Sterility testing plays an important role in the healthcare sector. It ensures the purity and safety of the product or a substance. This is a vital regulatory requirement for both pharmaceutical and medical device companies when bringing a product to market or assessing the post-launch safety of a product or device. It is an essential part of every sterilization validation and is an extremely difficult process that must be designed and executed for eliminating false positive results, which, are generally due to laboratory contamination from the testing environment or technician error.
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The major driving factor for the growth of the market are increasing manufactures of the medical devices & products, increasing prevalence of many infectious diseases, and increasing in the Research and development projects in life sciences. Increasing number of diseases has intensified the research activity which has significantly driven the market. Currently, about 27 million deaths occur each year in South and East Asia, 7 million among those are under 30 years of age, and 10 million fall in the middle-aged group. Beside this, huge population base in this region, rising outsourcing in the pharmaceutical sector to the emerging nations such as India and China, and rapid development in economy has provided a support for the growth of the market. Furthermore, growth of pharmaceutical industries, technological advances, increasing support provided by government and, the increasing R&D investments have fuelled the market growth in this region. However, a cumbersome approval process and strict regulatory rules are few factors responsible for restraining the market growth.
Sterility also relies on procedural measures that effectively prevent contamination of biological materials, such as clean room technology and other Good Manufacturing Practices.
The Asia Pacific sterility testing market is expected to grow at a CAGR of 10.2% during 2017-2023
Product manufacturers of sterility product
Sterility Testing Product Distributors
Government and private research companies
Research and Development (R&D) Companies
Hospitals and Laboratories
Medical Research Laboratories
Academic Medical Institutes and Universities
Asia Pacific sterility testing market is segmented on the basis of products, types of test, application, and end users.
On basis of type of product the market is segmented into instrument, reagent & services, kits and others.
On the basis of type of tests, the market is segmented into membrane filtration sterility testing, direct incubation sterility testing, direct transfer and others.
On Application, the market is segmented into pharmaceutical & biological manufacturing, medical devices manufacturing, and others.
On the basis of end user, they are segmented into pharmaceuticals, hospital & laboratories and other.
On the regional basis Asia Pacific is segmented into Japan, India, China, the republic of Korea, Australia and the Rest of Asia Pacific.
Japan holds a major shares of the market owing to increase in number of approval of new drugs and high spending on quality control.
China and India has a growing market due to huge population base, increasing demand for the better quality products, rapidly changing economy, increasing healthcare expenditure, and increasing number of pharmaceutical & biotechnological companies.
Reports suggest that China and Southeast Asia are poised to join the ranks of the high-growth Asian economies such as Korea and Taiwan
Rest of Asia Pacific holds the least share in the market.
Increasing number of healthcare organizations like hospital, private research institute has led to increase in the market in India.
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Some of the major player in the market are Avance Biosciences (U.S.), Boston Scientific Corporation (U.S.), Paragon Bioservices, Inc (U.S.), Merck KGaA (Germany), Thermo Fisher Scientific, Inc. (U.S.), Charles River Laboratories International, Inc. (U.S.), Avista Pharma Solutions (U.S.), and DYNALABS LLC. (U.S.)
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