Biologics Testing Market: By Product Type, By Test, By Application, By Region Forecast 2020-2031

Biologics Testing Market Size, Share, Growth, Trends, and Global Industry Analysis: By Product Type (Instruments, Kits, and Reagents, Services), By Test (Sterility Test, Endotoxin Test, Cell Line Authentication and Characterization, Residual Host Contamination Test, Others), By Application (Cellular and Gene related, Blood and Blood Products, Vaccines, Stem cell Research, Others), By Region Forecast 2020-2031

Biologics Testing Market size was valued at US$ 3.2 billion in 2023, growing at a significant CAGR of 11.8% from 2024-2030. The market report provides an in-depth analysis of the impact of COVID-19 on the market, along with revised market size due to the effects of the coronavirus. The increase in R&D investment in the biopharma industry coupled with the increase in new product launches are expected to bolster the market growth over the forecast period. Biologics are complex compounds made from the genes of live creatures and combined utilizing modern DNA technologies. Biologics are cutting-edge medications that are used to treat cancer, cardiovascular disease, rheumatoid arthritis, and other illnesses.

Large molecules such as monoclonal antibodies and recombinant proteins are classified as biologics, and their safety ensures patient safety because they are utilized to treat the diseases listed above. Recombinant proteins, tissues, genes, allergens, cells, blood components, and vaccinations are all examples of biological medications made from live creatures. Biologics are items that are made from living organisms and have specific properties. For new product categories, biological safety assessment is critical. Biological safety testing is done to guarantee that vaccines and biopharmaceuticals are not contaminated and that they meet safety quality standards. Kits and reagents, as well as instruments, make up the product segment.

Global Biologics Testing Market Summary

Study Period

2025-2031

Base Year

2024

CAGR

11.8%

Largest Market

North-America

Fastest Growing Market

Europe

Biologics Testing Market Dynamics

The biologics testing market is mainly driven by the strengthening of the regulatory procedures in many countries for the approval and marketing of the biological products. In addition, robust growth in biopharmaceutical industry and increase in prevalence of the diseases among the population expected to boost the market share.

Global Biologics Testing Market Segmentation Analysis

Report Benchmarks

Details

Report Study Period

2025-2031

Market Size in 2023

US$ 3.2 billion

Market CAGR

11.8%

By Product Type

  • Instruments
  • Kits and Reagents
  • Services

By Application

  • Cellular and Gene related
  • Blood and Blood Products
  • Vaccines
  • Stem cell Research
  • Others

By Test

  • Sterility Test
  • Endotoxin Test
  • Cell Line Authentication and Characterization
  • Residual Host Contamination Test
  • Others

By Region

  • North America (U.S., Canada)
  • Europe (Germany, U.K., France, Italy, Russia, Spain, Rest of Europe)
  • Asia-Pacific (China, India, Japan, Australia, Southeast Asia, Rest of Asia Pacific)
  • Latin America (Mexico, Brazil, Argentina, Columbia, Rest of Latin America)
  • Middle East & Africa (GCC, Egypt, Nigeria, South Africa, Rest of Middle East and Africa)

Key Features of the Report

  • The biologics testing market, report provides granular level information about the Market size, regional Market share, historic Market (2019-2023), and forecast (2024-2030)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key Market developments, and key strategies.
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the Market.
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the Market.
  • The report provides a plethora of information about Market entry strategies, regulatory framework, and reimbursement scenarios.
  • The report analyses the impact of the socio-political environment through PESTLE Analysis and competition through Porter's Five Force Analysis.

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Frequently Asked Questions

The global biologics testing market size was valued at US$ 3.2 billion in 2023, growing at a significant CAGR of 11.8% from 2024-2030.

The report covers the five regions and 15+ countries market data: North America (United States, Canada), Europe (Germany, France, Italy, Spain, and United Kingdom (UK), Asia Pacific (China, India, Japan, Australia & New Zealand), Latin America (Brazil, Mexico, Argentina) and Middle East and Africa (Saudi Arabia, United Arab Emirates, South Africa).

In our report, we provide 12-15 market players’ information into the report. However, based on the client’s request we will provide additional country and regional market players information as well.

Author image

Author

Muni Kumar Meravath

Muni Kumar Meravath is a seasoned Healthcare Market Research Analyst with over 6 years of experience in the healthc.....

1. Executive Summary
2. Global Biologics Testing Market Introduction 
2.1.Global Biologics Testing Market  - Taxonomy
2.2.Global Biologics Testing Market  - Definitions
2.2.1.Product Type 
2.2.2.Application
2.2.3.Test
2.2.4.Region
3. Global Biologics Testing Market Dynamics
3.1. Drivers
3.2. Restraints
3.3. Opportunities/Unmet Needs of the Market
3.4. Trends
3.5. Product Landscape
3.6. New Product Launches
3.7. Impact of COVID 19 on Market
4. Global Biologics Testing Market Analysis, 2020 - 2024 and Forecast 2025 - 2031
4.1.  Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
4.2.  Year-Over-Year (Y-o-Y) Growth Analysis (%) 
4.3.  Market Opportunity Analysis 
5. Global Biologics Testing Market  By Product Type , 2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
5.1. Instruments
5.1.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
5.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.1.3. Market Opportunity Analysis 
5.2. Kits and Reagents
5.2.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
5.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.2.3. Market Opportunity Analysis 
5.3. Services
5.3.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
5.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.3.3. Market Opportunity Analysis 
6. Global Biologics Testing Market  By Application, 2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
6.1. Cellular and Gene related
6.1.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
6.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.1.3. Market Opportunity Analysis 
6.2. Blood and Blood Products
6.2.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
6.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.2.3. Market Opportunity Analysis 
6.3. Vaccines
6.3.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
6.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.3.3. Market Opportunity Analysis 
6.4. Stem cell Research
6.4.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
6.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.4.3. Market Opportunity Analysis 
6.5. Others
6.5.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
6.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.5.3. Market Opportunity Analysis 
7. Global Biologics Testing Market  By Test, 2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
7.1. Sterility Test
7.1.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
7.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.1.3. Market Opportunity Analysis 
7.2. Endotoxin Test
7.2.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
7.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.2.3. Market Opportunity Analysis 
7.3. Cell Line Authentication and Characterization
7.3.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
7.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.3.3. Market Opportunity Analysis 
7.4. Residual Host Contamination Test
7.4.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
7.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.4.3. Market Opportunity Analysis 
7.5. Others
7.5.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
7.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.5.3. Market Opportunity Analysis 
8. Global Biologics Testing Market  By Region, 2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
8.1. North America
8.1.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
8.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.1.3. Market Opportunity Analysis 
8.2. Europe
8.2.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
8.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.2.3. Market Opportunity Analysis 
8.3. Asia Pacific (APAC)
8.3.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
8.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.3.3. Market Opportunity Analysis 
8.4. Middle East and Africa (MEA)
8.4.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
8.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.4.3. Market Opportunity Analysis 
8.5. Latin America
8.5.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
8.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.5.3. Market Opportunity Analysis 
9. North America Biologics Testing Market ,2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
9.1. Product Type  Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.1.1.Instruments
9.1.2.Kits and Reagents
9.1.3.Services
9.2.  Application Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.2.1.Cellular and Gene related
9.2.2.Blood and Blood Products
9.2.3.Vaccines
9.2.4.Stem cell Research
9.2.5.Others
9.3.  Test Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.3.1.Sterility Test
9.3.2.Endotoxin Test
9.3.3.Cell Line Authentication and Characterization
9.3.4.Residual Host Contamination Test
9.3.5.Others
9.4.  Country Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.4.1.United States of America (USA)
9.4.2.Canada
10. Europe Biologics Testing Market ,2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
10.1. Product Type  Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.1.1.Instruments
10.1.2.Kits and Reagents
10.1.3.Services
10.2.  Application Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.2.1.Cellular and Gene related
10.2.2.Blood and Blood Products
10.2.3.Vaccines
10.2.4.Stem cell Research
10.2.5.Others
10.3.  Test Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.3.1.Sterility Test
10.3.2.Endotoxin Test
10.3.3.Cell Line Authentication and Characterization
10.3.4.Residual Host Contamination Test
10.3.5.Others
10.4.  Country Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.4.1.Germany
10.4.2.France
10.4.3.Italy
10.4.4.United Kingdom (UK)
10.4.5.Spain
10.4.6.Rest of EU
11. Asia Pacific (APAC) Biologics Testing Market ,2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
11.1. Product Type  Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.1.1.Instruments
11.1.2.Kits and Reagents
11.1.3.Services
11.2.  Application Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.2.1.Cellular and Gene related
11.2.2.Blood and Blood Products
11.2.3.Vaccines
11.2.4.Stem cell Research
11.2.5.Others
11.3.  Test Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.3.1.Sterility Test
11.3.2.Endotoxin Test
11.3.3.Cell Line Authentication and Characterization
11.3.4.Residual Host Contamination Test
11.3.5.Others
11.4.  Country Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.4.1.China
11.4.2.India
11.4.3.Australia and New Zealand (ANZ)
11.4.4.Japan
11.4.5.Rest of APAC
12. Middle East and Africa (MEA) Biologics Testing Market ,2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
12.1. Product Type  Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.1.1.Instruments
12.1.2.Kits and Reagents
12.1.3.Services
12.2.  Application Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.2.1.Cellular and Gene related
12.2.2.Blood and Blood Products
12.2.3.Vaccines
12.2.4.Stem cell Research
12.2.5.Others
12.3.  Test Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.3.1.Sterility Test
12.3.2.Endotoxin Test
12.3.3.Cell Line Authentication and Characterization
12.3.4.Residual Host Contamination Test
12.3.5.Others
12.4.  Country Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.4.1.GCC Countries
12.4.2.South Africa
12.4.3.Rest of MEA
13. Latin America Biologics Testing Market ,2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
13.1. Product Type  Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.1.1.Instruments
13.1.2.Kits and Reagents
13.1.3.Services
13.2.  Application Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.2.1.Cellular and Gene related
13.2.2.Blood and Blood Products
13.2.3.Vaccines
13.2.4.Stem cell Research
13.2.5.Others
13.3.  Test Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.3.1.Sterility Test
13.3.2.Endotoxin Test
13.3.3.Cell Line Authentication and Characterization
13.3.4.Residual Host Contamination Test
13.3.5.Others
13.4.  Country Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.4.1.Brazil
13.4.2.Mexico
13.4.3.Rest of LA
14. Competition Landscape
14.1.  Market Player Profiles (Introduction, Brand/Product Sales, Financial Analysis, Product Offerings, Key Developments, Collaborations, M & A, Strategies, and SWOT Analysis) 
14.2.1.Eurofins Scientific (Luxembourg)
14.2.2.Charles River Laboratories, Inc. (U.S.)
14.2.3.SGS S.A. (Switzerland)
14.2.4.Sartorius AG (Germany)
14.2.5.Cytovance Biologics, Inc. (U.S.)
14.2.6.Pace Analytical Services, LLC. (U.S.)
15. Research Methodology 
16. Appendix and Abbreviations 

Key Market Players

  • Eurofins Scientific (Luxembourg)
  • Charles River Laboratories, Inc. (U.S.)
  • SGS S.A. (Switzerland)
  • Sartorius AG (Germany)
  • Cytovance Biologics, Inc. (U.S.)
  • Pace Analytical Services, LLC. (U.S.)

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