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Biological Safety Testing Market to Surpass USD 13.29 Billion by 2033 | Booming at a CAGR of 38.8%

07-04-2025 09:31 AM CET | Health & Medicine

Press release from: IMARC Group

Biological Safety Testing Market to Surpass USD 13.29 Billion

According to the latest report by IMARC Group, titled "Biological Safety Testing Market Size, Share, Trends, and Forecast by Product and Services, Test Type, Application, and Region, 2025-2033", offers a comprehensive analysis of the industry, which comprises insights on the global biological safety testing market. The report also includes competitor and regional analysis, and contemporary advancements in the global market.

The global biological safety testing market size was valued at USD 4.95 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 13.29 Billion by 2033, exhibiting a CAGR of 10.38% during 2025-2033. North America currently dominates the market, holding a significant market share of over 38.8% in 2024.

Request Free Sample Report: https://www.imarcgroup.com/biological-safety-testing-market/requestsample

Global Biological Safety Testing Market Dynamics:

Surge in Biopharmaceutical Development:

A primary factor which propels the biological safety testing market across the globe is the expanding biopharmaceutical sector. The expansion of the biopharmaceutical sector drives the need for biologics, gene therapies, cell-based therapies, and other novel therapeutics, which require stringent safety evaluations. With the higher complexity of the novel therapies, there is a greater need for specialized and advanced safety testing services, which in turn, facilitates the growth of the market.

Stringent Regulatory Scrutiny:

The global market is affected significantly due to the severe regulatory constraints that are implemented by the health authorities throughout the world. The FDA and EMA as regulatory bodies require all new drugs and biologics to have safety assessments such as sterilization, endotoxin, and viral safety testing, all performed before the drug is approved for use. Not meeting these regulations comes with harsh consequences such as delays, fines, or even market withdrawal and reputational damage. All this pressure further fuels the need for precise and dependable biological safety testing services.

Technological Advancements:

Technological advancements are revolutionizing the biological safety testing landscape. The emergence of advanced technologies such as next-generation sequencing, mass spectrometry, and artificial intelligence is enabling faster, more sensitive, and more accurate testing methods. These technologies are not only improving the speed and efficiency of testing but also enabling the development of novel testing approaches that can better address the challenges posed by complex biotherapeutics.

By the IMARC Group, Some of the Top Competitive Landscape Operating in the Biological Safety Testing Market are Given Below:

• Avance Biosciences
• Charles River Laboratories
• Creative Biogene
• Eurofins Scientific
• Lonza Group AG
• Maravai LifeSciences
• Pace Analytical Services Inc.
• Pacific BioLabs
• Sartorius AG
• SGS SA
• ViruSure GmbH (Asahi Kasei Corporation)
• WuXi Biologics

Contact Out Analysts for Brochure Requests, Customization, and Inquiries Before Purchase: https://www.imarcgroup.com/request?type=report&id=4634&flag=C

Global Biological Safety Testing Market Trends:

The global biological safety testing industry has some notable features. The shift towards advanced medicine like gene therapy and even cell therapy has created a need for specialized testing services, which is now an industry focal point.

In addition, the focus on developing in vitro and in silico approaches for animal testing is also gaining momentum. Such approaches have the potential to reduce costs as well as improve speed and ethical outcomes.

Key Market Segmentation:

Breakup by Product and Services:

• Kits and Reagents
• Instruments
• Services

According to the report, kits and reagents represented the largest segment.

Breakup by Test Type:

• Endotoxin Tests
• Sterility Tests
• Cell Line Authentication and Characterization Tests
• Bioburden Tests
• Residual Host Contaminant Detection Tests
• Adventitious Agent Detection Tests
• Others

According to the report, endotoxin tests accounted for the largest market share.

Breakup by Application:

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

According to the report, vaccine development represented the largest segment.

Regional Insights:

• North America (United States, Canada)
• Asia Pacific (China, Japan, India, Australia, Indonesia, Korea, Others)
• Europe (Germany, France, United Kingdom, Italy, Spain, Others)
• Latin America (Brazil, Mexico, Others)
• Middle East and Africa (United Arab Emirates, Saudi Arabia, Qatar, Iraq, Other)

According to the report, North America accounted for the largest market share.

Key highlights of the Report:

• Market Performance
• Market Outlook
• COVID-19 Impact on the Market
• Porter's Five Forces Analysis
• Historical, Current and Future Market Trends
• Market Drivers and Success Factors
• SWOT Analysis
• Structure of the Market
• Value Chain Analysis
• Comprehensive Mapping of the Competitive Landscape

Note: If you need specific information that is not currently within the scope of the report, we can provide it to you as a part of the customization.

Contact US:

IMARC Group
134 N 4th St. Brooklyn, NY 11249, USA
Email: sales@imarcgroup.com
Tel No:(D) +91 120 433 0800
United States: +1-631-791-1145

About Us

IMARC Group is a leading market research company that offers management strategy and market research worldwide. We partner with clients in all sectors and regions to identify their highest-value opportunities, address their most critical challenges, and transform their businesses.

IMARC's information products include major market, scientific, economic and technological developments for business leaders in pharmaceutical, industrial, and high technology organizations. Market forecasts and industry analysis for biotechnology, advanced materials, pharmaceuticals, food and beverage, travel and tourism, nanotechnology and novel processing methods are at the top of the company's expertise.

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