The Exocrine pancreatic insufficiency (EPI) market is projected to register a CAGR of 6.7% during the forecast period (2022 - 2027).
Gastrointestinal symptoms, especially diarrhea, are common with novel coronavirus SARS-CoV-2 infection. Angiotensin-converting enzyme-2 (ACE-2) receptors are heavily expressed in enterocytes and serve as entry receptors for SARS-CoV-2. ACE-2 receptors may also be responsible for pancreatic injury in patients infected with SARS-CoV-2. As per the study conducetd by Ni et al,. 2020, both SARS-CoV-2 and SARS-CoV enter host cells via the angiotensin-converting enzyme 2 (ACE2) receptor, which is expressed in various human organs. For example, up to 67% of patients who developed diarrhea during the course of SARS and quite a number of patients with COVID-19 showed enteric symptoms. Diarrhea associated with SARS-CoV-2 is usually believed to be due to viral invasion of enterocytes. However, exocrine pancreatic insufficiency resulting from SARS-CoV-2 is another plausible mechanism leading to diarrhea in such patients. As per the study conducetd by Zippi et al., 2020, the gastrointestinal system may be affected by COVID-19 infection with an incidence variable from 3% up to 79%. Therefore, the rising number of COVID-19 cases further leads to the increased cases of Exocrine pancreatic insufficiency and thus driving the market growth.
Certain factors that are driving the market growth include improved delivery system strategies. Bacterial engineering and gene transfer techniques could transform the delivery of pancreatic enzymes by producing the enzymes within the host. Strains of bacteria such as Lactococcus lactis - genetically modified to highly express bacterial lipases - have been derived. Several experiments are undergoing to demonstrate the effective delivery system such as the colonization of individuals with experimentally induced pancreatic insufficiency with lipase-producing L. lactis demonstrated increased CFA under a high-fat diet.
An increase in the prevalence of exocrine pancreatic insufficiency is due to the factors such as the increasing prevalence of diseases in cases of cystic fibrosis, chronic pancreatitis, and diabetes. Pancreatic insufficiency requires advanced therapeutics and presence of a significant number of pipeline drugs. Recent trends in therapeutics include lipase treatment in dietetic patients and optimizing the chymotrypsin and trypsin levels. However, in the painful chronic exocrine pancreatitis, high dose protease is estimated to be beneficial. Severe cases are advised for pancreatic replacement therapy along with pancreatin medication. As per the study published in Clinical and Experimental Gastroenterology in 2019, exocrine pancreatic insufficiency occurs in 40%-80% of gastric total/subtotal resection both for gastric tumors and peptic ulcer. Esophagectomy has also been associated with a rate of Exocrine pancreatic insufficiency of 16%. therefore it is clear that, Exocrine pancreatic insufficiency can result in clinical manifestation and biochemical alterations causing reduced quality of life and life-threating complications.
The current market holds pancreatic enzyme replacement therapy (PERT) which is the first line therapy in patients with Exocrine pancreatic insufficiency. PERT is safe and effective at treating pancreatic exocrine insufficiency. PERT comprises of different class of drugs that are currently used which include Pancrease, Creon, Pertzye, Viokace, and Zenpep. Since 2010 FDA approved different pancreatic enzyme replacement products for the treatment of Exocrine pancreatic insufficiency all consisting of extracts from porcine pancreas (pancrelipase). All but one of those preparations have a delayed release (Creon, Pancreaze, Zenpep, Pertzie) due to enteric-coated beads that protect lipase from denaturation from gastric acid.
As per the study published in National Library of Medecine in 2019, patients with severe insufficiency have steatorrhea (loose, greasy, foul- smelling, voluminous stools that are difficult to flush, float or stick to the bowl) and weight loss. Steatorrhea and weight loss develop late in the disease process after there is loss of 90% of pancreatic secretion. Therefore, PERT aims to supplement at least 10% of estimated pancreatic lipase to correct steatorrhea and improve digestion.
Since the optimal PERT therapy is based on its clinical efficacy, the initial dose might be doubled or tripled based on the clinical need and results. PERT, indeed, has shown over time an acceptable safety and tolerability with abdominal pain, abdominal distension, and diarrhea being the reported side effects.
This is expected to enable the pancreatic enzyme replacement therapy to hold the heighest market as it is safe and effective and also the standard of care for people with Exocrine pancreatic insufficiency.
The United States is the most affected country across the world, as thereare higher numbers of patients suffering from pancreatic diseases and higher in North America region as patient population is increasing compared to other countries.
North America expected to hold a major market share in the global Exocrine pancreatic insufficiency market due to rise in geriatric population, increasing prevalence and incidence of infectious diseases in this region. As per the study conducted by Ghodeif and Azer, 2022, as alcohol excess is a well-recognized cause of chronic pancreatitis. In the United States, heavy drinkers have a triple risk of developing chronic pancreatitis, and the risk was further increased in drinkers who are also heavy smokers. As per an article published by the National Library of Medicine in 2022, about 85% of cystic fibrosis patients have Exocrine pancreatic insufficiency, usually acquired soon after birth. EPI is prevalent in about 60% to 90% of patients diagnosed with chronic pancreatitis within 10 to 12 years of diagnosis. Chronic pancreatitis occurs in about 42 to 73 per 100,000 of the population in the United States and is the most common pancreatic disorder associated with pancreatic insufficiency, and this could be compared to 36 to 125 per 100,000 of the population in Japan, China, and India.
Moreover, increase in research and development activities and presence of favorable healthcare infrastructure is fueling the growth of the overall regional market to a large extent.
The Exocrine pancreatic insufficiency marketis fragmented competitive and consists of several major players. In terms of market share, a few of the major players are currently dominating the market. Some of the companies which are currently dominating the market are Digestive Care, AbbVie, Nestle, Alcresta Therapeutics, First Wave BioPharma, Chiesi Pharmaceuticals, Vivus, Aimmune Therapeutics, PerseoPharma, Codexis, Synspira Therapeutics and others.
This product will be delivered within 2 business days.
Gastrointestinal symptoms, especially diarrhea, are common with novel coronavirus SARS-CoV-2 infection. Angiotensin-converting enzyme-2 (ACE-2) receptors are heavily expressed in enterocytes and serve as entry receptors for SARS-CoV-2. ACE-2 receptors may also be responsible for pancreatic injury in patients infected with SARS-CoV-2. As per the study conducetd by Ni et al,. 2020, both SARS-CoV-2 and SARS-CoV enter host cells via the angiotensin-converting enzyme 2 (ACE2) receptor, which is expressed in various human organs. For example, up to 67% of patients who developed diarrhea during the course of SARS and quite a number of patients with COVID-19 showed enteric symptoms. Diarrhea associated with SARS-CoV-2 is usually believed to be due to viral invasion of enterocytes. However, exocrine pancreatic insufficiency resulting from SARS-CoV-2 is another plausible mechanism leading to diarrhea in such patients. As per the study conducetd by Zippi et al., 2020, the gastrointestinal system may be affected by COVID-19 infection with an incidence variable from 3% up to 79%. Therefore, the rising number of COVID-19 cases further leads to the increased cases of Exocrine pancreatic insufficiency and thus driving the market growth.
Certain factors that are driving the market growth include improved delivery system strategies. Bacterial engineering and gene transfer techniques could transform the delivery of pancreatic enzymes by producing the enzymes within the host. Strains of bacteria such as Lactococcus lactis - genetically modified to highly express bacterial lipases - have been derived. Several experiments are undergoing to demonstrate the effective delivery system such as the colonization of individuals with experimentally induced pancreatic insufficiency with lipase-producing L. lactis demonstrated increased CFA under a high-fat diet.
An increase in the prevalence of exocrine pancreatic insufficiency is due to the factors such as the increasing prevalence of diseases in cases of cystic fibrosis, chronic pancreatitis, and diabetes. Pancreatic insufficiency requires advanced therapeutics and presence of a significant number of pipeline drugs. Recent trends in therapeutics include lipase treatment in dietetic patients and optimizing the chymotrypsin and trypsin levels. However, in the painful chronic exocrine pancreatitis, high dose protease is estimated to be beneficial. Severe cases are advised for pancreatic replacement therapy along with pancreatin medication. As per the study published in Clinical and Experimental Gastroenterology in 2019, exocrine pancreatic insufficiency occurs in 40%-80% of gastric total/subtotal resection both for gastric tumors and peptic ulcer. Esophagectomy has also been associated with a rate of Exocrine pancreatic insufficiency of 16%. therefore it is clear that, Exocrine pancreatic insufficiency can result in clinical manifestation and biochemical alterations causing reduced quality of life and life-threating complications.
Key Market Trends
The Pancreatic Enzyme Replacement Therapy (PERT) Segment is Expected to Hold a Major Market Share in the EPI Market
The current market holds pancreatic enzyme replacement therapy (PERT) which is the first line therapy in patients with Exocrine pancreatic insufficiency. PERT is safe and effective at treating pancreatic exocrine insufficiency. PERT comprises of different class of drugs that are currently used which include Pancrease, Creon, Pertzye, Viokace, and Zenpep. Since 2010 FDA approved different pancreatic enzyme replacement products for the treatment of Exocrine pancreatic insufficiency all consisting of extracts from porcine pancreas (pancrelipase). All but one of those preparations have a delayed release (Creon, Pancreaze, Zenpep, Pertzie) due to enteric-coated beads that protect lipase from denaturation from gastric acid.
As per the study published in National Library of Medecine in 2019, patients with severe insufficiency have steatorrhea (loose, greasy, foul- smelling, voluminous stools that are difficult to flush, float or stick to the bowl) and weight loss. Steatorrhea and weight loss develop late in the disease process after there is loss of 90% of pancreatic secretion. Therefore, PERT aims to supplement at least 10% of estimated pancreatic lipase to correct steatorrhea and improve digestion.
Since the optimal PERT therapy is based on its clinical efficacy, the initial dose might be doubled or tripled based on the clinical need and results. PERT, indeed, has shown over time an acceptable safety and tolerability with abdominal pain, abdominal distension, and diarrhea being the reported side effects.
This is expected to enable the pancreatic enzyme replacement therapy to hold the heighest market as it is safe and effective and also the standard of care for people with Exocrine pancreatic insufficiency.
North America is Expected to Hold a Significant Share in the Market and Expected to do Same in the Forecast Period
The United States is the most affected country across the world, as thereare higher numbers of patients suffering from pancreatic diseases and higher in North America region as patient population is increasing compared to other countries.
North America expected to hold a major market share in the global Exocrine pancreatic insufficiency market due to rise in geriatric population, increasing prevalence and incidence of infectious diseases in this region. As per the study conducted by Ghodeif and Azer, 2022, as alcohol excess is a well-recognized cause of chronic pancreatitis. In the United States, heavy drinkers have a triple risk of developing chronic pancreatitis, and the risk was further increased in drinkers who are also heavy smokers. As per an article published by the National Library of Medicine in 2022, about 85% of cystic fibrosis patients have Exocrine pancreatic insufficiency, usually acquired soon after birth. EPI is prevalent in about 60% to 90% of patients diagnosed with chronic pancreatitis within 10 to 12 years of diagnosis. Chronic pancreatitis occurs in about 42 to 73 per 100,000 of the population in the United States and is the most common pancreatic disorder associated with pancreatic insufficiency, and this could be compared to 36 to 125 per 100,000 of the population in Japan, China, and India.
Moreover, increase in research and development activities and presence of favorable healthcare infrastructure is fueling the growth of the overall regional market to a large extent.
Competitive Landscape
The Exocrine pancreatic insufficiency marketis fragmented competitive and consists of several major players. In terms of market share, a few of the major players are currently dominating the market. Some of the companies which are currently dominating the market are Digestive Care, AbbVie, Nestle, Alcresta Therapeutics, First Wave BioPharma, Chiesi Pharmaceuticals, Vivus, Aimmune Therapeutics, PerseoPharma, Codexis, Synspira Therapeutics and others.
Additional Benefits:
- The market estimate (ME) sheet in Excel format
- 3 months of analyst support
This product will be delivered within 2 business days.
Table of Contents
1 INTRODUCTION
4 MARKET DYNAMICS
5 MARKET SEGMENTATION
6 COMPETITIVE LANDSCAPE
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Digestive Care
- AbbVie
- Nestle
- Alcresta Therapeutics
- First Wave BioPharma
- Vivus
- Perseo Pharma
- Codexis
- Synspira Therapeutics
Methodology
LOADING...
