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表紙：原発性胆汁性胆管炎治療の世界市場-2023-2030年
市場調査レポート
商品コード
1374821

原発性胆汁性胆管炎治療の世界市場-2023-2030年

Global Primary Biliary Cholangitis Treatment Market -2023-2030

出版日
ページ情報
英文 186 Pages
納期
即日から翌営業日
カスタマイズ可能
適宜更新あり
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=144.06円
原発性胆汁性胆管炎治療の世界市場-2023-2030年
出版日: 2023年11月01日
発行: DataM Intelligence
ページ情報: 英文 186 Pages
納期: 即日から翌営業日
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  • 概要
  • 目次
概要

概要

以前は原発性胆汁性肝硬変と呼ばれていた原発性胆汁性胆管炎（PBC）は、肝内胆管が徐々に破壊され、肝周囲の炎症と胆汁うっ滞を引き起こす自己免疫疾患です。肝胆汁うっ滞が長期化すると、肝硬変と門脈圧亢進症を引き起こします。この活動では、原発性胆汁性胆管炎の評価と治療、およびこの病態の患者の認識と管理における職種間チームの重要性について概説します。

原発性胆汁性胆管炎の病態は、遺伝的素因と環境的誘因の相互作用に関連していると考えられています。遺伝的素因は、オッズ比11という一親等の近親者における本疾患の強い有病率によって示唆され、一卵性双生児においても高い一致が認められます。原発性胆汁性胆管炎発症の相対リスクが最も高いのは、指標女性の娘です。

いくつかのヒト白血球抗原（HLA）対立遺伝子と原発性胆汁性肝硬変との関連が報告されており、DRB1、DR3、DPB1、DQA1、DQB1が含まれます。HLA-DRB1*08は欧州系やアジア系に多く、HLA-DRB1*11は予防的であることが判明しています。

市場促進要因：市場抑制要因

原発性胆汁性胆管炎の治療薬開発のための研究開発の増加

現在のところ、原発性胆汁性胆管炎を完治させる治療法はありませんが、様々な治療法によって進行を遅らせることは可能です。製薬会社は原発性胆汁性胆管炎のより効果的な治療法を開発するため、研究開発に多額の投資を行っています。したがって、開発中の新薬のような新しいものがたくさんあります。セラデルパルは第3相試験中で、登録間近です。エラフィブラノールは登録間近の第3相試験中です。これらはPPARとPPAR-α/γのデュアルアゴニストです。PPAR-α/γデュアルアゴニストであるサログリタザールも臨床試験中です。オベチコール酸とベザフィブラートの合剤試験が進行中です。

例えば、2023年9月、CymaBay Therapeutics社（CBAY）は、原発性胆汁性胆管炎を対象としたセラデルパーの第3相極めて重要なRESPONSE試験から良好な結果が得られたと発表しました。本試験は、原発性胆汁性胆管炎成人患者の治療薬として開発中の強力で選択的な経口活性デルパーまたはPPARdアゴニストであるセラデルパーの安全性と有効性を評価したものです。

さらに、原発性胆汁性胆管炎は長期的な管理が必要な慢性疾患であるため、原発性胆汁性胆管炎の有病率の上昇、原発性胆汁性胆管炎の治療の進歩、原発性胆汁性胆管炎に対する意識の高まりなどの要因も市場を牽引しています。

市場力学：市場抑制要因

原発性胆汁性胆管炎には合併症が伴うため、他の抑制要因とともに市場成長の妨げとなります。原発性胆汁性胆管炎を治療または改善させないと、骨粗鬆症、門脈圧亢進症、腹水、ビタミン欠乏症、肝臓がんのリスクがわずかに上昇します。骨粗鬆症は骨が弱くなること、門脈圧亢進症は腹部血管の血圧が上昇すること、腹水貯留は体液がたまること、ビタミン欠乏症は肝臓がんのリスクを高めることです。

また、原発性胆汁性胆管炎に関する認識不足、原発性胆汁性胆管炎の早期診断、限られた治療オプションは、原発性胆汁性胆管炎治療薬市場の成長を妨げると予想されています。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

  • 影響要因
    • 促進要因
      • 原発性胆汁性胆管炎の新薬治療薬開発のための研究開発の増加
      • 原発性胆汁性胆管炎の有病率の上昇
    • 抑制要因
      • 原発性胆汁性胆管炎に伴う合併症
    • 機会
    • 影響分析

第5章 産業分析

  • ポーターのファイブフォース分析
  • サプライチェーン分析
  • 価格分析
  • 規制分析
  • ロシア・ウクライナ戦争の影響分析
  • DMIの見解

第6章 COVID-19分析

第7章 ステージタイプ別

  • 第1期
  • 第2期
  • 第3期
  • 第4期

第8章 薬剤タイプ別

  • ウルソデオキシコール酸（UDCA）
  • オベチコール酸（オカリバ）
  • フィブラート系薬剤（トライコール）
  • ブデソニド
  • その他

第9章 投与経路別

  • 経口
  • 経鼻

第10章 エンドユーザー別

  • 病院薬局
  • 外来手術センター（ASC）
  • 小売薬局
  • オンライン薬局

第11章 地域別

  • 北米
    • 米国
    • カナダ
    • メキシコ
  • 欧州
    • ドイツ
    • 英国
    • フランス
    • イタリア
    • スペイン
    • その他欧州
  • 南米
    • ブラジル
    • アルゼンチン
    • その他南米
  • アジア太平洋
    • 中国
    • インド
    • 日本
    • オーストラリア
    • その他アジア太平洋
  • 中東・アフリカ

第12章 競合情勢

  • 競合シナリオ
  • 市況/シェア分析
  • M&A分析

第13章 企業プロファイル

  • Intercept Pharmaceuticals, Inc
    • 会社概要
    • 製品ポートフォリオと説明
    • 財務概要
    • 主な動向
  • Ice Pharma
  • Sun Pharma
  • Wellona Pharma
  • Zoic Life Sciences
  • Steris Healthcare
  • Cadila Pharma
  • Cipla
  • Brunet
  • AstraEureka Pharmaceuticals

第14章 付録

目次
Product Code: PH7247

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