ID: MRFR/HC/0104-CRR | June, 2018 | Region: Global | 115 pages | Cooked Research Reports
Global Sterility Testing Market Research Report: Product Type (Instruments, Services), Test Type (Membrane Filtration, Direct Transfer) End-User (Pharmaceutical Companies, Hospitals & Clinics, Academic & Research Laboratories) – Global Forecast Till 2023
The global sterility testing market is anticipated to reach USD 1,245.2 million by 2023, as per a new detailed report by Market Research Future (MRFR). It is expected to exhibit an 11.7% CAGR during the assessment period (2017-2023). High prevalence of cardiovascular diseases and various cancers are expected to induce market demand. Government support in terms of funding coupled with the expanding life science sector is anticipated to bode well for the market during the forecast period.
Sterility testing is essential for research and development purposes in pharmaceutical companies. It is a crucial step for determining the safety of drugs before consumption. In addition, sterility testing is also conducted in specific rooms in facilities to keep it germ-resistant. Drugs and vaccines undergone sterility testing can be commoditized and made commercially available to the masses. This can be beneficial to patients afflicted with cancer and cardiovascular diseases.
This report allows the user to gain a deeper understanding of the ongoing events and trends in the global market for sterility testing. By correlating the historical data with key market dynamics, analysts were able to make highly accurate projections in the report. MRFR’s report includes a thorough segmental analysis of the global sterility testing market segmented by product type, test type, end-user, and region with astute insights. This report has been prepared to assist industry participants in making informed decisions on growth strategies and operation management. Users will also come across drivers, trends, opportunities, and restraints which are likely to influence the growth of the market during the assessment period.
By product type, the sterility testing market has been segmented into instruments, consumables, and services. The services segment is further segmented into sterility assurance tests, sterility validations, cleaning and disinfection, and stability testing. By test type, the market is segmented into product flush sterility testing, membrane filtration sterility testing, direct transfer sterility testing, and others. By end-user, the market is segmented into academic and research laboratories, pharmaceutical companies, hospitals and clinics, and others.
The segments and sub-segments covered in the report are analyzed under four major regions –Americas, Europe, Asia Pacific (APAC), and the Middle East and Africa (MEA), with respective country-level market sizing. For the scope of research, the standard definition of the product/ service “sterility testing” is included in the report. The report discusses and interprets the current and future opportunities of the industry delivering an unbiased growth assessment.
Bioquell U.K. Ltd., Belimed Deutschland GmbH, Baxter BioPharma Solutions, Charles River Laboratories Inc., Boston Scientific Corporation, BioMérieux SA, Thermo Fisher Scientific Inc., SGS SA, Pacific BioLabs Inc., WuXi AppTec, Astell Scientific, Sartorius AG, Becton, Dickinson and Company, Merck KGaA, and others are prominent players in the sterility testing market.
The report offers comprehensive profiles on these market players and assesses their current standing in the sterility testing market. Company history coupled with annual turnover, segmental share, SWOT analysis, growth strategies, new product launches, M&A activities, and latest R&D initiatives are outlined in the report.
Market Research Future (MRFR) uses a combination of primary and secondary research to compile market reports. Primary data is accumulated from interviewing industry stalwarts and secondary research is collated by studying white papers and annual reports of leading players. Our analysts use top-down and bottom-up approaches to validate the findings of the report. The report consists of news, current trends, and future prospects related to the market, all of which can provide a thorough understanding of the market to clients. Industry leaders can make accurate business decisions based on our insights.
For the scope of research, the report offers a comprehensive analysis of the global sterility testing market.
Global Sterility Testing Market: Report Summary
The global sterility testing market is predicted to touch USD 1,245.2 million by 2023 from USD 575 million in 2016, expanding at an astounding CAGR of 11.7% during the assessment period (2017-2023). The rise in demands for sterile drugs can open up avenues for suppliers and manufacturers of sterility testing market. Developing countries, such as China and India, owing to advancements in biotechnology and pharmaceuticals, are emerging as prospective markets and have turned out to be the favorite destination of investment of various market players who are now expanding their operations in these regions.
The sterility testing market is segmented on the basis of product type, test type, and end-user. By product type, the global market for sterility testing is segmented into instruments, consumables, and services. The service segment is sub-segmented into sterility assurance tests, sterilization validations, cleaning and disinfection, stability testing, and others. Mostly, sterility assurance tests are performed to determine the sterility-assurance level (SAL) of perishable pharmaceutical products, such as injectable to ensure the sterility of the drugs. Owing to these features, the sterility assurance tests segment held the largest market in 2016 with a market valuation of USD 67.1 million. Current predictions estimate its valuation at USD 151.6 million by the end of the forecast period.
Segmentation based on test type includes membrane filtration sterility testing, direct transfer sterility testing, product flush sterility testing, and others. The membrane filtration sterility test is a regulatory method for filterable pharmaceutical samples containing preservatives, bacteriostatic compounds, inhibiting the microbial growth of potential contaminants. This method helps in retaining microorganisms via 0.45-micron pore size filter, and suitable solutions are used to rinse all the inhibiting compounds. The technique is followed by the selection of an appropriate media to support the growth of anaerobic and aerobic microorganisms on the membrane filters. The final results come after an incubation period of 14 days. Furthermore, its advantages, such as applicability to large volume samples and ability to remove inhibitory substances from the sample, boost the growth of this segment. Currently, the membrane filtration sterility testing segment generates the largest market share and is expected to reach USD 348.6 million by 2023 with a stellar CAGR of 12.1% during the forecast period.
End-users comprise pharmaceutical companies, hospital & clinics, academic & research laboratories, and others. Treatment of chronic diseases, such as cancer, cardiovascular diseases, and others have spurred the demands for sterile injectables, which in turn ensured pharmaceutical companies’ domination of the global market. A staggering growth has been predicted for this segment where it can reach USD 428.0 million, at a CAGR of 12.1% by the end of the foreccast period.
Regional Market Summary
The global sterility testing market, by regions, is segmented into the Americas, Europe, Asia Pacific (APAC) and the Middle East and Africa (MEA).
The Americas accounted for the most significant market share of about 42.1% in the global sterility testing market due to the presence of top-tier manufacturers, surging technological advancement in the pharmaceutical and biotechnology industries, and others.
Europe accounted for the second largest market share. The market in the region is experiencing a rapid increase in healthcare expenditures, and this can act as a market booster for sterility testing market.
The APAC market is expected to register the fastest CAGR of 12.4% during the forecast period. The region has a lot of developing economies with markets offering various opportunities making it a potential global influencer.
The MEA has a few deterrents, such as the presence of low-income countries and stringent government regulations, which impeded the growth in the past. The MEA market accounted for the least market share in 2016.
The key players of the global sterility testing market include Merck KGaA, Charles River Laboratories Inc., BioMérieux SA, Thermo Fisher Scientific Inc., BD, SGS SA, Baxter BioPharma Solutions, and others. Between 2014 and 2017, the primary market players were trying to sustain by adopting various growth strategies, such as expansion and mergers & acquisitions. For instance, BioMérieux SA acquired the U.S. company BioFire in 2014. Recently, consolidations are being witnessed in the market with the latest being the acquisition of MPI Research by Charles River Laboratories Inc. in 2018. Due to the substantial investments made by the key market players in expanding across borders, the global sterility testing market is experiencing an extensive growth.
Market Players have adopted the strategy of acquisitions, product launches, and partnerships for the development of the market
Merck KGaA is the market leader in the global sterility testing market with a market share of 18.7% in 2016. The company has a well-developed market, strong product portfolio, and effective distribution network around the globe. In the last three years, Merck KGaA has adopted the organic strategy of product launches and acquisitions to cement their position in the global sterility testing market. Moreover, the company has also increased investments in various R&D activities. This enabled them to launch innovative products in the market, thereby, expanding their market reach.
Charles River Laboratories Inc. assumed the second position in the global sterility testing market with a share of 12.4% in 2016. The company showed positive growth regarding revenue from 2015 to 2016 owing to strong sales in high potential emerging markets. Further, to sustain its place in the sterility testing market, the company follows strategic business strategies such as partnerships, collaborations, and acquisitions to expand their product portfolio and geographical reach. For instance, in July 2015, the company acquired Celsis International Ltd, which helped it in quality control testing of biopharmaceutical and consumer products industries.
BioMérieux SA was third in the global sterility testing market with a share of 9.3% in 2016. The company adopted the strategy of product launches to expand its market share and keep the sterility testing market updated. In addition, the company has a huge product portfolio and good brand identity.
Other prominent players in the market include Thermo Fisher Scientific Inc., Becton, Dickinson and Company (BD), SGS SA, and Baxter BioPharma Solutions. Other players accounted for a share of 48.2% in the market in 2016. Majority of the companies have adopted the strategy of acquisitions and product launches for market development. For instance, in September 2016, the company announced the acquisition of the laboratory products and services segment of Alfa Aesar, a company based in the U.K., forUSD 392 million. This acquisition would help in expanding the company’s existing portfolio of chemicals, solvents, and reagents.