Sterility Testing Market is Expanding at a CAGR of 7.0 % by 2025

The global sterility testing market was valued at approximately US$ 750.0 Mn in 2016 is projected to register cumulative annual growth rate (CAGR) of over 7.0% from 2017 to 2025, according to a new report published by Transparency Market Research (TMR) titled “Sterility Testing Market – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2017–2025”. The report suggests that increase in research & development activities is outgrowth the demand of sterility testing in the coming years (2017 to 2025). North America dominating the sterility testing market due to establishment of new biopharmaceutical companies as well as quick adoption of advanced technology. The emerging markets such as China, India and Brazil is likely to boost growth of Asia Pacific and Latin America sterility testing market at a CAGR of more than 7.0% from 2017 to 2025.

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Technological Advancement and Strategic partnerships to Drive Global Sterility Testing Market

Technological improvements in devices and reagents available for sterility testing have aided in easing the process and contributed to market growth. This change in sterility requirements is an exciting development for the rapid microbial testing business. Manufacturers operating in the sterility testing market have entered into various strategic mergers & acquisitions and partnerships that enabled them to enhance market position and expand customer base. For instance, bioMérieux and Shimadzu have worked in partnership to develop their linear MALDI-TOF mass spectrometry technology for improved incorporation into the microbiology laboratory workflow. Similarly, BD Diagnostics and Bruker entered into a partnership to improve Bruker MALDI Biotyper for microbial identification and antimicrobial susceptibility testing.

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Instruments and Biopharmaceutical Manufacturing Segment Market to Grow At High Rate

The kits and reagent segment dominate the sterility testing market in terms of revenue. The advantages of kits and reagents segment includes product affordability, easy product availability, increase in research and development activities and high awareness for kits and reagents are likely to fuel the growth of the segment. The instruments segment is the highly growing segment at a CAGR of more than 8.0%. Factors such as technological advancement, growing demand for automated products, favorable reimbursement scenario and rapid process are key factors driving the instruments segment. According to the European Federation of Pharmaceutical Industries & Associations, in 2016, the pharmaceutical sector in Brazil and China expanded at a growth rate of 10.0% and 6.9% respectively. The same year, the pharmaceutical sector in the European Union and the U.S. expanded at an average growth rate of 4.5% and 6.3% respectively. In terms of application sterility testing is highly preferred in biopharmaceutical manufacturing. Rising demand for high-quality and innovative products and growing prevalence of chronic diseases are key driving factors for the biopharmaceutical manufacturing segment.

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Traditional Sterility Tests Dominates In Term of Market Share

Sterility tests type is classified into traditional sterility tests and rapid sterility tests. In terms of test type traditional sterility tests contributes high market share. High acceptance among sterility testing service providers, high awareness about traditional sterility tests, low startup cost, high preference for membrane filtration tests are the key factors driving the traditional sterility tests segment. Rapid sterility tests is the highly growing segment at a CAGR of more than 8.0%. Increase in health care investment, technological advancements and rise in investment for research & development are expected to fuel the growth of the rapid sterility tests segment.

Asia Pacific to Offer Huge Incremental Opportunity

In terms of value, North America was leading contributor in global sterility testing market in 2016. Technological advancements, rapid adoption for newer technologies, and presence of a large number of providers of pharmaceuticals as well as medical devices are contributing factor for major share of the North America market. However launch of new, innovative products and an expanding skill base in North America implies that more people in the region will have access to advanced technology during the forecast period. Europe is the second largest market. Rise in research & development activities, increase in export of manufactured products to other countries are likely to accelerate Europe sterility testing market. The increase in number of pharmaceutical and biopharmaceutical companies and rising demand for drug products fueling the Asia Pacific sterility testing market. The Middle East & Africa region was valued at approximately US$ 27.1 Mn and likely to propel at a CAGR more than 6.5% from 2017 to 2025. Latin America and Middle East & Africa will create good market opportunity for sterility testing market. The increasing coverage of private health insurance coverage, rapid population growth, rise in prevalence of lifestyle diseases such as diabetes and cardiovascular disorders etc. are the factors fuel the rest of the Rest of the world sterility testing market.

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Key Players such as Merck KGaA, bioMérieux, Inc and Thermo Fisher Scientific Inc., are Likely to Continue to Lead the Global Sterility Testing Market

The report also provide profiles of leading players operating in global sterility testing market include Merck KGaA, bioMérieux, Inc, Sartorius AG, Thermo Fisher Scientific Inc., Charles River Laboratories International, Inc., Solvias AG, Becton, Dickinson and Company, Rapid Micro Biosystems, Inc. Merger & acquisition activities, new product innovation are the the key strategy adopted by many key players. In July 2015, Celsis International, Ltd., a leading provider of rapid testing systems for bacterial contamination acquired by Charles River Laboratories International, Inc.

Sterility Testing Market: Latest Trends & Insights 2025

Sterility testing is used for routine quality control, sterilization validation, as well as to detect contamination in a batch. It is an exceptionally tough process designed to eliminate false positive results caused by laboratory contamination from the testing environment or technician error. Sterility testing of cell lines, media, in-process material, and final products must be demonstrated during the manufacture of pharmaceuticals and medical devices. Products necessary for sterilization include injections, implants, syringes, and surgical instruments. Sterility testing is of three types: direct inoculation (immersion), membrane filtration, and direct transfer. In the former, the test articles are inoculated directly into tubes or bottles containing an appropriate medium and incubated for a period of 14 days. In the second method, the test article first passes through a size exclusion membrane capable of retaining microorganisms. Different tests exhibit different advantages.

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Factors such as the prevalence of chronic diseases, rapid population growth, increasing research and development activities, and government initiatives are predicted to drive the sterility testing market globally. Growing demand for high quality products, technological advancements, and the burgeoning pharmaceutical & biotechnological industries are bound to play a role too. Singapore invested US$ 2.8 Mn in research and development in biomedical sciences from 2011 to 2015. On the other hand, strict government regulation may hinder the development of the sterility testing market.
The market has been segmented by product type into the following categories: instruments and kits & reagents. The latter are expected to register a higher growth rate due to their ease of use and affordability. In terms of test type, the membrane filtration segment is projected to witness significant growth owing to new product launches and growth in the pharmaceutical & biotechnology industries. Based on end-user, the market is divided into the following groups: pharmaceuticals, medical devices, cosmeceuticals, and biotechnology.

Geographically, the sterility testing market is distributed over North America, Latin America, Europe, Asia Pacific, and Middle East & Africa. North America dominated the market due technological advancements, the burgeoning pharmaceutical & biotechnology industries, and increasing geriatric population in the region. Geriatrics represent about 14.5% of the U.S. population. According to the U.S. department of health and human services, by 2060, this number is likely to rise to 98 million – which is twice that of 2014. Europe is the second leading market for sterility testing on account of the increasing number of research and development activities. Asia Pacific is estimated to develop at a higher rate due to the rapid population growth, high prevalence of chronic diseases, government initiatives, and rising research & development in the region. According to SIRO Clinpharm, by 2050, Asia is likely to account for 60% of the world’s population, thereby offering tremendous opportunities for recruiting patients and expanding research of new lifestyle diseases treatment drugs.

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Key players operating in this market include Merck KGaA, Bioquell UK Ltd, bioMérieux SA, Sartorius AG, Thermo Fisher Scientific Inc., SGS SA, Charles River Laboratories, and WuXi Biologics.

The report offers a comprehensive evaluation of the market. It does so via in-depth qualitative insights, historical data, and verifiable projections about market size. The projections featured in the report have been derived using proven research methodologies and assumptions. By doing so, the research report serves as a repository of analysis and information for every facet of the market, including but not limited to: Regional markets, technology, types, and applications.