In 2024, the global pharmaceutical sterility testing market is expected to reach USD 1,959.9 million, with a projected compound annual growth rate (CAGR) of 11.5% between 2024 and 2030. By 2030, the market is anticipated to achieve a value of USD 3,763.0 million.
This market expansion is driven by the growth of pharmaceutical and biotechnology companies, an increase in their research and development activities, a rising incidence of diseases, and substantial government investments in the healthcare sector.
The prevalence of hematological cancers is increasing. According to The Leukemia & Lymphoma Society, someone in the U.S. is diagnosed with lymphoma, myeloma, or leukemia every three minutes. Biopharmaceuticals, including gene, immune, and cell therapies, are increasingly being adopted as alternative treatments for hematological cancers due to their high potency and effectiveness.
Sterility testing, particularly membrane filtration, has been a dominant segment in recent years, holding a 25% revenue share. Membrane filtration is widely used due to its high sensitivity, especially in testing liquid dosage forms. Its compatibility with samples containing bacteriostatic and fungistatic agents, as well as preservatives, is fueling the growth of this category.
Leading companies in the pharmaceutical excipients market are focusing on expanding their operations, launching new products, and forming joint ventures with universities. The need for innovative excipients is encouraging continuous introduction of advanced and modified excipients.
In terms of product type, the kits & reagents segment led the industry with a 50% revenue share in 2023, largely due to the widespread availability and ease of use of these products. The repetitive purchasing of these items is also contributing to the growth of this segment.
North America led the market in 2023, holding a 55% revenue share. This dominance is attributed to the presence of major pharmaceutical and biopharmaceutical companies, increased R&D activities, a growing number of product launches, a high prevalence of chronic diseases, and supportive government regulations for research and development facilities. Additionally, stringent healthcare regulations, strict drug approval requirements, rising public awareness of drug safety, and the adoption of advanced technologies, including gene and cell therapies for treating hematologic malignancies, are further driving the expansion of the regional market.
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