외분비 췌장기능부전 치료제 시장 규모, 점유율, 성장 및 세계 산업 분석 : 유형별, 용도별, 지역별 인사이트와 예측(2026-2034년)

Growth Factors of exocrine pancreatic insufficiency (EPI) therapeutics Market

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

• Pancreatic Enzyme Replacement Therapy (PERT): Dominates the market, growing at the highest CAGR due to its clinical effectiveness and broad adoption.
• Nutritional Therapy: Supports patient management but holds a smaller share and lower growth rate. Poor nutrition in EPI patients can lead to increased complications and mortality, highlighting the importance of this segment.

By Distribution Channel

• Hospital Pharmacies: Expected to hold the largest share (67.9% in 2025) as prescriptions are typically issued after clinical diagnosis.
• Retail Pharmacies & Drug Stores: Offer convenience and increasing online pharmacy integration, supporting secondary growth.

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

• Pancreatic Enzyme Replacement Therapy (PERT)
  • Creon
  • Zenpep
  • Others
• Nutritional Therapy

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies & Drug Stores
• Others

By Geography

• North America (U.S. and Canada)
• Europe (U.K., Germany, France, Italy, Spain, and Rest of Europe)
• Asia Pacific (Japan, China, India, Australia, and Rest of Asia Pacific)
• Rest of the World

Table of Content

1. Introduction

• 1.1. Research Scope
• 1.2. Market Segmentation
• 1.3. Research Methodology
• 1.4. Definitions and Assumptions

2. Executive Summary

3. Market Dynamics

• 3.1. Market Drivers
• 3.2. Market Restraints
• 3.3. Market Opportunities

4. Key Insights

• 4.1. Prevalence of Major Disorders Associated With Exocrine Pancreatic Insufficiency
• 4.2. Pipeline Analysis
• 4.3. Recent Industry Developments Such as Mergers, Partnerships & Acquisitions
• 4.4. Regulatory Scenario
• 4.5. New Product Launches

5. Global Exocrine Pancreatic Insufficiency Therapeutics Market Analysis, Insights and Forecast, 2021-2034

• 5.1. Key Findings / Summary
• 5.2. Market Analysis, Insights and Forecast - By Therapy
  • 5.2.1. Pancreatic Enzyme Replacement Therapy (PERT)
    • 5.2.1.1. Creon
    • 5.2.1.2. Zenpep
    • 5.2.1.3. Others
  • 5.2.2. Nutritional Therapy
• 5.3. Market Analysis, Insights and Forecast - By Distribution Channel
  • 5.3.1. Hospital Pharmacies
  • 5.3.2. Retail Pharmacies & Drug Stores
  • 5.3.3. Others
• 5.4. Market Analysis, Insights and Forecast - By Country
  • 5.4.1. North America
  • 5.4.2. Europe
  • 5.4.3. Asia Pacific
  • 5.4.4. Rest of the World

6. North America Exocrine Pancreatic Insufficiency Therapeutics Market Analysis, Insights and Forecast, 2021-2034

• 6.1. Key Findings / Summary
• 6.2. Market Analysis - By Therapy
  • 6.2.1. Pancreatic Enzyme Replacement Therapy (PERT)
    • 6.2.1.1. Creon
    • 6.2.1.2. Zenpep
    • 6.2.1.3. Others
  • 6.2.2. Nutritional Therapy
• 6.3. Market Analysis - By Distribution Channel
  • 6.3.1. Hospital Pharmacies
  • 6.3.2. Retail Pharmacies & Drug Stores
  • 6.3.3. Others
• 6.4. Market Analysis - By Country
  • 6.4.1. U.S.
  • 6.4.2. Canada

7. Europe Exocrine Pancreatic Insufficiency Therapeutics Market Analysis, Insights and Forecast, 2021-2034

• 7.1. Key Findings / Summary
• 7.2. Market Analysis - By Therapy
  • 7.2.1. Pancreatic Enzyme Replacement Therapy (PERT)
    • 7.2.1.1. Creon
    • 7.2.1.2. Zenpep
    • 7.2.1.3. Others
  • 7.2.2. Nutritional Therapy
• 7.3. Market Analysis - By Distribution Channel
  • 7.3.1. Hospital Pharmacies
  • 7.3.2. Retail Pharmacies & Drug Stores
  • 7.3.3. Others
• 7.4. Market Analysis - By Country
  • 7.4.1. U.K.
  • 7.4.2. Germany
  • 7.4.3. France
  • 7.4.4. Spain
  • 7.4.5. Italy
  • 7.4.6. Rest of Europe

8. Asia Pacific Exocrine Pancreatic Insufficiency Therapeutics Market Analysis, Insights and Forecast, 2021-2034

• 8.1. Key Findings / Summary
• 8.2. Market Analysis - By Therapy
  • 8.2.1. Pancreatic Enzyme Replacement Therapy (PERT)
    • 8.2.1.1. Creon
    • 8.2.1.2. Zenpep
    • 8.2.1.3. Others
  • 8.2.2. Nutritional Therapy
• 8.3. Market Analysis - By Distribution Channel
  • 8.3.1. Hospital Pharmacies
  • 8.3.2. Retail Pharmacies & Drug Stores
  • 8.3.3. Others
• 8.4. Market Analysis - By Country
  • 8.4.1. Japan
  • 8.4.2. China
  • 8.4.3. India
  • 8.4.4. Australia
  • 8.4.5. Rest of Asia Pacific

9. Rest of the World Exocrine Pancreatic Insufficiency Therapeutics Market Analysis, Insights and Forecast, 2021-2034

• 9.1. Key Findings / Summary
• 9.2. Market Analysis - By Therapy
  • 9.2.1. Pancreatic Enzyme Replacement Therapy (PERT)
    • 9.2.1.1. Creon
    • 9.2.1.2. Zenpep
    • 9.2.1.3. Others
  • 9.2.2. Nutritional Therapy
• 9.3. Market Analysis - By Distribution Channel
  • 9.3.1. Hospital Pharmacies
  • 9.3.2. Retail Pharmacies & Drug Stores
  • 9.3.3. Others
• 9.4. Market Analysis - By Country

10. Competitive Analysis

• 10.1. Key Industry Developments
• 10.2. Global Market Share Analysis (2025)
• 10.3. Competition Dashboard
• 10.4. Comparative Analysis - Major Players
• 10.5. Company Profiles
  • 10.5.1. AbbVie Inc.
    • 10.5.1.1. Overview,
    • 10.5.1.2. Products & services,
    • 10.5.1.3. SWOT analysis,
    • 10.5.1.4. Recent developments,
    • 10.5.1.5. strategies,
    • 10.5.1.6. financials (based on availability)
  • 10.5.2. Janssen Pharmaceuticals, Inc.
    • 10.5.2.1. Overview,
    • 10.5.2.2. Products & services,
    • 10.5.2.3. SWOT analysis,
    • 10.5.2.4. Recent developments,
    • 10.5.2.5. strategies,
    • 10.5.2.6. financials (based on availability)
  • 10.5.3. Allergan
    • 10.5.3.1. Overview,
    • 10.5.3.2. Products & services,
    • 10.5.3.3. SWOT analysis,
    • 10.5.3.4. Recent developments,
    • 10.5.3.5. strategies,
    • 10.5.3.6. financials (based on availability)
  • 10.5.4. AzurRx
    • 10.5.4.1. Overview,
    • 10.5.4.2. Products & services,
    • 10.5.4.3. SWOT analysis,
    • 10.5.4.4. Recent developments,
    • 10.5.4.5. strategies,
    • 10.5.4.6. financials (based on availability)
  • 10.5.5. CHIESI Farmaceutici S.p.A.
    • 10.5.5.1. Overview,
    • 10.5.5.2. Products & services,
    • 10.5.5.3. SWOT analysis,
    • 10.5.5.4. Recent developments,
    • 10.5.5.5. strategies,
    • 10.5.5.6. financials (based on availability)
  • 10.5.6. Other Prominent Players
    • 10.5.6.1. Overview,
    • 10.5.6.2. Products & services,
    • 10.5.6.3. SWOT analysis,
    • 10.5.6.4. Recent developments,
    • 10.5.6.5. strategies,
    • 10.5.6.6. financials (based on availability)