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市場調査レポート
商品コード
1696291
B型肝炎治療の世界市場:2025年~2033年Global Hepatitis B Treatment Market - 2025-2033 |
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カスタマイズ可能
適宜更新あり
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B型肝炎治療の世界市場:2025年~2033年 |
出版日: 2025年03月25日
発行: DataM Intelligence
ページ情報: 英文 180 Pages
納期: 即日から翌営業日
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世界のB型肝炎治療の市場規模は2024年に35億7,000万米ドルに達し、2033年には64億7,000万米ドルに達すると予測され、予測期間の2025年~2033年のCAGRは6.9%となる見込みです。
B型肝炎は、肝臓に炎症を引き起こすウイルス感染症であり、当初は軽症で済むこともありますが、場合によっては慢性化し、長期化することもあります。治療せずに放置しておくと、炎症が進行した結果、肝硬変や肝不全などの重大な肝障害を引き起こす可能性があります。B型肝炎ウイルスは、明らかな自覚症状がなくても重大な害をもたらす可能性があり、静かではあるが深刻な健康上の脅威となっています。
B型肝炎の治療法は、患者の年齢、全身の健康状態、感染段階、肝臓の既往症など、さまざまな要因によって異なります。治療の主な目標は、ウイルスを制御し、さらなる肝障害を予防し、病気の進行を遅らせることです。慢性感染者の場合、ウイルス複製を管理するために抗ウイルス薬が使用されることが多く、それによって重篤な肝合併症のリスクを低減することができます。
B型肝炎治療市場は、抗ウイルス療法の進歩、認知度の向上、B型慢性肝炎の世界的有病率の増加などに後押しされ、大きな成長を遂げています。B型肝炎財団によると、20億人がB型肝炎ウイルスに感染しており(3人に1人)、毎年約150万人が新たに感染しています。慢性感染者は約3億人。感染者の約10%が診断を受けています。B型肝炎は、肝硬変や肝がん(HCC)などの重篤な肝疾患を引き起こす可能性があるため、効果的な治療オプションに対する需要が高まっています。
テノホビルやエンテカビルのような現在の抗ウイルス治療は、HBVの複製を効果的に抑制しますが、ウイルスを排除することはできないです。ウイルス抑制を強化し、機能的治癒の可能性を高めるために、併用療法が開発されています。そのため、新興国市場の主な参入企業は、より良い治療のために併用療法の開発に注力しています。
例えば、2024年11月、Barinthus Biotherapeutics plcは進行中の第2b相HBV003臨床試験からこれまでに最も重要なデータを発表しました。この試験では、VTP-300と抗PD-1モノクローナル抗体である低用量ニボルマブとの併用による異なる投与レジメンを評価しており、データカットオフの時点で、8人の参加者がHBsAgを完全に消失したと報告され、2人の参加者が機能的治癒の基準を満たしたことが示されました。
さらに、Brii Biosciences Limitedは2024年11月、現在進行中の第2相ENSURE試験の新たなデータを発表しました。本試験では、より広範な患者集団における治癒の可能性を検討するため、ベースラインのHBsAg値が低い(100 IU/mL未満)HBV患者を除外しました。ENSURE試験の48週治療終了時(EOT)データでは、PEG-IFNaとエレブシラン200mgまたは100mgの併用療法を受けた患者の26.3%(5/19人)または33.3%(6/18人)が、PEG-IFNa単独療法を受けた患者の5.6%(1/18人)と比較して、EOT時にHBsAgセロクリアランスを達成したことが示されました。
併用療法は通常、抗ウイルス剤と免疫調整剤、チェックポイント阻害剤、RNAベース療法などの他の治療法を組み合わせたものです。これらのアプローチは、現在の治療法の限界に対処し、慢性HBV感染症の治癒的解決に向けた道筋を提供するものです。併用療法がより効果的な治療を提供し、長期治療の必要性を減らすことで、患者の転帰を改善し、慢性疾患の負担を軽減することが期待されます。その結果、特に資源の限られた地域では、治療がより身近なものとなります。
副作用と薬剤耐性はB型肝炎の治療における重要な課題であり、B型肝炎治療市場の成長を妨げています。これらの問題は、治療の失敗、患者のアドヒアランス低下、治療選択肢の制限につながり、最終的に市場拡大に影響を与えます。
テノホビルやエンテカビルなどのヌクレオシドアナログ(NA)などの抗ウイルス療法の長期使用は、HBVの薬剤耐性株の出現につながる可能性があるため、これらの治療の有効性が制限され、代替療法の開発が必要となります。例えば、HBVに使用された初期の抗ウイルス薬の一つであるラミブジンに対する耐性は、長期間の使用により一般的になっています。テノホビルやエンテカビルの耐性率は低くなっていまするが、それでも一部の患者には耐性がみられます。
HBVの薬剤耐性株は、最適な治療効果を得られず、治療法の変更や新薬の追加が必要となり、治療レジメンが複雑になります。例えば、Gilead Sciencesのテノホビル・アラフェナミド(Vemlidy)は、腎臓や骨の健康に関連する安全性の懸念に対処するために開発されました。患者が耐性を獲得すると、ペグインターフェロンや併用療法のような代替治療が必要となるが、これらはより高価で、患者にとって利便性が低いものとなっていす。
当レポートでは、世界のB型肝炎治療市場について調査し、市場の概要とともに、タイプ別、治療別、投与経路別、流通チャネル別、地域別動向、競合情勢、および市場に参入する企業のプロファイルなどを提供しています。
The global hepatitis B treatment market size reached US$ 3.57 billion in 2024 and is expected to reach US$ 6.47 billion by 2033, growing at a CAGR of 6.9% during the forecast period 2025-2033.
Hepatitis B is a viral infection that causes inflammation of the liver, which may initially present as mild but, in some cases, can develop into a chronic condition that persists over time. If left untreated, the ongoing inflammation can result in significant liver damage, including cirrhosis and liver failure. The virus can cause substantial harm even without obvious symptoms, making it a silent but serious health threat.
The approach to treating hepatitis B depends on various factors, including the patient's age, overall health, the stage of the infection, and any pre-existing liver issues. The main goals of treatment are to control the virus, prevent further liver damage, and slow the progression of the disease. For those with chronic infections, antiviral medications are often used to manage viral replication, thereby reducing the risk of severe liver complications.
The hepatitis B treatment market has experienced significant growth, fueled by advances in antiviral therapies, rising awareness and the increasing global prevalence of chronic hepatitis B. For instance, hepatitis B remains a major public health concern worldwide. According to the Hepatitis B Foundation, 2 billion people have been infected with the hepatitis B virus (1 out of 3 people). Approximately 1.5 million people become newly infected each year. Almost 300 million people are chronically infected. Approximately 10% of infected individuals are diagnosed. As the disease can lead to serious liver conditions, such as cirrhosis and liver cancer (HCC), the demand for effective treatment options has been on the rise.
Market Dynamics: Drivers & Restraints
Growing combination therapy approaches are significantly driving the hepatitis B treatment market growth
While current antiviral treatments like tenofovir and entecavir effectively suppress HBV replication, they don't eliminate the virus. Combination therapies are being developed to enhance viral suppression and increase the chance of a functional cure. Thus, key market players are focusing on the development of combination therapies for better treatment.
For instance, in November 2024, Barinthus Biotherapeutics plc announced the most significant data so far from the ongoing Phase 2b HBV003 clinical trial. The study is evaluating different dosing regimens of VTP-300 in combination with low-dose nivolumab, an anti-PD-1 monoclonal antibody, and showed that as of the data cut-off, eight participants were reported with complete HBsAg loss, and two participants met the criteria for functional cure.
Additionally, in November 2024, Brii Biosciences Limited released new data from its ongoing Phase 2 ENSURE study. The study excluded HBV patients with low baseline HBsAg levels (<100 IU/mL) to investigate the potential curative benefits in broader patient populations. The ENSURE 48-week end-of-treatment (EOT) data demonstrated that 26.3% (5/19) or 33.3% (6/18) of participants receiving 200 mg or 100 mg elebsiran in combination with PEG-IFNa versus 5.6% (1/18) receiving PEG-IFNa alone achieved HBsAg seroclearance at EOT.
Combination therapies typically combine antiviral agents with other modalities, such as immune modulators, checkpoint inhibitors, or RNA-based therapies. These approaches address the limitations of current treatments and offer a pathway towards curative solutions for chronic HBV infections. As combination therapies provide more effective treatments and reduce the need for long-term therapy, they are expected to improve patient outcomes and reduce the burden of chronic disease. This, in turn, makes treatment more accessible, especially in resource-limited regions.
Side effects and drug resistance hamper the market growth
Side effects and drug resistance are significant challenges in the management of hepatitis B, which are hampering the growth of the hepatitis B treatment market. These issues can lead to treatment failure, reduced patient adherence, and limited therapeutic options, ultimately affecting market expansion.
Long-term use of antiviral therapies, such as nucleoside analogs (NA), such as tenofovir, entecavir, can lead to the emergence of drug-resistant strains of HBV, which limits the efficacy of these treatments and necessitates the development of alternative therapies. For instance, resistance to lamivudine, one of the earliest antiviral drugs used for HBV, became common after prolonged use. Tenofovir and entecavir have shown lower resistance rates, but resistance still occurs in a subset of patients.
Drug-resistant strains of HBV can lead to suboptimal treatment responses, requiring changes in therapy or the addition of new drugs, which complicates treatment regimens. For instance, Gilead Sciences' tenofovir alafenamide (Vemlidy) was developed to address safety concerns related to renal and bone health. As patients develop resistance, alternative treatments like pegylated interferon or combination therapies are required, which are more expensive and less convenient for patients.
The global hepatitis B treatment market is segmented based on type, treatment, route of administration, distribution channel, and region.
The chronic hepatitis B from the type segment is expected to dominate the hepatitis B treatment market with the highest market share
There is a direct relationship between the risk of developing a chronic hepatitis B infection and the age of first exposure to hepatitis B virus: 90% of infected newborns and infants will become chronic hepatitis B carriers, Between 30% and 50% of infected children (aged 1-5 years) will develop chronic infection, 5-10% of infected adults will develop chronic hepatitis B (i.e. 90% would recover).
The chronic hepatitis B segment is expected to grow during the forecast period owing to factors like, rise in the incidence of chronic hepatitis B, which is leading to liver cancer and cirrhosis, advances in drug development, including novel antivirals and immunomodulators and other factors that helps the segment to grow during the forecast period.
For instance, according to an NCBI-published article, it is estimated that each year, chronic hepatitis B infection in the United States ranges from 700,000 to more than 2 million persons. As the chronic condition rises, market players are developing effective therapies for better treatment. For instance, in August 2024, the Japanese Ministry of Health, Labour and Welfare (MHLW) assigned the SENKU (previously known as SAKIGAKE) designation for bepirovirsen, an experimental antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB), by GSK Plc.
Additionally, in February 2024, GSK plc announced that Fast Track designation for bepirovirsen, an experimental antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB), has been awarded by the US Food and Drug Administration (FDA).
The vaccines from the treatment segment is expected to dominate the hepatitis B treatment market with the highest market share
The hepatitis B vaccine is a medication used to prevent infection, which can lead to chronic liver failure and hepatocellular carcinoma. It reviews its indications, action, and contraindications, highlighting its mechanism of action, adverse event profile, and other crucial factors for healthcare team members to reduce the burden of hepatitis B on patients and communities.
Two different vaccines are used to treat hepatitis B: combination vaccine and single antigen vaccine. The vaccines segment in hepatitis B treatment is expected to grow by various factors like the prevalence of the hepatitis B disease, increased awareness, government immunization programs and vaccine development advancements are driving demand, while investments in R&D and public-private partnerships are expanding vaccine accessibility and market growth.
For instance, in February 2024, TherVacB, a novel therapeutic vaccine designed by Helmholtz Munich, entered its first clinical trial. The Phase Ia trial, conducted at LMU University Hospital Munich's Division of Infectious Diseases and Tropical Medicine, will investigate the vaccine's safety and immunogenicity in healthy volunteers. The first clinical trial in patients with chronic hepatitis B is set to begin in 2024.
North America is expected to hold a significant position in the global hepatitis B treatment market with the highest market share
With the increased incidence of hepatitis B infection and the rising prevalence in the region, there is a growing demand for treatment. For instance, according to the report by the Centers for Disease Control and Prevention (CDC), in 2024, an estimated 850,000 to 2.2 million individuals in the United States are living with chronic hepatitis B virus (HBV) infection.
One of the major driving forces is the ongoing investment in research and development by both pharmaceutical companies and government bodies. North America includes the largest pharmaceutical companies, which are continuously working on improving existing treatments and developing new therapies for Hepatitis B. This includes advancements in antiviral medications, immune therapies, and potential cures.
For instance, in November 2024, the Coalition for Global Hepatitis Elimination launched the Center for Operational Research on Hepatitis B (COR-HEPB), a global center dedicated to catalyzing investments and coordinating research to expand access to hepatitis B care and treatments in low- and middle-income countries (LMICs). The center aims to prevent disability and premature mortality from hepatitis B, with generous support from Open Philanthropy.
Furthermore, in October 2024, Precision BioSciences received Clinical Trial Application (CTA) approval in Moldova for its lead candidate, PBGENE-HBV. The in vivo gene editing program aims to cure chronic hepatitis B by eliminating cccDNA, the key source of replicating HBV and inactivating integrated HBV DNA in hepatocytes. The company has opened its Phase 1 clinical program and is now moving towards dosing patients.
Top companies in the hepatitis B treatment market include Gilead Sciences, Inc., Merck & Co. Inc., GSK plc, Accord Healthcare Limited, APOTEX INC, Dynavax Technologies Corporation, Bharat Biotech, Serum Institute of India Pvt. Ltd, Sanofi S.A., VBI Vaccines Inc., and among others.
The global Hepatitis B Treatment market report delivers a detailed analysis with 70 key tables, more than 60 visually impactful figures and 172 pages of expert insights, providing a complete view of the market landscape.
Target Audience 2024