Sterility Testing Market

Global Sterility Testing Market Size (2024 to 2029)

The size of the global sterility testing market is estimated to be worth USD 3.026 billion by 2028 and USD 1.56 billion in 2023, growing at a CAGR of 14.12% from 2023 to 2028.

MARKET DRIVERS

The growing demand for sterilized pharmaceutical products is one of the major factors propelling the market growth. The awareness among healthcare professionals regarding the importance of sterilization of drugs, vaccines, and medical devices has increased significantly, especially in hospital settings to ensure patient safety. Pharmaceutical and biopharmaceutical companies have been doing rigorous sterility testing on their drugs, vaccines, and medical devices before releasing their products to the market, which is resulting in the increasing demand for sterility testing. Technological advancements are contributing to market growth. The development of rapid and accurate sterility testing methods accelerated the efficiency and accuracy of testing and due to this, the demand for sterility testing methods has grown notably.

In addition, a stringent regulatory environment for pharmaceutical products boosts the growth rate of the sterility testing market. The governments of several countries have made it mandatory that all pharmaceutical and biopharmaceutical products must undergo sterility testing before releasing them into the market and this has resulted in the increasing demand for sterility testing services. Rapid growing biopharmaceutical industry and massive production of biologics and biosimilars that require thorough sterility testing further boost the market’s growth rate.

Furthermore, the growing outsourcing of sterility testing services by pharmaceutical and biopharmaceutical companies, the rising use of combination products, the growing incidence of HAIs, and the rising adoption of personalized medicine contribute to the market’s growth rate. The growing number of surgeries and invasive procedures, rising emphasis on quality control and assurance, increasing demand for cleanroom technology, rising focus on bioburden testing and raising awareness of the importance of infection control support the growth rate of the market.

MARKET RESTRAINTS

Stringent regulatory requirements for sterility testing to ensure the safety and efficacy of pharmaceutical and biopharmaceutical products by regulatory bodies such as the FDA and EMA is one of the major factors hampering the market growth. High costs associated with equipment and testing used for sterility testing and the scarcity of skilled professionals further hinder the market growth. The competition from alternative testing methods such as rapid microbial detection methods and in vitro assays inhibits the growth rate of the market. Limited applications of sterility testing, issues with sample preparation and limited standardization of sterility testing impede the market growth.

Impact of COVID-19 on the global sterility testing market

The COVID-19 pandemic has accelerated the need for sterility testing and favored the sterility testing market growth. The demand for sterile products such as vaccines, medications and medical devices has increased significantly during the COVID-19 pandemic and resulted in the growing need for sterility testing to ensure the safety and efficacy of these products. The development of a vaccine for COVID-19 has become the top priority to the healthcare system during the COVID-19 pandemic. Several pharmaceutical and biotechnological companies have invested significant resources in the development of the vaccine and this has increased the demand for sterility testing services and supported the market growth. The adoption of automated sterility testing solutions has also increased notably during the COVID-19 pandemic as these solutions can significantly help streamline the testing process and reduce the risk of contamination. Such factors have contributed to the growth of the sterility testing market during the COVID-19 pandemic. The sterility testing market is also expected to continue the growing trend post-COVID-19 pandemic as well owing to the growing awareness among pharmaceutical companies regarding the importance of sterility testing practices.

REPORT COVERAGE

SEGMENTAL ANALYSIS

Sterility Testing Market - By Product Type:

• Kits and reagents
• Instruments
• Services

Based on product type, the kits and reagents segment held the major share of the worldwide market in 2022 and the segmental domination is anticipated to continue throughout the forecast period. The rising demand for pharmaceutical and biopharmaceutical products that require rigorous sterility testing to ensure their safety and efficacy, the development of new and innovative kits and reagents, such as rapid microbial detection kits and growth-based assays, increasing prevalence of chronic diseases and the growth of the biotechnology industry primarily drive the segmental growth.

The services segment had the second-largest share of the worldwide market in 2022 and is estimated to grow at a steady CAGR during the forecast period. The growing demand for outsourcing sterility testing services that can help companies reduce costs and improve efficiency, the rising complexity of sterility testing, the need for specialized expertise and the increasing adoption of sterility testing in emerging markets such as Asia Pacific and Latin America contribute to the growth of the segment.

The instruments segment is predicted to witness a moderate CAGR during the forecast period owing to factors such as the growing demand for automated and high throughput testing systems that improve the efficiency and accuracy of sterility testing and the development of new and innovative instruments, such as flow cytometers and real-time PCR systems.

Sterility Testing Market - By Type:

• Membrane filtration
• Inoculation
• Incubation

Based on the type, the membrane filtration segment had the major share of the worldwide market in 2022 and is expected to continue holding the largest share of the global market throughout the forecast period. The growing demand for sterile filtration in the pharmaceutical and biopharmaceutical industries and rapid adoption of membrane filtration in other industries, such as food and beverage and cosmetics drive the segmental growth.

The incubation segment is anticipated to grow at a steady CAGR during the forecast period owing to factors such as the growing demand for traditional testing methods, as well as the growing prevalence of chronic diseases and the resulting demand for sterile pharmaceutical and biopharmaceutical products.

The inoculation segment is expected to register a moderate CAGR in the coming years. Factors such as the rising demand for rapid microbial detection and identification, as well as the development of new and innovative culture media and detection systems boost the growth rate of the segment.

Sterility Testing Market - 

By Application:

• Pharmaceuticals
• Biological manufacturing
• Medical devices and manufacturing
• Others

Based on the application, the pharmaceuticals segment accounted for the leading share of the worldwide market in 2022 and the segmental domination is anticipated to continue throughout the forecast period. Factors such as the rising demand for sterile pharmaceutical products, the growing prevalence of chronic diseases and the resulting demand for advanced pharmaceutical products drive segmental growth.

The biological manufacturing segment is expected to grow at a promising CAGR in the coming years owing to the rising demand for biopharmaceutical products that require rigorous sterility testing to ensure their safety and efficacy, the growing prevalence of chronic diseases and the development of new and innovative biologic therapies.

The medical device manufacturing segment is estimated to grow at a steady CAGR during the forecast period. The growth of the segment is favored by increasing demand for sterile medical devices, as well as the growing emphasis on infection control and prevention in healthcare settings.

Sterility Testing Market - By End-Users:

• Pharmaceuticals
• Laboratories
• Hospitals
• Clinics

Based on the end-users, the pharmaceuticals segment had the largest share of the global sterility testing market in 2022 and is expected to grow at a healthy CAGR during the forecast period. Factors such as the growing demand for sterile pharmaceutical products and the need to ensure their safety and efficacy and stringent regulatory requirements regarding sterility testing contribute to the growth of the segment majorly.

The laboratories segment accounted for the second biggest share of the worldwide market in 2022 and is estimated to grow at a notable CAGR during the forecast period due to factors such as the demand for accurate and reliable testing services across various industries and the rising adoption of automated testing systems and the development of new and innovative testing methods.

The hospital segment is anticipated to witness a moderate CAGR during the forecast period.

Sterility Testing Market - By Region:

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa

North America dominated the sterility testing market in 2022. The North American market is expected to grow at a promising CAGR during the forecast period owing to factors such as the presence of major pharmaceutical companies that require stringent sterility testing protocols to comply with regulatory requirements, growing government investments in healthcare and stringent regulatory requirements regarding sterility testing. In addition, the rapid adoption of advanced technologies and increasing demand for personalized medicine contribute to the growth rate of the regional market. Furthermore, the growing prevalence of infectious diseases and chronic diseases in North America and the rising awareness about the importance of sterility testing in healthcare fuel the regional market. The U.S. held the major share of the North American market in 2022, followed by Canada. The U.S. market is expected to register a promising CAGR during the forecast period due to the presence of major pharmaceutical companies, such as Pfizer and Johnson & Johnson, the growing demand for sterile medical devices and drugs and the growing trend toward personalized medicine.

Europe occupied the second biggest share of the worldwide market in 2022 and is anticipated to grow at a noteworthy CAGR during the forecast period. The rising demand for sterile products due to the aging population and the increasing prevalence of chronic diseases in Europe and the need to ensure their safety and efficacy, growing focus on the development of biosimilars and generic drugs and rising demand for personalized medicine drive the regional market growth. Germany accounted for the leading share of the European market in 2022 and is anticipated to grow at a notable CAGR during the forecast period owing to the presence of a large and aging population, the rising trend towards biosimilars and generic drugs and a strong regulatory environment and increasing demand for personalized medicine.

APAC is a lucrative regional market for sterility testing and is estimated to occupy a considerable share of the global market during the forecast period. Factors such as the rapidly growing pharmaceutical industry, the increasing adoption of advanced technologies, the presence of a large patient population and increasing government investments in healthcare primarily drive the sterility testing market in the Asia-Pacific region. The growing trend towards medical tourism in the region that requires strict adherence to sterility testing standards further fuel the growth rate of the APAC market. Japan occupied the major share of the APAC market in 2022 and is expected to continue dominating the APAC market during the forecast period owing to the rapid adoption of new and advanced technologies, such as automation and AI.

Latin America is estimated to witness a healthy CAGR during the forecast period. The rising demand for sterile medical devices and drugs due to an increasing prevalence of chronic diseases, growing investments in healthcare infrastructure and the adoption of new technologies, the presence of a large and growing middle class and rising focus on the development of biosimilars and generic drugs that require extensive testing to ensure safety and efficacy drive the growth rate of the Latin American market.

MEA is expected to register a steady CAGR during the forecast period.

KEY PLAYERS IN THE GLOBAL STERILITY TESTING MARKET

Merck KGaA, Charles River Laboratories International, Inc., Biomérieux SA, SGS S.A., Danaher Corporation, Nelson Laboratories, Pacific Biolabs, Sartorius AG, Thermo Fisher Scientific Inc., Toxikon Corporation, and Wuxi Apptec are some of the dominating companies operating in the space of the sterility testing market.

RECENT HAPPENINGS IN THE MARKET

• In 2016, Merck KGaA, a German-based launched Steritest Symbio Pump systems accessory.
• In 2015, Danaher acquired US-based Pall Corporation. This helped the company to add up Pall Corporation’s sterility filtration products to its existing product portfolion

DETAILED SEGMENTATION OF THE GLOBAL STERILITY TESTING MARKET INCLUDED IN THIS REPORT

This market research report on the global Sterility Testing market has been segmented and sub-segmented based on the type, product type, application, end-user, and region.

By Product Type

• Kits and reagents
• Instruments
• Services

By Type

• Membrane filtration
• Inoculation
• Incubation

By Application

• Pharmaceuticals
• Biological manufacturing
• Medical devices and manufacturing
• Others

By End-Users

• Pharmaceuticals
• Laboratories
• Hospitals
• Clinics

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa