Global Exocrine Pancreatic Insufficiency Treatment Market - 2024-2031

Overview

The global exocrine pancreatic insufficiency treatment market reached US$ 3.30 billion in 2023 and is expected to reach US$ 5.37 billion by 2031, growing at a CAGR of 6.4% during the forecast period 2024-2031.

Exocrine pancreatic insufficiency (EPI) is a condition characterized by the deficiency of exocrine pancreatic enzymes, resulting in the inability of the pancreas to produce the digestive enzymes required for the proper breakdown of fats, sugars, and proteins. This condition can arise from most pancreatic diseases, including acute pancreatitis, chronic pancreatitis (CP), pancreatic cancer, and cystic fibrosis.

The market is driven by factors such as the rise in the prevalence of chronic pancreatitis & cystic fibrosis, increasing cases of exocrine pancreatic insufficiency, and demands for advanced therapeutics & improved drug delivery systems.

Market Dynamics

Drivers

Rise in the Prevalence of Chronic Pancreatitis (CP) & Cystic Fibrosis (CF)

The demand for the global exocrine pancreatic insufficiency treatment market is driven by multiple factors. exocrine pancreatic insufficiency treatment is a serious sequela of chronic pancreatitis and can also result from other syndromes including cystic fibrosis. Approximately one-third of children with chronic pancreatitis have exocrine pancreatic insufficiency.

Cystic fibrosis causes breathing issues by clogging the lungs with thick mucus. This mucus also clogs the pancreas and hampers the release of digestive enzymes. Over time, this can result in the small intestine becoming unable to digest food completely, meaning the digestive tract has to pass partially undigested food through it. This is a condition called exocrine pancreatic insufficiency treatment(EPI).

According to the World Journal of Gastroenterology, a research publication in August 2023, states that the prevalence of CP ranges from 13.5 to 163 cases per 100000 individuals, and the incidence of CP ranges from 5 to 31.7 new cases per 100000 person-years.

Moreover, major players in the industry focus on research & development, and technological innovations in the treatment propel this market growth. For instance, in April 2024, Norton Healthcare's Phase 1 trial for a broad-spectrum enzyme replacement therapy for cystic fibrosis. This new class of enzyme replacement therapy is designed to provide unparalleled performance with a broad-spectrum composition, lipase for fat, protease for protein, and amylase for carbohydrates.

Similarly, 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.

Restraints

Factors such are the high cost of treatment, stringent government regulations, limited availability & complexity of treatment, lack of awareness & diagnosis among people, lack of funding & healthcare infrastructure, and high cost of research & development, are expected to hamper the market.

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Segment Analysis

The global exocrine pancreatic insufficiency treatment market is segmented based on treatment, application, distribution channel and region.

The pancreatic enzyme replacement therapy segment accounted for approximately 36.5% of the global exocrine pancreatic insufficiency treatment share

The pancreatic enzyme replacement therapy segment is expected to hold the largest market share over the forecast period. Pancreatic enzyme replacement therapy is safe and effective at treating pancreatic exocrine insufficiency a debilitating condition of the GI tract that is caused by conditions that impair pancreatic function such as pancreatitis, pancreatic cancer, Crohn's disease, celiac disease, and cystic fibrosis.

Moreover, in February 2022, investigators at the University of Miami surveyed patients about their experience using pancreatic enzyme replacement therapy (PERT) and found education about this treatment is lacking.

In addition, key player's strategies such as partnerships & collaborations, and innovations in research & development help to drive this segment's growth. For instance, in December 2023, Codexis, Inc. announced it had entered into a purchase agreement with Nestle Health Science, a globally recognized leader in the field of nutritional science, for CDX-7108, an investigational therapy for the potential treatment of exocrine pancreatic insufficiency treatment(EPI).

Under the terms of the agreement, Codexis will receive up to $45M in potential milestone payments, including a $5M upfront payment, as well as single-digit net-sales-based royalties. Codexis will receive up to an additional $5M if Nestle Health Science exercises an option to purchase two additional early-stage enzymes being developed for EPI.

Also, in February 2023, Codexis, Inc. announced interim results from a Phase 1 study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of CDX-7108. CDX-7108 is a lipase variant specifically engineered to overcome the limitations of existing pancreatic enzyme replacement therapy (PERT).

Geographical Analysis

North America accounted for approximately 42.3% of the global exocrine pancreatic insufficiency treatment market share

North America region is expected to hold the largest market share over the forecast period owing to the higher prevalence of conditions linked to EPI, such as cystic fibrosis and chronic pancreatitis. The region has a well-established healthcare infrastructure, advanced diagnostic capabilities, and high levels of awareness about EPI, which contribute to early detection and effective management.

Furthermore, major pharmaceutical companies and research institutions that focus on EPI and related disorders are present in North America, further boosting its position in the market.

This region's proactive approach to healthcare and substantial investments in research and development underlines its dominance in addressing EPI and driving advancements in its treatment. For instance, in December 2022, First Wave BioPharma got approval from the U.S. Food and Drug Administration (FDA) for permission to start a Phase 2 clinical trial that would test the company's new formulation of adrulipase in people with cystic fibrosis (CF) who have exocrine pancreatic insufficiency.

Also, in April 2022, Alcresta Therapeutics, Inc., announced a series of commercial milestone achievements. Alcresta announced its first profitable year in 2021, the completion of royalty payments to the Cystic Fibrosis Foundation (CFF), and a doubling of its sales force to expand the promotion of RELiZORB, a first-of-its-kind digestive enzyme cartridge used in enteral feeding designed to mimic the function of pancreatic lipase. RELiZORB is the only enzyme product cleared by the FDA.

Market Segmentation

By Treatment

• Drug Type
  • Creon
  • Zenpep
  • Pancreaze
  • Ultra
  • Viokace
  • Others
• Nutritional management (Dietary Supplements)
• Pancreatic Enzyme Replacement Therapy

By Application

• Crohn's Disease
• Ulcerative Colitis
• GERD
• IBS
• Others

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Middle East and Africa

Competitive Landscape

The major global players in the exocrine pancreatic insufficiency treatment market include AbbVie, Codexis Inc., Nestle, Alcresta Therapeutics, Inc., First Wave BioPharma, Eli Lilly and Company, Cilian AG, Synspira Therapeutics, Perseo Pharma, and Vivus LLC among others.

Key Developments

• In May 2024, Alcresta Therapeutics, Inc., announced the commercial availability of the next-generation RELiZORB (iMMOBILIZED LIPASE) cartridge. The next-generation RELiZORB device was cleared by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA).
• In December 2023, Alcresta Therapeutics, Inc., announced 510(k) clearance of its next-generation RELiZORB (iMMOBILIZED LIPASE) cartridge by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA). The next-generation RELiZORB device was developed to address the enteral nutrition needs of a wider population of patients living with rare diseases.
• 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 treatment in cystic fibrosis (CF) patients.

Why Purchase the Report?

• To visualize the global exocrine pancreatic insufficiency treatment market segmentation based on treatment, application distribution channel, and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
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The global exocrine pancreatic insufficiency treatment market report would provide approximately 62 tables, 60 figures, and 182 Pages.

Target Audience 2024

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies