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Exocrine pancreatic insufficiency (EPI) is a condition associated with deficiency of exocrine pancreatic enzymes that results in the inability to digest food or maldigestion. EPI may be associated with certain diseases and conditions that affect the pancreas such as cystic fibrosis, chronic pancreatitis, Shwachman–Diamond syndrome, and others. Chronic pancreatitis (CP) is the most common cause of EPI in adults that is followed by cystic fibrosis (CF). CF is an inherited genetic condition that leads to chronic disease, which affects lungs, digestive, and reproductive system. Patients suffering from exocrine pancreatic insufficiency cannot properly digest proteins, fats, and carbohydrates in the food that results in poor absorption of nutrients in the body.

Furthermore, EPI is associated with uncomfortable gastrointestinal (GI) symptoms such as bloating, gas, and oily diarrhea that floats and is difficult to flush. The symptoms of EPI may be similar to other gastrointestinal disorders such as Crohn’s disease, celiac disease, irritable bowel syndrome (IBS), ulcerative colitis, and small intestinal bacterial overgrowth (SIBO), which makes EPI  difficult to diagnose. However, there are three major tests used for diagnosis of EPI that include, fecal elastase test, fecal fat test, and direct pancreatic function test.           

Exocrine Pancreatic Insufficiency (EPI) Therapeutics Market – Drivers

Exocrine pancreatic insufficiency is associated with certain diseases and conditions such as chronic pancreatitis, cystic fibrosis, pancreatectomy, pancreatic cancer, gastrointestinal surgery, type I and type III C diabetes, and other conditions including autoimmune pancreatitis, celiac disease, and inflammatory bowel disease. Moreover, high prevalence of these conditions leads to EPI, which in turn fuels growth of exocrine pancreatic insufficiency (EPI) therapeutics market. For instance, according to a report by the Cystic Fibrosis Foundation, 2010, around 1,000 new cases of cystic fibrosis are diagnosed globally every year.  

Furthermore, according to a report by the American Lung Association, 2010, cystic fibrosis is the second most inherited disorder in infants in the U.S. The report further stated that around 10 million cases in the U.S are symptomless carriers of the defective cystic fibrosis gene and around 3,708 deaths were reported due to cystic fibrosis between 1999 and 2006. Moreover, pancreatic cancer is a major factor that leads to EPI.  According to Cancer Research UK 2015, around 9,800 new pancreatic cancer cases were registered in the U.K. annually, from 2013 to 2015. The report further stated that pancreatic cancer is the 11th most common cancer in the U.K. that accounted for 3% of all new cancer cases, in 2015.

According to the American Cancer Society (ACS), in the U.S 2018, around 55, 440 people are expected to be diagnosed with pancreatic cancer, and around 44,330 people are expected to succumb to pancreatic cancer. Furthermore, according to the National Cancer Institute, from 2011 to 2015, 12.6 per 100,000 new cases of pancreatic cancer were registered, annually, in the U.S.    

According to a report by the, 2018, EPI was more evident in the people with insulin-dependent diabetes. According to the same source, in 2003, a study conducted on around 1,000 diabetic patients found that insulin-dependent diabetes was more likely to produce abnormally low levels of exocrine pancreatic enzymes. Furthermore, between 25% and 50% of insulin-dependent diabetes patients were found to have developed exocrine pancreatic insufficiency. Moreover, high prevalence of diabetes may increase the risk of EPI. For instance, according to International Diabetes Federation (IDF) Diabetes Atlas: 2017, number of people with diabetes, worldwide, aged between 20 to 79 years in 2017 was around  US$ 425 million, and the number is estimated to increase to 48% in 2045, accounting for around US$ 629 million.  

Exocrine Pancreatic Insufficiency (EPI) Therapeutics Market – Regional Analysis

Geographically, the global exocrine pancreatic insufficiency (EPI) therapeutics market is segmented into North America, Latin America, Europe, Middle East, Asia Pacific, and Africa. North America is expected to dominate the global exocrine pancreatic insufficiency (EPI) therapeutics market due to increasing incidence and prevalence cases of these conditions occurring in this region. EPI is mostly characterized with its associated conditions such as cystic fibrosis, pancreatic cancer, chronic pancreatitis, gastrointestinal surgery, and others.

Exocrine Pancreatic Insufficiency (EPI) Therapeutics Market – Competitive Analysis

Key players operating in the exocrine pancreatic insufficiency (EPI) therapeutics market include, AbbVie, Inc., Digestive Care, Inc., Janssen Pharmaceuticals, Inc., Anthera Pharmaceuticals, Inc., Allergan plc, AzurRx BioPharma, Inc., and others. Key players operating in this market are focused on product regulatory approvals and acquisition strategies to enhance their share in the market. For instance, in May 2013, AbbVie, Inc. announced the availability of CREON (pancrelipase) 36,000 Lipase-unit Capsules for patients with EPI in the U.S. Furthermore, in May 2018, VIVUS, Inc. entered into definitive agreement with Janssen Pharmaceuticals, Inc. to acquire all the product rights for PANCREAZE (pancrelipase) delayed-release capsules in the U.S. and Canada.

Exocrine Pancreatic Insufficiency (EPI) Therapeutics Market – Taxonomy

By Disease Management

  • Nutritional Management
  • Pancreatic Enzyme Replacement Therapy (PERT)

By Therapeutic Drugs

  • Creon
  • Zenpep
  • Pancreaze
  • Ultresa
  • Viokace
  • Others

By Region

  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East
  • Africa

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.

Data Triangulation Methodology | Coherent Market Insights

Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

Market Analysis | Coherent Market Insights

Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users