췌장 외분비 부전(EPI) : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the exocrine pancreatic insufficiency market size was valued at USD 3.02 billion in 2025 and estimated to grow from USD 3.18 billion in 2026 to reach USD 4.15 billion by 2031, at a CAGR of 5.45% during the forecast period (2026-2031).

This report is Segmented by Therapy (Pancreatic Enzyme Replacement Therapy, Nutritional Therapy), Disease Etiology (Cystic Fibrosis, Chronic Pancreatitis, Pancreatic Cancer, and More), Distribution Channel (Hospital Pharmacies, and More), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Exocrine Pancreatic Insufficiency (EPI) Market Trends and Insights

Rising Prevalence of EPI Linked to Chronic Pancreatitis & Pancreatic Cancer

Chronic pancreatitis and pancreatic cancer together shape the largest at-risk cohort for enzyme replacement therapy. Longitudinal data show that 80-90% of chronic pancreatitis cases progress to exocrine pancreatic insufficiency, and up to 80% of pancreatic cancer patients ultimately manifest digestive insufficiency symptoms. Despite the high incidence, real-world studies indicate that only 21% of symptomatic cancer patients receive guideline-recommended PERT, highlighting a sizable treatment gap. The disconnect is gradually closing as oncology guidelines emphasize early enzyme therapy alongside chemotherapeutic regimens. Heightened public health campaigns and improved imaging modalities are unveiling latent cases, transforming what was once acute palliation into a chronic supportive-care model that extends throughout a patient's survival journey. Consequently, demand patterns are shifting toward high-volume, long-duration prescriptions that favor sustained revenue visibility for manufacturers.

Increasing Cystic-Fibrosis Survival Rates Expanding Lifetime Patient Pool

Decades ago, cystic fibrosis was primarily a pediatric fatality; today, median survival in developed markets exceeds 45 years, courtesy of CFTR modulator therapies. Up to 85% of cystic-fibrosis patients exhibit pancreatic insufficiency at infancy and therefore initiate PERT soon after diagnosis. As these patients transition into adulthood and elderly age bands, lifetime prescription volumes multiply, embedding predictable, annuity-like demand for enzyme suppliers. Adult-centered care further magnifies product differentiation around pill burden, flavor masking, and digital dosing calculators that simplify adherence across diverse meal patterns. The sustained nature of therapy also strengthens the value proposition for long-acting recombinant options that reduce daily capsule counts, thereby improving quality of life and indirectly supporting nutritional status.

Intermittent Shortages of Porcine Pancreatin Supply

In 2024-2025, 96% of U.K. community pharmacies reported difficulty sourcing Creon, a shortage expected to linger through 2026. Root causes include a limited number of qualified slaughterhouses, batch-release testing delays, and pandemic-driven transportation bottlenecks. As inventory gaps widened, national regulators invoked Serious Shortage Protocols permitting pharmacists to make dose-for-dose substitutions, yet many patients rationed capsules or altered diets, risking malnutrition. The scarcity underscores the fragility of a supply chain reliant on a single animal source and catalyzes stakeholder interest in recombinant or microbial substitutes that circumvent porcine raw-material constraints.

Other drivers and restraints analyzed in the detailed report include:

1. Patent Expiries Spurring Affordable Generics
2. Supply-Chain Innovation in Microbial/Recombinant Enzymes
3. Low Clinician Confidence; Sub-Therapeutic PERT Dosing

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

The exocrine pancreatic insufficiency market size for pancreatic enzyme replacement therapy held an 80.92% revenue share in 2025. Reliance on porcine-derived pancrelipase remains the norm because the formulation delivers the triad of lipase, amylase, and protease in ratios clinicians trust. Yet recombinant and microbial formulations, though representing under 5% of volume today, are clocking an 8.55% CAGR as they respond to supply insecurities and dietary constraints. The exocrine pancreatic insufficiency market share of synthetic enzymes is forecast to inch past 10.25% by 2031 as late-stage candidates like adrulipase accumulate phase III data.

Manufacturers of conventional PERT are deploying controlled-release micro-granules that withstand gastric acidity, while innovators explore immobilized enzyme cartridges compatible with enteral feeding pumps. Differentiation extends to ancillary services, mobile adherence platforms, tele-nutrition counseling, and patient-assistance programs-that lock in prescriber loyalty even as generic erosion looms. These converging developments suggest a future landscape where porcine and recombinant options coexist, each targeting specific patient segments based on allergy status, cultural preferences, and source-of-origin ethics.

Complete Report Scope:

• By Therapy
  • Pancreatic Enzyme Replacement Therapy (PERT)
    • Porcine-derived formulations
    • Microbial/Recombinant formulations
  • Nutritional Therapy
    • Macronutrient-specific supplements
    • Pro- & Synbiotics
• By Disease Etiology
  • Cystic Fibrosis
  • Chronic Pancreatitis
  • Pancreatic Cancer
  • Post-surgical & Other Causes
• By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America retained a 41.22% revenue share in 2025, reflecting universal insurance coverage for approved PERT brands and a mature prescriber base familiar with high-dose regimens. Creon alone enjoys 93% preferred formulary placement across commercial and Medicare Part D plans. Nevertheless, episodic backorders linked to limited porcine gland supply have triggered payer scrutiny, nudging providers to consider future recombinant alternatives. Competitive dynamics may intensify as FDA guidances framed under the BLA pathway clarify requirements for biosimilar enzymes, accelerating generic filings post-2028.

Europe exhibits high clinical sophistication but is grappling with acutely constrained inventories. The European Medicines Agency expedited approval of Micrazym in June 2024 to diversify product availability. Despite this, 2025 surveys revealed U.K. patients resorting to dose rationing amid prolonged shortages. In response, national health systems are drafting contingency contracts that oblige suppliers to hold multi-month safety stocks, bolstering resilience until recombinant pipelines mature. Parallel developments in digital adherence tools exemplified by the MyCyFAPP app that customizes dosing based on meal photographs are quickly gaining traction among European cystic-fibrosis clinics.

Asia-Pacific is the fastest-growing region, charting a 6.29% CAGR through 2031 on the back of improved diagnostic reach, population aging, and rising chronic-disease burdens. Chinese epidemiological data reveal a disproportionate uptick in pancreatic cancer incidence among adults aged 35-49, a trend that directly feeds enzyme demand. Regulatory overhaul is equally salient: India's 2024 revision of its National Essential Medicines List now explicitly names pancrelipase, streamlining public-hospital procurement. However, fragmented reimbursement and a reliance on imported brands keep treatment access uneven. Multinational firms are therefore partnering with regional contract manufacturers to establish local fill-and-finish capacity, simultaneously lowering tariffs and strengthening political goodwill.

1. Abbvie
2. Viatris (Zenpep)
3. Nestle Health Science
4. Digestive Care Inc.
5. Nordmark Pharma
6. Alcresta Therapeutics
7. First Wave BioPharma
8. Perseo Pharma
9. Synspira Therapeutics
10. Codexis
11. Vivus LLC
12. Anthera Pharmaceuticals
13. Adare Pharma Solutions
14. Mayoly Spindler
15. Dr. Falk Pharma
16. Kreon Pharma
17. Zymtech
18. Laboratoires Mayoly-Spindler
19. AzurRx Biopharma

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

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