Market Report Source

Overview

Introduction
Detailed analysis of the antiretroviral therapy market. 10 year sales forecast for marketed drugs and key pipeline compounds, factoring in clinical trial results, new product launches and patent expiries.

Scope of this report

• In-depth analysis of the current HIV market across the major US and EU markets
• Thorough assessment of underlying commercial and clinical factors shaping the antiretroviral market
• Detailed sales forecasts for the three major antiretroviral classes, molecules and brands in each of the six major markets
• Case study analysis of the entry inhibitor class focusing on the competitive environment and critical success factors

Research and analysis highlights
By 2016 the HIV market is forecasted to grow to $11.5 billion. This growth will be driven mainly by the increase in numbers of patients accessing treatments as well as the launch of several new drugs and drug classes

The availability of several simple, once-daily treatments such as fixed dose combinations and once daily protease inhibitors has intensified the competition within the respective classes. Adherence to therapy is consequently expected to improve leading to a decline in the number of patients entering late-stage therapy.

The anticipated launches of pipeline antiretrovirals such as CCR5 inhibitors, integrase inhibitors and others, which demonstrate novel activity and efficacy against resistant mutants, will not only offer more variety to patients but will increase the overall value of the market.

Key reasons to read this report

• Understand the constantly evolving market dynamics of antiretroviral drugs
• Understand the impact of pending patent expiries and generic incursion on the ARV market, including product-specific case studies
• Obtain full global, country, class and product-specific forecasts of currently marketed and pipeline antiretrovirals from 2006 to 2016.

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Infectious Diseases pharmaceutical analysis team CHAPTER 1 EXECUTIVE SUMMARY Objective of the analysis Datamonitor insight into the HIV market Contributing experts

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Market definition for this report Current market situation

Overview of antiretroviral classes

Nucleoside reverse transcriptase inhibitors Cross-class fixed dose combination – Atripla Non-nucleoside reverse transcriptase inhibitors Protease inhibitors Entry Inhibitors Strategic scoping and focus Emerging markets CHAPTER 3 COUNTRY MARKET ASSESSMENTS Summary of environmental issues affecting HIV market size Six major market opportunities and threats Epidemiology: Increase in the HIV population Increase in diagnosis rates Increase in life expectancy Increase in risk behavior Increased immigration from areas of high HIV prevalence Continuing rise in development of resistance Acceleration and harmonization of approval procedures Threats

Generic incursion

Pricing pressure imposed by governments Parallel trade Preventative measures Vaccine/microbicide development US: opportunities and threats

HIV market overview

Opportunities Increased government funding for treatment of HIV Direct to Consumer Advertising Branded products achieve high prices as a result of the free pricing system Threats Introduction of Medicare Part D has resulted in difficulties in accessing treatment for HIV Waiting lists and other cost-containment measures implemented by several ADAPs due to underfunding Opposition to the rising prices of antiretrovirals Genericization

Parallel trade currently illegal in the US

France: opportunities and threats

HIV market overview

Opportunities

Critical attitude towards MRP slows down generic approvals

Creation of HAS facilitates P&R approval High volume of prescription Reimbursement system favors use of innovative drugs Threats Cost-containment policies aim at reducing expenditure on prescription drugs Genericization set to increase and be further supported Germany: opportunities and threats HIV market overview Opportunities Legalization of mail order Free pricing system in Germany facilitates novel drug development Threats Jumbo reference pricing Genericization Italy: opportunities and threats HIV market overview Opportunities Lack of confidence in generics may limit their uptake Reimbursement based on negotiations Threats Unpredictability of regulations hampers reliable strategic planning Reference pricing may result in downward price trends Changes in reimbursement rules for lipid-lowering drugs pose a significant threat to the protease inhibitor market Spain: opportunities and threats HIV market overview Opportunities Supportive legislation and reimbursement schemes for innovative drugs

Decentralized system provides localized opportunities

Threats Cost containment measures proposed by Spanish authorities The use of generics is being promoted by the Spanish government UK: opportunities and threats HIV market overview Opportunities A less stringent pricing and reimbursement system makes the UK attractive The UK has one of highest new infection rates in Europe Threats Improper management of HIV drugs budgets may lead to tighter restrictions on prescription of antiretrovirals Prevention programmes

NICE: the pre-guidance and post-guidance effect

CHAPTER 4 FORECAST ANALYSIS Key events Events not included Six major market events Increase in the population of HIV-infected patients New product launches Product-specific events New product launches in the NRTI class to have relatively small impact

Atripla to take market share away from NRTI FDCs

Tibotec’s compounds will be valuable additions to the NNRTI class Kaletra and Reyataz challenged by Prezista Novel classes to enter the EIs & others Antiretroviral patent expiries Retrovir patent expiry Hivid patent expiry Zerit patent expiry Videx patent expiry Ziagen patent expiry

Epivir patent expiry

Emtriva patent expiry

Invirase patent expiry

Crixivan patent expiry Viramune patent expiry Combivir patent expiry

Sustiva patent expiry

Agenerase patent expiry Norvir patent expiry Fuzeon patent expiry Viracept patent expiry Kaletra patent expiry Data definitions, limitations and assumptions

Derivation of sales forecasts and pricing trends

Forecasts Forecast methodology

CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES

Introduction Case studies Pfizer’s maraviroc, close to approval, despite hurdles along the way CCR5 inhibitors, a novel class of antiretrovirals Collaboration with Monogram to make tropism assay globally available with Maraviroc Setbacks suffered by GSK and Schering-Plough damage class reputation Clinical trials demonstrate good safety and efficacy profiles Maraviroc’s place in therapy Needle-free Fuzeon (enfuvirtide, T-20) Slow uptake of Fuzeon due to high cost and mode of administration Roche and Trimeris aim to develop needle-free format of Fuzeon Impact of a needle-free version

Commercial outlook for Roche HIV portfolio

BIBLIOGRAPHY

Journal papers and news articles Press releases Websites Datamonitor reports

APPENDIX A – MARKET DATA AND MAJOR BRAND KEY FACTS

Summary HIV market data NRTI market data NNRTI market data PI market data EI and others market data APPENDIX B – MARKET FORECAST DATA Six major market M5EU US France Germany Italy

Spain

UK APPENDIX C Contributing experts Report methodology About Datamonitor About Datamonitor Healthcare About the Infectious Diseases and Respiratory analysis team Disclaimer List of Tables

Table 1: Overview of the NRTIs, 2007

Table 2: Overview of the NNRTIs, 2007

Table 3: Overview of currently marketed PIs, 2007

Table 4: Overview of sales and market share of antiretrovirals by company, 2006 Table 5: Methods for HIV prevention in clinical development, 2007 Table 6: Overview of vaccines in development, 2007 Table 7: Total funding for Ryan White Care Act, 2006

Table 8: Summary HIV Market Data

Table 9: Key facts: Combivir Table 10: Key facts: Viread Table 11: Key facts: Trizivir Table 12: Key facts: Epivir Table 13: Key facts: Zerit

Table 14: Key facts: Abacavir

Table 15: Key facts: Videx Table 16: Key facts: Retrovir Table 17: Truvada Table 18: Key facts: Emtriva Table 19: Key facts: Epzicom Table 20: Key facts: Hivid Table 21: Key facts: Atripla Table 22: Key facts: Sustiva Table 23: Key facts: Viramune Table 24: Key facts: Kaletra Table 25: Key facts: Reyataz Table 26: Key facts: Viracept Table 27: Key facts: Norvir Table 28: Key facts: Crixivan Table 29: Key facts: Lexiva Table 30: Key facts: Invirase Table 31: Key facts: Agenerase

Table 32: Key facts: Prezista

Table 33: Key facts: Aptivus

Table 34: Key facts: Fuzeon

Table 35: Six major markets

Table 36: M5EU Table 37: US Table 38: France Table 39: Germany Table 40: Italy Table 41: Spain Table 42: UK List of Figures

Figure 1: Pharmaceutical sales across the seven major markets, 2002-06

Figure 2: Overview of sales of HIV treatments by class, 2002-06

Figure 3: Overview of 10 best-selling antiretrovirals and market share, 2007

Figure 4: Timeline of the development of the HIV market, 1985-2015

Figure 5: HIV market share by company, 2003-06

Figure 6: Regional HIV and AIDS overview, 2005 Figure 7: UK HIV diagnoses by the two main routes of transmission, 2005 Figure 8: HIV infections in the UK by the region they were acquired from Figure 9: US sales by class, 2003-06

Figure 10: Total funding for the Ryan White Care act, 1991-2006

Figure 11: France sales by class, 2002-06 Figure 12: Germany sales by class, 2003-06

Figure 13: Italy sales by class, 2003-06

Figure 14: Spanish sales by class 2003-06 Figure 15: UK sales by class, 2003-06 Figure 16: New HIV cases across Europe, 2006 Figure 17: Summary of opportunities and threats

Figure 18: Sales forecasts for antiretrovirals across six major markets 2006-2016

Figure 19: Sales forecasts for Atripla, Truvada and Sustiva 2006-2016 Figure 20: Sales forecasts for the NNRTI class 2006-2016 Figure 21: Sales forecasts Reyataz, Kaletra and Prezista 2006-2016 Figure 22: Sales forecasts Fuzeon, raltegravir and maraviroc Figure 23: Sales forecasts of marketed drugs 2006-2016 with key patent expiries Figure 24: HIV mechanism of entry into host cell Figure 25: Percentage of CCR5 tropic patients Figure 26: MOTIVATE trial design Figure 27: Mean change in CD4+ count in patients failing treatment Figure 28: Sales forecast for maraviroc 2006-2016 Figure 29: Overview of sales of Fuzeon in the US and Canada, 2003-06

Figure 30: SWOT analysis for Fuzeon

Figure 31: Sales forecasts for Fuzeon 2006-2016