The primary biliary cholangitis therapeutics market was valued at $683.95 million in 2022 and is estimated to reach $1.36 billion by 2032, exhibiting a CAGR of 7.1% from 2023 to 2032. Primary Biliary Cholangitis (PBC) therapeutics refers to the various treatment options available for managing and treating the condition. Primary biliary cholangitis (PBC), previously known as primary biliary cirrhosis, is a chronic autoimmune liver disease that primarily affects the small bile ducts within the liver. It is characterized by inflammation, destruction, and scarring of these bile ducts, leading to impaired bile flow and subsequent liver damage. The exact cause of PBC is still unknown, but it is believed to result from a combination of genetic predisposition and environmental triggers. The immune system mistakenly targets the bile ducts, leading to their destruction and the accumulation of bile within the liver. Over time, this ongoing inflammation and bile duct damage may progress to cirrhosis (scarring of the liver tissue) and liver failure. The goal of PBC therapeutics is to improve liver function, slow down disease progression, alleviate symptoms, and prevent complications.
Major factors that drive the growth of the global primary biliary cholangitis therapeutics market Include rapid advancements in treatment of primary biliary cholangitis; rise in number of research regarding primary biliary cholangitis therapeutics; and Increase in number of patients suffering from primary biliary cholangitis. For instance, according to the review article “autoimmune biliary diseases: primary biliary cholangitis and primary sclerosing cholangitis,” published in June 2021, the prevalence of primary biliary cholangitis and primary sclerosing cholangitis disease ranges from 1.9 to 40.2 per 100,000 people and has also grown over time. The Increased prevalence is probably attributable to a combination of better disease recognition and data collection, and Increased survival after the introduction of ursodeoxycholic acid (UDCA).
Furthermore, surge in demand for primary biliary cholangitis therapeutics, Increase in number of awareness programs regarding primary biliary cholangitis, and rise in number of clinical trials for the development of primary biliary cholangitis therapeutics boost the growth of primary biliary cholangitis therapeutics market. For instance, in October 2021, COUR Pharmaceuticals, a biotechnology company developing novel immune-modifying nanoparticles (CNPs) to treat immune disorders announced the U.S. FDA accepted an investigational new drug application (IND) for a proof-of-concept study of investigatory therapy CNP-104 of COUR Pharmaceuticals to address autoimmune causes of Primary Biliary Cholangitis (PBC). COUR nanoparticle platform (CNP) is a novel, proprietary system combining disease specific pathogenic antigens with state-of-the-art pharmaceutical nanoparticles that mimic normal removal of dead or dying cells from the body. PBC affects an estimated 130,000 people in the U.S., primarily women. Currently, healthcare professionals and patients rely on symptomatic therapies with limited results to slow down the progression of PBC but do not address its inherent cause, autoimmunity to PDC-E2 and the inflammatory cellular infiltration in the liver. This proof-of-concept trial will assess the safety and tolerability of CNP-104 in adults with PBC and aims to find the optimal dose level that strikes the best balance between safety and treatment activity.
In addition, Increase in target population, rise in diagnosis rate of primary biliary cholangitis diseases, and surge in the prevalence of autoimmune diseases propel the market growth. However, lack of early diagnosis of primary biliary cholangitis, and limited treatment options are expected to restrict the growth of primary biliary cholangitis therapeutics market. On the contrary, surge in healthcare expenditure and unmet medical demands to get better treatment options in developing countries are expected to create lucrative opportunities for the expansion of the global market in the future.
The primary biliary cholangitis therapeutics market is segmented on the basis of drug type, distribution channel, and region. On the basis of drug type, the market is bifurcated into primary drug and secondary drug. The primary drug segment is further categorized into obeticholic acid, ursodeoxycholic acid, others (PPARα/PPARδ agonist, and ileal bile acid transport inhibitors). On the basis of distribution channel, it is segregated into hospital pharmacies, drugs stores and retail pharmacies, and online pharmacies. On the basis of region, the market is analyzed across North America (the U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and Rest of Europe), Asia-Pacific (China, Japan, Australia, India, South Korea, and Rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, and Rest of LAMEA).
The major players profiled in the report are ABC Farmaceutici S.p.a., Alkem Laboratories Limited, AMAGEN INDIA LIFE SCIENCES, GENFIT, Intercept Pharmaceuticals, Inc., Ipsen Pharma, Leeford Healthcare Ltd, Lupin, Sun Pharmaceutical Industries Ltd., and Zydus Lifesciences Limited. These major players have adopted product approval, agreement, acquisition, and product launch as key developmental strategies to improve the product portfolio of the primary biliary cholangitis therapeutics market.
Major factors that drive the growth of the global primary biliary cholangitis therapeutics market Include rapid advancements in treatment of primary biliary cholangitis; rise in number of research regarding primary biliary cholangitis therapeutics; and Increase in number of patients suffering from primary biliary cholangitis. For instance, according to the review article “autoimmune biliary diseases: primary biliary cholangitis and primary sclerosing cholangitis,” published in June 2021, the prevalence of primary biliary cholangitis and primary sclerosing cholangitis disease ranges from 1.9 to 40.2 per 100,000 people and has also grown over time. The Increased prevalence is probably attributable to a combination of better disease recognition and data collection, and Increased survival after the introduction of ursodeoxycholic acid (UDCA).
Furthermore, surge in demand for primary biliary cholangitis therapeutics, Increase in number of awareness programs regarding primary biliary cholangitis, and rise in number of clinical trials for the development of primary biliary cholangitis therapeutics boost the growth of primary biliary cholangitis therapeutics market. For instance, in October 2021, COUR Pharmaceuticals, a biotechnology company developing novel immune-modifying nanoparticles (CNPs) to treat immune disorders announced the U.S. FDA accepted an investigational new drug application (IND) for a proof-of-concept study of investigatory therapy CNP-104 of COUR Pharmaceuticals to address autoimmune causes of Primary Biliary Cholangitis (PBC). COUR nanoparticle platform (CNP) is a novel, proprietary system combining disease specific pathogenic antigens with state-of-the-art pharmaceutical nanoparticles that mimic normal removal of dead or dying cells from the body. PBC affects an estimated 130,000 people in the U.S., primarily women. Currently, healthcare professionals and patients rely on symptomatic therapies with limited results to slow down the progression of PBC but do not address its inherent cause, autoimmunity to PDC-E2 and the inflammatory cellular infiltration in the liver. This proof-of-concept trial will assess the safety and tolerability of CNP-104 in adults with PBC and aims to find the optimal dose level that strikes the best balance between safety and treatment activity.
In addition, Increase in target population, rise in diagnosis rate of primary biliary cholangitis diseases, and surge in the prevalence of autoimmune diseases propel the market growth. However, lack of early diagnosis of primary biliary cholangitis, and limited treatment options are expected to restrict the growth of primary biliary cholangitis therapeutics market. On the contrary, surge in healthcare expenditure and unmet medical demands to get better treatment options in developing countries are expected to create lucrative opportunities for the expansion of the global market in the future.
The primary biliary cholangitis therapeutics market is segmented on the basis of drug type, distribution channel, and region. On the basis of drug type, the market is bifurcated into primary drug and secondary drug. The primary drug segment is further categorized into obeticholic acid, ursodeoxycholic acid, others (PPARα/PPARδ agonist, and ileal bile acid transport inhibitors). On the basis of distribution channel, it is segregated into hospital pharmacies, drugs stores and retail pharmacies, and online pharmacies. On the basis of region, the market is analyzed across North America (the U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and Rest of Europe), Asia-Pacific (China, Japan, Australia, India, South Korea, and Rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, and Rest of LAMEA).
The major players profiled in the report are ABC Farmaceutici S.p.a., Alkem Laboratories Limited, AMAGEN INDIA LIFE SCIENCES, GENFIT, Intercept Pharmaceuticals, Inc., Ipsen Pharma, Leeford Healthcare Ltd, Lupin, Sun Pharmaceutical Industries Ltd., and Zydus Lifesciences Limited. These major players have adopted product approval, agreement, acquisition, and product launch as key developmental strategies to improve the product portfolio of the primary biliary cholangitis therapeutics market.
Key Benefits For Stakeholders
- This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the primary biliary cholangitis therapeutics market analysis from 2022 to 2032 to identify the prevailing primary biliary cholangitis therapeutics market opportunities.
- The market research is offered along with information related to key drivers, restraints, and opportunities.
- Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
- In-depth analysis of the primary biliary cholangitis therapeutics market segmentation assists to determine the prevailing market opportunities.
- Major countries in each region are mapped according to their revenue contribution to the global market.
- Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
- The report Includes the analysis of the regional as well as global primary biliary cholangitis therapeutics market trends, key players, market segments, application areas, and market growth strategies.
Key Market Segments
By Drug type
- Primary Drug
- Type
- Obeticholic Acid
- Ursodeoxycholic Acid
- Others
- Secondary Drug
By Distribution Channel
- Hospital Pharmacies
- Drugs Stores and Retail Pharmacies
- Online Pharmacies
By Region
- North America
- U.S.
- Canada
- Mexico
- Europe
- Germany
- France
- UK
- Italy
- Spain
- Rest of Europe
- Asia-Pacific
- Japan
- China
- Australia
- India
- South Korea
- Rest of Asia-Pacific
- LAMEA
- Brazil
- Saudi Arabia
- South Africa
- Rest of LAMEA
Key Market Players
- ABC Farmaceutici S.p.a.
- Alkem Laboratories Ltd.
- AMAGEN INDIA LIFE SCIENCES
- GENFIT
- Intercept Pharmaceuticals, Inc.
- Ipsen Pharma
- Leeford Healthcare Limited
- Lupin
- Sun Pharmaceutical Industries Ltd
- Zydus Lifesciences Limited
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Table of Contents
CHAPTER 1: INTRODUCTION
CHAPTER 2: EXECUTIVE SUMMARY
CHAPTER 3: MARKET OVERVIEW
CHAPTER 4: PRIMARY BILIARY CHOLANGITIS THERAPEUTICS MARKET, BY DRUG TYPE
CHAPTER 5: PRIMARY BILIARY CHOLANGITIS THERAPEUTICS MARKET, BY DISTRIBUTION CHANNEL
CHAPTER 6: PRIMARY BILIARY CHOLANGITIS THERAPEUTICS MARKET, BY REGION
CHAPTER 7: COMPETITIVE LANDSCAPE
CHAPTER 8: COMPANY PROFILES
List of Tables
List of Figures
Executive Summary
According to a new report, titled, 'Primary Biliary Cholangitis Therapeutics Market,' The primary biliary cholangitis therapeutics market was valued at $683.95 million in 2022, and is estimated to reach $1.4 billion by 2032, growing at a CAGR of 7.1% from 2023 to 2032.Primary biliary cholangitis (PBC) therapeutics refers to the treatment options available for managing and treating primary biliary cholangitis, a chronic autoimmune liver disease. Primary biliary cholangitis (PBC) is also known as primary biliary cirrhosis, that primarily affects the small bile ducts within the liver.
Key factors driving the growth of the primary biliary cholangitis therapeutics market include a surge in cases of primary biliary cholangitis and a rise in awareness regarding primary biliary cholangitis further increasing the demand of primary biliary cholangitis therapeutics. For instance, according to a review article 'Guidelines on the Diagnosis and Management of Primary Biliary Cholangitis (2021)', published in February 2023, the annual incidence of primary biliary cholangitis was estimated to be 0.23-5.31/100,000 each year. In addition, as per the Research Outreach article, in May 2020, over 37,000 people in Japan are estimated to have primary biliary cholangitis (PBC). In addition, the rise in advancement in primary biliary cholangitis therapeutics across the world, and the rise in research and development of primary biliary cholangitis therapeutics drives the growth of the primary biliary cholangitis therapeutics market during forecast period. For instance, in February 2023, Setanaxib is under clinical development by GenKyoTex and currently in Phase III for primary biliary cholangitis (primary biliary cirrhosis). Phase III drugs for primary biliary cholangitis (primary biliary cirrhosis) have a 25% phase transition success rate (PTSR) indication benchmark for progressing into pre-registration. Hence, such type of all factors together drives the growth of the primary biliary cholangitis therapeutics market.
The market offers growth opportunities to the key players in the market including rise in awareness regarding the potential benefits of primary biliary cholangitis therapeutics, rise in adoption of key strategies such as acquisition. And the rise in demand for primary biliary cholangitis therapeutics across the globe also provides growth opportunity for the market. As a result, the key players engaged in the primary biliary cholangitis therapeutics industry have invested in R&D and increasing their production are expected to gain high traction and provide lucrative opportunity for the growth of primary biliary cholangitis therapeutics market.
The primary biliary cholangitis therapeutics market is segmented on the basis of drug type, distribution channel, and region. On the basis of drug type, the market is bifurcated into primary drug and secondary drug. The primary drug segment is further categorized into obeticholic acid, ursodeoxycholic acid, others (PPARα/PPARδ agonist, and ileal bile acid transport inhibitors). On the basis of distribution channel, it is segregated into hospital pharmacies, drugs stores and retail pharmacies, and online pharmacies. On the basis of region, the market is analyzed across North America (the U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and Rest of Europe), Asia-Pacific (China, Japan, Australia, India, South Korea, and Rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, and Rest of LAMEA).
The key players profiled in the study include ABC Farmaceutici S.p.a., Alkem Laboratories Limited, AMAGEN INDIA LIFE SCIENCES, GENFIT, Intercept Pharmaceuticals, Inc., Ipsen Pharma, Leeford Healthcare Ltd, Lupin, Sun Pharmaceutical Industries Ltd., and Zydus Lifesciences Limited. The players in the market such as Intercept Pharmaceuticals, Inc., Ipsen Pharma, Zydus Lifesciences Limited, Lupin have been actively engaged in the adoption of various strategies such as acquisition, product approval, partnership, and product launch to remain competitive and gain an advantage over the competitors in the market. For instance, in May 2023, global pharma major Lupin Limited (Lupin) announced that it has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Obeticholic Acid Tablets, 5 mg and 10 mg, a generic equivalent of Ocaliva Tablets, 5 mg and 10 mg, of Intercept Pharmaceuticals, Inc. This product is anticipated to be manufactured at Nagpur facility of Lupin in India.
Key Market Insights
- By drug type, the primary drug segment was the highest revenue contributor to the market in 2022 and is estimated to reach 1196.3 million by 2032. The same segment is expected to be the fastest-growing segment with a CAGR of 7.3% during the forecast period.
- Based on distribution channel, the drugs stores and retail pharmacies segment was the highest revenue contributor to the market in 2022. However, the online pharmacies segment is estimated to be the fastest-growing segment with a CAGR of 8.6% during the forecast period.
- Based on region, North America accounted for a major share of the primary biliary cholangitis therapeutics market in 2022 and is expected to maintain its dominance during the forecast period. Asia-Pacific is expected to witness a highest CAGR of 8.5% during the forecast period.
Companies Mentioned
- ABC Farmaceutici S.p.a.
- Alkem Laboratories Ltd.
- AMAGEN INDIA LIFE SCIENCES
- GENFIT
- Intercept Pharmaceuticals, Inc.
- Ipsen Pharma
- Leeford Healthcare Limited
- Lupin
- Sun Pharmaceutical Industries Ltd
- Zydus Lifesciences Limited
Methodology
The analyst offers exhaustive research and analysis based on a wide variety of factual inputs, which largely include interviews with industry participants, reliable statistics, and regional intelligence. The in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. The primary research efforts include reaching out participants through mail, tele-conversations, referrals, professional networks, and face-to-face interactions.
They are also in professional corporate relations with various companies that allow them greater flexibility for reaching out to industry participants and commentators for interviews and discussions.
They also refer to a broad array of industry sources for their secondary research, which typically include; however, not limited to:
- Company SEC filings, annual reports, company websites, broker & financial reports, and investor presentations for competitive scenario and shape of the industry
- Scientific and technical writings for product information and related preemptions
- Regional government and statistical databases for macro analysis
- Authentic news articles and other related releases for market evaluation
- Internal and external proprietary databases, key market indicators, and relevant press releases for market estimates and forecast
Furthermore, the accuracy of the data will be analyzed and validated by conducting additional primaries with various industry experts and KOLs. They also provide robust post-sales support to clients.
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