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.
Pharmaceutical companies are
focusing on enhancing research and development for introducing novel
therapeutics to address unmet patient needs. For instance, the discovery and
development of siRNA (small interfering RNA) therapeutics by Sirnaomics, Inc.,
with dual-target properties and polypeptide nanoparticle (PNP)-enhanced
delivery that directly controls the fibrotic and inflammatory activity is
expected to have wide applications in many inflammatory and fibrotic diseases.
The support 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. The UK 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). Also, 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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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 enables manufacturers
to accelerate the drug development process for providing 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. Also, 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.
Also, pharmaceuticals companies
are focusing on mergers and acquisitions to accelerate the development of new
treatment options 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). Also, in February 2018, Intercept Pharmaceuticals, Inc.
collaborated with Sumitomo Dainippon Pharma Co. Ltd., to develop and
commercialize Obeticholic Acid (OCA) for chronic liver disease in Japan, China,
and Korea.
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 providing
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. around 10 per 100,000 population, while it is far
less common in Southern Europe and Asia
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 factors that are expected to bolster market growth in the near
future.
Some of the 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.
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