빅타비(Biktarvy) 판매 예측, 시장 규모 분석(2034년)

Key Factors Driving Biktarvy Growth

1. Market Share Gains and New Patient Starts

• Biktarvy continues to be the leading HIV treatment worldwide, capturing significant market share across both treatment-naive and treatment-experienced populations.
• A consistent rise in new patient starts and high switching rates from older regimens are fueling strong prescription growth.
• Gilead's comprehensive commercial strategy, including robust physician education and patient support programs, has reinforced Biktarvy's position as the preferred HIV regimen.

2. Expansion Across Key Indications

• First-Line HIV Treatment: Biktarvy is firmly established as a first-line therapy for treatment-naive patients, supported by international guideline endorsements.
• Switch Therapy: Strong uptake in patients switching from other antiretroviral regimens due to its once-daily dosing, high barrier to resistance, and favorable safety profile.
• Long-Term Management: Its durability and low discontinuation rates make it a preferred long-term option.
• Pipeline & Lifecycle Management: Ongoing studies in adolescents, pediatrics, and special populations continue to expand its reach.

3. Geographic Expansion

• Biktarvy is approved and marketed across the US, Europe, Japan, and multiple emerging markets, driving global revenue leadership in HIV.
• Expansion in Latin America, Asia-Pacific, and Africa is supported by public health programs and global access partnerships.
• The Asia-Pacific region shows accelerated growth as governments prioritize advanced HIV regimens with better tolerability and adherence profiles.

4. New Indication Approvals

• Regulatory approvals for use in adolescents and children have broadened the eligible patient pool, reinforcing its role as a go-to option across age groups.
• Expanding labeling for renal and hepatic impaired populations enhances accessibility and clinical flexibility.
• Ongoing regulatory submissions in additional pediatric populations will further strengthen positioning.

5. Strong HIV Volume Momentum

• Biktarvy maintains strong prescription momentum in both naive and switch populations, driving robust global HIV franchise growth for Gilead.
• 2025 updates highlight continued strength in the US and EU, with sustained demand in public health-driven markets.
• High persistence rates, coupled with superior long-term virologic suppression and tolerability, support ongoing prescription expansion.

6. Competitive Differentiation and Market Trends

• As a single-tablet regimen (STR) with once-daily dosing, Biktarvy offers superior convenience and adherence advantages over multi-pill or injectable therapies.
• Its high barrier to resistance and favorable safety/tolerability profile differentiate it from competing integrase inhibitor-based regimens.
• The drug benefits from strong guideline recommendations across regions, solidifying its market leadership.
• Broader market trends toward simplified regimens, patient-centric care, and long-acting therapies are shaping future dynamics, but Biktarvy remains the dominant oral option.
• Real-World Evidence (RWE) continues to demonstrate consistent efficacy, tolerability, and quality-of-life improvements, reinforcing payer and physician confidence.

Biktarvy Recent Developments

• In July 2025, Gilead Sciences announced that the US Food and Drug Administration (FDA) granted a new approval for a novel indication for Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF). This new indication expands Biktarvy's label to include the treatment of people with HIV (PWH) with an antiretroviral treatment (ART) history who are not virologically suppressed, with no known or suspected resistance to the integrase strand inhibitor (INSTI) class, emtricitabine or tenofovir. The approval of this supplemental New Drug Application (sNDA) will help bridge an unmet public health need in PWH who are viremic and restarting ART given the limited treatment options approved by the FDA for this population to date.
• In March 2025, Gilead Sciences announced the presentation of late-breaking data and multiple oral presentations from its innovative HIV treatment portfolio and pipeline at the Conference on Retroviruses and Opportunistic Infections (CROI 2025). The new findings reflect a transformative portfolio and a rapidly advancing forward-looking pipeline focused on expanding choices and enhancing outcomes for those with HIV, while continuing to reach towards a cure.
• In February 2024, Gilead Sciences announced that the US Food and Drug Administration (FDA) approved a new, expanded indication for Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat people with HIV (PWH) who have suppressed viral loads with known or suspected M184V/I resistance, a common form of treatment resistance. HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH.

"Biktarvy Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of Biktarvy for approved indications like HIV-1 infections; as well as potential indication like Hepatitis B in the 7MM. A detailed picture of Biktarvy's existing usage in approved and anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 -2034 is provided in this report along with a detailed description of the Biktarvy for approved and potential indications. The Biktarvy market report provides insights about Biktarvy's sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current Biktarvy performance, future market assessments inclusive of the Biktarvy market forecast analysis for approved and potential indications in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of Biktarvy sales forecasts, along with factors driving its market.

Biktarvy Drug Summary

Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, INSTI-based STR available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the F/TAF backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines.

BIKTARVY is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing >=14 kg with no antiretroviral treatment history; or with an ARV treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir; or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir. The report provides Biktarvy's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Biktarvy is in the Phase III stage of clinical development for the treatment of patients with Hepatitis B (NCT03547908).

Scope of the Biktarvy Market Report

The report provides insights into:

• A comprehensive product overview including the Biktarvy MoA, description, dosage and administration, research and development activities in approved indications like HIV-1 infections; as well as potential indication like Hepatitis B.
• Elaborated details on Biktarvy regulatory milestones and other development activities have been provided in Biktarvy market report.
• The report also highlights Biktarvy's cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved and potential indications across the United States, Europe, and Japan.
• The Biktarvy market report also covers the patents information, generic entry and impact on cost cut.
• The Biktarvy market report contains current and forecasted Biktarvy sales for approved and potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The Biktarvy market report also features the SWOT analysis with analyst views for Biktarvy in approved and potential indications.

Methodology:

The Biktarvy market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

Biktarvy Analytical Perspective by DelveInsight

• In-depth Biktarvy Market Assessment

This Biktarvy sales market forecast report provides a detailed market assessment of Biktarvy for approved indications like HIV-1 infections; as well as potential indication like Hepatitis B in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted Biktarvy sales data uptil 2034.

• Biktarvy Clinical Assessment

The Biktarvy market report provides the clinical trials information of Biktarvy for approved and potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

Biktarvy Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

Biktarvy Market Potential & Revenue Forecast

• Projected market size for the Biktarvy and its key indications
• Estimated Biktarvy sales potential (Biktarvy peak sales forecasts)
• Biktarvy Pricing strategies and reimbursement landscape

Biktarvy Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• Biktarvy Market positioning compared to existing treatments
• Biktarvy Strengths & weaknesses relative to competitors

Biktarvy Regulatory & Commercial Milestones

• Biktarvy Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

Biktarvy Clinical Differentiation

• Biktarvy Efficacy & safety advantages over existing drugs
• Biktarvy Unique selling points

Biktarvy Market Report Highlights

• In the coming years, the Biktarvy market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The Biktarvy companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Biktarvy's dominance.
• Other emerging products for HIV-1 infections; as well as potential indication like Hepatitis B are expected to give tough market competition to Biktarvy and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of Biktarvy in approved and potential indications.
• Analyse Biktarvy cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted Biktarvy sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Biktarvy in approved and potential indications.

Key Questions:

• What is the class of therapy, route of administration and mechanism of action of Biktarvy? How strong is Biktarvy's clinical and commercial performance?
• What is Biktarvy's clinical trial status in each individual indications such as HIV-1 infections; as well as potential indication like Hepatitis B and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Biktarvy Manufacturers?
• What are the key designations that have been granted to Biktarvy for approved and potential indications? How are they going to impact Biktarvy's penetration in various geographies?
• What is the current and forecasted Biktarvy market scenario for approved and potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of Biktarvy in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What are the other emerging products available and how are these giving competition to Biktarvy for approved and potential indications?
• Which are the late-stage emerging therapies under development for the treatment of approved and potential indications?
• How cost-effective is Biktarvy? What is the duration of therapy and what are the geographical variations in cost per patient?

Table of Contents

1. Report Introduction

2. Biktarvy Overview in approved indications like HIV-1 infections; as well as potential indication like Hepatitis B

• 2.1. Product Detail
• 2.2. Biktarvy Clinical Development
  • 2.2.1. Biktarvy Clinical studies
  • 2.2.2. Biktarvy Clinical trials information
  • 2.2.3. Safety and efficacy
• 2.3. Other Developmental Activities
• 2.4. Product Profile

3. Biktarvy Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Biktarvy Therapies)

5. Biktarvy Market Assessment

• 5.1. Biktarvy Market Outlook in approved and potential indications
• 5.2. 7MM Analysis
  • 5.2.1. Biktarvy Market Size in the 7MM for approved and potential indications
• 5.3. Country-wise Market Analysis
  • 5.3.1. Biktarvy Market Size in the United States for approved and potential indications
  • 5.3.2. Biktarvy Market Size in Germany for approved and potential indications
  • 5.3.3. Biktarvy Market Size in France for approved and potential indications
  • 5.3.4. Biktarvy Market Size in Italy for approved and potential indications
  • 5.3.5. Biktarvy Market Size in Spain for approved and potential indications
  • 5.3.6. Biktarvy Market Size in the United Kingdom for approved and potential indications
  • 5.3.7. Biktarvy Market Size in Japan for approved and potential indications

6. Biktarvy SWOT Analysis

7. Analysts' Views

8. Appendix

• 8.1. Bibliography
• 8.2. Report Methodology

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options