The Significance and History of World Hepatitis Day

World Hepatitis Day (WHD), observed annually on July 28, aims to raise global awareness and unite stakeholders—including governments, medical professionals, and patient advocacy groups—to strengthen the prevention, screening, and control of viral hepatitis. Established in 2008 by the World Hepatitis Alliance (WHA), WHD gained global endorsement from the World Health Assembly in 2010, coinciding with the birthday of Dr. Baruch Samuel Blumberg, who discovered the hepatitis B virus (HBV) and developed the first vaccine for HBV.

The annual themes for WHD serve as strategic directives. The 2024 theme, “It’s Time for Action,” calls for moving beyond awareness to implementing increased access to diagnosis and treatment, reflecting impatience with slow progress. The 2025 theme, “Let’s Break It Down,” focuses on dismantling financial, social, and systemic barriers—including stigma—and emphasises the need to integrate hepatitis services into primary healthcare systems. This shift highlights the healthcare industry’s transition from seeking information to demanding practical solutions for testing, care linkage, and affordability.

Contextualising the Global Hepatitis Challenge

Viral hepatitis represents one of the most significant, yet often overlooked, public health crises of our time. Although advances in medicine have rendered some forms of the disease curable and others manageable, the global mortality rate continues to climb, nevertheless, exposing a deep chasm between scientific capability and healthcare delivery.

World Hepatitis Day serves as a critical catalyst, focusing global attention on this silent epidemic and mobilising a coordinated response.

Providing a comprehensive analysis of the worldwide hepatitis landscape, while examining the state of the science and the horizon of innovation, creating an outlook of the strategic imperatives for healthcare innovators, particularly small and medium-sized enterprises (SMEs), who are uniquely positioned to address the systemic failures that perpetuate this crisis.

A Deep Dive into the WHO 2024 Global Hepatitis Report

Although significant progress has been made in the treatment of hepatitis, these achievements have not yet translated into improved health outcomes for hepatitis patients, as the latest data from the World Health Organisation (WHO) shows this critical opportunity to improve global health.

Viral hepatitis, in particular, has become the second leading cause of death from infectious diseases worldwide, with a mortality rate similar to that of tuberculosis. In order to effectively combat these challenges and improve public health for all, targeted and collaborative efforts are necessary to raise awareness and enhance prevention and treatment strategies.

Rising Mortality: In 2022, viral hepatitis caused an estimated 1.3 million deaths globally, or about 3,500 daily, a rise from 1.1 million deaths in 2019. Most of these (83%) were due to complications from chronic hepatitis B, indicating a substantial failure in providing care despite available treatments.

Immense Global Burden: Chronic hepatitis infections remain a significant problem, with an estimated 254 million people living with chronic hepatitis B and 50 million with chronic hepatitis C in 2022. Most of these cases occur in people aged 30–54, with men accounting for 58% of cases.

Incidence and Prevention: New infections decreased slightly from 2.5 million in 2019 to 2.2 million in 2022, mainly due to primary prevention measures, including HBV vaccination and harm reduction services. However, with over 6,000 new infections daily, these efforts are still quite insufficient.

Geographic Concentration as a Strategic Roadmap: The global burden is concentrated, with the WHO African Region accounting for 63% of new HBV infections and ten countries—such as China, India, and Nigeria—shouldering nearly two-thirds of the burden. The WHO has stated that achieving universal access to prevention and treatment in these nations by 2025 is vital.

Analysing the Critical Gaps in the “Cascade of Care”

The single greatest obstacle to eliminating viral hepatitis is the catastrophic failure to connect infected individuals with the care they need. This breakdown in the “cascade of care”—from testing to diagnosis to treatment—is where the battle is being lost. The vast majority of those living with the virus are unaware of their status, forming a massive, silent reservoir of disease that drives ongoing transmission and mortality.

The “Missing Millions”: The statistics are staggering and expose the depth of the diagnostic gap. For chronic hepatitis B, a mere 13% of the 254 million infected people have been diagnosed. Of those diagnosed, only 22% are receiving the antiviral therapy they need, meaning that globally, only 3% of all people living with chronic HBV are on treatment. The situation is slightly better but still deeply concerning for hepatitis C. An estimated 36% of the 50 million infected people have been diagnosed. Of that group, 62% have received curative treatment, meaning only 20% of the total infected population has been cured. These are not just numbers; they represent millions of people who are at risk of developing liver cancer and cirrhosis, and who may be unknowingly transmitting the virus to others.

Systemic and Financial Barriers: This is not a failure of individual patients but of the health systems meant to serve them. The WHO reports that only 60% of countries offer viral hepatitis testing and treatment services free of charge or with subsidies in the public sector. The primary barriers are systemic and financial in nature. Testing remains highly centralised in many regions, requiring patients to make multiple visits to specialised facilities, a significant hurdle for rural and underserved populations. Furthermore, a chronic lack of dedicated funding plagues the global response. Unlike the robust global funds for HIV, tuberculosis, and malaria, no major international donor has committed to financing the fight against hepatitis, which is estimated to require an annual investment of US$6 billion. This financial vacuum forces low- and middle-income countries (LMICs), where the burden is highest, to fund their ambitious elimination programs, a task that is often impossible. The COVID-19 pandemic further strained these fragile systems, causing widespread disruptions to hepatitis testing and treatment services.

Assessing Progress and Hurdles to 2030 Elimination Horizon

In 2016, the World Health Assembly endorsed the Global Health Sector Strategy on viral hepatitis, setting ambitious targets for 2030 that aim for a 90% reduction in new infections and a 65% reduction in deaths from viral hepatitis compared to the 2015 baseline.

Achieving these goals would prevent an estimated 4.5 million premature deaths in LMICs alone.

Eight years later, in 2024, the WHO report indicates that the world is not on track to meet its targets set in 2016, as mortality rates are rising instead of falling. This trend shows that the global response is heading in the wrong direction regarding a critical metric.

Considering some of the notable pockets of success, such as Egypt’s remarkable progress toward HCV elimination and Georgia’s pioneering national program, highlights the exceptions to the rule. The primary impediments to achieving the 2030 goals come down to the fundamental challenges of insufficient funding, a massive diagnostic deficit, and fragmented health systems. In other words, without a dramatic acceleration of political will, financial investment, and innovative service delivery models, the promise of a hepatitis-free future will remain unattainable.

The Current Therapeutic and Diagnostic Landscape

Understanding the current standard of care for each of the five hepatitis viruses is crucial for identifying gaps and opportunities for improved healthcare outcomes. The management strategies are highly differentiated, reflecting the distinct virology and natural history of each pathogen, as well as market needs in terms of diagnostics, treatment, and patient support services.

Differentiated Management Strategies for Five Hepatitis Viruses

Hepatitis A Virus (HAV): Transmitted via the faecal-oral route, HAV causes an acute, self-limiting liver inflammation. There are no specific antiviral treatments; management is primarily supportive, involving rest and hydration. Because it does not cause chronic disease, the public health focus is entirely on prevention through improved sanitation, hygiene, and a highly effective vaccine that is recommended for all children and at-risk adults.

Hepatitis B Virus (HBV): A DNA virus that poses a formidable challenge due to its ability to establish a persistent reservoir of covalently closed circular DNA (cccDNA) within the nucleus of infected liver cells. This cccDNA acts as a template for viral replication and is the primary reason why current treatments can control, but not cure, the infection. Chronic HBV can lead to cirrhosis and hepatocellular carcinoma (HCC), the most common form of liver cancer.

Hepatitis C Virus (HCV): An RNA virus that, unlike HBV, does not integrate into the host’s genome or form a persistent nuclear reservoir. This key biological difference is what makes HCV curable. The majority of infections become chronic, also leading to a high risk of cirrhosis and liver cancer if left untreated.

Hepatitis D Virus (HDV): An incomplete or “satellite” RNA virus that is entirely dependent on HBV for its replication and transmission; it uses the HBV surface antigen (HBsAg) as its outer envelope. Co-infection of HBV and HDV results in the most severe and rapidly progressive form of chronic viral hepatitis, significantly accelerating the timeline to cirrhosis and liver-related death.

Hepatitis E Virus (HEV): Similar to HAV, HEV is typically an acute, self-limiting infection transmitted through contaminated water. However, it presents two major clinical concerns: it can cause fulminant hepatic failure with extremely high mortality rates (up to 42%) in pregnant women, and it can establish a chronic infection in immunosuppressed individuals, such as organ transplant recipients. A vaccine, Hecolin®, is licensed and used in China but is not widely available elsewhere.

The Impact and Nuances of Direct-Acting Antivirals (DAAs)

The development of Direct-Acting Antivirals (DAAs) has been one of the most significant medical breakthroughs of the 21st century, transforming HCV from a chronic, difficult-to-manage disease into a curable one.

Goal of Therapy: Eradication. The objective of HCV treatment is to achieve a Sustained Virologic Response (SVR), defined as having undetectable HCV RNA in the blood 12 weeks after completing therapy (SVR12). An SVR is achieved in over 95% of treated patients and is considered a definitive cure, with an extremely low chance of relapse.

AASLD-IDSA 2023 Guidance: The joint guidance from the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) is unequivocal: antiviral treatment is recommended for all adults and children aged three and older with acute or chronic HCV infection. The only exception is for individuals with a short life expectancy that cannot be improved by curing their hepatitis. This universal treatment recommendation is paired with a call for universal, one-time screening for all adults.

The Era of Simplified, Pan-Genotypic Regimens: Treatment has been radically simplified. The standard of care now involves short-course (typically 8 or 12 weeks), all-oral, pan-genotypic regimens that are effective against all major HCV genotypes, essentially eliminating the need for costly and complex genotyping tests prior to treatment—a crucial step for scaling up programs in resource-limited settings. The two leading recommended regimens are:

• Glecaprevir/pibrentasvir (Mavyret®): An 8-week course taken with food. It is not recommended for patients with moderate to severe cirrhosis (Child-Pugh class B or C).
• Sofosbuvir/velpatasvir (Epclusa®): A 12-week course. It is safe for use in patients with decompensated cirrhosis and is the preferred option for this population.

Minimal Monitoring as a Catalyst for Decentralisation: A key update in the 2023 guidance was the expansion of eligibility for simplified treatment protocols that require minimal on-treatment laboratory monitoring, rather than merely a clinical convenience, but rather a strategic decision designed to enable the decentralisation of care. By eliminating the need for frequent, complex lab monitoring, the guidelines empower non-specialists—such as primary care physicians, nurses, and community health workers—to prescribe and manage this life-saving treatment. This shift directly creates a market need for the tools that support a decentralised model, such as point-of-care diagnostics and digital health platforms.

First-Line Treatments and Monitoring for Hepatitis B

The management of chronic hepatitis B stands in stark contrast to that of hepatitis C. With no cure currently available, the therapeutic strategy focuses on long-term control.

Goal of Therapy: Suppression. The primary goal of HBV therapy is the lifelong suppression of HBV DNA replication, preventing liver inflammation, slowing or reversing the progression of liver fibrosis, and significantly reducing the long-term risk of developing cirrhosis and HCC. The ultimate goal is to find a “functional cure,” defined by the loss of HBsAg and the development of protective antibodies, unfortunately achieved in less than 5-7% of patients, even after years of current therapy.

First-Line Antivirals: The leading international guidelines from EASL and AASLD recommend potent nucleos(t)ide analogues (NAs) with a high barrier to developing drug resistance as first-line therapy. The preferred agents are:

• Tenofovir disoproxil fumarate (TDF, Viread®)
• Tenofovir alafenamide (TAF, Vemlidy®)
• Entecavir (Baraclude®)

Older drugs like lamivudine are no longer recommended for first-line use due to high rates of resistance.

Complex Treatment Indications: Unlike HCV, not every person with chronic HBV requires immediate treatment. The decision to initiate therapy is complex and is based on a careful assessment of several factors, including the patient’s age, HBV DNA level (viral load), serum Alanine Aminotransferase (ALT) levels (a marker of liver inflammation), HBeAg status, and the severity of underlying liver disease as determined by fibrosis assessment. The 2025 EASL guidelines specifically emphasise the need for simplified algorithms to help guide these decisions, particularly in resource-constrained settings where access to specialists is limited.

Lifelong Monitoring: All individuals with chronic HBV, whether on treatment or not, require lifelong monitoring. Untreated patients must be regularly assessed to determine if they meet the criteria to start therapy. Treated patients need ongoing monitoring to ensure viral suppression, check for drug side effects (particularly renal and bone health issues associated with TDF), and, crucially, undergo regular surveillance for HCC, as the risk is reduced but not eliminated by treatment.

Management of Hepatitis D and E in Co-Infections and Outbreaks

Hepatitis D Management (EASL 2023 Guidelines): The recent EASL guidelines have revolutionised the approach to HDV.

• Universal Screening: The most significant change is the strong recommendation to screen all HBsAg-positive individuals for anti-HDV antibodies at least once in their lifetime. This shift from older, risk-based screening strategies (still held by some other bodies, such as AASLD) is a recognition that the previous approach was missing a substantial number of cases of this severe co-infection. This guideline divergence is a leading indicator of a global shift in the standard of care, signalling a massive expansion of the market for HDV diagnostic tests.
• Treatment: The guidelines recommend that all patients with chronic hepatitis D and compensated liver disease should be considered for antiviral therapy. The two main options are:
• Pegylated Interferon-alpha (PegIFNα): Administered for a finite course of 48 weeks.
• Bulevirtide (Hepcludex®): A novel HBV/HDV entry inhibitor. As the optimal duration is not yet known, long-term treatment is currently recommended.

Hepatitis E Management:

• Acute HEV: Management is supportive, as the infection is typically self-limiting. No specific antiviral therapy is recommended.
• Chronic HEV: This rare condition, seen in immunosuppressed patients, requires intervention. The first-line approach is often to carefully reduce the patient’s immunosuppressive medication, allowing their immune system to clear the virus. If this is not feasible or fails, the antiviral drug Ribavirin is used off-label, typically for a three-month course, with close monitoring for its significant side effects.

Innovations Shaping the Future of Hepatitis Care

Even though current therapies have transformed the management of viral hepatitis, significant challenges remain, most notably the lack of a cure for HBV and the vast diagnostic gap for all forms of the disease. The scientific and biotechnology communities are responding with a wave of innovation aimed at overcoming these hurdles as the pursuit of a functional HBV cure, revolutionary gene-editing technologies, and the decentralisation of diagnostics define this next frontier of hepatitis care.

Novel Therapeutic Modalities for Hepatitis B

The central obstacle to curing HBV is the persistence of cccDNA in the nucleus of hepatocytes, a stable minichromosome that continuously produces viral components and is untouched by current NAs. The goal of the robust research pipeline is to achieve a “functional cure,” defined as the sustained loss of HBsAg and undetectable HBV DNA in the blood following a finite course of treatment that requires a multi-pronged attack on the viral lifecycle.

Silencing the Virus: RNA Interference (RNAi) and Antisense Oligonucleotides (ASOs) – These approaches utilise small strands of nucleic acids to specifically target and degrade viral messenger RNA (mRNA), thereby preventing the production of viral proteins, particularly HBsAg. By reducing the massive load of circulating HBsAg, these drugs aim to “unmask” the virus, allowing the patient’s immune system to regain control over it. Bepirovirsen, an ASO developed by GSK and Ionis Pharmaceuticals, is a leading candidate in Phase 3 trials and has received FDA Fast Track designation. It has demonstrated the ability to achieve clinically meaningful HBsAg reduction and functional cure in a subset of patients. Other RNAi agents, such as JNJ-3989, are also showing promise in clinical development, often as part of combination regimens.

Disrupting Assembly: Core Protein Allosteric Modulators (CpAMs): These small molecules target the HBV core protein, a critical component for packaging the viral genome into new virus particles. CpAMs induce the formation of faulty, empty capsids or aberrant non-capsid polymers, effectively halting the replication process. Both Type I and Type II CpAMs are advancing through clinical trials, with data showing potent antiviral activity.

Reawakening the Immune System: Therapeutic Vaccines: Unlike preventative vaccines, therapeutic vaccines are designed to treat an existing infection by stimulating a robust, targeted immune response. The chronic state of HBV infection is characterised by T-cell exhaustion, where the immune cells that should fight the virus are rendered ineffective. Therapeutic vaccines aim to reverse this. TherVacB, a German-developed candidate, entered first-in-human trials in early 2024 and is designed to activate HBV-specific CD4 and CD8 T-cells powerfully. Another promising immunotherapy, VTP-300 from Barinthus Biotherapeutics, has demonstrated significant and sustained reductions in HBsAg levels in Phase 2 trials, particularly when combined with an immune checkpoint inhibitor, such as nivolumab.

The Combination Play: The consensus in the field is that a single “magic bullet” for curing HBV is unlikely to exist. The complexity of the virus, with its persistent cccDNA and immune-suppressive nature, necessitates a combination approach. Future curative regimens will likely involve the sequential or concurrent use of these novel agents, where an RNA-silencing drug to reduce viral antigen load, followed by a therapeutic vaccine to reinvigorate the immune response, all on a backbone of NA therapy. To test a sequence of two investigational agents, such as GSK’s B-United clinical trials study, is already exploring this paradigm, meaning that the future HBV market will be a complex ecosystem, demanding strategic partnerships rather than a winner-takes-all scenario.

The Potential of CRISPR and Gene-Editing Technologies

Gene-editing technologies, particularly the CRISPR-Cas system, represent the most revolutionary—albeit long-term—approach to a cure for HBV. Instead of just controlling the virus, these tools offer the potential to eliminate it permanently from the body.

The Ultimate Goal: Destroying the cccDNA Reservoir. CRISPR technology acts like a pair of “molecular scissors,” allowing scientists to make precise cuts in a DNA sequence. For HBV, the ultimate goal is to use CRISPR-Cas9 to directly target, cut, and thereby destroy the cccDNA minichromosome within liver cells, constituting a proper “sterilising cure” that removes the source of viral persistence. Preclinical studies have demonstrated the feasibility of this approach as researchers have successfully utilised CRISPR to disrupt the HBV genome in both cell culture and humanised mouse models, resulting in significant reductions in viral markers. A related approach, utilising CRISPR-Cas13b, has been employed to target and eliminate HBV RNA in the laboratory, resulting in a reduction of viral protein production by up to 96%.

Epigenome Editing: A Potentially Safer Path to Silencing. A significant hurdle for traditional gene editing is the risk of “off-target” cuts in the human genome, which could have serious unintended consequences leading to the development of “epigenome editing.” This technique utilises a catalytically “dead” or “blunt” version of the Cas9 protein, which can no longer cut DNA. Instead, it is fused to enzymes that can deposit permanent silencing marks (epigenetic modifications) onto the cccDNA, effectively turning the viral genes off without altering the DNA sequence, potentially offering a safer path to the clinic. The startup Tune Therapeutics is pioneering this approach with its TUNE-401 candidate, which aims to achieve a functional cure by permanently silencing the virus’s expression through epigenetic modification, suggesting that the first “gene-editing-like” therapies to reach patients may, in fact, be highly precise gene silencers.

Hurdles to Clinical Use: Despite the immense promise, significant challenges must be overcome before these technologies are ready for human use. The two most critical are ensuring absolute precision to avoid off-target effects and developing safe and efficient in vivo delivery systems (such as lipid nanoparticles or AAV vectors) to transport the CRISPR machinery specifically to liver cells.

The Pivotal Role of Point-of-Care (POC) Diagnostics

The failure to meet the 2030 elimination goals is, at its core, a diagnostic failure. The reliance on centralised laboratories creates a multi-step, multi-visit process that is a significant bottleneck, especially in resource-limited and rural areas. Point-of-care (POC) diagnostics, which provide rapid results outside of a traditional laboratory, are the single most critical innovation for closing this gap and enabling the “test-and-treat” models essential for elimination.

From Screening to Confirmation in One Visit: While low-cost and straightforward rapid diagnostic tests (RDTs) based on lateral flow are valuable for initial screening (e.g., for anti-HCV or HBsAg), they often cannot provide a definitive diagnosis of active infection and require a follow-up laboratory test. The true game-changer is the advent of near-patient molecular tests. Platforms like the Cepheid Xpert system use automated, cartridge-based polymerase chain reaction (PCR) to deliver a quantitative viral load result for HBV DNA or HCV RNA in under an hour. This technology collapses the entire diagnostic cascade into a single patient encounter. In a landmark move in June 2024, the U.S. FDA approved the Xpert HCV test for use with a simple fingerstick blood sample in CLIA-waived, point-of-care settings allowing a non-specialist in a community clinic or mobile van to screen, definitively diagnose an active infection, and initiate curative treatment in a single visit, a paradigm shift for reaching the most vulnerable populations.

The Ideal POC Platform: The expert consensus on the ideal POC diagnostic platform is clear: it must be simple to operate with minimal training, use a minimally invasive sample like capillary blood, deliver accurate results in under an hour (ideally <30 minutes), be low-cost, and have the potential for self-testing capabilities.

How Digital Health Platforms are Enabling Integrated Care

As hepatitis care is increasingly decentralised, digital health solutions become the essential scaffolding required to manage patients, support providers, and monitor public health outcomes.

Managing Decentralised Care: Digital therapeutics and health platforms are crucial for overcoming the logistical challenges of moving care into the community. For patients, these tools can provide education, appointment and medication reminders (especially critical for long-term HBV therapy), as well as remote monitoring of their health status. For providers, they enable telehealth consultations with specialists through models like Project ECHO, which utilises case-based learning to build the capacity of primary care teams to manage complex diseases, such as hepatitis.

Accelerating R&D and Public Health: Digital tools are also transforming research and public health surveillance. They can accelerate clinical trials by improving patient recruitment and enabling remote monitoring, which reduces costs and generates richer, real-world data. For public health programs, digital platforms that aggregate anonymised data from thousands of decentralised POC testing sites can provide a real-time view of disease prevalence, help identify and respond to outbreaks, and allow for effective management of elimination efforts.

Translating Public Health Goals into Business Strategy

The global fight to eliminate viral hepatitis is not just a public health crusade; it is a vast and growing market defined by precise, unmet needs. For agile and innovative Small and Medium-sized Enterprises (SMEs) in the healthcare sector, this landscape presents a wealth of strategic opportunities. Success will belong to those who can translate the goals of the WHO and national elimination programs into targeted, effective business strategies.

The Diagnostic Opportunity with Driving the “Test-and-Treat” Model

The diagnostic gap is the central bottleneck in the hepatitis response, creating a massive and durable market for testing solutions. Albeit large corporations dominate the traditional laboratory space, SMEs are uniquely positioned to innovate in the rapidly expanding field of decentralised diagnostics.

Market Need: The demand is for tests that are accurate, affordable, rapid, and deployable in primary care clinics, community centres, and mobile outreach settings.

SME Role and Opportunities:

• Next-Generation POC Molecular Platforms: There is a significant opportunity to develop platforms that are even faster, cheaper, more portable, or easier to use than existing systems, such as GeneXpert. An SME that can deliver an accurate “sample-to-answer” molecular result in 15-20 minutes at a lower price point would be highly disruptive.
• Multiplex Testing: Public health programs are increasingly moving towards integrated screening for multiple infectious diseases. SMEs can develop multiplex cartridges for existing or new platforms that can test for HBV (HBsAg, DNA) and HCV (Antibody, RNA) from a single fingerstick sample, aligning perfectly with this trend.
• Non-Invasive Fibrosis Assessment: A critical part of hepatitis management is staging liver disease. SMEs can innovate in developing portable, non-invasive tools (e.g., handheld elastography devices or novel blood-based biomarker panels) that enable primary care providers to assess liver stiffness and make informed treatment decisions without referring patients for a specialist procedure, such as a liver biopsy.

Building the Digital Ecosystem by Software and Services for Decentralised Care

As soon as healthcare moves from centralised hospitals to decentralised community settings or patients’ homes, a digital infrastructure becomes essential to connect the dots, creating a significant market for software and service providers.

Market Need: A digital ecosystem is needed to manage patient pathways, support non-specialist providers, and track public health data.

SME Role and Opportunities:

• Patient Management and Adherence Platforms: Development of mobile apps and web-based platforms providing patients with educational content, appointment scheduling, and medication reminders is particularly valuable for patients with chronic conditions like HBV and HDV requiring lifelong therapy, as well as digital tools that monitor and encourage adherence.
• Telehealth and e-Consultation Services: Build and operate platforms that facilitate virtual consultations, connecting primary care physicians in remote areas with hepatology specialists at academic centres. Business models can be built around the Project ECHO framework, providing training and support to build local treatment capacity.
• Public Health Data Analytics: Create secure, cloud-based platforms that can receive, aggregate, and analyse anonymised data from a network of POC diagnostic devices, providing public health departments with a real-time dashboard to monitor their elimination programs, track key indicators, and identify emerging hotspots.

Reaching the Unreached

Elimination is impossible without successfully engaging hard-to-reach and marginalised populations, such as people who inject drugs, individuals in correctional facilities, people experiencing homelessness, and migrant communities. These groups are often poorly served by conventional healthcare systems, creating an opening for specialised service providers.

Market Need: Low-threshold, trusted, and accessible healthcare services tailored to the unique needs of vulnerable populations.

SME Role and Opportunities:

• Mobile Health Clinic Operations: Agile SMEs, including for-profit social enterprises and non-profits, can build business models around operating fleets of mobile health vans. Equipped with POC diagnostics, a small pharmacy of DAA/NA medications, and staffed by nurses or community health workers, these clinics can bring a “one-stop” test-and-treat service directly into underserved neighbourhoods.
• Integrated Care Partnerships: Create innovative service models through partnerships with established community organisations. A small or medium-sized enterprise (SME) can collaborate with networks of substance use treatment centres or homeless shelters to successfully integrate a hepatitis care program into their existing offerings by contributing skilled staff, advanced technology, and specialised expertise, enhancing the quality of care provided. A model based on this business-to-business (B2B) or business-to-government (B2G) relationship builds on existing trust and infrastructure, while also promoting the efficient and effective delivery of healthcare in the community.

Aligning SME Innovation with National and Global Strategy

It has to be understood that the relationship between public health programs and private sector innovators must be symbiotic, as national strategies, such as the proposed U.S. National Hepatitis C Elimination Plan, rely on innovative technologies to succeed, and conversely, SMEs require alignment with these large-scale programs to achieve market access, reimbursement, and scale.

The Path to Success:

• Problem-Oriented Design: SMEs should design their products and services to solve the specific bottlenecks identified by the WHO and national health bodies—namely, the diagnostic gap and the need for simplified, decentralised care.
• Stakeholder Engagement: Proactive engagement with public health officials, medical societies (such as AASLD/EASL), and patient advocacy groups (like the WHA) is crucial to ensuring that innovations are fit-for-purpose and build the support needed for their adoption and inclusion in clinical guidelines.
• Demonstrate Value: In today’s healthcare environment, clinical efficacy alone is insufficient, as there is a specific requirement to generate robust real-world evidence demonstrating that the solution is not only practical but also cost-effective. Gathering robust data is essential for securing favourable reimbursement decisions and convincing public health programs to invest in the technology.

The most successful solutions will be those that move beyond selling a single product to offering an integrated solution meeting the demand of a clinic that does not just need a POC test but instead requires a complete workflow. Such a solution can be described with a compelling value proposition of a “Hepatitis Care in a Box”, where the diagnostic device, bundled with a user-friendly digital platform for patient records and reporting, and a service component that helps the clinic navigate the complexities of reimbursement, transforming a simple product sale into a high-value, long-term service partnership.

Furthermore, as the highly successful HCV cure market matures, the strategic focus of the entire industry will inevitably shift to the next significant challenge: developing a functional cure for the much larger global population living with chronic hepatitis B. For R&D-focused SMEs and savvy investors, the next major value creation event in hepatology lies on the horizon of HBV.

Conclusion

World Hepatitis Day is more than an awareness campaign as it serves as an annual barometer of the global fight against a disease that, despite being preventable and increasingly treatable, continues to claim approximately 1.3 million lives each year. The paradox of rising mortality in an era of unprecedented medical advancement is a stark indictment of a collective failure in health systems delivery. The chasm between the millions infected and the few who are diagnosed and treated represents the central challenge and, simultaneously, the most incredible opportunity.

The path to achieving the WHO’s 2030 elimination goals is now clear. It does not hinge solely on the next blockbuster drug, but on the widespread deployment of innovations that can dismantle the barriers to care. The future of hepatitis management will be defined by the quest for a functional cure for HBV through novel combination therapies and gene-editing technologies, the decentralisation of care enabled by rapid, point-of-care molecular diagnostics, and the digital infrastructure required to support these new models.

For Small and Medium-sized Enterprises in the healthcare sector, this landscape is ripe with possibilities. The global health imperative to eliminate hepatitis has created distinct and compelling market needs in diagnostics, digital health, and specialised service delivery. The SMEs that will thrive are those that look beyond a single product to offer integrated solutions, that align their innovations with the strategic priorities of national and global health programs, and that possess the agility to bring care directly to the “missing millions.”

For medical innovators aiming to translate public health goals into focused business strategies, this will give a perfect backdrop of commercial success, all the while becoming indispensable partners in striving to eradicate the silent epidemic of hepatitis from the history books.