Global HIV Drugs industry

  • April 2010
  • -
  • Global Industry Analysts

This report analyzes the Worldwide markets for HIV Drugs in US$ Million. The report provides separate comprehensive analytics for US, Canada, Japan, Europe and Rest of World. Annual estimates and forecasts are provided for the period 2006 through 2015. The report profiles 52 companies including Abbott Laboratories, Boehringer Ingelheim GmbH , Bristol-Myers Squibb Company, F. Hoffmann-La Roche Ltd., Gilead Sciences, Inc., Koronis Pharmaceuticals, Inc., Merck & Co., Inc., Pfizer, Inc., Tibotec BVBA, ViiV Healthcare, and VIRxSYS Corp. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

Table Of Contents


HIV DRUGS MCP-6176
A GLOBAL STRATEGIC BUSINESS REPORT


CONTENTS


I. INTRODUCTION, METHODOLOGY and PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation and Reporting Level I-3
Quantitative Techniques and Analytics I-3
Product Definitions and Scope of Study I-3


II. EXECUTIVE SUMMARY

1. GLOBAL OUTLOOK II-1
Antiretroviral Drug Market Flourishes II-1
US Leads the Global HIV Drugs Market II-1
NRTIs - The Largest Selling Drug Class Worldwide II-2
HIV Prevalence on the Rise II-2
Table 1: Global Prevalence of HIV Infection by Region (2007 and
2008) in Millions (includes corresponding Graph/Chart) II-2

Table 2: Global Incidence of HIV Infection by Region (2007 and
2008) in Thousands (includes corresponding Graph/Chart) II-3

Table 3: Global HIV Related Deaths by Region (2007 and 2008) in
Thousands (includes corresponding Graph/Chart) II-4

Table 4: Global Distribution of HIV Prevalence, Incidence and
Mortality by Age Group (2008) (In Millions) (includes
corresponding Graph/Chart) II-4

Table 5: HIV Prevalence in Select Countries (2007) (includes
corresponding Graph/Chart) II-5
Antiretroviral Drugs - The Lone Treatment Option for HIV and AIDS II-6
Protease Inhibitors II-6
Select Protease Inhibitors; Dosing and Frequency II-7
Table 6: Leading Protease Inhibitors Drugs Worldwide (2006):
Value Breakdown for Kaletra, Reyataz, Norvir,
Agenerase/Lexiva, Viracept and Others (includes
corresponding Graph/Chart) II-7
Overview of Select Protease Inhibitors II-7
Kaletra (lopinavir/ritonavir) II-7
Reyataz (Atazanavir) II-7
Prezista (Darunavir) II-8
Viracept (nelfinavir mesylate) II-8
Kaletra and Reyataz to Maintain Market Dominance II-8
Nucleoside Reverse Transcriptase Inhibitors II-9
Approved NRTI Drugs; Dosing and Frequency II-9
Overview of Select NRTIs II-9
Emtriva (emtricitabine) II-9
Stavudine (Zerit)- Marred with Safety Issues II-9
Safety Concerns to Curb Ziagen’s Use II-10
Non-Nucleoside Reverse Transcriptase Inhibitors II-10
Overview of Select NNRTIs II-10
Viramune® (nevirapine) II-10
Intelence (Etravirine) II-10
Integrase Inhibitors II-11
Overview of Select Integrase Inhibitors II-11
Isentress (Raltegravir) II-11
Elvitegravir (Gilead Sciences) II-11
Chemokine Receptor 5 Inhibitors II-11
Selzentry (maraviroc) II-12
Selzentry Makes a Slow Start II-12
Fusion Inhibitors II-12
Combination Therapy II-13
Drug Resistance Issues Fuel Use of Combination Therapy II-13
Atripla (Bristol-Myers Squibb and Gilead Sciences) II-14
Epzicom (GlaxoSmithKline) II-14
Quad (Gilead Sciences) II-14
Drug Pipeline Laden With Efficacious Drugs and Novel Drug Classes II-15
Abandoned Trials in Recent Years II-15
Select Antiretroviral Pipeline Drugs II-16
HIV Drug Usage Picks Up; Major Population Still Lacks
Accessibility II-16
ART Penetration Posts Significant Growth in Recent Years II-17
Table 7: HIV-Infected Population Receiving Anti-Retroviral
Treatment in Low and Middle Income Countries (2004 - 2008)
(In Millions) (includes corresponding Graph/Chart) II-17

Table 8: HIV-Infected Population Receiving and In Need of
Anti-Retroviral Treatment in Low and Middle Income Countries
By Region (2008) (includes corresponding Graph/Chart) II-18

Table 9: Number of HIV Patients Receiving Antiretroviral
Drugs in Select Low- and Middle-Income Countries (2008)
(includes corresponding Graph/Chart) II-19

Table 10: Number of HIV Patients Receiving Antiretroviral
Drugs in Select Low- and Middle-Income Countries By Gender
(2008) (includes corresponding Graph/Chart) II-20

Table 11: Number of HIV Patients Receiving Antiretroviral
Drugs in Select Low- and Middle-Income Countries By Age
Group (2008) (includes corresponding Graph/Chart) II-21

Table 12: Number of HIV Patients Receiving Antiretroviral
Drugs in Select High-Income Countries (2008) (includes
corresponding Graph/Chart) II-22
Number of Children and Pregnant Women on ART Rises Dramatically II-23
Table 13: HIV-Infected Children Receiving and In Need of
Anti-Retroviral Treatment in Low and Middle Income Countries
By Region (2008) (includes corresponding Graph/Chart) II-23

Table 14: HIV-Infected Pregnant Women Receiving and In Need
of Anti-Retroviral Treatment in Low and Middle Income
Countries By Region (2008) (includes corresponding
Graph/Chart) II-24
Convenience and Efficacy - Key Growth Drivers II-24
Antiretrovirals as Preventive Medicine II-25
Cost of ARTs - A Major Barrier to Widespread Access II-25
Manufacturers Hindering Entry of Generics II-25
Indian Drug Manufactures Propose to Offer Low Cost Generic
Versions II-26
Need for Novel Drugs Continues II-26
Development of Vaccines for HIV - A Challenging Task II-26
Immune-Based Therapies Bode Promising Treatment Options for
Future II-27
Injecting Drug Users and HIV II-27

2. COMPETITIVE SCENARIO II-28
HIV Drug Industry - Rife With Activity II-28
Gilead Reaches the Top, While GSK Scrambles to Gain Lost Ground II-28
Table 15: Leading Companies in Global HIV Drugs Market (2005,
2007 and 2009): Percentage Breakdown of Revenues for Gilead
Sciences, GlaxoSmithKline, Bristol-Myers Squibb and Others
(includes corresponding Graph/Chart) II-29
Truvada Reigns Global HIV Drug Market; Atripla Fast Catching Up II-29
Table 16: Worldwide Sales of Select Leading HIV Drugs
(2006-2008) (includes corresponding Graph/Chart) II-30
Atripla to Ease Truvada’s Revenue Growth II-31
Atripla’s Success Propels Gilead’s Market Share Above GSK II-31

3. DISEASE OVERVIEW II-32
HIV - An Overview of the Deadly Virus II-32
Unique Genetic Variability of HIV II-32
Origin of HIV II-34
Types of HIV Virus II-34
HIV Transmission II-34
Sexual Route II-34
Blood Products or Blood II-34
Mother-to-Child II-35
Human Immune System and HIV Interaction II-35
Stages of HIV Infection II-35
Acute Stage of HIV Infection II-36
Latency Stage II-36
AIDS - Acquired Immune Deficiency Syndrome II-37
Symptoms of HIV and AIDS Infection II-37
HIV Testing II-38
Diagnostic Tests for HIV and AIDS Infection II-39
HIV Treatment II-39

4. RECENT DRUG APPROVALS II-41
Pfizer Obtains Expanded Indication for Selzentry from FDA II-41
Tibotec Obtains Traditional Approval for Intelence® II-41
FDA Confers Tentative Approval for Generic Efavirenz Tablets II-41
FDA Clears New Dosing Recommendations for Retrovir Syrup for
Infants II-42
FDA Confers Tentative Approval for Lamivudine and Tenofovir df
Tablets II-42
Abbott Obtains EC Approval for Once-daily Dosage of Kaletra® II-42
Merck Obtains Expanded indication for Isentress®, for use in
Treatment-Naïve HIV Patients II-43
Tibotec Obtains FDA Clearance for Using Prezista in Pediatric
Patients II-43
Tibotec Obtains EU Approval for Once-daily Dosing of Prezista II-43
Pfizer Receives FDA Clearance for Marketing Selzentryâ„¢ II-44
BMS Obtains FDA Approval for REYATAZ®/r Combination Therapy II-44
EU Clears Tibotec’s Intelence™ in HIV Combination Therapy II-44
Boehringer Obtains FDA Approval for Aptivus® OS II-45
Abbott Obtains EC Approval for Lower-Strength Kaletra for
Pediatric Use II-45

5. RECENT INDUSTRY ACTIVITY II-46
Gilead Completes Phase II Trial on Single-Dose HIV Drug, Quad II-46
Gilead Completes Phase II Trial on Cobicistat Boosting Agent,
Cobicista II-46
Merck to Refrain from Filing NDA for Vicriviroc in Treatment-
Experienced HIV-Patients II-47
Merck’s Isentress® Receives U.S. DHHS Recommendation for Use
in Treatment-Naïve Patients II-47
GSK and Pfizer Launch ViiV Healthcare II-47
GSK and Idenix to Co-Develop New HIV Drug II-48
Avexa Enters into Agreement with Tibotec II-48
Gilead Enters into Agreement with Piramal Lifesciences II-49
Avexa to Merge with Progen II-49
Myriad Acquires Bevirimat II-49
Vironova Signs Agreement with UMBC II-49
Ceragenix Signs License Agreement with FPBT II-49
Medivir to Transfer Alovudine License and IP to Beijing Mefuvir II-50
Gilead Sciences and Merck Ink Distributing Agreement for Atripla II-50
Boehringer Commences New Clinical Trial for Viramune® XR II-51
EC Reinstates Marketing Authorization for Viracept II-51
Virax Bags Additional Patent for HIV Vaccine, VIR201 II-51

6. FOCUS ON SELECT GLOBAL PLAYERS II-52
Abbott Laboratories (US) II-52
Boehringer Ingelheim GmbH (Germany) II-52
Bristol-Myers Squibb Company (US) II-53
F. Hoffmann-La Roche Ltd. (Switzerland) II-54
Gilead Sciences, Inc. (US) II-54
Koronis Pharmaceuticals, Inc. (US) II-55
Merck and Co., Inc. (US) II-55
Pfizer, Inc. (US) II-56
Tibotec BVBA (Belgium) II-56
ViiV Healthcare (UK) II-57
VIRxSYS Corp. (US) II-57

7. GLOBAL MARKET PERSPECTIVE II-58
Table 17: World Recent Past, Current and Future Analysis for HIV
Drugs by Geographic Region - US, Canada, Japan, Europe and
Rest of World Markets Independently Analyzed with Annual
Revenue Figures in US$ Million for Years 2006 through 2015
(includes corresponding Graph/Chart) II-58

Table 18: World 10-Year Perspective for HIV Drugs by
Geographic Region - Percentage Breakdown of Dollar Revenues
for US, Canada, Japan, Europe and Rest of World Markets for
Years 2006, 2009, and 2015 (includes corresponding Graph/Chart) II-59

Table 19: World Recent Past, Current and Future Analysis for HIV
Drugs by Product Segment - NRTIs, NNRTIs, PIs and Others
Markets Independently Analyzed with Annual Revenue Figures in
US$ Million for Years 2006 through 2015 (includes
corresponding Graph/Chart) II-60

Table 20: World 10-Year Perspective for HIV Drugs by Product
Segment- Percentage Breakdown of Dollar Revenues for NTRIs,
NNTRIs, PIs and Others Markets for Years 2006, 2009, and 2015
(includes corresponding Graph/Chart) II-61


III. MARKET

1. UNITED STATES III-1
A.Market Analysis III-1
HIV Drugs Market Continues to Prosper III-1
NRTIs Maintain the Lead III-1
Select FDA-Approved Antiretroviral Drugs and Approval Date III-1
Patent Expiries of Select Antiretroviral Drugs in the US
(2010 and Beyond) III-2
Atripla Tops US HIV Drug Chart III-3
Table 21: Leading HIV/AIDS Drugs in the US Market (2008)
in US$ Million (includes corresponding Graph/Chart) III-4
NRTIs Losing Share In Total Prescriptions; Top Spot Remains
Intact III-4
Table 22: Percentage Breakdown of US Total Prescriptions
of HIV Drugs By Class (2004-2008) (includes corresponding
Graph/Chart) III-5
Gilead Takes the Lead In NRTI Prescriptions III-5
Table 23: Percentage Breakdown of US Total Prescriptions
of NRTIs By Company (2004-2007) (includes corresponding
Graph/Chart) III-6

Table 24: Percentage Breakdown of US Total Prescriptions
of NRTIs By Drug (2006-2007) (includes corresponding
Graph/Chart) III-6
Atripla Leads in Treatment-Naïve HIV Market III-7
Table 25: Leading Drugs in Treatment-Naive HIV Patient
Therapeutic Market (2007) (includes corresponding
Graph/Chart) III-7
Patent Expiries to Dent Sales of GSK III-7
Drug Assistance Programs Take the Brunt of Recession III-7
New Drug Approvals III-8
Strategic Corporate Developments III-11
Select Players in the Region III-14
B.Market Analytics III-18
Table 26: US Recent Past, Current and Future Analysis for HIV
Drugs by Product Segment - NRTIs, NNRTIs, PIs and Others
Markets Independently Analyzed with Annual Revenue Figures
in US$ Million for Years 2006 through 2015 (includes
corresponding Graph/Chart) III-18

Table 27: US 10-Year Perspective for HIV Drugs by Product
Segment- Percentage Breakdown of Dollar Revenues for NTRIs,
NNTRIs, PIs and Others Markets for Years 2006, 2009, and 2015
(includes corresponding Graph/Chart) III-19

2. CANADA III-20
A.Market Analysis III-20
Current and Future Analysis III-20
Approval Delays Daunting Drug Access III-20
A Peek into the Canadian Drug Regulatory Environment III-20
PI Drugs Continue to Witness Growth III-21
Table 28: Canadian Sales of Protease Inhibitor Drugs (2007
and 2008) in US$ Million (includes corresponding Graph/Chart) III-21
Select Approved Antiretroviral Drugs in Canada (1995-2006) III-21
B.Market Analytics III-22
Table 29: Canadian Recent Past, Current and Future Analysis
for HIV Drugs with Annual Revenue Figures in US$ Million
for Years 2006 through 2015 (includes corresponding
Graph/Chart) III-22

3. JAPAN III-23
A.Market Analysis III-23
Japan - The Fastest Growing Market for HIV Drugs Worldwide III-23
Funding Scenario in Japan III-23
B.Market Analytics III-23
Table 30: Japanese Recent Past, Current and Future Analysis
for HIV Drugs with Annual Revenue Figures in US$ Million for
Years 2006 through 2015 (includes corresponding Graph/Chart) III-23

4. EUROPE III-24
A.Market Analysis III-24
Demand for HIV Drugs Continues to Rise III-24
European HIV Drug Market - An Overview III-24
Delayed Diagnosis - A Major Impediment to Increase in Survival III-24
Limiting Factors Hitting Growth Prospects Hard III-25
Number of New Patients Rises, While Discontinuation Rates
Plummet in Leading Markets III-25
Table 31: HIV Drugs Market in Leading EU Countries (2006):
Percentage Breakdown for Italy, Spain, France, United
Kingdom and Germany (includes corresponding Graph/Chart) III-26
HAART Continues to Gain Market Share III-26
New Drug Approvals III-26
Strategic Corporate Developments III-28
Select Players in the Region III-31
B.Market Analytics III-33
Table 32: European Recent Past, Current and Future Analysis
for HIV Drugs with Annual Revenue Figures in US$ Million for
Years 2006 through 2015 (includes corresponding Graph/Chart) III-33

5. REST OF WORLD III-34
A.Market Analysis III-34
Current and Future Analysis III-34
Funding Gap Threatens to Put Patients at Risk III-34
Drugs Resistance Prompts Chinese Government to Launch Novel
Drugs III-34
Strategic Corporate Developments III-35
B.Market Analytics III-35
Table 33: Rest of World Recent Past, Current and Future
Analysis for HIV Drugs with Annual Revenue Figures in US$
Million for Years 2006 through 2015 (includes corresponding
Graph/Chart) III-35


IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 52 (including Divisions/Subsidiaries - 61)

------------------------------------------
Region/Country Players
------------------------------------------
The United States 34
Canada 1
Europe 13
Germany 2
The United Kingdom 5
Spain 1
Rest of Europe 5
Asia-Pacific (Excluding Japan) 13
------------------------------------------

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