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
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
- North America
- Europe
- Western Europe
- Germany
- France
- Italy
- Spain
- UK
- Rest of Western Europe
- Eastern Europe
- Western 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
