Exocrine Pancreatic Insufficiency Market
DelveInsight's "Exocrine Pancreatic Insufficiency - Market Insights, Epidemiology, and Market Forecast-2030" report delivers an in-depth understanding of the Exocrine Pancreatic Insufficiency, historical and forecasted epidemiology as well as the Exocrine Pancreatic Insufficiency market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
The Exocrine Pancreatic Insufficiency market report provides current treatment practices, emerging drugs, Exocrine Pancreatic Insufficiency market share of the individual therapies, current and forecasted Exocrine Pancreatic Insufficiency market Size from 2017 to 2030 segmented by seven major markets. The Report also covers current Exocrine Pancreatic Insufficiency treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market.
- The United States
- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Study Period: 2017-2030
Exocrine Pancreatic Insufficiency Disease Understanding and Treatment Algorithm
Exocrine pancreatic insufficiency (EPI) refers to the presence of maldigestion and malabsorption of such nutrients. It is a consequence of the primary loss of functional parenchyma and/or secondarily impaired exocrine pancreatic function and insufficient pancreatic enzyme activity. EPI is sometimes defined simply as an enzyme output less than 10% of that necessary to sustain normal digestion; however, there is no consensus in the literature on the definition of EPI.
Furthermore, the clinical presentation of EPI can vary widely depending on the underlying cause, as well as disease stage, diet, and other factors. EPI is most commonly caused by diseases that destroy the pancreatic parenchyma, such as chronic pancreatitis and cystic fibrosis, as well as pancreatic resection. The incidence of EPI in chronic pancreatitis ranges from 30% of patients with mild disease to 85% with severe disease. Approximately 85% of infants with cystic fibrosis have EPI at birth.
There are several causes of Exocrine Pancreatic Insufficiency (EPI) which include Diabetes, Pancreatic cancer, Celiac disease, HIV/AIDS, Chronic Pancreatitis, Cystic Fibrosis Ulcerative Colitis, Schwachman–Diamond Syndrome, and others.
Exocrine pancreatic insufficiency Diagnosis
The diagnostic approach to EPI can be addressed to evaluate the maldigestion of nutrients or to quantify the exocrine pancreatic secretion specifically. Two categories of tests can be distinguished: direct and indirect. Indirect tests assess the consequence of exocrine insufficiency, evaluating quantitative changes of pancreatic secretion. Direct tests evaluate the secretive production directly, and, despite their good sensitivity, are invasive, time-consuming, expensive, and not useful in monitoring the response to pancreatic enzyme replacement therapy (PERT).
Moreover, they are not standardized because of lack of consensus about protocol, and present extensive variation in results, and are not widely available. The indirect tests includes Stool tests Coefficient of fat absorption, Fecal elastase-1 (FE-1), Stool chymotrypsin, Blood test Serum immunoreactive trypsinogen (IRT), and others whereas the direct tests for EPI includes Endoscopic secretin or CCK based pancreatic stimulation test, and Secretin-enhanced magnetic resonance cholangiopancreatography (s-MRCP).
Exocrine pancreatic insufficiency Treatment
Patients with EPI may be treated with Pancreatic enzyme replacement therapy (PERT) to aid in the digestion and absorption of fats; PERT is recommended for patients with EPI to address weight loss, malnutrition, and steatorrhea. Briefly, treatment is primarily based on oral PERT regimens to correct malnutrition and improve symptoms. The current drugs that fall under PERT includes Creon, Zenpep, Pancreaze, Viokase, and Pertzye respectively, Underlying diseases leading to EPI should be treated, and lifestyle modifications should also be undertaken, including alcohol abstinence (to reduce pain and increase gastric lipase secretion) and supplementation of fat-soluble vitamins as needed.
Dietary fat restriction is not necessary, especially for patients on enzyme supplementation. Frequent, low-volume meals are recommended, and difficult-to-digest foods such as legumes should be avoided.
It covers the details of conventional and current medical therapies available in the Exocrine Pancreatic Insufficiency (EPI) market for the treatment of the various types of Exocrine Pancreatic Insufficiency (EPI). It also provides the treatment guidelines and algorithms of the United States and Europe. The DelveInsight’s Exocrine Pancreatic Insufficiency (EPI) market report gives a thorough understanding of Exocrine Pancreatic Insufficiency (EPI) by including details such as disease definition, causes, risk factors, pathogenesis, and diagnosis.
Exocrine Pancreatic Insufficiency Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Prevalence of Causative Indications of EPI and Prevalence of Exocrine Pancreatic Insufficiency scenario of Exocrine Pancreatic Insufficiency (EPI) in the 7MM market covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2017 to 2030.
This section provides glimpse of the Exocrine Pancreatic Insufficiency (EPI) epidemiology in the 7MM.
- In the 7MM, the highest prevalence of Causative Indications of EPI was observed in Type 2 Diabetes Mellitus which was estimated to be 67,892,836 cases in 2017 during the forecast period (2020–2030).
- As per the estimates in Japan, 61,961, 66,261, 11,721, 25,319 patients were affected by Acute Pancreatitis, Chronic Pancreatitis, Cystic Fibrosis and Unresectable Pancreatic Cancer in 2017, respectively, which are anticipated to increase in the forecast period.
- Acute Pancreatitis, Chronic Pancreatitis, Cystic Fibrosis and Unresectable Pancreatic Cancer are assumed to play the foremost role in the development of EPI.
Country Wise- Exocrine Pancreatic Insufficiency (EPI) Epidemiology
The epidemiology segment also provides the Exocrine Pancreatic Insufficiency (EPI) epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
Exocrine Pancreatic Insufficiency Drug Chapters
The drug chapter segment of the Exocrine Pancreatic Insufficiency (EPI) report encloses the detailed analysis of Exocrine Pancreatic Insufficiency (EPI) marketed drugs and mid and late stage pipeline drugs. It also helps to understand the Exocrine Pancreatic Insufficiency (EPI) clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug and the latest news and press releases.
Exocrine Pancreatic Insufficiency (EPI) Marketed Drugs
1. Pertzye (pancrelipase): Digestive Care
Pertzye (pancrelipase)—a combination of porcine-derived lipases, proteases, and amylases—developed by Digestive Care is an orally administered drug in patients with exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. The pancreatic enzymes in Pertzye catalyze the hydrolysis of fats to monoglyceride, glycerol, and free fatty acids; proteins into peptides and amino acids; and starches into dextrins and short-chain sugars—maltose and maltotriose—in the duodenum and proximal small intestine, thereby, acting like digestive enzymes secreted by the pancreas physiologically. Digestive Care and its marketing partner Chiesi, in July 2017, announced FDA approval of a 24,000 USP lipase units capsule of Pertzye (pancrelipase) delayed-release capsules to treat exocrine pancreatic insufficiency (EPI). The newly available dosing strength caters specifically to children over 12 months and adults, which may allow for consumption of fewer capsules to reach the needed weight-based dose when compared to the other Pertzye capsule sizes.
Products detail in the report…
2. Creon (pancrelipase)/Lipacreon: AbbVie
Creon capsule, initially developed by Solvay Pharmaceuticals, is a pancrelipase—a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of EPI due to cystic fibrosis or other conditions. In June 2011, Abbott announced that the FDA had approved an infant-specific dose of Creon (pancrelipase) delayed-release capsules to treat EPI due to cystic fibrosis (CF). In April 2011, Abbott and Eisai received approval to market the pancreatic enzyme replacement drug Lipacreon (pancrelipase) in Japan as a pancreatic digestive enzyme replacement in patients with pancreatic exocrine insufficiency.
Products detail in the report…
3. Zenpep (pancrelipase): Nestle
In August 2009, Eurand announced the commercial availability of Zenpep (pancrelipase) delayed-release capsules, a pancreatic enzyme product (PEP) indicated for the treatment of exocrine pancreatic EPI due to cystic fibrosis (CF) or other conditions. In January 2007, Zenpep received a fast track designation from the US FDA. In January 2020, Nestle announced that it has entered into an asset purchase agreement with Allergan to acquire Zenpep. This move aims to expand the company's medical nutrition business and complement its portfolio of therapeutic products.
Products detail in the report…
Exocrine Pancreatic Insufficiency (EPI) Emerging Drugs
1. MS1819-SD: AzurRx BioPharma
AzurRx BioPharma specializes in the development of non-systemic, recombinant therapies for gastrointestinal diseases. The company is developing MS1819-SD, a yeast-derived recombinant lipase—an enzyme that breaks up fat molecules—for EPI associated with chronic pancreatitis (CP) and cystic fibrosis (CF). Also, MS1819-SD is considered recombinant because it was created from new combinations of genetic material in yeast called yarrowia lipolytica. The drug id currently in phase II clinical developmental trial in patients with EPI. The study enrolled 24 participants, and it is estimated to be complete by December 2020.
Products detail in the report…
Exocrine Pancreatic Insufficiency Market Outlook
The treatment landscape of EPI majorly includes pancreatic enzyme replacement therapy (PERT), 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). Pancreatic enzyme replacement therapy (PERT) is the first line therapeutic mainstay that is prescribed in patients. The pancreatic enzyme products (PEPs) 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 the paramount role in therapy. Pharmacological therapies are the mainstay treatment option followed by the patients with EPI. The market of EPI includes use of the drugs either as monotherapy and are not interchangeable. There are several approved drugs in the market of different classes.
The Exocrine Pancreatic Insufficiency (EPI) market outlook of the report helps to build a detailed comprehension of the historic, current and forecasted Exocrine Pancreatic Insufficiency (EPI) market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers, and demand of better technology.
This segment gives a thorough detail of Exocrine Pancreatic Insufficiency (EPI) market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.
According to DelveInsight, Exocrine Pancreatic Insufficiency (EPI) 7MM market is expected to change in the study period 2017–2030.
This section includes a glimpse of the Exocrine Pancreatic Insufficiency (EPI) 7MM market.
- The United States accounts for the largest market size of Exocrine Pancreatic Insufficiency (EPI), in comparison to EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.
- The market size of Exocrine Pancreatic Insufficiency (EPI) in the seven major markets is USD 1,695.26 Million in 2017 for the study period (2017–2030).
The United States Market Outlook
This section provides the total Exocrine Pancreatic Insufficiency (EPI) market size and market size by therapies in the United States.
EU-5 Market Outlook
The total Aspregillosis market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
Japan Market Outlook
The total Exocrine Pancreatic Insufficiency (EPI) market size and market size by therapies in Japan are provided.
Exocrine Pancreatic Insufficiency Drugs Uptake
This section focusses on the rate of uptake of the potential drugs recently launched in the Exocrine Pancreatic Insufficiency market or expected to get launched in the market during the study period 2017-2030. The analysis covers Exocrine Pancreatic Insufficiency market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Exocrine Pancreatic Insufficiency Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase II, and Phase III stage. It also analyses Exocrine Pancreatic Insufficiency key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing, patent details and other information for Exocrine Pancreatic Insufficiency emerging therapies.
Reimbursement Scenario in Exocrine Pancreatic Insufficiency
Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In a report, we take reimbursement into consideration to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
To keep up with current market trends, we take KOLs and SME's opinion working in Exocrine Pancreatic Insufficiency domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Exocrine Pancreatic Insufficiency market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
Competitive Intelligence Analysis
We perform Competitive and Market Intelligence analysis of the Exocrine Pancreatic Insufficiency Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
- The report covers the descriptive overview of Exocrine Pancreatic Insufficiency, explaining its causes, signs and symptoms, pathophysiology, diagnosis and currently available therapies
- Comprehensive insight has been provided into the Exocrine Pancreatic Insufficiency epidemiology and treatment in the 7MM
- Additionally, an all-inclusive account of both the current and emerging therapies for Exocrine Pancreatic Insufficiency are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
- A detailed review of Exocrine Pancreatic Insufficiency market; historical and forecasted is included in the report, covering drug outreach in the 7MM
- The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Exocrine Pancreatic Insufficiency market
- In the coming years, Exocrine Pancreatic Insufficiency market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
- The companies and academics are working to assess challenges and seek opportunities that could influence Exocrine Pancreatic Insufficiency R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
- Major players are involved in developing therapies for Exocrine Pancreatic Insufficiency. Launch of emerging therapies will significantly impact the Exocrine Pancreatic Insufficiency market
- A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Exocrine Pancreatic Insufficiency
- Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities
Exocrine Pancreatic Insufficiency Report Insights
- Patient Population
- Therapeutic Approaches
- Exocrine Pancreatic Insufficiency Pipeline Analysis
- Exocrine Pancreatic Insufficiency Market Size and Trends
- Market Opportunities
- Impact of upcoming Therapies
Exocrine Pancreatic Insufficiency Report Key Strengths
- 11 Years Forecast
- 7MM Coverage
- Exocrine Pancreatic Insufficiency Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Market
- Drugs Uptake
Exocrine Pancreatic Insufficiency Report Assessment
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- Market Drivers and Barriers
- What was the Exocrine Pancreatic Insufficiency market share (%) distribution in 2017 and how it would look like in 2030?
- What would be the Exocrine Pancreatic Insufficiency total market size as well as market size by therapies across the 7MM during the forecast period (2017-2030)?
- What are the key findings pertaining to the market across 7MM and which country will have the largest Exocrine Pancreatic Insufficiency market size during the forecast period (2017-2030)?
- At what CAGR, the Exocrine Pancreatic Insufficiency market is expected to grow in 7MM during the forecast period (2017-2030)?
- What would be the Exocrine Pancreatic Insufficiency market outlook across the 7MM during the forecast period (2017-2030)?
- What would be the Exocrine Pancreatic Insufficiency market growth till 2030, and what will be the resultant market Size in the year 2030?
- How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
- What is the disease risk, burden and unmet needs of the Exocrine Pancreatic Insufficiency?
- What is the historical Exocrine Pancreatic Insufficiency patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
- What would be the forecasted patient pool of Exocrine Pancreatic Insufficiency in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
- What will be the growth opportunities in the 7MM with respect to the patient population pertaining to Exocrine Pancreatic Insufficiency?
- Out of all 7MM countries, which country would have the highest prevalent population of Exocrine Pancreatic Insufficiency during the forecast period (2017-2030)?
- At what CAGR the population is expected to grow in 7MM during the forecast period (2017-2030)?
Current Treatment Scenario, Marketed Drugs and Emerging Therapies:
- What are the current options for the Exocrine Pancreatic Insufficiency treatment, along with the approved therapy?
- What are the current treatment guidelines for the treatment of Exocrine Pancreatic Insufficiency in the USA, Europe, and Japan?
- What are the Exocrine Pancreatic Insufficiency marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
- How many companies are developing therapies for the treatment of Exocrine Pancreatic Insufficiency?
- How many therapies are developed by each company for Exocrine Pancreatic Insufficiency treatment?
- How many are emerging therapies in mid-stage, and late stage of development for Exocrine Pancreatic Insufficiency treatment?
- What are the key collaborations (Industry - Industry, Industry - Academia), Mergers and acquisitions, licensing activities related to the Exocrine Pancreatic Insufficiency therapies?
- What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for Exocrine Pancreatic Insufficiency and their status?
- What are the key designations that have been granted for the emerging therapies for Exocrine Pancreatic Insufficiency?
- What are the global historical and forecasted market of Exocrine Pancreatic Insufficiency?
Reasons to buy
- The report will help in developing business strategies by understanding trends shaping and driving the Exocrine Pancreatic Insufficiency market
- To understand the future market competition in the Exocrine Pancreatic Insufficiency market and Insightful review of the key market drivers and barriers
- Organize sales and marketing efforts by identifying the best opportunities for Exocrine Pancreatic Insufficiency in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan
- Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
- Organize sales and marketing efforts by identifying the best opportunities for Exocrine Pancreatic Insufficiency market
- To understand the future market competition in the Exocrine Pancreatic Insufficiency market
What is Exocrine Pancreatic Insufficiency (EPI)?
Exocrine Pancreatic Insufficiency (EPI) is a degenerative disease caused by the insufficient production and secretion of pancreatic digestive enzymes which leads to maldigestion (an inability to breakdown nutrients) in the duodenum.
What was the EPI prevalence in the 7MM?
In the 7MM, the highest prevalence of Causative Indications of EPI was observed in Type 2 Diabetes Mellitus which was estimated to be 67,892,836 cases in 2017 during the forecast period (2020–2030).
What are the leading companies that are developing drugs for Exocrine Pancreatic Insufficiency (EPI)?
Synspira Therapeutics, AzurRx BioPharma, Cilian AG are some of the key companies advancing EPI market forward.
Which are the emerging therapies in Exocrine Pancreatic Insufficiency (EPI) market?
Expected launch of MS1819 (AzurRx BioPharma), SNSP003 (Synspira Therapeutics), Cilase (Cilian AG), and others shall fuel the growth of the EPI market during the forecast period 2017–2030.
How is epidemiology segmented for Exocrine Pancreatic Insufficiency (EPI)?
Exocrine pancreatic insufficiency epidemiology is segmented by Prevalence of Causative Indications of EPI and Prevalence of Exocrine Pancreatic Insufficiency scenario of Exocrine Pancreatic Insufficiency (EPI) in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2017 to 2030.