In this report, the Global Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market has been segmented by Treatment Type, Diagnostic Type, Application, End User and Geography.

Global Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market, Segmentation by Treatment Type

The Global Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market has been segmented by Treatment Type into Enzyme Replacement Therapy (ERT), Other Medications and Nutritional Therapies.

Enzyme Replacement Therapy (ERT)

Enzyme Replacement Therapy (ERT), especially Pancreatic Enzyme Replacement Therapy (PERT), dominates the EPI therapeutics space, contributing to over 65% of the market share. It is widely used as the primary treatment to restore digestive enzyme function—primarily lipase, protease, and amylase—in patients with pancreatic insufficiency. The segment continues to grow, supported by innovations in enteric-coated formulations and rising usage in managing chronic pancreatitis and cystic fibrosis.

Other Medications

Accounting for nearly 20% of the market, other medications play a supportive role in managing EPI. These include proton pump inhibitors (PPIs) that enhance enzyme efficiency by lowering gastric acidity, as well as prokinetic agents that improve gastrointestinal motility. As combination therapies become more common in clinical practice, the demand for these adjunct medications is steadily increasing.

Nutritional Therapies

Nutritional therapies represent about 15% of the market and focus on addressing malnutrition and micronutrient deficiencies caused by poor nutrient absorption. These treatments typically involve personalized dietary interventions and supplementation of fat-soluble vitamins (A, D, E, and K). With growing awareness of the nutritional challenges faced by EPI patients—especially among children and the elderly—this segment is gaining significant clinical and commercial traction.

Global Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market, Segmentation by Diagnostic Type

The Global Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market has been segmented by Diagnostic Type into Fecal Elastase-1 Test, Secretin Stimulation Test and Imaging Tests.

Fecal Elastase-1 Test

The Fecal Elastase-1 Test leads the EPI diagnostics segment with nearly 55% market share. As a non-invasive and highly sensitive method, it measures the level of pancreatic elastase in stool to assess exocrine function. Its ease of use and wide availability make it the preferred initial screening tool for clinicians worldwide.

Secretin Stimulation Test

Holding about 25% of the market, the test is considered one of the most accurate methods for diagnosing EPI. This test evaluates pancreatic secretion volume and enzyme output following secretin administration. Despite its precision, its usage is often limited to specialized settings due to its invasive nature and high cost.

Imaging Tests

Imaging diagnostics such as MRI, CT, and endoscopic ultrasound contribute around 20% to the diagnostic landscape for EPI. These methods provide detailed visualization of pancreatic tissue and help identify structural changes associated with chronic conditions. Imaging is often used alongside biochemical tests for comprehensive evaluation.

Global Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market, Segmentation by Application

The Global Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market has been segmented by Application into Oncology, Renal Diseases, and HIV.

Oncology

Oncology leads the application-based segmentation, accounting for nearly 45% of the EPI market. Patients undergoing treatment for pancreatic, gastric, or colorectal cancers are at a heightened risk of developing exocrine pancreatic insufficiency. Early intervention with enzyme replacement therapy and nutritional support plays a vital role in improving patient outcomes and treatment tolerance.

Renal Diseases

Renal disease applications make up about 30% of the market share. Individuals with chronic kidney disease, especially those in end-stage renal failure, often experience diminished pancreatic function. Managing EPI in these patients is essential for maintaining proper nutrient absorption and enhancing quality of life during long-term care.

HIV

HIV contributes to approximately 25% of EPI-related applications. Both the virus and prolonged antiretroviral therapy can impair pancreatic enzyme production, leading to digestive complications. With increased awareness and better diagnostic practices, EPI in HIV patients is being recognized earlier, allowing for timely treatment and improved nutritional status.

Global Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market, Segmentation by End User

The Global Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market has been segmented by End User Type into Hospitals, and Pharmacy.

Hospitals

Hospitals hold the largest share—approximately 70%—of the EPI end-user market. Their dominance is driven by comprehensive diagnostic capabilities, access to skilled healthcare professionals, and integrated treatment pathways. Hospitals are instrumental in early diagnosis and management of complex EPI cases, especially in oncology and critical care settings.

Pharmacy

Pharmacies contribute about 30% to the EPI therapeutics and diagnostics market. They play a vital role in the distribution of enzyme supplements and nutritional therapies, particularly for long-term and outpatient care. The rise in home-based treatment and patient-centric dispensing models has significantly increased the pharmacy segment’s relevance in managing EPI.

Global Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market, Segmentation by Geography

In this report, the Global Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East & Africa and Latin America.

Global Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market Share (%), by Geographical Region

North America

North America dominates the EPI therapeutics and diagnostics market with an estimated 40% share. This leadership is fueled by strong healthcare infrastructure, early adoption of innovative diagnostics, and the wide availability of enzyme therapies. The U.S., in particular, continues to set the pace with high awareness and clinical advancement.

Europe

Europe represents close to 25% of the global market and maintains steady growth, supported by universal healthcare systems and favorable regulatory policies. The presence of well-established clinical networks and access to reimbursement options enhances patient outcomes and market expansion in this region.

Asia Pacific

Asia Pacific, contributing around 20%, is the fastest-growing region in the global EPI market. Increased investment in healthcare, rising awareness of pancreatic disorders, and improving access to diagnostics in countries like China, India, and Japan are driving rapid growth in the region.

Middle East & Africa

Middle East & Africa account for roughly 8% of the global share. Although challenges such as limited healthcare access persist, gradual advancements in health infrastructure and diagnostic outreach are positioning this region for future growth in the EPI segment.

Latin America

Latin America makes up about 7% of the market. With gradual improvements in healthcare policies and a growing focus on gastrointestinal care, the region—led by Brazil and Mexico—is beginning to see increased adoption of diagnostic tools and enzyme therapies, despite existing economic constraints.