The imminent patent expiration of many biopharmaceutical products can turn out the possibility for generic versions of these therapeutic agents (i.e. biosimilar). However, there are variety of problems that will build approval of biosimilar rather more complicated than the approval of generic equivalents of standard prescribed drugs. These problems center on the intrinsic quality of biopharmaceutical agents, which area unit recombinant proteins in most cases, and the no uniformity of proteins made by completely different manufacturing processes (i.e. variations in host cells, purification and process, formulation and packaging). Major factors driveling by the increasing incorporation of biologics into the healthcare sector’s operations in recent years. Growing realization of the efficacy of biologics in treating stubborn conditions such as rheumatoid arthritis, diabetes, and cancer is likely to drive the global biologics market over the forecast period. Biologics have been shown to be both more effective and safer in medical applications than conventional medicine, leading to their growing usage in the global healthcare sector. Global Biologics Market Size is expected to reach a valuation of USD 285,525 million by the end of the forecast period from 2019 to 2027 with 7% CAGR over the forecast period.
Market Insights
The global Biologics Development and Manufacturing Testing market is expected to be around US$ 8 Billion by 2028, at a CAGR of 14% in the given forecast period.
The global Biologics Development and Manufacturing Testing market is segregated on the basis of Test Objective as Cell Processing, Cell Preservation, Distribution, and Handling, and Process Monitoring and Quality Control. Based on Test Application the global Biologics Development and Manufacturing Testing market is segmented in Market Breakdown by Test Application, Endotoxin Testing, Sterility Testing, Adventitious Agent Detection, Bioburden Testing, and Residual Host Contaminant (Host Cell Protein) Detection Testing. Based on Test Technology the global Biologics Development and Manufacturing Testing market is segmented in In Vivo Safety Testing, Toxicity-LD50 Test, Mutagenicity and Carcinogenicity, Toxic kinetics and ADME, Metabolic Toxicity, Pyrogenic Testing, Embryo toxicity, Endocrine Disruptors, Toxic genomics, and Cell Analysis.
The global Biologics Development and Manufacturing Testing market report provides geographic analysis covering regions, such as North America, Europe, Asia-Pacific, and Rest of the World. The Biologics Development and Manufacturing Testing market for each region is further segmented for major countries including the U.S., Canada, Germany, the U.K., France, Italy, China, India, Japan, Brazil, South Africa, and others.
Competitive Rivalry
Admecell Inc., American Type Culture Collection (ATCC), Catalent Inc., Charles River Laboratories, Covance, Eurofins Scientific, Intertek Group PLC, Sekisui XenoTech LLC, Selexis SA, SGS S.A. Corp., and others are among the major players in the global Biologics Development and Manufacturing Testing market. The companies are involved in several growth and expansion strategies to gain a competitive advantage. Industry participants also follow value chain integration with business operations in multiple stages of the value chain.
The Biologics Development and Manufacturing Testing Market has been segmented as below:
Biologics Development and Manufacturing Testing Market, By Test Objective
Biologics Development and Manufacturing Testing Market, By Test Application
Biologics Development and Manufacturing Testing Market, By Test Technology
Biologics Development and Manufacturing Testing Market, By Region
Biologics Development and Manufacturing Testing Market, By Company
The report covers:
Report Scope:
The global Biologics Development and Manufacturing Testing market report scope includes detailed study covering underlying factors influencing the industry trends.
The report covers analysis on regional and country level market dynamics. The scope also covers competitive overview providing company market shares along with company profiles for major revenue contributing companies.
The report scope includes detailed competitive outlook covering market shares and profiles key participants in the global Biologics Development and Manufacturing Testing market share. Major industry players with significant revenue share include Admecell Inc., American Type Culture Collection (ATCC), Catalent Inc., Charles River Laboratories, Covance, Eurofins Scientific, Intertek Group PLC, Sekisui XenoTech LLC, Selexis SA, SGS S.A. Corp., and others.
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1. Introduction
1.1 Key Insights
1.2 Report Overview
1.3 Markets Covered
1.4 Stakeholders
2. Research Methodology
2.1 Research Scope
2.2 Market Research Process
2.3 Research Data Analysis
2.4.1 Secondary Research
2.4.2 Primary Research
2.4.3 Models for Estimation
2.5 Market Size Estimation
2.5.1 Bottom-Up Approach – Segmental Market Analysis
2.5.2 Top-Down Approach – Parent Market Analysis
3. Executive Summary
4. Market Overview
4.1 Introduction
4.2.1 Drivers
4.2.2 Restraints
4.2.3 Opportunities
4.2.4 Challenges
4.2 Porter’s Five Force Analysis
5. Biologics Development and Manufacturing Testing Market, By Test Objective
5.1 Introduction
5.2 Cell Processing
5.2.1 Market Overview
5.2.2 Market Size and Forecast
5.3 Cell Preservation, Distribution, and Handling
5.3.1 Market Overview
5.3.2 Market Size and Forecast
5.4 Process Monitoring and Quality Control
5.4.1 Market Overview
5.4.2 Market Size and Forecast
6. Biologics Development and Manufacturing Testing Market, By Test Application
6.1 Introduction
6.2 Market Breakdown by Test Application
6.2.1 Market Overview
6.2.2 Market Size and Forecast
6.3 Endotoxin Testing
6.3.1 Market Overview
6.3.2 Market Size and Forecast
6.4 Sterility Testing
6.4.1 Market Overview
6.4.2 Market Size and Forecast
6.5 Adventitious Agent Detection
6.5.1 Market Overview
6.5.2 Market Size and Forecast
6.6 Bioburden Testing
6.6.1 Market Overview
6.6.2 Market Size and Forecast
6.7 Residual Host Contaminant (Host Cell Protein) Detection Testing
6.7.1 Market Overview
6.7.2 Market Size and Forecast
7. Biologics Development and Manufacturing Testing Market, By Test Technology
7.1 Introduction
7.2 In Vivo Safety Testing
7.2.1 Market Overview
7.2.2 Market Size and Forecast
7.3 Toxicity-LD50 Test
7.3.1 Market Overview
7.3.2 Market Size and Forecast
7.4 Mutagenicity and Carcinogenicity
7.4.1 Market Overview
7.4.2 Market Size and Forecast
7.5 Toxicokinetics and ADME
7.5.1 Market Overview
7.5.2 Market Size and Forecast
7.6 Metabolic Toxicity
7.6.1 Market Overview
7.6.2 Market Size and Forecast
7.7 Pyrogen Testing
7.7.1 Market Overview
7.7.2 Market Size and Forecast
7.8 Embryotoxicity
7.8.1 Market Overview
7.8.2 Market Size and Forecast
7.9 Endocrine Disruptors
7.9.1 Market Overview
7.9.2 Market Size and Forecast
7.10 Toxic genomics
7.10.1 Market Overview
7.10.2 Market Size and Forecast
7.11 Cell Analysis
7.11.1 Market Overview
7.11.2 Market Size and Forecast
8. Biologics Development and Manufacturing Testing Market, By Geography
8.1 Introduction
8.2 North America
8.2.1 North America Biologics Development and Manufacturing Testing, By Test Objective
8.2.2 North America Biologics Development and Manufacturing Testing, By Test Application
8.2.3 North America Biologics Development and Manufacturing Testing, By Test Technology
8.3 Europe
8.3.1 Europe Biologics Development and Manufacturing Testing, By Test Objective
8.3.2 Europe Biologics Development and Manufacturing Testing, By Test Application
8.3.3 Europe Biologics Development and Manufacturing Testing, By Test Technology
8.4 Asia-Pacific
8.4.1 Asia-Pacific Biologics Development and Manufacturing Testing, By Test Objective
8.4.2 Asia-Pacific Biologics Development and Manufacturing Testing, By Test Application
8.4.3 Asia-Pacific Biologics Development and Manufacturing Testing, By Test Technology
8.5 Rest of the World
8.5.1 Rest of the World Biologics Development and Manufacturing Testing, By Test Objective
8.5.2 Rest of the World Biologics Development and Manufacturing Testing, By Test Application
8.5.3 Rest of the World Biologics Development and Manufacturing Testing, By Test Technology
9. Competitive Insights
9.1 Key Insights
9.2 Company Market Share Analysis
9.3 Strategic Outlook
9.3.1 Mergers & Acquisitions
9.3.2 New Product Development
9.3.3 Portfolio/Production Capacity Expansions
9.3.4 Joint Ventures, Collaborations, Partnerships & Agreements
9.3.5 Others
10. Company Profiles
10.1 Admecell Inc.
10.1.1 Company Overview
10.1.2 Product/Service Landscape
10.1.3 Financial Overview
10.1.4 Recent Developments
10.2 American Type Culture Collection (ATCC)
10.2.1 Company Overview
10.2.2 Product/Service Landscape
10.2.3 Financial Overview
10.2.4 Recent Developments
10.3 Catalent Inc.
10.3.1 Company Overview
10.3.2 Product/Service Landscape
10.3.3 Financial Overview
10.3.4 Recent Developments
10.4 Charles River Laboratories
10.4.1 Company Overview
10.4.2 Product/Service Landscape
10.4.3 Financial Overview
10.4.4 Recent Developments
10.5 Covance
10.5.1 Company Overview
10.5.2 Product/Service Landscape
10.5.3 Financial Overview
10.5.4 Recent Developments
10.6 Eurofins Scientific
10.6.1 Company Overview
10.6.2 Product/Service Landscape
10.6.3 Financial Overview
10.6.4 Recent Developments
10.7 Intertek Group PLC
10.7.1 Company Overview
10.7.2 Product/Service Landscape
10.7.3 Financial Overview
10.7.4 Recent Developments
10.8 Sekisui XenoTech LLC
10.8.1 Company Overview
10.8.2 Product/Service Landscape
10.8.3 Financial Overview
10.8.4 Recent Developments
10.9 Selexis SA
10.9.1 Company Overview
10.9.2 Product/Service Landscape
10.9.3 Financial Overview
10.9.4 Recent Developments
10.10 SGS S.A. Corp.
10.10.1 Company Overview
10.10.2 Product/Service Landscape
10.10.3 Financial Overview
10.10.4 Recent Developments
The Biologics Development and Manufacturing Testing Market has been segmented as below:
Biologics Development and Manufacturing Testing Market, By Test Objective
Biologics Development and Manufacturing Testing Market, By Test Application
Biologics Development and Manufacturing Testing Market, By Test Technology
Biologics Development and Manufacturing Testing Market, By Region
Biologics Development and Manufacturing Testing Market, By Company
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