췌장 외분비 부전(EPI) : 시장 인사이트, 역학 및 예측(2036년)

Exocrine Pancreatic Insufficiency (EPI) Insights and Trends

• According to DelveInsight's analysis, the EPI market across the major markets, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, is anticipated to witness notable growth during the forecast period, driven by increasing disease awareness, improved diagnosis rates, and the expanding adoption of enzyme replacement therapies.
• EPI primarily results from chronic pancreatitis, pancreatic cancer, cystic fibrosis, acute pancreatitis, pancreatic or gastric surgery. Non-pancreatic causes include diabetes mellitus (Type 1 and Type 2), celiac disease, Zollinger-Ellison syndrome, inflammatory bowel disease (IBD), and others, where impaired pancreatic stimulation or glandular dysfunction contributes to enzyme deficiency.
• Management of EPI primarily involves Pancreatic Enzyme Replacement Therapy (PERT) to normalize nutrient absorption and correct nutritional deficiencies, particularly in patients with steatorrhea and progressive weight loss, alongside supportive measures such as dietary modifications, avoidance of alcohol and smoking, and supplementation of fat-soluble vitamins (A, D, E, and K).
• The prevalence of EPI ranges from 50% to 75%, with the highest risk in those with Chronic Pancreatitis (CP) due to alcohol and with long disease duration.
• Enzyme replacement therapy is the cornerstone of EPI treatment. Patients take oral pancreatic enzyme supplements, which contain lipase, amylase, and protease, to aid in the digestion of fats, carbohydrates, and proteins. These supplements are taken with meals and snacks to ensure that enzymes are available when food enters the digestive system.
• Strict FDA regulatory requirements for PERTs, including stringent standards for manufacturing consistency, stability, and clinical efficacy, can increase development timelines and commercialization costs. These regulatory challenges may limit new product entry and slow the adoption of novel enzyme replacement therapies in the EPI market.
• FDA-approved PERTs for the management of maldigestion associated with exocrine pancreatic insufficiency include CREON, PANCREAZE, PERTZYE, VIOKACE, and ZENPEP, which remain key branded treatment options within the current therapeutic landscape.
• Key players involved in the EPI market include AbbVie, Vivus, Digestive Care, Aptalis Pharma, and Nestle Health Science, collectively contributing to the competitive dynamics of the EPI treatment market.
• The pipeline for EPI is quite dry with only a few key players evaluating their assets in this space, such as Entero Therapeutics (adrulipase), Anagram Therapeutics' (ANG003), Alcresta Therapeutics (RELiZORB), and others. The limited pipeline presents a significant opportunity to develop more therapies for treating EPI.

DelveInsight's 'Exocrine Pancreatic Insufficiency (EPI)- Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the EPI, historical and forecasted epidemiology, as well as the EPI market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The EPI market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates EPI patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (historical & forecast 2022-2036) across global regions. The report highlights key unmet medical needs in EPI and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Exocrine Pancreatic Insufficiency (EPI) Market

• Increasing recognition and diagnosis of exocrine pancreatic insufficiency

Growing awareness among healthcare professionals regarding the symptoms and long-term complications of exocrine pancreatic insufficiency is leading to improved diagnosis rates. Enhanced screening in patients with chronic pancreatitis, cystic fibrosis, pancreatic cancer, and gastrointestinal disorders is contributing to a larger identified patient population requiring long-term management.

• Advancements in diagnostic approaches and pancreatic function assessment

Improvements in diagnostic technologies, including fecal elastase testing, direct pancreatic function tests, and advanced imaging techniques, are supporting earlier and more accurate detection of EPI. These developments are enabling timely therapeutic intervention and better monitoring of disease progression, thereby increasing demand for effective treatment options.

• Expanding use of pancreatic enzyme replacement therapies (PERTs)

The increasing adoption of pancreatic enzyme replacement therapies is significantly improving symptom control, nutritional absorption, and quality of life in patients with EPI. Ongoing research focused on optimizing enzyme formulations, dosing convenience, and therapeutic efficacy is further supporting market growth and advancing long-term disease management strategies.

Exocrine Pancreatic Insufficiency (EPI) Understanding and Treatment Algorithm

Exocrine Pancreatic Insufficiency (EPI) Overview and Diagnosis

EPI is a digestive disorder caused by inadequate secretion of pancreatic enzymes required for fat, protein, and carbohydrate digestion. It commonly occurs secondary to pancreatic and non-pancreatic diseases and leads to clinically significant malnutrition and gastrointestinal complications. It commonly occurs as a consequence of chronic pancreatitis, cystic fibrosis, pancreatic cancer, pancreatic surgery, or other gastrointestinal disorders that impair pancreatic function. Patients with EPI typically present with symptoms such as steatorrhea, diarrhea, abdominal discomfort, bloating, unintended weight loss, malnutrition, and deficiencies of fat-soluble vitamins due to impaired nutrient absorption. The condition can significantly affect quality of life and nutritional status if left untreated. Diagnosis involves a combination of clinical evaluation, assessment of symptoms, nutritional status, and laboratory investigations. Fecal elastase-1 testing is widely used as a noninvasive diagnostic tool to evaluate pancreatic enzyme secretion, while additional tests such as direct pancreatic function testing, fecal fat quantification, imaging studies, and nutritional assessments may provide supportive evidence. Management primarily focuses on PERT, dietary modifications, and correction of nutritional deficiencies to improve digestion, symptom control, and overall patient outcomes.

Current Exocrine Pancreatic Insufficiency (EPI) Treatment Landscape

Current Exocrine Pancreatic Insufficiency (EPI) management primarily focuses on restoring digestive function, improving nutrient absorption, and addressing the underlying cause of pancreatic dysfunction. PERT remains the cornerstone of treatment, with enzyme formulations containing lipase, protease, and amylase administered with meals and snacks to support adequate digestion and reduce symptoms such as steatorrhea, bloating, and weight loss. Treatment is individualized based on symptom severity, dietary intake, and degree of malabsorption, with dose adjustments often required to optimize clinical response. Nutritional management, including high-calorie diets, supplementation of fat-soluble vitamins, and monitoring for malnutrition, plays a critical supportive role in long-term care. In certain patients, acid-suppressive therapies such as proton pump inhibitors may be used to enhance enzyme activity by reducing gastric acid degradation. Management also involves treating associated conditions such as chronic pancreatitis, cystic fibrosis, pancreatic cancer, or gastrointestinal disorders contributing to EPI. Despite the effectiveness of currently available therapies in symptom control, unmet needs remain in achieving complete nutritional normalization, improving treatment adherence, and developing more convenient and targeted therapeutic approaches.

Exocrine Pancreatic Insufficiency (EPI) Unmet Needs

The section "unmet needs of EPI" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Delayed or Missed Diagnosis due to Nonspecific Gastrointestinal Symptoms

2. High Treatment Burden and Adherence Challenges with Pancreatic Enzyme Replacement Therapy

3. Need for More Effective and Targeted Therapeutic Approaches

4. Lack of Reliable Biomarkers for Disease Severity Monitoring and Treatment Optimization, and others.....

Exocrine Pancreatic Insufficiency (EPI) Epidemiology

Key Findings from Exocrine Pancreatic Insufficiency (EPI) Epidemiological Analysis and Forecast

• Autoimmune pancreatitis is often associated with EPI, it is prevalent in cystic fibrosis, affecting approximately 85% of individuals from birth or infancy. In pancreatic ductal adenocarcinoma, the rates of EPI range from 50% to 92% in unresectable cases.
• The prevalence of EPI in newly diagnosed Crohn's Disease (CD) patients ranges from 10.5% to 46.5%, with a pooled prevalence of 26.2% (95% CI 8.43-43.92%). In CD patients on a gluten-free diet (GFD), the rate of EPI ranges from 1.9% to 18.2%.
• As per DelveInsight estimates, in the United States, major causative indication of EPI were Type II diabetes, followed by Celiac disease, among the other causative diseases like Mild Acute Pancreatitis, Moderate to Severe Acute Pancreatitis Chronic Pancreatitis, Cystic Fibrosis, Crohn's Disease, and others.
• Among the EU4 and the UK, Germany accounted for highest prevalence cases of EPI by various causative indication and least cases were observed in Spain.

Exocrine Pancreatic Insufficiency (EPI) Drug Analysis & Competitive Landscape

The EPI drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, patents, collaborations, and strategic partnerships, upcoming key catalysts for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the EPI treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the EPI therapeutics market.

Approved Therapies for Exocrine Pancreatic Insufficiency (EPI)

PERTZYE: Digestive Care

It is a PERT indicated for the treatment of EPI associated with conditions such as cystic fibrosis, chronic pancreatitis, and pancreatectomy. The formulation contains a combination of lipase, protease, and amylase enzymes designed to support the digestion and absorption of fats, proteins, and carbohydrates in patients with impaired pancreatic function. PERTZYE utilizes bicarbonate-buffered enteric-coated microspheres intended to enhance enzyme stability and release in the small intestine, thereby improving nutrient absorption and reducing gastrointestinal symptoms such as steatorrhea, bloating, and malnutrition. The therapy is administered orally with meals and snacks, with dosing individualized according to patient age, weight, dietary fat intake, and severity of enzyme insufficiency.

In July 2012, Pancrelipase (PERTZYE) was approved by the US FDA for patients with exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

CREON: AbbVie

It is a widely used PERT indicated for the treatment of EPI resulting from conditions such as cystic fibrosis, chronic pancreatitis, pancreatectomy, and other disorders associated with pancreatic dysfunction. The formulation contains a mixture of digestive enzymes, including lipase, protease, and amylase, which help restore the digestion and absorption of fats, proteins, and carbohydrates in patients with inadequate pancreatic enzyme secretion. Creon is formulated as delayed-release capsules containing enteric-coated microspheres designed to protect enzymes from gastric acid degradation and facilitate their release in the small intestine for optimal digestive activity. The therapy has demonstrated effectiveness in improving nutrient absorption, reducing gastrointestinal symptoms such as steatorrhea and bloating, and supporting weight maintenance and nutritional status. Dosing is individualized based on patient characteristics, dietary fat intake, and severity of pancreatic insufficiency, with administration recommended during meals and snacks.

Exocrine Pancreatic Insufficiency (EPI) Pipeline Analysis

Adrulipase (FW-EPI): Entero Therapeutics

It is an investigational enzyme replacement therapy designed for the treatment of EPI. Adrulipase is a recombinant lipase engineered to improve fat digestion and nutrient absorption in patients with insufficient pancreatic enzyme secretion associated with conditions such as cystic fibrosis and chronic pancreatitis. Unlike conventional porcine-derived pancreatic enzyme replacement therapies, FW-EPI is being developed as a non-porcine alternative with the potential to offer improved formulation consistency, enhanced stability, and reduced treatment burden. The therapy is intended to address persistent unmet needs in EPI management, including variability in response to current pancreatic enzyme replacement therapies and challenges related to high pill burden and dosing complexity. Early clinical development efforts are focused on evaluating its safety, tolerability, and efficacy in improving fat absorption and gastrointestinal symptoms in affected patients.

ANG003: Anagram Therapeutics

It is a broad-spectrum recombinant oral enzyme replacement therapy designed for the treatment of EPI and related malabsorption disorders. The therapy contains lipase, protease, and amylase enzymes intended to improve the digestion and absorption of fats, proteins, and carbohydrates in patients with impaired pancreatic enzyme secretion, particularly those with cystic fibrosis-associated EPI. Unlike currently available porcine-derived pancreatic enzyme replacement therapies, ANG003 is being developed as a non-porcine alternative with the potential to reduce treatment burden, improve formulation consistency, and address global supply limitations associated with existing therapies. The therapy has been engineered to remain stable and active within the gastrointestinal tract without extensive enteric coating requirements, potentially enabling improved nutrient absorption and simplified dosing regimens. ANG003 is currently being evaluated in Phase II clinical studies assessing its safety, tolerability, and efficacy compared with standard pancreatic enzyme replacement therapies in patients with cystic fibrosis-related EPI.

Exocrine Pancreatic Insufficiency (EPI) Key Players, Market Leaders and Emerging Companies

• Digestive Care
• AbbVie
• Adare Pharma
• Nestle
• Vivus
• Alcresta Therapeutics
• Anagram Therapeutics
• Entero Therapeutics, and others

Exocrine Pancreatic Insufficiency (EPI) Drug Updates

• In May 2026, Anagram Therapeutics announced the enrollment of the first participants in its global Phase II study evaluating ANG003, an oral recombinant non-porcine enzyme therapy for exocrine pancreatic insufficiency associated with cystic fibrosis and other pancreatic disorders.
• In March 2026, Anagram Therapeutics expanded its senior leadership team to support the clinical advancement of ANG003, an orally delivered recombinant enzyme therapy being developed for cystic fibrosis-associated exocrine pancreatic insufficiency and other rare diseases.
• In September 2025, as per corporate presentation, Adrulipase (FW-EPI), an investigational oral non-animal-derived biologic for exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis, demonstrated improved formulation performance, safety, and tolerability in a Phase IIb study, with further program advancement anticipated in 2026.

Exocrine Pancreatic Insufficiency (EPI) Market Outlook

The treatment landscape for EPI is primarily centered on restoring digestive enzyme activity, improving nutrient absorption, and managing the underlying pancreatic disorder responsible for enzyme deficiency. PERT remains the cornerstone of care and is considered the standard treatment approach for patients experiencing maldigestion, steatorrhea, progressive weight loss, and nutritional deficiencies. PERT formulations contain a combination of lipase, amylase, and protease enzymes that support the digestion of fats, carbohydrates, and proteins, thereby improving gastrointestinal symptoms and overall nutritional status. These therapies are administered orally with meals and snacks to optimize digestive function and enhance nutrient assimilation.

Current management strategies focus not only on symptom control but also on normalization of gut absorption and long-term correction of malnutrition-related complications. In addition to enzyme supplementation, nutritional interventions such as high-calorie diets, fat-soluble vitamin supplementation, and individualized dietary counseling play a critical role in comprehensive disease management. Acid suppression therapies, including proton pump inhibitors, may also be utilized in select patients to improve enzyme stability and therapeutic efficacy. Management of the underlying disease etiology remains an essential component of treatment. Patients with chronic pancreatitis, cystic fibrosis, pancreatic cancer, diabetes, or those undergoing pancreatic surgery often require integrated multidisciplinary care to address inflammation, structural pancreatic damage, and associated gastrointestinal complications. In severe cases, surgical or endoscopic interventions may be necessary to relieve pancreatic duct obstruction or manage disease-related complications.

Several FDA-approved pancreatic enzyme products are currently available for the treatment of EPI, including pancrelipase formulations such as Creon, Pancreaze, Pertzye, Viokace, and Zenpep, which collectively dominate the current therapeutic landscape. These therapies have significantly improved patient outcomes; however, unmet needs remain regarding treatment adherence, variability in enzyme response, high pill burden, and incomplete symptom resolution in certain patient populations.

The EPI market is expected to witness continued growth driven by increasing disease awareness, improved diagnostic capabilities, and expanding recognition of EPI across gastrointestinal and pancreatic disorders. Furthermore, growing research activity focused on novel enzyme replacement platforms, personalized nutrition strategies, and earlier disease detection is expected to strengthen the future treatment landscape. Strategic collaborations, pipeline expansion, and increasing investment in rare gastrointestinal diseases are also contributing to the development of next-generation therapies aimed at improving long-term clinical outcomes and quality of life for patients with EPI.

Drug Class/Insights into Leading Emerging and Marketed Therapies in Exocrine Pancreatic Insufficiency (EPI) (2022-2036)

EPI pipeline comprises therapies targeting improved digestive enzyme replacement, enhanced nutrient absorption, reduction of gastrointestinal symptoms, optimization of enzyme delivery and stability, and development of non-porcine recombinant formulations, with the goal of improving digestive function, reducing treatment burden, correcting malnutrition, and enhancing long-term quality of life in patients with pancreatic enzyme deficiency.

• Pancreatic Enzyme: This includes lipase, amylase, and protease, are essential for the digestion and absorption of fats, carbohydrates, and proteins in the small intestine. In conditions such as Exocrine Pancreatic Insufficiency, chronic pancreatitis, cystic fibrosis, pancreatic cancer, or post-pancreatic surgery, insufficient enzyme secretion leads to maldigestion, steatorrhea, weight loss, and nutritional deficiencies. Pancreatic enzyme replacement therapies (PERTs) are therefore used to restore digestive function, improve nutrient absorption, and reduce gastrointestinal symptom burden.
• Recombinant Lipase Enzyme: They are bioengineered digestive enzymes developed using recombinant DNA technology to improve fat digestion in patients with pancreatic enzyme deficiency, particularly EPI. These therapies hydrolyze dietary fats into absorbable fatty acids and monoglycerides, thereby enhancing nutrient absorption and gastrointestinal function. Unlike conventional porcine-derived pancreatic enzyme replacement therapies, recombinant lipase products are manufactured through controlled microbial or yeast-based systems, offering potential advantages such as formulation consistency, improved scalability, and reduced risk of animal-derived contaminants.

Exocrine Pancreatic Insufficiency (EPI) Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the EPI drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.

Detailed insights into emerging therapies' drug uptake are included in the report.

Market Access and Reimbursement of Approved Therapies in Exocrine Pancreatic Insufficiency (EPI)

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

The programs available in the US are:

• Vaccines for Children Program (VFC)
• Children's Health Insurance Program (CHIP)
• Medicare and Medicaid Coverage

NOTE: Further Details are provided in the final report....

Exocrine Pancreatic Insufficiency (EPI) Therapies Price Scenario & Trends

Pricing and analogue assessment of EPI therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, the closest and most appropriate analogue selection for emerging therapies, and the understanding of how pricing influences market access, adherence, and long-term uptake.

Industry Experts and Physician Views for Exocrine Pancreatic Insufficiency (EPI)

To keep up with EPI market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on EPI emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in EPI, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as the Beth Israel Deaconess Medical Center, Universite Centre Leon Berard, Aichi Medical University, etc. were contacted. Their opinion helps understand and validate current and emerging EPI therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in EPI.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of EPI, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are mainly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report:

• The report covers a segment of key events, an executive summary, a descriptive overview of EPI, explaining its causes, signs and symptoms, pathogenesis, and currently available treatments.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the EPI market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM EPI market.

Report Insights

• Exocrine Pancreatic Insufficiency (EPI) Patient Population Forecast
• Exocrine Pancreatic Insufficiency (EPI) Therapeutics Market Size
• Exocrine Pancreatic Insufficiency (EPI) Pipeline Analysis
• Exocrine Pancreatic Insufficiency (EPI) Market Size and Trends
• Exocrine Pancreatic Insufficiency (EPI) Market Opportunity (Current and forecasted)

Report Key Strengths

• Epidemiology-based (Epi-based) Bottom-up Forecasting
• Artificial Intelligence (AI)-Enabled Market Research Report
• 11-Year Forecast
• Exocrine Pancreatic Insufficiency (EPI) Market Outlook (North America, Europe, Asia-Pacific)
• Patient Burden Trends (By Geography)
• Exocrine Pancreatic Insufficiency (EPI) Treatment Addressable Market (TAM)
• Exocrine Pancreatic Insufficiency (EPI) Competitive Landscape
• Exocrine Pancreatic Insufficiency (EPI) Major Companies Insights
• Exocrine Pancreatic InsufficiencPrice Trends and Analogue Assessment
• Exocrine Pancreatic Insufficiency (EPI) Therapies Drug Adoption/Uptake
• Exocrine Pancreatic Insufficiency (EPI) Therapies Peak Patient Share Analysis

Report Assessment

• Exocrine Pancreatic Insufficiency (EPI) Current Treatment Practices
• Exocrine Pancreatic Insufficiency (EPI) Unmet Needs
• Exocrine Pancreatic Insufficiency (EPI) Clinical Development Analysis
• Exocrine Pancreatic Insufficiency (EPI) Emerging Drugs Product Profiles
• Exocrine Pancreatic Insufficiency (EPI) Market attractiveness
• Exocrine Pancreatic Insufficiency (EPI) Qualitative Analysis (SWOT and Conjoint analysis)

FAQs:

Market Insights

• What was the EPI market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
• What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
• What can be the future treatment paradigm of EPI?
• What are the disease risks, burdens, and unmet needs of EPI? What will be the growth opportunities across the 7MM concerning the patient population with EPI?
• Who is the major future competitor in the market, and how will the competitors affect their market share?
• What are the current options for the treatment of EPI? What are the current guidelines for treating EPI in the US, Europe, and Japan?

Reasons to Buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the EPI market.
• Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
• This Artificial Intelligence (AI) enabled report summarizes and simplifies complex datasets within the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Exocrine Pancreatic Insufficiency (EPI)

4. Key Events

• 4.1. Upcoming Key Catalyst
• 4.2. Key Conferences and Meetings
• 4.3. Key Transactions and Collaborations
• 4.4. News Flow

5. Epidemiology and Market Forecast Methodology of Exocrine Pancreatic Insufficiency (EPI)

6. Exocrine Pancreatic Insufficiency (EPI) Market Overview at a Glance

• 6.1. Clinical Landscape Analysis (by Phase, MoA, and RoA)
• 6.2. Market Share (%) Distribution of Exocrine Pancreatic Insufficiency (EPI) by Therapies in the 7MM in 2025
• 6.3. Market Share (%) Distribution of Exocrine Pancreatic Insufficiency (EPI) by Therapies in the 7MM in 2036

7. Disease Background and Overview of Exocrine Pancreatic Insufficiency (EPI)

• 7.1. Introduction
• 7.2. Cause and Inheritance
• 7.3. Signs and Symptoms
• 7.4. Complications
• 7.5. Pathophysiology
• 7.6. Diagnosis
  • 7.6.1. Differential Diagnosis
  • 7.6.2. Diagnosis Algorithm
  • 7.6.3. Diagnosis Guidelines

8. Treatment

• 8.1. Treatment Algorithm
• 8.2. Treatment Guidelines
  • 8.2.1. Practical Guidelines for Managing Adults with Exocrine Pancreatic Insufficiency (EPI)
  • 8.2.2. Towards a Safety Net For Management of Exocrine Pancreatic Insufficiency (EPI): Guidelines

9. Epidemiology and Patient Population of Exocrine Pancreatic Insufficiency (EPI)

• 9.1. Key Findings
• 9.2. Assumptions and Rationale
• 9.3. Prevalence of Causative Indications of Exocrine Pancreatic Insufficiency (EPI) in the 7MM
• 9.4. Prevalence of Exocrine Pancreatic Insufficiency (EPI) in the 7MM
• 9.5. The United States
  • 9.5.1. Prevalence of Causative Indications of Exocrine Pancreatic Insufficiency (EPI) in the United States
  • 9.5.2. Prevalence of Exocrine Pancreatic Insufficiency (EPI) in the United States
  • 9.5.3. Diagnosed Prevalent Cases of Exocrine Pancreatic Insufficiency (EPI) in the United States
  • 9.5.4. Treated Cases of Exocrine Pancreatic Insufficiency (EPI) in the United States
• 9.6. EU4 and the UK
  • 9.6.1. Prevalence of Causative Indications of Exocrine Pancreatic Insufficiency (EPI) in EU4 and the UK
  • 9.6.2. Prevalence of Exocrine Pancreatic Insufficiency (EPI) in EU4 and the UK
  • 9.6.3. Diagnosed Prevalent Cases of Exocrine Pancreatic Insufficiency (EPI) in EU4 and the UK
  • 9.6.4. Treated Cases of EPI Exocrine Pancreatic Insufficiency (EPI) in EU4 and the UK
• 9.7. Japan
  • 9.7.1. Prevalence of Causative Indications of Exocrine Pancreatic Insufficiency (EPI) in Japan
  • 9.7.2. Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Japan
  • 9.7.3. Diagnosed Prevalent Cases of Exocrine Pancreatic Insufficiency (EPI) in Japan
  • 9.7.4. Treated Cases of EPI Exocrine Pancreatic Insufficiency (EPI) in Japan

10. Patient Journey of Exocrine Pancreatic Insufficiency (EPI)

11 . Marketed Therapies

• 11.1. Marketing Competitive Landscape
• 11.2. PERTZYE: Digestive Care
  • 11.2.1. Product Description
  • 11.2.2. Regulatory Milestones
  • 11.2.3. Other Developmental Activities
  • 11.2.4. Summary of Pivotal Trials
  • 11.2.5. Clinical Development
    • 11.2.5.1. Clinical Trial Information
• 11.6. Safety and Efficacy
• 11.7. Analyst Views
• 11.3. CREON: AbbVie
  • 11.3.1. Product Description
  • 11.3.2. Regulatory Milestones
  • 11.3.3. Other Developmental Activities
  • 11.3.4. Summary of Pivotal Trials
  • 11.3.5. Clinical Development
    • 11.3.5.1. Clinical Trial Information
  • 11.3.6. Safety and Efficacy
  • 11.3.7. Analyst Views

12. Emerging Therapies

• 12.1. Emerging Competitive Landscape
• 12.2. Adrulipase (FW-EPI): Entero Therapeutics
  • 12.3.1. Product Description
  • 12.3.2. Other Developmental Activities
  • 12.3.3. Clinical Development
    • 12.3.3.1. Clinical trial information
  • 12.3.4. Safety and Efficacy
  • 12.3.5. Analyst Views
• 12.4. ANG003: Anagram Therapeutics
  • 12.4.1. Product Description
  • 12.4.2. Other Developmental Activities
  • 12.4.3. Clinical Development
    • 12.4.3.1. Clinical trial information
  • 12.4.4. Safety and Efficacy
  • 12.4.5. Analyst Views

13. Exocrine Pancreatic Insufficiency (EPI): 7MM Analysis

• 13.1. Key Findings
• 13.2. Market Outlook
• 13.3. Conjoint Analysis
• 13.4. Key Market Forecast Assumptions
  • 13.4.1. Cost Assumptions and Rebates
  • 13.4.2. Pricing Trends
  • 13.4.3. Analogue Assessment
  • 13.4.4. Launch Year and Therapy Uptakes
• 13.5. Total Market Size of Exocrine Pancreatic Insufficiency (EPI) in the 7MM
• 13.6. The United States
  • 13.6.1. Total Market Size of Exocrine Pancreatic Insufficiency (EPI) in the United States
  • 13.6.2. Market Size of Exocrine Pancreatic Insufficiency (EPI) by Therapies in the United States
• 13.7. EU4 and the UK
  • 13.7.1. Total Market Size of Exocrine Pancreatic Insufficiency (EPI) in EU4 and the UK
  • 13.7.2. Market Size of Exocrine Pancreatic Insufficiency (EPI) by Therapies in EU4 and the UK
• 13.8. Japan
  • 13.8.1. Total Market Size of Exocrine Pancreatic Insufficiency (EPI) in Japan
  • 13.8.2. Market Size of Exocrine Pancreatic Insufficiency (EPI) by Therapies in Japan

14. Unmet Needs of Exocrine Pancreatic Insufficiency (EPI)

15. SWOT Analysis of Exocrine Pancreatic Insufficiency (EPI)

16. KOL Views of Exocrine Pancreatic Insufficiency (EPI)

17. Market Access and Reimbursement of Exocrine Pancreatic Insufficiency (EPI)

• 17.1. The US
• 17.2. In EU4 and the UK
  • 17.2.1. Germany
  • 17.2.2. France
  • 17.2.3. Italy
  • 17.2.4. Spain
  • 17.2.5. United Kingdom
• 17.3. Japan
• 17.4. Summary and Comparison of Market Access and Pricing Policy Developments in 2025
• 17.5. Market Access and Reimbursement of Exocrine Pancreatic Insufficiency (EPI) Therapies

18. Appendix

• 18.1. Bibliography
• 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight