DelveInsight’s ‘Hepatitis D Virus (HDV) - Market Insights, Epidemiology, and Market Forecast—2030’ report delivers an in-depth understanding of the HDV, historical and forecasted epidemiology as well as the HDV market trends in the United States, EU5 (Germany, France, Italy, Spain, and United Kingdom), and Japan.
The HDV market report provides current treatment practices, emerging drugs, HDV market share of the individual therapies, current and forecasted HDV market size from 2017 to 2030 segmented by seven major markets. The Report also covers current HDV 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.
• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Study Period: 2017–2030
Hepatitis D Virus (HDV): Disease Understanding and Treatment Algorithm
Hepatitis D Virus (HDV) Overview
Hepatitis D is caused by infection with the hepatitis D virus (HDV), also known as Delta Virus, and is considered to be the most severe form of viral hepatitis in humans due to more rapid progression toward liver-related death and hepatocellular carcinoma. HDV occurs only in individuals positive for the hepatitis B virus (HBV) surface antigen (HBsAg) as HDV is a defective RNA viroid that requires HBsAg for transmission. HDV shares common modes of transmission as HBV and can be acquired either as coinfection or superinfection to HBV. Simultaneous infection (i.e. co-infection) with HBV and HDV can lead to a mild-to-severe or even fulminant hepatitis, whereas the super-infection of HDV on chronic hepatitis B accelerates progression to a more severe disease in all ages and in 70‒90% of people.
The mode of transmission is commonly through contact with blood or other body fluids, including sexual contact with an infected partner, injection-drug use that involves sharing needles, syringes, or drug-preparation equipment and needle sticks or exposures to sharp instruments. Vertical transmission from mother to child is rare. Infection with HDV can worsen symptoms of HBV infection or hepatitis B-associated liver disease. It can cause symptoms to occur in people who previously did not have symptoms of HBV infection. The symptoms of HDV infection are similar to those experienced with HBV infection and can include yellowing of the skin and eyes (jaundice), gastrointestinal (GI) issues such as nausea, vomiting, and abdominal pain, tiredness, loss of appetite, dark-colored urine, joint pain, etc.
The severity of hepatitis D is influenced by the HDV genotype. Although infection with multiple genotypes may occur in patients at high risk of repeated exposure such as injecting drug users, a single genotype usually predominates with >10% of the viral load being represented by the minor strain. There are at least 8 genotypes (genetic variants) of HDV based on 14–38% sequence variation. These genotypes are associated with different long-term outcomes. Genotype 1 chronic HDV super-infection usually leads to a rapid progression to cirrhosis. Genotypes 2 and 4 cause a milder disease over a longer time course whereas genotype 3 is associated with advanced necroinflammatory.
Hepatitis D Virus (HDV) Diagnosis
The diagnosis of HDV is based on the medical history, a physical exam, and blood tests of the patients. HDV infection is diagnosed by high levels of Immunoglobulin G (IgG) and Immunoglobulin M (IgM) anti-HDV. As cases of hepatitis D are not clinically distinguishable from other types of acute viral hepatitis, diagnosis can be confirmed only by testing for the presence of antibodies against HDV and/or HDV RNA. The doctor may recommend tests to find out whether the patient has liver damage or how much liver damage or to rule out other causes of liver disease. These tests may include elastography, a special ultrasound that measures the stiffness of the liver, liver enzyme function tests, and a liver biopsy, wherein a doctor uses a needle to take a small piece of tissue from the liver.
Hepatitis D Virus (HDV) Treatment
Treatment options for HDV are limited and optimal treatment is not known. There are no known treatments for acute HDV. The goal of treatment is to suppress HDV replication which is shown by the inability to detect HDV RNA in serum and HDAg in the liver. Pegylated interferon-alpha has shown some efficacy, but the sustained virologic response rate (a measure of viral clearance) is low. The pegylated form of IFN alpha is recommended to be the preferred agent as per expert guidelines. Hepcludex is the first therapy approved in Europe and has been granted Conditional Marketing Authorization (CMA) for the treatment of HDV. It works as an entry inhibitor that is, it prevents HDV cells and the HBV cells upon which HDV is prevented, from entering healthy liver cells. Liver transplantation is the only treatment option for patients with end-stage liver cirrhosis resulting from HDV.
The HDV epidemiology division provides insights about the historical and current HDV patient pool and forecasted trends for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
In the year 2017, the Total Diagnosed Prevalent cases of HDV was 204,976 in the 7MM which are expected to grow during the study period, i.e., 2017–2030.
The disease epidemiology covered in the report provides historical as well as forecasted HDV epidemiology [segmented as Total Diagnosed Prevalent Cases of HDV, Gender-specific Diagnosed Prevalent Cases of HDV, Age-specific Diagnosed Prevalent Cases of HDV, Diagnosed Prevalent Cases of HDV by Impact on Liver and Treated cases of HDV] in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2017 to 2030.
Country Wise- HDV Epidemiology
Estimates show that the highest cases of HDV in the 7MM were in the United States, followed by Japan, Germany, Italy, Spain, the United Kingdom, and France in 2017.
• In the United States, the total diagnosed prevalent cases of HDV was 112,673 cases in the year 2017 which are expected to grow during the study period, i.e., 2017–2030.
• In the year 2017, the total diagnosed prevalent cases of HDV were 64,845 cases in EU-5 which are expected to grow during the study period, i.e., 2017–2030.
• In Japan, the total diagnosed prevalent cases of HDV was 27,458 cases in the year 2017 which are expected to grow during the study period, i.e., 2017–2030.
HDV Drug Chapters
The drug chapter segment of the HDV report encloses the detailed analysis of HDV marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the HDV 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.
HDV Emerging Drugs
Hepcludex/Bulevirtide (MYR Pharmaceuticals/Hepatera)
Hepcludex (Bulevirtide) is a novel drug candidate for the treatment of chronic HDV. Its antiviral mode of action relies on specific binding and blockage of the hepatocyte surface protein NTCP. Bulevirtide-mediated inhibition of NTCP prevents entry of HBV and HDV into the cell, hence infection of hepatocytes is prevented. It was previously known as Myrcludex B.
In August 2020, the European Commission (EC) granted the Conditional Marketing Authorization (CMA) for Hepcludex. It has been approved as the first treatment option for adult patients with chronic HDV infection and compensated liver disease in Europe. In September 2020, MYR Pharmaceuticals announced that Hepcludex (bulevirtide) has been successfully launched in Germany, France, and Austria.
Lonafarnib (Eiger Biopharmaceuticals)
Lonafarnib is in development as a first-in-class prenylation inhibitor, boosted with ritonavir, for the treatment of HDV infection. Lonafarnib is a well-characterized, orally active inhibitor of farnesyl transferase, an enzyme involved in the modification of proteins through a process called prenylation, a vital process in the life cycle of HDV.
In January 2014, an orphan designation (EU/3/13/1225) was granted by the European Commission to lonafarnib for the treatment of HDV infection. Then in December 2018, the European Medicines Agency (EMA) granted PRIME (PRIority MEdicines) designation for lonafarnib. Also, in 2018, the US FDA granted Breakthrough Therapy designation for lonafarnib for the treatment of HDV infection.
Peginterferon Lambda (Eiger Biopharmaceuticals)
Peginterferon Lambda is a well-characterized, late-stage, first in class, type III interferon (IFN) being developed as better-tolerated interferon. Lambda stimulates immune responses that are critical for the development of host protection during viral infections. Eiger Pharmaceuticals is developing it as both a monotherapy and in combination therapy with Lonafarnib + Ritonavir
In August 2019, the US FDA granted Breakthrough Therapy Designation for peginterferon lambda (Lambda) for the treatment of HDV infection. Previously, in September 2017, the US FDA granted an orphan designation for pegylated interferon lambda 1a as a potential treatment for chronic HDV infection. Also, in July 2017, the US FDA granted Fast Track designation for pegylated interferon lambda 1a (Lambda).
JNJ-73763989 (Janssen Biopharmaceuticals)
JNJ-73763989 also known as JNJ-3989 is a liver-targeted antiviral therapeutic for subcutaneous injection via ribonucleic acid interference mechanism. It is designed to silence all HBV gene products and intervenes upstream of the reverse transcription process. The trials are also being conducted by the company for JNJ-73763989 to treat chronic HBV infection.
Note: Detailed emerging therapies assessment will be provided in the final report.
HDV Market Outlook
Currently, treatment strategies for HDV mainly include interferon (IFN)-based therapy. Antiviral therapy with interferon alfa can be considered in patients with chronic hepatitis D virus (HDV) infection. The treatment course is usually at least 1 year. PegIFNa is the only available drug that has been proven to have some antiviral efficacy against chronic HDV infection. Interferons may be effective at a very early stage of infection when HDV is entering hepatocytes rather than at the stage of established intracellular hepatocyte HDV infection. Recently, Hepcludex has been approved as the first treatment option for adult patients with chronic HDV infection and compensated liver disease in Europe.
At present, some companies have indulged themselves to initiate clinical trials that investigate new treatment options. Key players such as Eiger Biopharmaceuticals (Lonafarnib, Peginterferon Lambda-1A), Janssen Pharmaceuticals (JNJ-73763989), and several others are investigating their candidates for the management of HDV in the 7MM.
The HDV market size in the 7MM is expected to change during the study period 2017–2030. The therapeutic market of HDV in the seven major markets was USD 285.1 million in 2017 which is expected to increase during the study period (2017–2030). According to the estimates, the highest market size of HDV is found in the United States followed by Japan and Germany.
The United States Market Outlook
In 2017, the total market size of HDV therapies was USD 212.4 million in the United States which is expected to increase in the study period (2017–2030).
EU-5 Countries: Market Outlook
In 2017, the total market size of HDV therapies was USD 49.2 million in the EU-5 countries which is expected to increase in the study period (2017–2030).
Japan Market Outlook
The total market size of HDV therapies in Japan was USD 23.5 million in 2017 which is expected to increase in the study period (2017–2030).
HDV Pipeline Development Activities
The drugs which are in pipeline include:
• Hepcludex/Bulevirtide (MYR Pharmaceuticals/Hepatera)
• Lonafarnib (Eiger Biopharmaceuticals)
• Peginterferon Lambda (Eiger Biopharmaceuticals)
• JNJ-73763989 (Janssen Biopharmaceuticals)
Note: Detailed emerging therapies assessment will be provided in the final report.
HDV Drugs Uptake
Among emerging therapies, Lonafarnib + Ritonavir ± Peginterferon-Alfa combo from Eiger BioPharmaceuticals expected to garner the highest patient share owing to expected early mover advantage, patient-friendly dosing (i.e. oral), and promising efficacy signals in early-stage trials.
Access and Reimbursement Scenario in HDV Therapies
Currently, no vaccine is available for hepatitis D. Hepatitis B vaccine is the single most crucial tool to prevent HBV-HDV coinfection since persons immune from HBV infection cannot become infected with HDV. In the UK, children and adults in high-risk groups are offered the vaccine. All babies in the UK born on or after 1 August 2017 are given three doses of hepatitis B-containing vaccine as part of the NHS routine vaccination schedule. These doses are given at 8, 12, and 16 weeks of age. Babies born to mothers with hepatitis B infection will be given 6 doses of hepatitis B-containing vaccine to ensure long-lasting protection.
Note: HTA assessment will be provided in the final report.
To keep up with current market trends, we take KOLs and SME’s opinion working in the HDV 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 HDV market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
Competitive Intelligence Analysis
We perform Competitive and Market Intelligence analysis of the HDV 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 Report
• The report covers the descriptive overview of HDV, explaining its causes, signs and symptoms, pathophysiology, and currently available therapies.
• Comprehensive insight has been provided into the HDV epidemiology and treatment in the 7MM.
• Additionally, an all-inclusive account of both the current and emerging therapies for HDV is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the HDV 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 HDV market.
• In the coming years, the HDV 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 HDV R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for HDV. The launch of emerging therapies will significantly impact the HDV market.
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for HDV.
• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), 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 overall scenario of the research and development activities.
HDV Report Insights
• Patient Population
• Therapeutic Approaches
• HDV Pipeline Analysis
• HDV Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies
HDV Report Key Strengths
• 11 Years Forecast
• 7MM Coverage
• HDV Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake
HDV Report Assessment
• SWOT Analysis
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Conjoint Analysis
• Market Attractiveness
• Market Drivers and Barriers
• What was the HDV Market share (%) distribution in 2017 and how it would look like in 2030?
• What would be the HDV 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 HDV market size during the study period (2017–2030)?
• At what CAGR, the HDV market is expected to grow in the 7MM during the study period (2017–2030)?
• What would be the HDV market outlook across the 7MM during the study period (2017–2030)?
• What would be the HDV 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 subsequent analysis of the associated trends?
• HDV 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 based on their clinical trial results?
• Among the emerging therapies, what are the potential therapies which are expected to disrupt the HDV market?
• What are the disease risk, burdens, and unmet needs of the HDV?
• What is the historical HDV 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 HDV 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 HDV?
• Out of all the 7MM countries, which country would have the highest prevalent population of HDV 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 HDV?
Current Treatment Scenario and Emerging Therapies:
• What are the current options for the treatment of HDV?
• What are the current treatment guidelines for the treatment of HDV in the US, Europe, and Japan?
• How many companies are developing therapies for the treatment of HDV?
• How many therapies are developed by each company for the treatment of HDV?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of HDV?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the HDV 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 HDV and their status?
• What are the key designations that have been granted for the emerging therapies for HDV?
• What is the global historical and forecasted market of HDV?
Reasons to buy
• The report will help in developing business strategies by understanding trends shaping and driving the HDV market.
• To understand the future market competition in the HDV market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for HDV in the US, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
• Identification of strong upcoming players in the 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 the HDV market.
• To understand the future market competition in the HDV market.
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