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Geriatric Medicine Development - Carving out New Opportunities to Treat Age-related Diseases

発行 CBR Pharma Insights 商品コード 299251
出版日 ページ情報 英文 58 Pages
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老年医学の発展:加齢性疾患の治療に関する新たな市場機会の開拓 Geriatric Medicine Development - Carving out New Opportunities to Treat Age-related Diseases
出版日: 2014年02月28日 ページ情報: 英文 58 Pages



現在、処方箋の50%以上が65歳以上の人々のために書かれています。多くの高齢者が合併症を患っており、患者の3人に1人が、1日最低5種類以上の医薬品を摂取しています。そのため、薬物有害事象(ADE)や入院加療のリスクが非常に高まっており、高齢者の緊急入院患者の最大1/3が薬物関連となっています。加齢性疾患の患者向けの医薬品で治験を経たものがまだ相対的に少ないことから、処方薬を決定するための臨床データがまだ不足しています。さらに、医薬品の多くが高齢者にふさわしい剤形となっておらず、法令順守の不備や治療効果の低さにつながっています。 欧州医薬品庁(EMA)は2011年に「高齢医学戦略」を導入し、開発プロセスに入る前に高齢者向けの留意事項をまとめるように指示しました。2012年にはICH E7ガイドラインが改訂され、より多くの高齢者を治験に参加させるように、多大な配慮が払われています。





  • 新たな課題
  • 臨床上のアンメットニーズ


  • 規制環境
  • 改革に向けた政治的意思


  • 老年医学発展の障壁
  • 治験上の考慮事項
  • 治療上のギャップと商業的機会を判定するための「ビッグデータ」の役割
  • 医師・患者の認知度の向上


  • 既存の治療法の改善
  • 新たな治療法の市場機会


Product Code: GBI047CBR

More than 50% of prescriptions is written for people aged 65 years and older. Many older people suffer from comorbid conditions and one in three takes at least five drugs or more on a daily basis. This significantly increases the risk of Adverse Drug Events (ADEs) and hospitalization. Up to one third of emergency admissions in elderly people is drug-related.

There remains a lack of clinical data to support prescription decisions as relatively few medicines have been clinically evaluated in age-appropriate patients. In addition, many drugs are not available in formulations that are suitable for the elderly, leading to non-compliance and lack of therapeutic efficacy. In 2011, the EMA introduced its Geriatric Medicines Strategy to ensure that the medical requirements of older people are identified earlier in the drug development process. In 2012, the ICH E7 guidelines were revised to include a greater focus on involving more geriatric patients in drug trials.


  • Reviews the current regulatory landscape and helps sponsors to understand the potential impact of recent guidelines.
  • Assesses the barriers to entry in geriatric medicines and identifies potential ways to overcome them and improve clinical decision making.
  • Evaluates the importance of establishing Target Quality Product Profiles (TQPP) to help sponsors determine the target patient population earlier on in drug development.
  • Identifies treatment gaps and commercial opportunities based on primary care real-time data and KOL insights.
  • Analyses different strategies to develop age-appropriate medicines in niche therapeutic fields and discusses methods to encourage the smarter prescription of medicines.

Key Reasons to Purchase

  • Utilize the insights from this study to analyze the barriers facing the geriatrics market
  • Understand the impact of drug development in this market now and in the future
  • Find out why regulators are paying more attention to unnecessary "exclusion criteria" and encouraging the inclusion of older people to ensure trials are age-appropriate and more representative of the real world setting.
  • Assess the opportunities available for companies to develop age-appropriate dosages and formulations for existing drug classes that are currently widely associated with ADEs in the elderly as well as new therapeutic prospects.

Table of Contents

  • Executive Summary
  • Methodology
  • Geriatric medicines: an overview
    • Emerging issues
    • Unmet clinical needs
  • Current landscape
    • Regulatory environment
    • Political will for change
  • Strategic considerations for developing geriatric medicines
    • Barriers to developing geriatric drugs
    • Clinical trial considerations
    • "Big data's" role in identifying treatment gaps and commercial opportunities
    • Raising physician and patient awareness
  • Commercial opportunities to address the treatment gap
    • Improving existing therapies
    • New therapeutic opportunities
  • Appendix
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