Exocrine pancreatic insufficiency (EPI) is a condition characterized by deficiency of exocrine pancreatic enzymes, resulting in the inability to digest food properly, a condition called maldigestion. These enzymes consist of lipases for fat digestion, proteases for protein digestion, and amylases for starch digestion. EPI results from various diseases such as cystic fibrosis, chronic pancreatitis, pancreatic cancer, cytomegalovirus infection, and HIV/AIDS. The symptoms of EPI are maldigestion or malabsorption and specifically malnutrition with weight loss, steatorrhoea, vitamin deficiencies (especially of vitamins A, D, E, K), and diabetes mellitus, which in turn may also be a cause of EPI. Diagnosis of exocrine pancreatic insufficiency (EPI) is primarily clinical. It may go unobserved because the signs and symptoms are similar to those of other GI diseases or because the signs and symptoms are not always evident due to dietary restrictions.
Management of EPI is based primarily on pancreatic enzyme replacement therapy (PERT), but could also include lifestyle modifications and vitamin supplementation. Increase in prevalence of diabetes and rise in prevalence of cystic fibrosis and chronic pancreatitis drives the exocrine pancreatic insufficiency market. However, drug regulatory agencies, including the U.S. Food and Drug Administration (FDA), have required the manufacturers to obtain regulatory approvals before marketing their products because of possible adverse effects and inadequate effectiveness. These stringent FDA regulations have made approval of pancrelipase products difficult. This is hampering market growth. The global exocrine pancreatic insufficiency market was valued at US$ 707.0 Mn in 2014 and is projected to reach US$ 1,588.8 Mn by 2023, expanding at a CAGR of 8.3% from 2015 to 2023.
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The pancreatic enzyme replacement therapy segment has been sub-segmented into Creon, Zenpep, Pancreaze, Ultresa, Viokace, and Pertzye. Creon accounted for the largest share of the EPI market in the U.S. in 2014 and is expected to lead this market in the next few years. Ultresa is expected to grow at the highest rate as it is technologically advanced compared to other products and has several advantages over them. Ultresa, formerly known as ‘Ultrase’, is an orally administered porcine pancreatic enzyme preparation (PEP) that was previously indicated for the treatment of EPI in adults and children. The market for Ultresa is likely to expand at the highest rate owing to high preference by patients and as it provides effective treatment option to the patient.
Based on diagnostic test, the exocrine pancreatic insufficiency market has been segmented into blood tests, endoscopic ultra-sonography (EUS), magnetic resonance imaging (MRI), and CT scanning. Computerized tomography (CT) scan is the traditionally used and most adopted imaging technique. The segment accounted for the majority share of the market in 2014. However, growth of the segment is expected to slow down in the near future due to introduction of advanced techniques in the market. Magnetic resonance imaging (MRI) is a more sensitive technique compared to CT and is emerging as the radiological imaging modality of choice for the assessment of chronic pancreatitis with unequivocal CT scan. Hence, the MRI segment is likely to expand at the highest CAGR during the forecast period.
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Based on geography, the exocrine pancreatic insufficiency market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America accounted for the largest share of the global exocrine pancreatic insufficiency (EPI) market in 2014. The region is expected to lead the market in the next few years. Increasing prevalence of exocrine pancreatic insufficiency and other causative diseases such as cystic fibrosis (CF) and chronic pancreatitis (CP) in the U.S. is a major factor contributing to the considerable market share of North America. According to recent data by Aptalis (Allergan), in the U.S., CP is estimated to occur in 28 to 42 cases per 100,000 adult population. Of these 30% to 40% will develop EPI over a ten-year period.
The exocrine pancreatic insufficiency market in Asia Pacific is anticipated to witness the fastest growth rate during the forecast period as compared to North America and Europe. Increasing geriatric population in countries such as Japan, China, and Singapore have accelerated the demand for accurate and reliable treatment products, thereby driving the market in the region. Moreover, rising disposable income and increase in health care infrastructure in countries such as India, China, and Malaysia are likely to support market growth. The exocrine pancreatic insufficiency market in Latin America is projected to expand at a significant CAGR during the forecast period from 2015 to 2023. Improving health care scenario, rising prevalence of chronic diseases, and growing investments by market players are the major factors fueling the growth of the exocrine pancreatic insufficiency market in Latin America.
Major players operating in the global exocrine pancreatic insufficiency market include AbbVie, Inc., Nordmark Arzneimittel GmbH & Co. KG, Allergan plc, Digestive Care, Inc., and Janssen Pharmaceuticals, Inc.
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