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市場調查報告書
商品編碼
1884038
乙型肝炎治療市場規模、佔有率、成長及全球產業分析:依類型、應用和地區劃分的洞察與預測(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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由於乙型肝炎病毒 (HBV) 感染率的上升以及抗病毒治療的廣泛應用,全球乙型肝炎治療市場正經歷顯著增長。 2024 年,該市場規模為 23.3 億美元,預計到 2025 年將達到 24.8 億美元。預計到 2032 年,該市場將進一步顯著成長至 62.5 億美元,呈現強勁的上升趨勢。北美在 2024 年佔市場主導地位,佔全球市場佔有率的 53.65%,這主要得益於其先進的醫療保健基礎設施、較高的治療普及率以及在乙型肝炎治療領域強大的研發投入。
市場推動因素
市場成長的主要推動因素是乙型肝炎在全球範圍內的日益流行。乙型肝炎是由乙型肝炎病毒 (HBV) 引起的一種嚴重肝臟感染。其傳染途徑包括血液、體液、性接觸、母嬰傳染。根據世界衛生組織 (WHO,2024 年 4 月) 的數據,截至 2022 年,全球約有 2.54 億人(約佔世界人口的 3.3%)感染乙型肝炎,而慢性乙型肝炎患者中僅有 2.6% 接受治療。如此龐大的患者群體凸顯了有效治療的必要性,從而推動了已開發市場和新興市場的需求。
政府主導的各項舉措,例如中國於2025年1月啟動的 "支持中國到2030年消除病毒性肝炎對公眾健康的威脅" 計劃,正在進一步提高公眾意識、改善診斷率並促進治療。同樣,吉利德科學公司和葛蘭素史克公司等大型製藥公司的策略活動,也透過先進的研發和新療法的開發,支持市場擴張。
市場限制因子
慢性B型肝炎患者抗藥性的出現是一項重大挑戰。長期抗病毒治療,尤其是使用核苷/核苷酸類似物時,會導致病毒突變。研究表明,約30%的患者在一年內會產生拉米夫定抗藥性的乙肝病毒株,五年後,20-29%的患者會出現阿德福韋酯抗藥性。這可能導致治療效果降低、病毒量增加,並進展為嚴重的肝病,從而限制市場成長。
市場機會
在研產品和聯合療法提供了巨大的機會。各公司正在開發針對病毒 cccDNA 的新型療法,並將聯合療法整合以克服抗藥性並實現更好的病毒抑制。例如,智蒙生物製藥於 2022 年 8 月啟動了 ZM-H1505R 與恩替卡韋聯合用藥的 IIa 期臨床試驗,這表明人們對創新療法的興趣日益濃厚。
市場挑戰
B型肝炎的診斷、長期治療和管理成本高昂仍然是一個重大障礙,尤其是在中低收入國家。每日口服藥物和長期堅持治療的需求也帶來了挑戰,影響患者的依從性並導致抗藥性的產生。
市場趨勢
值得關注的趨勢包括針對乙型肝炎病毒 (HBV) cccDNA 的新一代療法的出現,展現了治癒性治療的潛力。例如,Precision Biosciences 公司公佈了 ELIMINATE-B 試驗的中期結果,該試驗評估了 PBGENE-HBV 基因編輯療法,旨在根除 HBeAg 陰性慢性乙型肝炎患者的 cccDNA,這表明治療正朝著治癒性方向發展。
依藥物類別劃分,核苷類似物因其廣泛的處方歷史和高效性,在 2024 年佔市場主導地位。在沙烏地阿拉伯和阿聯酋,恩替卡韋錠的處方量佔所有病例的 73%。核苷類似物和乾擾素也貢獻顯著,預計新型療法將推動市場成長。
依年齡組劃分,成人市場佔主導地位,這主要歸因於較高的感染率,尤其是透過性接觸傳播的感染率。兒科治療正因疫苗接種計劃和適應症的增加而逐漸擴展。
依給藥途徑劃分,口服治療因其便利性和患者依從性,在2024年仍將佔市場主導地位。同時,注射劑型因其高生物利用度和療效而備受關注。
北美市場預計將在2024年以12.5億美元的規模引領市場,主要得益於高盛行率、先進的治療手段以及公共衛生計畫。美國佔最大佔有率,這得益於其報銷政策和強大的研發實力。亞太地區是成長最快的地區,這主要得益於價格合理的仿製藥、不斷上升的盛行率以及政府的宣傳活動。歐洲市場正經歷穩定成長,而拉丁美洲和中東及非洲地區則作為新興市場,其成長動力主要來自於提高公眾意識和擴大治療可近性的努力。
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