North America Hepatitis Delta Virus (HDV) Infection Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032

North America Hepatitis Delta Virus (HDV) Infection Market Size

• The North America hepatitis delta virus (HDV) infection market size was valued at USD 7.13 million in 2024 and is expected to reach USD 10.06 million by 2032, at a CAGR of 4.60% during the forecast period
• The market growth is largely fueled by the rising prevalence of co-infection with hepatitis B virus (HBV) and the increasing awareness regarding liver health, especially in endemic countries across the North America region. Government-led public health initiatives and improved diagnostic capabilities are enabling early detection and treatment of HDV, thus accelerating market expansion
• Furthermore, growing investment in antiviral research and the launch of advanced therapeutics—including RNA-targeted agents and novel interferon therapies—are establishing HDV-targeted treatments as a critical segment within the broader hepatology space. These converging factors are accelerating the uptake of North America Hepatitis Delta Virus (HDV) Infection solutions, thereby significantly boosting the industry's growth across emerging and developed healthcare markets in the region

North America Hepatitis Delta Virus (HDV) Infection Market Analysis

• The North America Hepatitis Delta Virus (HDV) Infection market is experiencing significant growth due to increasing awareness, improved diagnostic capabilities, and enhanced access to advanced healthcare services across developed countries in the region
• The growing burden of liver-related diseases, rising healthcare expenditures, and government-led hepatitis elimination programs are the primary factors driving market expansion in North America
• The U.S. dominated the North America hepatitis delta virus (HDV) infection market with the largest revenue share of 46.84% in 2024, driven by its robust healthcare infrastructure, advanced diagnostic technologies, and widespread implementation of hepatitis control programs across federal and state levels
• Mexico is expected to witness the fastest-growing country in the North America hepatitis delta virus (HDV) infection market with a CAGR of 6.9% during the forecast period, fueled by rising healthcare awareness, increasing investment in public health infrastructure, and collaborative efforts with international health agencies to expand hepatitis screening and treatment access
• The Parenteral route of administration segment dominated the North America hepatitis delta virus (HDV) infection market with a share of 66.5% in 2024, supported by the widespread use of injectable pegylated interferon as the standard treatment, ensuring effective viral suppression and alignment with established clinical protocols throughout the region

Report Scope and North America Hepatitis Delta Virus (HDV) Infection Market Segmentation

North America Hepatitis Delta Virus (HDV) Infection Market Trends

“Increasing Adoption of Advanced Diagnostic and Monitoring Technologies”

• A significant and accelerating trend in the North America hepatitis delta virus (HDV) infection market is the deepening integration of advanced diagnostic platforms and digital health ecosystems, aimed at improving early detection, disease monitoring, and patient compliance
  • For instance, leading diagnostic manufacturers are launching HDV-specific test kits and real-time PCR-based solutions that enable faster and more accurate detection of HDV in co-infected hepatitis B patients. These advancements are being increasingly adopted across hospitals and diagnostic centers in countries such as China, India, and Japan
• Digital health platforms are also enabling more efficient disease tracking, patient education, and follow-up care. Some mobile health apps now assist healthcare professionals in monitoring liver function, treatment adherence, and patient-reported outcomes, thereby facilitating more personalized HDV care pathways
• The seamless integration of diagnostic tools with electronic medical records (EMRs) and national hepatitis registries is further enhancing surveillance capabilities, enabling policymakers to allocate resources effectively and target high-risk populations
• This trend toward more intelligent, data-driven, and interconnected disease management solutions is fundamentally reshaping expectations around HDV care and treatment. As a result, companies and healthcare systems across the North America region are investing in scalable diagnostic innovations and telemedicine platforms to extend their reach
• The demand for reliable, fast, and integrated diagnostic tools is growing rapidly across both public and private healthcare sectors, as stakeholders increasingly prioritize early intervention, efficient patient tracking, and comprehensive infectious disease management

North America Hepatitis Delta Virus (HDV) Infection Market Dynamics

Driver

“Growing Need Due to Increasing Disease Burden and Unmet Medical Needs”

• The North America hepatitis delta virus (HDV) infection market is witnessing accelerated growth due to the rising prevalence of hepatitis B and D co-infections, which contribute to the growing demand for effective diagnostics and therapeutics in the region
  • For instance, countries such as China, India, and Pakistan report high HBV carrier rates, increasing the risk of HDV superinfections. This has prompted regional governments and health agencies to prioritize hepatitis screening and treatment programs, thereby boosting the HDV market
• Furthermore, increasing healthcare expenditure, expanding access to diagnostic testing, and heightened awareness campaigns regarding viral hepatitis are contributing significantly to the region’s demand for HDV treatment solutions
• Advancements in antiviral therapies and liver disease management, alongside partnerships between global pharmaceutical companies and local healthcare providers, are expected to accelerate HDV drug development and distribution across Asia-Pacific
• The emergence of new therapeutic approaches—such as bulevirtide and other entry inhibitors—and rising participation in clinical trials are strengthening the treatment landscape in the region

Restraint/Challenge

“Limited Access to Specialized Diagnostics and Cost Constraints”

• Despite growing demand, several countries across North America face challenges in diagnosing and treating Hepatitis D due to the limited availability of HDV-specific testing kits and the need for advanced laboratory infrastructure
• Delayed diagnosis due to low awareness among healthcare professionals and patients continues to be a major barrier, especially in rural or low-resource settings
• In addition, the high cost of HDV therapeutics, such as emerging biologics or entry inhibitors, limits affordability for a large segment of the population
• Reimbursement limitations and the absence of targeted national strategies in some APAC countries also hinder access to standardized HDV treatment pathways
• To overcome these challenges, increased funding for liver disease screening programs, development of affordable biosimilars, and stronger healthcare infrastructure are essential to unlock the full potential of the North America HDV Infection market

North America Hepatitis Delta Virus (HDV) Infection Market Scope

The market is segmented on the basis of type, treatment, drug type, route of administration, age group, gender, transmission, end user, and distribution channel.

• By Type

On the basis of type, the North America hepatitis delta virus (HDV) infection market is segmented into Acute Hepatitis D and Chronic Hepatitis D. The chronic hepatitis D segment dominated the largest market revenue share of 71.3% in 2024, driven by the higher burden of long-term infections, the need for extended treatment duration, and increased risk of liver complications such as cirrhosis and hepatocellular carcinoma. Chronic HDV cases are more frequently diagnosed due to improved testing among hepatitis B carriers.

The acute hepatitis D segment is anticipated to witness the fastest growth rate of 6.7% from 2025 to 2032, fueled by better disease surveillance, public health initiatives, and improved early-stage screening technologies.

• By Treatment

On the basis of treatment, the North America hepatitis delta virus (HDV) infection market is segmented into surgery (liver transplant) and medication. The medication segment dominated the market with the largest revenue share of 88.6% in 2024, primarily due to the widespread use of antiviral agents and pegylated interferon therapies as the first line of treatment. Increased R&D efforts targeting HDV-specific viral mechanisms further boost this segment.

The surgery (liver transplant) segment is expected to grow with the fastest CAGR of 5.1% from 2025 to 2032, largely used in cases with end-stage liver failure where medical therapy is no longer effective.

• By Drug Type

On the basis of drug type, the market is segmented into branded and generic drugs. The branded drug segment accounted for the largest revenue share of 63.8% in 2024, owing to the presence of patented therapies such as bulevirtide, with high efficacy and specialist prescribing patterns across tertiary care centers.

The generic segment is anticipated to register the fastest CAGR of 7.4% from 2025 to 2032, driven by affordability, increased local manufacturing, and inclusion in national drug lists in developing countries.

• By Route of Administration

On the basis of route of administration, the market is segmented into oral and parenteral. The parenteral segment held the largest market revenue share of 66.5% in 2024, supported by the standard use of injectable pegylated interferon in HDV treatment.

The oral segment is expected to witness the fastest CAGR of 8.3% from 2025 to 2032, with the emergence of promising oral antiviral agents under clinical trials and rising demand for non-invasive, patient-compliant therapies.

• By Age Group

On the basis of age group, the market is segmented into adults, geriatric, and pediatric. The adult segment held the dominant market share of 61.9% in 2024, attributed to higher prevalence of HBV-HDV co-infections among individuals in their working-age population and middle-aged adults.

The geriatric segment is anticipated to grow at the fastest CAGR of 7.1% from 2025 to 2032, as aging populations experience a higher risk of liver complications and more frequent healthcare access.

• By Gender

On the basis of gender, the market is segmented into male and female. The male segment captured the largest market share of 58.2% in 2024, reflecting the higher incidence rates due to behavioral risk factors and higher HBV prevalence in men.

The female segment is expected to grow with the fastest CAGR of 6.5% during the forecast period, supported by increasing awareness, improved maternal health programs, and gender-focused screening in reproductive health services.

• By Transmission

On the basis of transmission, the North America market is segmented into contaminated needles, exposure to infected blood, blood and plasma product transfusion, and others. The contaminated needles segment held the largest market share of 38.6% in 2024, due to unsafe injection practices and rising intravenous drug use in parts of the region.

The blood and plasma product transfusion segment is expected to register the fastest CAGR of 7.9% from 2025 to 2032, driven by increased testing accuracy and gaps in screening protocols in some healthcare facilities.

• By End User

On the basis of end user, the market is segmented into hospitals, specialty clinics, home care settings, research institutes and academic centers, ambulatory surgical centers, and others. The hospital segment dominated the market with a revenue share of 47.4% in 2024, backed by integrated diagnostics, inpatient treatment, and transplant infrastructure.

The specialty clinics segment is projected to witness the fastest CAGR of 7.6% from 2025 to 2032, supported by rising demand for outpatient liver care, availability of HDV-focused treatment, and urban expansion.

• By Distribution Channel

On the basis of distribution channel, the market is segmented into direct tender, retail sales, and others. The direct tender segment held the highest market share of 54.3% in 2024, owing to government procurement, hospital supplies, and public health agency partnerships for hepatitis programs.

The retail sales segment is expected to grow at the fastest CAGR of 7.8%, driven by increasing over-the-counter availability and expanded distribution through e-pharmacies and private clinics.

North America Hepatitis Delta Virus (HDV) Infection Market Regional Analysis

• The North America hepatitis delta virus (HDV) infection market is poised to grow at the fastest CAGR of 30.70% during the forecast period of 2025 to 2032, driven by increasing public health awareness, enhanced diagnostic capabilities, and expanding access to healthcare services across the region
• The growing burden of liver-related diseases, government-led hepatitis elimination programs, and increased healthcare funding are significantly accelerating the adoption of HDV diagnostic and therapeutic solutions
• Furthermore, regional efforts to integrate hepatitis B and D screening protocols into public health frameworks, along with improved treatment access and international collaborations, are contributing to sustained market expansion

U.S. Hepatitis Delta Virus (HDV) Infection Market Insight

The U.S. hepatitis delta virus (HDV) infection market dominated the North America market with the largest revenue share of 46.84% in 2024, driven by high hepatitis B prevalence, strong public health initiatives, and the presence of advanced diagnostic and treatment infrastructure. Federal and state-level programs aimed at eliminating viral hepatitis, coupled with collaborations with leading research institutes, continue to strengthen early detection and effective management of HDV cases across the country.

Canada Hepatitis Delta Virus (HDV) Infection Market Insight

The Canada hepatitis delta virus (HDV) infection market is witnessing steady growth due to its universal healthcare system, proactive disease awareness campaigns, and national strategies targeting hepatitis B and D. Government-supported screening initiatives, access to specialty care, and increased focus on underserved communities are driving improvements in HDV diagnosis and treatment throughout the country.

Mexico Hepatitis Delta Virus (HDV) Infection Market Insight

The Mexico hepatitis delta virus (HDV) infection market is expected to witness the fastest-growing CAGR of 6.9% in the North America Hepatitis Delta Virus (HDV) Infection market during the forecast period, fueled by growing public health investments, rising awareness of viral hepatitis, and enhanced access to diagnostic services. National hepatitis programs supported by international agencies are strengthening screening networks and improving access to antiviral treatments, particularly in rural and high-risk populations.

North America Hepatitis Delta Virus (HDV) Infection Market Share

The North America hepatitis delta virus (HDV) infection industry is primarily led by well-established companies, including:

• Gilead Sciences, Inc. (U.S.)
• Genentech, Inc. (U.S.)
• Alnylam Pharmaceuticals, Inc. (U.S.)
• Assembly Biosciences, Inc. (U.S.)
• Eiger BioPharmaceuticals (U.S.)
• GlobeImmune Inc. (U.S.)
• Huahui Health Ltd. (China)
• Johnson & Johnson Services, Inc. (U.S.)
• PharmaEssentia Corporation (Taiwan)
• Replicor (Canada)
• Vir Biotechnology, Inc. (U.S.)

Latest Developments in North America Hepatitis Delta Virus (HDV) Infection Market

• In September 2024, Gilead Sciences, Inc. and Genesis Therapeutics have formed a strategic collaboration to discover and develop novel therapies using advanced AI-driven drug discovery technologies. This partnership aims to accelerate the creation of innovative treatments, enhancing Gilead's pipeline and strengthening its position in the competitive biopharma industry
• In March 2024, Gilead Sciences Inc. completed the acquisition of CymaBay Therapeutics, gaining access to innovative therapies for liver and rare diseases. This acquisition expands Gilead’s research portfolio and strengthens its pipeline, enhancing its capacity to address unmet medical needs. The acquisition of CymaBay provides Gilead with promising new drug candidates and expertise in liver and rare diseases, boosting its research capabilities and expanding its therapeutic offerings
• In March 2024, Gilead Sciences, Inc. and Merus have announced a collaboration to discover novel antibody-based trispecific T-cell engagers, aiming to enhance cancer immunotherapy. This partnership combines Gilead’s expertise with Merus’ innovative technology to develop advanced treatments for cancer
• In March 2024, Alnylam Pharmaceuticals launched the Family Health History Road Trip to promote discussions on hereditary ATTR (hATTR) amyloidosis. Genealogist Bernice Bennett traveled cross-country to highlight the importance of family health history for earlier diagnosis

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