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HIV -- KOL Insight and Consensus Outlook Modules

  • February 2013
  • -
  • Firstword Pharma
  • -
  • 176 pages




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






Table Of Contents

HIV -- KOL Insight and Consensus Outlook Modules
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 and 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 and 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 and 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 and 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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