Chronic Hepatitis B Virus (CHB) Market

1. Chronic Hepatitis B Virus (CHB) 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 the 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 best of the opportunities and assesses underlying potential of the market. Geography Covered    The United States EU5 (Germany, France, Italy, Spain and the United Kingdom) Japan Study Period: 2017–2030 Download report: https://www.delveinsight.com/report-store/chronic-hepatitis- b-virus-market Chronic Hepatitis B Virus (CHB): Disease Understanding and Treatment Algorithm Chronic Hepatitis B Virus 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.

2. 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. 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. Request for sample pages: request/chronic-hepatitis-b-virus-market Chronic Hepatitis B Virus 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.Those who are HBsAg-negative and have detectable anti- HBs are already immune (generally from prior vaccination or recovery from an acute infection) and do not require further intervention or testing. A patient who tests positive for HBsAg has an active HBV infection, and further testing is needed to determine the phase of disease and course of action. Recommended initial follow-up testing includes serum ALT and HBV DNA levels, as well as serology for hepatitis B e antigen (HBeAg) and antibody to HBeAg (anti-HBe). Individuals with chronic HBV infection have circulating HBsAg persistently present in their serum for more than 6 months (without developing anti-HBs). The hepatitis B virus specifically attacks the liver, so health care providers order blood tests to monitor the health of the liver. Some of the most common liver-related blood tests are described below. These blood tests measure potential liver damage (or liver inflammation). If a person is infected with the hepatitis B virus, the liver cells can be injured by the virus, and then the liver enzymes can leak into the bloodstream. The higher the number, the greater the risk of potential liver damage. Chronic Hepatitis B Virus Treatment Currently, treatment strategies for CHB mainly include Antiviral medications. To this date, several drugs have been approved by the US 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. The therapies that are approved for the treatment of CHB are Tenofovir disoproxil (Viread), Tenofovir alafenamide (Vemlidy), Entecavir (Baraclude), Telbivudine (Tyzeka or Sebivo), Adefovir Dipivoxil (Hepsera), and Lamivudine (Epivir-HBV, Zeffix, or Heptodin), among others. https://www.delveinsight.com/sample-

3. Click https://www.delveinsight.com/sample-request/chronic-hepatitis-b-virus-market CHB Epidemiology The CHB epidemiology division provides the insights about historical and current CHB patient pool and forecasted trend for each 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. Key Findings In the year 2017, the total prevalent cases of CHB was 5,797,240 cases in the 7MM which are expected to grow during the study period, i.e., 2017–2030. The Chronic Hepatitis B Virus epidemiology covered in the report provides historical as well as forecasted CHB epidemiology segmented as [Total Prevalent Cases of CHB, Diagnosed cases of CHB, Gender-specific cases of CHB, Diagnosed cases of CHB by Age Distribution, Diagnosed cases of CHB by Impact on Liver, and Treated cases of CHB] scenario of CHB 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- CHB Epidemiology  Estimates show that the highest prevalent cases of CHB in the 7MM were in the United States, followed by Japan, Germany, the United Kingdom, France, Italy, and Spain in 2017.  The United States, in 2017, accounted for 2,276,030 CHB prevalent cases, which are expected to grow during the study period, i.e., 2017–2030.  In the year 2017, the total prevalent cases of CHB in EU5 were 2,231,406, which are expected to grow during the study period, i.e., 2017–2030.  In the year 2017, the total prevalent cases of CHB in Japan were 1,289,804, which are expected to grow during the study period, i.e., 2017–2030. CHB Drug Chapters Drug chapter segment of the CHB report encloses the detailed analysis of CHB marketed drugs and late stage (Phase-III and Phase-II) 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 Approved Drugs 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). It was observed that Vemlidy was usually well-tolerated by patients in both studies and discontinuations due to adverse events were approximately 1% and 1.2%, respectively, apart from this the most commonly reported adverse events in both studies included headache, abdominal pain, fatigue, cough, nausea and back pain and occurred at similar rates in patients receiving Vemlidy. here and get access to free sample pages:

4. Note: Detailed Current therapies assessment will be provided in the full report of CHB CHB Emerging Drugs JNJ-56136379/JNJ-6379 (Janssen Sciences) 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. Cemiplimab/REGN2810 (Regeneron Pharmaceuticals) Cemiplimab (REGN2810) is a human recombinant monoclonal IgG4 antibody to the programmed cell death receptor 1 (PD-1) which has distinctive immunomodulatory activity and is used in cancer immunotherapy. It is under investigation by Regeneron Pharmaceuticals for Hepatitis B Virus infection. Cemiplimab targets and blocks the PD-1 pathway, thus helping the immune system to fight cancer cells. It binds to the PD-1 receptor found on T-cells, blocking its interaction with PD ligand 1 (PD-L1) and PD-L2, thereby inhibiting T-cell proliferation and cytokine production. Cemiplimab was approved for use in cutaneous squamous cell carcinoma in the United States in 2018 and is currently under evaluation in several other forms of cancer, including non- small cell lung cancer, renal, ovarian and uterine carcinoma, lymphomas and multiple myeloma. Note: Detailed emerging therapies assessment will be provided in the final report. Request for sample pages: request/chronic-hepatitis-b-virus-market CHB Market Outlook Currently, treatment strategies for CHB mainly include Antiviral medications. To this date, several drugs have been approved by the US 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. It is important to mention that INF-α was the first substance licensed to treat CHB virus infections. At present, two types of interferon have been approved for Chronic Hepatitis B Virus treatment: interferon α- 2b (Intron A; Schering-Plough) and pegylated interferon α-2a (PEG-IFN; Pegasys; Roche). Lamivudine was approved in 1998 by the US FDA for the treatment of chronic hepatitis B infections. It was the first NAs to be approved for the treatment of CHB. In 1998, the approval for the drug was granted for adults and in 2001 for children aged 2–17 years. However, this drug has been used and approved for HIV infection since 1995. In addition to this, Adefovir is the second NA approved for the treatment of CHB and has been shown to be effective in both HBeAg-positive and HBeAg-negative CHB. Adefovir dipivoxil was licensed in the United States as Hepsera in 2002 for the treatment of CHB. Hepsera 10 mg is indicated for the treatment of chronic hepatitis B infection in patients 12 years of age and older. It is administered orally at a dose of 10 mg daily. This candidate was also initially developed as an antiretroviral drug for HIV infection, however, was abandoned due to the high rate of nephrotoxicity at high doses. This candidate is approved in Europe in 2003, and GlaxoSmithKline commercializes the product in Japan, China, and Saudi Arabia. “It is worth mentioning that, currently, the preferred first-line oral antiviral therapies for CHB as recommended by the American Association for the Study of Liver Diseases (AASLD) include tenofovir disoproxil fumarate, entecavir, and more recently, tenofovir alafenamide. In addition to the AASLD, as per the guidelines from the European Association https://www.delveinsight.com/sample-

5. for the Study of the Liver (EASL), the preferred regimens are entecavir, tenofovir disoproxil fumarate, and tenofovir alafenamide as monotherapies as one of the preferred first-line therapies to treat CHB.” In conclusion, it can be summarized that as many potential therapies are being investigated for the management of CHB, it is safe to predict that the treatment space will experience a significant impact during the forecast period of 2020–2030. Note: Detailed Market Outlook will be provided in the final report. Key Findings The Chronic Hepatitis B Virus market size in the 7MM is expected to change during the study period 2017– 2030. The therapeutic market of CHB in the seven major markets was USD 1,657 million in 2017 which is expected to increase during study period (2017–2030). According to the estimates, the highest market size of CHB is found in the United States followed by Japan and Germany. The United States Market Outlook In 2017, the total market size of CHB therapies was USD 1,097 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 CHB therapies was USD 312 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 CHB therapies in Japan was USD 249 million in 2017 which is expected to increase in the study period (2017–2030). CHB Pipeline Development Activities The drugs which are in pipeline include:            JNJ-56136379/JNJ-6379 (Janssen Sciences) Sci-B-Vac (VBI Vaccines) Vesatolimod/GS-9620 (Gilead Sciences) GS-9688/Selgantolimod (Gilead Sciences) RG7854 and RG7907 combination (Roche) JNJ-73763989 and/or JNJ-56136379 (Janssen/Arrowhead Pharmaceuticals) Cemiplimab/REGN2810 (Regeneron Pharmaceuticals) GSK3228836/ISIS 505358 or IONIS-HBVRX (GlaxoSmithKline/Ionis Pharma) GSK3389404/IONIS-HBV-LRX (GlaxoSmithKline/Ionis Pharma) ABI-H2158 (Assembly Biosciences) Vebicorvir/VBR, or ABI-H0731 (Assembly Biosciences) Note: Detailed emerging therapies assessment will be provided in the final report. View full report: https://www.delveinsight.com/report-store/chronic-hepatitis-b- virus-market Request for sample pages: request/chronic-hepatitis-b-virus-market https://www.delveinsight.com/sample-