising demand for biologics and biosimilars. Moreover, rising number of product launches for detection and quantitation of residual host cell proteins and DNA is propelling the segment growth in market.

The pharmaceutical & biotechnology companies segment dominated the biologics safety testing industry in 2023.

Based on end user, the biologics safety testing market is segmented into pharmaceutical & biotechnology companies, CROs and CDMOs, and academic and research institutes. In 2023, pharmaceutical & biotechnology companies segment held the largest market share in the global market owing to rising focus on development of novel biotherapeutics. Additionally, increasing investments and fundings for the advancement of biopharmaceutical industry are promoting the segment growth in market.

North America dominated the biologics safety testing industry in 2023.

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The global biologics safety testing market is segmented into six major regions—North America, Europe, the Asia Pacific, Latin America, Middle East, and Africa. North America accounted for the largest share of market in 2023, followed by Europe and the Asia Pacific. Factors such as significant expenditure on R&D activities, presence of a well-established healthcare market, growing need of advanced therapies are responsible for the largest share of North America region in market.

Key players in the biologics safety testing market include 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), 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).

Scope of the Biologics Safety Testing Industry:

This report categorizes the biologics safety testing market to forecast revenue and analyze trends in each of the following submarkets:

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

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

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

By End User

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

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

Recent Developments of Biologics Safety Testing Industry:

• In January 2024, Chales River Laboratories launched Endosafe Trillium rCR cartridge, a new animal-free testing solution for robust bacterial endotoxin testing.
• In November 2023, Merck KGaA has developed biosafety testing laboratories in Shanghai, China. The facility aims to enable the clients to locally access a broad range of testing services for cell line characterization and lot release from pre-clinical development to commercialization.
• In March 2023, LabCorp collaborated with Forge Biologics for gene therapy development and manufacturing. Under this partnership gene therapy clients will have access to drug development services, manufacturing capabilities, scientific expertise, for adeno-associated virus (AAV) mediated gene therapy programs.

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