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HIV - KOL Insight and Consensus Outlook Modules

February 2013 | 183 pages | ID: H7503C83FA0EN
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What do frontline clinicians really think about current HIV treatment pathways and what are the most pressing unmet needs that industry can respond to?

What’s driving long term growth in HIV?

The market for HIV therapies has been growing fast–a 5 year CAGR (2007-2012) of 12.0%–but sustaining growth will be a challenge. The HIV sector is mature with many tried and tested treatment options, so what has underpinned growth to date and how can companies drive market expansion in the future?

The patient population is key

Current HIV therapies are effective in suppressing HIV and are successfully increasing patients’ life expectancy. However, they are not curative and must be taken for the lifetime of the patient. This means the market for HIV therapies will be sustained from the long-term maintenance of the current patient base whose numbers will swell as new cases are diagnosed.

Good times, bad times?

Valued at US$16 billion in 2012, and with a 5-year CAGR (2007-2012) of 12.0 percent, the HIV sector is dominated by seven blockbuster drugs: Gilead’s Atripla and Truvada; Bristol Myers-Squibb’s Reyataz; Merck & Co.’s Isentress; Janssen Therapeutics’ Prezista; ViiV Healthcare’s Epzicom/Kivexa; and AbbVie’s Kaletra. With few payer restrictions on prescribing HIV therapies, no prospect of a cure or vaccine in the near future and limited uptake of generics to date, the sector is forecast to maintain stable returns until the end of the decade. However, driving high growth will be a challenge, and new products must show significant clinical and patient benefits if they are to succeed in a market already provided with established therapy options.

Game changers in the pipeline?

Medical adherence, improved efficacy and reducing toxicity are major challenges and there are a number of promising candidates in late trials–but how will they fare? Will ViiV Healthcare price Trii, its first single-tablet complete regimen, competitively? Tobira Therapeutics cenicriviroc has novel anti-inflammatory effects, but what are the regulatory hurdles it will have to overcome? And Gilead’s tenofovir alafenamide could address safety concerns associated with tenofovir; can it limit competition from generic alternatives?

Meeting the challenge of unmet need

Many of the challenges faced by clinicians are not related to efficacy, but include poor adherence to treatment, often exacerbated by societal and mental health issues, the stigma associated with diagnostic testing and low levels of early diagnosis. There are, however, opportunities for industry to improve patient outcomes. For example:

Poor adherence to prescribing programmes is a major issue in the management of HIV. Long acting injectable formulations and single dose combination therapies may help tackle this problem and in turn reduce transmission rates.

Under diagnosis or late diagnosis often leads to patients presenting with advanced infection. This is a notoriously difficult area to influence, but could home self diagnosis be part of the answer? Only OraQuick’s In-Home HIV test is approved in the US and there are none in Europe.

As first-line anti-retroviral regimens have similar efficacy, the choice of therapies is determined by the type and likelihood of long term adverse effects such a renal function impairment and cardiovascular disease. New complete combination regimens may address some of these safety concerns, but products with reduced side-effect profiles are both a development challenge and market opportunity.

A complete ongoing analysis of current trends, forecasts and landscape modifiers

Harnessing the real world insights from leading US/European KOLs and research analysts, this study critically examines the HIV sector to expose the real potential. If you need instant access to an accurate, unbiased, qualitative review of the latest treatment trends along with a five-year quantitative HIV market forecast and insights as to the how HIV treatment will develop, look no further than FirstWord’s Therapy Trends: HIV. This insightful FirstWord research is provided in two comprehensive modules:

The KOL Insight: HIV module provides a complete review underpinned by exclusive in-depth interviews with leading KOLs from the US and Europe

The Consensus Outlook: HIV data analysis module provides annual historical and forecast product-level sales data based on leading equity analysts’ projections. Key findings are given in a written analysis to support the visual data analyses provided in charts and tables.

KOL Insight

KOL Insight Report

A qualitative analysis of the current and predicted treatment trends, clinical products and commercial drivers and resistors in the global HIV market, informed by in-depth expert views of the leading clinicians

Compare the market’s key players, marketed products, late-stage pipeline drugs, current and future product positioning, in the context of HIV market trends.

Event Bulletins

Benefit from the latest KOL views about significant future event-driven changes in HIV treatment trends.

Consensus Outlook

Consensus Report

An in-depth 5-year Consensus Outlook report of predicted quantitative changes in key HIV market forecast parameters drawn from 13 leading analyst and brokerage companies

Chart HIV market size, product sales, market share by company, competitive status and detailed forecasts

Interactive Analytics File

Use the interactive Excel market analytics module of detailed market and product sales data from 2007 to 2017 to drill down and assess key company, market and product trends

KOL Insight

Therapy Trends KOL Insight: HIV analyses the current and predicted key issues, current products and late-stage pipeline products.

The report gives you qualitative, inside information from exclusive and detailed FirstWord interviews with 12 of the foremost key opinion leaders (KOLs) active in HIV treatment clinics in the US and Europe through the following:
  • KOL Insight Report—an in-depth analytical report on HIV treatment trends
  • Full report updates—delivered to you after each and every significant HIV market event
  • Event Bulletins—highlighting the latest KOL views in response to each event
Key Report Features and Benefits
  • Critical insights on products and market developments from leading US and European clinicians
  • Complete coverage of all therapeutic approaches
  • Assessment of current leading HIV products by class
  • Analysis of late-stage pipeline HIV therapies by class
  • Competitive evaluation of leading players
  • Current opinion and trends on the diagnosis and treatment of HIV
  • KOL predicted treatment trends and market leaders
  • Ongoing clinical and market updates
All current therapeutic approaches covered
  • Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
  • Non-nucleoside reverse transcriptase inhibitors (NNRTIs)
  • Integrase inhibitor
  • Protease inhibitors
  • CCR5 inhibitor
Expert Opinion for Real World Insights

The data and analysis in the report is enriched through the specific insights and opinions of leading clinicians working in HIV in the US and Europe. Their views on specific drugs and treatment pathways provide a unique front line perspective from those working in a clinical setting. The results of these detailed and extensive interviews are incorporated throughout the text so they can be read in the context of the issue or product being discussed.

Key Quotes from the Report
  • “We know that patients who are on therapy do better if they are taking one pill a day, as a combination pill, there is no question about that. We need the best possible fixed dose single combination pill.”
  • “Every patient who takes the drugs will be able to suppress the virus, so the question is not the potency of the combination, the question is the toxicity in the long-term. What about the kidneys? I mean everybody is taking tenofovir. We see the renal problems after years. We have an aging (HIV) population and we have to be prepared for the long run and I don't think we really are.”
  • “There are a lot of expectations with Trii. I cannot think of another drug where the expectations were as high. Trii could be a good option for many different patients, and you don’t have to worry about the renal issues. It's highly potent, very well tolerated, it doesn't have a signature toxicity. I see a bright future for Trii.”
  • “Current NNRTIs have a low barrier for resistance and a significant amount of patients are going to fail eventually with K103N [mutation]. Having an NNRTI that is able to overcome mutations is important.”
  • “My personal view is that it will have a very small impact. We know PrEP with Truvada works. The major problem is cost. You need to give the medicines to plenty of uninfected subjects to prevent a few cases of HIV.”
Consensus Outlook

Use this detailed report and powerful interactive Excel spread sheet to compare and contrast companies and products now and in the future. Therapy Trends Consensus Outlook: HIV includes the following comprehensive resources:
  • An in-depth forecast report based on consensus figures from 13 leading analysts. Rich in tables and charts, the report maps the impact of future events to predict product and company performance
  • An interactive forecast data analysis spreadsheet comparing critical market parameters including market size, product sales, market shares and competitive status over the period 2007 to 2017
  • Timely event-driven market forecast report and data analysis updates over 12 months.
Report features:
  • Historical HIV sales from 2007–2012
  • Forecast HIV sales from 2013-2017
  • Key competitors and drug developers
  • Current and late-stage pipeline drugs
  • Future event mapping to forecast data points
Use Consensus Outlook to:
  • Chart predicted market growth and product sales
  • Map your own market parameters
  • Tailor your strategic and investment focus
  • Assess your current and future sales resources
  • Set proactive launches and branding strategies
Analysts compared
  • Barclays Capital
  • Credit Suisse
  • Deutsche Bank
  • Goldman & Sachs
  • International Strategy & Investment
  • Jefferies
  • JP Morgan
  • Merrill Lynch
  • Morgan & Stanley
  • Societe Generale
  • Stifel Nicolaus
  • UBS
  • Wells Fargo
Content Highlights and Products Covered:
  • FirstWord Analysis Highlights
  • Research Methodology
  • HIV Marketplace
  • Key HIV Developers
  • HIV Class Dynamics
  • Atripla (tenofovir/emtricitabine/efavirenz; Gilead Sciences) forecast
  • Complera/Eviplera (tenofovir/emtricitabine/rilpivirine; Gilead Sciences) forecast
  • Reyataz (atazanavir; Bristol-Myers Squibb) forecast
  • Prezista (darunavir; Janssen Therapeutics) forecast
  • Kaletra (lopinavir/ritonavir; AbbVie) forecast
  • Isentress (raltegravir; Merck & Co) forecast
  • Stribild (tenofovir/emtricitabine/elvitegravir/cobicistat; Gilead Sciences) forecast
  • Tivicay (dolutegravir; ViiV Healthcare) forecast
  • Selzentry/Celsentri (maraviroc; ViiV Healthcare) forecast
  • Norvir (ritonavir, Abbvie) forecast
  • Sustiva (efavirenz; Bristol-Myers Squibb) forecast
  • Tenofovir (alafenamide/emtricitabine/cobicistat/elvitegravir; Gilead Sciences) forecast
  • Truvada (tenofovir/emtricitabine; Gilead Sciences) forecast
  • Viread (tenofovir; Gilead Sciences) forecast
  • Edurant (rilpivirine ; Janssen Therapeutics) forecast
  • Intelence (etravirine; Janssen Therapeutics) forecast
  • Prezista (darunavir; Janssen Therapeutics) forecast
  • Stocrin (efavirenz; Merck & Co) forecast
  • Combivir(lamivudine/zidovudine; ViiV Healthcare) forecast
  • Epzicom/Kivexa (abacavir/lamivudine; ViiV Healthcare) forecast
  • Lexiva/Telzir (fosamprenavir ;ViiV Healthcare) forecast
  • Tivicay/(Trii) (dolutegravir (+abacavir/lamivudine; ViiV Healthcare) forecast
  • Trizivir (abacavir/lamivudine/zidovudine; ViiV Healthcare) forecast
KOL, Analysts, Products and Companies

At a glance listings of those who contributed and the rich and varied sources used to produce this major analysis of the HIV market and its prospects.

Key Opinion Leaders
  • Dr Jay Dobkin MD, Associate Attending Physician, Columbia-Presbyterian Hospital, New York, USA
  • Dr Monica Gandhi MD, Associate Professor of Clinical Medicine, UCSF, California, USA
  • Dr Edwin DeJesus MD, HIV Specialist and Medical Director, Orlando Immunology Center, Florida, USA
  • Dr. Joel Gallant MD, Associate Medical Director of Specialty Services, Southwest CARE Center - Santa Fe, New Mexico, USA
  • Dr Richard Haubrich MD, Professor of Medicine in the Department of Medicine, Division of Infectious Diseases, UCSD, California, USA
  • Dr Bruce Agins MD, Medical Director New York State Department of Health AIDS Institute, New York, USA
  • Dr Barry Peters, Consultant Physician, Guy's and St Thomas Hospital, London‏, England
  • Dr Christian Hoffmann MD, Infektionsmedizinisches Centrum Hamburg (ICH), Hamburg Germany
  • Dr Magnus Gisslén, HIV Unit, Department of Infectious Diseases, Sahlgrenska University Hospital, Gothenburg, Sweden
  • Dr Jean-Michel Molina, Saint-Louis Hospital and University of Paris, France
  • Dr Pere Domingo Pedrol, Hospital Santa Creu I Sant Pau, Barcelona, Spain
  • Dr José Arribas, Hospital La Paz, Madrid, Spain
Analysts
  • Barclays Capital
  • Credit Suisse
  • Deutsche Bank
  • Goldman & Sachs
  • International Strategy & Investment
  • Jefferies
  • JP Morgan
  • Merrill Lynch
  • Morgan & Stanley
  • Societe Generale
  • Stifel Nicolaus
  • UBS
  • Wells Fargo
Products & Companies Covered
  • Truvada (tenofovir/emtricitabine); Gilead
  • Epzicom/Kivexa (abacavir/lamivudine); ViiV Healthcare
  • Atripla (tenofovir/emtricitabine/efavirenz); Gilead
  • Complera/Eviplera (tenofovir/emtricitabine/rilpivirine); Gilead
  • Reyataz (atazanavir); Bristol-Myers Squibb
  • Prezista (darunavir); Janssen Therapeutics
  • Kaletra (lopinavir/ritonavir); AbbVie
  • Isentress (raltegravir); Merck & Co.
  • Stribild (tenofovir/emtricitabine/elvitegravir/cobicistat); Gilead
  • Tivicay (dolutegravir); ViiV Healthcare
  • Selzentry/Celsentri (maraviroc); ViiV Healthcare
Ongoing Benefits

Updated Continually

This report is continually updated in response to market developments stay in touch with the latest developments and thinking and maximise the value of this report

The world of pharma is ever changing and executives must always be up-to-date with the latest developments that could affect their own products, position and research. That is why FirstWord’s guarantee to keep Therapy Trends updated offers real commercial advantage. Consider the benefits:
  • Content will be fully updated in response to market developments such as new product approvals or pivotal research results for 12 months from the date of purchase
  • Such updates are incorporated throughout the KOL reports ensuring the change is reflected in every aspect of the report
  • There is no limit and all relevant events will result in an update
  • You’ll receive these updated directly, within days of each event’s occurrence
  • All updates are included in the price.

Whatever happens in the market you’ll always be able to assess the impact with FirstWord Therapy Trends

Unrivalled Sources Ensure Complete Coverage

Our unique disease selection matrix pinpoints those disease sectors of the highest commercial potential, and draws information from multiple novel and expert sources, including:
  • Exclusive views from leading global experts
  • Comprehensive consensus research
  • Live meeting dispatches and critical industry data
  • Data from over 125 medical conferences attended by FirstWord researchers each year
  • Online opinions from 535,000 vetted physicians
  • Over 2,000 peer-reviewed medical journals
  • Over 450 pharmaceutical news sources
CONTENTS CONSENSUS OUTLOOK

1.CONTENTS

2.FIRSTWORD ANALYSIS HIGHLIGHTS

3.RESEARCH METHODOLOGY

4.HIV MARKETPLACE

5.KEY HIV DEVELOPERS

6.HIV CLASS DYNAMICS

7.SINGLE-TABLET COMPLETE REGIMENS

7.1.Atripla (tenofovir/emtricitabine/efavirenz; Gilead/Bristol-Myers Squibb) forecast
7.2.Complera/Eviplera (tenofovir/emtricitabine/rilpivirine; Gilead) forecast
7.3.Stribild (tenofovir/emtricitabine/elvitegravir/cobicistat; Gilead) forecast
7.4.Tenofovir alafenamide fumarate (TAF)/emtricitabine/cobicistat/elvitegravir; Gilead forecast
7.5.Trii (dolutegravir/abacavir/lamivudine; ViiV Healthcare) forecast

8.NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

8.1.Truvada (tenofovir/emtricitabine; Gilead) forecast
8.2.Epzicom/Kivexa (abacavir/lamivudine; ViiV Healthcare) forecast
8.3.Viread (tenofovir; Gilead) forecast

9.PROTEASE INHIBITORS

9.1.Prezista (darunavir; Janssen Therapeutics) forecast
9.2.Reyataz (atazanavir; Bristol-Myers Squibb) forecast
9.3.Kaletra (lopinavir/ritonavir; AbbVie) forecast
9.4.Norvir (ritonavir; AbbVie) forecast

10.INTEGRASE STRAND TRANSFER INHIBITORS

10.1.Isentress (raltegravir; Merck & Co.) forecast
10.2.Tivicay (dolutegravir; ViiV Healthcare) forecast

11.NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

11.1.Intelence (etravirine; Janssen Therapeutics) forecast
11.2.Sustiva/Stocrin (efavirenz; Bristol-Myers Squibb/Merck & Co.) forecast

12.ENTRY INHIBITORS

12.1.Selzentry/Celsentri (maraviroc; ViiV Healthcare) forecast

13.APPENDIX

CONTENTS KOL INSIGHT

1.EXECUTIVE SUMMARY

2.INTRODUCTION

3.METHODOLOGY

4.CURRENT HIV MARKET

4.1.HIV treatments
4.2.HIV treatment landscape
  4.2.1.HIV market definition
  4.2.2.Current market overview by class
  4.2.3.Current market overview by brand
4.3Reimbursement/formulary coverage of HIV drugs
  4.3.1.US
  4.3.2.Europe

5.CURRENT MARKETED THERAPIES

5.1.NRTI “backbone” drugs
  5.1.1.Truvada (tenofovir/emtricitabine); Gilead
  5.1.2.Epzicom/Kivexa (abacavir/lamivudine); ViiV Healthcare
5.2.NNRTI-based regimens
  5.2.1.Atripla (tenofovir/emtricitabine/efavirenz); Gilead
  5.2.2.Complera/Eviplera (tenofovir/emtricitabine/rilpivirine); Gilead
5.3.Protease inhibitor-based regimens
  5.3.1.Reyataz (atazanavir); Bristol-Myers Squibb
  5.3.2.Prezista (darunavir); Janssen Therapeutics
  5.3.3.Kaletra (lopinavir/ritonavir); AbbVie
5.4.Integrase inhibitor-based regimens
  5.4.1.Isentress (raltegravir); Merck & Co.
  5.4.2.Stribild (tenofovir/emtricitabine/elvitegravir/cobicistat); Gilead
  5.4.3.Tivicay (dolutegravir); ViiV Healthcare
5.5.CCR5 inhibitors
  5.5.1.Selzentry/Celsentri (maraviroc); ViiV Healthcare

6.PIPELINE HIV THERAPIES

6.1.Integrase inhibitor-based regimens
  6.1.1.Tenofovir alafenamide/emtricitabine/cobicistat/elvitegravir; Gilead
  6.1.2.Trii (dolutegravir/abacavir/lamivudine); ViiV Healthcare
  6.1.3.GSK1265744; ViiV Healthcare
6.2.Protease inhibitor-based regimens
  6.2.1.Tenofovir alafenamide/emtricitabine/cobicistat/darunavir; Gilead
6.3.NNRTI-based regimens
  6.3.1.Doravirine; Merck & Co.
6.4.CCR5 antagonists
  6.4.1.Cenicriviroc; Tobira Therapeutics
6.5.Treatment focus
  6.5.1.Unmet needs
  6.5.2.Unmet need one: Developing an HIV cure
  6.5.3.Unmet need two: Improve patient drug adherence
  6.5.4.Unmet need three: Identify interventions to reduce HIV infections
  6.5.5.Unmet need four: Reducing long term toxicities of ART
  6.5.6.Unmet need five: Improve HIV diagnosis Current HIV treatment algorithm
6.6.HIV treatment guidelines
  6.6.1.Cost of ART drugs
  6.6.2.Generics
6.7.Future treatment algorithm

7.APPENDIX

7.1.KOL biographies
  7.1.1.US KOLs
  7.1.2.European KOLs


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