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Market Research Report

Human Immunodeficiency Virus (HIV) Therapeutics - Global Drug Forecast and Market Analysis to 2029

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Human Immunodeficiency Virus (HIV) Therapeutics - Global Drug Forecast and Market Analysis to 2029
Published: February 26, 2021 Content info: 254 Pages
Description

Over three decades ago, researchers identified the human immunodeficiency virus (HIV) as the causative agent of a then-mysterious new illness, Acquired Immunodeficiency Syndrome (AIDS). A member of the Lentivirus genus, HIV belongs to the family of retroviruses, which are RNA viruses with the ability to reverse transcribe their single-stranded RNA genome into double-stranded DNA. Following reverse transcription, the viral DNA is incorporated into the host cell genome. An estimated 75 million people have been infected with HIV since 1981, and AIDS has claimed the lives of more than 32 million people. In some countries, AIDS is the leading cause of death. Globally, one million people die from AIDS-related infections per year.

Rapid progress has been underscored by the emergence of once-daily, single-tablet regimens (STRs) such as Gilead Science's Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate [TDF]), Stribild (elvitegravir/cobicistat/emtricitabine/TDF), Biktarvy (bictegravir sodium/emtricitabine/tenofovir alafenamide fumarate [TAF]), and Genvoya (elvitegravir/cobicistat/emtricitabine/TAF). ViiV Healthcare, which is a collaboration between Pfizer, GlaxoSmithKline, and Shionogi is the other major developer of STRs for HIV. These therapies have revolutionized the treatment landscape for HIV and offer patients an unparalleled level of convenience. Nonetheless, there is need for therapies delivered via non-oral routes of administration, and GlobalData expects a number of such treatment options to become available over the course of the forecast window which is 2019-2029.

GlobalData projects the global HIV marketplace - which, for the purposes of this report, comprises seven major pharmaceutical markets (US, France, Germany, Italy, Spain, UK, and Japan) - will experience modest growth during the forecast period. The HIV therapeutics market was valued at $22.9B in 2019. The launch of long-acting injectable therapies and continued success of single-tablet regimens (STRs) will drive growth in the market, which will expand at a Compound Annual Growth Rate (CAGR) of 2%. By 2029, sales of anti-HIV therapeutics will reach $28B.

Key Highlights

  • The global HIV market was worth an estimated $22.9B in 2019. GlobalData projects that this market will expand at a Compound Annual Growth Rate (CAGR) of 2%, reaching $28B in 2029.
  • Growth in the market is expected to be facilitated by the entry of non-oral therapies and pre-exposure prophylactic (PrEP) drugs, which will launch in all of the 7MM by the end of the forecast period.
  • The long-term efficacy of the pharmacologic management of HIV is highly dependent on patient compliance. Poor compliance is a risk factor for a shortened life expectancy and greater chance of contracting opportunistic infections. Pharmaceutical companies are attempting to address this issue by developing injectable therapies that are administered less frequently than market-leading oral drugs which are taken daily and are linked to side effects such as osteoporosis, hepatotoxicity, and kidney dysfunction.
  • By 2029, the US and 5EU markets will benefit from an influx of therapeutic agents that address different stages of HIV infection, including viral entry, reverse transcription, and integration of viral DNA into the host genome.
  • There will be several drivers that promote growth in the HIV therapeutics market. One example is the fact that non-oral therapies will launch in the 7MM. These drugs will diversify treatment options for patients. Other market drivers include the use of drugs with low frequencies of administration and the emergence of biologic drugs that have high annual costs of therapy (ACOT) which can be used to treat patients with multidrug-resistant infections.
  • Major barriers to growth in the HIV market during the forecast period will include the fact that social stigma prevents patients from seeking a diagnosis leading to a low diagnosis rate, increased disease transmission, and delayed initiation of antiretroviral therapy (ART). GlobalData also expects that lack of compliance among patients will persist, either because of the need to take multiple oral tablets on a daily basis in some treatment regimens, or because of undesirable side effects such as weight gain, changes in bone mineral density, lactic acidosis, or mental disorders.
  • Furthermore, marketed products such as ViiV Healthcare's Tivicay (dolutegravir) and Mylan's Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) will lose their patent protection during the forecast period, allowing cheaper generics to erode the sales of branded products.
  • The US accounted for the vast majority of sales, generating $19.5B in the base year of the forecast window. This equates to a market share of 85.2%. The 5EU markets generated a combined $3.2B in sales in 2019. GlobalData valued the Japanese market at $152.1M in 2019. Sales in all of the 7MM except for Germany are expected to increase over the course of the forecast window. The US is projected to gain market share during the forecast period, generating 85.8% of sales in 2029.
  • In 2029, the 5EU markets will generate $3.8B. Japan is expected to contribute $225M in sales in the final year of the forecast window.
  • The PrEP market was valued at $2.6B in 2019. Sales of therapeutics used in PrEP are expected to reach $3.3B in 2029. Drug sales will be limited by the impact of generic erosion.

Key Questions Answered in This Report

  • What were the market leading drugs for HIV in 2019?
  • When will the late-stage pipeline products launch in each of the 7MM?
  • What are the major clinical and environmental unmet needs in the HIV market?
  • What are the key commercial opportunities for pharmaceutical companies developing therapies for HIV?
  • What effect has COVID-19 had on the development and administration of HIV therapeutics?

Scope

  • Overview HIV epidemiological data, including the presence of hepatitis coinfection and incident cases in each of the 7MM.
  • Examination of pathophysiology, symptoms, diagnosis, and disease management.
  • Annualized forecast of sales of HIV therapeutics in the 7MM.
  • Discussion of the impact of COVID-19 on the market.
  • Examination of unmet needs, ongoing clinical trials, and profiles of individual marketed drugs.
  • Assessment of pipeline drugs, including clinical and commercial aspects of each therapy in development for the treatment of HIV-1 infection in children and adults.
  • Review of key market drivers and barriers.
  • Discussion of market potential and opportunities for drug developers in the HIV space.

Reasons to Buy

The report will enable you to -

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the HIV therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the HIV therapeutics market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
Table of Contents
Product Code: GDHC213PIDR

Table of Contents

1 Table of Contents

  • 1.1 List of Tables
  • 1.2 List of Figures

2 Human Immunodeficiency Virus: Executive Summary

  • 2.1 Convincing Progress in the Development of Non-Oral Therapies Will Boost Sales in the HIV Therapeutics Market, Which Will Reach $28B in 2029
  • 2.2 Dominance of Gilead and ViiV Expected to Remain Unchallenged by Market Entrants Developed by Other Pharmaceutical Companies
  • 2.3 Dynamic Deal-Making Landscape Will Contribute to Synchronized Growth for Key Players in the HIV Market
  • 2.4 Japanese HIV Market Lags Behind the US and 5EU Due to Lack of New Entry Inhibitors Expected to Launch During the Forecast Period
  • 2.5 Focus on Prophylaxis Will Diversify Treatment Options for Patients from 2019-2029
  • 2.6 What Do Physicians Think?

3 Introduction

  • 3.1 Catalyst
  • 3.2 Related Reports
  • 3.3 Upcoming Related Reports

4 Disease Overview

  • 4.1 Etiology and Pathophysiology
    • 4.1.1 Overview
    • 4.1.2 Etiology
    • 4.1.3 Pathophysiology
  • 4.2 Clinical Stages of HIV Infection
  • 4.3 Prognosis and Quality of Life

5 Epidemiology

  • 5.1 Disease Background
  • 5.2 Risk Factors and Comorbidities
  • 5.3 Global and Historical Trends
    • 5.3.1 Total Prevalence of HIV
    • 5.3.2 Diagnosed Prevalence of HIV
    • 5.3.3 Diagnosed Incidence of HIV
  • 5.4 Forecast Methodology
    • 5.4.1 Sources
    • 5.4.2 Sources Not Used
    • 5.4.3 Forecast Assumptions and Methods
    • 5.4.4 Total Prevalent Cases of HIV
    • 5.4.5 Diagnosed Prevalent Cases of HIV
    • 5.4.6 Diagnosed Prevalent Cases of HIV with HBV/HCV Coinfection
    • 5.4.7 Diagnosed Prevalent Cases of HIV on ART
    • 5.4.8 Diagnosed Incident Cases of HIV
    • 5.4.9 Prophylactic Population on PrEP
  • 5.5 Epidemiological Forecast for HIV (2019-2029)
    • 5.5.1 Total Prevalent Cases of HIV
    • 5.5.2 Diagnosed Prevalent Cases of HIV
    • 5.5.3 Age-Specific Diagnosed Prevalent Cases of HIV
    • 5.5.4 Sex-Specific Diagnosed Prevalent Cases of HIV
    • 5.5.5 Diagnosed Prevalent Cases of HIV with Coinfection
    • 5.5.6 Diagnosed Prevalent Cases of HIV on ART
    • 5.5.7 Diagnosed Incident Cases of HIV
    • 5.5.8 Age-Specific Diagnosed Incident Cases of HIV
    • 5.5.9 Sex-Specific Diagnosed Incident Cases of HIV
    • 5.5.10 Prophylactic Population on PrEP
  • 5.6 Discussion
    • 5.6.1 Epidemiological Forecast Insight
    • 5.6.2 COVID-19 Impact
    • 5.6.3 Limitations of the Analysis
    • 5.6.4 Strengths of the Analysis

6 Disease Management

7 Competitive Assessment

  • 7.1 Overview

8 Unmet Needs and Opportunity Assessment

  • 8.1 Overview
  • 8.2 Introducing Non-Oral Therapies to Diversify Treatment Options for Patients
  • 8.3 Therapies with Improved Safety and Tolerability Profiles
  • 8.4 Improved Diagnosis Rates and Access to PrEP
  • 8.5 Clearer Treatment Guidelines for General Practitioners and Primary Care Providers

9 Pipeline Assessment

  • 9.1 Overview
  • 9.2 Clinical Trials
  • 9.3 Late-Stage Pipeline Agents
  • 9.4 Innovative Drugs in Clinical Development
  • 9.5 Vaccines

10 Current and Future Players

11 Market Outlook

  • 11.1 Global Markets
    • 11.1.1 Forecast
    • 11.1.2 Drivers and Barriers - Global Issues
  • 11.2 US
    • 11.2.1 Forecast
    • 11.2.2 Key Events
    • 11.2.3 Drivers and Barriers
  • 11.3 5EU
    • 11.3.1 Forecast
    • 11.3.2 Key Events
    • 11.3.3 Drivers and Barriers
  • 11.4 Japan
    • 11.4.1 Forecast
    • 11.4.2 Key Events
    • 11.4.3 Drivers and Barriers

12 Appendix

List of Tables

List of Tables

  • Table 1: HIV: Key Metrics in the 7MM
  • Table 2: Symptoms of Acute, Chronic, and Advanced Stages of HIV Infection
  • Table 3: CDC Classification of the Stages of HIV-1 Infection in Patients Ages ≥6 Years
  • Table 4: Risk Factors and Comorbidities fo

List of Figures

List of Figures

  • Figure 1: Global Sales Forecast by Country for HIV in 2019 and 2029
  • Figure 2: Analysis of the Company Portfolio Gap in HIV During the Forecast Period
  • Figure 3: Competitive Assessment of Anti-HIV Therapeutics Expected to Launch in the 7MM During the Forecast Period
  • Figure 4: HIV Replication Cycle
  • Figure 5: 7MM, Total Prevalence of HIV, Men and Women, All Ages, 2009-2029 (%)
  • Figure 6: 7MM, Diagnosed Prevalence of HIV, Men and Women, All Ages, 2009-2029 (%)
  • Figure 7: 7MM, Diagnosed Incidence of HIV, Men and Women, All Ages, 2009-2029 (Cases per 100,000 Population)
  • Figure 8: Sources Used for Total Prevalent Cases of HIV
  • Figure 9: Sources Used for Diagnosed Prevalent Cases of HIV
  • Figure 10: Sources Used for Diagnosed Prevalent Cases of HIV Coinfected with HBV or HCV
  • Figure 11: Sources Used for Diagnosed Prevalent Cases of HIV on ART
  • Figure 12: Sources Used for Diagnosed Incident Cases of HIV
  • Figure 13: Sources Used for the Prophylactic Population on PrEP
  • Figure 14: 7MM, Total Prevalent Cases of HIV, Men and Women, All Ages, 2019 (N)
  • Figure 15: 7MM, Diagnosed Prevalent Cases of HIV, Men and Women, All Ages, 2019 (N)
  • Figure 16: 7MM, Age-Specific Diagnosed Prevalent Cases of HIV, Men and Women, 2019 (N)
  • Figure 17: 7MM, Sex-Specific Diagnosed Prevalent Cases of HIV, All Ages, 2019 (N)
  • Figure 18: 7MM, Diagnosed Prevalent Cases of HIV with Coinfection, Men and Women, All Ages, 2019 (N)
  • Figure 19: 7MM, Diagnosed Prevalent Cases of HIV on ART, Men and Women, All Ages, 2019 (N)
  • Figure 20: 7MM, Diagnosed Incident Cases of HIV, Men and Women, All Ages, 2019 (N)
  • Figure 21: 7MM, Age-Specific Diagnosed Incident Cases of HIV, Men and Women, 2019 (N)
  • Figure 22: 7MM, Sex-Specific Diagnosed Incident Cases of HIV, All Ages, 2019 (N)
  • Figure 23: 7MM, Prophylactic Population on PrEP, Men and Women, All Ages, 2019 (N)
  • Figure 24: Unmet Needs and Opportunities in HIV
  • Figure 25: Overview of the Drug Development Pipeline for HIV
  • Figure 26: Significant Phase II/III Trials for the Pipeline Agents that GlobalData Expects to Be Licensed for HIV in the 7MM, 2019-2029
  • Figure 27: Competitive Assessment of Anti-HIV Therapeutics Expected to Launch in the 7MM During the Forecast Period
  • Figure 28: Company Portfolio Gap Analysis in HIV, 2019-2029
  • Figure 29: Co-development Deals Concerning Non-oral HIV Therapeutics in the 7MM, 2010-Q3 2020
  • Figure 30: Global (7MM) Sales Forecast by Country for HIV in 2019 and 2029
  • Figure 31: Global (7MM) Sales of Late-Stage Pipeline Agents, 2029
  • Figure 32: Sales of HIV Therapeutics in the US by Drug Type, 2019 and 2029
  • Figure 33: Sales of Individual STRs in the US, 2019 and 2029
  • Figure 34: Sales of PrEP Therapies in the US, 2019 and 2029
  • Figure 35: Sales of Late-Stage Pipeline Agents in the US, 2029
  • Figure 36: Sales of HIV Therapeutics in the 5EU by Drug Type, 2019 and 2029
  • Figure 37: Sales of Individual STRs in the 5EU, 2019 and 2029
  • Figure 38: Sales of PrEP Therapies in the 5EU, 2019 and 2029
  • Figure 39: Sales of Late-Stage Pipeline Agents in the 5EU, 2029
  • Figure 40: Sales of HIV Therapeutics in Japan by Drug Type, 2019 and 2029
  • Figure 41: Sales of Individual STRs in Japan, 2019 and 2029
  • Figure 42: Sales of Late-Stage Pipeline Agents in Japan, 2029
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