Biktarvy Market Report: Trends, Forecast and Competitive Analysis to 2031

Biktarvy Market Trends and Forecast

The future of the global Biktarvy market looks promising with opportunities in the hospital and retail pharmacy markets. The global Biktarvy market is expected to grow with a CAGR of 2.7% from 2025 to 2031. The major drivers for this market are the rising prevalence of HIV/AIDS, the growing awareness & screening programs, and the increasing preference for single-tablet regimens.

• Lucintel forecasts that, within the type category, generic drugs are expected to witness higher growth over the forecast period.
• Within the application category, retail pharmacy is expected to witness higher growth.
• In terms of region, North America is expected to witness the highest growth over the forecast period.

Gain valuable insights for your business decisions with our comprehensive 150+ page report. Sample figures with some insights are shown below.

Emerging Trends in the Biktarvy Market

The Biktarvy market, as strong as it is, is not fixed. A number of very important trends are emerging that will shape its future direction and position within the overall HIV treatment environment. Some of these trends involve the creation and uptake of long-acting injectable treatments, the growing emphasis on the treatment of patients with comorbidities, the growing use of pre-exposure prophylaxis (PrEP), the continued relevance of single-tablet regimens, and the possible influence of patent losses and generic competition. Knowledge of these trends is essential to forecast future market trends.

• Long-Acting Injectable Therapies: Development and increasing use of long-acting injectable antiretroviral therapies, including cabotegravir and rilpivirine (Cabenuva), are a major trend in HIV therapy. These treatments bring the benefit of less frequent dosing (e.g., monthly or bi-monthly), which can simplify patient adherence and patient satisfaction by minimizing the pill burden. Whereas Biktarvy is a simple once-daily oral regimen, the attractiveness of even less-frequent dosing will appeal to some patients and could affect Biktarvy's market share over the long term.
• Increased Emphasis on Treating Patients with Comorbidities: Individuals with HIV are increasingly having comorbidities like cardiovascular disease, renal impairment, and bone health disorders. This requires HIV therapies that are not only efficacious in viral suppression but also safe and well-tolerated in the context of these other comorbidities. Long-term data on Biktarvy among older patients and those with comorbidities are being studied in ongoing research and clinical trials, which underscores the relevance of meeting these complicated patient requirements in the market.
• Pre-Exposure Prophylaxis Expansion: Although Biktarvy itself is not approved for PrEP, the increasing focus on HIV prevention regimens and the growth in PrEP use impact the size of the overall HIV market. The effectiveness of PrEP in preventing new HIV infections can, in turn, affect the size of the treatment market in the future. Gilead, the company that makes Biktarvy, also has a presence in the market for PrEP with other medications such as Decoy, suggesting a more general strategic interest in both treatment and prevention. The introduction of new, long-acting PrEP forms may further shift the scene.
• Ongoing Supremacy of Single-Tablet Regimens: Single-tablet regimens such as Biktarvy have become the standard of care for most individuals with HIV because they are simple and encourage improved adherence. The ease of taking only a single pill a day makes the treatment easier and can result in better outcomes. Biktarvy's success derives in part from its position as a small but effective STR that has a well-tolerated safety profile. This trend lines up with that STRs will maintain a very large share of the market though they will get competition from some new long-acting products on the horizon.
• Potential Effect of Patent Expirations and Generic Competition: Although Biktarvy is now under patent protection, the eventual lapse of these patents will allow generic competition. Generic forms of antiretroviral drugs can dramatically reduce the cost of treatment, potentially affecting the market share and revenue of branded medications such as Biktarvy. Gilead must be planning for this future competition by creating new and innovative HIV treatments in order to preserve its market dominance.

These new trends are all combined to reshape the Biktarvy market. Although Biktarvy's current status as a top single-tablet regimen is robust, it will have to adjust to the growing availability of long-acting injectables and the expanding emphasis on treating patients with comorbidities. The growth of PrEP may impact the total treatment market size, and the eventual launch of generics will bring pricing pressures. Gilead's innovative capacity and therapeutic development capabilities will be key in navigating these shifting market dynamics and keeping a solid footing in the HIV treatment space.

Recent Developments in the Biktarvy Market

Current events surrounding the Biktarvy market are focused on affirming its leadership as a first-line HIV treatment. These events include the introduction of long-term efficacy and safety data, studies of its application in varied patient populations such as those with co-infections, and evaluation of new formulations to improve patient convenience and outcomes. All these are aimed at expanding Biktarvy's use and affirming its place in the emerging HIV treatment landscape.

• Long-Term Efficacy and Safety Data: Ongoing clinical trials and real-world studies continue to generate long-term data on the efficacy and safety of Biktarvy. Presentations at key conferences, including the Conference on Retroviruses and Opportunistic Infections (CROI), typically include multi-year outcomes showing durable viral suppression and a good safety profile in patients receiving Biktarvy. This supports confidence in Biktarvy as a stable long-term treatment option.
• Studies in Specific Patient Populations: Research is being conducted to evaluate the effectiveness and safety of Biktarvy in specific subgroups of people living with HIV. This includes studies in treatment-naïve individuals, those switching from other antiretroviral regimens, older adults, and individuals with comorbidities such as hepatitis B virus (HBV) co-infection. Findings from these studies assist in guiding treatment and broadening the knowledge of Biktarvy's value to a wider group of patients. For instance, high viral suppression rates have been demonstrated in patients with HIV/HBV co-infection switching to Biktarvy.
• Investigation of New Formulations and Delivery Options: Although Biktarvy is presently marketed as a once-daily oral tablet, there is active research across the overall HIV therapy space for long-acting formulations. Although nonspecific to Biktarvy in the short run, technology advances in drug delivery systems could in the future create reformulated versions of Biktarvy or its individual elements with the goal of further enhancing convenience and adherence.
• Relative Efficacy and Safety Studies Compared to Other Antiretroviral Regimens: Further to define its position in therapy, Biktarvy has been compared to other widely used regimens of antiretroviral therapy through clinical trials. Relative efficacy, safety, and tolerability are all evaluated in such studies, which serve to help clinicians make informed treatment decisions. Favorable results from these relative efficacy and safety studies endorse Biktarvy as a preferred first-line treatment.
• Collection of Real-World Evidence: Outside of controlled clinical trials, collection and analysis of real-world evidence are becoming more critical. These trials assess how Biktarvy works under real-world clinical practice conditions, revealing its efficacy and tolerability in a heterogeneous group of patients outside the rare protocol conditions of clinical trials. Real-world evidence can be used to supplement clinical trial information and contribute further to treatment recommendations.

These recent advances collectively emphasize the continued efforts to maximize the utilization of Biktarvy in HIV management. The accumulation of long-term data, research in special populations, and the general trends in HIV treatment research are all leading to a better understanding of Biktarvy's place and promise in enhancing the lives of individuals living with HIV. These advances serve to further establish Biktarvy as an integral part of the contemporary HIV treatment era.

Strategic Growth Opportunities in the Biktarvy Market

Strategic growth areas for Biktarvy are to build on its proven efficacy and safety profile to expand its use across various stages of HIV treatment. These areas are to consolidate its role in first-line treatment, emerge as the first choice among those switching treatment regimens, increase its use in patients with co-infections, and look into new formulations to make it more convenient for patients and improve adherence. Building on these areas can further enhance Biktarvy's market presence.

• Initial Therapy for Naïve Patients: Biktarvy has already made a significant name for itself as an initial therapy for newly diagnosed HIV individuals. Its ability to provide fast and sustained viral suppression, combined with its tolerability profile and single-tablet once-daily regimen, makes it an appealing choice for initial therapy. Ongoing efforts towards educating healthcare professionals and newly diagnosed patients about these advantages can further establish its place in this critical use.
• Switch Therapy for Virologically Suppressed Patients: For patients who are already virologically suppressed on alternative antiretroviral regimens but perhaps having issues with tolerability, drug interactions, or pill burden, Biktarvy represents a streamlined and frequently better-tolerated option. Emphasizing Biktarvy as an exemplary switching option through clinical evidence illustrating superior outcomes or patient satisfaction can increase growth in this category.
• HIV/HBV Co-infected Individuals Treatment: HIV patients usually present with co-infections, and one such common co-infection is hepatitis B. Biktarvy's efficacy in suppressing both HIV and HBV has been shown in studies, which makes it an important choice for this particular patient group. Increased research and education among healthcare providers who treat co-infected patients can increase Biktarvy's application in this important use.
• Long-Acting Formulations Development: Although Biktarvy is already an oral tablet, the direction of long-acting injectable HIV treatments represents a future growth possibility. Gilead's knowledge in developing HIV drugs could be used to develop long-acting versions of Biktarvy or its active ingredients, providing improved convenience and adherence for those who want to take less medication more infrequently.
• Pediatric and Adolescent Use: Another opportunity for growth is extending the approved indication of Biktarvy to younger age groups, such as pediatric and adolescent patients. Clinical trials assessing the safety and efficacy of Biktarvy in these patient groups, with subsequent regulatory approvals, can extend its use and offer effective treatment to children and adolescents with HIV.

These strategic growth prospects, from establishing its place in first-line treatment to investigating new forms and broadening its application in certain patient populations, have the potential to greatly affect the Biktarvy market. By targeting these, Gilead is able to further build on the asset strengths of Biktarvy to meet the changing needs of individuals living with HIV while solidifying its leadership in the antiretroviral category.

Biktarvy Market Driver and Challenges

The trajectory of the Biktarvy market is defined by an intersection of drivers and challenges that result from technological advances in HIV therapy, economic determinants affecting drug pricing and availability, and the changing regulatory environment that defines pharmaceutical approvals and guidelines. These dynamics are essential for stakeholders to effectively navigate the market and for individuals living with HIV to obtain best-in-class care.

The factors responsible for driving the Biktarvy market include:

1. High Efficacy and Tolerability: Biktarvy's proven high viral suppression rates and good safety profile are key drivers of its commercial success. Clinical trial and real-world evidence all demonstrate its ability to suppress HIV with fewer side effects, and so it is a first choice for both treatment-naïve patients and treatment-experienced patients. Its robust clinical profile favors its prescription by clinicians.

2. Convenient Once-Daily Single-Tablet Regimen: The ease of once-daily single-tablet therapy greatly enhances treatment adherence. For those with a chronic illness such as HIV, pill burden reduction makes their daily life easier and more likely to maintain regular medication, resulting in improved virologic response. This ease is one of the key reasons Biktarvy is so well received.

3. Strong Recommendation in Treatment Guidelines: Most HIV treatment guidelines globally recommend INSTI-based regimens, such as Biktarvy, as the first-line therapy of choice. These recommendations, supported by strong clinical evidence, lead to the use of Biktarvy by healthcare providers as a safe and effective first-line treatment for the majority of individuals with HIV.

4. Ongoing Innovation in HIV Treatment: Ongoing research and development in the HIV sector lend support to success stories of medications such as Biktarvy. Ongoing developments in antiretroviral drugs, aiming for increased efficacy, lower toxicity, and easier convenience, push the market toward newer and superior treatment alternatives. Biktarvy is one such development, aided by the advances in INSTI development.

5. Increased Awareness and Access to HIV Treatment: Global efforts to increase awareness of HIV, increase testing, and enhance access to treatment drive the expansion of the overall HIV drug market, including Biktarvy. As more individuals become diagnosed and connected to care, demand for effective antiretroviral therapies such as Biktarvy continues to increase.

Challenges in the Biktarvy market are:

1. Competition from Other Antiretroviral Therapies: The market for HIV treatment is competitive, with a number of other effective antiretroviral regimens, including other single-tablet regimens and new long-acting injectable therapies. This competition can restrict Biktarvy's market share and impose pricing pressures as manufacturers compete for patient preference and payer coverage.

2. Pricing and Reimbursement Concerns: The affordability of newer antiretroviral agents such as Biktarvy may be problematic, especially where there are constraints in resources or limited insurance cover. Favorable pricing and proper reimbursement policies that are strong must be negotiated so that market access is sustained and widespread use of Biktarvy is enabled.

3. Risk for Long-Term Side Effects and Resistance: Though Biktarvy has a benign safety profile, the risk of long-term side effects, including some that will not be easily recognized, cannot be eliminated. Moreover, despite the high resistance barrier of Biktarvy, drug resistance, which can evolve over time, is a possibility with any antiretroviral regimen, possibly curtailing its long-term efficacy in certain patients.

The Biktarvy market is fueled by its high efficacy, tolerability, convenient presentation, and favorable positioning in treatment guidelines, within a backdrop of continuous innovation and expanding access to HIV care. But it has challenges posed by competition, price and reimbursement complexities, and long-term side effects or resistance risks. Managing these drivers and challenges will be essential for Biktarvy in order to preserve its market leadership and remain an essential part of HIV treatment.

List of Biktarvy Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. With these strategies, Biktarvy companies cater to increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the Biktarvy companies profiled in this report include:

• Gilead Sciences
• ABACUS MEDICINE
• Hetero Drugs
• Gador
• BMODESTO

Biktarvy Market by Segment

The study includes a forecast for the global Biktarvy market by type, application, and region.

Biktarvy Market by Type [Value from 2019 to 2031]:

• Brand Drugs
• Generic Drugs

Biktarvy Market by Application [Value from 2019 to 2031]:

• Hospitals
• Retail Pharmacy
• Others

Biktarvy Market by Region [Value from 2019 to 2031]:

• North America
• Europe
• Asia Pacific
• The Rest of the World

Country Wise Outlook for the Biktarvy Market

The Biktarvy market, a major HIV treatment segment worldwide, keeps growing in major geographies. Trends are influenced by drivers like growing adoption rates, competition from established and emerging antiretroviral therapies, pricing trends, and regulatory regimes. Gilead Sciences' Biktarvy, a once-daily, single-tablet regimen, has become a popular treatment because of its efficacy, safety profile, and convenience. Yet, market conditions differ significantly between countries, shaped by local healthcare systems, economic conditions, and HIV prevalence. It is important for stakeholders in the pharmaceutical sector and people living with HIV to understand these regional differences.

• United States: Biktarvy enjoys robust market leadership in the US, fueled by strong demand and favorable reimbursement. Sales continue to increase, with a 7% year-on-year increase seen in the first quarter of 2025, contributing largely to Gilead's overall revenues. Although long-acting injectables such as Cabenuva represent competitive pressure, Biktarvy's established track record of efficacy and the convenience of a once-daily oral regimen guarantee its continued solid standing. Recent price revisions have taken place, demonstrating a balance between revenue generation and market access for Gilead.
• China: Data on recent developments specifically for Biktarvy in China are sparse in the available search results. The overall Chinese pharmaceutical market, though, is seeing growth in traditional and specialty pharmaceuticals. Single-tablet regimens are becoming the norm for HIV, with branded therapies such as Biktarvy gaining strong share in the HIV segment. The overall pharmaceutical trend suggests a growing market for innovative treatments, which could positively impact Biktarvy's future trajectory in the region.
• Germany: There are no specific recent developments on Biktarvy in Germany set out in the search results given. Nevertheless, Germany is a major market across Europe, and trends in other large European markets, including attention to single-tablet regimens and the effect of pricing and reimbursement policy, are likely applicable. The general European market will experience competitive prices as a result of policy action, which might influence the market dynamics of Biktarvy in Germany.
• India: The search results do not yield particular recent updates on Biktarvy in India. The Indian pharma industry is, however, interested in bolstering its infrastructure to be a world leader. The overall antiviral drug market is growing, led by the rise in viral disease prevalence. As much as Biktarvy is an important global product, its particular market trends in India would be determined by local prices, access initiatives, and the availability of generic antiretrovirals.
• Japan: Recent data suggest that Biktarvy is approved and on the market in Japan. This evidence has been presented at international meetings by Gilead, highlighting the safety and efficacy of Biktarvy across a range of patient subgroups. Japan, as with other developed countries, would prefer effective, convenient HIV treatment, which would play in the favor of Biktarvy. Market conditions would be shaped by the healthcare system and regulation in Japan.

Features of the Global Biktarvy Market

Market Size Estimates: Biktarvy market size estimation in terms of value ($B).

Trend and Forecast Analysis: Market trends (2019 to 2024) and forecast (2025 to 2031) by various segments and regions.

Segmentation Analysis: Biktarvy market size by type, application, and region in terms of value ($B).

Regional Analysis: Biktarvy market breakdown by North America, Europe, Asia Pacific, and Rest of the World.

Growth Opportunities: Analysis of growth opportunities in different types, applications, and regions for the Biktarvy market.

Strategic Analysis: This includes M&A, new product development, and competitive landscape of the Biktarvy market.

Analysis of competitive intensity of the industry based on Porter’s Five Forces model.

This report answers the following 11 key questions:

Q.1. What are some of the most promising, high-growth opportunities for the Biktarvy market by type (brand drugs and generic drugs), application (hospitals, retail pharmacy, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)?

Q.2. Which segments will grow at a faster pace and why?

Q.3. Which region will grow at a faster pace and why?

Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?

Q.5. What are the business risks and competitive threats in this market?

Q.6. What are the emerging trends in this market and the reasons behind them?

Q.7. What are some of the changing demands of customers in the market?

Q.8. What are the new developments in the market? Which companies are leading these developments?

Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?

Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?

Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?

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