Primary Biliary Cholangitis Market

Market Overview:

The 7 major primary biliary cholangitis markets reached a value of US$ 510 Million in 2023. Looking forward, IMARC Group expects the 7MM to reach US$ 1,200 Million by 2034, exhibiting a growth rate (CAGR) of 8.06% during 2024-2034.

The primary biliary cholangitis market has been comprehensively analyzed in IMARC's new report titled "Primary Biliary Cholangitis Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034". Primary biliary cholangitis is a chronic autoimmune illness that primarily affects the tiny bile ducts located in the liver. As a result, bile builds up in the liver, leading to hepatic cell damage over time. Many individuals suffering from this condition may have little to no symptoms as well. The most common indications of the illness include lethargy, fatigue, itching, dry eyes and mouth, an enlarged liver or spleen, yellowing of the skin and eyes, abdominal pain, weak and brittle bones, diarrhea, swollen legs, ankles and feet, weight loss, fat deposits, hyperpigmentation, etc. Diagnosing primary biliary cholangitis typically requires a combination of thorough clinical assessment, medical history evaluation, as well as a complete blood workup and physical examination. The healthcare practitioner may also perform several other imaging studies, such as abdominal ultrasound and magnetic resonance imaging, to visualize the liver and bile ducts, assess their structure, and identify any abnormalities. In some cases, a liver biopsy is further utilized to confirm the diagnosis and determine the degree of liver damage among patients.

The rising cases of immune-mediated disorders, in which the body's defense system targets the cells that line the intrahepatic bile ducts, resulting in inflammation, are primarily driving the primary biliary cholangitis market. Additionally, the increasing prevalence of various risk factors, including genetic predisposition, hormonal changes, exposure to infectious agents or toxins, regular smoking, etc., is further propelling the market growth. Moreover, the widespread adoption of effective drugs, such as ursodeoxycholic acid and obeticholic acid, to help in reducing liver inflammation and improving bile flow within the body is acting as another significant growth-inducing factor. In line with this, the rising usage of immunosuppressive medications, like corticosteroids and azathioprine, for treating the condition is also augmenting the market growth. These therapeutic agents work by modulating the immune response to minimize hepatic damage, preserve liver function, and alleviate the symptoms of the ailment. Furthermore, the escalating demand for endoscopic retrograde cholangiopancreatography-guided implantation of a biliary endoprosthesis, owing to its numerous benefits, including relief of bile duct obstruction and improved quality of life for patients, is expected to drive the primary biliary cholangitis market during the forecast period.

IMARC Group's new report provides an exhaustive analysis of the primary biliary cholangitis market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for primary biliary cholangitis and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc., have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the primary biliary cholangitis market in any manner.

Recent Developments:

• In July 2024, GENFIT announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion for Ipsen's Iqirvo (elafibranor) for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients who cannot tolerate UDCA.
• In May 2024, Gilead Sciences, Inc., following the recent acquisition of CymaBay Therapeutics, Inc., released interim results from the ongoing ASSURE study, revealing that therapy with seladelpar, an experimental PPAR delta agonist, improved cholestasis indicators and decreased inflammation. Additional research shows that seladelpar can help reduce pruritus (itch) in persons with primary biliary cholangitis.

Key Highlights:

• Primary biliary cholangitis occurs in 0.33 to 5.8 per 100,000 people each year.
• The prevalence rate ranges from 1.91 and 40.2 per 100,000 individuals.
• Women are more likely to be impacted than men, with a 9:1 sex ratio.
• Primary biliary cholangitis typically occurs between the ages of 40 and 60.
• Primary biliary cholangitis is most widespread in Northern America and Northern Europe and the least prevalent in Asia-Pacific.

Drugs:

OCALIVA (obeticholic acid) is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone for adults who cannot tolerate UDCA. Obeticholic acid is a farnesoid-X receptor (FXR) agonist used to treat this condition, possibly allowing for increased survival.

Urso (Ursodeoxycholic acid) is a hepatoprotective medication. It works by reducing the amount of cholesterol in the blood and helps dissolve gallbladder stones that are composed mainly of cholesterol. It also improves liver enzymes, protects liver cells from injury caused due to toxic bile acids, and improves liver function. Ursodeoxycholic acid is a naturally occurring bile acid that comprises approximately 5% of the total bile acids found in humans.

Time Period of the Study

• Base Year: 2023
• Historical Period: 2018-2023
• Market Forecast: 2024-2034
   

Countries Covered

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan
   

Analysis Covered Across Each Country

• Historical, current, and future epidemiology scenario
• Historical, current, and future performance of the primary biliary cholangitis market
• Historical, current, and future performance of various therapeutic categories in the market
• Sales of various drugs across the primary biliary cholangitis market
• Reimbursement scenario in the market
• In-market and pipeline drugs

Competitive Landscape:

This report also provides a detailed analysis of the current primary biliary cholangitis marketed drugs and late-stage pipeline drugs.

In-Market Drugs

• Drug overview
• Mechanism of action
• Regulatory status
• Clinical trial results
• Drug uptake and market performance
   

Late-Stage Pipeline Drugs

• Drug overview
• Mechanism of action
• Regulatory status
• Clinical trial results
• Drug uptake and market performance
   

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.

Key Questions Answered in this Report:

Market Insights

• How has the primary biliary cholangitis market performed so far and how will it perform in the coming years?
• What are the markets shares of various therapeutic segments in 2023 and how are they expected to perform till 2034?
• What was the country-wise size of the primary biliary cholangitis market across the seven major markets in 2023 and what will it look like in 2034?
• What is the growth rate of the primary biliary cholangitis market across the seven major markets and what will be the expected growth over the next ten years?
• What are the key unmet needs in the market?
   

Epidemiology Insights

• What is the number of prevalent cases (2018-2034) of primary biliary cholangitis across the seven major markets?
• What is the number of prevalent cases (2018-2034) of primary biliary cholangitis by age across the seven major markets?
• What is the number of prevalent cases (2018-2034) of primary biliary cholangitis by gender across the seven major markets?
• How many patients are diagnosed (2018-2034) with primary biliary cholangitis across the seven major markets?
• What is the size of the primary biliary cholangitis patient pool (2018-2023) across the seven major markets?
• What would be the forecasted patient pool (2024-2034) across the seven major markets?
• What are the key factors driving the epidemiological trend of primary biliary cholangitis?
• What will be the growth rate of patients across the seven major markets?
   

Primary Biliary Cholangitis: Current Treatment Scenario, Marketed Drugs and Emerging Therapies

• What are the current marketed drugs and what are their market performance?
• What are the key pipeline drugs and how are they expected to perform in the coming years?
• How safe are the current marketed drugs and what are their efficacies?
• How safe are the late-stage pipeline drugs and what are their efficacies?
• What are the current treatment guidelines for primary biliary cholangitis drugs across the seven major markets?
• Who are the key companies in the market and what are their market shares?
• What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the primary biliary cholangitis market?
• What are the key regulatory events related to the primary biliary cholangitis market?
• What is the structure of clinical trial landscape by status related to the primary biliary cholangitis market?
• What is the structure of clinical trial landscape by phase related to the primary biliary cholangitis market?
• What is the structure of clinical trial landscape by route of administration related to the primary biliary cholangitis market?