老年醫學的發展:老齡化性疾病的治療相關新市場機會的開拓

現在，處方籤有50％以上是為了65歲以上的人們所寫。許多老年人有共病狀況，患者每3人中有1人，1日最低攝取5種以上藥品。為此，藥物不良事件(ADE)和住院治療的風險非常高，老年人的緊急住院患者最大1/3與藥物相關。適合老齡化性疾病患者的醫藥品，經臨床實驗的相對地少，為了決定處方藥的臨床資料仍不足。再加上很多醫藥品劑型不適合老年人，導致不合醫囑和治療效果低。歐洲藥品管理局(EMA)2011年導入「高齡醫學策略」，進入開發過程之前指示了老年人的注意事項歸結。2012年ICH E7指南修訂，採取很大的關注讓更多的老年人參加臨床實驗。

本報告提供全球的老年醫學的相關市場相關分析、市場現狀和課題、主要市場進入障礙、市場趨勢的實際成果及預測、治療上的差距和今後的市場機會、今後的技術開發、市場發展的策略等調查資料、考察，並將結果概述為以下內容。

摘要整理

分析方法

老年醫學:概要

• 新的課題
• 臨床上的未滿足需求

目前形勢

• 法規環境
• 改革取向的政治意願

老年醫學發展的策略性考察

• 老年醫學發展的障礙
• 臨床實驗上的考慮事項
• 為了判定治療上的差距和商業機會，「巨量資料」所扮演的角色
• 醫生、患者的認識度的提高

為了應對治療上的差距的商業機會

• 現有治療方法的改善
• 新治療方法的市場機會

附錄

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.

Scope

• 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