PUBLISHER: The Business Research Company | PRODUCT CODE: 2070264
PUBLISHER: The Business Research Company | PRODUCT CODE: 2070264
Exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics refer to the products and services used to diagnose, monitor, and manage a digestive disorder in which the pancreas fails to secrete sufficient digestive enzymes, primarily lipase, amylase, and protease into the small intestine. This deficiency results in impaired digestion and malabsorption of fats, proteins, and carbohydrates, leading to symptoms such as steatorrhea, weight loss, abdominal discomfort, bloating, and nutritional deficiencies.
The EPI therapeutics and diagnostics market consist of sales by entities (organizations, sole traders and partnerships) of EPI therapeutics and diagnostics serves pediatric, adult, and geriatric populations affected by underlying conditions such as chronic pancreatitis, pancreatic cancer, diabetes, and post-pancreatectomy status. These therapeutic and diagnostic solutions are used when patients present with clinical signs of malabsorption or when pancreatic disorders are suspected or confirmed. Management is typically long-term and often lifelong, depending on disease etiology.
The global EPI therapeutics and diagnostics market was valued at $4,267.3 million in 2020 which grew till 2025 at a compound annual growth rate (CAGR) of more than 7.00%.
Rising Demand For Personalized Medicine
The rising demand for personalized medicine fuelled the growth of the EPI therapeutics and diagnostics in the historic period. Recognizing that EPI can arise from diverse etiologist, such as cystic fibrosis, chronic pancreatitis, or pancreatic surgery, each requiring a nuanced approach, clinicians began leveraging advanced diagnostic tools to assess individual pancreatic function more precisely. This demand for personalization drove the adoption of sophisticated tests like fecal elastase-1 and coefficient of fat absorption (CFA) assays, which allow for accurate quantification of pancreatic insufficiency and fat malabsorption in individual patients. For instance, in February 2024, the Personalized Medicine Coalition, a US-based non-profit organization, in 2023, the FDA approved 16 new personalized treatments for rare disease patients, an increase from six in 2022. Among these approvals, seven were cancer drugs, while three targeted other diseases and conditions. Therefore, the rising demand for personalized medicine drove the growth of the EPI therapeutics and diagnostics market.
Biotechnology, Genomics & Precision Medicine
Major companies in the exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market are increasingly prioritizing biotechnology, genomics, and precision medicine to enable more accurate disease detection and personalized treatment strategies for pancreatic and gastrointestinal disorders. These initiatives use advanced biomarker-based diagnostics, molecular testing technologies, and targeted clinical data analysis to enable more precise identification of pancreatic dysfunction and improved monitoring of digestive health conditions. For example, in July 2025, QuidelOrtho Corporation, a US-based in vitro diagnostics company specializing in clinical chemistry and immunoassay technologies, in collaboration with BUHLMANN Laboratories AG, a Switzerland-based diagnostics company focused on biomarker assays, announced the availability of the BUHLMANN fCAL turbo and fPELA turbo assays on VITROS Systems, particle-enhanced turbidimetric immunoassays designed to measure fecal calprotectin and fecal pancreatic elastase, supporting rapid, non-invasive detection of inflammatory bowel disease and pancreatic insufficiency and enabling more precise diagnostic evaluation of gastrointestinal conditions.
The global EPI therapeutics and diagnostics market is highly concentrated, with large players operating in the market. The top 10 competitors in the market made up 58.82% of the total market in 2024.
Exocrine Pancreatic Insufficiency (EPI) Therapeutics And Diagnostics Global Market Opportunities And Strategies To 2035 from The Business Research Company provides the strategists; marketers and senior management with the critical information they need to assess the global exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market as it emerges from the COVID-19 shut down.
Where is the largest and fastest-growing market for pancreatic insufficiency (EPI) therapeutics and diagnostics? How does the market relate to the overall economy; demography and other similar markets? What forces will shape the market going forward? The pancreatic insufficiency (EPI) therapeutics and diagnostics market global report from The Business Research Company answers all these questions and many more.
The report covers market characteristics; size and growth; segmentation; regional and country breakdowns; competitive landscape; market shares; trends and strategies for this market. It traces the market's history and forecasts market growth by geography. It places the market within the context of the wider pancreatic insufficiency (EPI) therapeutics and diagnostics market; and compares it with other markets.