DelveInsight’s “Exocrine Pancreatic Insufficiency Market Insight, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of exocrine pancreatic insufficiency, historical and forecasted epidemiology as well as the exocrine pancreatic insufficiency market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
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Key Takeaways from the Exocrine Pancreatic Insufficiency Market Report
- In September 2024:- Société des Produits Nestlé (SPN)- A 3-part, Phase 1a/1b, First-in-human, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Oral CDX-7108 in Healthy Adult Subjects and to Evaluate Proof-of-concept Via Pharmacodynamics of a Single Dose of Oral CDX-7108 in Subjects with Exocrine Pancreatic Insufficiency.
- In September 2024:- Entero Therapeutics- This is an Phase 2, open label, single arm pilot study assessing the safety and efficacy of adrulipase in an enteric microgranule formulation. Patients with a confirmed diagnosis of cystic fibrosis who are 18 years of age or greater will be screened for eligibility if they have been clinically controlled on a stable dose of commercial pancreatic enzyme replacement therapy (PERT) for at least one month. Patients on cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies must have been on a stable dose for at least 3 months prior to study entry, and no dose changes will be made during the study.
- According to a study conducted by Nieto et al. (2016), several prevalence studies and the relation of EPI in both types of diabetes show a wide range, being higher in Type I diabetes with a prevalence of 25–74% versus a 28– 54% in type II diabetics.
- According to Jiuang et al. (2023), the prevalence of EPI in newly diagnosed Crohn’s Disease (CD) patients ranges from 10.5% to 46.5%, with a pooled prevalence of 26.2% (95% CI 8.43–43.92%). In CD patients on a gluten-free diet (GFD), the rate of EPI ranges from 1.9% to 18.2%.
- The total diagnosed prevalent cases of EPI in the US in 2023 were found to be highest among the 7MM.
- About ~80% of patients suffering from Cystic Fibrosis and Schwachman–Diamond Syndrom developed EPI in the US in the year 2023.
- In the United States the causative indication accounting for the highest cases of EPI were Celiac disease and Type II diabetes comprising about ~2,419,000 and ~32,205,000 cases respectively among the other causative diseases like Mild Acute Pancreatitis, Moderate to Severe Acute Pancreatitis Chronic Pancreatitis, Celiac Disease, Cystic Fibrosis, Crohn’s Disease, Diabetes (Type I and II) and others
- The leading Exocrine Pancreatic Insufficiency Companies such as AbbVie, Nestle, Digestive Care, Inc., AzurRx BioPharma, Inc., Abbott, Orlando Health, Inc., Chiesi Farmaceutici, and many others.
- Promising Exocrine Pancreatic Insufficiency Therapies such as PERTZYE (pancrelipase), CREON (pancrelipase)/LIPACREON, ZENPEP (pancrelipase), .PANCREAZE (pancrelipase), VIOKACE (pancrelipase), and others.
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Exocrine Pancreatic Insufficiency Overview
Exocrine pancreatic insufficiency (EPI) is a condition caused by reduced or inappropriate secretion or activity of pancreatic juice and its digestive enzymes, pancreatic lipase in particular. EPI can result in clinical manifestation such as steatorrhea, weight loss, and biochemical alterations related to lipids and liposoluble micronutrients malabsorption and maldigestion.
Exocrine Pancreatic Insufficiency Epidemiology Insights
- Exocrine Pancreatic Insufficiency Prevalence in the US
- Exocrine Pancreatic Insufficiency Prevalence of Causative Indications
- Exocrine Pancreatic Insufficiency Diagnosed and Treatable Cases
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Exocrine Pancreatic Insufficiency Treatment Market Landscape
The Exocrine Pancreatic Insufficiency treatment primarily focuses on supplementing the deficient pancreatic enzymes and managing the underlying causes to improve digestion and nutrient absorption. Effective management of EPI involves a combination of enzyme replacement therapy, dietary modifications, addressing underlying causes, and lifestyle changes. These treatments aim to improve digestive function, enhance nutrient absorption, and alleviate symptoms to improve the patient’s quality of life.
Exocrine Pancreatic Insufficiency Market Factors
Key factors contributing to the positive Exocrine Pancreatic Insufficiency market growth include the increasing prevalence of conditions like cystic fibrosis and chronic pancreatitis, advancements in pancreatic enzyme replacement therapy (PERT), and rising awareness and early diagnosis of EPI. Additionally, an aging population and increased healthcare expenditure enhance market demand. Regulatory approvals and investment in research and development also drive Exocrine Pancreatic Insufficiency market growth.
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Exocrine Pancreatic Insufficiency Marketed Drugs
- PERTZYE: Digestive Care
PERTZYE is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases. In July 2012, PERTZYE was approved by the US FDA in patients with exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. Further, in October 2016, the drug received FDA approval for an infant-specific dose of PERTZYE in a 4,000 USP lipase units capsule. The new capsule strength will enable guideline-recommended dosing and administration of PERTZYE for infants (up to 12 months) with exocrine pancreatic insufficiency.
- CREON: Solvay Pharmaceuticals
It is a pancreatic enzyme preparation consisting of a combination of lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. In May 2013, CREON received the US FDA approval for the commercial availability of a new, higher-dose variant of CREON delayed-release capsules to treat patients with EPI due to cystic fibrosis, swelling of the pancreas that lasts a long time (chronic pancreatitis), removal of some or all of the pancreas (pancreatectomy), or other conditions. In April 2011, CREON was approved in Japan under the brand name LIPACREON.
Exocrine Pancreatic Insufficiency Emerging Drugs
- FW-EPI (adrulipase): First Wave Biopharma
FW-EPI is a recombinant lipase enzyme administered as an oral, non-systemic biologic capsule for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. It is derived from the Yarrowia lipolytica yeast lipase and is designed to break up fat molecules in the digestive tract of exocrine pancreatic insufficiency patients so that they can be absorbed as nutrients. In developing adrulipase, First Wave is seeking to provide cystic fibrosis and chronic pancreatitis patients with a safe and effective therapy to control exocrine pancreatic insufficiency that is non-animal derived, offers the potential to dramatically reduce their daily pill burden, and can be manufactured on demand at high volumes safely and with a high degree of reproducibility. First Wave is developing adrulipase as a monotherapy and in combination with PERT.
- ANG003: Anagram Therapeutics
ANG003 is a novel broadspectrum orally delivered enzyme replacement therapy for the treatment of malabsorption and exocrine pancreatic insufficiency. The drug is currently in Phase I trial for adult subjects with CF-related EPI.
Exocrine Pancreatic Insufficiency Market Outlook
The treatment landscape of exocrine pancreatic insufficiency majorly includes pancreatic enzyme replacement therapy, lifestyle modifications (e.g., avoidance of fatty foods, limitation of alcohol intake, cessation of smoking, and consumption of a well-balanced diet), and vitamin supplementation (primarily the fat-soluble vitamins A, D, E, and K). PERT is the first-line therapeutic mainstay that is prescribed to patients.
The pancreatic enzyme products used for PERT are extracts of porcine pancreas that contain all three pancreatic enzymes (i.e., amylase, protease, and lipase) in varying proportions. However, it is lipase that plays a paramount role in therapy. Pharmacological therapies are the mainstay treatment option followed by patients with exocrine pancreatic insufficiency. The market of exocrine pancreatic insufficiency includes the use of the drugs either as monotherapy and are not interchangeable. There are several approved drugs in the market of different classes. The following PEPs have been approved by the FDA for the treatment of maldigestion in patients whose bodies do not produce sufficient pancreatic enzymes: CREON, PANCREAZE, PERTZYE, VIOKACE, and ZENPEP. Some medicines are needed to treat pain.
Scope of the Exocrine Pancreatic Insufficiency Market Report
- Coverage- 7MM
- Exocrine Pancreatic Insufficiency Companies- AbbVie, Nestle, Digestive Care, Inc., AzurRx BioPharma, Inc., Abbott, Orlando Health, Inc., Chiesi Farmaceutici, and many others.
- Exocrine Pancreatic Insufficiency Therapies- PERTZYE (pancrelipase), CREON (pancrelipase)/LIPACREON, ZENPEP (pancrelipase), .PANCREAZE (pancrelipase), VIOKACE (pancrelipase), and others.
- Exocrine Pancreatic Insufficiency Market Dynamics: Exocrine Pancreatic Insufficiency Market drivers and Exocrine Pancreatic Insufficiency Market Barriers
- Exocrine Pancreatic Insufficiency Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
- Exocrine Pancreatic Insufficiency Unmet Needs, KOL’s views, Analyst’s views, Exocrine Pancreatic Insufficiency Market Access and Reimbursement
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Table of Content
1. Key Insights
2. Report Introduction
3. Executive Summary
4. Exocrine Pancreatic Insufficiency (EPI) Market Overview at a Glance
5. Key Events
6. Epidemiology and Market Forecast Methodology
7. Disease Background and Overview
8. Epidemiology and Patient Population
9. Patient Journey
10. Marketed Products
11. Emerging Therapies
12 Exocrine Pancreatic Insufficiency: Seven Major Market Analysis
13. Unmet Needs
14. SWOT Analysis
15. KOL Views
16. Market Access and Reimbursement
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer
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