The North America and Europe pharmaceutical stability & storage services market was surpassed at USD 2.16 billion in 2022 and is expected to hit around USD 3.71 billion by 2032, growing at a CAGR of 5.55% from 2023 to 2032.
Report Scope of the North America And Europe Pharmaceutical Stability & Storage Services Market
|Market Size in 2022||USD 2.16 billion|
|Revenue Forecast by 2032||USD 3.71 billion|
|Growth rate from 2023 to 2032||CAGR of 5.55%|
|Forecast Period||2023 to 2032|
|Market Analysis (Terms Used)||Value (US$ Million/Billion) or (Volume/Units)|
|Companies Covered||Eurofins Scientific; Intertek Group plc; Lucideon Limited; Element Materials Technology; Q1 Scientific; Reading Scientific Services Ltd.; Catalent, Inc.; Quotient Sciences; Recipharm AB; Almac Group; Alcami Corporation; BioLife Solutions, Inc.; Sampled (Roylance Stability Storage Limited); Precision Stability Storage; Broughton|
The growing biopharmaceutical sector, rising outsourcing trends, and increasing pharmaceutical R&D spending are some of the major factors driving market growth in these regions.
The COVID-19 pandemic has significantly increased the demand for biological medicines, which require major pharmaceutical expenditure as they provide treatment for complex conditions. According to data published by AJMC (The Centers for Biosimilars), in 2022, biologics accounted for 35% of the total pharmaceutical expenditure. Despite biosimilars contributing USD 10.9 billion annually to spending in Europe, the wide-ranging impact of these drugs on patients, payers, and the healthcare system is substantial. This expenditure on medicine can be attributed to an increase in stability testing, as medicines are tested in different climatic conditions inside a chamber. This is expected to aid in the growth of the pharmaceutical stability and storage services market.
Pharmaceutical and biotechnology companies heavily invest in R&D to ensure the safety, efficacy, and regulatory compliance of their products. Stability testing and storage services are integral to this process, as they provide critical data on the stability profile and shelf life of pharmaceutical products. Robust stability studies are conducted to evaluate the effects of environmental factors on drug substances & formulations, and storage conditions are optimized to maintain product integrity throughout their shelf life.
Furthermore, increasing demand for biosimilars is expected to drive market growth. Biosimilars gained significant popularity in treating cancer, autoimmune diseases, and other chronic diseases. As biosimilars are cheaper than biologics, the demand for biosimilars has significantly increased in the past few years. The director of biosimilars at AmerisourceBergen has stated that the cost of biosimilars is expected to further decrease by 30% if its demand continues to grow. The rising demand for biosimilars is expected to increase the need for stability and storage over the forecast period.
The stability testing services segment dominated the pharmaceutical stability & storage services market in North America and Europe, accounting for 73% of the overall revenue share in 2022. Stability testing provides data on the changes in the quality of a drug product or drug substance over time, as influenced by various environmental factors including temperature, humidity, and light. Its objective is to determine a re-test period for the drug substance or shelf life for the drug product, along with the recommended storage conditions for it.
On the other hand, the storage segment is expected to witness a higher CAGR of 6.13% over the forecast period. Most players outsource their drug stability and storage management function, as it offers several advantages such as cost reduction, risk mitigation, and operational efficiency, which can drive segment growth. By partnering with companies with GMP-compliant facilities and experienced staff, organizations can streamline their stability studies and focus on their core competencies.
The small molecules segment dominated the North America and Europe pharmaceutical stability & storage services market, with 64% of the revenue share in 2022. Most pharmaceutical medications comprise small molecules, amounting to about 90% of all drugs. These medications treat fever, migraines, cancer, diabetes, and other common disorders. Small-molecule medications are used to treat numerous illnesses and disorders, which increases the need for stable testing and storage.
On the other hand, the large molecules segment is expected to show significant growth during the forecast period. The increasing demand for biological products such as tissues, recombinant therapeutic proteins, blood & blood components, allergens, somatic cells, and vaccinations drives segment growth. FDA states that biologics, despite being difficult and time-consuming to develop, may eventually prove to be the most effective means of treating a variety of medical illnesses and diseases for which no other medicines are available.
The in-house segment led the North America and Europe market for pharmaceutical stability & storage services, accounting for 61% of the revenue share in 2022. Conducting stability testing in-house can be more cost-effective than outsourcing it to external laboratories. It gives companies greater control over the testing process, reduces turnaround times, and allows for more efficient resource allocation. These factors collectively drive the need for in-house stability testing, enabling companies to meet regulatory requirements, ensure product quality & safety, optimize formulations, and enhance customer satisfaction.
On the other hand, the outsourcing segment is expected to show significant market growth in the coming years. Stability testing is crucial to product development and quality control, especially in the pharmaceutical & healthcare industries. Outsourcing allows access to specialized expertise and experience in stability testing. External laboratories or CROs often have dedicated teams with in-depth knowledge of regulatory requirements, testing methodologies, and data analysis techniques, which drives their demand.
North America And Europe Pharmaceutical Stability & Storage Services Market Segmentations: