The launch of the Pipeline therapies, increasing EPI prevalence shall fuel the Exocrine pancreatic insufficiency market size estimated to be approximately USD 1,695.26 Million in 2017.
A loss of acinar pancreatic cells that causes insufficient production of pancreatic enzymes in the duodenum results in Exocrine pancreatic insufficiency (EPI). It manifests as a malabsorption syndrome and a major burden on global healthcare due to high morbidity and mortality rates.
EPI is a consequence of several different indications, which share the common pathophysiologic end result of inadequate enzyme digestion, including Celiac Disease, Cystic Fibrosis, Ulcerative Colitis, Crohn’s Disease, Pancreatic Cancer (Unresectable), Schwachman–Diamond Syndrome, HIV/AIDS, and few others. Several cases reported the association of endocrine entities, such as Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, with EPI. EPI is highly prevalent in extrapancreatic diseases. As per DelveInsight’s EPI Epidemiological analysis, a total of 80,641 EPI cases were reported due to Acute Pancreatitis, and 237,255 cases due to Chronic Pancreatitis. At the same time, Cystic Fibrosis and Unresectable Pancreatic Cancer caused 62,204 and 59,036 EPI cases, respectively, in 2017 in the 7MM.
Severa times, dietary interventions such as a preference for the low-fat diet are recommended to manage malabsorption of fats (steatorrhea). However, this results in deficiencies of lipid-soluble lipases/ vitamins. As per recent research, it was demonstrated that patients should be encouraged to add high-fat/ dairy products as most of the time Malnutrition is considered to be an end-product of Exocrine pancreatic insufficiency. Thus, the treatment regimen guides patients to opt for a well-balanced diet and vitamin supplementation (primarily the fat-soluble vitamins A, D, E, and K). It is important to note that smoking and alcohol consumption on a regular basis contributes to the development of calcifications in the pancreas. Thus, besides dietary interventions, EPI patients are best advised to be abstinent from alcohol and smoking. However, the main pharmacologic treatment and the mainstay in the Exocrine pancreatic insufficiency market is Pancreatic enzyme replacement therapy (PERT). PERT is given concomitantly with food to prevent malnutrition, and improve fat absorption. The pancreatic enzyme products (PEPs) used for PERT are extracts of the porcine pancreas that contain all the three pancreatic enzymes (i.e., amylase, protease, and lipase) in varying proportions. Present Exocrine pancreatic insufficiency market homes five oral formulations of pancrelipase (amylases, lipases, and proteases) namely Creon, Zenpep, Pancreaze, Viokace, and Pertzye with each one differing in terms of particle size, dosing range, and pharmacokinetics. At times, the PEPs are accompanied by some medicines required to treat pain, such as acetaminophen (Tylenol) or ibuprofen (Advil, Motrin). In the case of no relief, stronger pain drugs, such as hydrocodone and oxycodone are prescribed to them.
However, PERT carries the risk of viral transmission because the enzymes are harbored from pigs. Also, it does not treat the underlying cause of the disease, hence, it is intended to be a long-term therapy. Moreover, the doses are not interchangeable because of different formulations and strengths; and are always prescribed in lower doses to annotate the efficacy and safety in the patients. In addition to a lack of standard treatment options in the Exocrine pancreatic insufficiency market, there is a need for standard guidelines for better diagnosing and managing it. Current guidelines do not state regarding the dose adjustments or follow-ups after PERT.
However, to address the unmet needs in the EPI market, several companies, including Chiesi Farmaceutici and AzurRx BioPharma, are investing in developing novel therapeutic approaches in their EPI pipeline to change the treatment landscape of EPI entirely. A few days back, AzurRx demonstrated the caliber of its recombinant lipase enzyme, MS1819 in the treatment of severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) in the first five patients in a Phase 2 combination therapy trial. The launch of the Pipeline therapies is anticipated to fuel the Exocrine pancreatic insufficiency market size estimated to be approximately USD 1,695.26 Million in 2017.
DelveInsight’s analysts anticipate the completion of clinical development and launch of these novel pipeline therapies in the market shall increase in the EPI market share of these pharma companies, which will extend to better management practices for the patients of EPI. EPI treatment is continuing to incline toward extended therapies as well as more novel approaches. As the number of EPI incident cases rises, the demand for a better treatment approach will increase. In terms of future competition, additional products are entering the market along with new technologies. Rising demand for standardized therapeutics and increasing the R & D in the domain shall further expedite the EPI market size growth.