Biologics Safety Testing Market Research Report - Global Forecast till 2027

Global 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)—Global Forecast till 2027

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

Please note that the assessment period of report has been updated from 2018–2023 to 2020-2027. Cordially fill the sample form for updated data.

Market Scenario:


The global biologics safety testing market 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 biologics safety testing 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 biologics safety testing 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 biologics safety testing market in Asia-Pacific has been segmented into Japan, China, India, South Korea, Australia, and the rest of Asia-Pacific. The biologics safety testing market in the Middle East and Africa has been segmented into the Middle East and 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., and Eurofins Scientific are some of the key players in the global biologics safety testing market.


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 biologics safety testing 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




Global Biologics Safety Testing Market, by 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



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