Pharmaceutical Product Approval Trends, 2007

Summary

Introduction to global pharmaceutical product approvals
Key global pharmaceutical markets
Key therapeutic markets
Key pharmaceutical products
Key pharmaceutical companies
Key pharma market trends and opportunities

Chapter 1 - Overview of global pharmaceutical product approvals (NMEs)

Global new pharma product approvals
Report overview

Methodology
Sources
Structure

Chapter 2 -Drug approval trends in key global markets

Global approval trends

Global launch strategy

US approval trends

Overall product approval trends

EU approval trends

Chapter 3 - Key therapeutic markets in relation to drug approvals

Therapeutic area trends
Antineoplastic and immunomodulating agents drug approvals
Alimentary tract and metabolism drug approvals
Nervous system drug approvals
Anti-infectives for systemic use drug approvals
Cardiovascular system drug approvals
Genito-urinary system and sex hormones drug approvals
Sensory organs drug approvals

Chapter 4 - Market analysis of recently approved products

Product approval trends
Top 11 products approved in 2006

Exforge/ Copalia/ Imprida/ Dafiro (amlodipine/ valsartan)
Prezista (darunavir)
Sprycel (dasatinib)
Gardasil/ Silgard (human papillomavirus vaccine)
Invega (paliperidone)
Vectibix (panitumumab)
Lucentis (ranibizumab)
Acomplia/ Zimulti (rimonabant)
Januvia/ Xelevia (sitagliptin)
Sutent (sunitinib)
Chantix/ Champix (varenicline)

Generic approval trends

Chapter 5 - Analysis of drug approvals by major pharmaceutical companies

Leading pharma companies and product approvals

Pfizer
GlaxoSmithKline
Sanofi-Aventis
Novartis
AstraZeneca
Johnson & Johnson
Merck
Roche
Eli Lilly
Wyeth

Chapter 6 - Analysis of drug approval trends

2007 new product approvals
2007 US approvable letters
2007 EU CHMP opinions

Sales forecasts for newly approved drugs

Key company trends

GlaxoSmithKline
Wyeth
Novartis
Shire
Cephalon
Roche

Appendix

Proprietary data sources

Product Approvals Database
Product Trends Database

New pharmaceutical product approvals, 2004-2006

Figures
Figure 1: Global new pharmaceutical product approvals, 2004-2006
Figure 2: Report structure
Figure 3: 2006 global sales for new medicines launched 2002-2006
Figure 4: New product launches per US$ billion of R&D, 2004-2006
Figure 5: Global launch order, 2004-2006
Figure 6: Global launch schedule, 2004-2006
Figure 7: New product brand strategies, 2004-2006
Figure 8: New product marketing strategies, 2004-2006
Figure 9: New US product approval trends, 2004-2006
Figure 10: New US product approvals by approval process, 2004-2006
Figure 11: New US product approvals by orphan drug status, 2004-2006
Figure 12: Average patent life for new US product approvals, 2004-2006
Figure 13: New US product approvals by post-approval patent life, 2004-2006
Figure 14: New US product approvals by market exclusivity, 2004-2006
Figure 15: New US product approvals, 1997-2006
Figure 16: New US product approvals by product category, 1997-2006
Figure 17: New US investigational new drug (IND) approvals, 1997-2006
Figure 18: New US new molecular entity approvals by indication, 2006
Figure 19: New EU product approval trends, 2004-2006
Figure 20: New EU product approvals by orphan drug status, 2004-2006
Figure 21: New EMEA initial-evaluation applications, 2004-2006
Figure 22: New EMEA post-authorization opinions and notifications, 2004-2006
Figure 23: New EMEA initial notices for parallel-distribution, 2004-2006
Figure 24: New EMEA initial-evaluation approvals by therapy area, 2006
Figure 25: Leading product classes by global product approvals, 2004-2006
Figure 26: Product approval trends by therapeutic category, 2004-2006
Figure 27: Leading therapeutic classes by global product approvals, 2004-2006
Figure 28: Leading antineoplastic and immunomodulating agents approval trends, 2004-2006
Figure 29: Leading alimentary tract and metabolism approval trends, 2004-2006
Figure 30: Leading nervous system approval trends, 2004-2006
Figure 31: Leading anti-infectives for systemic use approval trends, 2004-2006
Figure 32: Leading cardiovascular system approval trends, 2004-2006
Figure 33: Leading genito-urinary system and sex hormones approval trends, 2004-2006
Figure 34: Leading sensory organs approval trends, 2004-2006
Figure 35: New global product approval trends by product category, 2004-2006
Figure 36: New US generic approval trends, 2004-2006
Figure 37: New US generic approval trends by formulation, 2004-2006
Figure 38: New US generic approval trends by chemical composition, 2004-2006
Figure 39: Leading products by new US generic approvals, 2006
Figure 40: Brand sales of leading products by new US generic approvals, 2006
Figure 41: Leading companies by new US generic approvals, 2006
Figure 42: Leading companies by global new drug approvals, 2004-2006
Figure 43: New global drug approvals for leading companies, 2004-2006
Figure 44: Impact of new global drug approval trends for leading companies, 2004-2006
Figure 45: New US and EU drug approval trends for leading companies, 2004-2006
Figure 46: Pfizer's new global drug approval trends, 2004-2006
Figure 47: GlaxoSmithKline's new global drug approval trends, 2004-2006
Figure 48: Sanofi-Aventis's new global drug approval trends, 2004-2006
Figure 49: Novartis's new global drug approval trends, 2004-2006
Figure 50: Johnson & Johnson's new global drug approval trends, 2004-2006
Figure 51: Merck's new global drug approval trends, 2004-2006
Figure 52: Roche's new global drug approval trends, 2004-2006
Figure 53: Eli Lilly's new global drug approval trends, 2004-2006
Figure 54: New pharma product approvals and tentative approvals, 2007
Figure 55: Exforge/ Copalia/ Imprida/ Dafiro (amlodipine/ valsartan) global sales forecast, 2007-2011
Figure 56: Prezista (darunavir) global sales forecast, 2007-2011
Figure 57: Sprycel (dasatinib) global sales forecast, 2007-2011
Figure 58: Gardasil/ Silgard (human papillomavirus vaccine) global sales forecast, 2007-2011
Figure 59: Invega (paliperidone) global sales forecast, 2007-2011
Figure 60: Vectibix (panitumumab) global sales forecast, 2007-2011
Figure 61: Lucentis (ranibizumab) global sales forecast, 2007-2011
Figure 62: Acomplia/ Zimulti (rimonabant) global sales forecast, 2007-2011
Figure 63: Januvia/ Xelevia (sitagliptin) global sales forecast, 2007-2011
Figure 64: Sutent (sunitinib) global sales forecast, 2007-2011
Figure 65: Chantix/ Champix (varenicline) global sales forecast, 2007-2011
Figure 66: Key companies by pharma product approvals and tentative approvals, 2007

Tables
Table 1: Leading antineoplastic and immunomodulating agents approvals, 2004-2006
Table 2: Leading alimentary tract and metabolism approvals, 2004-2006
Table 3: Leading nervous system approvals, 2004-2006
Table 4: Leading anti-infectives for systemic use approvals, 2004-2006
Table 5: Leading cardiovascular system approvals, 2004-2006
Table 6: Leading genito-urinary system and sex hormones approvals, 2004-2006
Table 7: Leading sensory organs approvals, 2004-2006
Table 8: New global pharma drug approvals, 2004
Table 9: New global pharma drug approvals, 2005
Table 10: New global pharma drug approvals, 2006
Table 11: New global monoclonal antibody approvals, 2004-2006
Table 12: New global biologic approvals, 2004-2006
Table 13: Exforge/ Copalia/ Imprida/ Dafiro (amlodipine/ valsartan) profile, 2006
Table 14: Prezista (darunavir) profile, 2006
Table 15: Sprycel (dasatinib) profile, 2006
Table 16: Gardasil/ Silgard (human papillomavirus vaccine) profile, 2006
Table 17: Invega (paliperidone) profile, 2006
Table 18: Vectibix (panitumumab) profile, 2006
Table 19: Lucentis (ranibizumab) profile, 2006
Table 20: Acomplia/ Zimulti (rimonabant) profile, 2006
Table 21: Januvia/ Xelevia (sitagliptin) profile, 2006
Table 22: Sutent (sunitinib) profile, 2006
Table 23: Chantix/ Champix (varenicline) profile, 2006
Table 24: Pfizer's new global drug approvals, 2004-2006
Table 25: GlaxoSmithKline's new global drug approvals, 2004-2006
Table 26: Sanofi-Aventis's new global drug approvals, 2004-2006
Table 27: Novartis's new global drug approvals, 2004-2006
Table 28: AstraZeneca's new global drug approvals, 2004-2006
Table 29: Johnson & Johnson's new global drug approvals, 2004-2006
Table 30: Merck's new global drug approvals, 2004-2006
Table 31: Roche's new global drug approvals, 2004-2006
Table 32: Eli Lilly's new global drug approvals, 2004-2006
Table 33: Wyeth's new global drug approvals, 2004-2006
Table 34: New pharma product approvals in US and EU, 2007
Table 35: New pharma product approvable letters in US, 2007
Table 36: New pharma product CHMP opinions in EU, 2007
Table 37: New pharmaceutical product approvals, 2004
Table 38: New pharmaceutical product approvals, 2005
Table 39: New pharmaceutical product approvals, 2006