Dec 2018 131

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Biological safety testing is carried out to ensure non-contamination of biopharmaceuticals and vaccines and to comply with regulations regarding the same. It is a major step towards the launch of innovative biopharmaceutical products. Biological safety testing is essential to ensure product safety, and ensure the quality of biopharmaceutical products. It is conducted to ensure that the drug-producing microbes or cells are free from microbial or viral pathogens, for process validation of virus inactivation, clearance capability during biopharmaceutical production, and to test these biological materials during biopharmaceutical production for verifying the identity and characteristics. In addition, it is also used to ensure the purity, sterility, and genetic stability of the production cell bank. Bioburden testing, sterility testing, adventitious agent’s detection test, cell line authentication and characterization tests, endotoxin tests, and residual host contaminant detection tests are the major biological safety tests. Biological safety testing is used in vaccine, cellular, and gene therapy products, blood and blood products, tissue and tissue products, and stem cell products. It is performed by contract testing laboratories on the behalf of drug developers. These laboratories are confronted with a number of ethical issues and tasked with maintaining confidentiality in handling the results.

Scope of the Report:
This report studies the Biological Safety Testing market status and outlook of Global and major regions, from angles of players, countries, product types and end industries; this report analyzes the top players in global market, and splits the Biological Safety Testing market by product type and applications/end industries.
Rising need for biologics has resulted in unprecedented growth in number of biopharmaceutical companies. This increasing competition to develop therapeutically advanced drugs on a large scale has compelled manufacturers to improve on aspects such as productivity, cost efficiency, and deviations. Companies are thus implementing good manufacturing practices involving thorough biological testing at various levels of production cycles, thereby contributing toward market growth. Rising number of government initiatives to promote biological safety testing products is anticipated to drive overall market growth over the coming years. High microbial contamination rates and bioburden during pharmaceutical and biologics manufacturing are expected to drive government and private organizations to improve underlying biological safety practices. Moreover, presence of regulatory authorities to enforce significant safety standards is anticipated to provide boost adoption of testing tools. Stringent guidelines and recommendations laid down by these authorities increases incorporation of these tools by quality assurance technicians, thus providing a significant boost to the overall industry.
The Americas will be the major revenue contributor to the biosafety testing services market till 2021. The region has the presence of several NPOs and regulatory organizations that promote biological safety testing. Additionally, the focus of organizations such as the FDA, the CDC, and the American Biological Safety Association (ABSA) towards promoting biological safety in several industries such as pharmaceutical and biotechnology, will also drive the growth of the market in this region.
The global Biological Safety Testing market is valued at xx million USD in 2017 and is expected to reach xx million USD by the end of 2023, growing at a CAGR of xx% between 2017 and 2023.
The Asia-Pacific will occupy for more market share in following years, especially in China, also fast growing India and Southeast Asia regions.
North America, especially The United States, will still play an important role which cannot be ignored. Any changes from United States might affect the development trend of Biological Safety Testing.
Europe also play important roles in global market, with market size of xx million USD in 2017 and will be xx million USD in 2023, with a CAGR of xx%.

Market Segment by Companies, this report covers
- Thermo Fisher Scientific
- Charles River Laboratories International
- Merck
- Lonza Group
- Avance Biosciences
- Toxikon
- NuAire

Market Segment by Regions, regional analysis covers
North America (United States, Canada and Mexico)
Europe (Germany, France, UK, Russia and Italy)
Asia-Pacific (China, Japan, Korea, India and Southeast Asia)
South America (Brazil, Argentina, Colombia)
Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Market Segment by Type, covers
- Instruments
- Services
- Kits & Reagents

Market Segment by Applications, can be divided into
- Vaccine Development
- Blood Products
- Stem Cell Research

Table of Contents

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