The pancreas, a vital organ plays an important role of producing and secreting key digestive enzymes and hormones required for regulating glucose in the human body. Exocrine pancreatic insufficiency (EPI) is characterized by lack of digestive enzymes normally secreted from the pancreas into the digestive track leading to inappropriate digestion of food. Primarily, these digestive enzymes include proteases for protein digestion, lipases for fat digestion and amylases for starch digestion.

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In addition to these enzymes, several other key digestive enzymes, coenzymes and cofactors are also secreted by a normally functioning human pancreas for effective and efficient digestion and absorption of food. Exocrine pancreatic insufficiency to produce these enzymes in sufficient amounts leads to maldigestion and malabsorption. This ultimately hampers growth, immune response and life expectancy. Various diseases are responsible for the cause of exocrine pancreatic insufficiency such as chronic pancreatitis, cystic fibrosis, AIDS and cytomegalovirus infections. Other causes include surgical procedures such as extensive small bowel resection, open gastric bypass, and pancreatectomy.

Steatorrhea, diarrhea, weight loss and fatigue are the major symptoms of exocrine pancreatic insufficiency. Other symptoms for exocrine pancreatic insufficiency include flatulence, abdominal distention, edema, anemia, bleeding disorders, metabolic bone disease and neurologic manifestations caused due to malabsorption of certain vitamins and nutrients. For instance, motor weakness due to malabsorption of pantothenic acid and vitamin D, loss of senses due to lack of cobalamin, peripheral neuropathy due to thiamine deficiency, and seizures due to lack of biotin.

The global exocrine pancreatic insufficiency market is segmented base on disease management, diagnostic tests and geography. Disease management segment includes pancreatic enzyme replacement therapy, nutritional management and treatment of causative disease. Life style modifications approach such as smoking cessation, limiting alcohol intake and well balanced diet may also aid in managing exocrine pancreatic insufficiency. Drugs administered help in improved nutrition digestion and absorption thus preventing complications. Diagnostic tests for exocrine pancreatic insufficiency include imaging modalities such as magnetic resonance imaging (MRI), endoscopic ultrasonogrpahy (EUS) and CT scanning, blood tests and other tests which include tests for fat absorption, D-xylose, carbohydrate absorption, bile salt absorption, schilling test and C-D-xylose breath test. These tests along with the diagnosis of exocrine pancreatic insufficiency also assist in evaluating the extent of the malabsorption caused.

Pancreatic replacement therapy in exocrine pancreatic insufficiency is a widely accepted choice of treatment and helps in minimizing malabsorption and associated malnutrition. Exocrine pancreatic insufficiency is a frequent clinical condition, and thus poses a great challenge for diagnosis. In cases of mild exocrine pancreatic insufficiency the sensitivity and specificity of pancreatic functional tests is known to be very low. Individuals with high enzyme requirements might benefit by taking H2-blockers, such as cimetidine , famotidine, ranitidine or proton pump inhibitors, such as omeprazole, esomeprazole, orlansoprazole.

Pancreatic enzyme products (PEPs) approved by U.S. FDA in managing exocrine pancreatic insufficiency include Creon and Zenpep in 2009, Pancreaze in April 2010, Ultresa and Viokace in March 2012 and Pertzye in May 2012. Out of these approved drugs for exocrine pancreatic insufficiency, Creon, Pancreaze, Zenpep, Ultresa and Pertzye are enteric coated tablets causing delay in the drug release before it reaches the lower intestine thus preventing degradation of the drug in the stomach. As Viokace is not an enteric coated formulation, it is recommended with proton pump inhibitors which serve the purpose of decreasing acid secretion in the stomach preventing breaking down of the drug. Currently, U.S. FDA has not approved PEPs for administration through gastrostomy tubes, but may make it available in the near future benefiting patients who are unable to administer PEPS by oral route.

Some of the key players in the global exocrine pancreatic market include Aptalis Pharma, Inc., Axcan, Cilian AG, Eli Lilly & Co., Laboratoires Mayoly Spindler and Nordmark Arzneimittel GmbH & Co. KG.

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