Primary Biliary Cholangitis Treatment Market - Size, Share, and Outlook, 2018-2026

Primary Biliary Cholangitis (PBC) is a rare disease characterized by chronic progressive liver disorder. It majorly affects women and usually occurs in middle age ranging between 30 to 60 years. It is also called as biliary cirrhosis. PBC tends to affect the small bile duct present in the liver. Primary biliary cholangitis is divided into four stages including stage 1 with no significant scarring to stage 4 known as cirrhosis. PBC is triggered by the combination of factors such as autoimmune, genetic, and environmental factors.

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Market Dynamics

Increasing number of Food and Drug Administration (FDA) approvals for the drugs to treat PBC is contributing to the market growth. For instance, in May 2016, the U.S. Food and Drug Administration (FDA) approved Ocaliva (obeticholic acid) in combination with ursodeoxycholic acid (UDCA) for the treatment of Primary Biliary Cholangitis (PBC) in adults with an inadequate response to UDCA. Furthermore, in 2016, Ocaliva was assigned fast track designation and orphan drug designation by the U.S. FDA.

Moreover, in February 2018, U.S.FDA granted orphan drug designation (ODD) to Calliditas Therapeutics AB, specialty pharmaceutical company engaged in development of high quality pharmaceutical products for patients with a significant unmet medical need in niche indications, in Stockholm, Sweden, for the treatment of Primary biliary cholangitis (PBC).

Furthermore, key players are engaged in conducting clinical trial to develop treatment for primary biliary cholangitis. For instance, in February 2017, Zydus Cadila received the US Food and Drug Administration (USFDA) approval to initiate a Phase-2 clinical trial of Saroglitazar Magnesium (Mg) in patients with Primary Biliary Cholangitis of the liver.

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Manufacturers are engaged in developing therapeutic treatment for the patients with primary biliary cholangitis, which in turn is expected to drive the primary biliary cholangitis treatment market size. For instance, in March 2015, NGM Biopharmaceuticals, Inc., announced the positive results for phase 2 trial of NGM282 in patients with Primary Biliary Cirrhosis (PBC). NGM282 is an engineered protein variant of human hormone, fibroblast growth factor 19 (FGF19) that maintains bile acid and metabolic regulatory activities as well as eliminates tumorigenic effects of FGF-19. According to the study results, NGM282 is proven to be a potent regulator of bile acid synthesis.

However, lack of awareness among the patients, families and physicians, which result into delayed diagnosis for rare diseases, may hinder primary biliary cholangitis treatment market growth. Most of symptoms associated with rare diseases are masked by the symptoms of common illness and may not be detected by doctors.

Key players operating in the primary biliary cholangitis treatment market include Novartis AG, Bristol-Myers Squibb, NGM Biopharmaceuticals, Lumena Pharmaceuticals, Inc., TARGET PharmaSolutions, Inc., Intercept Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd, Retrophin, Inc., Calliditas Therapeutics AB., and GlaxoSmithKline (GSK) pharmaceutical.

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