Global Biologics Safety Testing Market Overview
Biologics are advanced drugs used in treatment of cancer, rheumatoid arthritis, and other diseases. These biologics constitutes large molecules such as monoclonal antibodies, recombinant proteins and their safety ensures patient safety as these are used in the treatment of different diseases. Biological safety testing refers to the testing procedures that are carried out to ensure non-contamination of biopharmaceuticals and vaccines and to comply with regulations regarding the same. This includes various types of sterility tests. Biologics Safety Testing Market accounted for US$ 2.7bn in 2020 and is estimated to be US$ 8.8Bn by 2030 and is anticipated to register a CAGR of 12.6%.
Global Biologics Safety Testing Market Dynamics
Increasing demand for biologics for treating various chronic diseases burden
The demand for the global biologics safety testing market is driven by increasing demand for biologics for treating various chronic diseases burden, increasing investments in life science research and development. In addition rapid growth in new product launches, growth in pharmaceutical and biopharmaceutical research and increasing prevalence of chronic disorders also boost growth of the target market.
Rise in pharmaceutical and biotechnology industry
Moreover, rise in pharmaceutical and biotechnology industry, huge R&D investment by key players in the life sciences industry, and increase in number of new drug launches in recent years drive the target market growth. However, stringent regulatory requirements and longer approval time may act as a restraining factor for the target market growth. Whereas government regulations for approval of biosimilars and high cost of drug development restricts the global market growth. Nevertheless, increased preference for pharmaceutical outsourcing and emerging markets are expected to act as new growth opportunities for major market players of biologics safety testing. In addition, governmental support towards providing funds for biologics development and its safety is expected to provide lucrative global market growth opportunities
Global Biologics Safety Testing Market Segmentation
The global biologics safety testing market is segmented based on product, application, test, and region.
Based on product, the global biologics safety testing market is segmented into reagent and kits, instruments, and other products. Rapid advancements and modifications in formulation of reagents and kits are expected to increase their adoption by laboratory technicians, especially in toxicology assessment. The instruments segment is expected to grow during the forecast period due to rising demand in biological safety testing laboratories. Based on application, the target market is bifurcated into vaccines and therapeutics, cellular and gene therapy, blood and blood and blood-based therapy, and others. Increasing vaccine and therapeutic drug development activities by major biopharmaceutical and pharmaceutical companies has attributed to the largest market share. Based on the test, the target market is segmented into sterility tests, cell line authentication and characterization tests, bioburden tests, endotoxin tests, adventitious agent detection tests, and other tests. Endotoxin test type segment held largest market share in 2018. Sterility test type segment will witness highest growth rate over the forecast period.
Regional Insights:
For detailed understanding of market dynamics, based on the region the global biologics safety testing market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The market in North America accounts highest revenue share to the global biologics safety testing market due to growing demand for advanced medical technologies and increasing geriatric population. Asia Pacific biologics safety testing market is projected to register a high CAGR over the forecast period owing to the growing trend of number of biopharmaceutical companies. Increasing competition to develop therapeutically advanced drugs on a large scale has compelled manufacturers to improve aspects of manufacturing processes such as productivity and cost-efficiency.
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Attribute |
Details |
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Base year for estimation |
2020 |
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Forecast period |
2020 – 2030 |
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Market representation |
Revenue in USD Million & CAGR from 2020 – 2030 |
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Market Segmentation |
By Analog: Vitamin D2 and Vitamin D3 By Application: Functional food and beverages, Pharmaceuticals, Animal feed and pet food, and Personal care By End-User Industry: Children, Adults, and Pregnant Women |
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Regional scope |
North America - U.S., Canada Europe - UK, Germany, Spain, France, Italy, Russia, Rest of Europe Asia Pacific - Japan, India, China, South Korea, Australia, Rest of Asia-Pacific Latin America - Brazil, Mexico, Argentina, Rest of Latin America Middle East & Africa - South Africa, Saudi Arabia, UAE, Rest of Middle East & Africa |
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Report coverage |
Revenue forecast, company share, competitive landscape, growth factors, and trends |
Detailed Segmentation:
Global Biologics Safety Testing Market, By Product:
- Reagent and Kits
- Instruments
- Other Products
Global Biologics Safety Testing Market, By Application:
- Vaccines and Therapeutics
- Cellular and Gene Therapy
- Blood and Blood and Blood-based Therapy
- Others
Global Biologics Safety Testing Market, By Test:
- Sterility Tests
- Cell Line Authentication and Characterization Tests
- Bioburden Tests, Endotoxin Tests
- Adventitious Agent Detection Tests
- Other Tests
Global Biologics Safety Testing Market, By Region:
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- North America
- North America Biologics Safety Testing Market, By Product
- North America Biologics Safety Testing Market, By Application
- North America Biologics Safety Testing Market, By Test
- North America Biologics Safety Testing Market, By Country
- The U.S.
- Canada
- Europe
- Europe Biologics Safety Testing Market, By Product
- Europe Biologics Safety Testing Market, By Application
- Europe Biologics Safety Testing Market, By Test
- Europe Biologics Safety Testing Market, By Country
- Germany
- UK
- France
- Russia
- Italy
- Rest of Europe
- Asia Pacific
- Asia Pacific Biologics Safety Testing Market, By Product
- Asia Pacific Biologics Safety Testing Market, By Application
- Asia Pacific Biologics Safety Testing Market, By Test
- Asia Pacific Biologics Safety Testing Market, By Country
- China
- India
- Japan
- South Korea
- Rest of Asia Pacific
- Latin America
- Latin America Biologics Safety Testing Market, By Product
- Latin America Biologics Safety Testing Market, By Application
- Latin America Biologics Safety Testing Market, By Test
- Latin America Biologics Safety Testing Market, By Country
- Brazil
- Mexico
- Rest of Latin America
- Middle East & Africa
- Middle East & Africa Biologics Safety Testing Market, By Product
- Middle East & Africa Biologics Safety Testing Market, By Application
- Middle East & Africa Biologics Safety Testing Market, By Test
- Middle East & Africa Biologics Safety Testing Market, By Country
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- North America
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Global Biologics Safety Testing Market Key Players
The key players operating the global biologics safety testing market involves Wuxi Apptec, Toxikon Corporation, Loza Group Ltd., Pace Analytical Services inc., BioMerieux SA, Genscript Biotech Corp., Thermo Fisher Scientific Inc., SGS S.A., Eurofins Scientific Se, Sigma-Aldrich Corporation (part of Merck KGaA), and Charles River Laboratories International,Inc. For instance, On 15 march 2019, Eurofins expands its leading footprint in biopharmaceutical products testing with the acquisition of chemical analysis in Australia.
Global Biologics Safety Testing Market Company Profile
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- Wuxi Apptec
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- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
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- Toxikon Corporation
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- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
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- Loza Group Ltd.
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- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
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- Pace Analytical Services, Inc.
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- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
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- BioMerieux SA
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- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
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- Genscript Biotech Corp.
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- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
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- Thermo Fisher Scientific Inc.
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- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
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- SGS S.A.
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- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
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- Eurofins Scientific Se
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- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
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- Sigma-Aldrich Corporation (part of Merck KGaA)
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- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
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- Charles River Laboratories International, Inc.
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- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
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- Wuxi Apptec
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Global Biologics Safety Testing Market Table of Contents
Table of Contents
- Research Objective and Assumption
- Preface
- Research Objectives
- Study Scope
- Years considered for the study
- Assumptions
- Abbreviations
- Research Methodology
- Research data
- Primary Data
- Primary Interviews
- Primary Breakdown
- Key data from Primary Sources
- Key Industry Insights
- Secondary Data
- Major Secondary Sources
- Secondary Sources
- Market Estimation
- Top-Down Approach
- Approach for estimating Market Share by Top-Down Analysis (Supply Side)
- Bottom-Up Approach
- Approach for estimating market share by Bottom-up Analysis (Demand Side)
- Market Breakdown and Data Triangulation
- Research Assumptions
- Market Purview
- Executive Summary
- Key Findings—Global Outlook for Biologics Safety Testing Strategies
- Key Questions this Study will Answer
- Market Snippet, By Products
- Market Snippet, By Application
- Market Snippet, By Test
- Market Snippet, By Region
- Opportunity Map Analysis
- Executive Summary—3 Big Predictions
- Market Dynamics, Regulations, and Trends Analysis
- Market Dynamics
- Drivers
- Restraints
- Market Opportunities
- Market Trends
- DR Impact Analysis
- PEST Analysis
- Porter’s Five Forces Analysis
- Opportunity Orbit
- Market Investment Feasibility Index
- Macroeconomic Factor Analysis
- Market Dynamics
- Global Biologics Safety Testing Market, By Products, 2020 – 2030, (US$ Mn)
- Overview
- Market Value and Forecast (US$ Mn), and Share Analysis (%), 2020 – 2030
- Y-o-Y Growth Analysis (%), 2020 – 2030
- Segment Trends
- Reagent and Kits
- Overview
- Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
- Instruments
- Overview
- Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
- Other Products
- Overview
- Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
- Overview
- Global Biologics Safety Testing Market, By Application, 2020 – 2030, (US$ Mn)
- Overview
- Market Value and Forecast (US$ Mn), and Share Analysis (%), 2020 – 2030
- Y-o-Y Growth Analysis (%), 2020 – 2030
- Segment Trends
- Vaccines and Therapeutics
- Overview
- Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
- Cellular and Gene Therapy
- Overview
- Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
- Blood and Blood and Blood-based Therapy
- Overview
- Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
- Others
- Overview
- Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
- Overview
- Global Biologics Safety Testing Market, By Test, 2020 – 2030, (US$ Mn)
- Overview
- Market Value and Forecast (US$ Mn), and Share Analysis (%), 2020 – 2030
- Y-o-Y Growth Analysis (%), 2020 – 2030
- Segment Trends
- Sterility Tests
- Overview
- Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
- Cell Line Authentication and Characterization Tests
- Overview
- Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
- Bioburden Tests
- Overview
- Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
- Endotoxin Tests
- Overview
- Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
- Adventitious Agent Detection Tests
- Overview
- Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
- Other Tests
- Overview
- Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
- Overview
- Global Biologics Safety Testing Market, By Region, 2020 – 2030, (US$ Mn)
- Overview
- Market Value and Forecast (US$ Mn), and Share Analysis (%), 2020 – 2030
- Y-o-Y Growth Analysis (%), 2020 – 2030
- Regional Trends
- North America
- Market Size and Forecast (US$ Mn), By Products, 2020 – 2030
- Market Size and Forecast (US$ Mn), By Application, 2020 – 2030
- Market Size and Forecast (US$ Mn), By Test, 2020 – 2030
- Market Size and Forecast (US$ Mn), By Country, 2020 – 2030
- U.S.
- Canada
- Europe
- Market Size and Forecast (US$ Mn), By Products, 2020 – 2030
- Market Size and Forecast (US$ Mn), By Application, 2020 – 2030
- Market Size and Forecast (US$ Mn), By Test, 2020 – 2030
- Market Size and Forecast (US$ Mn), By Country, 2020 – 2030
- Germany
- UK
- France
- Russia
- Italy
- Rest of Europe
- Asia Pacific
- Market Size and Forecast (US$ Mn), By Products, 2020 – 2030
- Market Size and Forecast (US$ Mn), By Application, 2020 – 2030
- Market Size and Forecast (US$ Mn), By Test, 2020 – 2030
- Market Size and Forecast (US$ Mn), By Country, 2020 – 2030
- China
- India
- Japan
- South Korea
- Rest of Asia Pacific
- Latin America
- Market Size and Forecast (US$ Mn), By Products, 2020 – 2030
- Market Size and Forecast (US$ Mn), By Application, 2020 – 2030
- Market Size and Forecast (US$ Mn), By Test, 2020 – 2030
- Market Size and Forecast (US$ Mn), By Country, 2020 – 2030
- Brazil
- Mexico
- Rest of Latin America
- Middle East & Africa
- Market Size and Forecast (US$ Mn), By Products, 2020 – 2030
- Market Size and Forecast (US$ Mn), By Application, 2020 – 2030
- Market Size and Forecast (US$ Mn), By Test, 2020 – 2030
- Market Size and Forecast (US$ Mn), By Country, 2020 – 2030
- GCC
- Israel
- South Africa
- Rest of Middle East
- Overview
- Competitive Landscape
- Heat Map Analysis
- Market Presence and Specificity Analysis
- Company Profiles
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- Wuxi Apptec
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Overview
- Toxikon Corporation
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Overview
- Loza Group Ltd.
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Overview
- Pace Analytical Services, Inc.
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Overview
- BioMerieux SA
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Overview
- Genscript Biotech Corp.
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Overview
- Thermo Fisher Scientific, Inc.
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Overview
- SGS S.A.
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Overview
- Eurofins Scientific Se
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Overview
- Sigma-Aldrich Corporation (part of Merck KGaA)
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Overview
- Charles River Laboratories International, Inc.
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Overview
- Wuxi Apptec
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- The Last Word
- Future Impact
- About Us
- Contact
FAQs
The global biologics safety testing market is segmented based on product, application, test, and region.
The demand for the global biologics safety testing market is driven by increasing demand for biologics for treating various chronic diseases burden, increasing investments in life science research and development.
North America accounts highest revenue share to the global biologics safety testing market due to growing demand for advanced medical technologies and increasing geriatric population.
The key players operating the global biologics safety testing market involves Wuxi Apptec, Toxikon Corporation, Loza Group Ltd., Pace Analytical Services inc., BioMerieux SA, Genscript Biotech Corp., Thermo Fisher Scientific Inc., SGS S.A., Eurofins Scientific Se, Sigma-Aldrich Corporation (part of Merck KGaA), and Charles River Laboratories International,Inc.