Summary

The 7 major exocrine pancreatic insufficiency markets reached a value of US$ 2.3 Billion in 2023. Looking forward, IMARC Group expects the 7MM to reach US$ 4.0 Billion by 2034, exhibiting a growth rate (CAGR) of 5.15% during 2024-2034.

The exocrine pancreatic insufficiency market has been comprehensively analyzed in IMARC's new report titled "Exocrine Pancreatic Insufficiency Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034". Exocrine pancreatic insufficiency (EPI) refers to a condition in which the pancreas is unable to produce enough digestive enzymes to break down and absorb nutrients from food. This progressive loss of enzymes results in maldigestion, shortage of vitamins, and nutrient malabsorption from routine digestive processes. The symptoms of EPI are similar to many other gastrointestinal conditions and can range from mild to severe. Individuals suffering from this disease may experience abdominal discomfort, belly pain, bloating, diarrhea, fatigue, flatulence, bleeding disorders, edema, foul-smelling or fatty stool, unexplained weight loss, etc. The diagnosis of exocrine pancreatic insufficiency typically involves a review of the patient's symptoms, medical history, and diagnostic procedures. Various tests used to diagnose EPI include fecal elastase, which measures the level of pancreatic enzymes in the stool, and a secretin stimulation test, which assesses the ability of the pancreas to produce digestive enzymes. Several blood tests are also performed to check for nutrient deficiencies or other underlying disorders. In some cases, numerous imaging tests, such as an MRI or CT scan, are used to examine the condition of the pancreas.

The increasing incidence of chronic pancreatitis, which causes inflammation of the pancreas and impairs its ability to produce digestive enzymes, is primarily driving the exocrine pancreatic insufficiency market. Apart from this, the rising prevalence of inherited diseases, such as cystic fibrosis, that can block the pancreatic passageways and prevent the release of essential enzymes is also augmenting the market growth. Moreover, the widespread utilization of pancreatic enzyme replacement therapy for treating EPI, since it significantly enhances fat digestion and improves disease symptoms, is further creating a positive outlook for the market. Besides this, the inflating application of secretin-enhanced magnetic resonance cholangiopancreatography (MRCP), a noninvasive technique, to evaluate exocrine function and visualize changes in the pancreatic duct, is also propelling the market growth. Furthermore, numerous key players are making substantial investments in the development of new formulations of enzyme replacement therapy, including delayed-release enzymes designed to be released slowly over time and enzymes encapsulated in liposomes to improve absorption. This, in turn, is acting as another significant growth-inducing factor. Additionally, the emerging popularity of combination treatments involving vitamin supplementation and lifestyle modification, such as cessation of smoking, limitation of alcohol intake, consumption of a healthy diet, etc., is expected to drive the exocrine pancreatic insufficiency market in the coming years.

IMARC Group's new report provides an exhaustive analysis of the exocrine pancreatic insufficiency market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for exocrine pancreatic insufficiency and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc., have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the exocrine pancreatic insufficiency market in any manner.

Recent Developments:
In December 2023, Codexis, Inc. announced that it had signed a purchase agreement with Nestle Health Science for CDX-7108, which is an experimental medication for the treatment of exocrine pancreatic insufficiency.
In September 2023, Anagram Therapeutics Inc. reported that the first participants had been dosed in a randomized, multicenter, parallel research study to assess the tolerability and safety of orally administered ANG003 in adult individuals with CF-related exocrine pancreatic insufficiency. ANG003 is an innovative broad-spectrum enzyme replacement therapy used orally to treat malabsorption and exocrine pancreatic insufficiency.
In July 2023, First Wave BioPharma, Inc. disclosed that it had received topline results from its Phase 2 SPAN clinical trial, which is investigating an enhanced enteric micro granule delivery formulation of adrulipase for treating exocrine pancreatic insufficiency in cystic fibrosis (CF) patients. According to preliminary study results, the increased adrulipase formulation was safe and well tolerated, and it outperformed previous adrulipase formulations.

Key Highlights:
Exocrine pancreatic insufficiency affects around 60% to 90% of patients with chronic pancreatitis within 10 to 12 years after diagnosis.
Exocrine pancreatic insufficiency is the most frequent pancreas condition in the United States, with 42-73 cases per 100,000 persons.
The prevalence of exocrine pancreatic insufficiency in type 1 diabetes varies from 14% to 77.5% (median 33%), whereas in type 2 diabetes, it ranges between 16.8% to 49.2% (median 29%).
The prevalence of exocrine pancreatic insufficiency rises with age and appears to be higher in males than in women.
About 85 percent of cystic fibrosis patients have exocrine pancreatic insufficiency, necessitating pancreatic enzyme replacement treatment.

Drugs:
Viokace is a compound made up of porcine-derived lipases, amylases, and proteases. In adults, Viokace combined with a proton pump inhibitor is approved for the treatment of exocrine pancreatic insufficiency caused by chronic pancreatitis or pancreatectomy. The drug contains the active component pancrelipase, which exists in the form of tablets that can be taken orally with each meal and snack.

CDX-7108 is a lipase variation designed to address the limits of current pancreatic enzyme replacement therapy (PERT) for treating exocrine pancreatic insufficiency. This therapeutic option is designed to be highly stable in acidic stomach conditions and resistant to proteases in the upper intestines.

MS1819 is a recombinant lipase produced from the yeast Yarrowia Lipolytica. It is under development to treat exocrine pancreatic insufficiency associated with chronic pancreatitis and CF. AzurRx is currently working on a Phase IIa trial of MS1819 to treat exocrine pancreatic insufficiency (EPI) caused by chronic pancreatic pancreatitis. The trial is being carried out at four sites in New Zealand and Australia, with a target enrollment of 12-15 participants.


Time Period of the Study

Base Year: 2023
Historical Period: 2018-2023
Market Forecast: 2024-2034

Countries Covered

United States
Germany
France
United Kingdom
Italy
Spain
Japan

Analysis Covered Across Each Country

Historical, current, and future epidemiology scenario
Historical, current, and future performance of the exocrine pancreatic insufficiency market
Historical, current, and future performance of various therapeutic categories in the market
Sales of various drugs across the exocrine pancreatic insufficiency market
Reimbursement scenario in the market
In-market and pipeline drugs

Competitive Landscape:
This report also provides a detailed analysis of the current exocrine pancreatic insufficiency marketed drugs and late-stage pipeline drugs.

In-Market Drugs

Drug Overview
Mechanism of Action
Regulatory Status
Clinical Trial Results
Drug Uptake and Market Performance

Late-Stage Pipeline Drugs

Drug Overview
Mechanism of Action
Regulatory Status
Clinical Trial Results
Drug Uptake and Market Performance

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.


Key Questions Answered in this Report:
Market Insights

How has the exocrine pancreatic insufficiency market performed so far and how will it perform in the coming years?
What are the markets shares of various therapeutic segments in 2023 and how are they expected to perform till 2034?
What was the country-wise size of the exocrine pancreatic insufficiency market across the seven major markets in 2023 and what will it look like in 2034?
What is the growth rate of the exocrine pancreatic insufficiency market across the seven major markets and what will be the expected growth over the next ten years?
What are the key unmet needs in the market?

Epidemiology Insights

What is the number of prevalent cases (2018-2034) of exocrine pancreatic insufficiency across the seven major markets?
What is the number of prevalent cases (2018-2034) of exocrine pancreatic insufficiency by age across the seven major markets?
What is the number of prevalent cases (2018-2034) of exocrine pancreatic insufficiency by gender across the seven major markets?
How many patients are diagnosed (2018-2034) with exocrine pancreatic insufficiency across the seven major markets?
What is the size of the exocrine pancreatic insufficiency patient pool (2018-2023) across the seven major markets?
What would be the forecasted patient pool (2024-2034) across the seven major markets?
What are the key factors driving the epidemiological trend of exocrine pancreatic insufficiency?
What will be the growth rate of patients across the seven major markets?

Exocrine Pancreatic Insufficiency: Current Treatment Scenario, Marketed Drugs and Emerging Therapies

What are the current marketed drugs and what are their market performance?
What are the key pipeline drugs and how are they expected to perform in the coming years?
How safe are the current marketed drugs and what are their efficacies?
How safe are the late-stage pipeline drugs and what are their efficacies?
What are the current treatment guidelines for exocrine pancreatic insufficiency drugs across the seven major markets?
Who are the key companies in the market and what are their market shares?
What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the exocrine pancreatic insufficiency market?
What are the key regulatory events related to the exocrine pancreatic insufficiency market?
What is the structure of clinical trial landscape by status related to the exocrine pancreatic insufficiency market?
What is the structure of clinical trial landscape by phase related to the exocrine pancreatic insufficiency market?
What is the structure of clinical trial landscape by route of administration related to the exocrine pancreatic insufficiency market?

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Table of Contents

​1 Preface

2 Scope and Methodology
2.1 Objectives of the Study
2.2 Stakeholders
2.3 Data Sources
2.3.1 Primary Sources
2.3.2 Secondary Sources
2.4 Market Estimation
2.4.1 Bottom-Up Approach
2.4.2 Top-Down Approach
2.5 Forecasting Methodology

3 Executive Summary

4 Exocrine Pancreatic Insufficiency - Introduction
4.1 Overview
4.2 Regulatory Process
4.3 Epidemiology (2018-2023) and Forecast (2024-2034)
4.4 Market Overview (2018-2023) and Forecast (2024-2034)
4.5 Competitive Intelligence

5 Exocrine Pancreatic Insufficiency - Disease Overview
5.1 Introduction
5.2 Symptoms and Diagnosis
5.3 Pathophysiology
5.4 Causes and Risk Factors
5.5 Treatment

6 Patient Journey

7 Exocrine Pancreatic Insufficiency - Epidemiology and Patient Population
7.1 Epidemiology - Key Insights
7.2 Epidemiology Scenario - Top 7 Markets
7.2.1 Epidemiology Scenario (2018-2023)
7.2.2 Epidemiology Forecast (2024-2034)
7.2.3 Epidemiology by Age (2018-2034)
7.2.4 Epidemiology by Gender (2018-2034)
7.2.5 Diagnosed Cases (2018-2034)
7.2.6 Patient Pool/Treated Cases (2018-2034)
7.3 Epidemiology Scenario - United States
7.3.1 Epidemiology Scenario (2018-2023)
7.3.2 Epidemiology Forecast (2024-2034)
7.3.3 Epidemiology by Age (2018-2034)
7.3.4 Epidemiology by Gender (2018-2034)
7.3.5 Diagnosed Cases (2018-2034)
7.3.6 Patient Pool/Treated Cases (2018-2034)
7.4 Epidemiology Scenario - Germany
7.4.1 Epidemiology Scenario (2018-2023)
7.4.2 Epidemiology Forecast (2024-2034)
7.4.3 Epidemiology by Age (2018-2034)
7.4.4 Epidemiology by Gender (2018-2034)
7.4.5 Diagnosed Cases (2018-2034)
7.4.6 Patient Pool/Treated Cases (2018-2034)
7.5 Epidemiology Scenario - France
7.5.1 Epidemiology Scenario (2018-2023)
7.5.2 Epidemiology Forecast (2024-2034)
7.5.3 Epidemiology by Age (2018-2034)
7.5.4 Epidemiology by Gender (2018-2034)
7.5.5 Diagnosed Cases (2018-2034)
7.5.6 Patient Pool/Treated Cases (2018-2034)
7.6 Epidemiology Scenario - United Kingdom
7.6.1 Epidemiology Scenario (2018-2023)
7.6.2 Epidemiology Forecast (2024-2034)
7.6.3 Epidemiology by Age (2018-2034)
7.6.4 Epidemiology by Gender (2018-2034)
7.6.5 Diagnosed Cases (2018-2034)
7.6.6 Patient Pool/Treated Cases (2018-2034)
7.7 Epidemiology Scenario - Italy
7.7.1 Epidemiology Scenario (2018-2023)
7.7.2 Epidemiology Forecast (2024-2034)
7.7.3 Epidemiology by Age (2018-2034)
7.7.4 Epidemiology by Gender (2018-2034)
7.7.5 Diagnosed Cases (2018-2034)
7.7.6 Patient Pool/Treated Cases (2018-2034)
7.8 Epidemiology Scenario - Spain
7.8.1 Epidemiology Scenario (2018-2023)
7.8.2 Epidemiology Forecast (2024-2034)
7.8.3 Epidemiology by Age (2018-2034)
7.8.4 Epidemiology by Gender (2018-2034)
7.8.5 Diagnosed Cases (2018-2034)
7.8.6 Patient Pool/Treated Cases (2018-2034)
7.9 Epidemiology Scenario - Japan
7.9.1 Epidemiology Scenario (2018-2023)
7.9.2 Epidemiology Forecast (2024-2034)
7.9.3 Epidemiology by Age (2018-2034)
7.9.4 Epidemiology by Gender (2018-2034)
7.9.5 Diagnosed Cases (2018-2034)
7.9.6 Patient Pool/Treated Cases (2018-2034)

8 Exocrine Pancreatic Insufficiency - Treatment Algorithm, Guidelines, and Medical Practices
8.1 Guidelines, Management and Treatment
8.2 Treatment Algorithm

9 Exocrine Pancreatic Insufficiency - Unmet Needs

10 Exocrine Pancreatic Insufficiency - Key Endpoints of Treatment

11 Exocrine Pancreatic Insufficiency - Marketed Products
11.1 List of Exocrine Pancreatic Insufficiency Marketed Drugs Across the Top 7 Markets
11.1.1 Viokace (Pancrelipase immediate release) - Nestle
11.1.1.1 Drug Overview
11.1.1.2 Mechanism of Action
11.1.1.3 Regulatory Status
11.1.1.4 Clinical Trial Results
11.1.1.5 Sales Across Major Markets
11.1.2 Zenpep (Pancrelipase delayed release) - Nestle
11.1.2.1 Drug Overview
11.1.2.2 Mechanism of Action
11.1.2.3 Regulatory Status
11.1.2.4 Clinical Trial Results
11.1.2.5 Sales Across Major Markets
11.1.3 Pancreaze (Pancrelipase) - Janssen Pharmaceuticals
11.1.3.1 Drug Overview
11.1.3.2 Mechanism of Action
11.1.3.3 Regulatory Status
11.1.3.4 Clinical Trial Results
11.1.3.5 Sales Across Major Markets
11.1.4 Ultresa (Pancrelipase (Ultrase) delayed-release) - AbbVie
11.1.4.1 Drug Overview
11.1.4.2 Mechanism of Action
11.1.4.3 Regulatory Status
11.1.4.4 Clinical Trial Results
11.1.4.5 Sales Across Major Markets
11.1.5 Creon (Pancrelipase delayed-release capsules) - AbbVie
11.1.5.1 Drug Overview
11.1.5.2 Mechanism of Action
11.1.5.3 Regulatory Status
11.1.5.4 Clinical Trial Results
11.1.5.5 Sales Across Major Markets

Kindly note that the above only represents a partial list of marketed drugs, and the complete list has been provided in the report.

12 Exocrine Pancreatic Insufficiency - Pipeline Drugs
12.1 List of Exocrine Pancreatic Insufficiency Pipeline Drugs Across the Top 7 Markets
12.1.1 CDX7108 - Codexis
12.1.1.1 Drug Overview
12.1.1.2 Mechanism of Action
12.1.1.3 Clinical Trial Results
12.1.1.4 Safety and Efficacy
12.1.1.5 Regulatory Status
12.1.2 MS 1819 - First Wave BioPharma/Mayoly-Spindler
12.1.2.1 Drug Overview
12.1.2.2 Mechanism of Action
12.1.2.3 Clinical Trial Results
12.1.2.4 Safety and Efficacy
12.1.2.5 Regulatory Status

Kindly note that the above only represents a partial list of pipeline drugs, and the complete list has been provided in the report.

13. Exocrine Pancreatic Insufficiency - Attribute Analysis of Key Marketed and Pipeline Drugs

14. Exocrine Pancreatic Insufficiency – Clinical Trial Landscape
14.1 Drugs by Status
14.2 Drugs by Phase
14.3 Drugs by Route of Administration
14.4 Key Regulatory Events

15 Exocrine Pancreatic Insufficiency - Market Scenario
15.1 Market Scenario - Key Insights
15.2 Market Scenario - Top 7 Markets
15.2.1 Exocrine Pancreatic Insufficiency - Market Size
15.2.1.1 Market Size (2018-2023)
15.2.1.2 Market Forecast (2024-2034)
15.2.2 Exocrine Pancreatic Insufficiency - Market Size by Therapies
15.2.2.1 Market Size by Therapies (2018-2023)
15.2.2.2 Market Forecast by Therapies (2024-2034)
15.3 Market Scenario - United States
15.3.1 Exocrine Pancreatic Insufficiency - Market Size
15.3.1.1 Market Size (2018-2023)
15.3.1.2 Market Forecast (2024-2034)
15.3.2 Exocrine Pancreatic Insufficiency - Market Size by Therapies
15.3.2.1 Market Size by Therapies (2018-2023)
15.3.2.2 Market Forecast by Therapies (2024-2034)
15.3.3 Exocrine Pancreatic Insufficiency - Access and Reimbursement Overview
15.4 Market Scenario - Germany
15.4.1 Exocrine Pancreatic Insufficiency - Market Size
15.4.1.1 Market Size (2018-2023)
15.4.1.2 Market Forecast (2024-2034)
15.4.2 Exocrine Pancreatic Insufficiency - Market Size by Therapies
15.4.2.1 Market Size by Therapies (2018-2023)
15.4.2.2 Market Forecast by Therapies (2024-2034)
15.4.3 Exocrine Pancreatic Insufficiency - Access and Reimbursement Overview
15.5 Market Scenario - France
15.5.1 Exocrine Pancreatic Insufficiency - Market Size
15.5.1.1 Market Size (2018-2023)
15.5.1.2 Market Forecast (2024-2034)
15.5.2 Exocrine Pancreatic Insufficiency - Market Size by Therapies
15.5.2.1 Market Size by Therapies (2018-2023)
15.5.2.2 Market Forecast by Therapies (2024-2034)
15.5.3 Exocrine Pancreatic Insufficiency - Access and Reimbursement Overview
15.6 Market Scenario - United Kingdom
15.6.1 Exocrine Pancreatic Insufficiency - Market Size
15.6.1.1 Market Size (2018-2023)
15.6.1.2 Market Forecast (2024-2034)
15.6.2 Exocrine Pancreatic Insufficiency - Market Size by Therapies
15.6.2.1 Market Size by Therapies (2018-2023)
15.6.2.2 Market Forecast by Therapies (2024-2034)
15.6.3 Exocrine Pancreatic Insufficiency - Access and Reimbursement Overview
15.7 Market Scenario - Italy
15.7.1 Exocrine Pancreatic Insufficiency - Market Size
15.7.1.1 Market Size (2018-2023)
15.7.1.2 Market Forecast (2024-2034)
15.7.2 Exocrine Pancreatic Insufficiency - Market Size by Therapies
15.7.2.1 Market Size by Therapies (2018-2023)
15.7.2.2 Market Forecast by Therapies (2024-2034)
15.7.3 Exocrine Pancreatic Insufficiency - Access and Reimbursement Overview
15.8 Market Scenario - Spain
15.8.1 Exocrine Pancreatic Insufficiency - Market Size
15.8.1.1 Market Size (2018-2023)
15.8.1.2 Market Forecast (2024-2034)
15.8.2 Exocrine Pancreatic Insufficiency - Market Size by Therapies
15.8.2.1 Market Size by Therapies (2018-2023)
15.8.2.2 Market Forecast by Therapies (2024-2034)
15.8.3 Exocrine Pancreatic Insufficiency - Access and Reimbursement Overview
15.9 Market Scenario - Japan
15.9.1 Exocrine Pancreatic Insufficiency - Market Size
15.9.1.1 Market Size (2018-2023)
15.9.1.2 Market Forecast (2024-2034)
15.9.2 Exocrine Pancreatic Insufficiency - Market Size by Therapies
15.9.2.1 Market Size by Therapies (2018-2023)
15.9.2.2 Market Forecast by Therapies (2024-2034)
15.9.3 Exocrine Pancreatic Insufficiency - Access and Reimbursement Overview

16 Exocrine Pancreatic Insufficiency - Recent Events and Inputs From Key Opinion Leaders

17 Exocrine Pancreatic Insufficiency Market - SWOT Analysis
17.1 Strengths
17.2 Weaknesses
17.3 Opportunities
17.4 Threats

18 Exocrine Pancreatic Insufficiency Market – Strategic Recommendations

19 Appendix