Sterility Testing Market Assessment, By Test Type [Rapid Sterility Tests, Conventional Sterility Tests], By Product and Service [Kits and Reagents, Instruments, Services], By Application [Pharmaceutical and Biopharmaceutical Manufacturing, Medical Device

Sterility Testing Market Assessment, By Test Type [Rapid Sterility Tests, Conventional Sterility Tests], By Product and Service [Kits and Reagents, Instruments, Services], By Application [Pharmaceutical and Biopharmaceutical Manufacturing, Medical Device Manufacturing, Others], By End-user [Pharmaceutical and Biotechnology Companies, Hospitals and Clinics, Academic and Research Laboratories, Others], By Region, Opportunities and Forecast, 2017-2031F

Global sterility testing market is projected to witness a CAGR of 10.73% during the forecast period 2024-2031, growing from USD 1.22 billion in 2023 to USD 2.76 billion in 2031. The market has undergone substantial growth and is expected to further grow manifold during the forecast period.

Pharmaceutical sterility testing is a critical quality control process used in the pharmaceutical industry to ensure that a pharmaceutical product is free from viable microorganisms, including bacteria, fungi, yeast, and other potentially harmful contaminants. The primary objective of sterility testing is to verify that a pharmaceutical product is sterile and safe for patient use. This testing process is especially vital for injectable drugs, ophthalmic preparations, and other sterile pharmaceuticals where the presence of microorganisms can pose significant health risks to patients. The pharmaceutical industry is expanding, with an increasing number of drugs and biologics in development. The growth generates a need for robust sterility testing to ensure product safety and efficacy. The COVID-19 pandemic highlighted the importance of rapid and reliable sterility testing. To address newly emerging infectious diseases, the pharmaceutical sector is probably going to keep concentrating on improved testing techniques. The pharmaceutical industry is becoming more and in its operations. For instance, the European Centre for Disease Prevention and Control (ECDC) stated in January 2024 that hospital sterilization services increased 15% throughout Europe over the previous year. The necessity to uphold strict cleanliness standards to stop Healthcare-Associated Infections (HAIs) and the development of COVID-19, especially in surgical wards and intensive care units, was the main cause of this spike. Standardized sterility testing procedures and regional regulatory harmonization are required for this expansion. Technological developments in biotechnology, such as gene and cell therapies, present novel obstacles for sterility testing and stimulate the creation of creative testing approaches. Sterile testing is frequently contracted out to specialized contract testing laboratories by pharmaceutical corporations. Access to knowledge, scalable capacity, and cost effectiveness are the main forces behind the outsourcing movement.

Rising Prevalence of Infectious Diseases to Lead to Market Expansion

The market for sterility testing has grown dramatically in recent years due to the increased occurrence of infectious diseases. Stricter testing protocols are needed to guarantee the safety and effectiveness of pharmaceuticals, medical devices, and biologics as infectious diseases become more widespread worldwide. Before these medical products are put in the market or given to the patients, sterility testing is essential in ensuring that there are no live germs present. To stop the spread of contagious diseases, governments and regulatory agencies around the world have put strict norms and regulations for the production and testing of medicines and medical equipment. The requirement for sterility testing has increased due to the current regulatory framework as market approval is liable to compliance.

Furthermore, technological developments have increased the accuracy and efficiency of sterility testing methods, increasing their dependability and affordability. These technological developments, support the market's expansion, including automated systems, quick testing procedures, and enhanced detection approaches. In conclusion, sterility testing has become more crucial than ever for guaranteeing product safety and regulatory compliance due to the increased incidence of infectious diseases. As a result, the market for sterility testing has grown as pharmaceutical businesses and healthcare providers place a higher priority on strict quality control procedures to safeguard public health.

For instance, the multidrug-resistant fungus Candida auris caused an outbreak in 2023, which brought attention to the urgent need for improved sterilization services. This bacterium quickly spread throughout healthcare facilities, posing a threat to the effectiveness of current infection control systems. It is known to cause severe infections with high fatality rates. As the Centers for Disease Control and Prevention (CDC) stresses upon the need of strict sterilization procedures to stop its spread, more money has been invested in innovative sterilization technologies. This case demonstrated the critical role sterilization services play in controlling drug-resistant infections that are evolving and propelling market expansion in response to pressing public health concerns.

Technological Development to Fuel Market Growth

Technological developments have greatly increased the sterility testing market's growth by improving the efficacy, precision, and dependability of testing procedures. Robotics and sophisticated instrumentation are examples of automated methods that have simplified the sterility testing procedure, decreasing human error and boosting throughput. Higher testing volumes and faster turnaround times are made possible by these systems, which are essential in sectors, such as biotechnology and pharmaceuticals, where time-to-market is a key. Moreover, quick microbiological testing procedures have been developed using methods such as flow cytometry, adenosine triphosphate (ATP) bioluminescence, and polymerase chain reaction (PCR). When compared to conventional culture-based procedures, these techniques allow faster diagnosis of any possible microbial contamination, which expedites the discharge of products and enhances overall operating efficiency. Improvements in technology have increased the sensitivity of detection, making it possible to identify toxins at low concentrations that may have gone undetected in the past.

This increased sensitivity makes sure that goods go through extensive testing and satisfy strict quality and regulatory criteria. Considering this, the incorporation of innovative technology into sterility testing procedures expands the capacities of testing facilities and bolster market expansion by satisfying the growing need for quicker, more dependable, and effective testing options in the biotechnology, pharmaceutical, and medical device industries. For instance, STEMart, which is a service provider based in the United States, introduced sterility testing services for all medical devices under the guidance of the ISO 11731 in April 2023. This method is called Bioburden Testing, and it estimates the number of microorganisms on the surface of the device whereas their sterility tests suggest, whether the device is sterile.

Pharmaceuticals and Biotechnology Companies to Dominate Amongst End-users

The market for sterility testing is growing due to the pharmaceutical and biological production sector, which is driven by strict regulations and the demand for efficacious and safe products. It is imperative for pharmaceutical businesses to guarantee that their medicines are devoid of microbiological contamination prior to their distribution to end-users, since minute quantities of impurities may jeopardize patient safety and result in legal actions. One of the most important steps in the production of biological and pharmaceutical goods is sterility testing. It confirms that there are no living microbes present, guaranteeing that pharmaceuticals, vaccines, biologics, and medical equipment adhere to the strictest quality and safety requirements. Strict sterility testing techniques are required by regulatory organizations like such as the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in Europe, and other organizations across the globe to preserve industry standards and safeguard public health.

Reliable sterility testing services are in greater demand as pharmaceutical and biological firms innovate and broaden their product pipelines to meet the growing concerns of global health. The need for accurate and effective sterility testing techniques is further fueled by developments in biotechnology, personalized medicine, and the complexity of pharmaceutical formulations.

The sterility testing market is primarily driven by the pharmaceutical and biological manufacturing segment, which prioritizes regulatory compliance and upholds the highest standards of product quality and safety. For instance, according to a report, global biopharmaceutical research and development expenditures were projected to reach over 202 billion in 2022. Sterile testing and related services have become more popular over time, which is thought to be the cause of the significant expenditures made in the sector leading to market growth.

North America Dominates the Sterility Testing Market

The market for sterility tests is dominated by North America due to several important reasons that add to the country's market domination. There is a big market for sterility testing goods and services because the pharmaceutical and biotechnology sectors in North America are among the biggest and most developed in the world. Pharmaceutical companies in North America rely extensively on sterility testing to assure the safety, efficacy, and regulatory compliance of their medicines, since they have a strong pipeline of medication candidates, a strong focus on innovation, and substantial investments in research and development. North America enjoys the advantages of an established regulatory framework, due to organizations, such as FDA, that impose strict guidelines on the approval, production, and quality control of drugs. There is a sizable market for sterility testing goods and services as FDA requirements necessitate rigorous sterility testing methodologies, validation studies, and documentation. Sterile testing is crucial for preserving product quality and safety, and this is further supported by the FDA's reputation of strict enforcement and sincerity in regulatory supervision.

Furthermore, the United States leads the world in sterility testing due to the number of top pharmaceutical corporations, contract manufacturing organizations (CMOs), and contract testing laboratories based in the country. These companies make investments in innovative technologies, highly qualified staff, and testing facilities of the highest calibre to satisfy the demanding standards of the pharmaceutical sector and offer complete sterility testing solutions to customers across the globe. Furthermore, the United States has a robust innovation and entrepreneurial culture that supports the creation of innovative sterility testing technology and procedures. The cooperation of established businesses, biotechnology startups, and academic research organizations pushes improvements in automation, fast testing methods, and microbiological detection that improve the effectiveness, precision, and dependability of sterility testing procedures.

For instance, to fulfill the rising demand for sterilization services across food, pharmaceutical, and medical device industries, Sterigenics U.S., LLC dramatically expanded its operations in North America in 2022 by building new facilities and renovating existing ones. Modern sterilization techniques such as ethylene oxide (EtO) and gamma irradiation, which are essential for guaranteeing the security and effectiveness of medical supplies, are now available from Sterigenics U.S., LLC due to this growth.

Future Market Scenario (2024 – 2031F)

Main factors contributing to the anticipated growth of sterility testing market are the rising awareness about patient safety and infection control, increasing prevalence of pathogens and microorganisms, and thus the rising requirement of sterilization services. However, the stringent regulations and rules to ensure certain sterilization processes are going to fuel market growth in the future. As technology is advancing, the market is expected to attain major innovations. Players in this market are expanding at an unparalleled rate, introducing cost-effective and efficient technologies. Government policies and policies made by welfare bodies are greatly fueling the market expansion. For instance, the Rapid System 2.0, an automated sterility testing kit from Milliflex (Merck KGaA), was launched in April 2023. It can calibrate test results in 5 days as opposed to the customary 14 days output. Image analysis, ATP bioluminescence, and membrane filtration are some of the technologies that Milliflex (Merck KGaA) uses. It takes 90 seconds to view these automatic results in 2D and 3D with a thorough analysis.

Key Players Landscape and Outlook

Several companies are expanding their business by planning and adopting new strategies. They are complying with new strategic initiatives regarding the launches of newly developed sterility testing technologies, to help researchers and to strengthen their presence in the market. New product launches, agreements based on contracts, acquisitions and mergers, investments, and partnerships are a few ways through which they are trying to achieve their shares in the market.

For instance, Berkshire Sterile Manufacturing (BSM) is a fill finish Contract Development and Manufacturing Organization (CDMO) for clinical and commercial sterile injectable products located in Massachusetts. In October 2023, Sharp Services, LLC, a leading global provider of clinical trial supply services and commercial pharmaceutical packaging, acquired BSM. Sharp Services, LLC is now able to provide the biopharmaceutical industry with a fully integrated small-to-medium size sterile injectable service offering.