Number of pages: 100 | Report Format: PDF | Published date: June 15, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
Report Attribute |
Details |
CAGR |
3.04% |
Base Year for Estimation |
2022 |
Forecast Period |
2023 to 2031 |
Historical Year |
2021 |
Segments Covered |
Type, Drug Class, Distribution Channel, and Region |
Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global hepatitis D market is expected to register a revenue CAGR of 3.04% during the predicted timeframe from 2023 to 2031.
Hepatitis D Market Fundamentals
Hepatitis D, also known as delta hepatitis, is a viral infection caused by the hepatitis D virus (HDV). It is considered a satellite virus because it can only replicate in the presence of the hepatitis B virus (HBV). HDV is an incomplete virus that requires the envelope proteins of HBV to form a complete infectious particle. Currently, the primary treatment option for hepatitis D involves using interferon alfa, specifically pegylated interferon alfa-2a or pegylated interferon alfa-2b. The use of antiviral drugs, such as nucleos(t)ide analogs used in the treatment of hepatitis B, is generally not effective against HDV.
Hepatitis D Market Dynamics
Growing awareness about hepatitis D among healthcare professionals and the general population has led to increased screening efforts. As a result, more cases of hepatitis D are being diagnosed, leading to a higher demand for diagnostic tests and potential treatments. The development of improved diagnostic technologies, such as nucleic acid amplification tests (NAATs) and serological assays, has enhanced the detection and monitoring of hepatitis D infection. These advancements contribute to early diagnosis, improved patient management, and a better understanding of disease epidemiology. Combination therapies involving pegylated interferon and nucleos(t)ide analogs or other antiviral agents are being explored as potential treatment approaches for hepatitis D. The aim is to achieve higher rates of sustained virological response and improved clinical outcomes compared to interferon monotherapy. Ongoing clinical trials and research studies are investigating novel therapeutic options for hepatitis D. This includes evaluating new antiviral agents, immunomodulatory drugs, and entry inhibitors that target specific stages of the viral life cycle. These studies contribute to the expansion of treatment options and potential breakthroughs in managing hepatitis D. For instance, in June 2021, Leading hepatology researchers designed a new development in hepatitis research at the International Liver Congress 2021. It included new data on antivirals to cure Hepatitis B and Hepatitis D and the application of infusion chemotherapy with P-1 inhibitors to treat liver cancer. Collaboration between pharmaceutical companies, research institutions, and government organizations is vital in advancing hepatitis D research and drug development. In December 2022, the New Zealand Medicines and Medical Devices Safety Authority permitted Bluejay Therapeutics a regulatory approval to initiate the clinical trials of BJT-778 for treating chronic hepatitis B and chronic hepatitis D. Partnerships facilitate the sharing of resources, expertise, and funding, accelerating progress in finding effective treatments for hepatitis D. Regulatory agencies and governments worldwide are recognizing the importance of addressing the unmet medical needs associated with hepatitis D. They are providing support and incentives to expedite drug development and facilitate access to potential therapies for patients with hepatitis D. The global burden of hepatitis D remains substantial, particularly in regions where hepatitis B is prevalent. For instance, according to ‘The Journal of Infectious Diseases,’ it was recorded that the overall prevalence of HDV (hepatitis D virus) in the general population was around 0.80% and 13.02% HBV carriers, equating to 48-60 million infections globally. This burden drives the need for improved diagnostics, treatment options, and public health interventions to prevent and manage hepatitis D, leading to increased investment and attention in the field.
Compared to other types of viral hepatitis, the treatment options for hepatitis D are limited. The complex interaction between HBV and HDV makes the management of hepatitis D challenging and necessitates a comprehensive approach. The cost of treatment for hepatitis D, particularly with pegylated interferon, can be significant. The prolonged duration of treatment and the potential need for retreatment in non-responders can further escalate the financial burden. Affordability and access to treatment pose challenges, especially in resource-limited settings or regions with a high prevalence of hepatitis D. The overall understanding of hepatitis D, including its epidemiology, natural history, and optimal treatment strategies, is still evolving. Limited research and clinical trials focusing specifically on hepatitis D restrict the availability of robust evidence-based guidelines and treatment recommendations. Managing co-infection (HBV and HDV simultaneous infection) and superinfection (HDV infection on top of chronic HBV infection) can be complex. Superinfection often leads to more severe liver disease, and managing the dual infection requires a tailored approach. The management of co-infection and superinfection may differ, posing additional challenges in treatment decisions.
Hepatitis D Market Ecosystem
The global hepatitis D market has been analyzed from the following perspectives: by type, drug class, distribution channel, and region.
Hepatitis D Market by Type
Based on the type, the global hepatitis D market is segmented into chronic hepatitis D and acute hepatitis D.
Chronic hepatitis D dominates the global market with the largest revenue share. Chronic hepatitis D is characterized by persistent infection and long-term liver inflammation caused by the hepatitis D virus (HDV). Unlike acute hepatitis D, which can resolve spontaneously in some cases, chronic hepatitis D tends to persist and progress over time. This leads to a higher number of individuals with chronic hepatitis D requiring ongoing medical management. Chronic hepatitis D is associated with more severe liver disease than hepatitis B alone. It has a higher risk of developing cirrhosis, liver failure, and hepatocellular carcinoma (liver cancer). The increased severity and complications of chronic hepatitis D necessitate regular monitoring, treatment, and specialized care, resulting in a higher demand for healthcare services and therapies specific to chronic hepatitis D. Spontaneous clearance of hepatitis D occurs in a minority of cases, particularly in co-infection with acute hepatitis B and D. However, in most cases of chronic hepatitis D, the infection persists long-term. The inability to clear the virus naturally leads to a higher prevalence of chronic hepatitis D cases than acute cases. The lack of specific antiviral drugs targeting HDV replication contributes to the challenges in managing chronic hepatitis D effectively. The limited treatment options and the need for ongoing management contribute to the dominance of the chronic hepatitis D segment in the market. Chronic hepatitis D requires long-term disease management and regular follow-up to monitor liver function, viral load, and disease progression. This leads to sustained demand for healthcare services, including diagnostic tests, routine monitoring, and potential treatment interventions. The need for continuous management of chronic hepatitis D patients drives the dominance of this segment in the market.
Hepatitis D Market by Drug Class
Based on the drug class, the global hepatitis D market is segmented into antiviral, interferons-alfa (pegylated interferon-alpha), and others (including Bulevirtide)
Interferon alfa leads the global market with a prominent revenue share. Interferon alfa, specifically pegylated interferon alfa-2a or pegylated interferon alfa-2b, is the most widely studied and established treatment option for hepatitis D. It has been used for many years. It has demonstrated some effectiveness in suppressing HDV replication and achieving a sustained virological response in a subset of patients. Interferon alfa has direct antiviral activity against HDV, which is crucial in managing hepatitis D. It can inhibit HDV replication, reduce viral load, and potentially slow down disease progression. This specific activity against HDV makes interferon alfa a key therapeutic option for hepatitis D treatment. Interferon alfa has shown the potential to induce sustained remission in some patients with chronic hepatitis D. Currently, there are no approved specific antiviral drugs targeting HDV replication available. This lack of alternatives further strengthens the position of interferon alfa as the dominant treatment option for hepatitis D. Interferon alfa has been widely used in the field of viral hepatitis, including hepatitis D, for many years. Its established market presence, familiarity among healthcare professionals, and availability in multiple regions contribute to its dominance in the market.
Hepatitis D Market by Distribution Channel
Based on the distribution channel, the global hepatitis D market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies.
Hospital pharmacies dominate the global market with the largest revenue share. The treatment options for hepatitis D, such as interferon alfa, are specialized medications that require proper handling, storage, and administration. Hospital pharmacies are well-equipped and staffed to handle these requirements. They have the necessary infrastructure, temperature-controlled storage facilities, and trained personnel to handle and dispense these specialized medications. The treatment of hepatitis D often involves complex treatment regimens, including the administration of injections and monitoring of patient response. Hospital pharmacies are better equipped to manage and coordinate the logistics of such treatment regimens, ensuring appropriate drug supply, dosage adjustments, and monitoring of patient adherence. Hospital pharmacies work closely with healthcare providers, including hepatologists and infectious disease specialists, who play a key role in diagnosing and managing hepatitis D. Collaboration between hospitals and healthcare providers ensures optimal medication selection, dosing, and monitoring based on individual patient needs and treatment response. Hospital pharmacies often provide specialized services, such as compounding medications, to tailor treatments to individual patient needs. In the case of hepatitis D, where treatment options are limited, hospital pharmacies may be involved in preparing individualized treatment regimens, such as compounding pegylated interferon, to meet specific patient requirements. Hospital pharmacies also provide patient counseling and support services to promote medication adherence and address any concerns or side effects related to hepatitis D treatment. Hospital pharmacies are well-versed in adhering to regulatory requirements for dispensing and administering specialized medications. They ensure compliance with regulations, such as proper documentation, record-keeping, and reporting adverse events, which is crucial in managing hepatitis D.
Hepatitis D Market by Region
Based on the region, the global hepatitis D market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America dominates the global market with the largest revenue share. North America has a significant burden of hepatitis D, particularly in certain populations. The region has pockets of high prevalence, including communities with high rates of injection drug use and individuals with chronic hepatitis B infection. The higher disease burden contributes to increased demand for diagnostic tests, treatment options, and specialized care, driving the dominance of the North America segment. North America boasts advanced healthcare infrastructure, including well-established healthcare systems, hospitals, and clinics. This infrastructure facilitates efficient diagnosis, treatment, and management of hepatitis D. Availability of specialized healthcare professionals, advanced diagnostic technologies, and access to specialized treatments like interferon alfa contribute to the dominance of this region. North America is a hub for medical research and development, including the field of viral hepatitis. Many clinical trials, studies, and research initiatives focused on hepatitis D take place in North America. This concentration of research activities drives innovation, advances in understanding the disease, and the development of new treatment approaches, further strengthening the dominance of the North America segment. Compared to some other regions, North America has relatively high access to healthcare services, including diagnostic testing, medications, and specialized care. The presence of comprehensive insurance systems, government healthcare programs, and a relatively high standard of living supports access to healthcare for individuals with hepatitis D, contributing to the dominance of the North America segment. Increased awareness campaigns, educational programs, and screening initiatives have contributed to the early detection, diagnosis, and management of hepatitis D in the region. This proactive approach to promoting awareness and screening helps identify cases and drive the demand for appropriate healthcare services and interventions. North America is home to several leading pharmaceutical companies and research institutions actively involved in developing hepatitis D treatments.
Hepatitis D Market Competitive Landscape
The prominent players operating in the global hepatitis D market are:
Hepatitis D Market Strategic Developments
Hepatitis D is a liver disease caused by the hepatitis D virus (HDV). HDV is known as a satellite virus because it can only infect people who are also infected by the hepatitis B virus (HBV). HDV infection can be acute or lead to chronic, long-term illness.
F. Hoffmann-La Roche Ltd., Merck & Co. Inc., and Janssen Pharmaceuticals Inc. are some of the major market players in the global hepatitis D market.
Lack of data and research and limitation in the availability of treatment are some of the restraints obstructing the growth of the global market.
The chronic Hepatitis D segment dominated the global hepatitis D market in 2022.
Growing cases of Hepatitis D among the people and increasing clinical trials for novel drug development are some of the major factors driving the global market.
*Insights on financial performance are subject to the availability of information in the public domain