Global Exocrine Pancreatic Insufficiency Market $7.1 Billion by 2029

The global market for exocrine pancreatic insufficiency (diagnostic and therapeutic products) expected to reach $7.1 billion by 2029, expanding at a CAGR of 8.0% over the forecast period, driven by increased tendency of patients contracting cystic fibrosis, diabetes and chronic pancreatitis worldwide.

Exocrine pancreatic insufficiency (EPI) is a major consequence of pancreatic diseases leading to a loss of pancreatic parenchyma, obstruction of the main pancreatic duct, decreased pancreatic stimulation, or acid-mediated inactivation of pancreatic enzymes.

• EPI results from various diseases such as cystic fibrosis, chronic pancreatitis, pancreatic cancer, cytomegalovirus infection, and HIV/AIDS.
  • Prevalence of EPI is increasing due to rise in diabetes across the globe, with prevalence widely ranging in different studies, in both Type I (25 to 74%) and Type II (28 to 54%) diabetes.

The commonly used to EPI diagnostic tests include fecal fat test, blood tests, and an endoscopic retrograde cholangio-pancreatography (ERCP).

• Quantification of the coefficient of fat absorption (CFA) after fecal fat determination by the classical Van de Kamer test is the gold standard for the diagnosis of fat maldigestion.
  • A mixed 13C-triglyceride (13C-MTG) breath test has been developed and optimized as an alternative to CFA for the diagnosis of pancreatic exocrine insufficiency in clinical routine.

EPI therapy is based on the oral administration of exogenous pancreatic enzymes. The role of complementary dietary modifications, though important in conventional therapy, should probably be reconsidered.

• Pancreatic digestive enzyme medications is usually the most effective form of treatment, a very low-fat diet and antioxidants, such as vitamins A, E, and C, as well as dietary supplements like methionine, selenium, and grape seed extract may help prevent further damage to the pancreas.
  • Enzyme substitution therapy should ideally mimic the physiological pattern of pancreatic exocrine secretion, and pancreatic enzymes in the form of enteric-coated mini-microspheres are considered as the most elaborated commercially available enzyme preparations.
    • The porcine-free pancreatic enzyme replacement therapy (PERT), liprotamase (Sollpura; Anthera Pharmaceuticals Inc. (a subsidiary of Eli Lilly)), which was in Phase III trials for the treatment of exocrine pancreatic insufficiency failed to get positive results, due to cystic fibrosis, therefore the company is planning to evaluate all strategic alternatives in order to maximize shareholder value.

The global exocrine pancreatic insufficiency market report provides market size ($million 2019 to 2029), market share, growth trends and forecast (CAGR%, 2023 to 2029).

The global exocrine pancreatic insufficiency market segmented by diagnostic test (blood tests, endoscopic ultrasonography, magnetic resonance imaging, computed tomography scanning); therapeutic product (pancrelipase) – (Creon, Pancreaze, Pertzye, Ultresa, Viokace, Zenpep); pipeline analysis (Phase I to III), and geography.

• Among the major segments, the diagnostic tests segment accounted for the largest share of the global market, whereas the U.S. therapeutic products segment anticipated to register the fastest growth rate over the forecast period.
• In terms of diagnostic tests, the computerized tomography scan segment accounted for the majority share of total EPI market, as CT scan is traditionally used and most adopted imaging technique globally.
  • However, the magnetic resonance imaging and endoscopic ultra-sonography segments being more sensitive compared to CT scanning are likely to grow at the fastest rates in the next few years.
• Based on therapeutic pancrelipase products, Creon accounted for the largest share of the total pancreatic enzyme replacement therapy (PERT) products market in the U.S., followed by Zenpep and Pancreaze segments, respectively.
  • Pancreatic enzyme replacement therapy is currently the mainstay of treatment for nutrient malabsorption, and it is secondary to pancreatic insufficiency.
    • PPERT is also indicated post-surgery in patients with clinically evident steatorrhoea, weight loss, or maldigestion-related symptoms.
  • The pancreatic enzyme products (PEPs) used for PERT are extracts of porcine pancreas that contain all 3 pancreatic enzymes such as amylase, protease, and lipase in varying proportions.
    • The FDA-approved PERT products for treatment of EPI and maldigestion in patients available in the US market are Creon, Zenpep, Pancreaze, Ultresa, Viokace and Pertzye.
  • Zenpep, Creon, and Ultresa pancrelipase segments expected to witness the fastest growth rate in the near future, respectively.

The global pancreatic exocrine insufficiency market research report is divided by geography (regional and country based) into North America (U.S., Canada), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), Latin America (Brazil, Mexico, Rest of LA) and Rest of the World.

• Geographically, the North America region dominated the global pancreatic exocrine insufficiency (PEI) market and also expected to continue its dominance in the coming years, due to increasing prevalence of exocrine pancreatic insufficiency and other causative diseases such as cystic fibrosis (CF) and chronic pancreatitis (CP) in the U.S.
  • However, the Asia Pacific region anticipated to grow at the fastest rate during the forecast period, attributed to increasing number of people suffering from EPI.

The global pancreatic exocrine insufficiency market report also provides the detailed market landscape (market drivers, restraints, opportunities), market attractiveness analysis and profiles of major competitors in the global market including company overview, financial snapshot, key products, technologies and services offered, and recent developments.

Major competitors operating in the global EPI market and included in this report are AbbVie, Inc. (Abbott Laboratories, Inc./Allergan plc), AzurRx BioPharma, Inc. (First Wave BioPharma, Inc.), Chiesi Farmaceutici S.p.A. (Chiesi USA, Inc.), Cilian AG, Digestive Care, Inc., Eisai Co., Ltd., Mayoly-Spindler, Nestlé Health Science S.A., Nordmark Arzneimittel GmbH & Co. KG., Viatris, Inc. (Mylan N.V.), and Vivus, Inc. (Johnson & Johnson/Janssen Pharmaceuticals, Inc.).

• Diagnostic Test
  • Blood Tests
  • Endoscopic Ultrasonography (EUS)
  • Magnetic Resonance Imaging (MRI)
  • Computed Tomography (CT or CAT) Scanning
• Therapeutic Product (Pancrelipase)
  • Creon
  • Pancreaze
  • Pertzye
  • Ultresa
  • Viokace
  • Zenpep
• Pipeline Analysis
  • Phase I – Phase III
• Geography
  • North America (U.S., Canada)
  • Europe (U.K., Germany, France, Italy, Spain, Rest of EU)
  • Asia Pacific (Japan, China, India, Rest of APAC)
  • Latin America (Brazil, Mexico, Rest of LA)
  • Rest of the World
• Company Profiles
  • Abbvie, Inc. (Abbott Laboratories, Inc./Allergan plc)
  • AzurRx BioPharma, Inc. (First Wave BioPharma, Inc.)
  • Chiesi Farmaceutici S.p.A. (Chiesi USA, Inc.)
  • Cilian AG
  • Digestive Care, Inc.
  • Eisai Co., Ltd.
  • Mayoly-Spindler
  • Nestlé Health Science S.A.
  • Nordmark Arzneimittel GmbH & Co. KG
  • Viatris, Inc. (Mylan N.V.)
  • Vivus, Inc. (Johnson & Johnson/Janssen Pharmaceuticals, Inc.)

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