Biologics Safety Testing Market Size to Cross USD 4.8 Billion by 2026
According to ARC, the global Biologics Safety Testing industry is likely to exceed revenue of $4.8 billion by 2026, jumping 11.7 percent during 2019 - 2026
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North America dominated the global biologics safety testing market in the year 2018. The region has experienced the potential growth owing to the presence of biologics safety testing companies such as Charles River Laboratories, Thermo Fisher Scientific Inc. and Cytovance Biologics, Inc. among others. The presence of a large customer base along with favorable reimbursement policies is additionally accelerating the regional market growth. Moreover, stringent government regulations regarding biologics and growing number of laboratories and clinic centers are expected to enhance the market growth in the global biologics safety testing market in future.
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) require all biopharmaceutical products and vaccines to undergo stringent testing to ensure the product is safe and free of contaminants. Growing prevalence of such chronic diseases further expected to rise the demand for biologics safety testing in North America. The Europe region is expected to exhibit a second-largest share in the biologics safety testing market. R&D Investments in Life Science and growing investment in healthcare industry, growing number of drug launches in countries, such as Germany, the UK, France, Spain, and Italy, are expected to enhance the market growth in the global biologics safety testing market during the forecast.
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Asia-Pacific region is expected to exhibit highest CAGR in the biologics safety testing market. The rapid growth in the urbanization, growing healthcare industry in developing countries, and liberalization of foreign direct investment in the healthcare sector are the major driving factor for the region in the global market. Moreover, the rising chronic diseases population and growing awareness regarding treatment options increases its dominance in the global Biologics safety testing market in future.
Growing demand for biologics safety testing in various applications, increase demand for new products and drugs in healthcare industry across the globe and rising number of pharmaceutical and biological firms are the main drivers for the market growth of the global biologics safety testing market over the forecast period. Furthermore, supportive government investment in life science and growing number of laboratory and research centers further grows the demand for biologics safety testing over the forecast the period. Moreover, technological advancement and increase in the number of applications, and availability of advanced healthcare facilities in developing countries are expected to enhance the market size. This also expected to open investment opportunities in the global market for the manufacturers in the coming years.
However, high costs of the research and development, stringent regulatory standards, time consuming approval process are expected to hamper the growth of the global biologics safety testing market during the forecast period.
Vaccine and therapeutic development segment have dominated the application segment in the year 2018 and the segment is projected to maintain its dominance over the forecast period from 2019 to 2026. The application segment further classified into vaccine and therapeutic development, blood and blood-related products testing, cellular and gene therapy, tissue and tissue-related products testing, and stem cell research. Several guidelines and recommendations issued by regulatory authorities and escalating demand for new drug launches further expected to drive the demand for the segment. The manufacturers ace Analytical Services Inc., Eurofins Scientific Se, Avance Biosciences Inc., and Source Bioscience are the mainly investing in the development of biologics safety testing for the vaccine and therapeutic development application, which expected the lead the market in the coming years.
Kits & Reagents segment dominated the biologics safety testing market on the basis of product type in the year 2018. The major factors that are driving the growth of this segment are growing demand for kits and reagents in test centers and laboratories and growing number of test centers and laboratories drives the consumption of kits & reagents across the globe. This expected to enhance the dominance of the Kits & Reagents in the global market over the forecast period.
Some of the leading competitors are Cytovance Biologics, Inc., Pace Analytical Services Inc., Eurofins Scientific Se, Avance Biosciences Inc., Source Bioscience, Toxikon Corporation, Charles River Laboratories, SGS SA, Lonza Group LTD, Merck KGaA, and WuXiApptec, Thermo Fisher Scientific Inc., Sartorius AG.
Some of the key observations regarding biologics safety testing industry include:
- In September 2018, Merck KGaA announced opening of new scientific laboratory in Singapore. This expansion of new laboratory focuses on developing new biologics and enhance customer base.
- In April 2018, Thermo Fisher Scientific Inc. launched new cloud-enabled biological safety cabinet. This product is designed to fortify workflow connectivity and contamination control and helped company to enhance its customer base in biologics safety testing market.
Market Segmentation
Market By Product Type
- Kits & Reagents
- Instruments
Market By Application
- Blood and Blood-related Products Testing
- Vaccine and Therapeutics Development
- Cellular and Gene Therapy
- Tissue and Tissue-related Products Testing
- Stem Cell Research
Market By Test Type
- Endotoxin Tests
- Sterility Tests
- Cell Line Authentication and Characterization Tests
- Residual Host Contamination Detection Tests
- Adventitious Agent Detection Tests
- Bioburden tests
- Other Tests
Market By Geography
- North America
- U.S.
- Canada
- Europe
- UK
- Germany
- France
- Spain
- Rest of Europe
- Asia-Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of Asia-Pacific
- Latin America
- Brazil
- Mexico
- Rest of Latin America
- Middle East & Africa
- GCC
- South Africa
- Rest of Middle East & Africa
Key Questions Answered in the Report
The report addresses key questions concerning the market evolution and overarching trends shaping global market growth. Some of the key questions answered in the report include-
- What is the overall structure of the market?
- What was the historical value and what is the forecasted value of the market?
- What are the key product level trends in the market?
- What are the market level trends in the market?
- Which of the market players are leading and what are their key differential strategies to retain their stronghold?
- Which are the most lucrative regions in the market space?
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TABLE OF CONTENT
CHAPTER 1. INDUSTRY OVERVIEW
1.1. Definition and Scope
1.1.1. Definition of Biologics Safety Testing
1.1.2. Market Segmentation
1.1.3. List of Abbreviations
1.2. Summary
1.2.1. Market Snapshot
1.2.2. Biologics Safety Testing Market By Application
1.2.2.1. Global Biologics Safety Testing Market Revenue and Growth Rate Comparison By Application (2015-2026)
1.2.2.2. Global Biologics Safety Testing Market Revenue Share By Application in 2017
1.2.2.3. Vaccine and Therapeutics Development
1.2.2.4. Blood and Blood-related Products Testing
1.2.2.5. Cellular and Gene Therapy
1.2.2.6. Tissue and Tissue-related Products Testing
1.2.2.7. Stem Cell Research
1.2.3. Biologics Safety Testing Market By Product Type
1.2.3.1. Global Biologics Safety Testing Market Revenue and Growth Rate Comparison By Product Type (2015-2026)
1.2.3.2. Global Biologics Safety Testing Market Revenue Share By Product Type in 2017
1.2.3.3. Kits & Reagents
1.2.3.4. Instruments
1.2.4. Biologics Safety Testing Market By Test Type
1.2.4.1. Global Biologics Safety Testing Market Revenue and Growth Rate Comparison By Test Type (2015-2026)
1.2.4.2. Global Biologics Safety Testing Market Revenue Share By Test Type in 2017
1.2.4.3. Sterility Tests
1.2.4.4. Endotoxin Tests
1.2.4.5. Cell Line Authentication and Characterization Tests
1.2.4.6. Residual Host Contamination Detection Tests
1.2.4.7. Adventitious Agent Detection Tests
1.2.4.8. Bioburden tests
1.2.4.9. Others
1.2.5. Biologics Safety Testing Market By Geography
1.2.5.1. Global Biologics Safety Testing Market Revenue and Growth Rate Comparison by Geography (2015-2026)
1.2.5.2. North America Biologics Safety Testing Market Revenue and Growth Rate (2015-2026)
1.2.5.3. Europe Biologics Safety Testing Market Revenue and Growth Rate (2015-2026)
1.2.5.4. Asia-Pacific Biologics Safety Testing Market Revenue and Growth Rate (2015-2026)
1.2.5.5. Latin America Biologics Safety Testing Market Revenue and Growth Rate (2015-2026)
1.2.5.6. Middle East and Africa (MEA) Biologics Safety Testing Market Revenue and Growth Rate (2015-2026)
CHAPTER 2. MARKET DYNAMICS AND COMPETITION ANALYSIS
2.1. Market Drivers
2.2. Restraints and Challenges
2.3. Growth Opportunities
2.4. Porter’s Five Forces Analysis
2.4.1. Bargaining Power of Suppliers
2.4.2. Bargaining Power of Buyers
2.4.3. Threat of Substitute
2.4.4. Threat of New Entrants
2.4.5. Degree of Competition
2.5. Value Chain Analysis
2.6. Cost Structure Analysis
2.6.1. Raw Material and Suppliers
2.6.2. Manufacturing Process Analysis
2.7. Regulatory Compliance
2.8. Competitive Landscape, 2017
2.8.1. Player Positioning Analysis
2.8.2. Key Strategies Adopted By Leading Players
CHAPTER 3. MANUFACTURING PLANTS ANALYSIS
3.1. Capacity and Commercial Production Date of Global Biologics Safety Testing Major Manufacturers in 2017
3.2. Manufacturing Plants Distribution of Global Biologics Safety Testing Major Manufacturers in 2017
3.3. R&D Status and Technology Source of Global Biologics Safety Testing Major Manufacturers in 2017
3.4. Raw Materials Sources Analysis of Global Biologics Safety Testing Major Manufacturers in 2017
CHAPTER 4. BIOLOGICS SAFETY TESTING MARKET BY APPLICATION
4.1. Global Biologics Safety Testing Revenue By Application
4.2. Vaccine and Therapeutics Development
4.2.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
4.2.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
4.3. Blood and Blood-related Products Testing
4.3.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
4.3.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
4.4. Cellular and Gene Therapy
4.4.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
4.4.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
4.5. Tissue and Tissue-related Products Testing
4.5.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
4.5.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
4.6. Stem Cell Research
4.6.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
4.6.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
CHAPTER 5. BIOLOGICS SAFETY TESTING MARKET BY PRODUCT TYPE
5.1. Global Biologics Safety Testing Revenue By Product Type
5.2. Kits & Reagents
5.2.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
5.2.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
5.3. Instruments
5.3.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
5.3.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
CHAPTER 6. BIOLOGICS SAFETY TESTING MARKET BY TEST TYPE
6.1. Global Biologics Safety Testing Revenue By Test Type
6.2. Sterility Tests
6.2.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
6.2.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
6.3. Endotoxin Tests
6.3.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
6.3.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
6.4. Cell Line Authentication and Characterization Tests
6.4.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
6.4.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
6.5. Residual Host Contamination Detection Tests
6.5.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
6.5.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
6.6. Adventitious Agent Detection Tests
6.6.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
6.6.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
6.7. Bioburden tests
6.7.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
6.7.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
6.8. Others
6.8.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
6.8.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
CHAPTER 7. NORTH AMERICA BIOLOGICS SAFETY TESTING MARKET BY COUNTRY
7.1. North America Biologics Safety Testing Market Revenue and Growth Rate, 2015 - 2026 ($Million)
7.2. North America Biologics Safety Testing Market Revenue Share Comparison, 2015 & 2026 (%)
7.3. U.S.
7.3.1. U.S. Biologics Safety Testing Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
7.3.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
7.3.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
7.4. Canada
7.4.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
7.4.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
7.4.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
CHAPTER 8. EUROPE BIOLOGICS SAFETY TESTING MARKET BY COUNTRY
8.1. Europe Biologics Safety Testing Market Revenue and Growth Rate, 2015 - 2026 ($Million)
8.2. Europe Biologics Safety Testing Market Revenue Share Comparison, 2015 & 2026 (%)
8.3. UK
8.3.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
8.3.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
8.3.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
8.4. Germany
8.4.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
8.4.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
8.4.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
8.5. France
8.5.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
8.5.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
8.5.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
8.6. Spain
8.6.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
8.6.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
8.6.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
8.7. Rest of Europe
8.7.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
8.7.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
8.7.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
CHAPTER 9. ASIA-PACIFIC BIOLOGICS SAFETY TESTING MARKET BY COUNTRY
9.1. Asia-Pacific Biologics Safety Testing Market Revenue and Growth Rate, 2015 - 2026 ($Million)
9.2. Asia-Pacific Biologics Safety Testing Market Revenue Share Comparison, 2015 & 2026 (%)
9.3. China
9.3.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
9.3.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
9.3.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
9.4. Japan
9.4.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
9.4.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
9.4.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
9.5. India
9.5.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
9.5.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
9.5.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
9.6. Australia
9.6.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
9.6.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
9.6.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
9.7. South Korea
9.7.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
9.7.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
9.7.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
9.8. Rest of Asia-Pacific
9.8.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
9.8.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
9.8.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
CHAPTER 10. LATIN AMERICA BIOLOGICS SAFETY TESTING MARKET BY COUNTRY
10.1. Latin America Biologics Safety Testing Market Revenue and Growth Rate, 2015 - 2026 ($Million)
10.2. Latin America Biologics Safety Testing Market Revenue Share Comparison, 2015 & 2026 (%)
10.3. Brazil
10.3.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
10.3.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
10.3.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
10.4. Mexico
10.4.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
10.4.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
10.4.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
10.5. Rest of Latin America
10.5.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
10.5.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
10.5.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
CHAPTER 11. MIDDLE EAST & AFRICA BIOLOGICS SAFETY TESTING MARKET BY COUNTRY
11.1. Middle East & Africa Biologics Safety Testing Market Revenue and Growth Rate, 2015 - 2026 ($Million)
11.2. Middle East & Africa Biologics Safety Testing Market Revenue Share Comparison, 2015 & 2026 (%)
11.3. GCC
11.3.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
11.3.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
11.3.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
11.4. Saudi Africa
11.4.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
11.4.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
11.4.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
11.5. Rest of Middle East & Africa
11.5.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
11.5.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
11.5.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
CHAPTER 12. COMPANY PROFILE
12.1. Charles River Laboratories
12.1.1. Company Snapshot
12.1.2. Overview
12.1.3. Financial Overview
12.1.4. Product Portfolio
12.1.5. Key Developments
12.1.6. Strategies
12.2. SGS SA
12.2.1. Company Snapshot
12.2.2. Overview
12.2.3. Financial Overview
12.2.4. Product Portfolio
12.2.5. Key Developments
12.2.6. Strategies
12.3. Lonza Group LTD
12.3.1. Company Snapshot
12.3.2. Overview
12.3.3. Financial Overview
12.3.4. Product Portfolio
12.3.5. Key Developments
12.3.6. Strategies
12.4. Merck KGaA
12.4.1. Company Snapshot
12.4.2. Overview
12.4.3. Financial Overview
12.4.4. Product Portfolio
12.4.5. Key Developments
12.4.6. Strategies
12.5. WuXi Apptec
12.5.1. Company Snapshot
12.5.2. Overview
12.5.3. Financial Overview
12.5.4. Product Portfolio
12.5.5. Key Developments
12.5.6. Strategies
12.6. Thermo Fisher Scientific Inc.
12.6.1. Company Snapshot
12.6.2. Overview
12.6.3. Financial Overview
12.6.4. Product Portfolio
12.6.5. Key Developments
12.6.6. Strategies
12.7. Sartorius AG
12.7.1. Company Snapshot
12.7.2. Overview
12.7.3. Financial Overview
12.7.4. Product Portfolio
12.7.5. Key Developments
12.7.6. Strategies
12.8. Cytovance Biologics, Inc.
12.8.1. Company Snapshot
12.8.2. Overview
12.8.3. Financial Overview
12.8.4. Product Portfolio
12.8.5. Key Developments
12.8.6. Strategies
12.9. Pace Analytical Services Inc.
12.9.1. Company Snapshot
12.9.2. Overview
12.9.3. Financial Overview
12.9.4. Product Portfolio
12.9.5. Key Developments
12.9.6. Strategies
12.10. Eurofins Scientific Se
12.10.1. Company Snapshot
12.10.2. Overview
12.10.3. Financial Overview
12.10.4. Product Portfolio
12.10.5. Key Developments
12.10.6. Strategies
12.11. Avance Biosciences Inc.
12.11.1. Company Snapshot
12.11.2. Overview
12.11.3. Financial Overview
12.11.4. Product Portfolio
12.11.5. Key Developments
12.11.6. Strategies
12.12. Source Bioscience
12.12.1. Company Snapshot
12.12.2. Overview
12.12.3. Financial Overview
12.12.4. Product Portfolio
12.12.5. Key Developments
12.12.6. Strategies
12.13. Toxikon Corporation
12.13.1. Company Snapshot
12.13.2. Overview
12.13.3. Financial Overview
12.13.4. Product Portfolio
12.13.5. Key Developments
12.13.6. Strategies
12.14. Others
12.14.1. Company Snapshot
12.14.2. Overview
12.14.3. Financial Overview
12.14.4. Product Portfolio
12.14.5. Key Developments
12.14.6. Strategies
CHAPTER 13. RESEARCH APPROACH
13.1. Research Methodology
13.1.1. Initial Data Search
13.1.2. Secondary Research
13.1.3. Primary Research
13.2. Assumptions and Scope
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