The global biological safety testing market should reach $13.1 billion by 2022 from $5.1 billion in 2017 at a compound annual growth rate (CAGR) of 20.9%, from 2017 to 2022

NEW YORK, Feb. 19, 2018 /PRNewswire/ -- The global biological safety testing market should reach $13.1 billion by 2022 from $5.1 billion in 2017 at a compound annual growth rate (CAGR) of 20.9%, from 2017 to 2022.

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? The analytical testing services segment of global biological safety testing market is expected to grow from $1.9 billion in 2017 to $4.9 billion in 2022 at a CAGR of 20.3% for the period 2017-2022.
? The in vitro (cell-based and reagents) segment of global biological safety testing market is expected to grow from $1.8 billion in 2017 to $5.5 billion in 2022 at a CAGR of 24.6% for the period 2017-2022.

Chapter 1: Introduction
This is a market and technology report on the global market for biologics safety testing, including the key segments: in vivo animal, in vitro and analytical testing services and products. Naturally a key driver for this market is the underlying market for biologics themselves.

The term biological refers to a number of different drug therapy and vaccine products. Other terms in the literature for these types of pharmaceutical products include the terms biologics and bio? therapeutics.

In this report, the term Biologics will refer to therapeutic proteins, antigens, recombinant proteins and antigens, and other living cell-derived agents that are used to produce these types of pharmaceutical products. Biologics are medical products derived from various natural sources such microorganisms, eukaryotic cell lines, and animals.

The biological products are either extracted from sources such as proteins, carbohydrates, and nucleic acids of living organisms, or produced by genetic engineering techniques or other technologies.

Biologics are the fastest growing sector of the biopharmaceutical industry. This shift towards commercialization of more protein?based drugs is mostly due to their high specificity, enhanced efficacy, affinity, solubility and low toxicity.

Biological safety testing is a process or method to check or ensure physical uniformity (or biosimilarity) to reference standards and noncontamination of vaccines and other biological products. Biological safety testing is a major step in the drug development process to ensure sterility, purity, stability, and overall quality of biological agents and processes to produce noncontaminated products.

Detection, authentication, and characterization are the major steps of biological safety testing to check whether biological products are free from bacteria, fungi, yeasts, mycoplasma, viruses, and other potential contaminants.

This report focuses on the global market for biologics safety testing, including the key segments: in vivo (or lab animal?based testing), in vitro (which includes both test tube and automated testing as well as cell and tissue?based testing), and analytical testing (which includes services and products offered by analytical testing labs). Naturally, a key driver for this market is the demand for biologics themselves.

Biological safety testing is an integral part of the protein?based drug and vaccine discovery, development, and commercialization process. Utilizing data obtained in vivo about physical, chemical and biological processes, and in conjunction with in vitro data obtained from chemical and cell?based testing assays, the safety and efficacy of new biologics and those in development stages are assessed.

Study Goals and Objectives
The objective of BCC Research in conducting this study is to provide an overview of the current and future characteristics of the global market for safety testing of biologics. The key objective is to present a comprehensive analysis of the current market and its future direction as an important tool for increasing the efficiency and specificity of the products and types of safety testing for biologics.

This report explores present and future strategies within the biological safety testing market, which includes the therapeutic, diagnostics, and molecular research sectors. Biological safety testing includes identification and characterization of adventitious agents such as prions, virinos, viruses, bacteria, yeast and molds.

The technology, applications, and end users of different types of biological safety testing are also discussed.
A detailed analysis of the structure of the biological safety testing industry has been conducted. Revenues are broken down by global region. Revenue figures are estimated for the five-year period from 2017 through 2022.

Applications or the uses of biological safety testing are also discussed separately in the report, with emphasis on the usage during the new drug development process. The report also covers the usage of biological safety testing for research and development, process development and scale-up, commercial scale production, and commercial lot release.

Reasons for Doing This Study
Biological safety testing is performed for many different types of pharmaceutical products including recombinant protein-based therapeutics, diagnostics, and vaccines. The growing market for new biologics and the industrial processes used to produce them has led to a corresponding growth in the biological safety testing industry.

Biological safety testing technology has made it possible to produce biologics that are nearly identical to naturally occurring forms of these proteins. The safety testing ensures that these similarities are preserved throughout the product lifecycle.

The commercial production of Biologics is subject to increasing regulation by the Federal Drug Administration (FDA) (U.S.), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) (E.U.), and other governmental and nongovernmental regulatory agencies all over the world. Safety testing regulations, new advancements in testing technology, and increased spending in research and development are key drivers of growth in the biological safety testing market.

The report also explores implications for biosimilars (generic biologics), a growing and dynamic sector where complex commercial and operations strategies are being established.

Scope of Report
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.

Information Sources
In order to analyze the current state of the biological safety testing market, many different resources were used to gather market information and the major players involved. Primary sources included company publications including annual shareholder reports, published financial data obtained from company reports and news alerts, as well as SEC filings.

In addition, senior level employees were interviewed along with information gathered from industry trade journal reports and articles. Secondary resources included internet searches, information obtained from second party sources, financial publications, and market forecasts.

Methodology
A comprehensive literature search was conducted, which included technical newsletters and journals, and many other sources. Data were collected through publications, website data, literature searches, and interviews with industry professionals. Projections were based on estimates such as the current number of end users, potential end users, mergers and acquisitions, and increasing regulatory requirements.

Approximately 60 different companies were examined in detail in order to estimate the global biological safety testing market. These companies represented the major players in each market segment, along with other smaller players.

In addition, the overall market for biological safety testing was assessed for growth capacity based upon industry reports and financial statements. The biopharmaceutical industry as a whole is poised for contained double digit growth through the forecast period of 2017 through 2022. This growth in the industry itself will create additional demand for biological safety testing applications and services.

Geographic Breakdown

In this report, the geographic regions considered for market analysis include, and only include:
? North America (U.S. and Canada).
? E.U. and Eastern Europe (Russia).
? Asia-Pacific (Japan, China, Australia).
? South America and Other (Brazil, Mexico, South Africa).

Biologics Safety Testing Market, by Test Technology
Animal Based Testing
In Vitro Testing (Kits & Reagents and Cell Lines)
Analytical Services

Biologics Safety Testing Market, by Test Objective
Sterility Testing
Adventitious Agents Detection Test
Bioburden Testing
Cell Line Authentication And Characterization Tests
Endotoxin Tests
Residual Host Contaminant Detection Tests
Product Release Tests (Efficacy Tests, Toxicity Tests, Stability Tests)

Biologics Safety Testing Market, by Test Application
Discovery and Development
Clinical Trials and Approval
Product Release
- Purity
- Potency
- Sterility
- Stability
- Excipient Testing

Chapter 2: Summary and Highlights
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 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.

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