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    Exocrine Pancreatic Insufficiency Market

    ID: MRFR/HC/25535-HCR
    128 Pages
    Rahul Gotadki
    October 2025

    Exocrine Pancreatic Insufficiency Market Research Report By Disease Type (Chronic Pancreatitis, Pancreatic Cancer, Cystic Fibrosis, Shwachman-Diamond Syndrome, Other Rare Conditions), By Treatment Type (Enzyme Replacement Therapy (ERT), Pancreatic Enzyme Supplements, Other Therapies (Insulin Therapy, Anti-Inflammatory Drugs, Surgery)), By Dosage Form (Capsules, Tablets, Powders, Granules), By Administration Route (Oral, Intravenous, Subcutaneous), By End User (Hospitals & Clinics, Home Healthcare Settings, Pharmacies & Retail Stores)...

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    Exocrine Pancreatic Insufficiency Market Infographic
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    Exocrine Pancreatic Insufficiency Market Summary

    The global exocrine pancreatic insufficiency market is projected to grow significantly from 3.17 USD billion in 2024 to 5.70 USD billion by 2035.

    Key Market Trends & Highlights

    Exocrine Pancreatic Insufficiency Key Trends and Highlights

    • The market is expected to experience a compound annual growth rate (CAGR) of 5.47 percent from 2025 to 2034.
    • By 2035, the market valuation is anticipated to reach 5.7 USD billion, indicating robust growth potential.
    • in 2024, the market is valued at 3.17 USD billion, reflecting the increasing awareness and diagnosis of exocrine pancreatic insufficiency.
    • Growing adoption of enzyme replacement therapy due to rising prevalence of pancreatic disorders is a major market driver.

    Market Size & Forecast

    2024 Market Size 3.17 (USD Billion)
    2035 Market Size 5.70 (USD Billion)
    CAGR (2025-2035) 5.48%

    Major Players

    AbbVie, Shire, Eli Lilly, Roche, Mylan, Merck Co, Hikma, Reddy's Laboratories, Zydus Cadila, Novo Nordisk, Pfizer, Baxter, Fresenius, Akorn, Johnson Johnson

    Exocrine Pancreatic Insufficiency Market Trends

    Key Market Drivers:The rise in incidences of chronic pancreatitis and cystic fibrosis, coupled with the increasing prevalence of digestive disorders, fuels the demand for exocrine pancreatic insufficiency treatment options. Advanced technologies and novel drug delivery systems offer effective solutions, driving market growth.Opportunities to be Explored:Emerging markets in Asia-Pacific and Latin America present lucrative opportunities due to rising healthcare expenditure and unmet medical needs.

    The development of precision medicine and personalized treatment approaches tailored to individual patient profiles offers untapped potential.Trends in Recent Times:The integration of artificial intelligence (AI) and machine learning in exocrine pancreatic insufficiency management enhances diagnosis accuracy and treatment optimization. The advent of minimally invasive surgical procedures and endoscopic techniques reduces patient discomfort and recovery time. Research into gene therapy and stem cell therapies holds promise for addressing the underlying causes of pancreatic insufficiency.

    Source: Primary Research, Secondary Research, MRFR Database and Analyst Review

    The increasing prevalence of exocrine pancreatic insufficiency, driven by rising incidences of pancreatic disorders and the aging population, underscores a growing need for effective management strategies and therapeutic interventions.

    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Exocrine Pancreatic Insufficiency Market Drivers

    Emerging Therapeutic Options

    The development of novel therapeutic options, including enzyme replacement therapies and dietary interventions, is reshaping the Global Exocrine Pancreatic Insufficiency Market Industry. These emerging treatments offer improved efficacy and patient compliance, addressing the limitations of traditional therapies. For instance, the introduction of enteric-coated pancreatic enzyme products has enhanced the bioavailability of enzymes, leading to better patient outcomes. As these innovative therapies gain traction, they are likely to drive market growth. The anticipated increase in market value to 3.17 USD Billion by 2024 underscores the potential impact of these advancements on patient care.

    Market Trends and Projections

    The Global Exocrine Pancreatic Insufficiency Market Industry is characterized by various trends that indicate its future trajectory. Projections suggest a market value of 5.7 USD Billion by 2035, with a compound annual growth rate of 5.47% from 2025 to 2035. This growth is influenced by factors such as rising prevalence of pancreatic disorders, advancements in diagnostics, and increasing awareness among healthcare providers and patients. The market's expansion reflects the ongoing need for effective management strategies and therapeutic options to address the challenges posed by exocrine pancreatic insufficiency.

    Growing Awareness and Education

    The rising awareness regarding exocrine pancreatic insufficiency among healthcare professionals and patients plays a pivotal role in the Global Exocrine Pancreatic Insufficiency Market Industry. Educational initiatives and campaigns aimed at highlighting the symptoms and consequences of the condition encourage timely diagnosis and treatment. As patients become more informed about their health, they are more likely to seek medical advice, leading to increased demand for therapeutic options. This heightened awareness is likely to contribute to a compound annual growth rate of 5.47% from 2025 to 2035, further solidifying the market's growth trajectory.

    Increasing Geriatric Population

    The global demographic shift towards an aging population is a significant driver of the Global Exocrine Pancreatic Insufficiency Market Industry. Older adults are more susceptible to pancreatic disorders due to age-related physiological changes and comorbidities. As the geriatric population continues to grow, the prevalence of exocrine pancreatic insufficiency is expected to rise correspondingly. This demographic trend necessitates the development of tailored treatment options and management strategies for older patients. Consequently, the market is poised for substantial growth, with projections indicating a market value of 5.7 USD Billion by 2035, reflecting the urgent need for targeted interventions.

    Advancements in Diagnostic Technologies

    Technological advancements in diagnostic tools significantly enhance the detection of exocrine pancreatic insufficiency, thereby propelling the Global Exocrine Pancreatic Insufficiency Market Industry. Innovations such as non-invasive imaging techniques and improved laboratory tests facilitate early diagnosis, which is crucial for effective treatment. For example, the introduction of fecal elastase testing has simplified the assessment of pancreatic function. As awareness of these diagnostic options increases, healthcare providers are more likely to identify and treat patients promptly, contributing to market growth. This trend is expected to sustain the market's trajectory towards an estimated value of 5.7 USD Billion by 2035.

    Rising Prevalence of Pancreatic Disorders

    The increasing incidence of pancreatic disorders, including chronic pancreatitis and cystic fibrosis, drives the Global Exocrine Pancreatic Insufficiency Market Industry. As more individuals are diagnosed with these conditions, the demand for diagnostic and therapeutic solutions rises. For instance, chronic pancreatitis affects approximately 50,000 to 100,000 individuals annually in the United States alone. This growing patient population necessitates effective management strategies, contributing to the market's expansion. By 2024, the market is projected to reach 3.17 USD Billion, reflecting the urgent need for innovative treatments and management options.

    Market Segment Insights

    Exocrine Pancreatic Insufficiency Market Disease Type Insights

    In 2023, the chronic pancreatitis segment accounted for the highest market share of the Exocrine Pancreatic Insufficiency Market and is anticipated to dominate the market during the forecast period. This is mainly attributed to the high incidence of chronic pancreatitis due to the increasing prevalence of obesity and alcohol intake.

    The second largest segment of the Exocrine Pancreatic Insufficiency Market is pancreatic cancer; this is mainly driven by the increasing incidence of pancreatic cancer, and due to the lack of proper medications, the prescription base for EPI available in the market is limited.Cystic fibrosis is a particularly rare genetic disorder that affects mostly exocrine glands such as the pancreas.

    The factors responsible for the growth of this segment are the increasing incidence of cystic fibrosis and the rise in demand for advanced treatments. Shwachman-Diamond syndrome is also a rare disease that mostly affects the bone marrow and other exocrine glands, such as the pancreas. The factors responsible for the development of this segment are increasing awareness about the Shwachman-Diamond syndrome and rising demand for the different medications for the treatment of this disease.Autoimmune pancreatitis and tropical pancreatitis are the other rare diseases responsible for the boost in the growth of the Exocrine Pancreatic Insufficiency Market.

    Source: Primary Research, Secondary Research, MRFR Database and Analyst Review

    Exocrine Pancreatic Insufficiency Market Treatment Type Insights

    Enzyme Replacement Therapy (ERT) dominates the Exocrine Pancreatic Insufficiency Market revenue, accounting for a significant market share in 2023. ERT involves administering pancreatic enzymes to aid digestion. Its efficacy in managing symptoms and improving nutrient absorption drives market growth. Pancreatic enzyme supplements, another treatment option, offer a convenient and cost-effective alternative to ERT. Other therapies, including insulin therapy, anti-inflammatory drugs, and surgery, address specific aspects of the condition.

    Surgery, for instance, may be necessary to remove blockages or tumors in the pancreas.The Exocrine Pancreatic Insufficiency Market segmentation provides insights into the relative performance of these treatment types, enabling stakeholders to optimize product development and marketing strategies.

    Exocrine Pancreatic Insufficiency Market Dosage Form Insights

    The Exocrine Pancreatic Insufficiency Market is segmented into Capsules, Tablets, Powders, and Granules based on Dosage Form. Among these, the Tablets segment held the largest market share in 2023, accounting for around 48.5% of the Exocrine Pancreatic Insufficiency Market revenue. This is due to the ease of administration and the availability of various strengths and formulations of tablets.

    The Capsules segment is also expected to witness significant growth during the forecast period, owing to factors such as the growing preference for convenient dosage forms.The Powders and Granules segments are expected to have a moderate growth rate, as they are preferred by patients who have difficulty swallowing tablets or capsules. Overall, the Exocrine Pancreatic Insufficiency Market is expected to witness steady growth over the forecast period, driven by the increasing prevalence of chronic pancreatitis and other exocrine pancreatic disorders.

    Exocrine Pancreatic Insufficiency Market Administration Route Insights

    The Exocrine Pancreatic Insufficiency Market is segmented based on Administration Route into Oral, Intravenous, and Subcutaneous. Among these, the Oral segment is expected to hold the largest market share in 2023 and is projected to continue its dominance throughout the forecast period, owing to the ease of administration and better patient compliance associated with oral medications.

    The Intravenous segment is expected to account for a significant share of the market, primarily due to the rapid onset of action and the ability to deliver high doses of medication.The Subcutaneous segment is expected to witness a steady growth rate during the forecast period, driven by the increasing adoption of subcutaneous formulations for patients who are unable to tolerate oral or intravenous medications.

    Exocrine Pancreatic Insufficiency Market End User Insights

    Hospitals Clinics held the largest share of the Exocrine Pancreatic Insufficiency Market in 2023, and this trend is expected to continue over the forecast period. The large number of patients diagnosed with exocrine pancreatic insufficiency who require specialized care and the availability of advanced diagnostic and therapeutic facilities in hospitals and clinics drive this segment's growth. The increasing prevalence of chronic pancreatitis, which is a major cause of exocrine pancreatic insufficiency, is also contributing to the growth of this segment.Home Healthcare Settings are expected to witness significant growth during the forecast period.

    The increasing demand for home healthcare services due to the rising number of patients with chronic conditions and the growing preference for home-based care are driving the growth of this segment.

    The availability of portable and easy-to-use devices for administering pancreatic enzyme replacement therapy (PERT) is also contributing to the growth of this segment. Pharmacies Retail Stores are expected to hold a moderate share of the Exocrine Pancreatic Insufficiency Market.The increasing availability of over-the-counter (OTC) PERT products and the growing awareness of exocrine pancreatic insufficiency among patients are driving the growth of this segment. The presence of well-established distribution channels and the convenience of purchasing PERT products from pharmacies and retail stores are also contributing to the growth of this segment.

    Get more detailed insights about Exocrine Pancreatic Insufficiency Market Research Report - Forecast till 2034

    Regional Insights

    Regionally, North America held the largest market share in 2023, accounting for over 40% of the global revenue. The region's dominance can be attributed to the high prevalence of chronic pancreatitis, cystic fibrosis, and other conditions that lead to exocrine pancreatic insufficiency. Europe and APAC are also significant markets, with Europe expected to witness a steady growth rate due to increasing awareness and diagnosis of the condition. South America and MEA are anticipated to show promising growth potential, driven by rising healthcare expenditure and improving healthcare infrastructure.

    Exocrine Pancreatic Insufficiency Market Regional Insights

    Source: Primary Research, Secondary Research, MRFR Database and Analyst Review

    Key Players and Competitive Insights

    The Exocrine Pancreatic Insufficiency Market industry’s major players are focused on developing new and innovative product offerings to cater to the needs of patients. Leading players in the Exocrine Pancreatic Insufficiency Market are channeling their investments into research and development to enhance the efficacy and safety of their product offerings. The Exocrine Pancreatic Insufficiency Market is projected to soon record an emerging phase as the incidence of chronic pancreatitis and other diseases causing exocrine pancreatic insufficiency rises.

    The Exocrine Pancreatic Insufficiency Market’s competitive landscape is characterized by a medium level of fragmentation, with a large number of small and medium-sized players present in the market. Nonetheless, the market for exocrine pancreatic insufficiency is expected to witness consolidation in the coming years as larger players acquire smaller players to achieve a better market standing.AbbVie is a major player in the Exocrine Pancreatic Insufficiency Market, with key products including Creon and Pancreaze for the treatment of exocrine pancreatic insufficiency. AbbVie is also involved in research and development to enhance the safety and efficacy profile of its product offerings.

    The company is also expanding its international presence through a healthy mix of acquisitions and partnerships. Shire is another prominent player in the Exocrine Pancreatic Insufficiency Market, with significant products including Pancrease and Kudel. Shire is involved in research and development to improve the safety and efficacy of product offerings and is also expanding its international presence through acquisitions and partnerships.The competitor company in the Exocrine Pancreatic Insufficiency Market is Eli Lilly, with premium product offerings, including Zenpep for the treatment of pancreatic exocrine insufficiency.

    Eli Lilly is focusing on research and development to develop enhanced safety and efficacy profiles of its product and is expanding its international presence through a healthy mix of acquisitions and partnerships. Eli Lilly is a major player in the Exocrine Pancreatic Insufficiency Market and is also expected to grow in the near future.

    Key Companies in the Exocrine Pancreatic Insufficiency Market market include

    Industry Developments

    • Q2 2024: Nestle Health Science launches Zenpep in new markets to expand exocrine pancreatic insufficiency portfolio Nestle Health Science announced the launch of Zenpep, a pancreatic enzyme replacement therapy, in several new international markets as part of its strategy to expand its exocrine pancreatic insufficiency (EPI) treatment portfolio.
    • Q1 2024: FDA approves Viatris’ generic pancrelipase delayed-release capsules for exocrine pancreatic insufficiency The FDA granted approval to Viatris for its generic version of pancrelipase delayed-release capsules, providing a new treatment option for patients with exocrine pancreatic insufficiency.
    • Q3 2024: AzurRx BioPharma Announces Completion of Enrollment in Phase 2b OPTION 2 Clinical Trial of MS1819 for Exocrine Pancreatic Insufficiency in Cystic Fibrosis AzurRx BioPharma reported the completion of patient enrollment in its Phase 2b OPTION 2 clinical trial evaluating MS1819, a recombinant lipase, for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis.
    • Q2 2024: Anthera Pharmaceuticals Announces Positive Topline Results from SOLUTION Clinical Study of Sollpura in Exocrine Pancreatic Insufficiency Anthera Pharmaceuticals announced positive topline results from its SOLUTION clinical study evaluating Sollpura, a non-porcine pancreatic enzyme replacement therapy, in patients with exocrine pancreatic insufficiency.
    • Q1 2025: AbbVie Receives European Commission Approval for Creon for Pediatric Exocrine Pancreatic Insufficiency AbbVie announced that the European Commission has approved Creon for the treatment of exocrine pancreatic insufficiency in pediatric patients, expanding its label in the European Union.
    • Q2 2025: Nestle Health Science acquires exclusive distribution rights for exocrine pancreatic insufficiency therapy in Asia-Pacific Nestle Health Science secured exclusive distribution rights for a leading exocrine pancreatic insufficiency therapy in the Asia-Pacific region, strengthening its presence in the EPI therapeutics market.
    • Q3 2024: AzurRx BioPharma Announces $15 Million Series C Financing to Advance MS1819 for Exocrine Pancreatic Insufficiency AzurRx BioPharma raised $15 million in Series C financing to support the continued development and commercialization of MS1819, its lead candidate for exocrine pancreatic insufficiency.
    • Q4 2024: Viatris and Synspira Therapeutics Announce Strategic Partnership to Develop Novel EPI Therapies Viatris and Synspira Therapeutics entered into a strategic partnership to co-develop and commercialize novel therapies for exocrine pancreatic insufficiency, aiming to address unmet needs in the market.
    • Q1 2025: AbbVie Opens New Manufacturing Facility for Creon Production in Ireland AbbVie inaugurated a new manufacturing facility in Ireland dedicated to the production of Creon, its flagship pancreatic enzyme replacement therapy for exocrine pancreatic insufficiency.
    • Q2 2024: AzurRx BioPharma Appoints Dr. James Pennington as Chief Medical Officer AzurRx BioPharma announced the appointment of Dr. James Pennington as Chief Medical Officer to lead clinical development of its exocrine pancreatic insufficiency pipeline.

    Future Outlook

    Exocrine Pancreatic Insufficiency Market Future Outlook

    The Exocrine Pancreatic Insufficiency Market is projected to grow at a 5.48% CAGR from 2024 to 2034, driven by rising prevalence and advancements in enzyme replacement therapies.

    New opportunities lie in:

    • Develop innovative enzyme formulations to enhance patient compliance and efficacy.
    • Expand telehealth services for remote monitoring and management of EPI patients.
    • Invest in educational programs targeting healthcare professionals to improve diagnosis rates.

    By 2035, the Exocrine Pancreatic Insufficiency Market is expected to exhibit robust growth, reflecting increased awareness and treatment advancements.

    Market Segmentation

    Exocrine Pancreatic Insufficiency Market End User Outlook

    • Hospitals Clinics
    • Home Healthcare Settings
    • Pharmacies Retail Stores

    Exocrine Pancreatic Insufficiency Market Regional Outlook

    • North America
    • Europe
    • South America
    • Asia Pacific
    • Middle East and Africa

    Exocrine Pancreatic Insufficiency Market Dosage Form Outlook

    • Capsules
    • Tablets
    • Powders
    • Granules

    Exocrine Pancreatic Insufficiency Market Disease Type Outlook

    • Chronic Pancreatitis
    • Pancreatic Cancer
    • Cystic Fibrosis
    • Shwachman-Diamond Syndrome
    • Other Rare Conditions

    Exocrine Pancreatic Insufficiency Market Treatment Type Outlook

    • Enzyme Replacement Therapy (ERT)
    • Pancreatic Enzyme Supplements
    • Other Therapies (Insulin Therapy, Anti-Inflammatory Drugs, Surgery)

    Exocrine Pancreatic Insufficiency Market Administration Route Outlook

    • Oral
    • Intravenous
    • Subcutaneous

    Report Scope

    Report Attribute/Metric Details
    Market Size 2024    3.17 (USD Billion)
    Market Size 2025    3.34 (USD Billion)
    Market Size 2035 5.70 (USD Billion)
    Compound Annual Growth Rate (CAGR) 5.48% (2025 - 2035)
    Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
    Base Year 2024
    Market Forecast Period 2025 - 2035
    Historical Data 2020 - 2024
    Market Forecast Units USD Billion
    Key Companies Profiled Roche, Mylan, AbbVie, Merck Co, Shire Plc, Hikma, Dr. Reddy's Laboratories, Zydus Cadila, Novo Nordisk, Pfizer, Baxter, Fresenius, Akorn, Eli Lilly, Johnson Johnson
    Segments Covered Disease Type, Treatment Type, Dosage Form, Administration Route, End User, Regional
    Key Market Opportunities Rising prevalence of chronic pancreatitis Growing demand for minimally invasive therapies Technological advancements in pancreatic enzyme replacement therapy Expanding access to healthcare in emerging markets Increasing awareness of Exocrine Pancreatic Insufficiency
    Key Market Dynamics The rising prevalence of chronic pancreatitis increasing healthcare expenditure, technological advancements, unmet medical needs, FDA approvals
    Countries Covered North America, Europe, APAC, South America, MEA

    FAQs

    What is the projected growth of the Exocrine Pancreatic Insufficiency market?

    The Exocrine Pancreatic Insufficiency market is the expected increase in total market value of 5.7 USD billion over a defined forecast period 2025–2035. It is driven by factors such as demand trends, technological advances, regulatory changes, and geographic expansion.

    What is the size of the Exocrine Pancreatic Insufficiency market?

    Exocrine Pancreatic Insufficiency market size was valued at approximately 3.17 billion USD in 2024. This figure will reach 5.7 billion USD covering all regions (America, Europe, Asia, MEA and ROW), focusing its segments / services / distribution channels till 2035.

    What is the CAGR of the Exocrine Pancreatic Insufficiency market?

    Exocrine Pancreatic Insufficiency market is expected to grow at a CAGR of 5.48% between 2025 and 2035.

    How much will the Exocrine Pancreatic Insufficiency market be worth by 2035?

    Exocrine Pancreatic Insufficiency market is expected to be worth of 5.7 billion USD, reflecting growth driven by usage, technology and global demands by the end of 2035.

    How will the Exocrine Pancreatic Insufficiency market perform over the next 10 years?

    Over the next 10 years the Exocrine Pancreatic Insufficiency market is expected to shift from usd billion 3.17 to 5.7 billion USD, led by adoption of advanced tech, demographic trends, regulatory approvals, with potential headwinds from 2025 to 2035.

    Which region is expected to hold the largest share of the Exocrine Pancreatic Insufficiency Market in 2035?

    North America is expected to hold the largest share of the Exocrine Pancreatic Insufficiency Market in 2035.

    Which application segment is expected to account for the largest share of the Exocrine Pancreatic Insufficiency Market in 2035?

    The chronic pancreatitis segment is expected to account for the largest share of the Exocrine Pancreatic Insufficiency Market in 2035.

    Who are some of the key competitors in the Exocrine Pancreatic Insufficiency Market?

    Some of the key competitors in the Exocrine Pancreatic Insufficiency Market include AbbVie, Shire, and Johnson Johnson.

    What are some of the key factors driving the growth of the Exocrine Pancreatic Insufficiency Market?

    The increasing prevalence of chronic pancreatitis and cystic fibrosis, as well as the rising demand for minimally invasive procedures, are key factors driving the growth of the Exocrine Pancreatic Insufficiency Market.

    What are some of the challenges facing the Exocrine Pancreatic Insufficiency Market?

    The high cost of treatment and the limited availability of skilled healthcare professionals are some of the challenges facing the Exocrine Pancreatic Insufficiency Market.

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