According to the new market research report sterility testing market is expected to reach USD 941.0 Million by 2021 from USD 528.0 Million in 2016, at a CAGR of 12.3% from 2016 to 2021. The growth of the sterility testing market can be attributed to the growth in the pharmaceutical and biotechnology industries, increase in the number of new drug launches, and increasing R&D in life science research.

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Market Dynamics

Drivers

Growth of pharmaceutical & biotechnology companies

Increasing number of drug launches

Government support for pharmaceutical and biotechnology industries

Increasing R&D investment in life sciences

Restraints

High degree of consolidation, major barrier for new market entrants

Stringent regulatory frameworks and time-consuming approval processes

Opportunities

Emerging markets

Increasingly pharmaceutical outsourcing

Challenges

Shortage of skilled professionals

Major players in the sterility testing market include Merck KGaA (Germany), Charles River Laboratories International, Inc. (U.S.), bioMérieux SA (France), SGS S.A. (Switzerland), Sartorius AG (Germany), WuXi AppTec (China), Nelson Laboratories (U.S.), Danaher Corporation (U.S.), Pacific Biolabs (U.S.), Toxikon Corporation (U.S.), and Thermo Fisher Scientific, Inc. (U.S.).

• Based on product, the market is segmented into kits and reagents, instruments, and services. The kits and reagents segment are the largest and the fastest-growing product segment in the sterility testing market. The large share of the kits and reagents segment can be attributed to the requirement of the repeat purchase of these products, coupled with the increasing preference for kit-based testing.
• Based on test, the market is segmented into membrane filtration, direct inoculation, and other sterility tests. The membrane filtration segment is estimated to account for the largest share of the sterility testing market in 2016. The large share of this segment can primarily be attributed to rapid growth in the pharmaceutical and biotechnology end-use industry.
• Based on application, the market is segmented into pharmaceutical and biological manufacturing, medical devices manufacturing, and other applications. The pharmaceutical and biological manufacturing segment is projected to witness the highest growth in this market due to the rapid growth in the pharma and biotech industries.

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Based on region, the global sterility testing market is segmented into North America, Europe, Asia, and the Rest of the World (RoW). The market is dominated by North America, followed by Europe, Asia, and the Rest of the World (RoW). However, the Asian market will witness the highest growth during the forecast period, primarily due to the increasing expenditure on life science research in the region and growing trend of pharmaceutical outsourcing to Asian countries like India and China. Growth in the outsourcing industry in Asia is another major factor supporting overall market growth in the region. The rapidly increasing demand for the outsourcing of microbial testing in countries such as China, India, Japan, and Singapore is expected to drive market growth during the forecast period. To capitalize on the opportunities in the Asian market, a number of companies have worked to increase their market share and customer base in the region.