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市場調查報告書
商品編碼
1971342

乙肝和丁肝市場－全球產業規模、佔有率、趨勢、機會、預測：按類型、診斷、地區和競爭格局分類，2021-2031年

Hepatitis D Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Acute, Chronic), By Diagnosis (Blood Tests, Elastography, Liver Biopsy, Serologic Testing, Others), By Region & Competition, 2021-2031F
出版日期: | 出版商: TechSci Research | 英文 180 Pages | 商品交期: 2-3個工作天內

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簡介目錄

全球丁型肝炎市場預計將從 2025 年的 20.1 億美元成長到 2031 年的 27.3 億美元，複合年成長率為 5.24%。

在這一領域，針對丁型肝炎病毒（HDV）的診斷檢測套組和抗病毒藥物的研發和市場推廣工作正在進行中。丁型肝炎病毒是一種衛星病毒，其複製依賴於B型肝炎病毒。推動該領域發展的關鍵因素包括新型病毒進入抑制劑的監管核准，以及全球對治療病毒性肝炎合併感染以延緩肝病進展日益成長的興趣。正如世界肝炎聯盟所指出的，到2025年，全球將有約1,200萬Delta肝炎患者，這是亟需治療方案的重要患者族群。這推動了對有效藥物治療的需求。

市場概覽
預測期 2027-2031
市場規模：2025年 20.1億美元
市場規模：2031年 27.3億美元
複合年成長率：2026-2031年 5.24%
成長最快的細分市場 慢性的
最大的市場 北美洲

另一方面，在資源匱乏且疾病高發生率的地區，診斷手段有限和公眾認知度低是市場擴張的重大障礙。 HDV RNA 檢測是確診的關鍵，但成本高昂且技術要求高，這往往阻礙了合格的患者的識別，並限制了已通過核准治療方法的市場滲透率。這種診斷缺口是市場准入的主要障礙，導致絕大多數感染者仍未被診斷，也無法獲得專業的醫療服務。

市場促進因素

新型抗病毒療法的核准和上市正在從根本上改變治療格局，此前該格局嚴重依賴仿單標示外干擾素療法，而這些療法也成為全球HDV市場的主要驅動力。First-in-Class進入抑制劑的成功上市和健保覆蓋證明了HDV特異性藥物的盈利，並推動了領先製藥公司的收入成長。這些標靶治療在肝病產品組合中的強勁表現清晰地印證了這一成功。例如，吉利德科學公司在第一季財報中指出，其肝病產品組合的銷售額成長了3%，達到7.58億美元，主要得益於對慢性HDV和乙型肝炎產品需求的成長。

同時，強大的病毒進入抑制劑和免疫調節劑臨床研發管線正在增強市場實力，帶動後期投資和收購活動的增加。製藥公司正積極收購單株抗體等前景廣闊的資產的權益，這反映了該產業的長期信心。一個典型的例子是，Miram Pharmaceuticals於2025年12月以6.2億美元的首付款收購了Blue Jay Therapeutics，獲得了後期抗體藥物brerovitag。儘管治療方法方面取得了這些進展，但公眾認知仍面臨挑戰。根據世界肝炎聯盟於2025年5月發布的《全球Delta肝炎疫情調查報告》，68.4%的受訪者表示，缺乏疾病相關知識是進行檢測和治療的主要障礙。

市場挑戰

診斷手段的持續匱乏嚴重阻礙了全球丁型肝炎市場的發展，限制了可治療的患者數量。製藥業高度依賴複雜的RNA確診檢測來確認活動性性行為感染，但這些檢測在感染率最高的地區要么無法獲得，要么價格昂貴。這些技術和經濟障礙使得醫療機構難以識別病例，導致疾病高發生率與實際藥物需求之間存在巨大差距。由於這些診斷工具無法廣泛普及，製藥公司無法有效觸及高需求市場，導致大量目標人口無法得到診斷和治療。

這種診斷瓶頸從根本上阻礙了患者的識別，從而限制了潛在的市場規模。根據世界肝炎聯盟（WHA）2024年報告，全球慢性B型肝炎患者的診斷率僅13%。由於丁型肝炎是一種重要的衛星病毒，需要以確診乙型肝炎為基礎才能進行檢測，因此如此低的初次檢出率從根本上限制了丁型肝炎領域的潛在成長。無法涵蓋如此大規模的感染族群直接削弱了新型抗病毒療法的商業性可行性，並限制了產生收入。

市場趨勢

隨著企業尋求降低研發風險並為後期研發專案建立商業性地位，策略性生物製藥授權協議和收購的增加正在重塑市場格局。與已通過核准藥物的內部成長不同，這一趨勢涉及高價值的獨家協議，尤其凸顯了融合RNA干擾和單株抗體的聯合治療的潛力。此類合作對於進入區域市場和應對孤兒藥複雜的監管環境至關重要。例如，根據Pharmabiz.com於2025年12月報道，Vir Biotechnology從Norgine公司獲得了5500萬歐元的首付款，以獲得其正在研發的RNAi-抗體聯合治療在歐洲的獨家權益。這凸顯了市場對處於研發後期階段的候選藥物的高度重視。

此外，業界正朝著以患者為中心的口服療法轉型，新型抗病毒療法不斷湧現，旨在解決傳統注射藥物給藥的難題。儘管目前的標準療法依賴每日皮下注射，但業界正大力投資於口服小分子化合物（透過抑制牛磺膽酸鈉共轉運多肽(NTCP) 來阻斷病毒入侵）。這項進展旨在提高患者的長期用藥依從性，並擴大社區醫療機構的治療覆蓋範圍。鑑於這些投資，Assembly Biosciences 在 2025 年 3 月發布的 2024 會計年度收益報告中指出，合作研究收入達到 2,850 萬美元。這主要得益於其下一代口服抗病毒藥物研發管線相關的里程碑付款。

目錄

第1章概述

第2章：調查方法

第3章執行摘要

第4章：客戶心聲

第5章：全球乙型肝炎和丁型肝炎市場展望

  • 市場規模及預測
    • 按金額
  • 市佔率及預測
    • 按類型（急性、慢性）
    • 診斷方法（血液檢查、彈性影像、切片檢查、血清學檢查等）
    • 按地區
    • 按公司（2025 年）
  • 市場地圖

第6章：北美乙型肝炎和丁型肝炎市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 北美洲：國別分析
    • 美國
    • 加拿大
    • 墨西哥

第7章：歐洲乙型肝炎和丁型肝炎市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 歐洲：國別分析
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙

第8章：亞太地區乙型肝炎與丁型肝炎市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 亞太地區：國別分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲

第9章：中東和非洲乙型肝炎和丁型肝炎市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 中東與非洲：國別分析
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非

第10章：南美洲B型肝炎和丁型肝炎市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 南美洲：國別分析
    • 巴西
    • 哥倫比亞
    • 阿根廷

第11章 市場動態

  • 促進因素
  • 任務

第12章 市場趨勢與發展

  • 併購
  • 產品發布
  • 近期趨勢

第13章：全球B型肝炎與丁型肝炎市場：SWOT分析

第14章：波特五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的議價能力
  • 顧客權力
  • 替代品的威脅

第15章 競爭格局

  • F. Hoffmann-La Roche Ltd
  • NanoGen Healthcare Pvt. Ltd.
  • PROBIOMED SA de CV
  • 3SBio Group
  • Hepion Pharmaceuticals, Inc.
  • Antios Therapeutics, Inc.
  • PharmaEssentia Corporation
  • Replicor
  • Apotex Corp.
  • Mylan NV
  • Aurobindo Pharma Limited

第16章 策略建議

第17章：關於研究公司及免責聲明

簡介目錄
Product Code: 23933

The Global Hepatitis D Market is projected to expand from USD 2.01 Billion in 2025 to USD 2.73 Billion by 2031, reflecting a compound annual growth rate of 5.24%. This sector involves the creation and sale of diagnostic assays and antiviral drugs specifically for managing Hepatitis D Virus (HDV), a satellite virus that depends on Hepatitis B for replication. Growth is primarily driven by the regulatory clearance of new entry inhibitors and an increased global emphasis on treating viral hepatitis co-infections to mitigate liver disease progression. As noted by the World Hepatitis Alliance, approximately 12 million individuals worldwide were living with hepatitis delta in 2025, constituting a significant patient base that urgently requires therapeutic solutions and fuels the demand for effective pharmaceutical treatments.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 2.01 Billion
Market Size 2031USD 2.73 Billion
CAGR 2026-20315.24%
Fastest Growing SegmentChronic
Largest MarketNorth America

Conversely, market expansion faces a substantial hurdle due to limited diagnostic accessibility and low awareness, especially in resource-constrained regions where the disease is most common. The expense and technical demands of confirmatory HDV RNA testing frequently hinder the identification of eligible patients, thereby restricting the market reach of approved therapies. This gap in diagnostics creates a formidable obstacle to market penetration, leaving a vast majority of the infected population undiagnosed and without access to specialized medical care.

Market Driver

The authorization and launch of novel antiviral therapies act as the primary engine for the Global Hepatitis D Market, fundamentally transforming a treatment landscape that previously relied on off-label interferon protocols. The successful introduction and reimbursement of first-in-class entry inhibitors have proven the profitability of HDV-specific medications, boosting revenue for major pharmaceutical players. This success is highlighted by the strong performance of liver disease portfolios featuring these targeted treatments; for instance, Gilead Sciences reported in its First Quarter 2025 Financial Results that liver disease portfolio sales rose by 3% to $758 million, largely attributed to heightened demand for chronic hepatitis delta virus (HDV) and hepatitis B products.

Simultaneously, the market is strengthened by a solid clinical pipeline of entry inhibitors and immunomodulators, attracting significant late-stage investment and acquisition deals. Pharmaceutical firms are actively acquiring rights to promising assets, such as monoclonal antibodies, signaling long-term industry confidence. A prime example occurred in December 2025, when Mirum Pharmaceuticals announced its acquisition of Bluejay Therapeutics for an upfront payment of $620 million to obtain the late-stage antibody brelovitug. Despite these therapeutic strides, educational hurdles remain; the World Hepatitis Alliance's May 2025 'Hepatitis Delta Global Landscape Survey Report' indicated that 68.4% of community respondents cited a lack of general disease knowledge as the primary barrier to accessing testing and treatment.

Market Challenge

A persistent shortage of diagnostic accessibility severely impedes the Global Hepatitis D Market by limiting the number of identified patients eligible for therapy. The industry depends heavily on complex confirmatory RNA tests to verify active infections, yet these tools are often inaccessible or cost-prohibitive in areas with the highest infection rates. These technical and financial obstacles prevent healthcare providers from confirming cases, effectively disconnecting high disease prevalence from actual pharmaceutical demand. Without broad access to these diagnostics, pharmaceutical companies are unable to effectively reach high-need markets, leaving the majority of the target demographic undiagnosed and untreated.

This diagnostic bottleneck restricts the total addressable market by stalling patient identification at the fundamental level. As reported by the World Hepatitis Alliance in 2024, only 13% of individuals with chronic Hepatitis B were diagnosed globally. Because Hepatitis D is an obligate satellite virus that requires a confirmed Hepatitis B diagnosis for identification, this low primary detection rate inherently limits the potential growth of the Hepatitis D sector. The failure to capture this large segment of the infected population directly compromises the commercial viability of new antiviral therapies and constrains revenue generation.

Market Trends

The increase in strategic biopharmaceutical licensing and acquisitions is restructuring the market as companies aim to reduce development risks and establish commercial presence for late-stage assets. Distinct from the organic growth of approved drugs, this trend involves high-value exclusive deals that confirm the potential of combination therapies, especially those merging RNA interference with monoclonal antibodies. Such collaboration is crucial for accessing regional markets and managing the intricate regulations of orphan drug indications. For example, Pharmabiz.com reported in December 2025 that Vir Biotechnology received an initial EUR 55 million payment from Norgine for exclusive European rights to its investigational RNAi and antibody combination, highlighting the significant value placed on advanced pipeline candidates.

The sector is also shifting toward patient-centric oral interventions through the emergence of novel viral entry inhibitor therapies, addressing the administration challenges of earlier injectable treatments. While current standards depend on daily subcutaneous injections, the industry is heavily investing in orally bioavailable small molecules that block viral entry via the sodium taurocholate cotransporting polypeptide (NTCP). This evolution seeks to improve long-term adherence and widen treatment availability in community settings. Reflecting this investment, Assembly Biosciences reported in its 'Year End 2024 Financial Results' in March 2025 that collaborative revenues reached $28.5 million, driven largely by milestone payments for its next-generation oral antiviral pipeline.

Key Market Players

  • F. Hoffmann-La Roche Ltd
  • NanoGen Healthcare Pvt. Ltd.
  • PROBIOMED SA de CV
  • 3SBio Group
  • Hepion Pharmaceuticals, Inc.
  • Antios Therapeutics, Inc.
  • PharmaEssentia Corporation
  • Replicor
  • Apotex Corp.
  • Mylan N.V
  • Aurobindo Pharma Limited

Report Scope

In this report, the Global Hepatitis D Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Hepatitis D Market, By Type

  • Acute
  • Chronic

Hepatitis D Market, By Diagnosis

  • Blood Tests
  • Elastography
  • Liver Biopsy
  • Serologic Testing
  • Others

Hepatitis D Market, By Region

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • United Kingdom
    • Italy
    • Germany
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Hepatitis D Market.

Available Customizations:

Global Hepatitis D Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Hepatitis D Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Type (Acute, Chronic)
    • 5.2.2. By Diagnosis (Blood Tests, Elastography, Liver Biopsy, Serologic Testing, Others)
    • 5.2.3. By Region
    • 5.2.4. By Company (2025)
  • 5.3. Market Map

6. North America Hepatitis D Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Type
    • 6.2.2. By Diagnosis
    • 6.2.3. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Hepatitis D Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Type
        • 6.3.1.2.2. By Diagnosis
    • 6.3.2. Canada Hepatitis D Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Type
        • 6.3.2.2.2. By Diagnosis
    • 6.3.3. Mexico Hepatitis D Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Type
        • 6.3.3.2.2. By Diagnosis

7. Europe Hepatitis D Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Type
    • 7.2.2. By Diagnosis
    • 7.2.3. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Hepatitis D Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Type
        • 7.3.1.2.2. By Diagnosis
    • 7.3.2. France Hepatitis D Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Type
        • 7.3.2.2.2. By Diagnosis
    • 7.3.3. United Kingdom Hepatitis D Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Type
        • 7.3.3.2.2. By Diagnosis
    • 7.3.4. Italy Hepatitis D Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Type
        • 7.3.4.2.2. By Diagnosis
    • 7.3.5. Spain Hepatitis D Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Type
        • 7.3.5.2.2. By Diagnosis

8. Asia Pacific Hepatitis D Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Type
    • 8.2.2. By Diagnosis
    • 8.2.3. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China Hepatitis D Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Type
        • 8.3.1.2.2. By Diagnosis
    • 8.3.2. India Hepatitis D Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Type
        • 8.3.2.2.2. By Diagnosis
    • 8.3.3. Japan Hepatitis D Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Type
        • 8.3.3.2.2. By Diagnosis
    • 8.3.4. South Korea Hepatitis D Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Type
        • 8.3.4.2.2. By Diagnosis
    • 8.3.5. Australia Hepatitis D Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Type
        • 8.3.5.2.2. By Diagnosis

9. Middle East & Africa Hepatitis D Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Type
    • 9.2.2. By Diagnosis
    • 9.2.3. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia Hepatitis D Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Type
        • 9.3.1.2.2. By Diagnosis
    • 9.3.2. UAE Hepatitis D Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Type
        • 9.3.2.2.2. By Diagnosis
    • 9.3.3. South Africa Hepatitis D Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Type
        • 9.3.3.2.2. By Diagnosis

10. South America Hepatitis D Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Type
    • 10.2.2. By Diagnosis
    • 10.2.3. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil Hepatitis D Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Type
        • 10.3.1.2.2. By Diagnosis
    • 10.3.2. Colombia Hepatitis D Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Type
        • 10.3.2.2.2. By Diagnosis
    • 10.3.3. Argentina Hepatitis D Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Type
        • 10.3.3.2.2. By Diagnosis

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Merger & Acquisition (If Any)
  • 12.2. Product Launches (If Any)
  • 12.3. Recent Developments

13. Global Hepatitis D Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. F. Hoffmann-La Roche Ltd
    • 15.1.1. Business Overview
    • 15.1.2. Products & Services
    • 15.1.3. Recent Developments
    • 15.1.4. Key Personnel
    • 15.1.5. SWOT Analysis
  • 15.2. NanoGen Healthcare Pvt. Ltd.
  • 15.3. PROBIOMED SA de CV
  • 15.4. 3SBio Group
  • 15.5. Hepion Pharmaceuticals, Inc.
  • 15.6. Antios Therapeutics, Inc.
  • 15.7. PharmaEssentia Corporation
  • 15.8. Replicor
  • 15.9. Apotex Corp.
  • 15.10. Mylan N.V
  • 15.11. Aurobindo Pharma Limited

16. Strategic Recommendations

17. About Us & Disclaimer