WiseGuyReports published new report, titled “Biologics Development and Manufacturing Testing”
Summary of Key Insights
Factors affecting the biological safety testing marketand 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
The in vivo testing market was valued at approximately REDACTED in 2017 and is expected to reach a value of approximately REDACTED in 2022. 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 with a REDACTED predicted CAGR 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.
The in vitro testing market was over REDACTED in 2017 and is anticipated to reach REDACTED in 2022 with a REDACTED CAGR over the forecast period. 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 and are expected to exceed REDACTED in 2022. As a consequence of the high manufacturing volume pharmaceutical and biotechnology companies are increasingly incorporating in vitro biological safety testing tools to produce highly potentand contamination-free Biologics to treat to the large population suffering from target diseases.
The analytical testing market was valued at approximately REDACTED in 2017. This market is expected to grow at a CAGR of over REDACTED during the forecast period to reach REDACTED in 2022. 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.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.
– 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.ADMECELL INC.
AMERICAN TYPE CULTURE COLLECTION (ATCC)
CHARLES RIVER LABORATORIES
INTERTEK GROUP PLC
PHARMACEUTICAL PRODUCT DEVELOPMENT LLC (PPD)
SEKISUI XENOTECH LLC
SGS S.A. CORP.
Wise Guy Reports is part of the Wise Guy Research Consultants Pvt. Ltd. and offers premium progressive statistical surveying, market research reports, analysis & forecast data for industries and governments around the globe.
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