Market Challenges And Opportunities

However, lack of disease awareness among people and healthcare providers, high cost of treatment therapies and long approval time for new drugs may negatively impact the market growth. Stringent regulatory policies for drug approval procedures in different countries can also hamper sales.

Nevertheless, ongoing R&D activities for developing advanced treatment options with better efficacy and minimal side effects provide lucrative opportunities for market players. In addition, increasing healthcare expenditure of governments worldwide on rare disease treatment creates a favorable market landscape. Partnerships between pharmaceutical companies and clinical research organizations are also contributing to the growth of the global primary biliary cholangitis treatment market.

Primary Biliary Cholangitis Treatment Market Drivers:

Increasing Prevalence of Primary Biliary Cholangitis: The rising prevalence of primary biliary cholangitis across the globe is one of the major factors fueling the growth of the global primary biliary cholangitis treatment market. With changing lifestyles and increased life expectancy, and liver diseases are on the rise which require effective treatment options. Primary biliary cholangitis treatment have emerged as a revolutionary approach to develop more targeted and efficient drugs to treat such complex diseases. For instance, in June 2021, according to a report published by National Center for Biotechnology Information (NCBI), the pooled point-prevalence rate of primary biliary cholangitis was 22.27 cases per 100,000 inhabitants.
Growing Adoption of Novel Drugs: Primary biliary cholangitis has traditionally been treated with ursodeoxycholic acid (UDCA) as the first-line therapy. However, with close to 40% of patients not responding adequately to UDCA, there was a considerable unmet need for alternative treatment options. This has prompted drug manufacturers to focus on developing novel precision therapies targeting specific disease pathways involved in PBC. In the last 5 years alone, three new drugs have been approved by regulatory agencies like the U.S. FDA and European Medicines Agency (EMA) - obeticholic acid (Ocaliva), fibric acid derivatives such as bezafibrate (Pemptor), and interleukin-12/23 inhibitors like mirikizumab (Kineret). Compared to conventional treatments, these novel drugs have demonstrated higher rates of biochemical response and incomplete biochemical response in clinical trials. For instance, in November 2020, GSK plc., a multinational pharmaceutical and biotechnology company, announced further progression in its R&D pipeline with the presentation of data for linerixibat, an investigational product for the potential treatment of cholestatic pruritus in patients with primary biliary cholangitis (PBC).

Primary Biliary Cholangitis Treatment Market Opportunities:

Increasing adoption of Combination Therapy: Combination therapy holds significant potential to drive the growth in the global primary biliary cholangitis treatment market. As per medical experts, combination of two or more treatment options may help achieve better clinical response for patients suffering from primary biliary cholangitis (PBC). PBC is an autoimmune disease where there is slow destruction of smaller bile ducts inside the liver over a period of time. Current treatment options, such as ursodeoxycholic acid (UDCA) and obeticholic acid, provide relief to some extent but not all patients respond equally to single drug therapies. Medical reports from the World Health Organization (WHO) suggest that maximum 50-60% patients respond to UDCA, leaving remainder with inadequate response. This is where combination therapies can make a difference. Combining UDCA with other immunomodulatory drugs holds promise. Recent clinical studies show that combining UDCA with fibric acid derivatives, such as bezafibrate, led to improved biochemical, serological, and histological responses in UDCA partial responders or non-responders. Similarly, combining UDCA and monoclonal antibodies targeting specific inflammatory pathways demonstrated enhanced therapeutic benefits over monotherapies. Ongoing phase 3 clinical trials evaluating safety and efficacy of UDCA in combination with immunomodulators like Budesonide and combination of Obeticholic acid with other agents are encouraging. Positive outcomes from such combination therapy trials can go a long way in better management of PBC and improving patient outcomes. This will likely fuel the increased adoption of combination drug regimens among physicians and healthcare providers for PBC treatment. Growing clinical evidence on benefits of combination approach is expected to drive higher treatment uptake beyond existing patient pools, thereby accelerating future growth prospects of the global primary biliary cholangitis treatment market over the forecast period.

Primary Biliary Cholangitis Treatment Market Restraints:

High Cost of Treatment: The high cost of treatment is one of the major factors restraining the growth of the global primary biliary cholangitis treatment market. Primary biliary cholangitis is a chronic and progressive liver disease that damages the smallest bile ducts in the liver over time. This causes bile buildup that can lead to scarring and damage to the liver. At present, there is no cure for primary biliary cholangitis and the treatment options mainly focus on managing the symptoms and slowing the progression of liver damage. The first line of treatment includes ursodeoxycholic acid tablets which need to be taken lifelong. While this drug helps improve liver tests and symptoms for many patients, its high cost poses a challenge. For instance, in February 2021, according to a study published by the National Center for Biotechnology Information (NCBI), the mean all-cause inpatient medical cost over a mean follow-up period of 22.3 months was US$ 3,905 per patient per month. An estimated 66% of this cost was due to PBC. This high out-of-pocket expenditure acts as a deterrent for proper treatment compliance. Some patients may omit doses or stop treatment due to affordability issues, which negatively impacts disease management in the long run.