Biologics Safety Testing Market Research Report - Forecast till 2027

Biologics Safety Testing Market Report: By Product (Kits & Reagents, Instruments, Services), Test (Sterility, Endotoxin, Cell Line Authentication), Application (Vaccine Development, Blood Products, Stem Cell Research)— Forecast till 2027

ID: MRFR/LS/5336-HCR | February 2021 | Region: Global | 100 pages

Biologics Safety Testing Market Scenario:


The biologics safety testing market size is expected to grow significantly over the forecast period. The market held a market value of USD 2.79 billion in 2017 and is projected to register a CAGR of 13.6% over the forecast period. Biologics safety testing is required for all biopharmaceutical products and vaccines to ensure that the product is safe and free of contaminants. Recently, CDER approved 46 novel drugs in 2017, whereas 22 in 2016.

Factors such as the growth in pharmaceutical and biotechnology industries, the increase in a number of drug launches, and increasing R&D investments in life science are expected to propel the growth of the market. However, stringent government regulations for the approval of biosimilars and high cost of drug development are likely to hamper the market growth over the forecast period.

Segmentation:

The global biologics safety testing market has been segmented into product, test type, and application.

Based on product, the market is segmented into kits and reagents, services, and instruments. The kits and reagents segment accounted for the largest share of the market in 2017.

Based on test type, the market is segmented into sterility tests, endotoxin tests, cell line authentication and characterization tests, residual host contamination detection tests, adventitious agent detection tests, bioburden tests, and others.


Based on application, the market is segmented into vaccine and therapeutics development, blood and blood-related products testing, cellular and gene therapy, tissue and tissue-related products testing, and stem cell research.


The market has been segmented, by region, into the Americas, Europe, Asia-Pacific, and the Middle East and Africa. The market in the Americas has further been segmented into North America and South America, with the North American market divided into the US and Canada.


The European market has been segmented into Western Europe and Eastern Europe. Western Europe has further been classified as Germany, France, the UK, Italy, Spain, and the rest of Western Europe.


The market in Asia-Pacific has been segmented into Japan, China, India, South Korea, Australia, and the rest of Asia-Pacific. The market in the Middle East and Africa has been segmented into the Middle East and Africa.


Regional Market Summary


Global Biologics Safety Testing Market Share (%), by Region, 2017


Source: Annual Reports, Sec Filings, and Press Release


Geographically, the Americas is anticipated to dominate the global biologics safety testing market owing to a well-established player, new product launches, and increasing demand for biological products.


Europe is expected to hold the second largest position in the global market.


The biologics safety testing market in Asia-Pacific region consists of countries namely China, Japan, Republic of Korea, India, Australia and Rest of Asia-Pacific. The Asia-Pacific region is expected to be the fastest growing region owing to the growth in pharmaceutical and biotech industries.


The Middle East & Africa has the least share of the market. Majority of the market of this region is expected to be held by the Middle East region due to a well-developed healthcare sector.


Global Biologics Safety Testing Market, by Product



  • Kits & Reagents

  • Services

  • Instruments


Global Biologics Safety Testing Market, by Test Type



  • Sterility Tests

  • Endotoxin Tests

  • Cell Line Authentication and Characterization Tests

  • Residual Host Contamination Detection Tests

  • Adventitious Agent Detection Tests

  • Bioburden Tests

  • Others


Global Biologics Safety Testing Market, by Application



  • Vaccine and Therapeutics Development

  • Blood and Blood-Related Products Testing

  • Cellular and Gene Therapy

  • Tissue and Tissue-Related Products Testing

  • Stem Cell Research


Global Biologics Safety Testing Market, by Region



  • Americas

    • North America

      • US

      • Canada



    • South America



  • Europe

    • Western Europe

      • Germany

      • France

      • Italy

      • Spain

      • UK

      • Rest of Western Europe



    • Eastern Europe



  • Asia-Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Rest of Asia-Pacific



  • Middle East & Africa

    • Middle East

    • Africa




Key Players:



  • Merck KGaA

  • Charles River Laboratories

  • Sartorius AG

  • Lonza Group Ltd.

  • SGS S.A.

  • Thermo Fisher Scientific Inc

  • Wuxi Apptec

  • Cytovance Biologics, Inc.

  • Avance Biosciences Inc.

  • Eurofins Scientific


Intended Audience



  • Biologics safety testing products manufacturers and vendors

  • Various research and consulting firms

  • Biologics safety testing Distributors

  • Biologics safety testing services providers



Report Scope:
Report Attribute/Metric Details
  Market Size   Significant Value
  CAGR   13.6%
  Base Year   2019
  Forecast Period   2027
  Historical Data   2018
  Forecast Units   Value (USD Million)
  Report Coverage   Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
  Segments Covered   Product, Test Type, and Application
  Geographies Covered   North America, Europe, Asia-Pacific, and Rest of the World (RoW)
  Key Vendors   3D Systems Corporations, Stratasys Ltd., SLM Solutions Group AG, EnvisionTEC, Arcam AB, Organovo Holdings, Inc., Oxford Performance Materials, Inc., Materialise NV, Bio3D Technologies, Cyfuse Medical K.K.EOS GmbHConcept, Laser GmbH, Renishaw plc, Prodways Group, 3T RPD Ltd.
  Key Market Opportunities   Biologics safety testing products manufacturers
  Key Market Drivers

  • Increase in a number of drug launches
  • Increasing R&D investments in life science


  • Table of Contents:

    Chapter 1. Report Prologue

    Chapter 2. Market Introduction

    2.1 Definition

    2.2 Scope of the Study

    2.2.1 Research Objective

    2.2.2 Assumptions

    2.2.3 Limitations

    Chapter 3. Research Methodology

    3.1 Introduction

    3.2 Primary Research

    3.3 Secondary Research

    3.4 Market Size Estimation

    Chapter 4. Market Dynamics

    4.1 Drivers

    4.2 Restraints

    4.3 Opportunities

    4.4 Challenges

    4.5 Macroeconomic Indicators

    4.6 Technology Trends & Assessment

    Chapter 5. Market Factor Analysis

    5.1 Porter’s Five Forces Analysis

    5.1.1 Bargaining Power of Suppliers

    5.1.2 Bargaining Power of Buyers

    5.1.3 Threat of New Entrants

    5.1.4 Threat of Substitutes

    5.1.5 Intensity of Rivalry

    5.2 Value Chain Analysis

    5.3 Investment Feasibility Analysis

    5.4 Pricing Analysis

    Chapter 6. Global Biologics Safety Testing Market, by Product

    6.1 Introduction

    6.2 Kits & Reagents

    Market Estimates & Forecast, by Region, 2020-2027

    Market Estimates & Forecast, by Country, 2020-2027

    6.3 Services

    Market Estimates & Forecast, by Region, 2020-2027

    Market Estimates & Forecast, by Country, 2020-2027

    6.4 Instruments

    Market Estimates & Forecast, by Region, 2020-2027

    Market Estimates & Forecast, by Country, 2020-2027

    Chapter 7. Global Biologics Safety Testing Market, by Test Type

    7.1 Introduction

    7.2 Sterility Tests

    Market Estimates & Forecast, by Region, 2020-2027

    Market Estimates & Forecast, by Country, 2020-2027

    7.3 Endotoxin Tests

    Market Estimates & Forecast, by Region, 2020-2027

    Market Estimates & Forecast, by Country, 2020-2027

    7.4 Cell Line Authentication and Characterization Tests

    Market Estimates & Forecast, by Region, 2020-2027

    Market Estimates & Forecast, by Country, 2020-2027

    7.5 Residual Host Contamination Detection Tests

    Market Estimates & Forecast, by Region, 2020-2027

    Market Estimates & Forecast, by Country, 2020-2027

    7.6 Adventitious Agent Detection Tests

    Market Estimates & Forecast, by Region, 2020-2027

    Market Estimates & Forecast, by Country, 2020-2027

    7.7 Bioburden Tests

    Market Estimates & Forecast, by Region, 2020-2027

    Market Estimates & Forecast, by Country, 2020-2027

    7.8 Others

    Market Estimates & Forecast, by Region, 2020-2027

    Market Estimates & Forecast, by Country, 2020-2027

    Chapter 8. Global Biologics Safety Testing Market, by Application

    8.1 Introduction

    8.2 Vaccine And Therapeutics Development

    Market Estimates & Forecast, by Region, 2020-2027

    Market Estimates & Forecast, by Country, 2020-2027

    8.3 Blood and Blood-Related Products Testing

    Market Estimates & Forecast, by Region, 2020-2027

    Market Estimates & Forecast, by Country, 2020-2027

    8.4 Cellular and Gene Therapy

    Market Estimates & Forecast, by Region, 2020-2027

    Market Estimates & Forecast, by Country, 2020-2027

    8.5 Tissue and Tissue-Related Products Testing

    Market Estimates & Forecast, by Region, 2020-2027

    Market Estimates & Forecast, by Country, 2020-2027

    8.6 Stem Cell Research

    Market Estimates & Forecast, by Region, 2020-2027

    Market Estimates & Forecast, by Country, 2020-2027

    Chapter 9. Global Biologics Safety Testing Market, by Region

    9.1 Introduction

    9.2 Americas

    9.2.1 North America

    9.2.1.1 US

    9.2.1.2 Canada

    9.2.2 South America

    9.3 Europe

    9.3.1 Western Europe

    9.3.1.1 Germany

    9.3.1.2 France

    9.3.1.3 Italy

    9.3.1.4 Spain

    9.3.1.5 UK

    9.3.1.6 Rest of Western Europe

    9.3.2 Eastern Europe

    9.4 Asia-Pacific

    9.4.1 Japan

    9.4.2 China

    9.4.3 India

    9.4.4 Australia

    9.4.5 South Korea

    9.4.6 Rest of Asia-Pacific

    9.5 Middle East & Africa

    9.5.1 Middle East

    9.5.2 Africa

    Chapter 10. Company Landscape

    10.1 Introduction

    10.2 Market Share Analysis

    10.3 Key Development & Strategies

    Chapter 11. Company Profiles

    11.1 Merck KGaA

    11.1.1 Company Overview

    11.1.2 Product Overview

    11.1.3 Financials Overview

    11.1.4 Key Developments

    11.1.5 SWOT Analysis

    11.2 Charles River Laboratories

    11.2.1 Company Overview

    11.2.2 Product Overview

    11.2.3 Financial Overview

    11.2.4 Key Developments

    11.2.5 SWOT Analysis

    11.3 Sartorius AG

    11.3.1 Company Overview

    11.3.2 Product Overview

    11.3.3 Financial Overview

    11.3.4 Key Development

    11.3.5 SWOT Analysis

    11.4 Lonza Group Ltd.

    11.4.1 Company Overview

    11.4.2 Product Overview

    11.4.3 Financial Overview

    11.4.4 Key Development

    11.4.5 SWOT Analysis

    11.5 SGS S.A.

    11.5.1 Company Overview

    11.5.2 Product Overview

    11.5.3 Financial overview

    11.5.4 Key Developments

    11.5.5 SWOT Analysis

    11.6 Thermo Fisher Scientific Inc

    11.6.1 Company Overview

    11.6.2 Product Overview

    11.6.3 Financial Overview

    11.6.4 Key Developments

    11.6.5 SWOT Analysis

    11.7 Wuxi Apptec

    11.7.1 Overview

    11.7.2 Product Overview

    11.7.3 Financial Overview

    11.7.4 Key Developments

    11.7.5 SWOT Analysis

    11.8 Cytovance Biologics, Inc.

    11.8.1 Overview

    11.8.2 Product Overview

    11.8.3 Financials

    11.8.4 Key Developments

    11.8.5 SWOT Analysis

    11.9 Avance Biosciences Inc.

    11.9.1 Overview

    11.9.2 Product Overview

    11.9.3 Financials

    11.9.4 Key Developments

    11.9.5 SWOT Analysis

    11.10 Eurofins Scientific

    11.10.1 Overview

    11.10.2 Product Overview

    11.10.3 Financials

    11.10.4 Key Developments

    11.10.5 SWOT Analysis

    11.11 Others

    Chapter 12 MRFR Conclusion

    12.1 Key Findings

    12.1.1 From CEO’s Viewpoint

    12.1.2 Unmet Needs of the Market

    12.2 Key Companies to Watch

    12.3 Predictions for the Biologics Safety Testing Industry

    Chapter 13. Appendix

    LIST OF TABLES

    Table 1 Global Biologics Safety Testing Market Synopsis, 2020-2027

    Table 2 Global Biologics Safety Testing Market Estimates and Forecast, 2020-2027

    (USD Million)

    Table 3 Global Biologics Safety Testing Market, by Region, 2020-2027 (USD Million)

    Table 4 Global Biologics Safety Testing Market, by Product, 2020-2027 (USD Million)

    Table 5 Global Biologics Safety Testing Market, by Test Type, 2020-2027 (USD Million)

    Table 7 Global Biologics Safety Testing Market, by Application, 2020-2027 (USD Million)

    Table 8 North America: Biologics Safety Testing Market, by Product, 2020-2027 (USD Million)

    Table 9 North America: Biologics Safety Testing Market, by Test Type, 2020-2027 (USD Million)

    Table 10 North America: Biologics Safety Testing Market, by Application, 2020-2027

    (USD Million)

    Table 11 US: Biologics Safety Testing Market, by Product, 2020-2027

    (USD Million)

    Table 12 US: Biologics Safety Testing Market, by Test Type, 2020-2027

    (USD Million)

    Table 13 US: Biologics Safety Testing Market, by Application, 2020-2027 (USD Million)

    Table 14 Canada: Biologics Safety Testing Market, by Product, 2020-2027 (USD

    Million)

    Table 15 Canada: Biologics Safety Testing Market, by Test Type, 2020-2027 (USD

    Million)

    Table 16 Canada: Biologics Safety Testing Market, by Application, 2020-2027 (USD

    Million)

    Table 17 South America: Biologics Safety Testing Market, by Product, 2020-2027

    (USD Million)

    Table 18 South America: Biologics Safety Testing Market, by Test Type, 2020-2027

    (USD Million)

    Table 19 South America: Biologics Safety Testing Market, by Application, 2020-2027

    (USD Million)

    Table 20 Europe: Biologics Safety Testing Market, by Product, 2020-2027 (USD

    Million)

    Table 21 Europe: Biologics Safety Testing Market, by Test Type, 2020-2027 (USD

    Million)

    Table 22 Europe: Biologics Safety Testing Market, by Application, 2020-2027 (USD

    Million)

    Table 23 Western Europe: Biologics Safety Testing Market, by Product, 2018–

    2023 (USD Million)

    Table 24 Western Europe: Biologics Safety Testing Market, by Test Type, 2018–

    2023 (USD Million)

    Table 25 Western Europe: Biologics Safety Testing Market, by Application, 2020-2027

    (USD Million)

    Table 26 Eastern Europe: Biologics Safety Testing Market, by Product, 2018–

    2023 (USD Million)

    Table 27 Eastern Europe: Biologics Safety Testing Market, by Test Type, 2020-2027

    (USD Million)

    Table 28 Eastern Europe: Biologics Safety Testing Market, by Application, 2020-2027

    (USD Million)

    Table 29 Asia-Pacific: Biologics Safety Testing Market, by Product, 2020-2027

    (USD Million)

    Table 30 Asia-Pacific: Biologics Safety Testing Market, by Test Type, 2020-2027

    (USD Million)

    Table 31 Asia-Pacific: Biologics Safety Testing Market, by Application, 2020-2027 (USD

    Million)

    Table 32 Middle East & Africa: Biologics Safety Testing Market, by Product,

    2020-2027 (USD Million)

    Table 33 Middle East & Africa: Biologics Safety Testing Market, by Test Type, 2018–

    2023 (USD Million)

    Table 34 Middle East & Africa: Biologics Safety Testing Market, by Application, 2018–

    2023 (USD Million)

    LIST OF FIGURES

    Figure 1 Research Process

    Figure 2 Segmentation for Global Biologics Safety Testing Market

    Figure 3 Segmentation Market Dynamics for Global Biologics Safety Testing Market

    Figure 4 Global Biologics Safety Testing Market Share, by Product, 2020

    Figure 5 Global Biologics Safety Testing Market Share, by Test Type, 2020

    Figure 6 Global Biologics Safety Testing Market Share, by Application, 2020

    Figure 7 Global Biologics Safety Testing Market Share, by Region, 2020

    Figure 8 North America: Biologics Safety Testing Market Share, by Country, 2020

    Figure 9 Europe: Biologics Safety Testing Market Share, by Country, 2020

    Figure 10 Asia-Pacific: Biologics Safety Testing Market Share, by Country, 2020

    Figure 11 Middle East & Africa: Biologics Safety Testing Market Share, by Country, 201

    Figure 12 Global Biologics Safety Testing Market: Company Share Analysis, 2020 (%)

    Figure 13 Merck KGaA: Key Financials

    Figure 14 Merck KGaA: Segmental Revenue

    Figure 15 Merck KGaA: Geographical Revenue

    Figure 16 Charles River Laboratories: Key Financials

    Figure 17 Charles River Laboratories: Segmental Revenue

    Figure 18 Charles River Laboratories: Geographical Revenue

    Figure 19 Sartorius AG: Key Financials

    Figure 20 Sartorius AG: Segmental Revenue

    Figure 21 Sartorius AG: Geographical Revenue

    Figure 22 Lonza Group Ltd.: Key Financials

    Figure 23 Lonza Group Ltd.: Segmental Revenue

    Figure 24 Lonza Group Ltd.: Geographical Revenue

    Figure 25 SGS S.A.: Key Financials

    Figure 26 SGS S.A.: Segmental Revenue

    Figure 27 SGS S.A.: Geographical Revenue

    Figure 28 Thermo Fisher Scientific Inc: Key Financials

    Figure 29 Thermo Fisher Scientific Inc.: Segmental Revenue

    Figure 30 Thermo Fisher Scientific Inc.: Geographical Revenue

    Figure 31 Wuxi Apptec: Key Financials

    Figure 32 Wuxi Apptec: Segmental Revenue

    Figure 33 Wuxi Apptec: Geographical Revenue

    Figure 34 Cytovance Biologics, Inc.: Key Financials

    Figure 35 Cytovance Biologics, Inc.: Segmental Revenue

    Figure 36 Cytovance Biologics, Inc.: Geographical Revenue

    Figure 37 Avance Biosciences Inc: Key Financials

    Figure 38 Avance Biosciences Inc: Segmental Revenue

    Figure 39 Avance Biosciences Inc: Geographical Revenue

    Figure 40 Eurofins Scientific: Key Financials

    Figure 41 Eurofins Scientific: Segmental Revenue

    Figure 42 Eurofins Scientific: Geographical Revenue