Hepatitis B Market

 Market Overview:

The hepatitis B market reached a value of US$ 3.3 Billion across the top 7 markets (US, EU4, UK, and Japan) in 2024. Looking forward, IMARC Group expects the top 7 markets to reach US$ 4.9 Billion by 2035, exhibiting a growth rate (CAGR) of 3.83% during 2025-2035.

The hepatitis B market has been comprehensively analyzed in IMARC's new report titled "Hepatitis B Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2025-2035". Hepatitis B refers to a viral infection that severely affects the liver and is caused by the hepatitis B virus (HBV). The virus can cause acute and chronic conditions, with the latter being more serious and fatal. The symptoms of acute hepatitis B infection can range from mild to severe and include muscle and joint pain, fever, fatigue, nausea, vomiting, abdominal pain, loss of appetite, etc. As the disease progresses, several other indications, such as jaundice, dark urine, pale stools, etc., may also develop. Chronic hepatitis B infection often has no symptoms in its early stages, but over time it can lead to cirrhosis, liver damage, liver cancer, and even liver failure. The diagnosis of the ailment typically involves a blood test to check for the presence of hepatitis B virus (HBV) antigens and antibodies, as well as liver function tests to assess the level of liver enzymes and proteins in the blood. If the blood tests suggest an active HBV infection, further procedures, such as a hepatitis B viral load test, may be done to evaluate the amount of virus in the blood. Additionally, a liver biopsy may also be performed to determine the extent of liver damage in cases of chronic hepatitis B infection.

The rising cases of infections from the hepatitis B virus, which is transmitted through contact with infected blood or bodily fluids like semen and vaginal secretions, are primarily driving the hepatitis B market. Furthermore, the widespread adoption of antiviral medications, including entecavir, tenofovir, lamivudine, etc., for suppressing the replication of the virus in the body and preventing liver damage is also creating a positive outlook for the market. Apart from this, the emerging popularity of interferon therapy among patients with chronic hepatitis B who have not responded to other therapeutic procedures is acting as another significant growth-inducing factor. Additionally, the introduction of new treatment modalities for hepatitis B, including gene therapy and RNA interference (RNAi), which hold the potential to provide more effective and durable treatments for patients with chronic hepatitis B infection, is further propelling the market growth. Moreover, the inflating demand for immune modulators, such as pegylated interferon and thymosin alpha-1, since they boost the immune response and enhance the effectiveness of antiviral medications, is expected to drive the hepatitis B market in the coming years.

IMARC Group's new report provides an exhaustive analysis of the hepatitis B market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for hepatitis B and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc., have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the hepatitis B market in any manner.

Recent Developments:

• In March 2024, Gilead Sciences, Inc. revealed that the U.S. FDA has granted the supplemental new drug application for Vemlidy (tenofovir alafenamide) tablets at a dosage of 25 mg once daily for chronic hepatitis B infection in pediatric patients aged ≥ 6 years and weighing no less than 25 kg with compensated liver disease.
• In February 2024, TherVacB, a new therapeutic vaccine to address chronic hepatitis B, began its first clinical trial. The vaccine was developed and designed under the leadership of Helmholtz Munich. It aims to cure the disease by boosting the body’s innate system to fight against the infection.
• In February 2024, GSK declared that the U.S. FDA approved Fast Track designation for bepirovirsen, an experimental antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B. Bepirovirsen decreases viral DNA replication in the body, reduces the quantity of hepatitis B surface antigen in the blood, and boosts the immune system, thereby increasing the likelihood of a long-lasting and sustained response.
• In February 2024, Chula researchers devised a unique wireless hepatitis B virus test kit that screens for infection and collects data for an online database in a single step. This innovative diagnostic kit for targeting Hepatitis B surface antigen (HBsAg) uses an electrochemical biosensor based on the distinctive interaction of antigens and antibodies.

Key Highlights:

• It is estimated that more than 2 billion people are infected with hepatitis B worldwide.
• As per the Centers for Disease Control and Prevention (CDC), hepatitis B contributes to an estimated 820,000 deaths every year.
• The rate of acute hepatitis B infection cases reduced by 32% after 2019, possibly due to the disruptions caused by the COVID-19 pandemic.
• 25% of chronic hepatitis B infections progress to liver cancer.
• In the U.S., an estimated 880,000 to 1.89 million persons are chronically infected with the hepatitis B virus.

Drugs:

Baraclude (entecavir) is an oral antiviral drug used to manage chronic hepatitis B virus infection in people who have active viral replication, persistently elevated serum aminotransferases (ALT or AST), or histologically active illness. It is designed to specifically inhibit the hepatitis B virus by blocking all three steps in the replication process.

VIR-2218 is an experimental subcutaneously administered hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) that stimulates an immunological response and has effective antiviral action against hepatitis B and hepatitis delta viruses. It works by targeting the hepatitis B virus (HBV) genome, particularly HBsAg.

NCO-48 fumarate is a novel tenofovir liver-targeted prodrug (LTP). The liver-targeting ability of oral NCO-48 fumarate relies on the chemical change of tenofovir into an inactive prodrug form that is quickly absorbed and efficiently converted to tenofovir diphosphate in the liver. This results in high tenofovir diphosphate levels in the liver, where viral replication occurs, and low levels of tenofovir in the systemic circulation and kidney, which are susceptible to toxicity.

Time Period of the Study

• Base Year: 2024
• Historical Period: 2019-2024
• Market Forecast: 2025-2035

Countries Covered

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan
   

Analysis Covered Across Each Country

• Historical, current, and future epidemiology scenario
• Historical, current, and future performance of the hepatitis B market
• Historical, current, and future performance of various therapeutic categories in the market
• Sales of various drugs across the hepatitis B market
• Reimbursement scenario in the market
• In-market and pipeline drugs

Competitive Landscape:

This report also provides a detailed analysis of the current hepatitis B marketed drugs and late-stage pipeline drugs.

In-Market Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance    
   

Late-Stage Pipeline Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance
   

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.

Key Questions Answered in this Report:

Market Insights

• How has the hepatitis B market performed so far and how will it perform in the coming years?
• What are the markets shares of various therapeutic segments in 2024 and how are they expected to perform till 2035?
• What was the country-wise size of the hepatitis B market across the seven major markets in 2024 and what will it look like in 2035?
• What is the growth rate of the hepatitis B market across the seven major markets and what will be the expected growth over the next ten years?
• What are the key unmet needs in the market?
   

Epidemiology Insights

• What is the number of prevalent cases (​2019-2035​) of hepatitis B across the seven major markets?
• What is the number of prevalent cases (​2019-2035​) of hepatitis B by age across the seven major markets?
• What is the number of prevalent cases (​2019-2035​) of hepatitis B by gender across the seven major markets?
• What is the number of prevalent cases (​2019-2035​) of hepatitis B by type across the seven major markets?
• How many patients are diagnosed (​2019-2035​) with hepatitis B across the seven major markets?
• What is the size of the hepatitis B patient pool (2019-2024) across the seven major markets?
• What would be the forecasted patient pool (2025-2035) across the seven major markets?
• What are the key factors driving the epidemiological trend of hepatitis B?
• What will be the growth rate of patients across the seven major markets?
   

Hepatitis B: Current Treatment Scenario, Marketed Drugs and Emerging Therapies

• What are the current marketed drugs and what are their market performance?
• What are the key pipeline drugs and how are they expected to perform in the coming years?
• How safe are the current marketed drugs and what are their efficacies?
• How safe are the late-stage pipeline drugs and what are their efficacies?
• What are the current treatment guidelines for hepatitis B drugs across the seven major markets?
• Who are the key companies in the market and what are their market shares?
• What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the hepatitis B market?
• What are the key regulatory events related to the hepatitis B market?
• What is the structure of clinical trial landscape by status related to the hepatitis B market?
• What is the structure of clinical trial landscape by phase related to the hepatitis B market?
• What is the structure of clinical trial landscape by route of administration related to the hepatitis B market?