1. 方法論と範囲
1.1. 調査方法
1.2. 調査目的と調査範囲
2. 定義と概要
3. エグゼクティブ・サマリー
3.1. タイプ別スニペット
3.2. 形態別スニペット
3.3. 用途別スニペット
3.4. 販売チャネル別スニペット
3.5. 地域別スニペット
4. ダイナミクス
4.1. 影響要因
4.1.1. 推進要因
4.1.1.1. 肝疾患の有病率の増加
4.1.2. 阻害要因
4.1.2.1. UDCAに関連する副作用
4.1.3. 機会
4.1.4. 影響分析
5. 産業分析
5.1. ポーターのファイブフォース分析
5.2. サプライチェーン分析
5.3. 価格分析
5.4. 規制分析
6. タイプ別
6.1. はじめに
6.1.1. 市場規模分析および前年比成長率分析(%), タイプ別
6.1.2. 市場魅力度指数(タイプ別
6.2. 合成ウルソデオキシコール酸(UDCA)*市場
6.2.1. 序論
6.2.2. 市場規模分析と前年比成長率分析(%)
6.3. 生物学的ウルソデオキシコール酸(UDCA)
7. 形態別
7.1. はじめに
7.1.1. 市場規模分析および前年比成長率分析(%), 形態別
7.1.2. 市場魅力度指数(形態別
7.2. 錠剤
7.2.1. はじめに
7.2.2. 市場規模分析と前年比成長率分析(%)
7.3. カプセル
7.4. 懸濁液
8. 用途別
8.1. 導入
8.1.1. 用途別市場規模分析および前年比成長率分析(%)
8.1.2. 市場魅力度指数、用途別
8.2. 胆石
8.2.1. 序論
8.2.2. 市場規模分析と前年比成長率分析(%)
8.3. 原発性胆汁性胆管炎(PBC)
8.4. 原発性硬化性胆管炎(PSC)
8.5. 非アルコール性脂肪性肝疾患(NAFLD)
8.6. その他の肝疾患および胆道疾患
9. 流通チャネル別
9.1. はじめに
9.1.1. 市場規模分析および前年比成長率分析(%), 流通チャネル別
9.1.2. 市場魅力度指数(流通チャネル別
9.2. 病院薬局
9.2.1. はじめに
9.2.2. 市場規模分析と前年比成長率分析(%)
9.3. 小売薬局
9.4. オンライン薬局
10. 地域別
10.1. はじめに
10.1.1. 地域別市場規模分析および前年比成長率分析(%)
10.1.2. 市場魅力度指数、地域別
10.2. 北米
10.2.1. 序論
10.2.2. 主な地域別ダイナミクス
10.2.3. 市場規模分析および前年比成長率分析(%), タイプ別
10.2.4. 市場規模分析および前年比成長率分析(%), 形状別
10.2.5. 市場規模分析および前年比成長率分析(%), 用途別
10.2.6. 市場規模分析および前年比成長率分析(%), 流通チャネル別
10.2.7. 市場規模分析および前年比成長率分析(%), 国別
10.2.7.1. 米国
10.2.7.2. カナダ
10.2.7.3. メキシコ
10.3. ヨーロッパ
10.3.1. はじめに
10.3.2. 主な地域別ダイナミクス
10.3.3. 市場規模分析および前年比成長率分析(%), タイプ別
10.3.4. 市場規模分析および前年比成長率分析 (%)、形状別
10.3.5. 市場規模分析および前年比成長率分析(%), 用途別
10.3.6. 市場規模分析および前年比成長率分析(%), 流通チャネル別
10.3.7. 市場規模分析および前年比成長率分析(%), 国別
10.3.7.1. ドイツ
10.3.7.2. イギリス
10.3.7.3. フランス
10.3.7.4. スペイン
10.3.7.5. イタリア
10.3.7.6. その他のヨーロッパ
10.4. 南米
10.4.1. はじめに
10.4.2. 地域別主要市場
10.4.3. 市場規模分析および前年比成長率分析(%), タイプ別
10.4.4. 市場規模分析および前年比成長率分析 (%)、形状別
10.4.5. 市場規模分析および前年比成長率分析(%), 用途別
10.4.6. 市場規模分析および前年比成長率分析(%), 流通チャネル別
10.4.7. 市場規模分析および前年比成長率分析(%), 国別
10.4.7.1. ブラジル
10.4.7.2. アルゼンチン
10.4.7.3. その他の南米諸国
10.5. アジア太平洋
10.5.1. 序論
10.5.2. 主な地域別ダイナミクス
10.5.3. 市場規模分析および前年比成長率分析(%), タイプ別
10.5.4. 市場規模分析および前年比成長率分析(%), 形状別
10.5.5. 市場規模分析および前年比成長率分析(%), 用途別
10.5.6. 市場規模分析および前年比成長率分析(%), 流通チャネル別
10.5.7. 市場規模分析および前年比成長率分析(%), 国別
10.5.7.1. 中国
10.5.7.2. インド
10.5.7.3. 日本
10.5.7.4. 韓国
10.5.7.5. その他のアジア太平洋地域
10.6. 中東・アフリカ
10.6.1. 序論
10.6.2. 主な地域別ダイナミクス
10.6.3. 市場規模分析および前年比成長率分析(%), タイプ別
10.6.4. 市場規模分析および前年比成長率分析 (%)、形状別
10.6.5. 市場規模分析および前年比成長率分析(%), 用途別
10.6.6. 市場規模分析および前年比成長率分析(%):流通チャネル別
11. 競争環境
11.1. 競争シナリオ
11.2. 市場ポジショニング/シェア分析
11.3. M&A分析
12. 企業プロフィール
12.1. Glenmark Pharmaceuticals Inc.*
12.1.1. 会社概要
12.1.2. 製品ポートフォリオと内容
12.1.3. 財務概要
12.1.4. 主な展開
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 (*リストは除外)
13. 付録
13.1. 会社概要とサービス
13.2. お問い合わせ
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 α, 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
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
❖ 世界のウルソデオキシコール酸市場に関するよくある質問(FAQ) ❖
・ウルソデオキシコール酸の世界市場規模は?
→DataM Intelligence社は2023年のウルソデオキシコール酸の世界市場規模を5億8,117万米ドルと推定しています。
・ウルソデオキシコール酸の世界市場予測は?
→DataM Intelligence社は2031年のウルソデオキシコール酸の世界市場規模を1億1,055万米ドルと予測しています。
・ウルソデオキシコール酸市場の成長率は?
→DataM Intelligence社はウルソデオキシコール酸の世界市場が2024年~2031年に年平均9.8%成長すると予測しています。
・世界のウルソデオキシコール酸市場における主要企業は?
→DataM Intelligence社は「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.、Capteeなど ...」をグローバルウルソデオキシコール酸市場の主要企業として認識しています。
※上記FAQの市場規模、市場予測、成長率、主要企業に関する情報は本レポートの概要を作成した時点での情報であり、納品レポートの情報と少し異なる場合があります。