Human Immunodeficiency Virus Type-1 (HIV-1) Market

DelveInsight’s ‘Human Immunodeficiency Virus Type-1 (HIV-1)―Market Insights, Epidemiology, and Market Forecast–2030’ report deliver an in-depth understanding of the HIV-1, historical and forecasted epidemiology as well as the HIV-1 market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

The HIV-1 market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM HIV-1 market size from 2018 to 2030. The Report also covers current HIV-1 treatment practice, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2018–2030

HIV-1 Disease Understanding and Treatment Algorithm

HIV-1 Overview

HIV is a virus that attacks cells that help the body fight infection, making a person more vulnerable to other infections and diseases. HIV is a retrovirus built of RNA rather than the typical DNA. It attacks the cells (T lymphocytes and other white blood cells with CD4 receptors on their surfaces) that are a part of the body’s immune system.

It is spread by contact with certain bodily fluids of a person with HIV, most commonly during unprotected sex (sex without a condom or HIV medicine to prevent or treat HIV) or through sharing injection drug equipment. If left untreated, HIV can lead to the disease AIDS (acquired immunodeficiency syndrome).

HIV is classified into two broad categories HIV-1 and HIV-2. HIV-1 is the most common; more than 90% of people living with HIV have HIV-1. HIV-1 is further subcategorized into groups: M, N, O, and P. Among these groups, group M is most common, further divided into nine subtypes (from A to K except E and I). HIV-1 is more easily transmitted from one person to another or from mother to child. HIV-1 is spread across all over the world.

HIV-1 Diagnosis

HIV-1 can be diagnosed via several methods, including antibody tests, antigen/antibody tests, and Nucleic Acid Tests (NATs). Additional tests during treatment include viral load, CD4 count, and drug resistance testing. The diagnosis of HIV infection is most commonly accomplished using tests to detect antibodies to HIV in blood or oral fluid using a screening test, followed by a supplemental test for confirmation. Enzyme immunoassays (EIAs) are the most commonly used methods to perform antibody tests.

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HIV-1 Treatment

The treatment for HIV is called antiretroviral therapy (ART). ART involves taking a combination of HIV medicines (called an HIV treatment regimen) every day. The main goal of HIV treatment is to reduce a person’s viral load to an undetectable level. An undetectable viral load means that the level of HIV in the blood is too low to be detected by a viral load test. People with HIV who maintain an undetectable viral load have effectively no risk of transmitting HIV to their HIV-negative partners through intercourse. There is no effective cure for HIV. But proper medical care can control HIV.

To date, many drugs have been approved in ART. Reverse transcriptase inhibitors were the first class that came into existence. Reverse transcriptase inhibitors are approved for two main viral infections. The first approved use is for the treatment of HIV, specifically the HIV-1 strain. The first class is the nucleoside/nucleotide reverse transcriptase inhibitors, and the second class is the non-nucleoside reverse transcriptase inhibitors. Other than reverse transcriptase inhibitors, there are many approved classes of ART. Each class has a significant role in the treatment of HIV-1.

HIV-1 Epidemiology        

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases of HIV, total diagnosed prevalent cases of HIV, type-specific diagnosed prevalent cases of HIV, gender-specific diagnosed prevalent cases of HIV-1, diagnosed prevalent cases of HIV-1 by route of transmission, and age-specific diagnosed prevalent cases of HIV-1 scenario of HIV-1 in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2018 to 2030.

Key Findings

• Total prevalent cases of HIV in the 7MM was found to be 1,926,925 in 2020. These cases are expected to increase by 2030 at a CAGR of 1.26% during study period (2018–2030).
• The diagnosed prevalent cases of HIV in the 7MM was found to be 1,597,714 in 2020 which is expected to increase at a CAGR of 1.75% for the study period of 2018-2030.
• Among 7MM, the United States has the highest diagnosed prevalent cases of HIV with 991,073 cases in 2020.
• The diagnosed prevalent cases HIV were further divided into two broad categories, HIV-1 and HIV-2. There were total 990,974 cases of HIV-1 and 99 cases of HIV-2 in 2020 in the United States.
• Assessments as per DelveInsight’s analysts show that the majority of cases of HIV-1 are occupied by males as compared to females. There was a total of 723,411 male and 267,563 female cases of HIV-1 in 2020 in the United States.
• There are a plethora of modes of transmission of HIV1, among which the most common types of routes are male-to-male sexual contact which accounts for approximately 396,390 cases, Heterosexual contact (297,292), Injecting drug users (IDUs) (237,834), and other routes with 59,458 cases in 2020 in the US.
• The age‐specific data revealed that the highest number of HIV-1 people affected with was found in the age group of 30-39 years followed by patients of age group 40-49 years (second-highest). In comparison, they are relatively less common in 13-19 years and <13 years.
• In EU-5, France reported the highest diagnosed prevalent cases of HIV-1 with 153,253 cases in 2020, followed by Spain (127,233), Italy (116,573), UK (100,633), and Germany (82,081) in 2020.
• In 2020, Japan had 26,870 diagnosed prevalent cases of HIV-1. These cases are expected to increase by 2030 at a CAGR of 2.61%.

Country-Wise HIV-1 Epidemiology

The epidemiology segment also provides the HIV-1 epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

HIV-1 Drug Chapters

The drug chapter segment of the HIV-1 report encloses the detailed analysis of HIV-1 marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the HIV-1 clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug and the latest news and press releases.

HIV-1 Marketed Drugs

Pifeltro (Doravirine): Merck Sharp & Dohme Corp

Pifeltro, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.

Products detail in the report…

Isentress/Isentress HD (Raltegravir): Merck

Isentress was the first Integrase strand transfer inhibitor (InstIs) developed for the treatment of HIV-1 infection. Isentress is recommended regimen option in combination with other antiretroviral agents as first-line therapy in treatment-naive HIV-1 infected adults. Isentress chewable tablets and oral suspension, each in combination therapy, are approved to treat pediatric patients aged at least 4 weeks and weighing less than 20 kg. Isentress HD is a 1200 mg once-daily dose of the company’s integrase inhibitor, Isentress (raltegravir), to be administered orally as two 600 mg film-coated tablets.

Products detail in the report…

Truvada (Emtricitabine and Tenofovir Disoproxil Fumarate): Gilead Sciences, Inc

Truvada is an oral formulation indicated in combination with other antiretroviral agents to treat HIV-1 infection in certain patients. It is a fixed-dose combination of Gilead’s antiretroviral medications: TDF and emtricitabine (FTC). Truvada is also approved by the FDA for a PrEP (pre-exposure prophylaxis) indication to reduce the risk of sexually acquired HIV-1 infection in certain at-risk patients.

Products detail in the report…

Dovato (Dolutegravir and Lamivudine): ViiV Healthcare

Dovato is a once-daily, single-pill, two-drug regimen (2DR) that combines the integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay, 50 mg) with the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine (Epivir, 300 mg).

Products detail in the report…

Cabenuva (Vocabria/Rekambys Injection): ViiV Healthcare

Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir (brand name: Vocabria) or rilpivirine (injectable brand name: Rekambys). Cabenuva is administered as two intramuscular injections (cabotegravir and rilpivirine) in the buttocks during the same visit at a specialist clinic by a healthcare professional.

Products detail in the report…

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HIV-1 Emerging Drugs

Lenacapavir (GS-6207): Gilead Sciences

Lenacapavir is a potential first-in-class, long-acting HIV-1 capsid inhibitor in development to treat and prevent HIV-1 infection. Lenacapavir’s multi-stage mechanism of action is distinguishable from currently approved classes of antiviral agents and is designed to provide a new avenue for developing long-acting therapy options for people living with or at risk for HIV-1. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV-1 at multiple stages of its lifecycle and has no known cross-resistance to other existing drug classes.

Products detail in the report…

GSK3640254 (GSK’254): GlaxoSmithKline/ViiV Healthcare

GSK3640254 is a next-generation HIV-1 Maturation Inhibitor (MI) that acts during the last step of the HIV lifecycle. GSK3640254 binds to HIV-1 Gag, inhibiting the final protease-mediated cleavage event between capsid (CA) protein p24 and spacer peptide 1 (SP1) within the Gag polyprotein. Prevention of Gag polyprotein separation to its component proteins p24/CA and SP1 results in the release of immature, noninfectious virions. The drug is currently being investigated in the Phase II trial.

Products detail in the report…

MK-8591A (Islatravir/doravirine; DOR/ISL): Merck & Co., Inc.

Merck Sharp & Dohme Corp. is evaluating MK-8591A (islatravir/doravirine; DOR/ISL), a combination of islatravir – the company’s investigational oral nucleoside reverse transcriptase translocation inhibitor (NRTTI) – and doravirine (Pifeltro), for the treatment of HIV-1 infection. The combinational drug is currently being evaluated in a Phase III clinical study for the treatment and prevention of HIV.

Products detail in the report…

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HIV-1 Market Outlook

The United States contributes to the major share of the HIV-1 market as compared to other countries, such as EU5 (Italy, Spain, United Kingdom, France, and Germany) and Japan.

There are many medicines available for HIV regimens. Approved antiretroviral (ARV) HIV drugs are divided into seven drug classes based on how each drug interferes with the HIV life cycle: nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), fusion inhibitors, CCR5 antagonists, post-attachment inhibitors, and integrase strand transfer inhibitors (INSTIs). Fusion inhibitors, CCR5 antagonists, and post-attachment inhibitors can also be known as entry inhibitors as they prevent the entry of HIV into the CD4 cells.

The choice of an HIV regimen depends on a person’s individual needs. When choosing an HIV regimen, people with HIV and their health care providers consider many factors, including possible side effects of HIV medicines and potential drug interactions.

The current antiretroviral drugs, including newer classes, can be partially or fully inactive because of the emergence of drug-resistant virus strains. Now oral pre-exposure prophylaxis (PrEP) is recommended in the risk group population, there are high chances of resistance if patients taking PrEP become infected. This could reduce treatment options due to the overlapping resistance profiles between antiretroviral drugs used for both PrEP and treatment. Truvada and Descovy are currently approved as oral therapies for PrEP, and new therapies, such as islatravir, are in a clinical trial.

Initially, patients have to take multiple drug products of different active pharmaceutical ingredients (API) daily. To solve the problems with MTR, single treatment regimens (STR) have emerged. STR combines two or more antiretroviral drugs from more than one drug class in a single pill. The first STR, a fixed-dose combination of three drugs in one tablet called Atripla, was introduced in 2006. There are some common trends observed in the HIV-1 treatment market. The first one is the emergence of tenofovir alafenamide (TAF)-based regimens over tenofovir disoproxil fumarate (TDF) - based regimens. The main concern with TAD is that it can cause renal toxicity, decreased bone mineral density (BMD), and increased bone turnover markers. Due to this, physicians now prefer TAF-based regimens, and this preference has affected the market of TDF-based regimens. The second trend is the rise of integrase/NRTI triple therapies. The growth of INSTI is affecting the market of PIs and NRTIs.

The HIV-1 treatment market is expected to show steady growth in the coming years. However, it might get affected due to the wave of patent expiry of some of the products. According to DelveInsight, HIV-1 7MM is expected to change in the study period 2018–2030.

Key Findings

• The market size of HIV-1 in seven major markets was USD 22,663 million in 2020, which is further expected to increase by 2030 at a Compound Annual Growth Rate (CAGR) of 4.60% for the study period (2018–2030).
• The total market size includes the market size of therapies for treatment naïve or experienced patients, multiple drug resistance (MDR), and pre-exposure prophylaxis. The market size of these groups of therapies was USD 20,947 million, USD 60 million, and USD 1,656 million, respectively in 2020, in the 7MM.
• Expected Launch of potential therapies may increase market size in the coming years, assisted by an increase in diagnosed prevalent population of HIV-1.
• Upcoming therapies for treatment naïve or experienced patients such as GSK3640254, Lenacapavir + ARV, MK-8591A (Islatravir/doravirine), and MK8591B (islatravir + MK-8507), for multiple drug resistance (MDR) treatment [Rukobia + OBR, MK-8591A (Islatravir/doravirine), Lenacapavir + OBR, and Vyrologix (leronlimab) + OBR] and for PrEP [Lenacapavir, Islatravir, and Vocabria (Cabotegravir LA)] have the potential to create a significant positive shift in the HIV-1 market size.
• The United States accounts for the largest market size of HIV-1, with USD 19,153 million in 2020, in comparison to EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.
• Among the EU5 countries, France had the highest market size with USD 865 million in 2020, while Germany had the lowest market size of HIV-1 with USD 457 million in 2020.
• Japan consistently captured lowest market size among 7MM countries, i.e., USD 216 million in 2020.

The United States Market Outlook

This section provides the total HIV-1 market size and; market size by therapies in the United States.

EU-5 Market Outlook

The total HIV-1 market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total HIV-1 market size and market size by therapies in Japan are provided.

HIV-1 Drugs Uptake

This section focusses on the rate of uptake of the potential drugs recently launched in the HIV-1 market or expected to get launched in the market during the study period 2018–2030. The analysis covers HIV-1 market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

HIV-1 Development Activities

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

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for HIV-1 emerging therapies.

Reimbursement Scenario in HIV-1

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

We perform competitive and market Intelligence analysis of the HIV-1 market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of HIV-1, explaining its etiology, signs and symptoms, pathophysiology, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the HIV-1 epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for HIV-1 is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the HIV-1 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 HIV-1 market.

Report Highlights

• The robust pipeline with novel MOA and oral ROA and increasing incidence will positively drive the HIV-1 market.
• The companies and academics are working to assess challenges and seek opportunities that could influence HIV-1 R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for HIV-1. Launch of emerging therapies will significantly impact the HIV-1 market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

HIV-1 Report Insights

• Patient Population
• Therapeutic Approaches
• HIV-1 Pipeline Analysis
• HIV-1 Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

HIV-1 Report Key Strengths

• 10-Years Forecast
• 7MM Coverage
• HIV-1 Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

HIV-1 Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• SWOT analysis

Key Questions

Market Insights:

• What was the HIV-1 market share (%) distribution in 2018 and how it would look like in 2030?
• What would be the HIV-1 total market size as well as market size by therapies across the 7MM during the forecast period (2021–2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest HIV-1 market size during the forecast period (2021–2030)?
• At what CAGR, the HIV-1 market is expected to grow at the 7MM level during the forecast period (2021–2030)?
• What would be the HIV-1 market outlook across the 7MM during the forecast period (2021–2030)?
• What would be the HIV-1 market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What is the disease risk, burden and unmet needs of HIV-1?
• What is the historical HIV-1 patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK) and Japan?
• What would be the forecasted patient pool of HIV-1 at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to HIV-1?
• Out of the above-mentioned countries, which country would have the highest incident population of HIV-1 during the forecast period (2021–2030)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2021–2030)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of HIV-1 along with the approved therapy?
• What are the current treatment guidelines for the treatment of HIV-1 in the US and Europe?
• What are the HIV-1 marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of HIV-1?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of HIV-1?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the HIV-1 therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for HIV-1 and their status?
• What are the key designations that have been granted for the emerging therapies for HIV-1?
• What are the 7MM historical and forecasted market of HIV-1?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving the HIV-1.
• To understand the future market competition in the HIV-1 market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for HIV-1 in the US, Europe (Germany, Spain, Italy, France, 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 HIV-1 market.
• To understand the future market competition in the HIV-1 market.