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.
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.
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.
Global Exocrine Pancreatic Insufficiency Market: Overview
Over the past decade, the increasing incidence of diseases such as cystic fibrosis, chronic pancreatitis, and diabetes has significantly contributed to the growth of the global exocrine pancreatic insufficiency (EPI) market. The incidence of EPI is markedly observed in patients suffering from cystic fibrosis. According to the Cystic Fibrosis Foundation, a non-profit organization in the United States, about 70,000 people worldwide are living with cystic fibrosis (CF), with around 30,000 people living with CF in the U.S. alone. In addition, 1,000 new cases of cystic fibrosis are diagnosed every year in the U.S., which is expected to augment the market growth in the forthcoming years. 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, registering a CAGR of 8.3% from 2015 to 2023.
The report provides a comprehensive analysis of drivers, restraints, and opportunities that are impacting the market’s trajectory across various segments. To provide an in-depth analysis, the report broadly segments the exocrine pancreatic insufficiency market based on therapeutics, diagnostic test, and geography.
To provide an accurate and in-depth analysis of the market dynamics, the report provides up-to-date and pertinent data on the size and share of different segments in key geographical regions. The study provides a comparative analysis of the market shares of major players in exocrine pancreatic insufficiency market. In addition, the emerging business strategies and plans analyzed in the report are intended to help market players, established as well as new entrants, to create effective strategies for growth across regions.
Global Exocrine Pancreatic Insufficiency Market: Trends and Opportunities
The incidence of EPI is expected to rise dramatically due to the increasing incidence of diseases such as cystic fibrosis, chronic pancreatitis, and diabetes. This is in turn propelling the growth of the exocrine pancreatic insufficiency market across the globe. Advancements in pancreatic enzyme replacement therapies are anticipated to offer vast growth opportunities for players in the exocrine pancreatic insufficiency market.
In addition, developments witnessed in the market are fuelled by the demand for more reliable treatments for EPI and increasing availability of medications with enhanced efficacy in different developing countries. For instance, the rising disposable incomes and significant improvements in healthcare infrastructure in emerging economies such as India, China, and Malaysia are expected to offer momentum to the market.
Ultresa, an orally administered porcine pancreatic enzyme preparation (PEP), is anticipated to exhibit a high CAGR since it is more technologically advanced compared to other similar PERT products. As a result, the market is expected to witness tremendous demand for Ultresa. Advancements in diagnostic technologies have led to the adoption of magnetic resonance imaging (MRI) as the preferred radiological imaging modality for the assessment of chronic pancreatitis.
Global Exocrine Pancreatic Insufficiency Market: Regional Outlook
North America is expected to account for the maximum share in the global exocrine pancreatic insufficiency (EPI) market along the forecast period. The demand will be chiefly driven by the increasing prevalence of exocrine pancreatic insufficiency and other causative diseases such as cystic fibrosis (CF) and chronic pancreatitis (CP) in the U.S. However, Asia Pacific is projected to exhibit the most promising CAGR during the forecast period; the growth will be driven by a rise in geriatric population in countries such as Japan, China, and Singapore. Furthermore, the exocrine pancreatic insufficiency market in Latin America is projected to register a significant CAGR through the forecast period.
Companies Mentioned in the Report
To offer a detailed competitive landscape and in-depth strategic assessment of the market players, the report extensively profiles companies such as AbbVie, Inc., Nordmark Arzneimittel GmbH & Co. KG, Allergan plc, Digestive Care, Inc., and Janssen Pharmaceuticals, Inc. The strategic assessment includes the recent product launches and key strategies adopted by major market players to consolidate their market positions.
Global Exocrine Pancreatic Insufficiency Market is segmented as:
Global Exocrine Pancreatic Insufficiency Market, by Therapeutics
- Pancreatic Enzyme Replacement Therapy (PERT) Drugs
- Exocrine Pancreatic Insufficiency Drugs, Pipeline Analysis, Sollpura (Liprotamase)
Global Exocrine Pancreatic Insufficiency Market, by Diagnostic Tests
- Blood Tests
- Endoscopic Ultra-Sonography (EUS)
- Magnetic Resonance Imaging (MRI)
- CT Scanning
Global Exocrine Pancreatic Insufficiency Market, by Geography
- North America
- Rest of North America
- Rest of Europe
- Asia Pacific
- Rest of APAC
- Latin America
- Rest of LATAM
- Rest of the World
- South Africa
- Rest of RoW
This report gives you access to decisive data such as:
- Market growth drivers
- Factors limiting market growth
- Current market trends
- Market structure
- Market projections for the coming years
Key highlights of this report
- Overview of key market forces propelling and restraining market growth
- Up-to-date analyses of market trends and technological improvements
- Pin-point analyses of market competition dynamics to offer you a competitive edge
- An analysis of strategies of major competitors
- An array of graphics and SWOT analysis of major industry segments
- Detailed analyses of industry trends
- A well-defined technological growth map with an impact-analysis
- Offers a clear understanding of the competitive landscape and key product segments