The 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%.
Sterility testing market drivers include growth in the pharmaceutical and biotechnology industries, increase in the number of new drug launches, and increasing R&D in life science research.
Over the years, the number of drug approvals in North American has increased. In 2015, the FDA’s Center for Drug Evaluation and Research (CDER) approved 45 novel drugs as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs); as opposed to this, only 22 novel drugs were approved in 2006. The increasing number of drug approvals will boost the sterility testing market.
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The key players in the sterility testing market include Merck KGaA (Germany), Charles River Laboratories International, Inc. (U.S.), bio MérieuxSA (France), SGS S.A. (Switzerland), Sartorius AG (Germany), WuXi AppTec (China), and Thermo Fisher Scientific, Inc. (U.S.).
According to OECD estimates, in 2015, the total number of biotechnology companies in the U.S. was 11,367. Owing to the rise in the number of biotechnology companies, biopharmaceutical production has increased globally. Sterility testing is carried out at all levels of pharmaceutical and biopharmaceutical manufacturing process to minimize the risk of product contamination. Growth in pharmaceutical and biotechnology industries will drive the growth of the sterility testing market.
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On the basis of product, the sterility testing market is segmented into kits and reagents, instruments, and services. The kits and reagents segment is projected to witness the highest growth in this 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.
On the basis of test, the sterility testing market is segmented into membrane filtration, direct inoculation, and other sterility tests. The membrane filtration segment is projected to witness the highest growth in this market due to new product launches and growth in the pharmaceutical and biotechnology industries.
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On the basis of application, sterility testing market is segmented into pharmaceutical and biological manufacturing, medical devices manufacturing, and others applications. The pharmaceutical and biological manufacturing segment is projected to witness the highest growth in this market due to rapid growth in the pharma and biotech industries.
Geographically, the sterility testing market is dominated by North America, followed by Europe, Asia, and the Rest of the World (RoW).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.
Research Coverage
In addition to comprehensive geographic and product analysis and market sizing, the report also provides a competitive landscape that covers the growth strategies adopted by industry players over the last three years. The company profiles in this report comprise the product portfolios, developments, and strategies adopted by players to maintain and increase their shares in the market. The abovementioned market research data, current market size, and forecast of future trends will help key market players and new entrants to make the necessary decisions regarding product offerings, geographic focus, change in strategic approach, and levels of output in order to remain successful in the sterility testing market.
Reasons to Access the Report:
This report will enable both established firms as well as new entrants/smaller firms to gauge the pulse of the market, which in turn will help these firms garner greater market shares. Firms purchasing the report can use any one or a combination of the below-mentioned five strategies (market penetration, product development/innovation, market development, market diversification, and competitive assessment) for strengthening their market shares.
The report provides insights on the following pointers:
- Market Penetration: Comprehensive information on the product portfolios of the top players in the sterility testing market. The report analyses the in sterility testing market byproduct, test, and application
- Product Development/Innovation: Detailed insights on the upcoming technologies, R&D activities, and new product launches in the sterility testing market
- Competitive Assessment: In-depth assessment of the market strategies, geographic and business segments, and product portfolios of the leading players in the sterility testing market
- Market Development: Comprehensive information about emerging markets. This report analyzes the market for various sterility testing products across geographies
- Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the sterility testing market.
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