ウルソデオキシコール酸の世界市場：2024年～2031年

レポート概要

世界のウルソデオキシコール酸市場は、2023年に5億8,117万米ドルに達し、2031年までには11億2,055万米ドルに達すると予測され、2024年から2031年の予測期間中にCAGR9.8%で成長する見込みです。

ウルソデオキシコール酸（UDCA）は、胆汁うっ滞性肝疾患の治療と管理に利用される治療薬です。UDCAは胆汁酸の一種で、肝臓・胆嚢疾患の治療を目的とした医薬品の有効成分（API）として重要な役割を果たしています。天然源から単離されるか、または研究室で合成されます。

UDCAは主に、肝臓で生成される消化液である胆汁の組成を変化させることで機能します。胆汁中のコレステロール濃度を低下させ、胆汁のコレステロール飽和度を下げます。胆汁中のコレステロール濃度が高いと胆石の形成につながるため、この作用は重要です。コレステロール胆石の溶解を促進することで、UDCAは非外科的治療の選択肢となり、特に年齢や併存疾患などの様々な健康上の懸念により手術の候補とならない患者にとって有用です。

市場力学：

促進要因

肝疾患の有病率の増加

世界のウルソデオキシコール酸市場の需要は、複数の要因によって牽引されています。主な要因の一つは、肝疾患の有病率の増加です。肝疾患、特に原発性胆汁性胆管炎（PBC）や非アルコール性脂肪性肝疾患（NAFLD）などの胆汁うっ滞性肝疾患の世界の負担は著しく増加しています。この増加の主な原因は、ライフスタイルの変化、肥満、高齢化であり、これらが総体的にウルソデオキシコール酸（UDCA）のような治療薬の需要増につながっています。

2023年2月のNCBI調査発表によると、非アルコール性脂肪性肝疾患（NAFLD）は世界的に最も流行している肝疾患の一つです。NAFLDの推定世界罹患率は、1,000人あたり約47例で、女性よりも男性の方が高いです。さらに、成人におけるNAFLDの推定世界有病率は32％で、男性の40％が罹患しているのに対し、女性は26％です。

さらに、この業界の主要企業の製品発売、研究開発活動などの政府の取り組み、臨床試験件数の増加が、この市場の成長を後押ししています。例えば、業界大手のBiofield Pharma Pvt Ltdは、1錠300mgのウルソデオキシコール酸を含有する新製品「URSOGET」を発売しました。錠剤はALU-ALUブリスターパック入りで、1パック10錠入り（10×10サイズ）です。

また、2023年6月、IpsenとGENFITは、主要なELATIVE第III相試験からの良好なトップラインデータを発表しました。この試験では、現在の標準治療であるウルソデオキシコール酸に効果不十分または不耐容の希少な胆汁性肝疾患である原発性胆汁性胆管炎患者の治療薬として、デュアルa,ホエエPPARアゴニストであるエラフィブラノールの有効性と安全性が評価されています。

抑制要因

UDCAに関連する副作用、代替治療オプションの利用可能性、規制上の課題、個人の認知度の低さなどの治療要因が、市場の阻害要因になると予想されます。

市場セグメンテーション

世界のウルソデオキシコール酸市場は、タイプ、形状、用途、流通チャネル、地域によって区分されます。

原発性胆汁性胆管炎（PBC）セグメントはウルソデオキシコール酸世界市場シェアの約48.6％を占める

予測期間中、原発性胆汁性胆管炎（PBC）セグメントが最大の市場シェアを占める見込み原発性胆汁性胆管炎（PBC）は、肝臓内の胆管が徐々に破壊されることを特徴とする長期にわたる自己免疫性肝疾患です。この疾患では、免疫系が誤って胆管に並ぶ細胞を標的とし、炎症と瘢痕化を引き起こします。この損傷によって胆管が徐々に狭窄・閉塞し、肝臓からの胆汁の正常な流れが妨げられます。

胆管が損傷して胆汁が肝臓に蓄積すると、さらに炎症が誘発され、肝臓組織がさらに傷つくことになります。この蓄積は時間の経過とともに肝硬変を引き起こす可能性があります。肝硬変は、健康な肝臓組織が瘢痕組織に置き換わり、肝臓の機能を著しく損なう深刻な状態です。

さらに、業界の主要企業がUDCA治療に一層注力し、臨床試験で良好な結果を得ていることが、このセグメントの市場成長を後押ししています。例えば、2023年8月、CymaBay Therapeutics, Inc.は、原発性胆汁性胆管炎（PBC）の治療薬としてセラデルパルを評価したENHANCE第3相国際共同試験の結果がHepatologyに掲載されたと発表しました。本試験は、第一選択治療、特にウルソデオキシコール酸（UDCA）に十分な反応を示さないPBC患者を対象に、選択的ペルオキシソーム増殖剤活性化受容体デルタ（PPARデルタ）作動薬であるセラデルパーの安全性と有効性を検討したものであり、意義深いものです。

市場地域別シェア

北米がウルソデオキシコール酸の世界市場シェアの約43.4%を占める

北米地域では、特に原発性胆汁性胆管炎（PBC）、原発性硬化性胆管炎（PSC）、非アルコール性脂肪性肝疾患（NAFLD）などの肝疾患の有病率の増加が、北米におけるウルソデオキシコール酸（UDCA）需要の重要な促進要因となっているため、予測期間中に最大の市場シェアを占めると予想されます。

さらに、この地域には主要企業が多数存在し、ヘルスケアのインフラが整備されており、研究開発活動が活発化していることも市場成長の原動力となっています。2022年10月のNCBI調査発表によると、米国では推定2,000万人から2,500万人が胆石、重大な健康合併症につながる可能性のある状態に罹患しています。胆石は、胆嚢にできる消化液の固まった沈着物で、多くの人が胆石を持っている可能性がありますが、すべての人が症状を経験したり、治療を必要としたりするわけではありません。しかし、症状を緩和し合併症を予防するために、年間70万件以上の胆嚢摘出術（胆嚢の外科的除去術）が行われています。

加えて、主要企業の製品上市と承認がこの市場成長の原動力となっています。例えば、2024年6月、Ipsenは、米国食品医薬品局（FDA）が原発性胆汁性胆管炎（PBC）治療薬Iqirvo（エラフィブラノール）の早期承認を付与したと発表しました。この承認は、UDCA治療で十分な効果が得られない成人患者に対して、ウルソデオキシコール酸（UDCA）と併用する2つの特定の状況でのイキルボの使用を認めるものです。UDCAに耐えられない患者に対する単独療法として使用されています。

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
    • 肝疾患の有病率の増加
  • 抑制要因
    • UDCAに伴う副作用
  • 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

第6章 タイプ別

• 合成ウルソデオキシコール酸（UDCA）
• 生物学的ウルソデオキシコール酸（UDCA）

第7章 形状別

• 錠剤
• カプセル剤
• 懸濁液

第8章 用途別

• 胆石症
• 原発性胆汁性胆管炎（PBC）
• 原発性硬化性胆管炎（PSC）
• 非アルコール性脂肪性肝疾患（NAFLD）
• その他の肝・胆道疾患

第9章 流通チャネル別

• 病院薬局
• 小売薬局
• オンライン薬局

第10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
  • スペイン
  • イタリア
  • 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
  • 韓国
  • その他アジア太平洋
• 中東・アフリカ

第11章 競合情勢

• 競合シナリオ
• 市場ポジショニング / シェア分析
• M&A分析

第12章 企業プロファイル

• Glenmark Pharmaceuticals Inc.
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• Biobrick Pharma
• Casca Remedies Pvt. Ltd.
• Wellona Pharma
• ADDII BIOTECH PRIVATE LIMITED.
• Curivo Healthcare
• Zoic Life Sciences
• Biofield Pharma Pvt Ltd
• Jabs Biotech Pvt. Ltd
• Captab（*LIST NOT EXHAUSTIVE）

第13章 付録

Report Overview

The Global Ursodeoxycholic Acid Market reached US$ 581.17 million in 2023 and is expected to reach US$ 1120.55 million by 2031 growing with a CAGR of 9.8% during the forecast period 2024-2031.

Ursodeoxycholic acid (UDCA) is a therapeutic agent utilized in the treatment and management of cholestatic liver diseases. It is a bile acid that plays a crucial role as an active pharmaceutical ingredient (API) in medications aimed at treating liver and gallbladder disorders. It is either isolated from natural sources or synthesized in laboratories.

UDCA functions primarily by modifying the composition of bile, which is a digestive fluid produced by the liver. It reduces the concentration of cholesterol in bile, thereby decreasing the saturation of bile with cholesterol. This action is significant because high cholesterol levels in bile can lead to the formation of gallstones. By promoting the dissolution of cholesterol gallstones, UDCA serves as a non-surgical treatment option, particularly for patients who are not candidates for surgery due to various health concerns, such as age or comorbidities.

Market Dynamics: Drivers

Increasing prevalence of liver diseases

The demand for the global ursodeoxycholic acid market is driven by multiple factors. One of the primary factors is the increasing prevalence of liver diseases. The global burden of liver diseases, particularly cholestatic liver disorders such as primary biliary cholangitis (PBC) and non-alcoholic fatty liver disease (NAFLD), is increasing significantly. This rise is largely attributed to lifestyle changes, obesity, and an aging population, which collectively contribute to a higher demand for therapeutic agents like ursodeoxycholic acid (UDCA).

As per NCBI research publication in February 2023, nonalcoholic fatty liver disease (NAFLD) is one of the most prevalent liver diseases globally. The estimated global incidence of NAFLD is approximately 47 cases per 1,000 individuals, with a higher occurrence in males than in females. Furthermore, the estimated global prevalence of NAFLD among adults stands at 32%, with 40% of men affected compared to 26% of women.

Moreover, key players in the industry product launches, government initiatives such as R&D activities, and a rising number of clinical trials are driving this market growth. For instance, one of the major players in the industry Biofield Pharma Pvt Ltd has launched a new product called 'URSOGET' containing 300 mg of ursodeoxycholic acid as a tablet. The tablets are packaged in ALU-ALU blister packs, with each pack containing 10 tablets (10 x 10 size).

Also, 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 a, δ 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.

Restraints

Factors such as adverse effects associated with the UDCA, availability of alternative treatment options, regulatory challenges, and limited awareness among individuals, are expected to hamper the market.

Market Segment Analysis

The global ursodeoxycholic acid market is segmented based on type, form, application, distribution channels, and region.

The primary biliary cholangitis (PBC) segment accounted for approximately 48.6% of the global ursodeoxycholic acid market share

The primary biliary cholangitis (PBC) segment is expected to hold the largest market share over the forecast period. Primary biliary cholangitis (PBC) is a long-lasting autoimmune liver disease marked by the gradual destruction of the bile ducts within the liver. In this condition, the immune system erroneously targets the cells that line the bile ducts, resulting in inflammation and scarring. This damage leads to the gradual narrowing and blockage of the bile ducts, which hampers the normal flow of bile from the liver.

As bile builds up in the liver due to these damaged ducts, it can trigger additional inflammation and further harm the liver tissue. Over time, this accumulation may result in cirrhosis, a serious condition where healthy liver tissue is replaced by scar tissue, severely impairing the liver's functionality.

Moreover, key players in the industry more focus on UDCA treatment, and getting positive results from the clinical trials are helping to propel this segment's growth in the market. For instance, in August 2023, CymaBay Therapeutics, Inc. announced that results from the ENHANCE phase 3 global study evaluating seladelpar for treating primary biliary cholangitis (PBC) have been published in the journal Hepatology. This study is significant as it investigates the safety and efficacy of seladelpar, a selective peroxisome proliferator-activated receptor delta (PPAR-delta) agonist, in patients with PBC who have not responded adequately to first-line treatments, particularly ursodeoxycholic acid (UDCA).

Market Geographical Share

North America accounted for approximately 43.4% of the global ursodeoxycholic acid market share

North America region is expected to hold the largest market share over the forecast period owing to the increasing prevalence of liver diseases, particularly primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and non-alcoholic fatty liver disease (NAFLD), is a significant driver for the demand for ursodeoxycholic acid (UDCA) in North America.

Moreover, in this region, a major number of key player's presence, well-advanced healthcare infrastructure, and growing R&D activities are driving this market growth. As per NCBI research publications in October 2022, in the United States, an estimated 20-25 million people are affected by gallstones, a condition that can lead to significant health complications. Gallstones are hardened deposits of digestive fluid that can form in the gallbladder, and while many individuals may have gallstones, not all will experience symptoms or require treatment. However, for those who do, over 700,000 cholecystectomies (surgical removal of the gallbladder) are performed annually to alleviate symptoms and prevent complications.

In addition, key player's product launches and approvals are driving this market growth. For instance, in June 2024, Ipsen announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo (elafibranor) for treating primary biliary cholangitis (PBC). This approval permits the use of Iqirvo in two specific situations in conjunction with ursodeoxycholic acid (UDCA) for adults who have not shown sufficient response to UDCA treatment. As a standalone therapy for patients who are unable to tolerate UDCA.

Market Segmentation

By Type

Synthetic Ursodeoxycholic Acid (UDCA)

Biological Ursodeoxycholic Acid (UDCA)

By Form

Tablets

Capsules

Suspension

By Application

Gallstones

Primary Biliary Cholangitis (PBC)

Primary Sclerosing Cholangitis (PSC)

Non-Alcoholic Fatty Liver Disease (NAFLD)

Other Liver and Biliary Diseases

By Distribution Channel

Hospital Pharmacies

Retail Pharmacies

Online Pharmacies

By Region

North America

U.S.

Canada

Mexico

Europe

Germany

U.K.

France

Spain

Italy

Rest of Europe

South America

Brazil

Argentina

The rest of South America

Asia-Pacific

China

India

Japan

South Korea

Rest of Asia-Pacific

Middle East and Africa

Market Competitive Landscape

The major global players in the ursodeoxycholic acid market include Glenmark Pharmaceuticals Inc., Biobrick Pharma, Casca Remedies Pvt. Ltd., Wellona Pharma, ADDII BIOTECH PRIVATE LIMITED., Curivo Healthcare, Zoic Life Sciences, Biofield Pharma Pvt Ltd, Jabs Biotech Pvt. Ltd, and Captee among others.

Key Developments

In August 2024, Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC). This approval allows Livdelzi to be used in combination with ursodeoxycholic acid (UDCA) for adults who have not responded adequately to UDCA and as a monotherapy for patients who are unable to tolerate UDCA.

Why Purchase the Report?

To visualize the global ursodeoxycholic acid market segmentation based on type, form, application, distribution channels, and region and understand key commercial assets and players.

Identify commercial opportunities by analyzing trends and co-development.

Excel data sheet with numerous data points of the ursodeoxycholic acid market with all segments.

PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.

Product mapping is available in Excel consisting of key products of all the major players.

The global ursodeoxycholic acid market report would provide approximately 70 tables, 63 figures, and 183 pages.

Target Audience 2024

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 Type
• 3.2. Snippet by Form
• 3.3. Snippet by Application
• 3.4. Snippet by Distribution Channels
• 3.5. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Increasing Prevalence of Liver Diseases
  • 4.1.2. Restraints
    • 4.1.2.1. Adverse Effects Associated with the UDCA
  • 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

6. By Type

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 6.1.2. Market Attractiveness Index, By Type
• 6.2. Synthetic Ursodeoxycholic Acid (UDCA)*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Biological Ursodeoxycholic Acid (UDCA)

7. By Form

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Form
  • 7.1.2. Market Attractiveness Index, By Form
• 7.2. Tablets *
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Capsules
• 7.4. Suspension

8. By Application

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 8.1.2. Market Attractiveness Index, By Application
• 8.2. Gallstones *
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Primary Biliary Cholangitis (PBC)
• 8.4. Primary Sclerosing Cholangitis (PSC)
• 8.5. Non-Alcoholic Fatty Liver Disease (NAFLD)
• 8.6. Other Liver and Biliary Diseases

9. By Distribution Channels

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels
  • 9.1.2. Market Attractiveness Index, By Distribution Channels
• 9.2. Hospital Pharmacies *
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Retail Pharmacies
• 9.4. Online Pharmacies

10. By Region

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 10.1.2. Market Attractiveness Index, By Region
• 10.2. North America
  • 10.2.1. Introduction
  • 10.2.2. Key Region-Specific Dynamics
  • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Form
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels
  • 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.2.7.1. U.S.
    • 10.2.7.2. Canada
    • 10.2.7.3. Mexico
• 10.3. Europe
  • 10.3.1. Introduction
  • 10.3.2. Key Region-Specific Dynamics
  • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Form
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels
  • 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.3.7.1. Germany
    • 10.3.7.2. U.K.
    • 10.3.7.3. France
    • 10.3.7.4. Spain
    • 10.3.7.5. Italy
    • 10.3.7.6. Rest of Europe
• 10.4. South America
  • 10.4.1. Introduction
  • 10.4.2. Key Region-Specific Dynamics
  • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Form
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels
  • 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.4.7.1. Brazil
    • 10.4.7.2. Argentina
    • 10.4.7.3. Rest of South America
• 10.5. Asia-Pacific
  • 10.5.1. Introduction
  • 10.5.2. Key Region-Specific Dynamics
  • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Form
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels
  • 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.5.7.1. China
    • 10.5.7.2. India
    • 10.5.7.3. Japan
    • 10.5.7.4. South Korea
    • 10.5.7.5. Rest of Asia-Pacific
• 10.6. Middle East and Africa
  • 10.6.1. Introduction
  • 10.6.2. Key Region-Specific Dynamics
  • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Form
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels

11. Competitive Landscape

• 11.1. Competitive Scenario
• 11.2. Market Positioning/Share Analysis
• 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

• 12.1. Glenmark Pharmaceuticals Inc.*
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. Biobrick Pharma
• 12.3. Casca Remedies Pvt. Ltd.
• 12.4. Wellona Pharma
• 12.5. ADDII BIOTECH PRIVATE LIMITED.
• 12.6. Curivo Healthcare
• 12.7. Zoic Life Sciences
• 12.8. Biofield Pharma Pvt Ltd
• 12.9. Jabs Biotech Pvt. Ltd
• 12.10. Captab (*LIST NOT EXHAUSTIVE)

13. Appendix

• 13.1. About Us and Services
• 13.2. Contact Us