Hepatitis D Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Acute, Chronic), By Diagnosis (Blood Tests, Elastography, Liver Biopsy, Serologic Testing, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 2.01 Billion
CAGR (2026-2031)	5.24%
Fastest Growing Segment	Chronic
Largest Market	North America
Market Size (2031)	USD 2.73 Billion

Market Overview

The Global Hepatitis D Market will grow from USD 2.01 Billion in 2025 to USD 2.73 Billion by 2031 at a 5.24% CAGR. The Global Hepatitis D Market encompasses the development and commercialization of diagnostic assays and antiviral therapeutics designed to manage Hepatitis D Virus (HDV), a satellite virus that obligatorily requires the Hepatitis B Virus for replication. The primary drivers supporting market growth include the recent regulatory approval of novel entry inhibitors and the escalating global focus on managing viral hepatitis co-infections to reduce liver disease progression rates. According to the World Hepatitis Alliance, in 2025, an estimated 12 million people globally were living with hepatitis delta, representing a critical target demographic that necessitates urgent therapeutic access and drives the demand for effective pharmaceutical interventions.

However, a significant challenge impeding market expansion is the persistent lack of diagnostic accessibility and awareness, particularly in resource-limited settings where the disease is most prevalent. The high cost and technical complexity associated with confirmatory HDV RNA testing often prevent the identification of eligible patients, thereby limiting the commercial reach of approved treatments. This diagnostic gap creates a substantial barrier to market penetration, as a large portion of the infected population remains undiagnosed and unable to access specialized care.

Key Market Drivers

The Approval and Commercialization of Novel Antiviral Therapies serves as the primary catalyst propelling the Global Hepatitis D Market, fundamentally altering a treatment landscape previously limited to off-label interferon regimens. The successful market entry and reimbursement of first-in-class entry inhibitors have validated the commercial viability of HDV-specific drugs, driving revenue growth for key pharmaceutical stakeholders. This commercial traction is evidenced by the sustained performance of approved liver disease portfolios which now include targeted HDV therapies. According to Gilead Sciences, April 2025, in the 'First Quarter 2025 Financial Results', the company reported that its Liver Disease portfolio sales increased 3% to $758 million, primarily driven by increased demand for chronic hepatitis delta virus (HDV) and hepatitis B products.

Concurrently, the market is bolstered by a Robust Clinical Pipeline of Entry Inhibitors and Immunomodulators, which has attracted substantial late-stage investment and strategic acquisition activity. Pharmaceutical companies are aggressively securing rights to promising candidates such as monoclonal antibodies that neutralize viral entry, confirming the industry's long-term confidence in these therapeutic mechanisms. According to Mirum Pharmaceuticals, December 2025, in the 'Mirum to Acquire Bluejay Therapeutics' announcement, the company agreed to acquire Bluejay Therapeutics for an upfront payment of $620 million to secure rights to the late-stage antibody brelovitug. Despite these advancements, educational barriers persist; according to the World Hepatitis Alliance, May 2025, in the 'Hepatitis Delta Global Landscape Survey Report', 68.4% of community-based respondents identified a lack of general knowledge about the disease as the leading barrier to accessing testing and treatment.

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Key Market Challenges

The persistent lack of diagnostic accessibility significantly hampers the growth of the Global Hepatitis D Market by restricting the identifiable patient pool eligible for treatment. The market relies heavily on the administration of complex confirmatory RNA tests to verify active infection, yet these diagnostic tools are frequently unavailable or prohibitively expensive in the regions with the highest disease burden. This technical and economic barrier prevents healthcare providers from confirming cases, thereby severing the link between high disease prevalence and actual pharmaceutical demand. Without widespread access to these specific diagnostics, pharmaceutical companies cannot effectively penetrate high-need markets, as the majority of the target demographic remains undiagnosed and untreated.

This diagnostic bottleneck limits the total addressable market size by stalling patient discovery rates at the foundational level. According to the World Hepatitis Alliance, in 2024, only 13% of people living with chronic Hepatitis B infection were diagnosed globally. Since Hepatitis D is an obligate satellite virus that can only be identified after a confirmed Hepatitis B diagnosis, this low primary detection rate fundamentally caps the potential expansion of the Hepatitis D sector. The inability to capture this vast segment of the infected population directly undermines the commercial viability of novel antiviral therapies and restricts revenue generation.

Key Market Trends

The Rise in Strategic Biopharmaceutical Licensing and Acquisitions is reshaping the market structure as companies seek to mitigate development risks and secure commercial footprints for late-stage assets. Unlike the organic revenue growth seen with approved therapies, this trend is characterized by high-value exclusive agreements that validate the commercial potential of combination regimens, particularly those integrating RNA interference with monoclonal antibodies. This collaborative momentum is essential for capitalizing on regional markets and navigating the complex regulatory landscape of orphan drug indications. According to Pharmabiz.com, December 2025, in the 'Norgine inks exclusive licensing agreement with Vir Biotechnology' article, Vir Biotechnology secured a EUR 55 million initial payment to grant exclusive European rights for its investigational RNAi and antibody combination, underscoring the high market valuation placed on advanced pipeline candidates.

The Emergence of Novel Viral Entry Inhibitor Therapies is transitioning the sector towards patient-centric oral interventions, addressing the administration limitations of first-generation injectables. While current standards rely heavily on daily subcutaneous injections, the industry is aggressively funding the development of orally bioavailable small molecules that block viral entry via the sodium taurocholate cotransporting polypeptide (NTCP). This technological shift aims to enhance long-term adherence and expand treatment availability in non-specialized community settings. According to Assembly Biosciences, March 2025, in the 'Year End 2024 Financial Results', the company reported collaborative revenues of $28.5 million, largely driven by milestone payments for its next-generation oral antiviral pipeline, reflecting strong industry investment in non-injectable therapeutic alternatives.

Segmental Insights

The Chronic segment constitutes the fastest-growing category in the Global Hepatitis D Market, propelled by the urgent requirement for prolonged therapeutic regimens to manage persistent infections. This trajectory is underpinned by the aggressive nature of chronic Hepatitis D, which rapidly advances to cirrhosis and necessitates continuous medical oversight. Furthermore, the approval of novel antiviral agents by authorities such as the US Food and Drug Administration has validated the commercial viability of long-term treatments. Consequently, the increased focus on preventing liver decompensation through sustained medication is actively driving the rapid expansion of this market sector.

Regional Insights

North America maintains a dominant position in the Global Hepatitis D market, primarily driven by robust healthcare infrastructure and substantial investment in clinical research. The region benefits significantly from supportive regulatory environments, where agencies like the U.S. Food and Drug Administration (FDA) actively facilitate the approval process for novel therapeutics through special designations. Additionally, the strong presence of key pharmaceutical manufacturers encourages continuous innovation in treatment options. The widespread implementation of effective screening programs for viral co-infections further ensures higher diagnosis rates, thereby reinforcing North America’s leading status in the global landscape.

Recent Developments

• In May 2025, Gilead Sciences released final results from the pivotal Phase 3 MYR301 study concerning bulevirtide, a first-in-class entry inhibitor for chronic hepatitis D. The long-term data demonstrated that a significant proportion of adults treated with the drug maintained virologic suppression for nearly two years after stopping the treatment. Specifically, 36% of participants who achieved undetectable virus levels at the end of the therapy sustained this response during the follow-up period. This breakthrough research highlighted the potential for finite treatment durations to provide durable efficacy for patients living with this severe form of viral hepatitis.
• In December 2024, Assembly Biosciences announced a significant expansion of its collaboration with Gilead Sciences to advance the development of novel therapeutics for serious viral diseases, including hepatitis D. As part of this agreement, Gilead Sciences made a $20.1 million equity investment in Assembly Biosciences and provided additional funding to accelerate the clinical program for ABI-6250, an oral entry inhibitor for the hepatitis D virus. This strategic partnership aimed to leverage the combined expertise of both organizations to expedite the delivery of new treatment options to patients. The company expected to release further clinical data from its ongoing studies in the following year.
• In November 2024, Vir Biotechnology announced positive outcomes from the SOLSTICE Phase 2 clinical trial, which evaluated the safety and efficacy of tobevibart and elebsiran in individuals with chronic hepatitis D. The study results revealed that the combination therapy achieved a 100% virologic response rate and rapid suppression of the virus in participants. Based on these findings, the company confirmed plans to initiate a Phase 3 registrational program to further assess the combination regimen. The Executive Vice President of Vir Biotechnology highlighted the urgent need for effective therapies to prevent disease progression to cirrhosis and liver cancer.
• In June 2024, Bluejay Therapeutics presented positive preliminary data from a Phase 2 clinical trial evaluating BJT-778, a monoclonal antibody for the treatment of chronic hepatitis D. The results, shared at a major liver congress, demonstrated that 100% of patients in the first treatment arm achieved a virologic response after 28 weeks of therapy. Additionally, the data indicated that the treatment was well-tolerated and led to significant reductions in markers of liver inflammation. The Founder and CEO of Bluejay Therapeutics stated that these findings supported the potential of the drug to address unmet medical needs for patients globally.

Key Market Players

• F. Hoffmann-La Roche Ltd
• NanoGen Healthcare Pvt. Ltd.
• PROBIOMED SA de CV
• 3SBio Group
• Hepion Pharmaceuticals, Inc.
• Antios Therapeutics, Inc.
• PharmaEssentia Corporation
• Replicor
• Apotex Corp.
• Mylan N.V
• Aurobindo Pharma Limited

By Type	By Diagnosis	By Region
Acute Chronic	Blood Tests Elastography Liver Biopsy Serologic Testing Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Hepatitis D Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Hepatitis D Market, By Type:

• Acute
• Chronic

• Hepatitis D Market, By Diagnosis:

• Blood Tests
• Elastography
• Liver Biopsy
• Serologic Testing
• Others

• Hepatitis D Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE