세계의 원발성 담즙성 담관염(PBC) 치료 시장(2023-2030년)

Overview

Primary Biliary Cholangitis (PBC), formerly termed primary biliary cirrhosis, is an autoimmune disorder that leads to the gradual destruction of intrahepatic bile ducts, resulting in periportal inflammation and cholestasis. Prolonged hepatic cholestasis subsequently causes cirrhosis and portal hypertension. This activity reviews the evaluation and treatment of primary biliary cholangitis and the importance of the interprofessional team in recognizing and managing patients with this condition.

The pathogenesis of primary biliary cholangitis is thought to be related to the interaction between genetic predisposition and environmental triggers. The genetic predisposition is suggested by a strong prevalence of the disease in first-degree relatives, with an odds ratio of 11. There is also a high degree of concordance in monozygotic twins. Daughters of index women have the highest relative risk for the development of primary biliary cholangitis.

Several human leukocyte antigen (HLA) allele associations have been reported with primary biliary cirrhosis, which includes DRB1, DR3, DPB1, DQA1, and DQB1. HLA-DRB1*08 is common in European and Asian descent, whereas HLA-DRB1*11 has been found to be protective.

Market Dynamics: Drivers and Restraints

Increasing R&D for the development of new drug therapeutics for primary biliary cholangitis

Currently, there is no cure for primary biliary cholangitis, but various treatments can slow its progression. Pharmaceutical companies are investing heavily in R&D to develop more effective treatments for primary biliary cholangitis. Hence there are a lot of new things, like new medications in development. Seladelpar is in a phase 3 trial that is close to enrollment. Elafibranor is in a phase 3 trial that's close to enrollment. These are PPAR and PPAR-? dual agonists. Saroglitazar, which is a PPAR-?-γ dual agonist, is also in clinical trials. There's a fixed-dose combination study that's ongoing with obeticholic acid and bezafibrate.

For instance, in September 2023, CymaBay Therapeutics Inc. (CBAY) stated positive results from its Phase 3 pivotal RESPONSE study of seladelpar in primary biliary cholangitis. The study evaluated the safety and efficacy of seladelpar, a potent, selective, orally active delpar or PPARd agonist, in development for the treatment of adult patients with primary biliary cholangitis.

Furthermore, primary biliary cholangitis is a chronic condition that requires long-term management hence this market is driven by other factors like a rise in the prevalence of primary biliary cholangitis, Advancements in primary biliary cholangitis treatment, growing awareness about primary biliary cholangitis and others.

Market Dynamics: Restraint

Complications are involved with primary biliary cholangitis which indeed hamper the market growth along with other restraint factors If primary biliary cholangitis is not treated or advanced, it can lead to osteoporosis, portal hypertension, ascites, vitamin deficiencies, and a slightly increased risk of liver cancer. Osteoporosis is a weakening of bones, portal hypertension increases blood pressure in abdominal blood vessels, ascites buildup causes fluid accumulation, and vitamin deficiencies increase the risk of liver cancer.

Also, lack of awareness regarding primary biliary cholangitis, early diagnosis of primary biliary cholangitis, and limited treatment options are expected to hinder the growth of the primary biliary cholangitis therapeutics market.

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Segment Analysis

The global primary biliary cholangitis is segmented based on stage type, drug type, route of administration, distribution channel and region.

The Ursodeoxycholic acid (UDCA) from the drug type segment accounted for approximately 41.2% of the market share

The Ursodeoxycholic acid (UDCA) from the drug type segment accounted for 41.2% and it is expected to dominate during the forecast period. Ursodeoxycholic acid (UDCA) is a secondary bile acid, which means that it is a bacterial metabolite of primary bile acids produced in the liver. It is a C7 epimer of chenodeoxycholic acid, one of the two primary human bile acids. Ursodeoxycholic acid (UCDA) is the only approved first-line treatment for primary biliary cholangitis, slowing disease progression and reducing Liver Transplantation need. Long-term outcomes assessment is challenging due to slow clinical progression.

For instance, in June 2023, Ipsen and GENFIT stated positive topline data from the pivotal ELATIVE Phase III trial. In the trial the efficacy and safety of elafibranor, an investigational dual α,-Delta PPAR agonist, is being assessed for the treatment of patients with the rare cholestatic liver disease, Primary Biliary Cholangitis, who have an inadequate response or intolerance to the current standard of care therapy, ursodeoxycholic acid.

Geographical Analysis

North America accounted for approximately 38.4% of the market share in 2022

North America is estimated to hold about 38.4% of the total market share throughout the forecast period owing to well-established healthcare infrastructure, presence of key market players and recent product launches. Moreover, the growing number of patients with primary biliary cirrhosis and the growing demand for therapeutics are anticipated to fuel the market growth over the forecast period.

For instance, in July 2023, Gannex Pharma Co., Ltd, a wholly-owned company of Ascletis Pharma Inc. stated that the completion of enrollment of 98 patients with primary biliary cholangitis in the Phase II clinical trial of ASC42, a novel Farnesoid X receptor (FXR) agonist.

Moreover, in June 2023, Intercept Pharmaceuticals, Inc stated a restructuring to strengthen the Company's focus on rare and serious liver diseases and significantly reduce operating expenses, including discontinuing all nonalcoholic steatohepatitis (NASH)-related investment.

COVID-19 Impact Analysis

The COVID-19 pandemic affected the primary biliary cholangitis therapeutics industry negatively, such as various healthcare industries being affected due to the postponement of non-emergency services. The pandemic has disrupted research activities, including clinical trials, restrictions on patient recruitment and new product development.

However, with the relaxation in lockdowns and the decline in COVID-19 cases, companies have re-started their processes to meet the demand for primary biliary cholangitis therapeutics. In addition, the rise in product approvals, and the increase in research and development of advanced medicine of primary biliary cholangitis therapeutics drive the growth of the primary biliary cholangitis therapeutics market.

Competitive Landscape

The major global players in the primary biliary cholangitis market include: Intercept Pharmaceuticals, Inc., Ice Pharma, Sun Pharma, Wellona Pharma, Zoic Life Sciences, Steris Healthcare, Cadila Pharma, Cipla, Brunet, AstraEureka Pharmaceuticals and among others.

Key Developments

• In June 2022, Intercept Pharmaceuticals Inc., declared outcomes from two investigations planned to assess clinical results in patients with primary biliary cholangitis on Ocaliva COBALT, a Phase 3b/4 confirmatory clinical results investigation and HEROES-US, one of two HEROES real-world investigations.
• In May 2022, Intercept Pharmaceuticals, Inc. declared that the earliest patient has been dosed in a Phase 2 investigation assessing a fixed-dose combination of obeticholic acid (OCA) and bezafibrate (BZF) for the treatment of patients with primary biliary cholangitis who have not accomplished a sufficient biochemical response to ursodeoxycholic acid.
• In May 2022, Intercept Pharmaceuticals, Inc. declared that it has entered into an agreement to market to Advanz Pharma, a pharmaceutical firm with a strategic focus on speciality and hospital pharmaceuticals in Europe, some foreign subsidiaries and rights concerning Intercept's international operations, inclusive of a license to commercialize Ocaliva (obeticholic acid) external of the U.S.

Why Purchase the Report?

• To visualize the global primary biliary cholangitis treatment market segmentation-based stage type, drug type, route of administration, distribution channel and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of primary biliary cholangitis treatment market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global primary biliary cholangitis treatment market report would provide approximately 69 tables, 70 figures, and 185 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Stage Type
• 3.2. Snippet by Drug Type
• 3.3. Snippet by Route of Administration
• 3.4. Snippet by Distribution Channel
• 3.5. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Driver
    • 4.1.1.1. Increasing R&D for the development of new drug therapeutics for primary biliary cholangitis
    • 4.1.1.2. Rise in the prevalence of primary biliary cholangitis
  • 4.1.2. Restraints
    • 4.1.2.1. Complications associated with primary biliary cholangitis
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis
• 5.5. Russia-Ukraine War Impact Analysis
• 5.6. DMI Opinion

6. COVID-19 Analysis

• 6.1. Analysis of COVID-19
  • 6.1.1. Scenario Before COVID
  • 6.1.2. Scenario During COVID
  • 6.1.3. Scenario Post COVID
• 6.2. Pricing Dynamics Amid COVID-19
• 6.3. Demand-Supply Spectrum
• 6.4. Government Initiatives Related to the Market During Pandemic
• 6.5. Manufacturers Strategic Initiatives
• 6.6. Conclusion

7. By Stage Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Stage Type
  • 7.1.2. Market Attractiveness Index, By Stage Type
• 7.2. Stage 1*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Stage 2
• 7.4. Stage 3
• 7.5. Stage 4

8. By Drug Type

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
  • 8.1.2. Market Attractiveness Index, By Drug Type
• 8.2. Ursodeoxycholic acid (UDCA)*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Obeticholic acid (Ocaliva)
• 8.4. Fibrates (Tricor)
• 8.5. Budesonide
• 8.6. Others

9. By Route of Administration

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 9.1.2. Market Attractiveness Index, By Route of Administration
• 9.2. Oral *
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Nasal

10. By End User

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.1.2. Market Attractiveness Index, By End User
• 10.2. Hospital Pharmacies *
  • 10.2.1. Introduction
  • 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 10.3. Ambulatory Surgical Centers (ASCs)
• 10.4. Retail Pharmacies
• 10.5. Online Pharmacies

11. By Region

• 11.1. Introduction
  • 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 11.1.2. Market Attractiveness Index, By Region
• 11.2. North America
  • 11.2.1. Introduction
  • 11.2.2. Key Region-Specific Dynamics
  • 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Stage Type
  • 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
  • 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.2.7.1. U.S.
    • 11.2.7.2. Canada
    • 11.2.7.3. Mexico
• 11.3. Europe
  • 11.3.1. Introduction
  • 11.3.2. Key Region-Specific Dynamics
  • 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Stage Type
  • 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
  • 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.3.7.1. Germany
    • 11.3.7.2. UK
    • 11.3.7.3. France
    • 11.3.7.4. Italy
    • 11.3.7.5. Spain
    • 11.3.7.6. Rest of Europe
• 11.4. South America
  • 11.4.1. Introduction
  • 11.4.2. Key Region-Specific Dynamics
  • 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Stage Type
  • 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
  • 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.4.7.1. Brazil
    • 11.4.7.2. Argentina
    • 11.4.7.3. Rest of South America
• 11.5. Asia-Pacific
  • 11.5.1. Introduction
  • 11.5.2. Key Region-Specific Dynamics
  • 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Stage Type
  • 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
  • 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.5.7.1. China
    • 11.5.7.2. India
    • 11.5.7.3. Japan
    • 11.5.7.4. Australia
    • 11.5.7.5. Rest of Asia-Pacific
• 11.6. Middle East and Africa
  • 11.6.1. Introduction
  • 11.6.2. Key Region-Specific Dynamics
  • 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Stage Type
  • 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
  • 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel

12. Competitive Landscape

• 12.1. Competitive Scenario
• 12.2. Market Positioning/Share Analysis
• 12.3. Mergers and Acquisitions Analysis

13. Company Profiles

• 13.1. Intercept Pharmaceuticals, Inc
  • 13.1.1. Company Overview
  • 13.1.2. Product Portfolio and Description
  • 13.1.3. Financial Overview
  • 13.1.4. Key Developments
• 13.2. Ice Pharma
• 13.3. Sun Pharma
• 13.4. Wellona Pharma
• 13.5. Zoic Life Sciences
• 13.6. Steris Healthcare
• 13.7. Cadila Pharma
• 13.8. Cipla
• 13.9. Brunet
• 13.10. AstraEureka Pharmaceuticals

LIST NOT EXHAUSTIVE

14. Appendix

• 14.1. About Us and Services
• 14.2. Contact Us