Primary Sclerosing Cholangitis: Market Growth

Global Cholangitis Market Growing at a CAGR of 4.56% over the Forecast Period (2019-2026)

Cholangitis is an inflammation of the bile duct system. Autoimmune diseases like primary sclerosing cholangitis can cause inflammation of the bile ducts. Cholangitis is also caused due to one or more gallstones passing from the gallbladder and becoming lodged, thus obstructing flow of bile from the liver to the small intestine. There are other causes of causes of cholangitis such as bacterial infection, blockages, and tumor. Cholangitis poses a significant health risk, and even death, if not treated promptly. It primarily affects people in their 50s and 60s.

Rising Prevalence of Primary Sclerosing Cholangitis and Increasing Approval of Drugs Fuel the Market Growth

Rising incidence and prevalence rate of liver failure and bile cancer associated with cholangitis is one of the major factors driving the growth of the market. For instance, According to a study of NCBI, there were approximately 0.2 - 1.2 million people having primary sclerosing cholangitis as of 2018, in Northern European countries and North America where the disease is most common, almost more than half of these cases could have been avoided with the availability of proper medical treatment. Thus, increasing number of cholangitis cases is expected to boost the market growth over the forecast period. In addition, with rising product approvals by several regulatory authorities across the globe, the market for cholangitis is growing rapidly. For instance, in July 2019, GENFIT, a biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, granted the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) Orphan Drug Designation to elafibranor, a PPAR alpha/delta agonist, for the treatment of Primary Biliary Cholangitis (PBC).

Stringent Regulations and Long Time Frame for Approval of Drugs Hinders the Market Progress

However, withdrawal of novel molecules from late stage clinical trials is expected to hinder the growth of the market. Also, stringent regulations for the approval of the drugs are a major factor hampering the growth of the market. For instance, approval of Ursodeoxycholic acid (UDCA) by the US Food and Drug Administration (FDA) for the treatment of Primary Biliary Cholangitis (PBC) required overcoming several barriers to drug development, and these barriers continue to pose challenges for current and future drug development. As cholangitis is a rare disease, recruitment of adequate numbers of PBC patients to power clinical trials requires many participating sites. In addition, clinical outcomes, including liver transplantation and survival, occur at a low rate, particularly in patients with early-stage disease. Thus, the time frame for a clinical trial to demonstrate clinical benefits is not practical, especially for therapies that may be most effective in early-stage disease. Hence, these challenges are expected to hamper the market growth in future.

Primary Sclerosing Cholangitis (PSC) Anticipated to Gain Largest Market Share

By type, the global cholangitis market is segmented into acute cholangitis, primary sclerosing cholangitis, secondary sclerosing cholangitis, and recurrent pyogenic cholangitis. Among these, the primary sclerosing cholangitis (PSC) is expected to hold the largest revenue share over the forecast period, owing to increasing patient suffering from PSC and growing research & development activities for the treatment. Primary sclerosing cholangitis is a progressive, rare, and chronic cholestatic liver disorder that is characterized by thickening, inflammation, and fibrosis of the bile ducts. Both intra- and extra-hepatic bile ducts are affected. This generally leads to cholestasis, liver cirrhosis, and eventually liver failure.

North America Dominates the Global Cholangitis Market

DMI segments the global cholangitis market into – North America, South America, Europe, Asia-Pacific (APAC), and Middle East and Africa.

North America accounted for largest share of the market in 2018, and expected to dominate over the forecast period, owing to rising bile duct cancer and growing healthcare awareness. In 2016, there were an estimated 83,081 people living with liver and intrahepatic bile duct cancer in the United States. Also, increasing research & development activities for the treatment of cholangitis is also fueling the growth of the market in this region. For instance, in July 2019, French biopharmaceutical firm Genkyotex has secured US regulatory approval to conduct a Phase II clinical trial of GKT831, an inhibitor of NADPH oxidase 1 (NOX1) and NOX4 to treat fibrotic diseases, including primary biliary cholangitis (PBC), as well as type 1 diabetes and kidney disease (DKD). This programme is supported by an $8.9m grant from the US National Institutes of Health (NIH).

Highly Competitive Market with Large Number of Players

The global Cholangitis market is highly fragmented with presence of large number of players. Some of the key market players include – Acorda Therapeutics Inc., Gilead Sciences Inc., Intercept Pharmaceuticals Inc., Shire Plc., NGM Biopharmaceuticals Inc., Dr. Falk Pharma GmbH, Allergan Plc., Conatus Pharmaceuticals Inc., Durect Corporation, Sirnaomics Inc., among others.

Key players are highly investing in R&D for advent of first-in-class drug types to sustain and improve market competitiveness. Few competitors are also adopting inorganic growth strategies such as mergers & acquisitions to diversify product portfolio and improve geographic footprint. For instance,

On 27th March, 2019, Gilead Sciences, Inc. announced the company’s research and development programs in primary sclerosing cholangitis (PSC) will be presented at The International Liver Congress™ 2019 in Vienna. Currently the novel molecule, Cilofexor has not get the approval but once it gets approval it will generate the revenue for the company and contribute towards the growth of the market.

Cholangitis Market Taxonomy:

By Type

• Acute Cholangitis
• Primary Sclerosing Cholangitis (PSC)
• Secondary Sclerosing Cholangitis
• Recurrent Pyogenic Cholangitis

By Application

• Clinical Practices
• Others

By Region

• North America
• South America
• Europe
• Asia-Pacific
• Middle-East & Africa

 

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