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Diagnostics and Therapeutics for HIV: Global Markets

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    Report

  • 186 Pages
  • October 2023
  • Region: Global
  • BCC Research
  • ID: 4662604

This report organizes information from diverse sources into sections such as an overview, industry structure, diagnostic test type, treatment by drug categories, leading drug profiles and historic drug sales, regulations, reimbursements, and patents. The scope of this report includes an overview of the global market scenario for the diagnosis and treatment of HIV, with base year data from 2022, estimations for 2023 and forecasts for 2028 that are derived using projections of CAGR during the forecast period. Market value data is provided at global, regional, and country levels for treatments by drug categories. Market data for HIV diagnostics is provided for regional levels, with details on test types. Estimated values are based on companies’ total revenues. Projected and forecasted revenue values are in constant U.S. dollars that have not been adjusted for inflation.

The report forecasts the global market for HIV therapeutics by drug class. It discusses market data for nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), protease inhibitors (PIs), single tablet regimen fixed-dose combination (STR FDC), HIV integrase strand transfer inhibitors (INSTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs). The enzyme inhibitor drug class has been excluded when calculating the global HIV therapeutics market, as there are no late-stage pipeline molecules.

Diagnostic tests such as antigen-and antibody-based tests, CD4 tests and viral load tests are detailed with current and forecasted market data. Antigen-and antibody-based tests cover enzyme-linked immunosorbent assay (ELISA) tests, enzyme immunoassay (EIA) tests, rapid tests, and NAT tests; CD4 tests include tests conducted to monitor the CD4 load; and viral load tests include all PCR-based tests.

A detailed analysis illustrating market dynamics and market structure is incorporated into the report. A Porter’s Five Forces analysis and the supply and distribution chain are discussed in detail to provide an in-depth understanding of this market. The report covers the current regulations and guidelines for diagnostics and therapeutics for HIV, and it provides a survey of the top market players, detailing their business operations, segment focus, revenue, and strategy analysis. The report also features a market share analysis of these leading players, including information about product launches and pipeline products.

In terms of geography, the report analyzes the market across the following regions: North America, Europe, Asia-Pacific and Rest of the World (RoW). Key countries like the U.S., Canada, Mexico, Germany, France, UK, Italy, China, India and Japan are given special focus due to the high concentration of HIV diagnostics and therapeutics manufacturing companies and contract manufacturing organizations located in these areas.

The base year for the market data in this report is 2022, historical data is provided for 2020 and forecast data is given for 2028. Historical, base year and forecast data are provided for each market segment of the report.

Report Includes

  • 27 data tables and 41 additional tables
  • An overview of the global markets for diagnostics and therapeutics for HIV
  • An estimate of the market’s size and analyses of global market trends, with data from 2020-2022, estimates for 2023, and projections of compound annual growth rates (CAGRs) through 2028
  • Quantification of the market potential of diagnostics and therapeutics for HIV by drug category, diagnostic test type, and region
  • Coverage of HIV timeline and milestones, HIV life cycle, its treatment and mechanism of action, and description of HIV prophylaxis
  • Evaluation of market dynamics such as drivers and restraints, current industry trends and patterns, and an assessment of the cost implications for treatments in many countries
  • Information on regional awareness programs, WHO initiatives and development of novel therapies, and discussion on rising comorbidities in HIV patients and social stigma associated with STDs
  • Coverage of ongoing research and predictions of the market’s future direction
  • Insights into the regulatory scenario for the U.S., Europe and Japan, to provide an overview of the regulations for new drug launches and diagnostic kits
  • Descriptions of the competitive landscape, product mapping, the strategic initiatives of the leading companies, including their R&D activities
  • Profiles of the key companies, including Medtronic, Abbott, Sanofi, Roche, Bio-Rad Laboratories Inc., and Danaher Corp.

Table of Contents

Chapter 1 Introduction
  • Study Goals and Objectives
  • Reasons for Doing this Study
  • What's New in this Update?
  • Scope of Report
  • Information Sources and Methodology
  • Secondary Research
  • Primary Research
  • Research Methodology
  • Geographic Breakdown
Chapter 2 Summary and Highlights
  • Overview
  • Market Outlook
Chapter 3 Market and Technology Background
  • Overview of Human Immunodeficiency Virus (Hiv)
  • Report Overview
  • Disease Prognosis
  • Symptoms
  • Treatments
  • Hiv Timeline and Milestones
  • Hiv Life Cycle: Treatment and Mechanism of Action
  • Hiv Prophylaxis
  • Pre-Exposure Prophylaxis (Prep)
  • Post-Exposure Prophylaxis (Pep)
  • Drug Resistance
  • Medication Adherence
  • Who Initiatives
Chapter 4 Global Industry Trends
  • Trends in Global Hiv Transmission
  • Regional Awareness Programs
  • Development of Novel Therapies
  • Public-Private Partnerships
  • Rising Comorbidities in Hiv Patients With An Increase in the Longevity of Patients
  • Global Programs to Counter Hiv
  • Preventing Transmission from Mother to Child
  • Challenges
  • Underestimating the Risk of Contracting the Disease
  • Social Stigma Associated With Stds
  • High Cost of Treatment
Chapter 5 Market Breakdown by Hiv Therapeutic
  • Global Market Forecast for Hiv Therapeutics
  • Regional Markets for Hiv Therapeutics
  • North America
  • Market Analysis and Forecast
  • Epidemiology
  • Hiv Testing and Recommendations
  • Regulation of the North American Market for Hiv Therapeutics
  • European Market for Hiv Therapeutics
  • Market Analysis and Forecast
  • Epidemiology
  • Hiv Testing and Recommendations
  • Regulations Impacting the European Hiv Market
  • Asia-Pacific Market for Hiv Therapeutics
  • Southeast Asian Regions
  • Western Pacific Regions
  • Prevention and Screening Programs
  • Regulation of the Asia-Pacific Hiv Market
  • Market Impact of Generic Manufacturers
  • Market Analysis and Forecast
  • Rest of the World (Row) Market for Hiv Therapeutics
  • African Region
  • Global Investments in the Hiv Market
Chapter 6 Hiv Market by Arv Drug Category
  • Overview
  • Timeline of Therapies
  • First-Line Treatment Regimen
  • Second-Line Treatment Regimen
  • Third-Line/Salvage Treatment Regimen
  • Market Overview by Drug Category
  • Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (Nrtis)
  • Protease Inhibitors (Pis)
  • Single-Tablet Regimen (Str)/Fixed-Dose Combination (Fdc) Drugs
  • Integrase Strand Transfer Inhibitors (Insti)
  • Non-Nucleotide Reverse Transcriptase Inhibitors (Nnrtis)
  • Entry Inhibitors
Chapter 7 Emerging Technologies
  • Overview
  • Molecular Diagnostics
  • Next-Generation Sequencing (Ngs)
  • Point-Of-Care Testing
  • Artificial Intelligence (Ai)
  • Other Emerging Techniques
Chapter 8 Evaluation of Market for Hiv Diagnostics
  • Market for Hiv Diagnostics by Test Type
  • Evolution of Hiv Tests
  • Antigen- and Antibody-Based Tests
  • Future Perspective
  • Cd4 Testing
  • Viral Load Testing
  • Hiv Diagnostic Product Profiles by Test Type
  • Cd4 Testing Products
  • Viral Load Testing Products
Chapter 9 Patents
  • Overview
Chapter 10 Competitive Landscape
  • Mergers, Acquisitions and Collaborations
Chapter 11 Company Profiles
  • Abbott
  • Astrazeneca
  • B. Braun Se
  • Becton, Dickinson and Company
  • Biocon
  • Bio-Rad Laboratories Inc.
  • Boehringer Ingelheim International GmbH
  • Danaher Corp.
  • Dexcom Inc.
  • Insulet Corp.
  • Johnson & Johnson Services Inc.
  • Lifescan Ip Holdings LLC
  • Lilly
  • Medtronic
  • Merck & Co. Inc.
  • Nova Biomedical
  • Novartis AG
  • Novo Nordisk A/S
  • Qiagen N.V.
  • Roche (F. Hoffmann-La Roche Ltd.)
  • Sanofi
  • Siemens Healthineers AG
  • Terumo Corp.
  • Thermo Fisher Scientific Inc.
  • Ypsomed Ag
List of Tables
Summary Table: Global Market for HIV Diagnostics and Therapeutics, by Drug Category, Through 2028
Table 1: Milestones in the History of HIV
Table 2: Life Cycle of HIV Therapeutics Target Points
Table 3: Global Market for HIV Therapeutics, by Drug Category, Through 2028
Table 4: Global Market for HIV Therapeutics, by Region, Through 2028
Table 5: Generic Drug Manufacturers in the Asia-Pacific Region
Table 6: WHO Recommendations for ART Treatment
Table 7: Approved NRTIs, 2022
Table 8: Approved Generic NRTIs, 2022
Table 9: Global Market for NRTIs, by Region, Through 2028
Table 10: Approved PIs, 2022
Table 11: Approved Generic PIs, 2022
Table 12: Global Market for Protease Inhibitors, by Region, Through 2028
Table 13: Approved STRs, 2022
Table 14: Approved STR FDC Generics, 2022
Table 15: Global Market for Single-Tablet Regimen FDC, by Region, Through 2028
Table 16: FDA Approved INSTIs, 2022
Table 17: Global Market for INSTIs, by Region, Through 2028
Table 18: Approved NNRTIs, 2022
Table 19: Approved Generic NNRTIs, 2022
Table 20: Global Market for NNRTIs, by Region, Through 2028
Table 21: Approved Entry Inhibitors, 2022
Table 22: Global Market for HIV Diagnostics, by Region, Through 2028
Table 23: Global Market for HIV Diagnostics, by Test Type, Through 2028
Table 24: Antibody HIV Tests, 2022
Table 25: FDA Approved Antigen-Antibody Combo Tests, 2012
Table 26: Point-of-Care CD4 Tests
Table 27: Viral Load Tests
Table 28: Select Patent Applications Filed on HIV Diagnostics and Therapeutics, 2023
Table 29: M&A Activity among Diagnostics and Therapeutics Manufacturing Companies, 2023
Table 30: Abbott: Financials, 2019-2022
Table 31: Abbott: Product Portfolio, by Business Segment
Table 32: Abbott: Recent Developments, 2023
Table 33: AstraZeneca: Financial Performance, 2020-2022
Table 34: AstraZeneca: Selected Key Developments, 2023
Table 35: Braun: Financials, 2021
Table 36: Becton, Dickinson and Company: Company Financials, 2022
Table 37: Becton, Dickinson and Company: Product Portfolio
Table 38: Biocon: Selected Key Developments, 2022
Table 39: Bio-Rad Laboratories Inc.: Company Financials, 2022
Table 40: Bio-Rad Laboratories Inc.: Product Portfolio
Table 41: Boehringer Ingelheim: Selected Key Developments, 2023
Table 42: Danaher Corp.: Company Financials, 2022
Table 43: Danaher Corp.: Product Portfolio
Table 44: Dexcom: Financials, 2021 and 2022
Table 45: Insulet Corp.: Revenue, by Segment, 2020-2022
Table 46: Johnson & Johnson: Financials, 2022
Table 47: Johnson & Johnson: Recent Developments and Strategies, 2017-2022
Table 48: Lilly: Financial Performance, 2018-2021
Table 49: Lilly: Key Developments, 2023
Table 50: Medtronic: Financials, 2020-2022
Table 51: Medtronic: Product Portfolio
Table 52: Medtronic: Patient Monitoring Device Product Portfolio
Table 53: Medtronic: Recent Developments, 2015-2022
Table 54: Merck & Co. Inc.: Financial Performance, 2020-2022
Table 55: Novartis: Key Financials, 2021-2022
Table 56: Novartis Key Developments, 2022
Table 57: Novo Nordisk: Key Financials, 2021-2022
Table 58: Novo Nordisk: Selected Key Developments, 2023
Table 59: Qiagen: Product Portfolio
Table 60: Roche: Financials, 2021-2022
Table 61: Roche: Revenue, by Business Segment, 2021 and 2022
Table 62: Roche: Product Portfolio
Table 63: Roche: Recent Developments, 2023
Table 64: Sanofi: Business Segment
Table 65: Sanofi: Financial Performance, 2021 and 2022
Table 66: Sanofi: Key Developments, 2023
Table 67: Siemens Healthineers AG: Product Portfolio

List of Figures
Summary Figure: Global Market for HIV Diagnostics and Therapeutics, 2020-2028
Figure 1: Types of Drug Failure Encountered During HIV Treatment
Figure 2: Summary of the Global HIV Epidemic, 2022
Figure 3: Global Market for HIV Therapeutics, 2020-2028
Figure 4: Global Market Shares of HIV Therapeutics, by Drug Category, 2022
Figure 5: Global Market for HIV Therapeutics, by Region, 2020-2028
Figure 6: Number of People Living with HIV Globally, by Region, 2010-2022
Figure 7: North American Market for HIV Therapeutics, 2020-2028
Figure 8: HIV Diagnoses in the U.S., by Transmission Category, 2021
Figure 9: European Market for HIV Therapeutics, 2020-2028
Figure 10: European Market for HIV Therapeutics, by Country, 2020-2028
Figure 11: Asia-Pacific Market for HIV Therapeutics, 2020-2028
Figure 12: Asia-Pacific Market for HIV Therapeutics, by Country, 2020-2028
Figure 13: Rest of the World Market for HIV Therapeutics, 2020-2028
Figure 14: Treatment Switching
Figure 15: Global Market for NRTIs, 2020-2028
Figure 16: Global Market for NRTIs, by Region, 2020-2028
Figure 17: Global Market for Protease Inhibitors, 2020-2028
Figure 18: Global Market for Protease Inhibitors, by Region, 2020-2028
Figure 19: Global Market for Single-Tablet Regimen, 2020-2028
Figure 20: Global Market for Single-Tablet Regimen FDC, by Region, 2020-2028
Figure 21: Global Market for INSTIs, 2020-2028
Figure 22: Global Market for INSTIs, by Region, 2020-2028
Figure 23: Global Market for NNRTIs, 2020-2028
Figure 24: Global Market for NNRTIs, by Region, 2020-2028
Figure 25: HIV Diagnostics Test Types, by Category
Figure 26: Global Market for HIV Diagnostics, 2020-2028
Figure 27: Abbott: Revenue Share, by Country/Region, 2021 and 2022
Figure 28: Abbott: Revenue Share, by Business Segment, 2021 and 2022
Figure 29: AstraZeneca: Sales Share, by Segment, 2022
Figure 30: AstraZeneca: Revenue Share, by Region/Country, 2022
Figure 31: Braun: Revenue, 2015-2021
Figure 32: Braun: Revenue Share, by Country/Region, 2021
Figure 33: Braun: Revenue Share, by Segment, 2021
Figure 34: Becton, Dickinson and Company: Revenue Share, by Business Segment, 2022
Figure 35: Becton, Dickinson and Company: Revenue Share, by Region/Country, 2022
Figure 36: Bio-Rad Laboratories Inc.: Revenue Share, by Business Segment, 2022
Figure 37: Bio-Rad Laboratories Inc.: Revenue Share, by Region/Country, 2022
Figure 38: Boehringer Ingelheim: Annual Revenue, 2021 and 2022
Figure 39: Boehringer Ingelheim: Revenue Share, by Business Segment, 2021 and 2022
Figure 40: Boehringer Ingelheim: Revenue Share, by Region, 2021 and 2022
Figure 41: Danaher Corp.: Revenue Share, by Business Segment, 2022
Figure 42: Danaher Corp.: Revenue Share, by Region, 2022
Figure 43: Dexcom Inc.: Annual Revenue, 2019-2021
Figure 44: Dexcom: Revenue Share, by Region/Country, 2022
Figure 45: Dexcom: Revenue Share, by Sales Channel, 2022
Figure 46: Johnson & Johnson: Financials, 2017-2021
Figure 47: Johnson & Johnson: Revenue Share, by Country/Region, 2021
Figure 48: Johnson & Johnson: Revenue Share, by Segment, 2021
Figure 49: Lilly: Total Sales Share, by Product Segment, 2022
Figure 50: Medtronic: Financials, 2015-2022
Figure 51: Medtronic: Revenue Share, by Country/Region, 2022
Figure 52: Medtronic: Revenue Share, by Key Disease Segment, 2022
Figure 53: Merck & Co. Inc.: Revenue Share, by Business Segment, 2022
Figure 54: Merck & Co. Inc.: Revenue Share, by Region/Country, 2022
Figure 55: Novartis: Revenue Share, by Business Segment, 2022
Figure 56: Novartis: Total Revenue Share, by Region/Country, 2022
Figure 57: Novo Nordisk: Revenue Share, by Region, 2022
Figure 58: Novo Nordisk: Revenue Share, by Business Segment, 2022
Figure 59: Qiagen: Total Revenue, 2020-2022
Figure 60: Qiagen: Market Share, by Product Type, 2022
Figure 61: Roche: Revenue, by Country/Region, 2022
Figure 62: Sanofi: Net Sales Share, by Business Segment, 2022
Figure 63: Sanofi: Net Sales Share, by Region/Country, 2022
Figure 64: Siemens Healthineers AG: Total Revenue, 2020-2022
Figure 65: Siemens Healthineers AG: Market Share, by Business Segment, 2022
Figure 66: Thermo Fisher Scientific Inc.: Annual Revenue, 2020-2022
Figure 67: Thermo Fisher Scientific Inc.: Market Share, by Business Segment, 2022

Executive Summary

In 2019, around 38 million people worldwide were HIV-positive. About 20.7 million of those infected with HIV lived in Eastern and Southern Africa. Of the 25 countries with the highest prevalence of HIV in 2019, all were in Africa. HIV prevalence in North America and Europe is significantly lower than in other regions, attributed to better awareness, higher hygiene standards and better HIV prevention.

After a peak in 2004-2005, the number of AIDS deaths has steadily declined Still, there were approximately 690,000 AIDS-related deaths worldwide in 2019, with most of them again occurring in Sub-Saharan Africa. South Africa had the highest number of deaths due to AIDS, with around 72,000 in 2019. Among countries outside Africa, India has the highest number of AIDS-related deaths.

Effective antiretroviral treatment is available to manage HIV/AIDS, and treatment coverage has been extended to developing nations. In the absence of an effective treatment that cures the disease, governments rely on HIV diagnostics and prevention methods to slow the spread of this epidemic.

HIV is transmitted through the exchange of body fluids, which can occur through sexual encounters and the use of contaminated blood or blood products. It can also be transmitted from a pregnant woman to her infant during pregnancy, delivery or breastfeeding. It has additionally been reported that transmission can occur from organ transplants if the donor is HIV-positive. HIV is highly divergent, and several subtypes exist globally. The two major HIV subtypes are HIV-1 and HIV-2. HIV testing is conducted to ensure the safety of blood, blood products, organ transplantation and patient diagnosis.

For effective HIV management, the key strategies are early diagnosis, rapid antiretroviral therapy (ART) initiation and viral load monitoring. A vital issue with existing HIV therapies is that they fail to address two rising concerns: the long-term adverse effects of therapeutic drugs and their effectiveness against drug-resistant HIV strains.

The global market for diagnostics and therapeutics for HIV was valued at $28.8 billion in 2022. This market is forecast to grow at a compound annual growth rate (CAGR) of 5.3% to reach $39.3 billion in 2028.

The single-tablet regimen FDC segment holds 37.2% of the market share of the global HIV therapeutics market, as this has become the preferred therapy for HIV treatment due to greater patient compliance. As fixed-dose combinations reduce dosing errors and lower the likelihood of the HIV virus becoming drug resistant, they are increasingly preferred. By 2028, NRTIs will hold 29.0% of the global market, a $11.0 billion value, as they form the backbone of any antiretroviral therapy.

Companies Mentioned

  • Abbott
  • Astrazeneca
  • B. Braun Se
  • Becton, Dickinson and Company
  • Biocon
  • Bio-Rad Laboratories Inc.
  • Boehringer Ingelheim International GmbH
  • Danaher Corp.
  • Dexcom Inc.
  • Insulet Corp.
  • Johnson & Johnson Services Inc.
  • Lifescan Ip Holdings LLC
  • Lilly
  • Medtronic
  • Merck & Co. Inc.
  • Nova Biomedical
  • Novartis AG
  • Novo Nordisk A/S
  • Qiagen N.V.
  • Roche (F. Hoffmann-La Roche Ltd.)
  • Sanofi
  • Siemens Healthineers AG
  • Terumo Corp.
  • Thermo Fisher Scientific Inc.
  • Ypsomed Ag

Table Information