Exocrine pancreatic insufficiency (EPI) is a condition characterized by the deficiency of the exocrine pancreatic enzymes, causing failure to digest food properly. Exocrine pancreatic insufficiency is caused due to damage to pancreas. The common causes of EPI are cystic fibrosis, chronic pancreatitis, and Shwachman-Diamond syndrome. The peculiar symptoms of EPI include frequent diarrhea, weight loss, foul-smelling greasy stools, gas and bloating, and stomach ache. Exocrine pancreatic insufficiency is treatable with pancreatic enzyme replacement therapy, which helps in digestion, improves malabsorption and vitamin deficiencies, and fuels weight gain.

Pancreatic enzyme replacement therapy products contain a defined amount of digestive enzymes such as lipases, proteases, and amylases, which are required by the body to metabolize fats, proteins, and sugar from food. Without these enzymes, patients with EPI are less capable of absorbing vital nutrients from food and can become undernourished. Effective management of EPI includes life-long pancreatic enzyme replacement therapy (PERT), lifestyle modifications, modifications with specialized food supplements such as vitamins and nutrients that do not require pancreatic enzymes for digestion, and transplantation of pancreatic cells.

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Factors such as the increasing prevalence of diseases such as cystic fibrosis, chronic pancreatitis and diabetes are contributing to an increase in the prevalence of exocrine pancreatic insufficiency. According to recent data released by the Cystic Fibrosis Foundation, about 30,000 people are living with cystic fibrosis in the U.S. and 70,000 across the globe. Approximately 1,000 new cases of cystic fibrosis are diagnosed each year in the U.S. With such alarming rise in the number of people suffering from cystic fibrosis, the risk of incidence related to the disease also increases. 

People suffering from cystic fibrosis face breathing complications as mucus clogs their lungs and makes them susceptible to infections. Thick mucus also chokes the pancreas and obstructs the release of digestive enzymes leading to the deficiency of these enzymes. EPI is observed in a considerable proportion among the CF patients, with roughly 50% of children with CF suffering from this condition at birth. In addition, 25% of the population develops EPI within the first six months of life. Furthermore, 15% develop EPI in late childhood. According to recent data released by Aptalis (Allergan), chronic pancreatitis is observed in roughly 0.03% to 0.04% adults in the U.S. Of these, around 30% to 40% are expected to develop EPI over a span of 10 years.

Prevalence of EPI is expected to rise due to increase in the number of people suffering from diabetes. According to data published by the Centers for Disease Control and Prevention in 2014, the prevalence of diabetes in the U.S. has increased from 4.40% in 2000 to 7.18% in 2013. Examinations of people suffering from diabetes have shown greater than normal inflammation and damage to pancreatic tissue, signifying the increase in the risk of exocrine pancreatic insufficiency in people suffering from diabetes. The EPI market is also driven by the opportunities offered by developing countries. With an increasing incidence of diseases in this region, demand for PERT products is expected to grow in the next few years. However, stringent FDA regulations for the approval of PERT products are expected to hamper the growth of this market.

Major players in this market are AbbVie, Inc. (U.S.), Allergan plc (Ireland), Nordmark Arzneimittel GmbH & Co. KG (Germany), Digestive Care, Inc. (U.S.), Cilian AG (Germany), Anthera Pharmaceuticals, Inc. (U.S.), Janssen Pharmaceuticals, Inc. (U.S.), and AzurRx BioPharma, Inc. (U.S.).

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