The scope of this study encompasses all aspects of biological safety testing used for characterization and release of biopharmaceutical, veterinary and medical diagnostics products. This 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.
- 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.
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
2. Summary and Highlights
Summary of Key Insights
Market Segment Breakdown
Stability and Release
Growth in Biological Manufacturing
4. Market Breakdown by Test Objective
Market Breakdown by Objective
Product Lot Release Testing
Product Stability Testing
5. Market Breakdown by Test Application
Market Breakdown by Test Application
Adventitious Agent Detection
Residual Host Contaminant (Host Cell Protein) Detection Testing
6. Market Breakdown by Test Technology
In Vivo Safety Testing
Mutagenicity and Carcinogenicity
Toxicokinetics and ADME
In Vitro Safety Testing
Nucleic Acids-based Testing
Tissue and Cell-based Testing
Cell Line Development and Testing
Safety Testing Analytical Services
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)
8. Patent Review/ New Developments
Future of Biological Patents and Biosimilars
Biologics: Patent Expiration by Year
9. Analysis of Market Opportunities
Implications for Safety Testing
Key Trends in In Vivo Testing
Key Trends in In Vitro Testing
Key Trends in Analytical Testing Services
10. Company Profiles
AMERICAN TYPE CULTURE COLLECTION (ATCC)
Biological Safety Testing Services
Oral Drug Delivery Technologies
CHARLES RIVER LABORATORIES
Types of Biological Products Tested
Types of Biological Safety Testing Performed
Covance Research Products
RESEARCH-Life Science Reagents and Kits
PROCESS DEVELOPMENT-Single-use manufacturing
INTERTEK GROUP PLC
Ensuring Regulatory Requirements are Met
Ensuring a safe and efficacious product
Quality Biopharmaceutical Data to Meet Milestones
Biopharmaceutical Product Services:
Cell Culture Products
PHARMACEUTICAL PRODUCT DEVELOPMENT LLC (PPD)
Biosafety Testing Services
SEKISUI XENOTECH LLC
SGS S.A. CORP.
Life Sciences Laboratory Services
SGS Bio/Analytical Methods
SGS Biosimilar Testing Services
Bioanalytical Testing Services
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
Summary of Key Insights:
Factors affecting the biological safety testing market and its potential for growth in the forecast period include: 1) The decline in in vivo testing due to development of newer in vitro toxicology and efficacy tests; 2) Public opposition to in vivo testing based upon ethical considerations; 3) The anticipated growth for in vitro testing, especially due to the cell-based segment; 4) Development of new cell lines that express specific biomarkers for disease states and comparative diagnostics; 5) The growth of “personalized medicines” based upon the advancement of autologous cell replacement or transfusion- based (i.e., CAR/T) therapies and elucidation of mechanisms of disease using in vitro models; 6) Finally, the increasing number of brand name biologics coming off patent protection will result in a growing market for “biosimilars” or generic biologics-many of which will be manufactured overseas by contract manufacturing organizations (or CMO’s) and will drive the need for increased bioequivalence testing in many markets (especially in Europe and Asia-Pacific )and will serve to increase the overall percentage of outsourced biological safety testing by large pharmaceutical and biopharmaceutical companies.
Market Segment Breakdown:
This sector consists mainly of in vivo safety testing, including efficacy testing, absorption dissemination metabolism and excretion (ADME) testing, in vivo toxicology testing, pharmacokinetics and pharmacodynamics (PK/PD) testing, dosage determination, and long-term exposure monitoring. This sector of the global biological safety testing market is expected to have the lowest growth potential over the forecast period. This lower growth rate represents the decline in new animal-based testing models for toxicity and the development of more reliable in vitro toxicology methods for assessing the inherent toxicological properties of Biologics.
This segment includes tests for cytoxicity and cell-based potency. Bioproduction of vaccines and peptide-based antibiotics are the foremost application areas among the foremost application areas for biologics testing. As a consequence of the high manufacturing volume pharmaceutical and biotechnology companies are increasingly incorporating in vitro biological safety testing tools to produce highly potent and contamination-free Biologics to treat to the large population suffering from target diseases.
This segment includes the majority of product release testing applications such as sterility, bioburden, adventitious agents, endotoxin, host cell protein, and excipients testing. The growing production of a new generation Biologics by major pharmaceutical and biotechnology companies is a high-impact growth driver of the market. The subsequent increase is believed to be a consequence of high global prevalence of target diseases, which has triggered the companies to produce advanced Biologics. Consequently, the high need for Biologics has resulted in an unprecedented growth in the number of biopharmaceutical companies. This rise in the number of companies has engendered a high demand
for analytical testing services to eliminate contamination risks using safety assurance measures in the manufacturing processes.
- Admecell Inc.
- American Type Culture Collection (Atcc)
- Avance Biosciences
- Bsl Bioservice
- Catalent Inc.
- Charles River Laboratories
- Cytovance Biologics
- Emd Millipore
- Eurofins Scientific
- Intertek Group PLC
- Lonza Group
- Pharmaceutical Product Development LLC (Ppd)
- Sartorius AG
- Sekisui Xenotech LLC
- Selexis Sa
- Sgs S.A. Corp.
- Toxikon Corp.
- Wuxi Apptec