医薬品認可動向：2007年（主な市場ベンチマークと戦略）

“Among the 23 new pharmaceutical products approved in the first half of 2007, there were 22 small molecule pharmaceutical drugs and one monoclonal antibody.”

Pharmaceutical Product Approval Trends 2007: Key market benchmarks and strategic insights presents a detailed analysis of the new pharmaceutical products approved globally.

The 120-page report outlines the key therapeutic markets, significant pharmaceutical entities which were approved, assesses major companies and identifies key trends and opportunities in order to help inform pharmaceutical decision-making, particularly in the areas of corporate planning, portfolio management and market forecasting.

• The US and Europe accounted for 90% of the 2006 global sales of new medicines launched between 2002 and 2006
• More than 70% of all new pharmaceutical products approved between 2004 and 2006 received an initial approval in the US
• A total of 38 new pharmaceutical products were approved in the US in 2006 and a total of 31 new pharmaceutical products were approved in Europe in the same year.
• The leading companies by number of new drug approvals in the first half of 2007 were GSK with three and Wyeth with two.
• The leading therapy areas for new drug approvals in 2007 were genito-urinary system and sex hormones (ATC code G) and nervous system (ATC code N) with four.
• The leading generic product by number of applicant approvals in 2006 was meloxicam, which was approved for 21 different companies.

• Comprehensive overview of the global approval trends with sections on U.S and E.U approval trends.
• Identifies the top 11 products approved in 2006 including Exforge, Prezista, Gardasil, Invega, Acomplia and Chantix.
• Therapy area trends for antineoplastic and immunomodulating agents, alimentary tract and metabolism, nervous system, anti-infectives for systemic use, cardiovascular system, genitourinary system and sex hormones as well as sensory organs.
• Detailed profiles of major companies (AstraZeneca, Eli Lilly, GlaxoSmithKline, Johnson and Johnson, Merck & Co, Novartis, Pfizer, Roche, Sanofi-Aventis Wyeth.)
• Analysis of key company trends for leading companies by current and prospective new product approvals. (GlaxoSmithKline,Wyeth, Novartis, Shire, Cephalon and Roche.)
• 120 pages long, with 66 figures and 40 tables to illustrate the market trends.
• Coverage US, Europe and Japan

• 1. Benchmark your portfolio against key market trends and forecasts in order to plan better for success.
• 2. Identify key areas of pharmaceutical market growth and key opportunities for delivering successful sales growth over the next five years.
• 3. Support internal planning and decision-making with an external perspective founded on detailed analysis and transparent market forecasts.

The report methodology provides a detailed but transparent analysis of key pharmaceutical market trends, including key markets, therapy areas, products and companies. It compares new product approvals in 2006 with data from the previous two years.

All data used in outlining historical trends is clearly sourced within the report and any data limitations or additional assumptions are explicitly detailed within the text of the report. Future market forecasts are projected based on both historical trends and future expectations over market conditions and events. The assumptions used to form the basis of key market forecasts are outlined in detail within the text of the report.

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