PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1933338
PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1933338
The global exocrine pancreatic insufficiency (EPI) therapeutics market is witnessing steady growth due to the rising prevalence of pancreatic disorders and increasing awareness of gastrointestinal health. Exocrine pancreatic insufficiency is a condition marked by the deficiency of exocrine pancreatic enzymes, resulting in maldigestion and nutrient malabsorption. Diagnosis often involves specialized tests such as blood, stool, and pancreatic function assessments, as symptoms are frequently under-detected. In 2025, the market was valued at USD 2.43 billion, projected to grow to USD 2.55 billion in 2026, and expected to reach USD 3.51 billion by 2034, reflecting a CAGR of 4.06% from 2026 to 2034. North America dominated the market in 2025 with a 3.85% share, supported by high awareness, rapid adoption of advanced therapies, and robust R&D infrastructure.
Market Drivers and Trends
Rising Awareness and Therapeutic Innovations
The growth of the EPI therapeutics market is fueled by increased awareness of the disorder and its impact on overall health. Acute pancreatitis, cystic fibrosis, and pancreatic tumors are major contributors to EPI prevalence. For instance, in October 2019, AzurRx BioPharma dosed patients with MS1819-SD, an innovative therapeutic for EPI. The rising recognition of EPI has propelled the development and adoption of therapies such as Pancreatic Enzyme Replacement Therapy (PERT), which remains the conventional and most effective treatment.
Increasing Prevalence of Associated Disorders
The prevalence of gastrointestinal and pancreatic disorders, including autoimmune pancreatitis and Shwachman-Diamond syndrome, directly influences EPI incidence. This has led to continued R&D innovation in therapeutics, enhancing efficacy and safety profiles, which drives market expansion globally.
Technological and Clinical Advancements
Advancements in diagnostic tools and treatment regimens, coupled with rising R&D investments, have facilitated improved therapeutic options. PERT, projected to generate USD 2.12 billion in revenue by 2025, dominates the market due to its efficiency, potency, and established clinical outcomes.
Market Segmentation
By Therapy
By Distribution Channel
Regional Analysis
North America dominated the market with USD 1.89 billion in 2025, rising to USD 1.98 billion in 2026, driven by strong R&D, high treatment adoption, and increasing disease awareness. The U.S. market alone is projected to reach USD 1.69 billion by 2026.
Asia Pacific is poised for the fastest growth due to increasing disposable incomes, adoption of advanced therapeutics, and better awareness. Key markets include Japan (USD 0.09 billion in 2026), China (USD 0.06 billion in 2026), and India (USD 0.03 billion in 2026).
Europe is growing steadily with opportunities in under-penetrated regions. Countries such as the U.K. (USD 0.05 billion in 2026) and Germany (USD 0.07 billion in 2026) are expanding due to rising awareness and improved therapeutic access.
Latin America and Middle East & Africa are expected to experience moderate growth due to under-penetration and emerging healthcare infrastructure.
Competitive Landscape
The market is concentrated with major players such as AbbVie Inc., Janssen Pharmaceuticals, and Allergan, leveraging broad product portfolios and global presence. Smaller and emerging players, including AzurRx and CHIESI Farmaceutici S.p.A., contribute through innovation and new therapeutic pipelines. AbbVie's 2024 gastroenterology portfolio update at the ECCO Congress highlights ongoing R&D commitment to EPI and related disorders.
Conclusion
The global exocrine pancreatic insufficiency therapeutics market is set to expand from USD 2.43 billion in 2025 to USD 3.51 billion by 2034, at a CAGR of 4.06%. Market growth is primarily driven by increasing prevalence of associated disorders, rising awareness, innovations in therapeutics such as PERT, and robust R&D investments. North America remains the dominant region, while Asia Pacific offers the fastest growth potential due to rising healthcare adoption and disposable incomes. Despite challenges like under-penetration in certain regions and ongoing regulatory requirements, the EPI therapeutics market is positioned for sustained growth over the forecast period.
Segmentation By Therapy
By Distribution Channel
By Geography