Pharmaceutical Product Approval Trends, 2007: Key market benchmarks and strategic insights

Table of Contents

• 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

• Global new pharma product approvals
• Report overview
  • Methodology
  • Sources
  • Structure

• Global approval trends
  • Global launch strategy
• US approval trends
  • Overall product approval trends
• EU approval trends

• 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

• 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

• Leading pharma companies and product approvals
  • Pfizer
  • GlaxoSmithKline
  • Sanofi-Aventis
  • Novartis
  • AstraZeneca
  • Johnson & Johnson
  • Merck
  • Roche
  • Eli Lilly
  • Wyeth

• 2007 new product approvals
• 2007 US approvable letters
• 2007 EU CHMP opinions
• Sales forecasts for newly approved drugs
  • 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)
• Key company trends
  • GlaxoSmithKline
  • Wyeth
  • Novartis
  • Shire
  • Cephalon
  • Roche

• Proprietary data sources
  • Product Approvals Database
  • Product Trends Database
• New pharmaceutical product approvals, 2004-2006

• 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

• 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