Report Overview

United States PrEP (Pre-Exposure Prophylaxis) Market- Industry Trends & Forecast Report 2027

United States PrEP (Pre-Exposure Prophylaxis) market was worth USD 5,774.0 Million in 2020, further projected to grow at a CAGR of 15.40% during the forecast period (2021-2027) to reach the valuation of USD 15,515.2 Million by 2027. The growing approval rate of generic medicine across the region contributes to the growth of the United States PrEP market. Generic drugs are tested for pharmacological equivalency and shown to be just as safe and effective as their brand-name counterparts. As expected, more competition has resulted in a significant drop in pricing. For example, Generic Truvada can be obtained for as little as $69 per month with discount coupons, according to drug prices comparison sites such as GoodRx(.)com and RxSaver(.)com. The United States PrEP market has the highest uptake rate (22.6 % of at-risk adults in 2020). Globally, it generates most of the PrEP income, although generic versions of Truvada (Brand) launched in the market in October 2020 have seen sales of this drug drop sharply.

Source: BlueWeave Consulting

United States PrEP Market Overview

PrEP, or pre-exposure prophylaxis, is a medicine to prevent HIV. People who are not infected with HIV can take this medicine to decrease the risk of contracting HIV if they get infected with the virus. PrEP is used to stop HIV from spreading throughout one's body. At present, only two daily oral PrEP medications are FDA-approved. Truvada and Descovy are the drugs approved by the FDA for oral usage. Physicians prescribe PrEP to adults and adolescents who are HIV negative and at a higher risk of getting HIV due to sex or injection use.

United States PrEP Market Trend

Growth Drivers

Insurance Coverage of HIV drugs

U.S. insurance companies are increasingly covering HIV drugs under new therapeutics, which has prompted a surge in the use of PrEP. For example, in May 2019, the U.S. government stated that it had reached an agreement with Gilead Sciences Inc. to provide Truvada to 200,000 people each year for up to 11 years, or until a generic version becomes available. Thus, the cost for the distribution of the drug is covered by the U.S. government.

Since its enactment in 2010, the Affordable Care Act (ACA) has improved healthcare coverage and quality for people across the United States. The ACA covers prEP drugs in the U.S., and they must be accessible to all medical insurance policies. PrEP provision has been made easier by the inclusion of PrEP coverage in health insurance policies. People are looking forward to significant advances in PrEP access, particularly in HIV-infected areas. Thus, the government's provision of medicines and services has helped propel the market growth for the U.S.

Impact of COVID-19

The pandemic caused by COVID-19 caused significant volatility and uncertainty in the U.S. and global economies, elevating operational risks in early 2020. There has been a substantial impact in the various verticals of the manufacturing companies. Several verticals in the manufacturing industry have been significantly impacted, either positively or negatively. The pandemic has also exacerbated distribution and supply chain problems.

The pandemic has adversely affected clinical trials, including their inability to be completed within expected timeframes.  During ongoing trials, some clinical trial sites have implemented restrictions on patient visits in order to reduce the risk of exposure to COVID-19. Additionally, the companies ran into problems with participant adherence to the clinical trial schedules as a result of quarantines, travel restrictions, and healthcare disruption Last but not least, with increasing pandemic regulations, clinical sites also ran the risk of closures.

United States PrEP Market: By Brand

There are only two leading brands of PrEP drugs currently available, i.e., Descovy and Truvada, offered by Gilead. Due to the high cost of the drugs in 2020, the market for the government-approved generic version of Truvada is experiencing tremendous growth. Truvada was authorized by the US Food and Drug Administration for the first time in 2004. This antiretroviral drug is used in combination with other antiretrovirals to treat HIV-1 infection in some patients. The combination consists of TDF and Emtricitabine, two antiretroviral drugs. The FDA has also approved Truvada for use as a PrEP to help lower the risk of sexually transmitted HIV-1 infection when used in combination with safer sex practices.

Competitive Landscape

The United States PrEP market is highly consolidated. The rising prevalence of HIV cases in men and women, regulatory approvals, and the global HIV epidemic have aided the firms in launching new medications and clinical studies. Gilead Science Inc., Teva Pharmaceuticals Industries Ltd., and others are among the leading market competitors in the US PrEP industry. Positive measures, such as government-funded HIV/AIDS treatment and increasing acceptance of the LGBTQ population, have boosted the sector and allowed market players to offer new treatments and products.

Recent Developments

• In August 2021, Gilead Sciencesdiscovered tampered and counterfeit versions of Biktarvy (Bictegravir 50 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 25 mg tablets) Descovy (Emtricitabine 200 mg and Tenofovir Alafenamide 25 mg tablets) in circulation inside US drug distribution networks. Genuine Gilead bottles have been altered with a counterfeit foil induction seal or label that contains incorrect tablets. Distributors not authorized by Gilead to sell Gilead-branded medicine have sold these counterfeits to pharmacies where genuine Gilead bottles have been tampered with,with a counterfeit foil induction seal or label and contain incorrect tablets.

In July 2021, the favorable results of the AMBITION clinical trial, which were reported on 21 July 2021at the 11th International AIDS Society (IAS) Conference on HIV Science, were welcomed by Gilead Sciences. In treating HIV-associated cryptococcal meningitis, the study found that a single dose of AmBisome (liposomal amphotericin B) given with 14 days of flucytosine was non-inferior to 14 days of conventional dose L-AmB in terms of fungal burden reduction.

Scope of the Report

1. Research Framework
1. Research Objective
2. Product Overview
2. Research Methodology
1. Qualitative Research
1. Primary and Secondary Sources
2. Quantitative Research
1. Primary and Secondary Sources
3. Breakdown of Primary Research Respondents, By Industry Participants

2.4.   Market Breakdown & Data Triangulation

2.5. Assumptions & Limitations

3. Executive Summary
4. U.S. PrEP Market – Industry Insights
1. Industry Value Chain Analysis
2. DROC Analysis
1. Growth Drivers
2. Restraints
3. Opportunity
4. Challenges
3. Recent Developments
4. Regulatory Framework
5. Porter’s Five Forces Analysis
5. U.S PrEP Market Disease Insights
1. Epidemiology of HIV/AIDS

5.2.   HIV Diagnoses

3. Incidence Rate of HIV/AIDS
4. Regulatory Scenario by Key Countries
5. Overview of Current Advances in R&D for HIV Drugs
6. U.S. PrEP (Pre-Exposure Prophylaxis) Market Size & Forecast by Value, 2017-2027
7. Competitive Landscape
1. List of Key Players and Their Offerings
2. Market Share Analysis (2020)
3. Competitive Benchmarking, By Operating Parameters
4. Key Strategies Employed by Market Leaders
8. Brand Analysis of PrEP
9. Impact of COVID-19 on U.S. PrEP Market

10. Company Profiles (Company Overview, Financial Matrix, Key Product landscape, Key Personnel, Key Competitors, Contact Address, and Strategic Outlook) *

10.1. Gilead Sciences Inc.

10.2. Lupin

10.3. Strides Pharma Science Limited

10.4. Teva Pharmaceutical Industries Ltd.

10.5 List of Companies Under Clinical Development of PrEP Drugs

11. Key Strategic Recommendations

*Financial details of unlisted companies will be available as per data availability in final deliverable

**The segmentation and the companies are subjected to modifications based on in-depth secondary for the final deliverable.

List of Figures

Figure 1: Advantages of PrEP

Figure 2:  Simplified Conceptual Diagram of Health States in The Markov Model

Figure 3:  U.S. PrEP Healthcare Industry Value Chain

Figure 4:  Process of a Drug Clinical Trial & Approval

Figure 5:  Scatterplot of HIV Prevalence by US County Population Stratified by US Census Region, 2018

Figure 6:  PrEP Coverage, by State, United States, 2018

Figure 7:  Estimated Raw Number of LGBT People (Ages 13+) Living in Each State

Figure 8:  Porters Five Forces Analysis

Figure 9 Number of New HIV Diagnoses by US County, 2018

Figure 10:  Diagnosed HIV Prevalence by US County, 2018

Figure 11:  Scatterplot of HIV Prevalence by US County Population Stratified by US Census Region, 2018

Figure 12:  HIV Diagnoses Overall andby Age inThe USA, 2009–18

Figure 13:  Annual Number of HIV Infections 2015-2019

Figure 14: Composition of the Global HIV Prevention R&D Investment Base, 2018-2019

Figure 15:  The Future of Antiretroviral Medications-Based Prevention and More (June 2021)

Figure 16:  Investment in Women Focused PrEP R&D, 2019

Figure 17:  U.S. PrEP (Pre-Exposure Prophylaxis) Market Size, By Value (USD Million), 2020-2027

Figure 18 Company Market Share Analysis, 2020

List of Tables

Table 1: New HIV Diagnoses in the US and Dependent Areas by Age at Diagnosis, 2019

Table 2:  New HIV Diagnoses Among Adults and Adolescents in the US and Dependent Areas by Race/Ethnicity, 2019

Table 3: New HIV Diagnoses Among Adults and Adolescents in the US and Dependent Areas by Transmission Category, 2019

Table 4: New HIV Diagnoses Among Adults and Adolescents by Top 10 States, 2019

Table 5: States with Laws That Broadly Allow Minors to Autonomously Consent to Any Health Care Services or Procedures

Table 6: Competitive Benchmarking, by Operating Parameters

Table 7: Brand Comparison Amidst Descovy V/S Truvada

Table 8: GiLead Sciences Inc. Overview

Table 9: GiLead Sciences Inc. Financial Analysis (USD Million)

Table 10:  Lupin Overview

Table 11:   Strides Pharma Science Limited Overview

Table 12: Teva Pharmaceutical Industries Ltd. Overview

Table 13: Teva Pharmaceutical Industries Ltd. Financial Analysis (USD Million)

Table 14:  List of Companies Under Clinical Development of PrEP Drugs