The global biologics safety testing market is witnessing remarkable growth, valued at USD 4.03 billion in 2024, growing to USD 4.58 billion in 2025, and projected to reach approximately USD 14.45 billion by 2034, expanding at a CAGR of 13.64% (2025–2034).
This surge is fueled by the increasing demand for biologics, advancements in testing tools, and the integration of AI and machine learning (AI/ML) technologies. North America dominates with a 42% market share (2024), while Asia-Pacific is set to be the fastest-growing region.
Let’s explore the market drivers, key trends, and detailed profiles of the top companies shaping the biologics safety testing landscape.
The rise in biologic therapies for diseases like cancer, autoimmune disorders, and infectious diseases creates a strong need for advanced safety testing solutions.
Strict government regulations mandate rigorous testing for biologics to ensure patient safety, boosting market demand.
The introduction of innovative kits, reagents, and AI-powered instruments enhances the accuracy and efficiency of safety testing.
Key players are heavily investing in R&D and forging partnerships to develop robust safety testing tools for biologics.
Market Size 2024: USD 4.03 billion
Forecast 2034: USD 14.45 billion
CAGR (2025–2034): 13.64%
Largest Region (2024): North America (42% revenue share)
Fastest-Growing Region: Asia-Pacific
Top Segment (2024): Kits & Reagents (54% share)
Fastest-Growing Segment: Instruments
Leading Test Type (2024): Endotoxin Tests (38% share)
Here’s a closer look at the leading players driving innovation in the biologics safety testing market.
About: A leading provider of preclinical and clinical laboratory services for the pharmaceutical, medical device, and biotechnology industries.
Products: Microbial detection systems, in vitro and in vivo safety testing services.
Market Cap: Approx. USD 11 billion.
About: A German life sciences company focused on laboratory instruments and consumables for biotech applications.
Products: Bioreactors, filtration systems, endotoxin testing kits.
Market Cap: Approx. USD 27 billion.
About: A global leader in serving science with a comprehensive portfolio in diagnostics and testing.
Products: LAL assays, mycoplasma detection kits, contamination testing solutions.
Market Cap: Approx. USD 200 billion.
About: A leading player in life science solutions with expertise in biologics safety testing.
Products: Pyrogen testing kits, endotoxin detection systems, filtration units.
Market Cap: Approx. USD 90 billion.
About: A Swiss multinational focusing on custom manufacturing of biologics and related testing services.
Products: Microbial detection tools, endotoxin testing, biosafety solutions.
Market Cap: Approx. USD 35 billion.
About: Provides bioanalytical testing and laboratory services worldwide.
Products: Biologics safety testing, bioassay services, endotoxin detection.
Market Cap: Approx. USD 18 billion.
About: A Swiss multinational offering inspection, verification, testing, and certification services.
Products: Biologics safety and efficacy testing, endotoxin assays.
Market Cap: Approx. USD 20 billion.
About: A Chinese provider of comprehensive testing, manufacturing, and research services.
Products: Mycoplasma detection kits, sterility testing, contamination control solutions.
Market Cap: Approx. USD 25 billion.
About: Specializes in biosafety testing and quality control for biologics.
Products: Adventitious agent testing, mycoplasma detection, endotoxin assays.
Market Cap: Integrated under Merck KGaA.
About: Provides analytical testing and laboratory services for life sciences and environmental industries.
Products: Microbial testing, endotoxin detection, contamination testing services.
Market Cap: Private company (estimated valuation in billions).
About: A global medical technology company providing solutions in diagnostics and biosciences.
Products: Endotoxin detection systems, sterility testing kits.
Market Cap: Approx. USD 70 billion.
About: A leader in providing innovative solutions for life sciences research and testing.
Products: Mycoplasma detection assays, cell-based biosafety testing kits.
Market Cap: Private company (estimated valuation in billions).
About: Supplies products and systems for clinical diagnostics and life science research.
Products: Pyrogen detection kits, microbial contamination testing solutions.
Market Cap: Approx. USD 15 billion.
About: A leading provider of full lifecycle microbiology testing services.
Products: Biologics safety testing, sterility and pyrogen testing.
Market Cap: Private company.
About: Offers preclinical CRO services including safety and efficacy testing of biologics.
Products: Preclinical biosafety testing, mycoplasma detection.
Market Cap: Private company.
About: A biotechnology company developing cell culture media, reagents, and instruments.
Products: Mycoplasma detection kits, sterility testing tools.
Market Cap: Private company (estimated valuation in billions).
If you have any questions, please feel free to contact us at sales@towardshealthcare.com
1. What is biologics safety testing?
Biologics safety testing ensures that biologic products like vaccines, antibodies, and cell therapies are free from harmful contaminants before they reach patients.
2. Why is the biologics safety testing market growing?
The market is driven by increased biologics demand, regulatory requirements, and advancements in testing technologies.
3. Which region leads the biologics safety testing market?
North America leads with 42% revenue share, while Asia-Pacific shows the fastest growth.
4. What are the top products in biologics safety testing?
Kits & reagents dominate with a 54% share (2024), and instruments are the fastest-growing segment.
5. Who are the major players in the biologics safety testing market?
Key companies include Thermo Fisher Scientific, Merck KGaA, Sartorius AG, Charles River Laboratories, and Lonza Group AG.
Source : https://www.towardshealthcare.com/insights/biologics-safety-testing-market-sizing
Invest in Our Premium Strategic Solution: https://www.towardshealthcare.com/price/5843
The rare disease treatment market is witnessing significant global momentum as governments, healthcare providers, and pharmaceutical companies work together to… Read More
The rare disease treatment market is witnessing remarkable growth, with the U.S. and Canada leading innovation and accessibility. This progress… Read More
The global metagenomics market is experiencing rapid growth, with countries like Canada emerging as key players driving innovation and adoption.… Read More
The global metagenomics market is entering a new era of innovation, driven by technological breakthroughs, expanding applications, and strong regulatory… Read More
The metagenomics market is witnessing explosive growth globally, and at the heart of this surge lies North America, which captured… Read More
The global cell harvesting market is witnessing remarkable growth, fueled by advancements in healthcare, biotechnology, and the integration of AI… Read More