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市场调查报告书
商品编码
1884038
乙型肝炎治疗市场规模、占有率、成长及全球产业分析:依类型、应用和地区划分的洞察与预测(2024-2032)Hepatitis B Therapeutics Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2024-2032 |
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由于乙型肝炎病毒 (HBV) 感染率的上升以及抗病毒治疗的广泛应用,全球乙型肝炎治疗市场正经历显着增长。 2024 年,该市场规模为 23.3 亿美元,预计到 2025 年将达到 24.8 亿美元。预计到 2032 年,该市场将进一步显着成长至 62.5 亿美元,呈现强劲的上升趋势。北美在 2024 年占市场主导地位,占全球市场占有率的 53.65%,这主要得益于其先进的医疗保健基础设施、较高的治疗普及率以及在乙型肝炎治疗领域强大的研发投入。
市场推动因素
市场成长的主要推动因素是乙型肝炎在全球范围内的日益流行。乙型肝炎是由乙型肝炎病毒 (HBV) 引起的一种严重肝臟感染。其传染途径包括血液、体液、性接触、母婴传染。根据世界卫生组织 (WHO,2024 年 4 月) 的数据,截至 2022 年,全球约有 2.54 亿人(约占世界人口的 3.3%)感染乙型肝炎,而慢性乙型肝炎患者中仅有 2.6% 接受治疗。如此庞大的患者群体凸显了有效治疗的必要性,从而推动了已开发市场和新兴市场的需求。
政府主导的各项举措,例如中国于2025年1月启动的 "支持中国到2030年消除病毒性肝炎对公众健康的威胁" 计划,正在进一步提高公众意识、改善诊断率并促进治疗。同样,吉利德科学公司和葛兰素史克公司等大型製药公司的策略活动,也透过先进的研发和新疗法的开发,支持市场扩张。
市场限制因子
慢性B型肝炎患者抗药性的出现是一项重大挑战。长期抗病毒治疗,尤其是使用核苷/核苷酸类似物时,会导致病毒突变。研究表明,约30%的患者在一年内会产生拉米夫定抗药性的乙肝病毒株,五年后,20-29%的患者会出现阿德福韦酯抗药性。这可能导致治疗效果降低、病毒量增加,并进展为严重的肝病,从而限制市场成长。
市场机会
在研产品和联合疗法提供了巨大的机会。各公司正在开发针对病毒 cccDNA 的新型疗法,并将联合疗法整合以克服抗药性并实现更好的病毒抑制。例如,智蒙生物製药于 2022 年 8 月启动了 ZM-H1505R 与恩替卡韦联合用药的 IIa 期临床试验,这表明人们对创新疗法的兴趣日益浓厚。
市场挑战
B型肝炎的诊断、长期治疗和管理成本高昂仍然是一个重大障碍,尤其是在中低收入国家。每日口服药物和长期坚持治疗的需求也带来了挑战,影响患者的依从性并导致抗药性的产生。
市场趋势
值得关注的趋势包括针对乙型肝炎病毒 (HBV) cccDNA 的新一代疗法的出现,展现了治癒性治疗的潜力。例如,Precision Biosciences 公司公布了 ELIMINATE-B 试验的中期结果,该试验评估了 PBGENE-HBV 基因编辑疗法,旨在根除 HBeAg 阴性慢性乙型肝炎患者的 cccDNA,这表明治疗正朝着治癒性方向发展。
依药物类别划分,核苷类似物因其广泛的处方历史和高效性,在 2024 年占市场主导地位。在沙乌地阿拉伯和阿联酋,恩替卡韦锭的处方量占所有病例的 73%。核苷类似物和干扰素也贡献显着,预计新型疗法将推动市场成长。
依年龄组划分,成人市场占主导地位,这主要归因于较高的感染率,尤其是透过性接触传播的感染率。儿科治疗正因疫苗接种计划和适应症的增加而逐渐扩展。
依给药途径划分,口服治疗因其便利性和患者依从性,在2024年仍将占市场主导地位。同时,注射剂型因其高生物利用度和疗效而备受关注。
北美市场预计将在2024年以12.5亿美元的规模引领市场,主要得益于高盛行率、先进的治疗手段以及公共卫生计画。美国占最大占有率,这得益于其报销政策和强大的研发实力。亚太地区是成长最快的地区,这主要得益于价格合理的仿製药、不断上升的盛行率以及政府的宣传活动。欧洲市场正经历稳定成长,而拉丁美洲和中东及非洲地区则作为新兴市场,其成长动力主要来自于提高公众意识和扩大治疗可近性的努力。
The global hepatitis B therapeutics market is witnessing substantial growth due to the rising prevalence of hepatitis B virus (HBV) infections and increased adoption of antiviral treatments. The market was valued at USD 2.33 billion in 2024, projected to reach USD 2.48 billion in 2025, and expected to grow significantly to USD 6.25 billion by 2032, reflecting a strong upward trend. North America dominated the market in 2024, accounting for 53.65% of the global share, owing to advanced healthcare infrastructure, high treatment adoption, and robust R&D investments in HBV therapies.
Market Drivers
The primary driver of market growth is the increasing global prevalence of hepatitis B, a severe liver infection caused by HBV. Transmission occurs via blood, body fluids, sexual contact, and from mother to child during birth. According to the World Health Organization (WHO, April 2024), approximately 254 million people worldwide-around 3.3% of the global population-were infected with hepatitis B in 2022, while only 2.6% of chronic HBV patients received treatment. This high patient population necessitates effective therapeutics, driving demand in both developed and emerging markets.
Government initiatives, such as China's "Supporting China's Action to Eliminate the Public Health Threat of Viral Hepatitis by 2030" program launched in January 2025, are further increasing awareness, improving diagnosis rates, and promoting therapeutic adoption. Similarly, strategic activities by key pharmaceutical players like Gilead Sciences, Inc. and GSK plc support market expansion through advanced R&D and novel treatment development.
Market Restraints
A significant challenge is the emergence of drug resistance in chronic hepatitis B patients. Long-term antiviral therapy can lead to mutations in the virus, particularly with nucleoside and nucleotide analogs. Studies indicate that around 30% of patients develop lamivudine-resistant HBV strains within a year, while resistance to adefovir dipivoxil appears in 20-29% of patients after five years. This reduces treatment efficacy, potentially leading to increased viral loads and progression to severe liver disease, thereby restraining market growth.
Market Opportunities
Emerging pipeline products and combination therapies offer significant opportunities. Companies are developing novel therapeutics targeting viral cccDNA and integrating combination treatments to overcome resistance and achieve better viral suppression. For example, Zhimeng Biopharma initiated a Phase IIa clinical trial in August 2022 for ZM-H1505R in combination with Entecavir, demonstrating the growing focus on innovative therapies.
Market Challenges
High treatment costs for diagnosis, long-term therapy, and management of hepatitis B remain a major barrier, particularly in low- and middle-income countries. Daily oral regimens and long-term adherence requirements also pose challenges, impacting patient compliance and contributing to the development of resistance.
Market Trends
A notable trend is the emergence of next-generation therapies targeting HBV cccDNA, offering potential curative options. For instance, Precision BioSciences, Inc. reported interim results from its ELIMINATE-B trial, evaluating PBGENE-HBV, a gene-editing therapy aimed at eradicating cccDNA in HBeAg-negative chronic HBV patients, signaling a shift toward curative treatments.
By drug class, nucleoside analogues dominated in 2024 due to widespread prescriptions and high efficacy, with entecavir tablets prescribed in 73% of cases in Saudi Arabia and UAE. Nucleotide analogues and interferons also contribute significantly, while novel therapies are expected to boost growth.
By age group, adults dominate the market due to higher transmission rates, especially through sexual contact. Pediatric therapeutics are expanding gradually due to vaccination programs and supplemental indications.
By route of administration, oral therapeutics led the market in 2024, favored for convenience and patient compliance, while parenteral forms are gaining traction due to better bioavailability and efficacy.
North America led in 2024 with USD 1.25 billion, driven by high prevalence, advanced treatment access, and public health programs. The U.S. accounts for the largest share, supported by reimbursement policies and strong R&D. Asia Pacific is the fastest-growing region, propelled by affordable generic drugs, increasing prevalence, and government campaigns. Europe is growing steadily, and Latin America and the Middle East & Africa are emerging markets with expanding awareness and access initiatives.
Competitive Landscape
Key players include Gilead Sciences, Inc., Bristol-Myers Squibb Company, GSK plc, Excision BioTherapeutics, Arbutus Biopharma, Assembly Biosciences, and Aligos Therapeutics. Companies are focusing on R&D, strategic collaborations, and novel drug development to expand market share.
Conclusion
With a market size of USD 2.33 billion in 2024, projected to grow to USD 2.48 billion in 2025 and USD 6.25 billion by 2032, the hepatitis B therapeutics market is poised for strong growth. Rising prevalence, emergence of next-generation therapies, government initiatives, and strategic efforts by pharmaceutical companies are driving the adoption of advanced treatments globally.
Segmentation By Drug Class
By Age Group
By Route of Administration
By Distribution Channel
By Region