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Biologics Development and Manufacturing Testing: Technologies and Global Markets

Biologics Development and Manufacturing Testing: Technologies and Global Markets

Report Scope:

The scope of this study encompasses all aspects of biological safety testing used for characterization and release of biopharmaceutical, veterinary and medical diagnostics products. BCC Research analyzes each market and its applications, regulatory environments, technology, market projections, and market share. Technological issues discussed in the report include the latest trends and developments.

Report Includes:

- An overview of the global market for biological safety testing and related technologies.
- Analyses of global market trends, with data from 2016 and 2017, and projections of compound annual growth rates (CAGRs) through 2022.
- Discussion of the latest market trends, regulatory environments, market projections, and market share.
- A look at future of biological patents and biosimilars along with biologics patents by year.
- Company profiles of major players in the industry, including Charles River Laboratories, WuXi AppTec, SGS SA, Thermo Fisher Scientific and Lonza Group.


Chapter 1 Introduction
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Geographic Breakdown
Analyst's Credentials
Related BCC Research Reports
Chapter 2 Summary and Highlights
Summary of Key Insights
Market Segment Breakdown
Chapter 3 Overview
Drug Discovery
Process Development
Formulation Development
Manufacturing
Process Validation
Stability and Release
Growth in Biological Manufacturing
Chapter 4 Market Breakdown by Test Objective
Market Breakdown by Objective
Safety
Efficacy
Potency
Stability
Product Lot Release Testing
Potency
Purity
Excipients
Product Stability Testing
Chapter 5 Market Breakdown by Test Application
Market Breakdown by Test Application
Endotoxin Testing
Sterility Testing
Adventitious Agent Detection
Bioburden Testing
Residual Host Contaminant (Host Cell Protein) Detection Testing
Chapter 6 Market Breakdown by Test Technology
In Vivo Safety Testing
Toxicity-LD50 Test
Mutagenicity and Carcinogenicity
Toxicokinetics and ADME
Metabolic Toxicity
Pyrogen Testing
Embryotoxicity
Endocrine Disruptors
Toxicogenomics
In Vitro Safety Testing
Nucleic Acids-based Testing
Tissue and Cell-based Testing
Cell Analysis
Cell Line Development and Testing
Safety Testing Analytical Services
Chapter 7 Market Breakdown by Region
Global Biological Safety Testing Market, by Region
North America (U.S., Canada)
E.U. and Eastern Europe
Asia-Pacific and Other (Japan, China, Australia, South America)
Chapter 8 Patent Review/ New Developments
Future of Biological Patents and Biosimilars
Biologics: Patent Expiration by Year
Chapter 9 Analysis of Market Opportunities
Biosimilars
Biobetters
Implications for Safety Testing
Key Trends in In Vivo Testing
Key Trends in In Vitro Testing
Key Trends in Analytical Testing Services
Chapter 10 Company Profiles
ADMECELL INC.
AMERICAN TYPE CULTURE COLLECTION (ATCC)
AVANCE BIOSCIENCES
Products:
Services:
Applications:
Biological Safety Testing Services
BIORELIANCE
BSL BIOSERVICE
Preclinical Services
CATALENT INC.
Predevelopment Technologies
Oral Drug Delivery Technologies
Sterile Technologies
Biologics
CHARLES RIVER LABORATORIES
Types of Biological Products Tested
Types of Biological Safety Testing Performed
COVANCE
Covance Research Products
CYTOVANCE BIOLOGICS
Process Development
Manufacturing
Support Services
EMD MILLIPORE
RESEARCH-Life Science Reagents and Kits
Laboratory Services
PROCESS DEVELOPMENT-Single-use manufacturing
EUROFINS SCIENTIFIC
INTERTEK GROUP PLC
Biopharmaceutical Services
Ensuring Regulatory Requirements are Met
Ensuring a safe and efficacious product
Quality Biopharmaceutical Data to Meet Milestones
Biopharmaceutical Product Services:
LONZA GROUP
Cell Culture Products
Electrophoresis Products
Biological Assays
Endotoxin Detection
PHARMACEUTICAL PRODUCT DEVELOPMENT LLC (PPD)
SARTORIUS AG
Biosafety Testing Services
SEKISUI XENOTECH LLC
SELEXIS SA
SGS S.A. CORP.
Life Sciences Laboratory Services
SGS Bio/Analytical Methods
SGS Biosimilar Testing Services
SIGMA-ALDRICH
TOXIKON CORP.
Bioanalytical Testing Services
WUXI APPTEC
List of Tables
Summary Table : Global Market for Biological Safety Testing, by Market Segmentation, Through 2022
Table 1 : Definition of Biologics
Table 2 : Market Segments for Biological Safety Testing
Table 3 : Definition of Protein-based Drugs and Vaccines
Table 4 : Global Biological Safety Testing Market, by Protein-based Drugs, Through 2022
Table 5 : Global Market for Biological Safety Testing, by Objective
Table 6 : Analytical Methods used for Determination of Protein Structure
Table 7 : Global Market for Biological Safety Testing, by Objective, Through 2022
Table 8 : Segmentation of Biological Safety Testing Market, by Application
Table 9 : Global Market for Biological Safety Testing, by Application, Through 2022
Table 10 : Segmentation of Biological Safety Testing Market, by Test Technology
Table 11 : Drivers of Cell Analysis Market Growth
Table 12 : Segmentation of Analytical Testing Services Market, by Technology
Table 13 : Global Market for Biological Safety Testing, by Test Technology, Through 2022
Table 14 : Segmentation of the Biological Safety Testing Market, by Region
Table 15 : Global Market for Biological Safety Testing, by Region, Through 2022
Table 16 : Biologics: Patent Expiration, by Year, 2003-2019
Table 17 : Key Trends in In Vivo Based Testing
Table 18 : Key Trends in Cell-Based In Vitro Safety Testing
Table 19 : Key Trends in Analytical Testing Services
List of Figures
Summary Figure : Global Market for Biological Safety Testing, by Market Segmentation, 2016-2022
Figure 1 : Value Chain Model for Biological Safety Testing and Product Lifecycle
Figure 2 : Global Market for Biological Safety Testing, by Objective, 2016-2022
Figure 3 : Global Market for Biological Safety Testing, by Application, 2016-2022
Figure 4 : Value Chain Model for Biological Analytical Testing and Good Practice
Figure 5 : Global Market for Biological Safety Testing, by Test Technology, 2016-2022
Figure 6 : Global Market for Biological Safety Testing, by Region, 2016-2022

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