Wilmington, Delaware, United States, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Transparency Market Research Inc. - The sterility testing industry was valued at US$ 1.8 billion in 2022. A CAGR of 6.2% is projected from 2023 to 2031, reaching US$ 3.1 billion by the end of the forecast year. Sterile testing will benefit greatly from continued technological advancements in the future. A faster, more efficient way to test could be developed and adopted to speed up the process.
Rapid microbiological methods are being explored and adopted by the pharmaceutical industry for sterility testing. Traditional methods take longer to provide results, preventing product release and ensuring contamination issues are dealt with quickly. These methods provide faster results, reducing the time required for product release.
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Nucleic acid amplification techniques (NAT) have made significant advances in recent years. For the detection of unknown contaminants, NAT assays are preferable to broad general tests. The technology can also be used as an alternative to or in conjunction with cell culture, using appropriate techniques for mycoplasma detection, following validation by the national regulatory agency, in lieu of either of the compendial mycoplasma detection methods.
Key Findings of the Market Report
- Kits and reagents are predicted to dominate the market in the future.
- The biopharmaceutical industry is expected to generate demand in the next few years.
- Based on test type, the rapid sterility tests segment is expected to be a significant market by 2031.
- North America dominated the global market in 2022.
Global Sterility Testing Market: Growth Drivers
- Growing demand for innovative treatments and aging populations have driven the growth of the pharmaceutical and biotechnology sectors. Testing pharmaceutical products for sterility is vital to ensuring their safety and efficacy. Several regulatory agencies, such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), impose strict guidelines for the approval of pharmaceutical products. Sterility testing is crucial in the regulatory process to ensure patient safety and compliance with quality standards.
- The pharmaceutical industry invests significantly in research and development to introduce new drugs to the market. Testing sterility ensures that the final product is contamination-free during development and approval. The growth of the sterility testing market is largely attributed to technological advancements in sterility testing, such as microbiological rapid testing methods, automated testing, and novel detection methods. Tests are often conducted more efficiently using these technologies, which provide faster, more accurate results.
- With the globalization of pharmaceutical manufacturing, standard testing methods are becoming increasingly crucial to product safety and quality. Sterility testing is vital to maintaining quality throughout the global pharmaceutical supply chain. Medical product quality control is a growing concern for pharmaceutical companies as they strive to ensure patient safety. As a result, the sterility testing market is driven by concerns about patient safety.
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Global Sterility Testing Market: Regional Landscape
- Sterile tests are expected to be the most popular market in North America. Biotechnology and pharmaceutical industries are important parts of the global market in North America. In addition to continuously developing new drugs and biologics, the demand for sterility testing is driven by the need for reliable testing methods.
- Pharmaceuticals and biotechnology products are regulated rigorously in North America, particularly the United States. Product quality and safety are highly regulated by the FDA, including the requirement for sterility testing. This regulatory framework drives sterile testing products and services.
- North America is often a leader in the adoption of new technologies. In order to improve efficiency and accuracy, companies in the region are likely to adopt advances in sterility testing methods and technologies such as rapid methods and automation. Pharmaceutical companies often outsource sterility tests to specialized laboratories. A focus on core competencies and cost-effectiveness are driving this trend.
Global Sterility Testing Market: Key Players
Leading companies are expanding their global presence through acquisitions and partnerships. Sterility testing manufacturers offer advanced testing kits based on the latest market trends. Their research and development efforts are focused on achieving high levels of accuracy and quick results.
- bioMerieux SA
- Merck KGaA
- Thermo Fisher Scientific
- Sartorius AG
- Charles River Laboratories International Inc.
- Solvias AG
- Becton, Dickinson, and Company
- Rapid Micro Biosystems Inc.
Key Developments
- In October 2023, Sharp purchased Berkshire Sterile Manufacturing (BSM), a Massachusetts-based product developer and manufacturer of injectable sterile products. Through the acquisition, Sharp can provide small and mid-scale biopharmaceutical companies with fully integrated sterile injectable service offerings.
- In December 2023, Symbiosis Pharmaceuticals will be able to test small molecules, biological products, and advanced therapeutic medicinal products (ATMPs) as part of a €1 million investment. In addition to sterility tests, the new labs will offer microbiology and analytical testing in addition to existing subcontracting services.
Global Sterility Testing Market: Segmentation
By Product
- Kits and Reagents
- Instruments
- Others
By Application
- Biopharmaceutical Manufacturing
- Medical Device Manufacturing
- Others
By Test Type
- Traditional Sterility Tests
- Membrane Filtration
- Immersion Test
- Rapid Sterility Tests
- Solid Phase Cytometry
- Flow Cytometry
- Bioluminescence
- Nucleic Acid Amplification
- Immunological Methods
- Others
By Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
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