Impact Analysis of Covid-19
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Global Primary Sclerosing Cholangitis Market, by Drug (BT1023, GS-9674, NGM282, OCA, LUM001, and Others) and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) has potential pipeline products and is estimated to reach US$ 140.4 Mn by 2023.
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Pharmaceutical companies are focusing on research and development for developing novel therapeutics to cater to unmet patient needs. For instance, Sirnaomics, Inc developed siRNA (small interfering RNA) therapeutics with dual-target properties and polypeptide nanoparticle (PNP)-enhanced delivery that directly controls the fibrotic and inflammatory activity. This is further expected to have wide applications in many inflammatory and fibrotic diseases such as primary sclerosing cholangitis (PSC).
Moreover, initiatives from the public and private organizations such as PSC Support Organization and National Organization for Rare Disorders serves as the hub of rare disease community, providing assistance programs for patients and advancing clinical trials by granting funds for advanced research programs. For instance, the U.K. PSC Support Organization granted US$ 20,000 to the University of Birmingham for supporting the research and investigation of Vascular Adhesion Protein (VAP-1) in primary sclerosing cholangitis (PSC). Similarly, in 2017, the Falk Foundation funded a European multi-center phase II study led by the Medical University of Vienna in collaboration with the Medical University of Graz and the Medical University of Hannover, to treat primary sclerosing cholangitis.
Browse through 134 Pages and an in-depth TOC on Primary Sclerosing Cholangitis Market, by Drug (BT1023, GS-9674, NGM282, OCA, LUM001, and Others) and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa).
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Additionally, orphan drug designation granted by regulatory agencies such as the Food and Drug Administration (FDA) and European Medicine Agency (EMA) for the treatment of PSC has driven manufacturers to develop drug, in order to offer new drug treatments to patients in need. For instance, in 2017, Conatus Pharmaceuticals Inc. was granted orphan designation to IDN-7314 by the FDA and EMA. The drug completed two successful pre-clinical trials, of which the second one was completed in 2017. Similarly, in 2016, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for BTT1023 drug candidate developed by Acorda Therapeutics, which is in Phase 2 clinical trials currently.
Furthermore, pharmaceuticals companies are focusing on mergers and acquisitions to fuel development of new treatment options, in order to address the unmet needs of patients suffering from rare diseases by advancing the therapies into clinical trials. For instance, in 2015, Gilead Sciences, Inc. acquired Phenex Pharmaceuticals AG, to gain access to Phenex’s Farnesoid X Receptor (FXR) program comprising small molecule FXR agonists for the treatment of liver diseases including PSC and nonalcoholic steatohepatitis (NASH). Similarly, in February 2018, Intercept Pharmaceuticals, Inc. entered into a collaboration with Sumitomo Dainippon Pharma Co. Ltd., to develop and commercialize Obeticholic Acid (OCA) for chronic liver disease in Japan, China, and Korea.
Furthermore, in 2014, Shire acquired Lumena Pharmaceuticals, to gain access to its late-stage rare disease pipeline assets indicated for gastrointestinal conditions- LUM001 and LUM002, thus offering potential treatment options to patients with rare cholestatic liver disease and adding products to its rare disease portfolio.
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Key Takeaways of the Primary Sclerosing Cholangitis Market:
- According to the Research Institute of Radiological Science, 2016, the prevalence of PSC is higher in Northern Europe and the U.S. that is around 10 per 100,000 population, while it is low in Southern Europe and Asia
- Moreover, 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 the factors that are expected to augment the market growth over the forecast period.
- Key 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., among others
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