Chronic Hepatitis B Virus Market

DelveInsight’s ‘Chronic Hepatitis B Virus (CHB) - Market Insights, Epidemiology, and Market Forecast—2030’ report delivers an in-depth understanding of the CHB, historical and forecasted epidemiology as well as the CHB market trends in the United States, EU5 (Germany, France, Italy, Spain, and United Kingdom), and Japan.

The CHB market report provides current treatment practices, emerging drugs, CHB market share of the individual therapies, current and forecasted CHB market size from 2017 to 2030 segmented by seven major markets. The Report also covers current CHB treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2017–2030

CHB Understanding 

Overview

Hepatitis B is the most common serious liver infection in the world. It is caused by the hepatitis B virus that attacks and injures the liver. Millions of people are living with a chronic hepatitis B infection all around the world. The hepatitis B virus (HBV) is transmitted through blood and infected bodily fluids. It can be passed to others through direct contact with blood, unprotected sex, and use of illegal drugs, unsterilized or contaminated needles. Children with hepatitis B are more likely to contract it through:

• Being born to a mother who has hepatitis B
• Living in the same house with someone who is infected with hepatitis B, and sharing items such as toothbrushes or razorblades
• Receiving multiple transfusions of blood or blood products
• Being bitten so that the skin is broken by someone whose saliva contains the hepatitis B virus
• Being a hemodialysis patient

HBV is most commonly spread through sexual contact, accounting for nearly two-thirds of acute HBV cases. It is considered as a “silent epidemic” because most people do not have symptoms when they are newly infected or chronically infected. Thus, they can unknowingly spread the virus to others and continue the silent spread of hepatitis B. Most hepatitis B infections clear up within 1–2 months without treatment. When the infection lasts more than 6 months, it can develop into chronic hepatitis B, which can lead to chronic inflammation of the liver, cirrhosis (scarring of the liver), liver cancer, and/or liver failure. HBV infection has been identified as an important cause of chronic hepatitis (35.9%) and liver cirrhosis (44.2%).

The symptoms of hepatitis B include fatigue, poor appetite, stomach pain, fever, nausea, vomiting, and occasionally joint pain, hives, or rash. Urine may become darker in color, and then jaundice (yellowing of the skin and whites of the eyes) may appear. Adults are more likely than children to develop symptoms; however, up to 50% of adults who have acute infection do not have any symptoms. The symptoms may appear within 6 weeks to 6 months after exposure, but usually 4 months. The virus can be found in blood and other body fluids several weeks before symptoms appear and generally persists for several months afterward.

CHB Diagnosis

This condition is diagnosed with blood tests, which are also used to monitor its effects on the liver. For chronic cases, a liver biopsy may be needed. A biopsy is the removal of a sample of liver tissue for testing. Screening for HBV involves a simple and relatively low-cost blood test to detect the presence of hepatitis B surface antigen (HBsAg) and antibody to HBsAg (anti-HBs) in serum. Patients who are HBsAg-negative and do not have antibodies are given the hepatitis B vaccine.

CHB Treatment

Currently, treatment strategies for CHB mainly include Antiviral medications. To this date, several drugs have been approved by the United States Food and Drug Administration (FDA) for the treatment of CHB: interferon-alpha and pegylated interferon-alpha, nucleoside analogs (NA) and nucleotide analog prodrugs. Oral antiviral medications include Tenofovir disoproxil (Viread), Tenofovir alafenamide (Vemlidy), Entecavir (Baraclude), Telbivudine (Tyzeka or Sebivo), Adefovir Dipivoxil (Hepsera), and Lamivudine (Epivir-HBV, Zeffix, or Heptodin). The aforementioned therapies help to fight the virus and slow its ability to damage the liver. Although NAs are well tolerated and exhibit an early and potent antiviral effect, however the selection of resistant mutants and nephrotoxicity during long-term therapy limit their use.

CHB Epidemiology

In 2020, the overall prevalent cases of CHB accessed to be around 5,858,038 in the 7MM, which are expected to grow during the forecast period, i.e., 2021–2030.

The disease epidemiology covered in the report provides historical as well as forecasted  Chronic Hepatitis B Virus epidemiology segmented as [Total Prevalent cases of CHB, Total Diagnosed Prevalent cases of  CHB, Gender-Specific Cases of CHB, Age-Specific Cases of CHB, CHB cases by Impact on Liver (i.e., decompensated and compensated), and Total treated cases of CHB] in the 7MM, covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom), and Japan from 2017 to 2030.

Country Wise- CHB Epidemiology

Key Findings from CHB Epidemiological Analyses and Forecast

• Among the 7MM, the United States accounted for nearly 40% of the total prevalent population of CHB in the year 2020.
• In EU-5 countries the highest number of diagnosed cases of CHB were in Germany, followed by Italy.
• As per the secondary findings, overall CHB Virus affects more males than females. In addition, around half of the CHB cases are reported in the people age group of 44 years and below. In the 7MM, the age-specific diagnosed prevalent cases of CHB were 60,561, 519,638, 479,929, 510,925, 366,771, and 93,968 cases for the age group less than 18 years, 18–34 years, 35–44 years, 45–54 years, 55–64 years, and ≥65 years, in 2020.

CHB Drug Chapters

Drug chapter segment of the CHB report encloses the detailed analysis of CHB developmental stage pipeline drugs. It also helps to understand the CHB 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.

CHB Marketed Therapies

• Vemlidy (tenofovir alafenamide): Gilead Sciences

Vemlidy is a novel, targeted prodrug of tenofovir manufactured by Gilead Sciences that has exhibited antiviral efficacy quite identical as Gilead’s Viread (tenofovir disoproxil fumarate, TDF) 300mg. Vemlidy was basically approved for the treatment of hepatitis B infection on the basis of a 48-week data from two international Phase III studies (Studies 108 and 110). At present, Gilead Sciences’ conducting a Phase II clinical trial (NCT02932150; Recruiting) with the objective to evaluate of the pharmacokinetics, safety, and antiviral efficacy of Tenofovir Alafenamide in children and adolescent subjects with Chronic Hepatitis B Virus Infection.

Note: Full and detailed list of marketed therapies will be provided in the final report.

CHB Emerging Drugs

• GSK3228836 (IONIS-HBVRx): GlaxoSmithKline/Ionis Pharma

GlaxoSmithKline and Ionis Pharma’s candidate—GSK3228836 is an antisense oligonucleotide drug which is planned in order to lessen or inhibit the occurrence of the viral proteins linked with HBV infection and replication. The company has recently initiated a Phase II clinical trial (NCT04449029), which is in its  Active, not recruiting stage in order to evaluate if treatment with GSK3228836 can achieve sustained virologic response (SVR), that is HBsAg less than (<) lower limit of quantitation (LLOQ) and HBV deoxyribonucleic acid (DNA) <LLOQ sustained for 24 weeks post-GSK3228836 treatment end.

• JNJ-56136379 /JNJ-6379/ Bersacapavir: Janssen Sciences Ireland

JNJ-56136379 (JNJ-6379), is a Capsid Assembly Modulator (CAMs) being developed by Janssen Sciences. CAMs are basically being approached as new antiviral therapies having the potential to target capsid assembly that is defined as a very important step in the HBV life cycle, mediated by the core protein. JNJ-56136379 works via a dual mechanism of action, formerly by interfering with capsid assembly followed by preventing covalently closed circular DNA (cccDNA) formation at the time of de novo infection. It gets attached to HBV core protein and obstructing both early and late-stage processes in the HBV life cycle.

• JNJ-73763989 and/or JNJ-56136379: Janssen/Arrowhead Pharmaceuticals

JNJ-3989, formerly ARO-HBV, is being developed in collaboration by Arrowhead Pharmaceuticals and Janssen Pharmaceuticals as a potentially curative therapy for patients with chronic hepatitis B infection when used in combination with other direct antivirals. JNJ-3989 is a ribonucleic acid interference (RNAi) therapy candidate which is designed to silence all HBV gene products and intervenes upstream of the reverse transcription process where current standard-of-care nucleotide and nucleoside analogues act. Currently, JNJ-73763989 in combination with JNJ-56136379 is being evaluated in Phase II (NCT03982186) to establish the dose-response relationship for antiviral activity of 3 dose levels of JNJ-73763989 + nucleos(t)ide analog (NA) and to evaluate the efficacy of combination regimens of JNJ-73763989+NA (with and without JNJ-56136379) and of JNJ-56136379+NA. JNJ-56136379 is an orally administered capsid assembly modulator that is being developed for the treatment of chronic HBV infection.

• RG7854/RG7907/RG6346: Roche

Combination product RG7907 + RG7854 + RG6346+ NUC, developed by Roche is also being investigated for the treatment of adult patients with Chronic Hepatitis B Infection by Roche. At present, it is being investigated in Phase II clinical study (NCT04225715; Recruiting). RG7854 is a TLR7 agonist, oral, small molecule immuno-modulator, activating the TLR (toll-like receptor) 7 and to a weaker extent TLR8. It has been developed as a best-in-disease for finite chronic hepatitis B combination therapy. Also, RG7907 (CpAM) is an orally administered small molecule, class I hepatitis B virus (HBV) core protein allosteric modulator, that disrupts HBV nucleocapsids assembly and induces the depletion of functional core proteins, thereby effectively inhibiting HBV replication. RG6346 is an investigational GalXC RNAi therapy in development with Roche for the treatment of chronic hepatitis B virus (HBV) infection. RG6346 is designed to knock down selectively viral hepatitis B surface antigen (HBsAg) messenger RNA (mRNA) and protein expression in liver hepatocytes.

• Selgantolimod (GS-9688): Gilead Sciences

Gilead Sciences’ Selgantolimod (GS-9688) is an investigational oral selective small molecule agonist of toll-like receptor 8 (TLR8). Selgantolimod induces the cellular immune mediators, interleukin (IL)-12 and IL-8, as well as the antiviral cytokines tumor necrosis factor-α and interferon-γ (IFNγ) in vitro in human peripheral blood mononuclear cells. Selgantolimod also activates natural killer (NK) and mucosal associated invariant T cells, stimulates cluster of differentiation (CD)-8+ T-cell proliferation, and increase IFNγ production, while lowering programmed cell death protein 1 expression by HBV-specific CD8+-T cells in vitro in peripheral blood mononuclear cells.

Note: Full and detailed list of emerging therapies will be provided in the final report.

CHB Market Outlook

Key Findings

The CHB market size in the 7MM is expected to change during the study period 2017–2030, at a CAGR of 16.0%. According to the estimates, the highest market size of CHB is accessed in the United States followed Japan, and Germany, in 2020.

The United States Market Outlook

In United States, the total market size of CHB is expected to increase at a CAGR of 16.9% during the study period (2017–2030).

EU-5 Countries: Market Outlook

In EU-5, the total market size of CHB is expected to increase at a CAGR of 14.4% during the study period (2017–2030).

Japan Market Outlook

The total market size of CHB in Japan is estimated to rise at a CAGR of 14.1%, during the study period (2017–2030).

CHB Pipeline Development Activities

The drugs which are in pipeline include:

• GSK3228836 (IONIS-HBVRx): GlaxoSmithKline/Ionis Pharma
• JNJ-56136379 /JNJ-6379/ Bersacapavir: Janssen Sciences Ireland
• Selgantolimod (GS-9688): Gilead Sciences
• RG7854/RG7907/RG6346: Roche
• JNJ-73763989 and/or JNJ-56136379: Janssen/Arrowhead Pharmaceuticals
• GSK3389404 (IONIS-HBV-LRX): GlaxoSmithKline /Ionis Pharmaceuticals
• Vebicorvir (VBR, or ABI-H0731): Assembly Biosciences
• VIR-2218 + VIR-3434: Vir Biotechnology
• VIR-2218 ± PEG-IFN-⍺: Vir Biotechnology
• REP 2139: Replicor
• REP 2165 + REP 2139: Replicor
• AB-729 (GaINAc-RNAi): Arbutus Biopharma

And others…

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

CHB Drugs Uptake

Analysts Insight

Tenofovir alafenamide is slowly making its way into the CHB market but the uptake is not so fast especially in the European countries. Despite the persistence of HBV DNA in the liver, several studies have demonstrated that seroclearance of HBsAg is related to improved clinical outcomes in individuals with HBV. The penetration rate of a functional cure for HBV infection is expected in the future, as most HBV patients are keen to attain a functional cure to reduce their mortality and morbidity risks. Nevertheless, recently several advancements and initiatives have been taken towards the functional cure of CHB. These numerous scientific and clinical advances are leading to more effective treatment strategies for patients with CHB. During the forecast period, the size of the CHB market is expected to change significantly.

CHB Therapies Market Access and Reimbursement

• In February 2006, Adefovir dipivoxil and peginterferon alfa-2a recommended by the National Institute for Health and Care Excellence (NICE) as an option for the initial treatment of adults with chronic hepatitis B (HBeAg-positive or HBeAg-negative), within its licensed indications.
• In August 2008, Entecavir, recommended by NICE as an option for the treatment of people with chronic HBeAg-positive or HBeAg-negative hepatitis B in whom antiviral treatment is indicated.
• In January 2019, Tenofovir alafenamide was recommended by IQWiG for added benefit not proven for any of the 4 sub indications.  

Latest KOL Views on CHB Therapies

To keep up with current market trends, we take KOLs and SME’s opinion working in the CHB domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or CHB market trend. This will support the clients in potential upcoming novel treatment by identifying the over CHB scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform Competitive and Market Intelligence analysis of the CHB Market by using various Competitive Intelligence tools that includes – SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the CHB Report

• The report covers the descriptive overview of CHB, explaining its causes, signs and symptoms, pathophysiology, and currently available therapies.
• Comprehensive insight has been provided into the CHB epidemiology and treatment in the 7MM.
• Additionally, an all-inclusive account of both the current and emerging therapies for CHB is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of CHB market; historical and forecasted is included in the report, covering drug outreach in the 7MM.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the global CHB market.

Report Highlights

• In the coming years, CHB market is set to change due to the rising awareness of the disease and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies and academics are working to assess challenges and seek opportunities that could influence CHB R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for CHB.
• Our in-depth analysis of the pipeline assets across different stages of development different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the over CHB scenario of the research and development activities.

CHB Report Insights

• Patient Population
• Therapeutic Approaches
• CHB Pipeline Analysis
• CHB Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

CHB Report Key Strengths

• 10 Years Forecast
• 7MM Coverage
• CHB Epidemiology Segmentation
• Highly Analyzed Market
• Drugs Uptake

CHB Report Assessment

• SWOT Analysis
• Current Treatment Practices
• Unmet Needs
• Market Attractiveness
• Market Drivers and Barriers

Market Insights:

• What was the CHB Market share (%) distribution in 2017 and how it would look like in 2030?
• What would be the CHB total market size as well as market size by therapies across the 7MM during the study period (2017–2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest CHB market size during the study period (2017–2030)?
• At what CAGR, the CHB market is expected to grow in the 7MM during the study period (2017–2030)?
• What would be the CHB market outlook across the 7MM during the study period (2017–2030)?
• What would be the CHB market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers and future opportunities affect the market dynamics and a subsequent analysis of the associated trends?
• CHB patient types/pool where unmet need is more and whether emerging therapies will be able to address the residual unmet need?
• How emerging therapies are performing on the parameters like efficacy, safety, route of administration (RoA), treatment duration and frequencies on the basis of their clinical trial results?
• Among the emerging therapies, what are the potential therapies which are expected to disrupt the CHB market?

Epidemiology Insights:

• What is the disease risk, burden and unmet needs of the CHB?
• What is the historical CHB patient pool in the seven major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
• What would be the forecasted patient pool of CHB in the 7 major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
• What will be the growth opportunities in the 7MM with respect to the patient population pertaining to CHB?
• Out of CHB the 7MM countries, which country would have the highest prevalent population of CHB during the study period (2017–2030)?
• At what CAGR the population is expected to grow in the 7MM during the study period (2017–2030)?
• What are the various recent and upcoming events which are expected to improve the diagnosis of CHB?

Current Treatment Scenario and Emerging Therapies:

• What are the current options for the treatment of CHB?
• What are the current treatment guidelines for the treatment of CHB in the US, Europe and Japan?
• How many companies are developing therapies for the treatment of CHB?
• How many therapies are developed by each company for the treatment of CHB?
• How many emerging therapies are in mid stage, and late stage of development for the treatment of CHB?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the CHB therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for CHB and their status?
• What are the key designations that have been granted for the emerging therapies for CHB?
• What is the global historical and forecasted market of CHB?

Reasons to buy CHB Report

• The report will help in developing business strategies by understanding trends shaping and driving the CHB market.
• To understand the future market competition in the CHB market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for CHB in the US, Europe (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
• Identification of strong upcoming players in market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for CHB market.
• To understand the future market competition in the CHB market.