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Exocrine Pancreatic Insufficiency (EPI) Market 2026-2031 - Market to Reach USD 4.15 Billion by 2031 as Demand for Enzyme Replacement Therapy Rises

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ABBV AbbVie Inc. is listed as a company profile in the EPI market report, suggesting its involvement in the sector, but no specific positive or negative performance is detailed. VTRS Viatris is mentioned for its product Zenpep in the EPI market, indicating its presence, but the article does not provide specific sentiment on its performance or prospects. CDXS Codexis Inc. is mentioned as a company profile within the EPI market report, suggesting its involvement in enzyme technology, but no specific sentiment is detailed.

Exocrine Pancreatic Insufficiency (EPI) Market 2026-2031 - Market to Reach USD 4.15 Billion by 2031 as Demand for Enzyme Replacement Therapy Rises Dublin, Aug. 25, 2026 (GLOBE NEWSWIRE) -- The "Exocrine Pancreatic Insufficiency (EPI) - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)" has been added to ResearchAndMarkets.com's offering.

The global exocrine pancreatic insufficiency market was valued at USD 3.02 billion in 2025 and is projected to increase from USD 3.18 billion in 2026 to USD 4.15 billion by 2031. The market is expected to register a compound annual growth rate of 5.45% during the 2026-2031 forecast period, supported by rising diagnoses, longer cystic fibrosis survival, and sustained demand for pancreatic enzyme replacement therapy (PERT).

Chronic Pancreatitis and Pancreatic Cancer Drive Treatment Demand

The increasing prevalence of exocrine pancreatic insufficiency associated with chronic pancreatitis and pancreatic cancer is a major market growth driver. Longitudinal data indicate that 80% to 90% of chronic pancreatitis cases progress to exocrine pancreatic insufficiency, while up to 80% of patients with pancreatic cancer eventually experience digestive insufficiency symptoms.

A substantial treatment gap remains, with real-world evidence showing that only 21% of symptomatic cancer patients receive guideline-recommended PERT. Greater emphasis on early enzyme therapy within oncology care, combined with public health initiatives and improved imaging, is expected to increase diagnosis and treatment rates. This shift is supporting demand for high-volume, long-duration prescriptions throughout the patient care journey.

Longer Cystic Fibrosis Survival Expands the Patient Population

Improved cystic fibrosis outcomes are also contributing to exocrine pancreatic insufficiency market expansion. Median survival in developed markets now exceeds 45 years, supported by advances in CFTR modulator therapy. Up to 85% of people with cystic fibrosis develop pancreatic insufficiency during infancy and begin PERT shortly after diagnosis.

As more patients transition into adulthood and older age groups, lifetime prescription volumes are increasing. This trend is encouraging product innovation focused on reducing pill burden, improving dosing convenience, supporting adherence, and accommodating varied meal patterns. Long-acting recombinant therapies could further strengthen treatment adoption by reducing daily capsule requirements and improving nutritional management.

Pancreatic Enzyme Supply Constraints Accelerate Innovation

Intermittent shortages of porcine pancreatin remain a significant market restraint. During 2024 and 2025, 96% of community pharmacies in the United Kingdom reported difficulty sourcing Creon, with supply disruption expected to continue through 2026. Contributing factors include the limited number of qualified slaughterhouses, batch-release testing delays, and transportation bottlenecks.

These shortages have increased the risk of dose rationing, dietary changes, and inadequate nutritional support. They have also highlighted the vulnerability of a supply chain dependent on a single animal-derived source. As a result, industry interest in microbial, recombinant, and synthetic enzyme alternatives is growing. Patent expirations, generic competition, and advances in enzyme manufacturing are expected to support broader access, although low clinician confidence and sub-therapeutic dosing remain barriers.

PERT Maintains Market Leadership

Pancreatic enzyme replacement therapy accounted for 80.92% of market revenue in 2025. Porcine-derived pancrelipase remains the standard treatment because it provides established combinations of lipase, amylase, and protease. However, microbial and recombinant formulations are expanding at a projected CAGR of 8.55%, driven by supply security concerns, dietary restrictions, allergies, cultural preferences, and source-of-origin considerations.

Synthetic enzymes are forecast to capture more than 10.25% of the exocrine pancreatic insufficiency market by 2031 as late-stage candidates, including adrulipase, advance through clinical development. Conventional PERT manufacturers are also introducing controlled-release micro-granules designed to withstand gastric acidity, while developers investigate immobilized enzyme cartridges for enteral feeding systems. Digital adherence platforms, dosing tools, tele-nutrition services, and patient-assistance programs are becoming increasingly important components of treatment support.

Regional Exocrine Pancreatic Insufficiency Market Outlook

North America held 41.22% of global revenue in 2025, supported by broad insurance coverage, established prescribing practices, and strong formulary access for approved PERT products. Supply-related backorders may encourage providers and payers to evaluate recombinant alternatives, while evolving regulatory guidance could facilitate additional enzyme therapy filings after 2028.

Europe continues to demonstrate strong clinical adoption but faces persistent inventory constraints. Regulatory action to diversify product availability, supplier safety-stock requirements, and digital adherence tools are expected to improve treatment continuity. European cystic fibrosis clinics are increasingly adopting personalized dosing technologies to support enzyme use across different meals.

Asia-Pacific is projected to be the fastest-growing regional market, recording a 6.29% CAGR through 2031. Growth is being fueled by expanding diagnostic access, population aging, increasing pancreatic cancer incidence, and rising chronic disease burdens. Regulatory initiatives, including India's inclusion of pancrelipase in its National Essential Medicines List, are expected to streamline public procurement. Local manufacturing partnerships may also improve affordability and reduce dependence on imported products, although fragmented reimbursement continues to limit equitable access in parts of the region.

Key Topics Covered:

1 Introduction

1.1 Study Assumptions & Market Definition

1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

4.1 Market Overview

4.2 Market Drivers

4.2.1 Rising Prevalence of EPI Linked to Chronic Pancreatitis & Pancreatic Cancer

4.2.2 Increasing Cystic-Fibrosis Survival Rates Expanding Lifetime Patient Pool

4.2.3 Patent Expiries Spurring Affordable Generics

4.2.4 Supply-Chain Innovation in Microbial/Recombinant Enzymes

4.2.5 Digital Dosing Apps Improving Adherence & Outcomes

4.2.6 Strategic Guideline Updates Mandating Early PERT Initiation

4.3 Market Restraints

4.3.1 Intermittent Shortages of Porcine Pancreatin Supply

4.3.2 Low Clinician Confidence; Sub-Therapeutic PERT Dosing

4.3.3 Regional Reimbursement Gaps for Long-Term PERT

4.3.4 Stringent cGMP & Viral Safety Requirements Inflating COGS

4.4 Porter's Five Forces Analysis

4.4.1 Threat of New Entrants

4.4.2 Bargaining Power of Buyers

4.4.3 Bargaining Power of Suppliers

4.4.4 Threat of Substitutes

4.4.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value in USD)

5.1 By Therapy

5.1.1 Pancreatic Enzyme Replacement Therapy (PERT)

5.1.1.1 Porcine-derived formulations

5.1.1.2 Microbial/Recombinant formulations

5.1.2 Nutritional Therapy

5.1.2.1 Macronutrient-specific supplements

5.1.2.2 Pro- & Synbiotics

5.2 By Disease Etiology

5.2.1 Cystic Fibrosis

5.2.2 Chronic Pancreatitis

5.2.3 Pancreatic Cancer

5.2.4 Post-surgical & Other Causes

5.3 By Distribution Channel

5.3.1 Hospital Pharmacies

5.3.2 Retail Pharmacies

5.3.3 Online Pharmacies

5.4 By Geography

5.4.1 North America

5.4.1.1 United States

5.4.1.2 Canada

5.4.1.3 Mexico

5.4.2 Europe

5.4.2.1 Germany

5.4.2.2 United Kingdom

5.4.2.3 France

5.4.2.4 Italy

5.4.2.5 Spain

5.4.2.6 Rest of Europe

5.4.3 Asia-Pacific

5.4.3.1 China

5.4.3.2 Japan

5.4.3.3 India

5.4.3.4 Australia

5.4.3.5 South Korea

5.4.3.6 Rest of Asia-Pacific

5.4.4 Middle East & Africa

5.4.4.1 GCC

5.4.4.2 South Africa

5.4.4.3 Rest of Middle East & Africa

5.4.5 South America

5.4.5.1 Brazil

5.4.5.2 Argentina

5.4.5.3 Rest of South America

6 Competitive Landscape

6.1 Market Concentration

6.2 Market Share Analysis

6.3 Company Profiles (includes Global-level Overview, Market-level Overview, Core Segments, Financials, Strategic Info, Market Rank/Share, Products & Services, Recent Developments)

6.3.1 AbbVie Inc.

6.3.2 Viatris (Zenpep)

6.3.3 Nestle Health Science

6.3.4 Digestive Care Inc.

6.3.5 Nordmark Pharma

6.3.6 Alcresta Therapeutics

6.3.7 First Wave BioPharma

6.3.8 Perseo Pharma

6.3.9 Synspira Therapeutics

6.3.10 Codexis Inc.

6.3.11 Vivus LLC

6.3.12 Anthera Pharmaceuticals

6.3.13 Adare Pharma Solutions

6.3.14 Mayoly Spindler

6.3.15 Dr. Falk Pharma

6.3.16 Kreon Pharma

6.3.17 Zymtech

6.3.18 Laboratoires Mayoly-Spindler

6.3.19 AzurRx Biopharma

7 Market Opportunities & Future Outlook

7.1 White-space & Unmet-Need Assessment

For more information about this report visit https://www.researchandmarkets.com/r/srmz41

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