Biktarvy Sales Forecast, and Market Size Analysis - 2034
상품코드:1855034
리서치사:DelveInsight
발행일:On Demand Report
페이지 정보:영문 30 Pages
라이선스 & 가격 (부가세 별도)
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한글목차
Biktarvy의 주요 성장 촉진요인
1. 시장 점유율 확대 및 신규 환자 확보
Biktarvy는 치료 경험이 있는 환자군과 치료 경험이 없는 환자군 모두에서 큰 시장 점유율을 차지하고 있으며, 전 세계적으로 주요 HIV 치료제로 자리매김하고 있습니다.
신규 환자 수의 지속적인 증가와 기존 치료제로부터의 높은 전환율이 처방액 증가를 견인하고 있습니다.
Biktarvy는 탄탄한 의사 교육 및 환자 지원 프로그램을 포함한 길리어드의 종합적인 상업적 전략을 통해 HIV 치료제로서 높은 평가를 받고 있습니다.
2. 주요 적응증 확대
Biktarvy는 HIV 치료의 첫 번째 선택약물로서 미치료 환자의 첫 번째 선택약물로서 확고한 입지를 구축하고 있으며, 국제적인 가이드라인의 지지를 받고 있습니다.
스위치 요법: 1일 1회 투여, 높은 내성 장벽, 우수한 안전성 프로파일로 다른 항레트로바이러스 요법에서 전환하는 환자들에게 높은 지지를 받고 있습니다.
장기 투여: 내구성과 낮은 투약 중단율로 인해 장기적으로 선호되는 선택이 되고 있습니다.
파이프라인 라이프사이클 관리: 청소년, 소아, 특수 집단을 대상으로 진행 중인 임상시험을 통해 적응증 범위가 계속 확대되고 있습니다.
3. 지리적 확장
Biktarvy는 미국, 유럽, 일본 및 여러 신흥 시장에서 승인 및 출시되어 HIV 분야에서 전 세계 매출의 견인차 역할을 하고 있습니다.
라틴아메리카, 아시아태평양 및 아프리카에서의 확장은 공중 보건 프로그램과 세계 액세스 파트너십에 의해 뒷받침되고 있습니다.
아시아태평양에서는 각국 정부가 더 나은 내약성과 순응도 프로파일을 가진 선진 HIV 치료제를 우선시하고 있기 때문에 성장이 가속화되고 있습니다.
4. 신규 적응증 승인
청소년 및 소아에 대한 사용 승인으로 대상 환자군이 확대되어 연령대를 넘어서는 선택지로써의 역할이 강화되었습니다.
신장 및 간 손상 환자군에 대한 적응증 확대로 접근성과 임상적 유연성이 향상되었습니다.
현재 진행 중인 소아 환자 대상 추가 승인 신청으로 그 입지는 더욱 강화될 전망입니다.
5. 강력한 HIV 수치 모멘텀
Biktarvy는 미치료 집단과 전환 집단 모두에서 강력한 처방 모멘텀을 유지하며 길리어드의 세계 HIV 프랜차이즈의 강력한 성장을 촉진하고 있습니다.
2025년 최신 정보에서는 미국과 유럽에서의 지속적인 강세와 공중보건 중심의 시장에서의 지속적인 수요를 강조하고 있습니다.
높은 지속율과 장기적으로 우수한 바이러스학적 억제력과 내약성이 지속적인 처방 확대를 뒷받침하고 있습니다.
6. 경쟁사와의 차별화와 시장 동향
1일 1회 복용하는 단일정제 요법(STR)인 Biktarvy는 다제 병용요법이나 주사 요법에 비해 편의성과 복약 순응도가 우수합니다.
높은 내성 장벽과 우수한 안전성/내약성 프로파일로 경쟁하는 인테그라제 억제제 기반 요법과 차별화됩니다.
이 약은 각 지역에서 강력한 가이드라인 추천을 받고 있으며, 시장에서의 리더십을 확고히 하고 있습니다.
처방의 단순화, 환자 중심 치료, 장기 지속형 치료와 같은 광범위한 시장 트렌드가 향후 시장 역학을 형성하고 있지만, Biktarvy는 여전히 경구용 의약품의 유력한 선택입니다.
리얼월드에비던스(RWE)가 일관된 유효성, 내약성, 삶의 질 개선을 지속적으로 입증하며 보험사와 의사의 신뢰를 강화하고 있습니다.
Biktarvy의 주요 7개국(미국, 독일, 프랑스, 이탈리아, 스페인, 영국, 일본) 시장을 조사 분석했으며, 매출 예측, 작용기전(MoA), 용법·용량, 연구개발(R&D)에 관한 정보를 전해드립니다.
목차
제1장 보고서 소개
제2장 Biktarvy 개요 : HIV-1 감염증 등의 승인된 적응증, B형 간염 등의 잠재적 적응증
제품 상세
Biktarvy 임상 개발
Biktarvy 임상 연구
Biktarvy 임상시험 정보
안전성과 유효성
기타 개발 활동
제품 프로파일
제3장 Biktarvy 경쟁 구도(출시된 치료법)
제4장 경쟁 구도(후기 단계의 새로운 Biktarvy 요법)
제5장 Biktarvy 시장 평가
승인된/잠재적 적응증의 Biktarvy 시장 전망
주요 7개 시장 분석
주요 7개 시장 승인된/잠재적 적응증용 Biktarvy 시장 규모
각국의 시장 분석
미국의 승인된/잠재적 적응증용 Biktarvy 시장 규모
독일의 승인된/잠재적 적응증용 Biktarvy 시장 규모
영국의 승인된/잠재적 적응증용 Biktarvy 시장 규모
제6장 Biktarvy SWOT 분석
제7장 애널리스트의 견해
제8장 부록
제9장 DelveInsight의 서비스 내용
제10장 면책사항
제11장 DelveInsight 소개
제12장 보고서 구입 옵션
KSM
영문 목차
영문목차
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
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
