North America Hepatitis B Infection Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032

North America Hepatitis B Infection Market Size

• The North America hepatitis B infection market size was valued at USD 2.46 billion in 2024 and is expected to reach USD 3.61 billion by 2032, at a CAGR of 4.90% during the forecast period
• The market growth is largely fueled by the growing adoption of advanced diagnostic technologies and therapeutic innovations for Hepatitis B, coupled with increasing digitalization and integration of electronic health systems across Europe
• Furthermore, rising consumer and public health demand for accurate, accessible, and preventive solutions is establishing Hepatitis B management protocols as a central focus of healthcare policy. These converging factors are accelerating the adoption of vaccination, screening, and antiviral therapies, thereby significantly boosting the Hepatitis B Infection market growth across the region

North America Hepatitis B Infection Market Analysis

• Hepatitis B treatments and diagnostics are increasingly vital components of North America’s public health infrastructure, especially in both hospital and outpatient settings, due to rising infection awareness, improved testing accessibility, and advancements in antiviral therapies
• The escalating demand for effective Hepatitis B management is primarily fueled by widespread immunization efforts, increased HBV-HDV co-infection screening, and the rising burden of chronic liver diseases—particularly among aging populations and immigrant communities
• U.S. dominated the North America hepatitis B infection market with the largest revenue share of 57.9% in 2024, characterized by strong public health policies, the early adoption of advanced diagnostic technologies, and high HBV testing rates. The country has also witnessed significant growth in treatment uptake, especially among high-risk groups, fueled by public awareness campaigns, state-level elimination plans, and expanded insurance coverage for hepatitis care
• Mexico is expected to be the fastest-growing country within the North America hepatitis B infection market during the forecast period, supported by increasing urbanization, improved vaccination coverage, expanding government funding for hepatitis elimination, and enhanced access to healthcare services across both urban and rural areas
• The chronic hepatitis B segment dominated the North America hepatitis B infection market with a market share of 62.4% in 2024, owing to the persistent nature of the disease, the need for long-term antiviral therapy, and improved detection through targeted screening programs and integration of hepatitis testing into primary care

Report Scope and North America Hepatitis B Infection Market Segmentation

North America Hepatitis B Infection Market Trends

“Enhanced Convenience Through Integrated Care and Advanced Treatment Access”

• A significant and accelerating trend in the North America hepatitis B infection market is the growing integration of multidisciplinary care models and advanced treatment access through centralized healthcare systems. This trend is significantly improving patient outcomes and adherence by enabling seamless communication between general practitioners, hepatologists, and public health institutions
  • For instance, several Western European countries have implemented national hepatitis action plans that allow patients to receive early diagnosis, antiviral treatment, and regular follow-up care under one coordinated framework. Germany’s integrated care model, for instance, enables efficient linkage from diagnosis to treatment, reducing disease progression rates
• Efforts such as centralized patient registries, digital health record systems, and streamlined referral pathways are optimizing hepatitis B infection management by enabling timely intervention and monitoring. These systems allow healthcare providers to track liver function, treatment response, and co-infections such as hepatitis D in real-time
• The integration of advanced diagnostics with routine primary care services facilitates early detection of both acute and chronic cases. This centralized approach, combined with affordable access to newer antiviral therapies, enhances both individual patient care and broader public health surveillance
• This trend toward more streamlined, coordinated, and technology-supported hepatitis B care is fundamentally reshaping expectations within national healthcare systems. As a result, many European governments are expanding access to viral hepatitis screening, particularly among vulnerable and high-risk populations such as migrants, intravenous drug users, and the elderly
• The demand for accessible, efficient, and integrated hepatitis B treatment models is rapidly growing across both public and private healthcare sectors, as stakeholders increasingly focus on long-term disease control and alignment with the World Health Organization’s 2030 hepatitis elimination goals

North America Hepatitis B Infection Market Dynamics

Driver

“Growing Need Due to Rising Disease Burden and Preventive Healthcare Adoption”

• The increasing prevalence of hepatitis B infections across Europe, along with heightened awareness about liver diseases, is significantly driving the demand for early diagnosis, vaccination, and treatment solutions
  • For instance, in April 2024, GlaxoSmithKline plc (GSK) expanded its European hepatitis B vaccine supply through a strategic partnership with regional healthcare systems, aiming to improve immunization rates across high-risk populations. Such initiatives by key market players are expected to fuel growth in the North America Hepatitis B Infection market over the forecast period
• As public health authorities and consumers become more aware of the long-term complications associated with chronic hepatitis B—such as cirrhosis and liver cancer—the adoption of preventive strategies such as vaccination and early screening continues to rise
• Furthermore, the integration of hepatitis B testing into routine health check-ups and the growing popularity of point-of-care diagnostic technologies are making hepatitis B management more accessible and efficient across Europe
• The availability of effective vaccines, oral antiviral drugs, and the development of advanced immune modulators are enabling better disease control. Government funding, reimbursement policies, and WHO-led hepatitis elimination goals are also boosting adoption rates in both public and private healthcare settings

Restraint/Challenge

“Concerns Regarding Treatment Accessibility and High Cost of Advanced Therapies”

• Despite medical advancements, limited access to advanced antiviral therapies and immune modulators in certain parts of North America remains a challenge, particularly in Eastern and Southern North America where healthcare disparities persist
  • For instance, studies published in early 2024 indicated that some EU member states still face shortages in hepatitis B vaccines and limited access to novel treatment regimens due to procurement and reimbursement issues
• Bridging this gap requires policy-level efforts to harmonize hepatitis B care standards across all European nations, particularly through EU-level funding support, price negotiations, and streamlined regulatory approvals
• Moreover, while first-line antiviral drugs are becoming more affordable, newer generation therapies with improved efficacy often come at a higher cost, potentially limiting their uptake among uninsured or low-income populations
• Public mistrust or vaccine hesitancy, especially in post-pandemic Europe, is another barrier that must be addressed through awareness campaigns and healthcare provider engagement
• Overcoming these challenges through expanded insurance coverage, public-private partnerships, and increased investment in regional healthcare infrastructure will be crucial to sustaining long-term growth in the North America Hepatitis B Infection market

North America Hepatitis B Infection Market Scope

The market is segmented on the basis of type, and treatment.

• By Type

On the basis of type, the North America hepatitis B infection market is segmented into chronic and acute. The chronic segment dominated the largest market revenue share of 62.4% in 2024, primarily due to the high prevalence of chronic HBV cases and the need for lifelong disease management through antiviral therapies and monitoring.

The acute segment is anticipated to witness the fastest growth rate with a CAGR of 6.4% from 2025 to 2032, fueled by enhanced early screening efforts, public health initiatives, and growing awareness leading to timely diagnosis and treatment.

• By Treatment

On the basis of treatment, the North America Hepatitis B Infection market is segmented into vaccine, antiviral drugs, immune modulator drugs, and surgery. The vaccine segment held the largest revenue share of 41.2% in 2024, supported by national vaccination drives, increased birth-dose immunization, and strong uptake among high-risk adult populations.

The antiviral drugs segment is projected to witness the fastest CAGR of 7.1% from 2025 to 2032, driven by the expanding chronic HBV patient pool, advancements in oral therapies, and favorable reimbursement policies.

North America Hepatitis B Infection Market Regional Analysis

• North America dominated the hepatitis B infection market with the largest revenue share of 33.27% in 2024, driven by robust public health infrastructure, widespread vaccination programs, and growing awareness about hepatitis B transmission and prevention
• The region is characterized by cutting-edge diagnostic technologies, well-established immunization protocols, and proactive government-led hepatitis surveillance initiatives
• This strong uptake of preventive and therapeutic strategies is further supported by extensive healthcare access, ongoing R&D funding, and a focused effort on early detection and disease management, solidifying North America’s role as a key contributor to the global Hepatitis B Infection market

U.S. Hepatitis B Infection Market Insight

The U.S. hepatitis B infection market dominated the North America market with the largest revenue share of 57.9% in 2024, attributed to its advanced healthcare infrastructure, widespread HBV vaccination coverage, and early adoption of screening and diagnostic protocols. Government efforts such as CDC-recommended universal screening guidelines, along with strong support for HBV-HDV co-infection testing, are driving market growth. In addition, large-scale awareness campaigns and private sector innovation in antiviral therapies contribute to consistent demand.

Canada Hepatitis B Infection Market Insight

The Canada hepatitis B infection market accounted for 25.6% of the North America market revenue in 2024. The country benefits from a publicly funded healthcare system, universal vaccination programs for children, and a strong emphasis on immigrant screening and maternal testing. Ongoing collaborations between government and research institutions have improved access to diagnostics and treatment for chronic HBV, particularly in underserved and Indigenous communities.

Mexico Hepatitis B Infection Market Insight

The Mexico hepatitis B infection market contributed 16.5% of the regional market share in 2024 and is expected to experience the fastest CAGR of 6.9% during the forecast period. Growth is supported by increasing government investment in infectious disease prevention, enhanced vaccination programs for infants and adolescents, and the expansion of diagnostic access in rural areas. Public-private partnerships and educational initiatives are also helping raise awareness about hepatitis B and reduce stigma, contributing to earlier detection and improved treatment outcomes.

North America Hepatitis B Infection Market Share

The North America hepatitis B infection industry is primarily led by well-established companies, including:

• Gilead Sciences, Inc. (U.S.)
• GSK plc (U.K.)
• Dynavax Technologies (U.S.)
• F. Hoffmann-La Roche Ltd (Switzerland)
• Bristol-Myers Squibb Company (U.S.)
• Merck & Co., Inc. (U.S.)
• Novartis AG (Switzerland)
• Arrowhead Pharmaceuticals Inc. (U.S.)
• Arbutus Biopharma (Canada)
• Teva Pharmaceuticals, Inc. (Israel)
• Zydus Pharmaceuticals (India)
• Aurobindo Pharma (India)
• Lupin Pharmaceuticals, Inc. (India)

Latest Developments in North America Hepatitis B Infection Market

• In September 2024, Gilead Sciences and Genesis Therapeutics announced a strategic collaboration to discover and develop novel small molecule therapies using Genesis’ GEMS AI platform. Gilead gained exclusive rights to develop and commercialize products from this partnership
• In July 2024, Gilead Sciences, Inc. presented research data, showcasing long-term efficacy and safety of Biktarvy in diverse HIV populations, including Hispanic/Latine individuals and older adults with comorbidities. Investigational once-daily and weekly dosing regimens were also highlighted
• In February 2024, GSK completed its acquisition of Aiolos Bio, including the promising AIO-001 monoclonal antibody for severe asthma. GSK paid USD 1000 million upfront and up to USD 400 million in milestone payments, expanding its respiratory biologics portfolio

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