HIV 관련 신경 인지장애(HAND) 시장 - 시장 인사이트, 역학, 시장 예측(2034년)

Key Highlights:

• HIV-associated neurocognitive disorder (HAND) describes a variety of cognitive, motor, and mood disturbances affecting people living with HIV. It ranges from asymptomatic impairment and mild neurocognitive disorder to severe dementia.
• According to DelveInsight estimates, there were 2 million diagnosed prevalent cases of HIV in the 7MM in 2024, which are projected to increase during forecast period (2025-2034).
• Among the 7MM, the prevalence of HAND varies significantly. In the US, it affects nearly half of all individuals living with HIV, while in EU4 and the UK, Spain shows the highest burden among member countries.
• ANI is the most common HAND subtype, indicating many HIV-positive individuals have detectable cognitive changes without obvious symptoms.
• The number of diagnosed prevalent cases of HAND was higher among males than females in the 7MM.
• HAND is highly prevalent, impacting 20-59% of individuals worldwide. Despite the lack of a cure, more than 90% of HAND patients pursue treatment, demonstrating a clear demand for therapies that alleviate symptoms, support cognitive function, and improve quality of life. This reflects a considerable unmet medical need and a strong market potential for symptomatic and supportive treatments.
• Since the advent of combination antiretroviral therapy (ART) in 1996, the neurologic complications associated with HIV infection have shifted from those associated with severe immunocompromise, such as opportunistic infections of the (Central Nervous System) CNS, to complications related to treatment.
• The use of antiretroviral therapy has decreased the prevalence of the most severe dementia associated with HIV, but the milder forms of HIV-associated neurocognitive disorder have remained highly prevalent.
• HAND management relies on ART as the foundation, supported by cognitive rehabilitation, pharmacologic options, and psychosocial care to address cognitive deficits and improve quality of life.
• Currently, there are no FDA-approved medications specifically indicated for the treatment of HAND. ART serves as the foundational treatment by reducing HIV replication in the CNS, thereby helping to slow or prevent progression of neurocognitive impairment.
• The HAND pipeline remains sparse. WinSanTor's pirenzepine (WST-057) has completed a Phase II trial for HIV-associated distal sensory polyneuropathy, demonstrating safety and tolerability. Meanwhile, baricitinib is being evaluated in an Emory University led Phase II trial for its potential to reduce HIV levels in the CNS. Moreover, NIAID, in collaboration with Cipla, is set to initiate a Phase II trial comparing pramipexole vs. escitalopram for the treatment of major depressive disorder (MDD) and MDD with mild neurocognitive disorder (MND) in people living with HIV.

DelveInsight's "HIV Associated Neurocognitive Disorders (HAND) - Market Insights, Epidemiology and Market Forecast - 2034" report delivers an in-depth understanding of historical and forecasted epidemiology as well as market trends in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan. The HAND market report provides current treatment practices, emerging drug, market share of individual therapies, and current and forecasted 7MM market size from 2020 to 2034. The report also covers current treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

HIV Associated Neurocognitive Disorders (HAND) Understanding and Treatment

HIV Associated Neurocognitive Disorders Overview

HAND encompasses a spectrum of cognitive, behavioral, and motor impairments caused by HIV's impact on the central nervous system, ranging from asymptomatic neurocognitive impairment (ANI) to mild neurocognitive disorder (MND) and HIV-associated dementia (HAD). HIV enters the brain early, infecting macrophages and microglia, which triggers neuroinflammation, neuronal damage, and synaptic dysfunction. Risk factors include advanced disease, low CD4 count, high viral load, co-infections, aging, and cardiovascular/metabolic comorbidities. Symptoms may involve memory loss, attention deficits, slowed thinking, mood changes, and motor difficulties. Diagnosis uses neuropsychological testing, imaging, and HIV monitoring. While ART has reduced severe cases, milder forms remain common, requiring early treatment, comorbidity management, and cognitive support, with an ongoing need for better biomarkers and neuroprotective therapies.

HIV Associated Neurocognitive Disorders Diagnosis

Diagnosis of HAND typically starts when a person living with HIV experiences symptoms such as memory problems, slowed thinking, mood changes, or coordination difficulties. The healthcare provider gathers a detailed medical history, performs a neurological examination, and conducts neuropsychological tests to evaluate cognitive function. Brain MRI is used to exclude other causes, while HIV viral load, CD4 count, and CSF analysis help detect ongoing infection or inflammation. Combined findings confirm HAND and inform an individualized treatment approach.

HIV Associated Neurocognitive Disorders Treatment

While there is no cure for HAND, antiretroviral therapy (ART) remains the cornerstone of treatment, aiming to control HIV and reduce its impact on the brain. ART regimens may be selected for their ability to penetrate the central nervous system, though evidence on cognitive benefits varies. Supportive care includes managing comorbidities, addressing mood disorders, and treating reversible causes of cognitive decline. Cognitive rehabilitation can aid daily functioning, and drugs with strong anticholinergic effects should be avoided as they may worsen cognition. Ongoing monitoring, timely ART adjustments, and multidisciplinary care are essential, as mild impairments often persist despite viral suppression.

HIV Associated Neurocognitive Disorders Epidemiology

The HAND epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by diagnosed prevalent cases of HIV, diagnosed prevalent cases of HAND, type-specific cases of HAND, gender-specific cases of HAND, diagnosed prevalent cases of distal sensory polyneuropathy in HIV, and the treated eligible patient pool of HAND in the 7MM covering the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In 2024, an estimated 610,000 individuals in the US were diagnosed with HAND, with this number expected to rise over the forecast period (2025-2034).
• In the US, among the type-specific cases, asymptomatic neurocognitive impairment accounts for the major contribution of about 70% followed by mild neurocognitive disorder.
• In EU4 and the UK, Distal Sensory Polyneuropathy in HIV accounted for about 40%.
• In Japan, among the gender-specific diagnosed prevalent cases, males had the highest contribution; ~90% in 2024.
• HAND treatment eligible pool in the US is more than 500,000 in 2024.

Drug Chapters

The drug chapter segment of the disease report encloses a detailed analysis of current treatment and emerging drug. It also helps understand the HAND clinical trial details, the expressive pharmacological action, agreements and collaborations, advantages and disadvantages of each included drug, and the latest news and press releases.

Emerging Drug

Pirenzepine: WinSanTor

Pirenzepine is the only therapy being evaluated by the company. Pirenzepine, a muscarinic M1 receptor antagonist, is being developed for HIV-associated distal sensory polyneuropathy. A 16-week Phase II trial (NCT05005078) was completed in 2023, with earlier Phase I and II studies showing topical WST-057 to be safe and well-tolerated in diabetic peripheral neuropathy for up to six months. However, Phase III trials are still needed.

Drug Class Insights

Antiretroviral Drugs (ART)

The cornerstone of HAND treatment is effective ART aimed at suppressing HIV replication, particularly in the CNS. Classes used include nucleoside reverse transcriptase inhibitors (NRTIs) such as zidovudine and lamivudine with good CNS penetration, non-nucleoside reverse transcriptase inhibitors (NNRTIs) like nevirapine and efavirenz, protease inhibitors (PIs), and integrase strand transfer inhibitors (INSTIs). ART regimens with higher CNS penetration effectiveness (CPE scores) are often preferred for HAND to reduce viral load in the brain.

Market Outlook

Since the early HIV/AIDS era, HAND has persisted as a major neurological complication, now affecting almost half of people with HIV, even in the cART era. While cART can help prevent or slow its progression in some, there is still no definitive biomarker or approved therapy, leaving HAND an unmet clinical challenge.

The primary strategy for managing HAND is effective HIV control with cART, which suppresses viral replication, may reduce CNS inflammation, and can improve cognition. Key drugs include NRTIs (abacavir, zidovudine, etc.), NNRTIs (efavirenz, nevirapine), integrase inhibitors (dolutegravir, raltegravir), and protease inhibitors (lopinavir, indinavir). Zidovudine has the best BBB penetration, while efavirenz may cause neuropsychiatric effects that usually diminish over time. ART can have various neuropsychiatric side effects.

Supportive care includes physical, occupational, and speech therapies to improve function, mental health support for depression or anxiety, and management of coexisting conditions contributing to cognitive decline.

Clinical progress in HAND remains limited. WinSanTor's pirenzepine, a muscarinic M1 receptor antagonist, is being developed for HIV-associated distal sensory polyneuropathy. Its Phase II trial (NCT05005078) was completed in 2023.

Additionally, Eli Lilly's Baricitinib is currently being evaluated in a Phase II clinical trial (NCT05452564) led by Emory University, aimed at determining its safety and effectiveness in reducing HIV levels in the central nervous system. The trial is actively recruiting participants. Considering that Eli Lilly is neither collaborating nor sponsoring this particular trial, we remain unsure about its future development from a regulatory aspect and do not anticipate any commercial progress in the absence of Lilly making any statements around this development.

Moreover, the National Institute of Allergy and Infectious Diseases (NIAID), in collaboration with Cipla, is set to initiate a Phase II trial (NCT06705478) comparing pramipexole vs. escitalopram for the treatment of major depressive disorder (MDD) and MDD with mild neurocognitive disorder (MND) in people living with HIV. This study is currently in the "Not yet recruiting" stage, with an estimated start date of October 2025, according to ClinicalTrials.gov. However, we have excluded this asset from our analysis due to its generic presence.

The approval of Pirenzepine is anticipated to reshape the market dynamics during the forecast period (2025-2034).

• In 2024, the US captured the highest market share of HAND, i.e., nearly USD 9,000 million among the 7MM.
• In Japan, the HAND market size accounted for nearly USD 70 million in 2024, and is expected to increase at a significant CAGR during the forecast period (2025-2034).
• In 2024, among all the therapies for HAND, the highest revenue was generated by the NNRTI-based regimen, followed by the PI-based regimen in the US.

HIV Associated Neurocognitive Disorders Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034. The landscape of HAND treatment has experienced a profound transformation with the uptake of novel drugs.

HIV Associated Neurocognitive Disorders Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I/II. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for HAND emerging therapies.

KOL-Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, PhD, Research Project Manager, Director, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or HAND market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Delveinsight's analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. University of Johns Hopkins University School of Medicine, The Icahn School of Medicine at Mount Sin, Yuka Kotozaki, Iwate Medical University, etc., were contacted. Their opinion helps understand and validate HAND epidemiology and market trends.

Qualitative Analysis

We perform qualitative and market intelligence analysis using various approaches, such as SWOT analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and a payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US.

The major healthcare programs, including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a descriptive overview of HAND, explaining its causes, signs and symptoms, pathogenesis, and currently available and emerging therapies.
• Comprehensive insight has been provided into HAND epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for HAND is provided, along with the assessment of new therapies that will have an impact on the current treatment landscape.
• A detailed review of the HAND market, historical and forecasted, is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM HAND market.

HIV Associated Neurocognitive Disorders Report Insights

• Patient population
• Therapeutic approaches
• HAND market size and trends
• Market opportunities
• Impact of upcoming therapies

HIV Associated Neurocognitive Disorders Report Key Strengths

• Ten years forecast
• 7MM coverage
• HAND epidemiology segmentation
• Highly analyzed market
• Drugs uptake

HIV Associated Neurocognitive Disorders Report Assessment

• Current treatment practices
• Unmet needs
• Pipeline product profiles
• Market attractiveness
• Qualitative analysis (SWOT analysis)

FAQs:

• What was the HAND market share (%) distribution in 2024, and what would it look like in 2034?
• What would be the HAND total market size as well as market size by therapies across the 7MM during the study period (2020-2034)?
• Which country will have the largest HAND market size during the study period (2020-2034)?
• What are the disease risks, burdens, and unmet needs of HAND?
• What is the historical HAND patient pool in the United States, the EU4 (Germany, France, Italy, and Spain), and the UK, and Japan?
• What will be the growth opportunities across the 7MM concerning the patient population of HAND?
• What are the key collaborations (Industry-Industry, Industry-Academia), mergers and acquisitions, and licensing activities related to HAND therapies?
• What are the clinical studies going on for HAND and their status?

Reasons to Buy:

• The report will help in developing business strategies by understanding trends shaping and driving HAND.
• Organize sales and marketing efforts by identifying the best opportunities for HAND in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the HAND market.
• To understand the future market competition in the HAND market.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of HAND

4. Epidemiology and Market Forecast Methodology

5. HANDS Overview at a Glance

• 5.1. Market Share (%) Distribution of HANDS by Therapies in 2024
• 5.2. Market Share (%) Distribution of HANDS by Therapies in 2034

6. Disease Background and Overview

• 6.1. Introduction
• 6.2. Signs and Symptoms
• 6.3. Causes
• 6.4. Type
• 6.5. Pathophysiology
• 6.6. Clinical manifestations
• 6.7. Diagnosis

7. Treatment

• 7.1. Treatment Strategies for HANDS
• 7.2. Treatment Algorithm

8.. Epidemiology and Patient Population of HANDS in the 7MM

• 8.1. Key Findings
• 8.2. Assumptions and Rationale
• 8.3. Total Diagnosed Prevalent Cases of HIV in the 7MM
• 8.4. Diagnosed Prevalent Cases of HANDS in the 7MM
• 8.5. The United States
  • 8.5.1. Diagnosed Prevalent Cases of HIV in the United States
  • 8.5.2. Diagnosed Prevalent Cases of HAND in the United States
  • 8.5.3. Type-specific Cases of HAND in the United States
  • 8.5.4. Gender-specific Cases of HAND in the United States
  • 8.5.5. Diagnosed Prevalent Cases of Distal Sensory Polyneuropathy in the United States
  • 8.5.6. Treated Eligible Pool of HAND in the United States
• 8.6. EU4 and the UK
  • 8.6.1. Diagnosed Prevalent Cases of HIV in EU4 and the UK
  • 8.6.2. Diagnosed Prevalent Cases of HAND in EU4 and the UK
  • 8.6.3. Type-specific Cases of HAND in EU4 and the UK
  • 8.6.4. Gender-specific Cases of HAND in EU4 and the UK
  • 8.6.5. Diagnosed Prevalent Cases of Distal Sensory Polyneuropathy in EU4 and the UK
  • 8.6.6. Treated Eligible Pool of HAND in EU4 and the UK
• 8.7. Japan
  • 8.7.1. Diagnosed Prevalent Cases of HIV in Japan
  • 8.7.2. Diagnosed Prevalent Cases of HAND in Japan
  • 8.7.3. Type-specific Cases of HAND in Japan
  • 8.7.4. Gender-specific Cases of HAND in Japan
  • 8.7.5. Diagnosed Prevalent Cases of Distal Sensory Polyneuropathy in Japan
  • 8.7.6. Treated Eligible Pool of HAND in Japan

9. Patient Journey

• 9.1. Patient Journey Description

10. Emerging Therapy

• 10.1. Pirenzepine: WinSanTor
  • 10.1.1. Product Description
  • 10.1.2. Other Developmental Activities
  • 10.1.3. Clinical Development
    • 10.1.3.1. Clinical Trials Information
  • 10.1.4. Safety and Efficacy
  • 10.1.5. Analyst Views

11. HANDS: 7MM Analysis

• 11.1. Key Findings
• 11.2. Market Outlook
• 11.3. Key Market Forecast Assumptions
  • 11.3.1. Cost Assumptions and Rebates
  • 11.3.2. Pricing Trends
  • 11.3.3. Analogue Assessment
  • 11.3.4. Launch Year and Therapy Uptake
• 11.4. Total Market Size of HAND in the 7MM
• 11.5. The United States
  • 11.5.1. Total Market Size of HAND in the United States
  • 11.5.2. Market Size of HAND by Therapies in the United States
• 11.6. EU4 and the UK
  • 11.6.1. Total Market Size of HAND in EU4 and the UK
  • 11.6.2. Market Size of HAND by Therapies in EU4 and the UK
• 11.7. Japan Market Size
  • 11.7.1. Total Market Size of HAND in Japan
  • 11.7.2. Market Size of HAND by Therapies in Japan

12. Unmet Needs

13. SWOT Analysis

14. KOL Views

15. Market Access and Reimbursement

16. Appendix

• 16.1. Bibliography
• 16.2. Report Methodology

17. DelveInsight Capabilities

18. Disclaimer

19. About DelveInsight