Table of Contents

1 Introduction (Page No. - 13)
    1.1 Objectives of the Study
    1.2 Market Definition
           1.2.1 Markets Covered
           1.2.2 Years Considered for the Study
    1.3 Currency
    1.4 Limitations
    1.5 Stakeholders

2 Research Methodology (Page No. - 16)
    2.1 Research Approach
    2.2 Research Data
           2.2.1 Secondary Sources
                    2.2.1.1 Key Data From Secondary Sources
           2.2.2 Primary Sources
                    2.2.2.1 Key Data From Primary Sources
                    2.2.2.2 Breakdown of Primary Interviews
    2.3 Market Size Estimation
    2.4 Market Breakdown and Data Triangulation
    2.5 Research Assumptions

3 Executive Summary (Page No. - 23)

4 Biologics Safety Testing Market: Premium Insights (Page No. - 27)
    4.1 Biologics Safety Testing: Market Overview
    4.2 Geographic Analysis: By Product & Service (2017)
    4.3 Geographic Snapshot of the Global Market
    4.4 Global Market, By Application 2017 vs 2022

5 Market Overview (Page No. - 31)
    5.1 Introduction
    5.2 Market Dynamics
           5.2.1 Drivers
                    5.2.1.1 Growth in Pharmaceutical and Biotechnology Industries Driven By Government Support
                    5.2.1.2 Positive Trend of R&D Investments in Life Science
                    5.2.1.3 Increase in Number of Drug Launches
                    5.2.1.4 High Incidence and Large Economic Burden of Chronic Diseases
           5.2.2 Opportunities
                    5.2.2.1 Emerging Markets
                    5.2.2.2 Increasing Pharmaceutical Outsourcing
           5.2.3 Challenge
                    5.2.3.1 Dearth of Skilled Professionals

6 Biologics Safety Testing Market, By Product and Service (Page No. - 36)
    6.1 Introduction
    6.2 Kits & Reagents
    6.3 Services
    6.4 Instruments

7 Biologics Safety Testing Market, By Test Type (Page No. - 40)
    7.1 Introduction
    7.2 Endotoxin Tests
    7.3 Sterility Tests
    7.4 Cell Line Authentication and Characterization Tests
    7.5 Bioburden Tests
    7.6 Residual Host Contaminant Detection Tests
    7.7 Adventitious Agent Detection Tests
    7.8 Other Tests

8 Biologics Safety Testing Market, By Application (Page No. - 47)
    8.1 Introduction
    8.2 Vaccine & Therapeutics Development
    8.3 Blood and Blood-Related Products Testing
    8.4 Cellular and Gene Therapy
    8.5 Tissue and Tissue-Related Products Testing
    8.6 Stem Cell Research

9 Biologics Safety Testing Market, By Region (Page No. - 53)
    9.1 Introduction
    9.2 North America
           9.2.1 U.S.
           9.2.2 Canada
    9.3 Europe
           9.3.1 Germany
           9.3.2 U.K.
           9.3.3 France
           9.3.4 Italy
           9.3.5 Spain
           9.3.6 Rest of Europe (RoE)
    9.4 Asia
           9.4.1 China
           9.4.2 Japan
           9.4.3 India
           9.4.4 Rest of Asia
    9.5 Rest of the World
           9.5.1 South America, Central America, and the Caribbean
           9.5.2 Pacific and Oceania
           9.5.3 Africa

10 Competitive Landscape (Page No. - 91)
     10.1 Overview
             10.1.1 Visionary Leaders
             10.1.2 Innovators
             10.1.3 Dynamic Differentiators
             10.1.4 Emerging Companies
     10.2 Competitive Benchmarking
             10.2.1 Strength of Product Portfolio
             10.2.2 Business Strategy Excellence
     10.3 Market Share Analysis

*Top 25 Companies Analyzed for This Studies are - Sartorius AG (Germany), SGS SA (Switzerland), Thermo Fisher Scientific, Inc. (U.S.), Lonza Group Ltd (Switzerland), Charles River Laboratories, Inc. (U.S.), Merck KGaA (Germany), Eurofins Scientific  Se (Luxembourg), Source Bioscience (U.K.), F. Hoffmann-La Roche Ltd. (Switzerland), Cytovance Biologics (U.S.), Toxikon Corporation (U.S.), Avance Biosciences Inc. (U.S.), Pace Analytical Services LLC. (U.S.), Wuxi Apptec (China), Biomérieux Sa (France), Sterigenics International LLC (U.S.), Clean Cells (France), Bsl Bioservice Scientific Laboratories Munich GmbH (Germany), North American Science Associates Inc. (U.S.), Promocell GmbH (Germany), Genscript (China), Gibraltar Laboratories (U.S.), Invivogen (U.S.), Neopharm Labs Inc. (Canada), Virusure GmbH (Austria)

11 Company Profiles (Page No. - 97)
(Overview, Products Offered, Product Offering Scorecard, Business Strategy Scorecard, Recent Developments)*
     11.1 Charles River Laboratories International, Inc.
     11.2 Merck KGaA
     11.3 Lonza Group Ltd.
     11.4 SGS S.A.
     11.5 Thermo Fisher Scientific Inc.
     11.6 Wuxi Apptec
     11.7 Sartorius AG
     11.8 Cytovance Biologics, Inc.
     11.9 Pace Analytical Services Inc.
     11.10 Toxikon Corporation
     11.11 Eurofins Scientific Se
     11.12 Avance Biosciences Inc.
     11.13 Source Bioscience

*Details on Marketsandmarkets View, Overview, Products Offered, Product Offering Scorecard, Business Strategy Scorecard, and Recent Developments Might Not Be Captured in Case of Unlisted Companies.

12 Appendix (Page No. - 131)
     12.1 Insights of Industry Experts
     12.2 Discussion Guide
     12.3 Knowledge Store: Marketsandmarkets¡¯ Subscription Portal
     12.4 Introducing RT: Real-Time Market Intelligence
     12.5 Available Customizations
     12.6 Related Reports
     12.7 Author Details

List of Tables (66 Tables)

Table 1 Biologics Safety Testing Market Summary
Table 2 Market, By Product and Service, 2015–2022 (USD Million)
Table 3 Biologics Safety Testing Kits and Reagents Market, By Region, 2015–2022 (USD Million)
Table 4 Biologics Safety Testing Services Market, By Region, 2015–2022 (USD Million)
Table 5 Biologics Safety Testing Instruments Market, By Region, 2015–2022 (USD Million)
Table 6 Market Size, By Test Type, 2015–2022 (USD Million)
Table 7 Endotoxin Tests Market, By Region, 2015–2022 (USD Million)
Table 8 Sterility Tests Market, By Region, 2015–2022 (USD Million)
Table 9 Cell Line Authentication and Characterization Tests Market, By Region, 2015–2022 (USD Million)
Table 10 Bioburden Tests Market, By Region, 2015–2022 (USD Million)
Table 11 Residual Host Contaminant Detection Tests Market, By Region, 2015–2022 (USD Million)
Table 12 Adventitious Agent Detection Tests Market, By Region, 2015–2022 (USD Million)
Table 13 Other Biologics Safety Tests Market, By Region, 2015–2022 (USD Million)
Table 14 Biologics Safety Testing Market, By Application, 2015–2022 (USD Million)
Table 15 Market for Vaccine and Therapeutics Development, By Region, 2015–2022 (USD Million)
Table 16 Market for Blood and Blood-Related Products Testing, By Region, 2015–2022 (USD Million)
Table 17 Market for Cellular and Gene Therapy Products, By Region, 2015–2022 (USD Million)
Table 18 Market for Tissue and Tissue-Related Products Testing, By Region, 2015–2022 (USD Million)
Table 19 Market for Stem Cell Research, By Region, 2015–2022 (USD Million)
Table 20 Market, By Region, 2015–2022 (USD Million)
Table 21 North America: Biologics Safety Testing Market, By Country, 2015–2022 (USD Million)
Table 22 North America: Market, By Application, 2015–2022 (USD Million)
Table 23 North America: Market, By Product & Service, 2015–2022 (USD Million)
Table 24 North America: Market, By Test Type, 2015–2022 (USD Million)
Table 25 U.S.: Market, By Application, 2015–2022 (USD Million)
Table 26 U.S.: Market, By Product & Service, 2015–2022 (USD Million)
Table 27 Canada: Biologics Safety Testing Market, By Application, 2015–2022 (USD Million)
Table 28 Canada: Market, By Product & Service, 2015–2022 (USD Million)
Table 29 Europe: Market, By Country, 2015–2022 (USD Million)
Table 30 Europe: Market, By Application, 2015–2022 (USD Million)
Table 31 Europe: Market, By Product & Service, 2015–2022 (USD Million)
Table 32 Europe: Market, By Test Type, 2015–2022 (USD Million)
Table 33 Germany: Biologics Safety Testing Market, By Application, 2015–2022 (USD Million)
Table 34 Germany: Market, By Product & Service, 2015–2022 (USD Million)
Table 35 U.K.: Market, By Application, 2015–2022 (USD Million)
Table 36 U.K.: Market, By Product & Service, 2015–2022 (USD Million)
Table 37 France: Biologics Safety Testing Market, By Application, 2015–2022 (USD Million)
Table 38 France: Market, By Product & Service, 2015–2022 (USD Million)
Table 39 Italy: Market, By Application, 2015–2022 (USD Million)
Table 40 Italy: Market, By Product & Service, 2015–2022 (USD Million)
Table 41 Spain: Market, By Application, 2015–2022 (USD Million)
Table 42 Spain: Market, By Product & Service, 2015–2022 (USD Million)
Table 43 RoE: Biologics Safety Testing Market, By Application, 2015–2022 (USD Million)
Table 44 RoE: Market, By Product & Service, 2015–2022 (USD Million)
Table 45 Asia: Market, By Country, 2015–2022 (USD Million)
Table 46 Asia: Market, By Application, 2015–2022 (USD Million)
Table 47 Asia: Market, By Product & Service, 2015–2022 (USD Million)
Table 48 Asia: Market, By Test Type, 2015–2022 (USD Million)
Table 49 China: Biologics Safety Testing Market, By Application, 2015–2022 (USD Million)
Table 50 China: Market, By Product & Service, 2015–2022 (USD Million)
Table 51 Japan: Market, By Application, 2015–2022 (USD Million)
Table 52 Japan: Market, By Product & Service, 2015–2022 (USD Million)
Table 53 India: Biologics Safety Testing Market, By Application, 2015–2022 (USD Million)
Table 54 India: Market, By Product & Service, 2015–2022 (USD Million)
Table 55 Rest of Asia: Market, By Application, 2015–2022 (USD Million)
Table 56 Rest of Asia: Market, By Product & Service, 2015–2022 (USD Million)
Table 57 RoW: Biologics Safety Testing Market, By Region, 2015–2022 (USD Million)
Table 58 RoW: Market, By Application, 2015–2022 (USD Million)
Table 59 RoW: Market, By Product & Service, 2015–2022 (USD Million)
Table 60 RoW: Market, By Test Type, 2015–2022 (USD Million)
Table 61 South America, Central America, & the Caribbean: Market, By Application, 2015–2022 (USD Million)
Table 62 South America, Central America, & the Caribbean: Market, By Product & Service, 2015–2022 (USD Million)
Table 63 Pacific and Oceania: Biologics Safety Testing Market, By Application, 2015–2022 (USD Million)
Table 64 Pacific and Oceania: Market, By Product & Service, 2015–2022 (USD Million)
Table 65 Africa: Market, By Application, 2015–2022 (USD Million)
Table 66 Africa: Market, By Product & Service, 2015–2022 (USD Million)

List of Figures (35 Figures)

Figure 1 Research Design
Figure 2 Breakdown of Primary Interviews: By Company Type, Designation, and Region
Figure 3 Market Size Estimation Methodology: Bottom-Up Approach
Figure 4 Market Size Estimation Methodology: Top-Down Approach
Figure 5 Data Triangulation Methodology
Figure 6 Biologics Safety Testing Market Size, By Product & Service, 2017 vs 2022 (USD Million)
Figure 7 Global Market Size, By Application, 2017 vs 2022 (USD Million)
Figure 8 Global Market Size, By Test Type, 2017 vs 2022 (USD Million)
Figure 9 Global Market Size, By Region, 2017 vs 2022 (USD Million)
Figure 10 Global Market to Register A High, Double-Digit Growth Rate in the Forecast Period
Figure 11 Kits & Reagents Segment to Dominate the Biologics Safety Testing Market in 2017
Figure 12 Asia to Register the Highest CAGR During the Forecast Period
Figure 13 Vaccine and Therapeutics Development Will Continue to Dominate the Global Market 2022
Figure 14 Global Market: Drivers, Restraints, Opportunities, & Challenges
Figure 15 Kits & Reagents Segment to Dominate the Market During the Forecast Period
Figure 16 Endotoxin Tests Segment to Dominate the Global Market During the Forecast Period
Figure 17 Vaccine & Therapeutics Development to Dominate the Biologics Safety Testing Market During the Forecast Period
Figure 18 North America to Dominate the Global Market in 2017
Figure 19 Asia to Register the Highest CAGR During the Forecast Period (2017–2022)
Figure 20 U.S. to Witness the Highest Growth Rate in the North American Global Market During the Forecast Period (2017–2022)
Figure 21 North America: Market Snapshot
Figure 22 Germany to Witness the Highest Growth Rate in the European Market During the Forecast Period (2017–2022)
Figure 23 Asia: Market, By Country (2017)
Figure 24 Asia: Market Snapshot
Figure 25 Rest of the World: Market, By Region (2017)
Figure 26 Market (Global) Competitive Leadership Mapping, 2017
Figure 27 Market: Market Share (2016)
Figure 28 Charles River Laboratories International, Inc.: Company Snapshot (2016)
Figure 29 Merck KGaA: Company Snapshot (2016)
Figure 30 Lonza Group Ltd.: Company Snapshot (2016)
Figure 31 SGS S.A.: Company Snapshot (2016)
Figure 32 Thermo Fisher Scientific Inc.: Company Snapshot (2016)
Figure 33 Sartorius AG: Company Snapshot (2016)
Figure 34 Eurofins Scientific Se: Company Snapshot (2016)
Figure 35 Source Bioscience: Company Snapshot (2015)

Title: Biologics Safety Testing Market by Product (Instruments, Services, Kits & Reagents), Test (Endotoxin, Sterility Test, Cell Line Authentication, Bioburden), Application (Vaccine Development, Blood Products, Stem Cell Research) - Global Forecast to 2022

 The biologics safety testing market was valued at USD 2.75 Billion in 2017 and is expected to grow at a CAGR of 12.2% to reach USD 4.90 Billion in 2022.

Years considered in this report

2016 – Base Year
2017 – Estimated Year
2022 – Projected Year

Selected Market Dynamics in Biologics Safety Testing Market

Increase in number of drug launches

A rapid growth in the number of product launches in the pharmaceutical industry is indicative of a strong product pipeline. The number of biologics launched annually has witnessed a strong upward trend between 2003 and 2013. According to National Center for Biotechnology Information (NCBI) the number of products launched increased from 29 in 2003 to 56 in 2013. According to the Center for Drug Evaluation and Research (CDER), on an average, about 30 novel drugs received approval each year between 2007 and 2015.

Furthermore, the patent cliff is driving pharmaceutical companies to develop new products. This patient cliff helps industry to create entry for smaller companies to the generics market.

High incidence and large economic burden of chronic diseases

Over the years, the prevalence of chronic diseases such as cancer, diabetes, and cardiovascular diseases (CVDs) has rapidly increased. According to International Diabetes Federation (IDF) Diabetes Atlas, the number of patients who have diabetes was estimated at 366 million in 2011, worldwide. This figure is expected to grow to almost 552 million by 2030. Furthermore, the prevalence of cancer and CVDs has risen across the globe. According to GLOBOCAN, around 14.1 million new cancer cases and 8.2 million cancer-related deaths were recorded globally in 2012. The International Agency for Research on Cancer (ICRA) and the WHO have estimated that by 2025, around 19.3 million new cancer cases will be diagnosed per year. This significant growth in the number of new cancer cases can primarily be attributed to the rapid growth in the geriatric population and changing lifestyles.

According to the American Heart Association (AHA), the prevalence of CVDs in the U.S. is projected to reach 40.5% of the total population by 2030 from 37.8% in 2015. The rise in the prevalence of these diseases will increase the demand for biologics such as, vaccines, blood and blood products. This, in turn, aids the growth of the biologics safety testing market.

The objectives of this study are as follows:

• To define, describe, and forecast the global market on the basis of product & service, test type, application,  and region
• To provide detailed information regarding the major factors influencing growth of the market (drivers, opportunities and challenges)
• To strategically analyze micromarkets with respect to individual growth trends, prospects, and contributions to the overall market
• To analyze the opportunities in the market for stakeholders and provide details of a competitive landscape for market leaders
• To forecast revenue of the market segments with respect to four main regional segments, namely, North America, Europe, Asia, and the Rest of the World (RoW)
• To profile key players and comprehensively analyze their market shares and core competencies in terms of market development and growth strategies
• To track and analyze competitive developments such as agreements, collaborations, and partnerships; acquisitions; expansion; and product & service launches in the global market

Research Methodology

Top-down and bottom-up approaches were used to estimate and validate the size of the biologics safety testing market and to estimate the size of various other dependent submarkets. The overall market size was used in the top-down approach to estimate the sizes of other individual markets (mentioned in the market segmentation—by product & service, test type, application, and region) through percentage splits from secondary and primary research. The bottom-up approach was also implemented (wherever applicable) for data extracted from secondary research to validate the market segment revenues obtained. Various secondary sources referred to for this research study including publications from the World Bank, World Health Organization, Centers for Disease Control and Prevention (CDC), America Society for Microbiology, World Intellectual Property Organization (WIPO) European Federation of Biotechnology, and India Brand Equity Foundation (IBEF); corporate filings such as annual reports, SEC filings, investor presentations, and financial statements have been used to identify and collect information useful for this extensive commercial study of the market. Primary sources such as experts from related industries and suppliers have been interviewed to obtain and verify critical information as well as to assess prospects of the global market. The breakdown of profiles of primaries is shown in the figure below:

To know about the assumptions considered for the study, download the pdf brochure

Key players operating in the biologics safety testing market include Lonza Group LTD. (Switzerland), Charles River Laboratories (U.S.), Merck KGaA (Germany), SGS SA (Switzerland), WuXi Apptec (China), Thermo Fisher Scientific Inc. (U.S.), Sartorius AG (Germany), Cytovance Biologics, Inc. (U.S.), Pace Analytical Services Inc. (U.S.), and Toxikon Corporation (U.S.).

Stakeholders for this report include:

• Biologics safety testing manufacturers and vendors
• Association related to pharmaceutical and biotechnology research
• Distributors of biologics safety testing
• Various research and consulting companies
• Research institutes and contact research organizations (CROs)

Value Addition for the Buyer:

This report aims to provide insights into the global biologics safety testing market. It provides valuable information on market by product & service, test type, applications, end users, and regions. Details of the regional markets for these segments are also presented in this report. In addition, leading players in the market are profiled to understand the strategies undertaken by them to be competitive in this market.

Scope of the Report:

This report categorizes the biologics safety testing market into the following segments:

By Product & Service

• Kits & Reagents
• Services
• Instruments

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

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

By Region

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia
  • China
  • Japan
  • India
  • Rest of Asia (RoA)
• Rest of the World (RoW)
  • South America, Central America, and The Caribbean
  • Pacific and Oceania
  • Africa

Customization Options:

• Detailed analysis and profiling of additional market players (up to 5)

Biologics safety testing is a mandatory process in pharmaceutical and biotechnological companies. It is used as a quality control measure for the drug development process. The biologics safety testing market is expected to reach USD 4.90 Billion by 2022 from USD 2.75 Billion in 2017, at a CAGR of 12.2% from 2017 to 2022. Growth in pharmaceutical and biotechnology industry driven by government support in both industries, the positive trend of R&D investment in the life sciences industry and an increase in the number of new drug launches are the major factors driving the growth of this market.

On the basis of products and services, the global market is segmented into kits & reagents, services, and instruments. The kits & reagents segment accounted for the largest share of the products segment. This growth can be attributed to the regular and repeated purchase of kits & reagents as compared to instruments.

On the basis of applications, the global 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 vaccine and therapeutics development segment holds the largest share in the market. The growth of this segment is primarily attributed to the increase in initiatives for immunization, increase company investment in Vaccines development and the rising prevalence of diseases.

By region, the global biologics safety testing market is segmented into North America, Europe, Asia, and the Rest of the World (RoW). While North America holds the largest share of the market in 2016 followed by Europe, Asia is expected to grow at the highest CAGR during the forecast period. The presence of emerging economies like China and India; large population; growth in pharmaceutical and biotechnology industry; and growth in the outsourcing industry in this region are key factors driving the high growth of this regional segment.

The top four players in this market are Lonza Group LTD. (Switzerland), Charles River Laboratories (U.S.), Merck KGaA (Germany) and SGS SA (Switzerland) are. These companies have a broad product & service portfolio with comprehensive features and have a strong geographical presence.