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The Biologics Safety Testing Market size was estimated at USD 5.62 billion in 2023, USD 6.43 billion in 2024, and is expected to grow at a CAGR of 14.71% to reach USD 14.70 billion by 2030. Speak directly to the analyst to clarify any post sales queries you may have.
Biologics safety testing is majorly the stringent testing of biopharmaceuticals conducted by drug manufacturers to ensure all biologic materials, across the development process, are safe and free of contaminants. The increased need for safety monitoring & testing in clinical trial activities, along with the growing focus on medical device evaluation, is expanding the adoption of biologics safety testing systems and services. The growing number of drug recalls, and government initiatives and standards for biologics product safety is the major driver for product penetration. However, the high-cost requirement of safety testing for the development of drugs and the limited availability of skilled professionals to perform accurate testing impedes proper testing activities. Technological innovation and advancements in biologics safety testing can assist in addressing operational factors and serve users with cost-effective products. Ongoing research for improved safety recombinant protein and cell & gene therapy is expected to proliferate the development of new customized testing services.
Regional Insights
The biologics safety testing market is advancing in the Americas, owing to the highly valued medical and pharmaceutical sector, rapid adoption of genomics, proteomics, oncology, and diagnostic screening, and the presence of major players continuously engaged in the development of advanced tools for life science research. The U.S. and Canada observe a well-regulated environment for medicine safety with the existence of Health Canada and the U.S. Food & Drug Administration. Increasing research and development (R&D) expenditure and the growing adoption of innovative and advanced testing tools among biopharmaceutical companies facilitate market growth in the APAC region. Market players in the Asia-Pacific are emerging internationally by offering comprehensive biosafety testing packages compliant with global pharmacopeia standards, carried out in facilities accredited by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK. The EMEA is also a major hub of medical device production and drug discovery processes, with investments in expanding sterility and bioburden testing facilities.FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Biologics Safety Testing Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Biologics Safety Testing Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.Key Company Profiles
The report delves into recent significant developments in the Biologics Safety Testing Market, highlighting leading vendors and their innovative profiles. These include Accugen Laboratories, Inc., Agilent Technologies, Inc., Almac Group Limited, Associates of Cape Cod, Inc., Becton, Dickinson and Company, Bio-Rad Laboratories, Inc., bioMérieux SA, BSL Bioservice Scientific Laboratories Munich GmbH, Charles River Laboratories International, Inc., Creative Biolabs, Inc., Eagle Analytical Services, Eurofins Scientific Limited, F. Hoffmann-La Roche Ltd., FUJIFILM Wako Pure Chemical Corporation, Laboratory Corporation of America Holdings, Lonza Group AG, Maravai Lifesciences, Merck KGaA, Microcoat Biotechnologie GmbH, Nelson Laboratories, LLC by Sterigenics International LLC, Pacific BioLabs by Northview Biosciences, Inc., Promega Corporation, PromoCell GmbH, QIAGEN GmbH, Rockland Immunochemicals, Inc., Samsung Biologics, Sartorius AG, SGS S.A., SGS Société Générale de Surveillance SA, and Thermo Fisher Scientific, Inc.Market Segmentation & Coverage
This research report categorizes the Biologics Safety Testing Market to forecast the revenues and analyze trends in each of the following sub-markets:- Product
- Consumable
- Instruments
- Services
- Test Type
- Bioburden Tests
- Endotoxin Tests
- Mycoplasma Tests
- Residual Host-Cell Proteins & DNA Detection Tests
- Sterility Tests
- Virus Safety Tests
- Application
- Blood & Blood-Related Products Development
- Cellular & Gene Therapy Products Development
- Monoclonal Antibodies Development
- Vaccine & Therapeutics Development
- End-User
- Academic & Research Institutes
- Contract Research Organization/ Contract Manufacturing Organization
- Pharmaceutical & Biotechnology Companies
- Region
- Americas
- Argentina
- Brazil
- Canada
- Mexico
- United States
- California
- Florida
- Illinois
- New York
- Ohio
- Pennsylvania
- Texas
- Asia-Pacific
- Australia
- China
- India
- Indonesia
- Japan
- Malaysia
- Philippines
- Singapore
- South Korea
- Taiwan
- Thailand
- Vietnam
- Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom
- Americas
The report offers valuable insights on the following aspects
- Market Penetration: It presents comprehensive information on the market provided by key players.
- Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
- Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
- Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
- Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
The report addresses key questions such as
- What is the market size and forecast of the Biologics Safety Testing Market?
- Which products, segments, applications, and areas should one consider investing in over the forecast period in the Biologics Safety Testing Market?
- What are the technology trends and regulatory frameworks in the Biologics Safety Testing Market?
- What is the market share of the leading vendors in the Biologics Safety Testing Market?
- Which modes and strategic moves are suitable for entering the Biologics Safety Testing Market?
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Table of Contents
1. Preface
2. Research Methodology
4. Market Overview
5. Market Insights
6. Biologics Safety Testing Market, by Product
7. Biologics Safety Testing Market, by Test Type
8. Biologics Safety Testing Market, by Application
9. Biologics Safety Testing Market, by End-User
10. Americas Biologics Safety Testing Market
11. Asia-Pacific Biologics Safety Testing Market
12. Europe, Middle East & Africa Biologics Safety Testing Market
13. Competitive Landscape
14. Competitive Portfolio
15. Appendix
List of Figures
List of Tables
Companies Mentioned
- Accugen Laboratories, Inc.
- Agilent Technologies, Inc.
- Almac Group Limited
- Associates of Cape Cod, Inc.
- Becton, Dickinson and Company
- Bio-Rad Laboratories, Inc.
- bioMérieux SA
- BSL Bioservice Scientific Laboratories Munich GmbH
- Charles River Laboratories International, Inc.
- Creative Biolabs, Inc.
- Eagle Analytical Services
- Eurofins Scientific Limited
- F. Hoffmann-La Roche Ltd.
- FUJIFILM Wako Pure Chemical Corporation
- Laboratory Corporation of America Holdings
- Lonza Group AG
- Maravai Lifesciences
- Merck KGaA
- Microcoat Biotechnologie GmbH
- Nelson Laboratories, LLC by Sterigenics International LLC
- Pacific BioLabs by Northview Biosciences, Inc.
- Promega Corporation
- PromoCell GmbH
- QIAGEN GmbH
- Rockland Immunochemicals, Inc.
- Samsung Biologics
- Sartorius AG
- SGS S.A.
- SGS Société Générale de Surveillance SA
- Thermo Fisher Scientific, Inc.
Methodology
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Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 191 |
| Published | March 2024 |
| Forecast Period | 2024 - 2030 |
| Estimated Market Value ( USD | $ 6.43 Billion |
| Forecasted Market Value ( USD | $ 14.7 Billion |
| Compound Annual Growth Rate | 14.7% |
| Regions Covered | Global |
| No. of Companies Mentioned | 30 |
