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Global Statistics Representing Sterility Testing Market Scenario

Sterility testing is used for the quality assurance in the biopharmaceutical industry and medical devices industry. Skilled professionals are required to carry out the sterility testing procedure which assures the authentic sterility test data. Sterility testing exclusivity in various industries is the factor for rise in demand which is anticipated to boost the market growth across the globe.

Ongoing research & development, surge in prevalence of chronic and severe disease, and rise in demand for sterility testing are some of the factors driving the global sterility testing market. High prevalence of chronic diseases such as cancers, cardiac diseases, and other severe diseases across the globe is the vital factor for increasing demand for sterility testing. According to the American Cancer Society, in 2017, over 1.7 million cases of cancer were registered in the U.S. Moreover, according to the American Heart Association and America Stroke Association, due to cardiac diseases around 2,200 Americans die every day in the U.S. Some of the other factors supporting the market growth are developing diagnostics & healthcare infrastructures and growing pharmaceutical and biotechnology companies worldwide.

However, stringent regulatory guidelines and time consuming approval processes are the vital factors which are likely to affect the sterility testing market adversely and restrain the market growth during the forecast period 2019–2026. Other factors which may slow the market growth are lack of skilled professionals and high degree of consolidation which acts as barrier for the new entrants of the market.

The sterility testing market was valued at USD 810 million in 2017 and is projected to witness CAGR growth of 7.4% during the forecast period 2019-2026 to surpass the value of USD 1,617 million by 2026.

Segmental Insights

The global sterility testing market is segmented on the basis of test type, product type, application, and region.

Based on test type, the sterility testing market is segmented into rapid sterility tests and conventional sterility tests. Rapid sterility tests is further segmented into Solid phase cytometry, bioluminescence, flow cytometry, immunological methods, nucleic acid amplification, and others. Conventional sterility tests are further segregated into membrane filtration and immersion test. Conventional sterility tests segment is expected to account for largest share of the global sterility testing market. Growth of the conventional sterility tests is attributed to the low setup cost and return on investment within short period of time. Rapid sterility tests segment is expected to experience swift growth during the forecast period 2019–2026.

Based on product type, the market is segregated into instruments, kits & reagents, and others. Amongst product type, kits & reagents segment is expected to account for major share of the global sterility testing market owing to the requirement of repetitive purchase, easy product affordability, and ongoing research & development activity. Instruments segment is anticipated to account for significant share of the market.

On the basis of application, the market is segregated into medical devices manufacturing, biopharmaceutical manufacturing, and others. Biopharmaceutical manufacturing is anticipated to dominate the market owing to the ongoing research and development for several chronic and severe diseases. Medical devices manufacturing is expected to grow significantly over the forecast period 2019–2026.

Regional Insights

In terms of region the global sterility testing market is segmented into North America, Europe, Asia Pacific, the Middle East & Africa, and Latin America.

North America dominates the global sterility testing market owing to the highly developed healthcare and research & development facilities in the region. Presence of leading biopharmaceutical and biotechnology companies along with ongoing research & development for cure on the chronic diseases are some of the other factors supporting the market growth in the region.

Europe sterility testing market is expected to experience significant growth over the forecast period 2019–2026. High number of diagnostics labs and research & development facilities in the region and rise in the demand for sterility testing are some of the vital factors driving the Europe sterility testing market.

Asia Pacific is the fastest growing market for sterility testing owing to the high number of pathology labs, diagnostics labs, and research & development facilities. Increasing prevalence of chronic diseases in the region is the other factor for rise in demand for sterility testing which in turn supports the Asia Pacific sterility testing market growth.

The Middle East & Africa is anticipated to account for significant share of the global sterility testing market owing to the developing healthcare and diagnostic infrastructure. Increasing tourism and rising medical tourism in the region is the other factor positively influencing the market growth.

Latin America accounts for least share of the global sterility testing market owing to the poor healthcare and diagnostics infrastructure and lack of awareness among people regarding the sterility testing. Other factor which may hamper the market growth is lack of skilled professionals in the region along with less healthcare expenditure.

Key Players

Some of the key players in the global sterility testing market are Merck KGaA, Sartorius AG, Thermo Fisher Scientific Inc., bioMerieux SA, Sartorius AG, Becton, Dickinson and Company and Rapid Micro Biosystems, Inc.

Segmentation

By Test Type

  • Rapid Sterility Tests
    • Solid phase Cytometry
    • Bioluminescence
    • Flow Cytometry
    • Immunological methods
    • Nucleic acid amplification
    • Others
  • Conventional Sterility Tests
    • Membrane Filtration
    • Immersion Test

By Product Type

  • Instruments
  • Kits & Reagents
  • Others

By Application

  • Medical Devices Manufacturing
  • Biopharmaceutical Manufacturing
  • Others

By Region

  • North America (U.S.  and Canada)
  • Europe (France, Germany, Italy and Rest of Europe)
  • Asia-Pacific (India, South Korea, China, Japan, and Rest of Asia-Pacific)
  • MEA (Saudi Arabia, UAE, South Africa, andRest of MEA)
  • Latin America (Argentina, Brazil, and Rest of Latin America)

Why Buy This Report?

In July 2018, Food & Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), published 6 gene therapy related guidance’s through which FDA promoted rapid sterility testing for human gene therapy products.

FDA approvals of sterility testing for new vast area of application is expected to drive the market growth in the near future. Ongoing research & development activities for advanced sterility testing is expected to support the market growth.

Our report covers the sterility testing market insights, focusing on recent developments in the market in different regions and development strategies of the companies. Moreover, following sections are specifically covered in the report.

  • Definitive Market Data
  • Sterility Testing Market Analysis
  • Recent Opportunities in the Market
  • 6-7 year performance forecasts: major segments covering test type, product type, application and region
  • Market Share Analysis
  • Potential Venture Avenues


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