慢性B型肝炎市場 - 市場の洞察、疫学、市場予測：2032年

慢性B型肝炎に感染しても自覚症状がないことが多く、診断されない人が多いため、主要7ヶ国全体で診断率が低い主な原因となっている可能性があります。

2022年、慢性B型肝炎の市場規模は主要7ヶ国の中で米国が最も大きく、約15億米ドルを占め、2032年までに拡大すると予測されています。

主要7ヶ国における慢性B型肝炎の総市場規模は、2022年に約15億米ドルであり、予測期間中（2023年～2032年）に拡大すると予測されています。主要7ヶ国の市場規模は、疾患に対する認知度の向上とWHOの取り組み、機能的治癒を目指す新たな治療法の発売により、CAGR 24%で拡大するとみられています。EU4ヶ国の中では、2022年の市場規模はドイツが最大で、スペインは最下位です。

当レポートでは、主要7ヶ国における慢性B型肝炎市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2032年までの市場規模予測、および医療のアンメットニーズなどを提供しています。

目次

第1章 重要な洞察

第2章 レポートのイントロダクション

第3章 慢性B型肝炎市場概要

第4章 慢性B型肝炎のエグゼクティブサマリー

第5章 疫学と市場調査手法

第6章 疾患の背景と概要

第7章 B型肝炎感染の診断

• B型肝炎感染症のスクリーニング検査
• 肝臓関連の血液検査
• B型肝炎ウイルスを診断するための検査
• B型肝炎ウイルスの肝生検
• B型肝炎感染症の診断ガイドライン
• B型肝炎感染の予防

第8章 現在の治療法

• 治療アルゴリズム
• 治療ガイドライン

第9章 疫学と患者数

• 主な調査結果
• 仮定と根拠
• 主要7ヶ国における疫学シナリオ
• 米国における疫学シナリオ
• EU4ヶ国と英国における疫学シナリオ
• 日本における疫学シナリオ

第10章 患者動向

第11章 慢性B型肝炎の臨床試験における主要なエンドポイント

第12章 上市済み治療法

第13章 新しい治療法

第14章 中止された薬剤

第15章 慢性B型肝炎：主要7ヶ国分析

• 主な調査結果
• 市場の見通し
• コンジョイント分析
• 主要な市場予測の前提条件
• 主要7ヶ国の市場規模
• 米国の市場規模
• EU4ヶ国と英国の市場規模
• 日本の市場規模

第16章 市場アクセスと償還

第17章 KOLのビュー

第18章 SWOT分析

第19章 アンメットニーズ

第20章 付録

第21章 DelveInsightのサービス内容

第22章 免責事項

第23章 DelveInsightについて

List of Tables

• Table 1: Summary of Chronic Hepatitis B, Market, Epidemiology, and Key Events (2019-2032)
• Table 2: Anti-hepatitis B Virus (HBV) Cytokine and Nucleot(S)Ide Analog Therapeutic Agents
• Table 3: Recommendation of EASL
• Table 4: Preferred Antiviral Treatment of the HBsAg (+) Patient
• Table 5: Guidelines For Chronic Hepatitis B
• Table 6: Prevalent Cases of Chronic Hepatitis B in the 7MM, in millions (2019-2032)
• Table 7: Prevalent Cases of Chronic Hepatitis B in the US, in millions (2019-2032)
• Table 8: Diagnosed Prevalent Cases of Chronic Hepatitis B in the US , in millions (2019-2032)
• Table 9: Gender-specific Diagnosed Prevalent Cases of Chronic Hepatitis B in the US, in millions (2019-2032)
• Table 10: Age-specific Diagnosed Prevalent Cases of Chronic Hepatitis B in the US, in millions (2019-2032)
• Table 11: Type-specific Diagnosed Prevalent Cases of Chronic Hepatitis B in the US, in millions (2019-2032)
• Table 12: Total Treated Cases of Chronic Hepatitis B in the US, in millions (2019-2032)
• Table 13: Prevalent Cases of Chronic Hepatitis B in EU4 and the UK, in millions (2019-2032)
• Table 14: Diagnosed Prevalent Cases of Chronic Hepatitis B in EU4 and the UK, in millions (2019-2032)
• Table 15: Gender-specific Diagnosed Prevalent Cases of Chronic Hepatitis B in EU4 and the UK, in millions (2019-2032)
• Table 16: Age-specific Diagnosed Prevalent Cases of Chronic Hepatitis B in EU4 and the UK, in millions (2019-2032)
• Table 17: Type-specific Diagnosed Prevalent Cases of Chronic Hepatitis B in EU4 and the UK, in millions (2019-2032)
• Table 18: Total Treated Cases of Chronic Hepatitis B in EU4 and the UK, in millions (2019-2032)
• Table 19: Prevalent Cases of Chronic Hepatitis B in Japan, in millions (2019-2032)
• Table 20: Diagnosed Prevalent Cases of Chronic Hepatitis B in Japan, in millions (2019-2032)
• Table 21: Gender-specific Diagnosed Prevalent Cases of Chronic Hepatitis B in Japan, in millions (2019-2032)
• Table 22: Age-specific Diagnosed Prevalent Cases of Chronic Hepatitis B in Japan, in millions (2019-2032)
• Table 23: Type-specific Diagnosed Prevalent Cases of Chronic Hepatitis B in Japan, in millions (2019-2032)
• Table 24: Total Treated Cases of Chronic Hepatitis B in Japan, in millions (2019-2032)
• Table 25: Patents
• Table 26: Trials Conducted With Vemlidy in Adults With Chronic HBV Infection
• Table 27: Trial Results
• Table 28: Tenofovir Alafenamide (TAF), Clinical Trial Description, 2023
• Table 29: Comparison of Emerging Drugs Under Development
• Table 30: GSK3228836 (bepirovirsen), Clinical Trial Description, 2023
• Table 31: Hydronidone, Clinical Trial Description, 2023
• Table 32: GSK3228836 followed by GSK3528869A, Clinical Trial Description, 2023
• Table 33: ASC22, Clinical Trial Description, 2023
• Table 34: VIR-2218 and VIR-3434, Clinical Trial Description, 2023
• Table 35: BRII-835 and BRII-179: Clinical Trial Description, 2023
• Table 36: JNJ-3989, Clinical Trial Description, 2023
• Table 37: Key Competitors - Discontinued Drugs
• Table 38: Vebicorvir (VBR/ABI-H0731), Clinical Trial Description, 2023
• Table 45: Bersacapavir (JNJ-56136379/JNJ-6379), Clinical Trial Description, 2023
• Table 46: Vesatolimod (GS-9620), Clinical Trial Description, 2023
• Table 47: GS-4774, Clinical Trial Description, 2023
• Table 48: ALG-020572, Clinical Trial Description, 2023
• Table 49: ALG-010133, Clinical Trial Description, 2023
• Table 50: Key Market Forecast Assumptions for GSK3228836 (bepirovirsen)
• Table 51: Key Market Forecast Assumptions for Bepirovirsen + Peginterferon a2a
• Table 52: Key Market Forecast Assumptions for GSK3528869A ± Bepirovirsen
• Table 53: Key Market Forecast Assumptions for Hydronidone
• Table 54: Key Market Forecast Assumptions for Envafolimab (ASC22)
• Table 55: Key Market Forecast Assumptions for VIR-3434 ± VIR-2218 + Peginterferon a2a
• Table 56: Key Market Forecast Assumptions for BRII-835 + BRII-179 ± Peginterferon a2a
• Table 57: Key Market Forecast Assumptions for JNJ-73763989 + NA + Peginterferon a2a
• Table 58: Market Size of Chronic Hepatitis B in the 7MM, USD million (2019-2032)
• Table 59: Market Size of Chronic Hepatitis B in the US, USD million (2019-2032)
• Table 60: Market Size of Chronic Hepatitis B by Therapies in the US, USD million (2019-2032)
• Table 61: Market Size of Chronic Hepatitis B in EU4 and the UK, in USD million (2019-2032)
• Table 62: Market Size of Chronic Hepatitis B by Therapies in EU4 and the UK, in USD million (2019-2032)
• Table 63: Market Size of Chronic Hepatitis B in Japan, USD million (2019-2032)
• Table 64: Market Size of Chronic Hepatitis B by Therapies in Japan, USD million (2019-2032)
• Table 65: Key HTA Decisions for Chronic Hepatitis B

List of Figures

• Figure 1: Epidemiology and Market Methodology
• Figure 2: Progression of Hepatitis B Infection
• Figure 3: Acute Hepatitis B Infection
• Figure 4: Chronic Hepatitis B Infection
• Figure 5: Signs and Symptoms of Hepatitis B Infection
• Figure 6: Signs and Symptoms of Acute and Chronic Hepatitis B Infection
• Figure 7: Risk Factors of Hepatitis B Infection
• Figure 8: Transmission of Hepatitis B Virus
• Figure 9: Steps in HBV Replication
• Figure 10: Pathophysiology of Hepatitis B Infection
• Figure 11: Serologic Course of Hepatitis B Virus (HBV) Infection
• Figure 12: Complications of Hepatitis B Infection
• Figure 13: HBV Screening Algorithm for at-risk Patients
• Figure 14: Hepatitis B Infection Profile
• Figure 15: Classes of Drugs for the Treatment of HBV Infection
• Figure 16: Types of Interferons
• Figure 17: Types of NRTIs
• Figure 18: Treatment Algorithm for Chronic Hepatitis B HBeAg-positive Patients
• Figure 19: Treatment Algorithm for Chronic Hepatitis B HBeAg-negative Patients
• Figure 20: Treatment Algorithm for Chronic Hepatitis B Patients who Have Cirrhosis
• Figure 21: Treatment Algorithm in the Case of HBsAg (+) and HBeAg (+)
• Figure 22: Treatment Algorithm in the Case of HBeAg Negative
• Figure 23: Prevalent Cases of Chronic Hepatitis B in the 7MM (2019-2032)
• Figure 24: Prevalent Cases of Chronic Hepatitis B in the US (2019-2032)
• Figure 25: Diagnosed Prevalent Cases of Chronic Hepatitis B in the US (2019-2032)
• Figure 26: Gender-specific Diagnosed Prevalent Cases of Chronic Hepatitis B in the US (2019-2032)
• Figure 27: Age-specific Diagnosed Prevalent Cases of Chronic Hepatitis B in the US (2019-2032)
• Figure 28: Type-specific Diagnosed Prevalent Cases of Chronic Hepatitis B in the US (2019-2032)
• Figure 29: Total Treated Cases of Chronic Hepatitis B in the US (2019-2032)
• Figure 30: Prevalent Cases of Chronic Hepatitis B in EU4 and the UK (2019-2032)
• Figure 31: Diagnosed Prevalent Cases of Chronic Hepatitis B in EU4 and the UK (2019-2032)
• Figure 32: Gender-specific Diagnosed Prevalent Cases of Chronic Hepatitis B in EU4 and the UK (2019-2032)
• Figure 33: Age-specific Diagnosed Prevalent Cases of Chronic Hepatitis B in EU4 and the UK (2019-2032)
• Figure 34: Type-specific Diagnosed Prevalent Cases of Chronic Hepatitis B in EU4 and the UK (2019-2032)
• Figure 35: Total Treated Cases of Chronic Hepatitis B in EU4 and the UK (2019-2032)
• Figure 36: Prevalent Cases of Chronic Hepatitis B in Japan (2019-2032)
• Figure 37: Diagnosed Prevalent Cases of Chronic Hepatitis B in Japan (2019-2032)
• Figure 38: Gender-specific Diagnosed Prevalent Cases of Chronic Hepatitis B in Japan (2019-2032)
• Figure 39: Age-specific Diagnosed Prevalent Cases of Chronic Hepatitis B in Japan (2019-2032)
• Figure 40: Type-specific Diagnosed Prevalent Cases of Chronic Hepatitis B in Japan (2019-2032)
• Figure 41: Total Treated Cases of Chronic Hepatitis B in Japan (2019-2032)
• Figure 42: Market Size of Chronic Hepatitis B in the 7MM, USD million (2019-2032)
• Figure 43: Market Size of Chronic Hepatitis B in the US, USD million (2019-2032)
• Figure 44: Market Size of Chronic Hepatitis B by Therapies in the US, USD million (2019-2032)
• Figure 45: Market Size of Chronic Hepatitis B in EU4 and the UK, USD million (2019-2032)
• Figure 46: Market Size of Chronic Hepatitis B by Therapies in EU4 and the UK, USD million (2019-2032)
• Figure 47: Market Size of Chronic Hepatitis B in Japan, USD million (2019-2032)
• Figure 48: Market Size of Chronic Hepatitis B by Therapies in Japan, USD million (2019-2032)
• Figure 49: Unmet Needs

Key Highlights:

• People infected with Chronic Hepatitis B often have no symptoms, which may be the primary cause of the low diagnosis rate across the 7MM since many people go undiagnosed.
• In 2022, the market size of Chronic Hepatitis B was highest in the US among the 7MM accounting for approximately USD 1,500 million, is expected to increase by 2032.
• Gilead Science's VEMLIDY (tenofovir alafenamide) is the only approved drug for adults and pediatric patients aged 12 with compensated liver disease.
• Most of the treatment guidelines like AASLD, APASL, EASL, and WHO recommend entecavir (ETV), VIREAD (tenofovir disoproxil fumarate), and VEMLIDY (tenofovir alafenamide) as the first choice of treatment regimens and the market is currently dominated by ETV and TDF.
• VEMLIDY (tenofovir alafenamide) is progressively entering the Hepatitis B market, but the uptake is not so fast, particularly in European nations.
• The advantage of VEMLIDY over VIREAD is that VEMLIDY is less likely to cause unfavorable changes in kidney and bone biomarkers as it could treat the Hepatitis B virus at less than 1/10 the dose of VIREAD.
• VEMLIDY is expected to lose patent protection in 2025 in the US and 2026 in Europe.
• Other emerging therapies such as GSK's bepirovirsen (monotherapy, bepirovirsen + peginterferon a2a, GSK3528869A ± bepirovirsen), Ascletis's envafolimab, Vir Biotechnology's VIR-3434 + VIR-2218 + peginterferon a2a, Janssen and Arrowhead Pharmaceutical's JNJ-73763989 + peginterferon a2a + Nucleoside and nucleotide analogs have the potential to create a significant positive shift in the Chronic Hepatitis B market size.

DelveInsight's "Chronic Hepatitis B - Market Insight, Epidemiology, and Market Forecast - 2032" report delivers an in-depth understanding of the Chronic Hepatitis B, historical and forecasted epidemiology as well as the Chronic Hepatitis B market trends in the United States, EU4 (Germany, France Italy, and Spain) and the United Kingdom, and Japan.

The Chronic Hepatitis B market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Chronic Hepatitis B market size from 2019 to 2032. The report also covers current Chronic Hepatitis B treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's underlying potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2019-2032

Chronic Hepatitis B Disease Understanding and Treatment Algorithm

Chronic Hepatitis B Overview

Hepatitis B is a potentially life-threatening and one of the most common liver infections caused by the hepatitis B virus (HBV), which attacks and injures the liver. Hepatitis B is a "silent epidemic" because most people do not exhibit symptoms when newly or chronically infected. As a result, they have the potential to unintentionally infect others and prolong the slow spread of hepatitis B. If an individual suffers from a Hepatitis B virus infection that lasts more than 6 months, the infection becomes chronic.

Chronic Hepatitis B increases the risk of developing liver failure, liver cancer, or cirrhosis. The risk of developing a Chronic hepatitis B infection is also directly related to the age at which one first becomes exposed to the hepatitis B virus. Males are more prone to develop Chronic hepatitis B.

Chronic Hepatitis B Diagnosis

Since it is impossible to distinguish between hepatitis B and other viral hepatitis based on clinical findings, laboratory confirmation of the diagnosis is crucial. The diagnosis of Chronic Hepatitis B is based on results from tests assessing as anti-HBc IgG, HBeAg, HBsAg quantitative, ALT, AST, AFP, and others. For chronic cases, a liver biopsy may be needed.

The initial evaluation should include a focused clinical history, physical examination, assessment of liver disease activity and severity, and markers of HBV infection. Sometimes an anti-HBc IgM or anti-HBc IgG blood test is to clarify if a person has a new "acute" or "chronic" infection. A positive/reactive anti-HBc IgG test usually indicates a chronic infection.

The patient's journey begins with a referral to a hepatologist/gastroenterologist. However, the current approach to diagnosing these patients is similar to WHO guidelines, based on an assessment of laboratory parameters. WHO recommends that all adults have access to and be offered HBsAg testing with linkage to prevention, care, and treatment services as needed.

In addition, WHO recommends that all infants receive the hepatitis B vaccine as soon as possible after birth, preferably within 24 h, followed by two or three doses of the hepatitis B vaccine at least 4 weeks apart to complete the vaccination series. No booster vaccinations are required for those who have completed the three-dose vaccination schedule.

The American Association for the Study of Liver Diseases (AASLD) guidelines focus on screening, counseling, prevention, specialized virological/serological tests, and monitoring untreated patients. Screening is recommended in all persons born in countries with an HBsAg seroprevalence of 2%.

Further details related to country-based variations are provided in the report.

Chronic Hepatitis B Treatment

Based on real-world-prescription pattern analysis, patients suffering from Chronic Hepatitis B receive treatment with certain drugs such as pegylated interferon, interferon alpha, entecavir (ETV), VIREAD (tenofovir disoproxil fumarate), and VEMLIDY (tenofovir alafenamide), and other antiviral drugs (lamivudine, telbivudine, and adefovir dipivoxil).

In 2016, the WHO planned to eliminate Chronic Hepatitis B by 2030 due to its public health threat. With the development of antiviral therapies in the past decade, the treatment goal for chronic hepatitis B has been elevated beyond viral suppression (i.e., sustained undetectable HBV DNA levels) and seroconversion/loss of hepatitis B e antigen (HBeAg). The US Chronic Hepatitis B Market over the next few years is expected to substantially change and experience growth, as the use of interferon followed by TDF will dominate it. We have also anticipated the launch of an emerging product in the US market. VEMLIDY is expected to capture share mainly from its predecessor VIREAD and is expected to peak by 2025 in the US before the generics are expected to enter from 2025.

Notably, most infected individuals had a fairly low chance of a cure with the currently available antiviral drugs. However, novel therapies aimed at functional cures are under active development. Emerging drugs and therapies may play a vital role in suppressing HBV DNA and RNA, producing a meaningful decline in HBsAg levels and restoring HBV-specific immune responses. Developing combination strategies toward a functional cure would dramatically reduce the disease burden associated with Chronic Hepatitis B infection. Novel drugs and therapies of innovative molecules will ultimately lead to the functional cure of Chronic Hepatitis B in the near future.

Chronic Hepatitis B Epidemiology

As the market is derived using the patient-based model, the Chronic Hepatitis B epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Cases of Chronic Hepatitis B, Total Diagnosed Prevalent Cases of Chronic Hepatitis B, Gender-specific Diagnosed Prevalent Cases of Chronic Hepatitis B, Age-specific Diagnosed Prevalent Cases of Chronic Hepatitis B, Type-specific Diagnosed Prevalent Cases of Chronic Hepatitis B, and Total Treated Cases of Chronic Hepatitis B in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032.

• The total prevalent cases of Chronic Hepatitis B in the 7MM comprised approximately 56,333,000 cases in 2022 and are projected to decrease during the forecast period
• The total prevalent cases of Chronic Hepatitis B in the United States were around 22,56,700 cases in 2022.
• In the United States, approximately 55% of the patient share is attributed to males, whereas around 40% of females suffer from Chronic Hepatitis B.
• Among the EU4, Germany accounted for the largest number of Chronic Hepatitis B cases, followed by France, whereas Spain accounted for the lowest number of cases in 2022.
• According to DelveInsight estimates, there were around 3,04,900 and 53,800 cases of compensated and decompensated liver in Japan in 2022. These cases are projected to increase during the forecast period.

Chronic Hepatitis B Drug Chapters

The drug chapter segment of the Chronic Hepatitis B report encloses a detailed analysis of Chronic Hepatitis B marketed drugs and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps understand the Chronic Hepatitis B clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Marketed Drugs

VEMLIDY (tenofovir alafenamide): Gilead Sciences

VEMLIDY is an HBV nucleoside analog reverse transcriptase inhibitor. It is approved for treating Chronic Hepatitis B infection in adults and pediatric patients 12 years and older with compensated liver disease.

Recently, VEMLIDY received approval for pediatric patients 12 years and older with Chronic Hepatitis B infection with compensated liver disease in November 2022 in the United States. However, the drug was first approved in the United States and Japan, followed by approvals in the EU (2017) for adult patients with Chronic Hepatitis B.

VEMLIDY is more stable than VIREAD in plasma and delivers the active metabolite to hepatocytes more efficiently, allowing a lower dose with similar antiviral activity and less systemic exposure.

Within the HBV space, the growth of VEMLIDY's sales is due to higher sales volume in certain international locations. Also, VEMLIDY's sales growth contrasts with the decline of sales of other leading drugs, such as VIREAD and BARACLUDE, in the hepatitis B treatment market. Besides VEMLIDY's expected patent expiry in 2025 for the United States market, the drug might face competition from therapies such as GSK's bepirovirsen, Janssen Research & Development's JNJ-73763989, and others.

Note: Detailed current therapies assessment will be provided in the full report of Chronic Hepatitis B.

Emerging Drugs

Bepirovirsen (GSK3228836): GlaxoSmithKline/Ionis Pharma

Bepirovirsen (GSK3228836) is an investigational antisense oligonucleotide (ASO) designed to specifically recognize the RNA that the hepatitis B virus uses to replicate itself in the infected liver cells (hepatocytes) and make the viral antigens (proteins) that facilitate chronicity of the disease by helping avoid clearance by the immune system. The assets were in-licensed by GSK from Ionis Pharmaceuticals in August 2019.

The drug potentially could be a next therapy competitor. The company is running trials as monotherapy and in combination. This drug is being evaluated in Phase III and two Phase II clinical trials for patients with active Chronic Hepatitis B. Recently, it completed a Phase II B-Clear study. The results demonstrated promising results suggesting the drug can suppress both the surface antigen and the virus of hepatitis B, leading to the possibility of a functional cure. These encouraging data support further investigation of bepirovirsen, both as monotherapy and combination, as a potentially transformative new treatment option for patients with Chronic Hepatitis B.

The drug is expected to launch by 2026 for a monotherapy regimen. Likewise, even the key opinion Leaders (KOLs) were bullish when the data was presented, stating that "Reduction in hepatitis B surface antigen and HBV DNA to below the lower limit of quantification has the potential to be clinically meaningful and lead to a functional cure. This could help people living with Chronic Hepatitis B and healthcare providers manage the long-term consequences of Chronic Hepatitis B, including the social burden and the risk of developing life-threatening liver complications."

Note: Detailed emerging therapies assessment will be provided in the final report.

Drug Class Insights

The existing Chronic Hepatitis B treatment is mainly dominated by antiviral drugs such as entecavir, VEMLIDY, VIREAD, telbivudine, adefovir dipivoxil, and lamivudine.

Lamivudine was the first NA to be given the go-ahead by US FDA for treating Chronic hepatitis B. The drug was given adult approval in 1998, while pediatric approval for children aged 2-17 was given in 2001. But since 1995, this drug has been used and licensed for treating HIV infection. With few side effects, it can be used successfully in various patients. However, lamivudine therapy for a prolonged time is linked to significant rates of drug resistance, which cause virological relapse and biochemical flare. Lamivudine is suggested as a second-line therapy for managing Hepatitis B.

Adefovir, the second NA licensed for treating Chronic Hepatitis B, is furthermore efficacious in both Chronic Hepatitis B with HBeAg positivity and HBeAg negativity. To treat Chronic Hepatitis B, adefovir dipivoxil was granted a license in the US in 2002 under the name HEPSERA. The high risk of nephrotoxicity at high dosages of this candidate, which was also initially developed as an antiviral medication for HIV infection, led to its abandonment. This candidate received European Commission approval in 2003, and GlaxoSmithKline markets the drug in Japan. In 2008, Tenofovir disoproxil fumarate was approved for adults with Chronic Hepatitis B infection. Although tenofovir is similar in structure to adefovir, it has lower nephrotoxicity than adefovir. Thus, a higher dose is used for treatment.

In addition, the once-daily oral NA reverse transcriptase inhibitor VEMLIDY (tenofovir alafenamide) inhibits reverse transcriptase, a key enzyme in Chronic Hepatitis B infection and HIV infection. VEMLIDY is approved for treating Chronic Hepatitis B in people with compensated liver disease in the US.

Moving onto Interferon, IFN-a and its pegylated form have been used for over 30 years to treat Chronic Hepatitis B with the advantages of finite treatment duration and sustained virologic response; however, the efficacy is limited, and side effects are common. Standard PEG-IFN monotherapy is administered once weekly as an SC injection for 48 weeks, with the advantages of finite treatment duration and sustained virologic response. In addition, treatment by PEG-IFN has been suggested to be associated with a lower incidence of Hepatocellular Carcinoma than NAs treatment in Chronic Hepatitis B infection. IFN-a treatment can induce an antiviral state in hepatocytes by regulating gene expression and protein translation, which exert non-cytolytic antiviral effects in several stages of the Hepatitis B virus life cycle.

Moreover, the upcoming treatment landscape is poised to see further expansion after the emergence of new classes such as HBsAg/Antisense Oligonucleotide, Programmed Death-Ligand 1 Inhibitor, siRNA, and others.

Chronic Hepatitis B Market Outlook

Chronic Hepatitis B treatment in the US is entering a new era with changing dynamics. To this date, several drugs have been approved by the US FDA to treat Chronic Hepatitis B: interferon-alpha and pegylated interferon-alpha, nucleoside analogs (NA), and nucleotide analog prodrugs. Oral antiviral medications include VIREAD (tenofovir disoproxil), VEMLIDY (tenofovir alafenamide), BARACLUDE (entecavir), TYZEKA or SEBIVO (telbivudine), HEPSERA (adefovir dipivoxil), and lamivudine (Epivir-HBV, Zeffix, or Heptodin). The aforementioned therapies help fight the virus and slow its ability to damage the liver.

It is worth mentioning that the American Association for the Study of Liver Diseases (AASLD) presently recommends tenofovir disoproxil fumarate, entecavir, and, more recently, tenofovir alafenamide as the preferred first-line oral antiviral treatments for Chronic Hepatitis B. According to the European Association for the Study of the Liver's (EASL) recommendations, entecavir, tenofovir disoproxil fumarate, and tenofovir alafenamide are favored regimens in addition to the AASLD as one of the preferred first-line therapies to treat Chronic Hepatitis B.

As per the WHO's latest updates on hepatitis B, Chronic Hepatitis B infection can be treated with either pegylated interferon or oral antiviral agents. These treatments are expected to slow the progression of cirrhosis, reduce the incidence of liver cancer and improve long-term survival. Only a proportion (estimates vary from 10% to 40% depending on setting and eligibility criteria) of people with Chronic Hepatitis B infection will require treatment. And this might be one reason for the low treatment observed across the secondary findings.

The current market has been segmented into different commonly used drugs based on the prevailing treatment pattern across the 7MM, presenting minor variations in the overall prescription pattern. Interferons (pegylated interferon and interferon alpha), entecavir, VEMLIDY, VIREAD, and other antiviral drugs (telbivudine, adefovir dipivoxil, and lamivudine) are the major drugs that have been covered in the forecast model.

The expected launch of upcoming therapies and greater integration of early patient screening, medication in secondary care and other clinical settings, research on best methods for implementation, and an upsurge in awareness will eventually facilitate the development of effective treatment options. However, there are a few roadblocks regarding the timely diagnosis and treatment of these patients, for instance, entry of generics due to the expiration of the patent protection and increasing healthcare expenses because the current treatment is lifelong. These factors often become a hindrance when adopting newer therapies.

Key players such as GlaxoSmithKline (bepirovirsen; GSK3528869A), Beijing Continent Pharmaceutical (hydronidone), Ascletis (ASC22), Vir Biotechnology (VIR-2218), Brii Biosciences (BRII-835 [VIR-2218]; BRII-179), Janssen Research & Development (JNJ-73763989), and several others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Chronic Hepatitis B.

However, to ascertain the success rate of these medications and their effectiveness in causing a long-lasting functional cure, larger, longer, and well-designed clinical studies are required. Given the intricacy of Chronic Hepatitis B, the future of Hepatitis B virus treatments is probably in the combination of novel drugs with various modalities, particularly if the eradication of cccDNA is the ultimate objective.

• The total market size of Chronic Hepatitis B in the 7MM is approximately USD 1,500 million in 2022 and is projected to increase during the forecast period (2023-2032).
• The market size in the 7MM will increase at a CAGR of 24% due to increasing awareness of the disease and WHO initiatives and the launch of the emerging therapy aiming at a functional cure.
• Among EU4, Germany accounts for the maximum market size in 2022, while Spain occupied the bottom of the ladder in 2022.
• By 2032, among all the emerging therapies, the highest revenue will be generated by the bepirovirsen + peginterferon a2a combination in the 7MM.

Chronic Hepatitis B Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in 2019-2032. For example, for bepirovirsen, the company is running trials in different combinations such as bepirovirsen + peginterferon a2a, monotherapy, and GSK3528869A ± bepirovirsen; and it expect the drug uptake to be medium with a probability-adjusted peak share of 6.4%, years to the peak is expected to be 5 years from the year of launch for monotherapy.

Further detailed analysis of emerging therapies drug uptake in the report…

Chronic Hepatitis B Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Chronic Hepatitis B emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on Chronic Hepatitis B evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, and drug uptake along with challenges related to accessibility, include Medical/scientific writers, Medical Oncologists and Professors, Pediatric Gastroenterologist of Rady Children's Hospital, Hepatitis B Foundation, and Others.

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies and treatment patterns or Chronic Hepatitis B market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in Chronic Hepatitis B trials, one of the most important primary outcome measures is the HBsAg loss confirmed on two occasions at least 6 months apart without the requirement for anti-HBs seroconversion plus undetectable Hepatitis B virus DNA.

Both EMA and the FDA believe the endpoint in Phase II clinical trials should be tailored to the drug in question, and the benefit should outweigh the risk, allowing subsequent drug development. Given that HBsAg loss is the preferred primary endpoint for Phase III clinical trials. Thus, Phase II trials should look for an early signal of finite treatment efficacy. A decrease in HBsAg level to <100 IU/mL was proposed as a clinically meaningful endpoint for Phase II trials, but HBsAg decline must still be sufficiently validated and scientifically justified.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The risk of hepatitis B is low in the UK, and children and adults in high-risk groups are offered the vaccine. All babies in the UK born on or after August 1, 2017, are given three doses of hepatitis B-containing vaccine as part of the NHS routine vaccination schedule. In November 2022, CMS recently released the "National Fee Schedule for Medicare Part B Vaccine Administration" covering the hepatitis B vaccine. Under Section 1861(s) (10) of the Social Security Act (the Act), Part B covers both the vaccine and its administration for Hepatitis B virus (if a doctor of medicine or osteopathy orders it and is available to Medicare patients who are at high or intermediate risk of contracting hepatitis B). In 2022, CMS finalized a payment rate of USD 30 for administering the Hepatitis B virus vaccine.

In September 2018, the independent Institute for Quality and Efficiency in Health Care (Germany) considered that no added benefit is seen in VEMLIDY compared to VIREAD in treatment-naive adults with Chronic Hepatitis B. In March 2020, Haute Autorite de sante (France) considered that the clinical benefit of VIREAD is substantial in the indication extension to treat Chronic Hepatitis B in pediatric patients aged 2 to <12 years with compensated liver disease.

The committee considers that VIREAD (tenofovir), in the same way as BARACLUDE and PEGASYS, provides a minor clinical added value (CAV IV) to treat Chronic Hepatitis B in pediatric patients aged 2 to <12 years with compensated liver disease. The committee issues an unfavorable opinion for inclusion in the hospital and the retail formulary lists of reimbursed proprietary medicinal products approved for use in the indication extension and at the MA dosages to treat Chronic Hepatitis B in pediatric patients aged 2 to <12, with compensated liver disease.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state-government prescription drug programs, etc.

Scope of the Report:

• The report covers a segment of key events, an executive summary, descriptive overview of Chronic Hepatitis B, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Chronic Hepatitis B market, historic and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Chronic Hepatitis B market.

Chronic Hepatitis B Report Insights

• Patient Population
• Therapeutic Approaches
• Chronic Hepatitis B Pipeline Analysis
• Chronic Hepatitis B Market Size and Trends
• Existing and future Market Opportunity

Chronic Hepatitis B Report Key Strengths

• Ten Years Forecast
• The 7MM Coverage
• Chronic Hepatitis B Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Drugs Uptake and Key Market Forecast Assumptions

Chronic Hepatitis B Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions

• What was the Chronic Hepatitis B total market size, the market size by therapies, market share (%) distribution in 2019, and how would it all look in 2032? What are the contributing factors for this growth?
• How will interferon as a class affect the treatment paradigm in Chronic Hepatitis B?
• What kind of uptake, Hepatitis B surface antigen expression inhibitors/Antisense Oligonucleotide, bepirovirsen, is going to witness in Chronic Hepatitis B patients in the coming 10 years?
• What will be the impact of VEMLIDY's expected patent expiry in 2025 (US) and 2026 (EU), respectively?
• How will emerging drugs compete with existing therapies such as VEMLIDY, VIREAD, ETV, and others in the market?
• What are the pricing variations among different geographies for approved and off-label therapies?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Chronic Hepatitis B?
• What is the historical and forecasted Chronic Hepatitis B patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• Why is the current year diagnosis rate not high?
• What are the current treatment guidelines for treating Chronic Hepatitis B in the US and Europe?
• How many companies are developing therapies for the treatment of Chronic Hepatitis B?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?

Reasons to buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Chronic Hepatitis B market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy

Table of Contents

1. Key Insights

2. Report Introduction

3. Chronic Hepatitis B Market Overview at a Glance

• 3.1. Market Share (%) Distribution of Chronic Hepatitis B in 2019
• 3.2. Market Share (%) Distribution of Chronic Hepatitis B in 2032

4. Executive Summary of Chronic Hepatitis B

• 4.1. Key Events

5. Epidemiology and Market Methodology

6. Disease Background and Overview

• 6.1. Introduction
• 6.2. Acute and Chronic Hepatitis B Infection
• 6.3. Signs and Symptoms
• 6.4. Risk Factors and Causes
• 6.5. Transmission of Hepatitis B Virus
• 6.6. Pathophysiology
• 6.7. Stages of HBV Infection
• 6.8. Complications of Hepatitis B Virus Infection

7. Diagnosis of Hepatitis B Infection

• 7.1. Screening Tests for Hepatitis B Infection
• 7.2. Liver Related Blood Tests
• 7.3. Tests to Diagnose Hepatitis B Virus
  • 7.3.1. Medical History and Physical Exam
  • 7.3.2. Imaging Tests
  • 7.3.3. MRI and CT Scans
• 7.4. Liver Biopsy for Hepatitis B Virus
• 7.5. Diagnostic Guidelines of Hepatitis B Infection
  • 7.5.1. World Health Organization (WHO) Diagnostic Guidelines, 2015
  • 7.5.2. American Association for the Study of Liver Diseases (AASLD) Diagnostic Guidelines, 2018
  • 7.5.3. European Association for the Study of the Liver (EASL) Diagnostic Guidelines, 2017
• 7.6. Prevention of Hepatitis B Infection

8. Current Treatment Practices

• 8.1. Treatment Algorithm
• 8.2. Treatment Guidelines
  • 8.2.1. AASLD 2018 Practice Guidelines for Treatment of Chronic Hepatitis
  • 8.2.2. European Association for the Study of the Liver (EASL) 2017 Clinical Practice Guidelines for Hepatitis
  • 8.2.3. Hepatitis B management: Guidance for the primary care provider
  • 8.2.4. World Health Organization Guidelines for the management and treatment of Chronic Hepatitis B
  • 8.2.5. Guidelines for Treatment of Chronic Hepatitis B by the Chinese Society of Infectious Diseases and the Chinese Society of Hepatology, 2019

9. Epidemiology and Patient Population

• 9.1. Key Findings
• 9.2. Assumptions and Rationale
• 9.3. Epidemiology Scenario in the 7MM
  • 9.3.1. Prevalent cases of Chronic Hepatitis B in the 7MM
• 9.4. Epidemiology Scenario in the US
  • 9.4.1. Prevalent cases of Chronic Hepatitis B in the US
  • 9.4.2. Diagnosed prevalent cases of Chronic Hepatitis B in the US
  • 9.4.3. Gender-specific diagnosed prevalent cases of Chronic Hepatitis B in the US
  • 9.4.4. Age-specific diagnosed prevalent cases of Chronic Hepatitis B in the US
  • 9.4.5. Type-specific diagnosed prevalent cases of Chronic Hepatitis B in the US
  • 9.4.6. Total treated cases of Chronic Hepatitis B in the US
• 9.5. Epidemiology Scenario in EU4 and the UK
  • 9.5.1. Prevalent cases of Chronic Hepatitis B in EU4 and the UK
  • 9.5.2. Diagnosed prevalent cases of Chronic Hepatitis B in EU4 and the UK
  • 9.5.3. Gender-specific diagnosed prevalent cases of Chronic Hepatitis B in EU4 and the UK
  • 9.5.4. Age-specific diagnosed prevalent cases of Chronic Hepatitis B in EU4 and the UK
  • 9.5.5. Type-specific diagnosed prevalent cases of Chronic Hepatitis B in EU4 and the UK
  • 9.5.6. Total treated cases of Chronic Hepatitis B in EU4 and the UK
• 9.6. Epidemiology Scenario in Japan
  • 9.6.1. Prevalent Cases of Chronic Hepatitis B in Japan
  • 9.6.2. Diagnosed prevalent cases of Chronic Hepatitis B in Japan
  • 9.6.3. Gender-specific diagnosed prevalent cases of Chronic Hepatitis B in Japan
  • 9.6.4. Age-specific diagnosed prevalent cases of Chronic Hepatitis B in Japan
  • 9.6.5. Type-specific diagnosed prevalent cases of Chronic Hepatitis B in Japan
  • 9.6.6. Total treated cases of Chronic Hepatitis B in Japan

10. Patient Journey

11. Key Endpoints in Chronic Hepatitis B Clinical Trials

12. Marketed Therapies

• 12.1. Key Cross of Marketed Therapies
• 12.2. VEMLIDY (tenofovir alafenamide): Gilead Sciences
  • 12.2.1. Product description
  • 12.2.2. Regulatory milestones
  • 12.2.3. Other developmental activities
  • 12.2.4. Pivotal clinical trial
  • 12.2.5. Ongoing pipeline activity

13. Emerging Therapies

• 13.1. Key cross competition - Emerging Therapies
• 13.2. GSK3228836 (bepirovirsen): GlaxoSmithKline/Ionis Pharma
  • 13.2.1. Product description
  • 13.2.2. Other developmental activities
  • 13.2.3. Clinical developmental activities
  • 13.2.4. Safety and efficacy
• 13.3. Hydronidone (F-351): Beijing Continent Pharmaceutical
  • 13.3.1. Product description
  • 13.3.2. Other developmental activities
  • 13.3.3. Clinical developmental activities
  • 13.3.4. Safety and efficacy
• 13.4. Bepirovirsen (GSK3228836) followed by GSK3528869A: GlaxoSmithKline
  • 13.4.1. Product description
  • 13.4.2. Clinical developmental activities
• 13.5. ASC22 (envafolimab): Ascletis Pharmaceuticals
  • 13.5.1. Product description
  • 13.5.2. Other developmental activities
  • 13.5.3. Clinical developmental activities
  • 13.5.4. Safety and efficacy
• 13.6. VIR-2218 and VIR-3434: Vir Biotechnology
  • 13.6.1. Product description
  • 13.6.2. Other developmental activities
  • 13.6.3. Clinical developmental activities
  • 13.6.4. Safety and efficacy
• 13.7. BRII-835 (VIR-2218) and BRII-179 (VBI-2601): Brii Biosciences and Vir Biotechnology
  • 13.7.1. Product description
  • 13.7.2. Other developmental activities
  • 13.7.3. Clinical developmental activities
  • 13.7.4. Safety and efficacy
• 13.8. JNJ-73763989 (JNJ-3989) and JNJ-56136379 (JNJ-6379): Janssen and Arrowhead Pharmaceuticals
  • 13.8.1. Product description
  • 13.8.2. Other developmental activities
  • 13.8.3. Clinical developmental activities
  • 13.8.4. Safety and efficacy

14. Discontinued Drugs

• 14.1. Key Cross of Discontinued Drugs
• 14.2. Vebicorvir (VBR/ABI-H0731): Assembly Biosciences
  • 14.2.1. Product description
  • 14.2.2. Other developmental activities
  • 14.2.3. Clinical developmental activities
  • 14.2.4. Safety and efficacy
• 14.3. Bersacapavir (JNJ-56136379/JNJ-6379): Janssen Sciences Ireland
  • 14.3.1. Product description
  • 14.3.2. Clinical developmental activities
  • 14.3.3. Safety and efficacy
• 14.4. Vesatolimod (formerly GS-9620): Gilead Sciences
  • 14.4.1. Product description
  • 14.4.2. Clinical developmental activities
  • 14.4.3. Safety and efficacy
• 14.5. GS-4774: Gilead Sciences
  • 14.5.1. Product description
  • 14.5.2. Other developmental activities
  • 14.5.3. Clinical developmental activities
  • 14.5.4. Safety and efficacy
• 14.6. ALG-020572: Aligos Therapeutics
  • 14.6.1. Product description
  • 14.6.2. Clinical developmental activities
• 14.7. ALG-010133: Aligos Therapeutics
  • 14.7.1. Product description
  • 14.7.2. Clinical developmental activities
• 14.8. AB-506: Arbutus Biopharma
  • 14.8.1. Product description
  • 14.8.2. Safety and efficacy

15. Chronic Hepatitis B: The 7MM Analysis

• 15.1. Key Findings
• 15.2. Market Outlook
• 15.3. Conjoint Analysis
• 15.4. Key Market Forecast Assumptions
• 15.5. The 7MM Market Size
  • 15.5.1. Total market size of Chronic Hepatitis B in the 7MM
• 15.6. The United States Market Size
  • 15.6.1. Total Market Size of Chronic Hepatitis B in the US
  • 15.6.2. Market size of Chronic Hepatitis B by therapies in the US
• 15.7. EU4 and the UK Market Size
  • 15.7.1. Total Market Size of Chronic Hepatitis B in EU4 and the UK
  • 15.7.2. The Market Size of Chronic Hepatitis B by therapies in EU4 and the UK
• 15.8. Japan Market Size
  • 15.8.1. Total market Size of Chronic Hepatitis B in Japan
  • 15.8.2. Market Size of Chronic Hepatitis B by therapies in Japan

16. Market Access and Reimbursement

• 16.1. Key HTA decisions for Chronic Hepatitis B
• 16.2. Patient access programs

17. KOL Views

18. SWOT Analysis

19. Unmet Needs

20. Appendix

• 20.1. Bibliography
• 20.2. Acronyms and Abbreviations
• 20.3. Report Methodology

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight