查看购物车
  • Traditional Chinese
  • English
  • Japanese
封面
市场调查报告书
商品编码
1971342

乙肝和丁肝市场－全球产业规模、份额、趋势、机会、预测：按类型、诊断、地区和竞争格局划分，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个工作天内

价格

We offer 8 hour analyst time for an additional research. Please contact us for the details.

简介目录

全球丁型肝炎市场预计将从 2025 年的 20.1 亿美元成长到 2031 年的 27.3 亿美元，复合年增长率为 5.24%。

在这一领域，针对丁型肝炎病毒（HDV）的诊断检测套组和抗病毒药物的研发和市场推广工作正在进行中。丁型肝炎病毒是一种卫星病毒，其复製依赖于B型肝炎病毒。推动该领域发展的关键因素包括新型病毒进入抑制剂的监管核准，以及全球对治疗病毒性肝炎合併感染以延缓肝病进展日益增长的兴趣。正如世界肝炎联盟所指出的，到2025年，全球将有约1,200万Delta肝炎患者，这是亟需治疗方案的重要患者族群。这推动了对有效药物治疗的需求。

市场概览
预测期 2027-2031
市场规模：2025年 20.1亿美元
市场规模：2031年 27.3亿美元
复合年增长率：2026-2031年 5.24%
成长最快的细分市场 慢性的
最大的市场 北美洲

另一方面，在资源匮乏且疾病高发生率的地区，诊断手段有限和公众认知度低是市场扩张的重大障碍。 HDV RNA 检测是确诊的关键，但成本高昂且技术要求高，这往往阻碍了合格的患者的识别，并限制了已通过核准治疗方法的市场渗透率。这种诊断缺口是市场准入的主要障碍，导致绝大多数感染者仍未被诊断，也无法获得专业的医疗服务。

市场驱动因素

新型抗病毒疗法的核准和上市正在从根本上改变治疗格局，此前该格局严重依赖仿单标示外干扰素疗法，而这些疗法也成为全球HDV市场的主要驱动力。First-in-Class进入抑制剂的成功上市和健保覆盖证明了HDV特异性药物的盈利，并推动了领先製药公司的收入成长。这些标靶治疗在肝病产品组合中的强劲表现清晰地印证了这一成功。例如，吉利德科学公司在第一季财报中指出，其肝病产品组合的销售额成长了3%，达到7.58亿美元，主要得益于对慢性HDV和乙型肝炎产品需求的成长。

同时，强大的病毒进入抑制剂和免疫调节剂临床研发管线正在增强市场实力，带动后期投资和收购活动的增加。製药公司正积极收购单株抗体等前景广阔的资产的权益，这反映了该产业的长期信心。一个典型的例子是，Miram Pharmaceuticals于2025年12月以6.2亿美元的首付款收购了Blue Jay Therapeutics，获得了后期抗体药物brerovitag。儘管治疗方法方面取得了这些进展，但公众认知仍面临挑战。根据世界肝炎联盟于2025年5月发布的《全球Delta肝炎疫情调查报告》，68.4%的受访者表示，缺乏疾病相关知识是进行检测和治疗的主要障碍。

市场挑战

诊断手段的持续匮乏严重阻碍了全球丁型肝炎市场的发展，限制了可治疗的患者数量。製药业高度依赖复杂的RNA确诊检测来确认活动性性行为感染，但这些检测在感染率最高的地区要么无法获得，要么价格昂贵。这些技术和经济障碍使得医疗机构难以识别病例，导致疾病高发生率与实际药物需求之间存在巨大差距。由于这些诊断工具无法广泛普及，製药公司无法有效触及高需求市场，导致大量目标人口无法得到诊断和治疗。

这种诊断瓶颈从根本上阻碍了患者的识别，从而限制了潜在的市场规模。根据世界肝炎联盟（WHA）2024年报告，全球慢性B型肝炎患者的诊断率仅13%。由于丁型肝炎是一种重要的卫星病毒，需要以确诊乙型肝炎为基础才能进行检测，因此如此低的初次检出率从根本上限制了丁型肝炎领域的潜在增长。无法涵盖如此大规模的感染族群直接削弱了新型抗病毒疗法的商业性可行性，并限制了产生收入。

市场趋势

随着企业寻求降低研发风险并为后期研发专案建立商业性地位，策略性生物製药授权协议和收购的增加正在重塑市场格局。与已通过核准药物的内部成长不同，这一趋势涉及高价值的独家协议，尤其凸显了融合RNA干扰和单株抗体的联合治疗的潜力。此类合作对于进入区域市场和应对孤儿药复杂的监管环境至关重要。例如，根据Pharmabiz.com于2025年12月报道，Vir Biotechnology从Norgine公司获得了5500万欧元的首付款，以获得其正在研发的RNAi-抗体联合治疗在欧洲的独家权益。这凸显了市场对处于研发后期阶段的候选药物的高度重视。

此外，业界正朝着以患者为中心的口服疗法转型，新型抗病毒疗法不断涌现，旨在解决传统注射药物给药的难题。儘管目前的标准疗法依赖每日皮下注射，但业界正大力投资于口服小分子化合物（透过抑制牛磺胆酸钠共转运多肽(NTCP) 来阻断病毒入侵）。这项进展旨在提高患者的长期用药依从性，并扩大社区医疗机构的治疗覆盖范围。鑑于这些投资，Assembly Biosciences 在 2025 年 3 月发布的 2024 财年收益报告中指出，合作研究收入达到 2,850 万美元。这主要得益于其下一代口服抗病毒药物研发管线相关的里程碑付款。

目录

第一章概述

第二章：调查方法

第三章执行摘要

第四章：客户心声

第五章：全球乙型肝炎和丁型肝炎市场展望

  • 市场规模及预测
    • 按金额
  • 市占率及预测
    • 按类型（急性、慢性）
    • 诊断方法（血液检查、弹性影像、切片检查、血清学检查等）
    • 按地区
    • 按公司（2025 年）
  • 市场地图

第六章：北美乙型肝炎和丁型肝炎市场展望

  • 市场规模及预测
  • 市占率及预测
  • 北美洲：国别分析
    • 我们
    • 加拿大
    • 墨西哥

第七章：欧洲乙型肝炎和丁型肝炎市场展望

  • 市场规模及预测
  • 市占率及预测
  • 欧洲：国别分析
    • 德国
    • 法国
    • 英国
    • 义大利
    • 西班牙

第八章：亚太地区乙型肝炎与丁型肝炎市场展望

  • 市场规模及预测
  • 市占率及预测
  • 亚太地区：国别分析
    • 中国
    • 印度
    • 日本
    • 韩国
    • 澳洲

第九章：中东和非洲乙型肝炎和丁型肝炎市场展望

  • 市场规模及预测
  • 市占率及预测
  • 中东与非洲：国别分析
    • 沙乌地阿拉伯
    • 阿拉伯聯合大公国
    • 南非

第十章：南美洲B型肝炎和丁型肝炎市场展望

  • 市场规模及预测
  • 市占率及预测
  • 南美洲：国别分析
    • 巴西
    • 哥伦比亚
    • 阿根廷

第十一章 市场动态

  • 促进因素
  • 任务

第十二章 市场趋势与发展

  • 併购
  • 产品发布
  • 近期趋势

第十三章：全球B型肝炎与丁型肝炎市场：SWOT分析

第十四章：波特五力分析

  • 产业竞争
  • 新进入者的潜力
  • 供应商的议价能力
  • 顾客权力
  • 替代品的威胁

第十五章 竞争格局

  • 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

第十六章 策略建议

第十七章：关于研究公司及免责声明

简介目录
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