Report Overview:
It is expected that from 2022 to 2030, the pharmaceutical sterility testing market, which was valued at USD 1,270.2 million in 2021, would grow at a CAGR of 11.5%. Government spending on healthcare, rising R&D activity, an increase in drug launches, and a growing focus on quality and sterility are all predicted to have a positive impact on the industry. Therefore, clinical research on COVID-19 vaccines is presently being conducted. There is still a need to produce a safe and effective COVID-19 treatment for all the new viral variants. It is projected that the market will profit from the substantial amount of research being done for COVID-19 medications during the post-pandemic era.
As a result of the rising prevalence of chronic and infectious illnesses, there is an increasing need for medicines on a global scale. For instance, the World Health Organisation (WHO) announced in February 2021 that cardiovascular illnesses remain one of the leading causes of mortality globally, killing 17.9 million people year. Future illness load is anticipated to increase demand for medications, supporting the need for pharmaceutical sterility testing.
Many developing nations have sped up medication introductions and reduced regulatory clearance timelines in response to the rising demand for healthcare. These regulatory changes are projected to quicken market expansion. Additionally, because biopharmaceutical goods like Elagolix and Lanadelumab require specific sterility testing, their debut is strongly assisting the market's growth.
Drug firms are concentrating on creating biologics and biosimilars in the post-pandemic period since they are very successful in treating some major illnesses including cancer, psoriasis, and Alzheimer's disease. For instance, in June 2021, Lonza teamed up with Pint aeon Therapeutics, a biotechnology business that specialises in creating Alzheimer's disease treatments.
As per this collaboration agreement Lonza decided to manufacture PNT001, Novel Tau Antibody of Pinteon Therapeutics used in the treatment of Alzheimer’s and traumatic brain injury. The growing burden of these diseases, worldwide, is expected to improve R&D and the manufacturing of these drugs. This is expected to boost demand for sterility testing in the post-pandemic period, thereby supporting the market growth.
Type Insights
By accounting for 55.0% of the market in 2021, the outsourcing sector had the highest share. The market is divided into two types according to type: outsourcing and in-house. A desirable alternative is to outsource sterility testing. Small and medium-sized manufacturers of pharmaceuticals and medical devices might not have the resources to undertake reliable sterility testing, thus they would rather outsource these services to meet FDA standards.
Additionally, outsourcing helps pharmaceutical and medical device businesses save time and money since they don't have to find and educate new personnel or buy new equipment. Pharmaceutical sterility testing services are gradually being outsourced by large pharmaceutical firms as they attempt to concentrate on their core capabilities, such as R&D and marketing. These elements have had a major role in the segment's growth.
During the projected period, a CAGR of 11.3% is predicted for the in-house segment. Throughout the projected period, the market for pharmaceutical sterility testing outsourcing is anticipated to grow due to quality and compliance challenges. Small outsourcing companies do not have the requisite infrastructure, which will likely lower the standard of sterility testing. These factors will probably increase market demand for in-house pharmaceutical sterility testing.
Testing Type Insights
The market share held by the sector for testing bacterial endotoxin in 2021 was 39.4%. The market is divided into sterility testing, bioburden testing, bacterial endotoxin testing, membrane filtration, direct inoculation, container closure integrity testing, antimicrobial efficacy testing, and Rapid micro test based on the kind of testing used.
All medications delivered parenterally must undergo testing for bacterial endotoxins. Additionally, these tests are used to evaluate medical equipment like implants. The market for this category is expanding as a result of rising parenteral medication and implant demand. Along with an increase in the number of medication and medical device releases, there is a growing emphasis on product quality. It is predicted that this will aid in the sectors' expansion.
During the projected period, bioburden testing is anticipated to grow at the quickest rate with a CAGR of 11.6%. Pharmaceuticals, biologics, and all class I, II, and III medical devices are subjected to bioburden testing. One of the key factors promoting segment expansion is the rising demand for the aforementioned items. Additionally, since microbial development in the product might result in recalls later, this testing is crucial during the production process.
Market Insights
37.7% of the market was accounted for by pharmaceuticals in 2021. The market is divided into three categories based on the sample: medicines, medical devices, and biopharmaceuticals. Products like parenteral, aerosols, ointments, eye drops, and others are included in the pharmaceutical category. These dose types are the most popular ones. One of the key reasons fostering the market's expansion is an increase in demand for the aforementioned dosage forms on a global scale. The necessity for sterility testing of medicines is further supported by the growing frequency of recalls of these dosage forms due to a lack of sterility.
During the projection period, the biopharmaceutical segment is anticipated to expand at a CAGR of 11.7%. Due to their efficiency in treating critical illnesses including cancer, neurological disorders, infectious diseases, and others, biologics and biosimilar medications are in greater demand now than ever before. The expansion of the sector market has been further boosted by improvements in biologic and biosimilar approvals over the past five years and rising demand for biologics such COVID-19 vaccines.
End-Use Insights
During the projection period, it is expected that the other segment will grow at a CAGR of 11.7%. The market is divided into pharmaceutical firms, medical device firms, compounding pharmacies, and others based on end-use. Hospitals, clinics, research labs, and associated CROs are included in the other component of the economy.
Research facilities must guarantee that test participants and laboratory apparatus are free from contamination. In order to protect patient safety, other end users require sterility testing for routine quality control and detection of microbiological contamination of the equipment and pharmaceutical items. This helps the segment's expansion even more.
In 2021, the pharmaceutical businesses category had the most proportion, with 42.9%. Since the majority of these medications are oral dosage forms that patients consume, pharmaceutical companies must perform sterility testing to verify the safety of the goods. The requisite sterility tests that must be carried out for a particular medicine are specified in detail in the pharmacopoeia of each nation.
Regional Insights
In terms of region, North America held the largest market share of 49.6% in 2021. This may be attributed to the increasing number of pharmaceutical industries within the U.S. and Canada. The presence of a large number of major market players in this region is expected to contribute significantly to the market growth. Stringent regulatory requirements for the sterility testing of pharmaceuticals and medical devices in this region further support the growth of the regional market.
During the projection period, Asia Pacific is expected to see the fastest growth. This is a result of emerging countries increasingly harmonising their regulatory norms with ICH standards. Additionally, a number of the region's growing nations are adopting a variety of steps to expand the local pharmaceutical industry and are enticing global corporations to establish operations there (collaborations that promote outsourcing activities). Such efforts are probably going to help with regional development.
Key Companies & Market Share Insights
The market is characterised by the presence of several domestic and international businesses. Due to the existence of several local and MNC contract service providers and research facilities, the market is extremely fragmented. The main tactics employed by the majority of these organisations are regional growth, digitization of service delivery for sterility testing, and M&A activity. For instance, Charles River Laboratories introduced their Celsis automated detection system and EndoScan-V software platform for evaluating endotoxins in September 2019. The following companies are some of the major participants in the worldwide pharmaceutical sterility testing market:
-
Pacific Bio labs
-
STERIS
-
Boston Analytical
-
Nelson Laboratories, LLC
-
Sartorius AG
-
SOLVIAS AG
-
SGS SA
-
Laboratory Corporation of America Holding
-
Pace Analytical
-
Charles River Laboratories
-
Thermo Fisher Scientific, Inc.
-
Rapid Micro Biosystems, Inc.
-
Thermo Fisher Scientific Inc
-
Almac Group