The Global Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market was valued at USD 3.505 Billion in 2023 and is projected to reach USD 5.032 Billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 4.10% during the forecast period (2023–2032). This growth is being driven by the rising incidence of pancreatic disorders such as chronic pancreatitis and cystic fibrosis, increased patient awareness, and ongoing advancements in pancreatic enzyme replacement therapies (PERT) along with improved diagnostic tools like imaging and stool tests in hospitals and specialty clinics.
As healthcare providers focus more on gastrointestinal conditions and personalized treatment options, attention turns to the leading companies pioneering solutions in EPI management. These firms are at the forefront of developing effective therapies and accurate diagnostics to alleviate symptoms like maldigestion and malnutrition. In this blog, we profile the Top 10 Companies in the Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market—a blend of pharmaceutical powerhouses, biotech specialists, and diagnostic innovators transforming patient outcomes in digestive health.
🔟 1. AbbVie Inc.
Headquarters: North Chicago, Illinois, USA
Key Offering: Pancreatic enzyme replacement therapy (PERT) products like Creon
AbbVie stands as a dominant force in the EPI market, leveraging its extensive pharmaceutical expertise to deliver comprehensive solutions for patients suffering from exocrine pancreatic insufficiency. Through its flagship product Creon, the company provides enteric-coated pancrelipase capsules that help break down fats, proteins, and carbohydrates, addressing key nutritional deficiencies. AbbVie’s commitment extends to clinical research, ensuring therapies align with evolving guidelines from bodies like the American Gastroenterological Association. This focus has solidified its position in treating underlying conditions such as cystic fibrosis and post-pancreatectomy EPI, serving millions globally. Furthermore, the company’s robust distribution network ensures accessibility in both developed and emerging markets, where EPI prevalence is on the rise due to lifestyle factors and improved survival rates for chronic illnesses.
Key Initiatives:
- Ongoing clinical trials to optimize enzyme dosing and delivery mechanisms
- Partnerships with patient advocacy groups for education and awareness
- Expansion of pediatric formulations to support early intervention
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9️⃣ 2. Allergan (now part of AbbVie)
Headquarters: Madison, New Jersey, USA
Key Offering: Zenpep, a PERT formulation for EPI management
Allergan, integrated into AbbVie since 2020, continues to contribute significantly to the EPI landscape with Zenpep, a delayed-release pancrelipase that minimizes enzyme degradation in the stomach. This product has been pivotal in treating EPI associated with cystic fibrosis and chronic pancreatitis, offering consistent dosing for better patient compliance. Allergan’s legacy in gastroenterology drives its innovation, focusing on formulations that reduce pill burden—a common challenge for patients requiring multiple capsules per meal. By emphasizing bioequivalence and safety profiles, the company supports clinicians in tailoring treatments. Its global reach, particularly in North America where EPI diagnostics are advanced, has helped streamline therapy access amid growing demand driven by aging populations and increased diabetes-related pancreatic damage.
Key Initiatives:
- Research into next-generation enzyme coatings for improved efficacy
- Collaborations with diagnostic firms to integrate therapy with early detection
8️⃣ 3. Nordmark Arzneimittel GmbH & Co. KG
Headquarters: Uetersen, Germany
Key Offering: Pancreatin-based therapies and diagnostic support tools
Nordmark Arzneimittel is a European leader in EPI therapeutics, specializing in high-quality pancreatin extracts for enzyme replacement. Its products are widely used in hospitals across Europe for managing EPI in conditions like pancreatic cancer survivors. The company’s strength lies in its rigorous manufacturing standards, ensuring purity and potency that meet EU regulatory demands. Nordmark’s approach includes educational programs for healthcare professionals, enhancing diagnostic accuracy through fecal elastase tests. As awareness of EPI grows in regions with high chronic disease rates, Nordmark’s focus on sustainable sourcing of raw materials positions it well for future expansion, particularly as personalized medicine gains traction.
Key Initiatives:
- Development of porcine-derived enzyme alternatives
- Integration of digital tools for patient monitoring and adherence
7️⃣ 4. Digestive Care, Inc.
Headquarters: Bethlehem, Pennsylvania, USA
Key Offering: Viokase pancrelipase tablets for EPI treatment
Digestive Care excels in providing non-porcine PERT options with Viokase, which is particularly useful for patients with allergies or religious preferences. This innovation addresses a niche but critical segment, ensuring inclusive care in diverse populations. The company’s tablets are prescribed in ambulatory settings, supporting outpatient management of EPI symptoms. With a dedication to evidence-based formulations, Digestive Care collaborates with gastroenterologists to refine dosing strategies, reducing gastrointestinal side effects. As the market shifts toward patient-centric solutions, Digestive Care’s agile response to regulatory changes and market needs underscores its role in the competitive diagnostics and therapeutics arena.
Key Initiatives:
- Expansion of indication studies for broader EPI applications
- Partnerships with specialty clinics for integrated care models
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6️⃣ 5. Janssen Pharmaceuticals
Headquarters: Beerse, Belgium
Key Offering: Pancreaze, a PERT with bicarbonate buffering
Janssen, a Johnson & Johnson subsidiary, brings cutting-edge PERT with Pancreaze, featuring a bicarbonate buffer to protect enzymes from acidic environments. This has revolutionized treatment for pediatric and adult EPI patients, especially those with cystic fibrosis. Janssen’s global footprint enables widespread availability, while its investment in pharmacogenomics aims to personalize therapy based on genetic factors influencing enzyme needs. The company’s emphasis on long-term safety data helps build trust among prescribers, contributing to higher adherence rates in specialty clinics.
Key Initiatives:
- Advanced formulation research for reduced dosing frequency
- Global health programs targeting underserved regions
5️⃣ 6. Chiesi Farmaceutici S.p.A.
Headquarters: Parma, Italy
Key Offering: Creon and other enzyme supplements for EPI
Chiesi Farmaceutici is renowned for its Creon portfolio, tailored for various EPI severities, from mild malabsorption to severe cases. Operating extensively in Europe and beyond, Chiesi integrates diagnostics like stool analysis kits with its therapeutics, offering a holistic approach. Its research into recombinant enzymes promises synthetic alternatives, reducing reliance on animal sources. This positions Chiesi as a forward-thinker in sustainable EPI care, aligning with global health trends toward eco-friendly pharmaceuticals.
Key Initiatives:
- Pilot programs for recombinant PERT development
- Educational campaigns in Asia-Pacific markets
4️⃣ 7. Anthera Pharmaceuticals
Headquarters: Hayward, California, USA
Key Offering: Investigational therapies targeting EPI-related inflammation
Anthera Pharmaceuticals focuses on biotech innovations for EPI, developing small-molecule inhibitors to address underlying pancreatic inflammation. While in clinical stages, its pipeline holds promise for adjunctive therapies complementing traditional PERT. Anthera’s expertise in autoimmune and rare diseases extends to EPI diagnostics, supporting biomarker research for earlier detection. This strategic pivot enhances its market presence amid rising R&D investments in precision medicine.
Key Initiatives:
- Phase II trials for novel anti-inflammatory agents
- Collaborations with imaging tech firms for advanced diagnostics
Download FREE Sample Report: Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market – View in Detailed Research Report
3️⃣ 8. AzurRx Biopharma
Headquarters: Brooklyn, New York, USA
Key Offering: MS1819, a non-systemic PERT in development
AzurRx Biopharma is pushing boundaries with MS1819, a yeast-derived lipase designed for site-specific activation in the gut, minimizing systemic exposure. This could transform EPI treatment by offering a single-capsule option, improving quality of life for patients. AzurRx’s focus on microbial-derived enzymes aligns with biotech trends, and its partnerships accelerate regulatory pathways. As diagnostics evolve with genetic testing, AzurRx’s work integrates therapeutic innovation with predictive tools.
Key Initiatives:
- Phase III preparation for MS1819 approval
- Exploration of microbiome modulation for EPI
2️⃣ 9. Nestlé Health Science
Headquarters: Vevey, Switzerland
Key Offering: Nutritional supplements and PERT adjuncts like Peptamen
Nestlé Health Science bridges therapeutics and nutrition in EPI management, offering Peptamen as a specialized supplement to enhance enzyme efficacy. Its holistic approach includes diagnostic guidance through fecal tests and dietary counseling, particularly valuable in ambulatory centers. With a strong presence in emerging markets like Asia-Pacific, Nestlé addresses malnutrition risks in EPI, combining science-backed nutrition with therapeutic support for comprehensive care.
Key Initiatives:
- Nutrigenomics research for personalized EPI diets
- Expansion of point-of-care diagnostic kits
1️⃣ 10. Eurofarma Laboratórios
Headquarters: São Paulo, Brazil
Key Offering: Generic PERT and diagnostic aids for South American markets
Eurofarma leads in Latin America with affordable generic pancrelipase options, making EPI treatment accessible in resource-limited settings. Its portfolio includes endoscopic ultrasonography support for diagnostics, catering to high-prevalence areas. Eurofarma’s investment in local manufacturing reduces costs, while R&D focuses on culturally adapted patient education. This regional dominance, coupled with biosimilar development, positions it as a key player in global EPI expansion.
Key Initiatives:
- Biosimilar enzyme production scaling
- Telemedicine integrations for remote diagnostics
Read Full Report: Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market – View in Detailed Research Report
🌍 Outlook: The Future of Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Is More Targeted and Integrated
The EPI market is evolving rapidly, with traditional enzyme replacements giving way to innovative diagnostics and therapies that promise better outcomes. Investments in R&D are surging, particularly in non-invasive testing and biologic alternatives, as the burden of pancreatic diseases increases worldwide. North America continues to lead due to advanced healthcare infrastructure, but Asia-Pacific shows the fastest growth thanks to rising chronic conditions and improved access.
📈 Key Trends Shaping the Market:
- Advancements in non-invasive diagnostics like fecal elastase and breath tests
- Rise of recombinant and microbial enzymes to replace porcine sources
- Integration of AI in imaging for precise EPI detection
- Focus on combination therapies addressing malnutrition and comorbidities
Market Trends Shaping the Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market
- Increased prevalence of cystic fibrosis and chronic pancreatitis — As survival rates improve for these conditions, more patients require long-term EPI management, driving demand for reliable PERT and market expansion in pediatric and adult segments.
- Shift toward personalized dosing and formulations — Companies are developing adjustable enzyme products based on genetic and dietary profiles, enhancing efficacy and reducing side effects for better patient adherence.
- Growth in endoscopic and imaging diagnostics — Techniques like MRI and CT scanning are becoming standard, allowing earlier intervention and integration with therapeutic planning in specialty clinics.
- Emergence of biosimilars and generics — Cost-effective alternatives are entering markets in emerging regions, improving accessibility while challenging innovators to advance novel pipelines.
- Holistic care models incorporating nutrition — Partnerships between pharma and nutrition firms are creating bundled solutions, addressing EPI’s nutritional impacts through supplements and monitoring apps.
Read Full Report: Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market – View in Detailed Research Report
The companies listed above are not only treating exocrine pancreatic insufficiency—they’re spearheading the drive toward more effective, patient-friendly solutions in digestive health.