Global Sterility Testing Market Size, Share & Industry Trends Analysis Report By Product, By Test Type (Membrane Filtration, Direct Inoculation and Others), By Application, By End User, By Regional Outlook and Forecast, 2023 - 2029

Global Sterility Testing Market Size, Share & Industry Trends Analysis Report By Product, By Test Type (Membrane Filtration, Direct Inoculation and Others), By Application, By End User, By Regional Outlook and Forecast, 2023 - 2029

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.

COVID-19 Impact Analysis

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.

Market Growth Factor

Growing production capacities of pharmaceutical & biopharmaceutical companies

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.

Emergence of advanced technology in pharmaceutical testing

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.

Market Restraining Factor

Rising acceptance of single use technology

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.

Product Outlook

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.

Test Type Outlook

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.

Application Outlook

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.

End User Outlook

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.

Regional Outlook

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.

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.

Scope of the Study

Market Segments covered in the Report:

By Product

Kits & Reagents
Instruments
Services
By Test Type

Membrane Filtration
Direct Inoculation
Others
By Application

Pharmaceuticals & Biologicals
Medical Devices
Others
By End User

Pharmaceutical Companies
Biotechnology Companies
Others
By Geography

North America
US
Canada
Mexico
Rest of North America
Europe
Germany
UK
France
Russia
Spain
Italy
Rest of Europe
Asia Pacific
China
Japan
India
South Korea
Singapore
Malaysia
Rest of Asia Pacific
LAMEA
Brazil
Argentina
UAE
Saudi Arabia
South Africa
Nigeria
Rest of LAMEA
Companies Profiled

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)
Pacific Biolabs, Inc.
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