The Global Sterility Testing Market size is expected to reach $2 billion by 2029, rising at a market growth of 10.2% CAGR during the forecast period.
Pharmaceutical, biotechnology, and medical device companies use sterility testing to evaluate the quality of the raw materials, process control, and the result. Through sterility testing, the existence or absence of living bacteria that are capable of procreating and multiplying under optimum conditions is identified.
Additionally, sterility testing is done on raw materials, cell banks, and pharmaceuticals in bulk and final form. The rising demand for sterilized goods will likely lead to growth in the sterility testing market in the near future. However, the growth media must also be properly produced and tested to guarantee the most effective microbiological growth during sterility testing.
The market is expanding due to rising life sciences research and development, increased drug launches, and rising sterilized product demand. During the forecast period, it is also anticipated that the market will be driven by the rising demand for sterilized products around the world as well as a few potential safety concerns related to the products, which typically arise from manufacturing processes that involve the complicated biological or structural characteristics of the products.
Infectious disease detection is a diagnostic method that uses various diagnostic tools and is carried out by trained technicians or medical professionals to identify the presence of foreign antigens or organisms. The sample of mucus, urine, blood, or other body fluids is examined using various diagnostic techniques and tools to reveal details about the pathogenic organism.
While pharmaceutical and biotech companies get to find a cure for the COVID-19 coronavirus, speedy testing is essential to guarantee that the vaccine is secure, efficient, and approved by regulatory bodies. A final product sterility test must be performed on each vaccine and injection before they may be given to patients. Because of the existing procedure that many vaccine producers utilize, each lot of vaccine must wait two weeks before it is made available to the general public. Before a COVID-19 vaccine is approved by the regulatory body, manufacturers and governments must seek quick solutions to meet the need for mass production and the market. Therefore, during the pandemic periods, the sterility testing market continued to witness growth, which will remain the same after the pandemic.
Sterility testing is carried out at all stages of manufacture in the pharmaceutical and biopharmaceutical sectors to reduce the possibility of product contamination. Therefore, expanding this end-use business in the upcoming years will significantly increase the usage of sterility testing. The need for sterility testing goods and services will increase as the production capacity of pharmaceuticals & biopharmaceuticals increases globally. Pharmaceutical and biopharmaceutical products must undergo sterility testing at every stage of production. As a result, more kits, reagents, and equipment for sterility testing will be used due to increasing production capacity in the pharmaceutical and biopharmaceutical industries.
Traditional microbiological testing techniques for detection, enumeration, sterilization, and identification frequently relied heavily on culture procedures and were time- and labor-intensive. The limitation of such processes regarding practical concerns frequently restricts how frequently microbiological tests are used for both microbiological quality assurance and formulation development. Numerous more cutting-edge and forthcoming techniques exist, like the Merk Millipore MF sterility test device, which aseptically filters liquid samples for sterility testing and may have broad applications in the pharmaceutical industry. This is anticipated to be one of the key drivers of the sterility testing market's expansion.
Single-use technology replaces the stainless-steel & hard-piped configurations utilized in sterile production or aseptic processing. Single-use technology employs gamma-irradiated pre-assembled process systems. This technique is utilized for both upstream and downstream processing in addition to the aseptic filling. The fundamental advantage of single-use technology is that no time or money is spent on labor-intensive cleaning, costly sterilization validation tests, or their ongoing revalidation. It also eliminates the need for system sterilization and cleaning in between batches. The need for sterility testing for both products and services will be hampered by the adoption of such technology.
By product & service, the sterility testing market is divided into kits & reagents, services, and instruments. The services segment garnered a significant revenue share in the sterility testing market in 2022. To create new drugs & medical equipment, the pharmaceutical & biotech companies are significantly funding R&D. To assure the security and effectiveness of these products, this has boosted the need for sterility testing.
Based on test type, the sterility testing market is segmented into membrane filtration, direct inoculation and other tests. In 2022, the membrane filtration segment registered the maximum revenue share in the sterility testing market. Test samples are passed over a conventional membrane that captures and holds bacteria during membrane filtration sterility testing. Membrane filtration is often utilized for all purposes, including vaccines and samples with adjuvant gel. When utilizing membrane filtration, microorganisms are held in place by a 0.45 m pore-size filter, and all interfering substances are removed using the proper rinsing solution. This testing is most popular in the pharmaceutical industry.
On the basis of application, the sterility testing market is bifurcated into pharmaceuticals & biologicals, medical devices, and other applications. The medical devices segment acquired a substantial revenue share in the sterility testing market in 2022. For assessing the sterility of medical devices, direct transfer sterility is advised. Throughout the incubation period, when any microorganisms in or on the device will develop and propagate, the test device is in direct contact with the test media. For items with hollow tubes, including transfusion & infusion assemblies, product flush sterility testing is suggested when the fluid channel is indicated as sterile.
By end-user, the sterility testing market is categorized into pharmaceutical companies, biotechnical companies and others. In 2022, the pharmaceutical companies segment witnessed the largest revenue share in the sterility testing market. Since most of these medicines are consumed by patients, pharmaceutical companies must undergo sterility testing to guarantee product safety, particularly for oral dosage forms. The requisite sterility tests that must be carried out for a particular drug are specified in detail in each nation's pharmacopeia according to predefined regulations.
| Report Attribute | Details |
|---|---|
| Market size value in 2022 | USD 1 Billion |
| Market size forecast in 2029 | USD 2 Billion |
| Base Year | 2022 |
| Historical Period | 2019 to 2021 |
| Forecast Period | 2023 to 2029 |
| Revenue Growth Rate | CAGR of 10.2% from 2023 to 2029 |
| Number of Pages | 241 |
| Number of Table | 440 |
| Report coverage | Market Trends, Revenue Estimation and Forecast, Segmentation Analysis, Regional and Country Breakdown, Companies Strategic Developments, Company Profiling |
| Segments covered | Product, Test Type, Application, End User, Region |
| Country scope | US, Canada, Mexico, Germany, UK, France, Russia, Spain, Italy, China, Japan, India, South Korea, Singapore, Malaysia, Brazil, Argentina, UAE, Saudi Arabia, South Africa, Nigeria |
| Growth Drivers |
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| Restraints |
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Region wise, the sterility testing market is analyzed across North America, Europe, Asia Pacific and LAMEA. In 2022, the North America region led the sterility testing market by generating the highest revenue share. Expanding the pharmaceutical businesses in the United States and Canada may be responsible for this. A significant expansion in the market is anticipated as a result of the huge number of prominent market players present in this region. The expansion is further supported by the region's strict regulatory requirements for the sterility testing of pharmaceuticals & medical equipment.
Free Valuable Insights: Global Sterility Testing Market size to reach USD 2 Billion by 2029
The market research report covers the analysis of key stakeholders of the market. Key companies profiled in the report include Thermo Fisher Scientific, Inc., Charles River Laboratories International, Inc., SGS S.A., Merck KGaA, BioMérieux S.A., WuXi AppTec Co., Ltd., Sartorius AG, Samsung Biologics Co., Ltd. (Samsung Group), Nelson Laboratories, LLC (Sotera Health Company) and Pacific Biolabs, Inc.
By Product
By Test Type
By Application
By End User
By Geography
The Market size is projected to reach USD 2 billion by 2029.
Emergence of advanced technology in pharmaceutical testing are driving the Market in coming years, however, Rising acceptance of single use technology restraints the growth of the Market.
Thermo Fisher Scientific, Inc., Charles River Laboratories International, Inc., SGS S.A., Merck KGaA, BioMérieux S.A., WuXi AppTec Co., Ltd., Sartorius AG, Samsung Biologics Co., Ltd. (Samsung Group), Nelson Laboratories, LLC (Sotera Health Company) and Pacific Biolabs, Inc.
The Pharmaceuticals & Biologicals market generated the high revenue in the Global Sterility Testing Market by Application in 2022; thereby, achieving a market value of $1.1 billion by 2029.
The Kits & Reagents market is leading the segment in the Global Sterility Testing Market by Product in 2022; thereby, achieving a market value of $1.1 billion by 2029.
The North America market dominated the Market by Region in 2022; thereby, achieving a market value of $829.9 million by 2029.
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