The global pharmaceutical sterility testing market revenue is expected to reach USD 2,953.9 million by 2030, exhibiting a CAGR of 11.2% during 2022–2030. This is owing to the rising number of drug launches, surging frequency of collaborations among players, increasing government focus on supporting research and development activities, and growing public awareness of and strict regulatory requirements for maintaining drug quality.
Over time, severe long-term ailments, such as heart conditions and cancer, have risen in prevalence across the globe. This has led to the growing demand for safe and efficacious therapeutics, which, in turn, has increased the number of drugs launched globally. Similarly, the rising incidence of contagious ailments is a major contributing factor for the increase in the volume of pharmaceutical sterility tests.
Additionally, in the biopharmaceutical and pharmaceutical sectors, maintaining the sterility of drugs is a mandatory criterion, before any drug can be launched. Therefore, sterility testing is carried out at every production stage to reduce the chances of product contamination.
Essentially, the growing demand for effective care has led to significant production capacity expansions in the pharmaceutical and biopharmaceutical sectors, which have a positive impact on the pharmaceutical sterility testing market progress. For instance, in March 2023, Eli Lilly and Company invested around USD 1 billion for its next-generation biotechnology facility. This manufacturing facility is expected to hire approximately 300 individuals across several disciplines, including pharmaceutical quality control.
Additionally, in September 2022, Novartis AG announced that it would invest USD 300 million in a completely integrated scientific environment for next-generation biotherapeutics, which would strengthen the capabilities and capacity for the rapid development of biologics. This investment would be distributed across its facilities in Austria, Switzerland, and Slovenia.
The pharmaceuticals and biologicals category dominated the application segment, with a market share of 45%, in 2022. This is owing to the wide usage of dosage forms such as ointments, eye drops, aerosols, and injectables. The sterility testing of such dosage forms is a mandatory requirement, and the increasing number of product recalls because of inadequate levels of sterility is further propelling the demand for sterility tests for conventional and biological medications.
Moreover, the rising incidence of cancer, viral diseases, neurological conditions, and other chronic diseases across the globe has led to the adoption of more-targeted and efficacious treatment options, such as vaccines, gene therapies, and other kinds of biologics.
Apart from the key end users, CROs, research labs, clinics, hospitals, and CDMOs are also witnessing an increase in the volume of pharmaceutical sterility tests.
Many small and medium-sized biopharmaceutical and pharmaceutical firms outsource their sterility testing services to CROs and CDMOs due to a lack of infrastructure. Even many pharmaceutical giants do the same, in order to expand their geographical presence and focus on their core competencies. This results in an increase in the volume of pharmaceutical sterility tests conducted in these facilities.
Furthermore, research labs have to also ensure the sterility of instruments and test subjects. Similarly, hospitals and clinics have to ensure patient safety by ensuring that the pharmaceuticals and medical devices are free of microbial contamination.
Pharmaceutical companies held the largest share. This is because in order to introduce a new drug in the market, it is mandatory for pharmaceutical firms to conduct sterility tests, to ensure the safety of the therapeutics. Moreover, most of the drugs available are consumed through the oral route; hence, ensuring their safety becomes crucial. Furthermore, every country has its specific guidelines about the sterility tests that need to be conducted for a specific drug.
The Asia-Pacific market is expected to showcase the highest growth rate during the projection period. This is because of the rising prevalence of acute and chronic diseases in the region, the increasing focus of regional governments on the healthcare sector, and the rising geriatric population. Additionally, the developing nations in the region are taking initiatives to motivate overseas pharma and biotech businesses to establish their operations here. All such initiatives are expected to support and strengthen the domestic pharmaceutical sector, in turn, driving the demand for drug sterility testing services.
The top players in the market include STERIS plc, Boston Analytical, Sartorius AG, Arbro Pharmaceuticals Private Limited & Auriga Research Private Limited, Lucideon Limited, Pace Analytical Life Sciences LLC, SGS SA, Nelson Laboratories LLC, Merck KGaA, and Pall Corporation.