Global Primary Sclerosing Cholangitis Market Increased International Trade Opening New Opportunities

Press Release

Primary sclerosing cholangitis market report provides detailed information about various candidates that are presently in the preclinical and clinical trials by the manufacturers and research organizations. The drug segment will provide quick snapshot about the clinical phase of the study, study outcomes, estimated launch date, and the upcoming drug molecules. Moreover, the report entails information regarding the major events taking place in the global market, thereby gaining insights about drug approvals, merger agreements, and acquisitions undertaken by the manufacturing companies. Also, incidence and prevalence of PSC and its associated conditions at regional as well as global level are provided in the report, thereby indicating the total number of addressable patient pool in the respective regions and market opportunity for the same.

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Market Dynamics

Major factors that are expected to augment growth of the primary sclerosing cholangitis market include increasing number of organizations focusing on clinical innovation and scientific progress on understanding the mechanisms and risk factors for primary sclerosing cholangitis (PSC). For instance, the International PSC study group (IPSCSG), founded in 2010, aims to coordinate PSC research projects between leading institutions worldwide, thereby allowing feasible translational research and advancing efficient research. Also, increasing number of clinical and preclinical trials conducted by the research universities and pharmaceuticals companies is expected to favor market growth over the forecast period.

However, failure of drug candidates to provide desired study outcomes and the withdrawal of late phase clinical trials of potential drug molecules are factors hindering the market growth.

Global Primary Sclerosing Cholangitis Market- Optimistic Scenario:

Currently, over five products are in clinical trials Phase 2 and some of them have shown good results in Phase 2. For instance, ASEOP trial, testing Obeticholic acid (OCA) for primary sclerosing cholangitis, is being conducted by Intercept Pharmaceuticals, Inc. Also, Shire Plc. completed Phase 2 clinical trial for the drug candidate LUM001 in February, 2016.

If these potential molecules pass through the advanced clinical trials phase (i.e. Phase 3) and secure regulatory approval, these would be among the first-to-get-approval for this disease.

Moreover, most of the patients are in developed economies such as Europe and North America where diagnosis percentage and affordability is generally higher compared to emerging economies in regions such as Asia Pacific, which would result in higher adoption rate of novel products with significantly high yearly cost (i.e. more than US$ 50,000 for orphan drugs). Due to the above mentioned factors, the global primary sclerosing cholangitis market is expected to reach US$ 140.4 Mn by 2023.

However, withdrawal of potential therapeutic molecules from late-stage clinical trials have limited the availability of efficient treatment, thus compelling the patient pool to adopt alternative treatment therapies such as bile acid sequestrants, antibiotics, antihistamines, opioid antagonists, and ursodeoxycholic acid (UDCA).

According to a study published by Gastroenterology and Hepatology Journal, 2016, current medical therapies such as ursodeoxycholic acid improves liver enzymes. However, it does not prevent the progression of PSC or reduce the risk of recurrence. Thus, unavailability of approved drugs targeting the condition in practical medical use is a factor hindering growth of the global primary sclerosing cholangitis market.

Increasing incidence of liver failure and bile cancer associated with PSC

Increasing prevalence of diseases associated with PSC such as liver cancer and inflammatory bowel disease is expected to enhance the therapeutic adoption of efficient drugs to manage the condition, thus driving growth of the primary sclerosing cholangitis market. According to the World Journal of Gastroenterology, 2017, inflammatory bowel disease (IBD) is diagnosed in around 50-80% of the patients with PSC, with ulcerative colitis (UC) comprising around 80-90% of these cases.

Furthermore, individuals with PSC are at a greater risk of developing cancer in bile ducts called cholangiocarcinoma, as compared to general populace. According to the National Organization for Rare Disorders (NORD), 2016, around 8-15% of the PSC affected individuals eventually develop cholangiocarcinoma and have enhanced risk of developing gall bladder cancer. Moreover, NORD states that patients with PSC are at a greater risk of developing Crohn’s disease, colon cancer, and immune-mediated disorders such as thyroid disease, Peyronie’s disease, retroperitoneal fibrosis, psoriasis, rheumatoid arthritis, Celiac disease, and others.

Affordable options in comparison with the currently available treatments is expected to increase the adoption of PSC drugs

Currently, liver transplant is the only known cure for primary sclerosing cholangitis and is one of the major causes for liver transplantation in the U.S. However, as per the survey by Mayo Clinic, the disease is expected to recur in the transplanted liver in 27.2% of the patients, thereby demanding efficient and affordable therapeutic solutions to cater to unmet patient needs. According to the United Network for Organ Sharing (UNOS), 2011, estimated bill charges of a liver transplant procedure is around US$ 577,100 in the U.S.

Thus, requirement of providing affordable treatment, owing to high costs associated with liver transplantation coupled with increasing risk factors resulting in the development of serious disorders are major factors that are expected to increase the adoption of PSC drugs, in turn favoring market growth in the near future.

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Major players operating in the global primary sclerosing cholangitis market include Acorda Therapeutics, Inc., Gilead Sciences, Inc., NGM Biopharmaceuticals, Inc., Intercept Pharmaceuticals, Inc., Dr. Falk Pharma GmbH, Allergan Plc., Shire Plc., Durect Corporation, Conatus Pharmaceuticals, Inc., Sirnaomics, Inc., and Shenzhen HighTide Biopharmaceutical Ltd.

This post was originally published on Trading Herald

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