Primary Biliary Cholangitis Therapeutics Market – By Drug (Ursodeoxycholic Acid, Obeticholic Acid), Use (Human, Veterinary), Distribution Channel (Hospital Pharmacies, Drug Store & Retail Pharmacies, Online Pharmacies) – Global Forecast (2024 ­ 2032)

Primary Biliary Cholangitis Therapeutics Market – By Drug (Ursodeoxycholic Acid, Obeticholic Acid), Use (Human, Veterinary), Distribution Channel (Hospital Pharmacies, Drug Store & Retail Pharmacies, Online Pharmacies) – Global Forecast (2024 ­ 2032)

Primary biliary cholangitis therapeutics Market Size

Primary BilSummary iary Cholangitis Therapeutics Market size was valued at USD 677.2 million in 2023 growing at a CAGR of 7.1% between 2024 and 2032, driven by factors such as the increase in the prevalence of primary biliary cholangitis.

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For instance, as per the report published by Haymarket Media, Inc., it has been reported that the incidence and prevalence of PBC differ by geographic location such as the North America has the highest prevalence (21.81 per 100,000 individuals), followed by Europe (14.59 per 100,000 persons). The Asia-Pacific region had the lowest prevalence at 9.82 per 100,000 persons. Thus, the increasing prevalence of primary biliary cholangitis, especially among middle-aged women, drive the demand for effective treatments that is anticipated to boost the growth of the market.

Moreover, surge in technological advancement in diagnostic devices enable earlier and more accurate detection of PBC, leading to timely treatment and better patient outcomes, thereby augmenting the market growth.

Therapeutics for PBC focus on managing symptoms, slowing disease progression, and addressing complications. Ursodeoxycholic acid (UDCA) is the first-line treatment, helping improve bile flow, reduce liver inflammation, and delay disease progression, though it may not be effective for all patients. Obeticholic acid (OCA), a second-line treatment, is used for those with inadequate response to UDCA and works by reducing bile acid synthesis and improving bile flow.
 

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Primary Biliary Cholangitis Therapeutics Market Trends

• The rise in the prevalence of primary biliary cholangitis (PBC) significantly propels the growth of the PBC therapeutics market by increasing the number of patients requiring treatment and driving demand for innovative therapies. In addition, as the awareness and diagnosis of PBC improve, more patients are identified and treated, which in turn fuels the market for therapeutic solutions.
• For instance, a study published in the journal of National Institute of Health in August 2022 reported that the global prevalence of PBC is in the range from 1.9 to 40.2 per 100 000 individuals. Diagnosis is typically made between 55 and 65 years of age, and women are disproportionately affected with a female-to-male ratio of up to 91. Thus, as the number of diagnosed cases grows, the demand for effective treatment options also escalates.
• Further, patients diagnosed with PBC require long-term management to slow disease progression and mitigate symptoms, necessitating a steady and growing market for PBC therapeutics.
• Moreover, pharmaceutical companies are intensely involved in research and development activities to introduce new and improved therapies. The expansion of the patient population creates a lucrative market for both existing drugs and novel treatments, thereby fostering innovation and competition within the industry.

Primary Biliary Cholangitis Therapeutics Market Analysis 

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Based on the drug, the market is classified into ursodeoxycholic acid, obeticholic acid, and other drugs. The ursodeoxycholic acid segment dominated the market with revenue of USD 329.6 million in 2023.

• Ursodeoxycholic acid is widely recognized for its efficacy in improving liver function and delaying disease progression in PBC patients. Its long-standing use and favorable safety profile make it a preferred first-line treatment.
• Moreover, clinical studies have demonstrated that ursodeoxycholic acid significantly improves survival rates and reduces the need for liver transplantation in primary biliary cholangitis patients. Such evidence-based studies along with companies focusing on the novel treatment products will supplement the market growth.

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Based on the use, the global primary biliary cholangitis therapeutics market is classified into human and veterinary. The human segment dominated the market with market share of 88.2% in 2023.

• Primary biliary cholangitis predominantly affects women, particularly those between the age of 40 and 60. This rising prevalence necessitates increased therapeutic interventions that is anticipated to boost the growth of the market.
• Further, well-developed healthcare infrastructure for human patients facilitates the effective delivery of PBC treatments. Hospitals, clinics, and specialized healthcare providers are more equipped to handle human cases, thereby promoting the use of advanced therapeutics.

Based on distribution channel, the primary biliary cholangitis therapeutics market is classified into hospital pharmacies, drugs store & retail pharmacies, and online pharmacies. The hospital pharmacies segment is expected to exhibit 7.4% CAGR between 2024 - 2032.

• Hospital pharmacies support healthcare specialists by ensuring the availability of necessary medications and managing complex therapeutic regimens. Also, hospital pharmacies are equipped to stock and dispense advanced and specialized therapeutics that may not be readily available in retail or community pharmacies. This includes biologics and other high-cost medications used in the treatment of PBC.
• Further, hospitals often serve as sites for clinical trials and research studies, providing access to new and experimental treatments. Thus, hospital pharmacies play a crucial role in the logistics and management of these trials, facilitating the availability of cutting-edge therapeutics.

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In 2023, North America secured a substantial market share of 45.2% in the global primary biliary cholangitis therapeutics market and is expected to dominate throughout the forecast period.

• North America has a relatively high prevalence of PBC compared to other regions. The large patient population creates a significant market demand for PBC therapeutics. In addition, the region boasts advanced healthcare infrastructure with well-established healthcare systems, including hospitals, clinics, and research institutions. This facilitates early diagnosis, treatment, and access to innovative therapies for PBC patients.
• Further, the rigorous regulatory standards set by the U.S. Food and Drug Administration (FDA) ensure the safety, efficacy, and quality of PBC therapeutics. FDA approvals provide market authorization and instill confidence among healthcare providers and patients, thereby driving adoption and market growth.

Germany to experience the highest growth rate in the market, outstripping other countries in Europe in the assessment period.

• Germany boasts a robust healthcare infrastructure with universal health coverage, ensuring access to diagnosis and treatment for patients with PBC. The well-developed network of healthcare facilities and specialists facilitates early detection and management of the condition.
• Moreover, the growing emphasis on personalized medicine and tailored treatment approaches help to advance in molecular diagnostics and biomarker identification This enable personalized treatment strategies for PBC patients, leading to improved outcomes and driving market growth.

The India primary biliary cholangitis therapeutics market is expected to grow with a significant CAGR during the forecast period.

• Increasing healthcare spending in India driven by economic growth and government initiatives allows for better access to healthcare services, including diagnosis and treatment of chronic diseases including PBC. This increased investment supports market growth for therapeutics and has anticipated boosting the market growth.
• Moreover, India's robust pharmaceutical industry, known for its production of generic drugs and active pharmaceutical ingredients (APIs), ensures a steady supply of PBC therapeutics at competitive prices. Therefore, the presence of domestic pharmaceutical companies also fosters innovation and drives market growth.

Primary Biliary Cholangitis Therapeutics Market Share

The competitive landscape of the market is characterized by the presence of established pharmaceutical companies that manufacture advanced primary biliary cholangitis therapeutics products vying for market share. Key players are engaging in strategic initiatives such as collaboration, product launch, investment, and partnerships to strengthen their product portfolio. The companies are actively adopting a multi-pronged approaches to address the rising demand for primary biliary cholangitis therapeutics.

Primary Biliary Cholangitis Therapeutics Market Companies

Prominent players operating in the market are as mentioned below

• Abbott Laboratories
• Arlak Biotech Pvt. Ltd
• Cadila Pharmaceuticals
• Drag Pharma
• Gilead Sciences, Inc.
• Intercept Pharmaceuticals, Inc.
• Ipsen
• Leeford Healthcare Limited
• Lupin
• Sun Pharmaceuticals Ltd.
• Viatris, Inc. (Mylan N.V.)
• Vivaldis

Primary Biliary Cholangitis Therapeutics Industry News

• In February 2024, Gilead Sciences, Inc. and CymaBay Therapeutics, Inc. announced a definitive agreement under which Gilead will acquire CymaBay. The acquisition aimed to add CymaBay’s investigational lead product candidate, seladelpar for the treatment of primary biliary cholangitis (PBC) including pruritus, complements Gilead’s existing liver portfolio.
• In February 2024, Intercept Pharmaceuticals, Inc., a biopharmaceutical company, and wholly owned subsidiary of Alfasigma S.p.A. announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Ocaliva for the treatment of individuals with primary biliary cholangitis (PBC). This strategy is expected to help company to generate substantial revenue from its sales.

The primary biliary cholangitis therapeutics market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 - 2032 for the following segments

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Market, By Drug

• Ursodeoxycholic acid
• Obeticholic acid
• Other drugs

Market, By Use

• Human
• Veterinary

Market, By Distribution channel

• Hospital pharmacies
• Drug store & retail pharmacies
• Online pharmacies  

The above information is provided for the following regions and countries

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East and Africa
  • South Africa
  • Saudia Arabia
  • UAE
• Rest of Middle East and Africa