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市場調查報告書

兒童用醫藥品的開發:法規方面的課題與商業方面的機會

Pediatric drug development - Regulatory challenges and commercial opportunities

出版商 CBR Pharma Insights 商品編碼 312351
出版日期 內容資訊 英文 64 Pages
商品交期: 最快1-2個工作天內
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兒童用醫藥品的開發:法規方面的課題與商業方面的機會 Pediatric drug development - Regulatory challenges and commercial opportunities
出版日期: 2014年07月31日 內容資訊: 英文 64 Pages
簡介

兒童人口佔全球整體人口的2/3,不過兒童用醫藥品的市場規模佔整體10%以下保持相對小的狀態。至美國(1997年)和EU(2007年)時小兒科相關法案成立為止,製藥企業開發兒童用醫藥品的獎勵幾乎沒有奏效。可是,法案成立後巨額的資金投入兒童用醫藥品的領域,也開發了許多產品,目前已進行臨床試驗。同時,複雜的法律規章也了妨礙臨床實驗進展,市場改革的空間還很大。法規重新評估,還有新興國家的處方、投藥、劑型方面的改善,及進行難治之症與被忽視的疾病的對應,今後將帶來巨大的市場機會。

本報告提供全球的兒童用醫藥品的開發現況與未來展望相關分析、目前法規情形(美國、EU等)和今後的改革方向性、產品開發、市場擴大相關今後主要課題、未來的市場機會、各企業應選擇策略之調查、考察。

摘要整理

  • 關於兒童用醫藥品開發的商業誘因
  • 製藥企業投資兒童用醫藥品的理由

分析方法

兒童用醫藥品:概況

  • 全球兒童人口
  • 兒童用醫藥品開發的基礎知識和主要課題
  • 臨床上的未滿足需求

市場現狀

  • 法規、法規
  • 世界水準的法規調整

老年用醫藥品開發的策略性考察

  • 臨床實驗相關考察
  • 兒童用醫藥品的處方相關問題
  • 小兒科的網路
  • 患者方面的取用
  • 商業機會
  • 學名藥的處方和劑型
  • 難治之症與被忽視疾病的相關問題
  • 兒童用疫苗

附錄

目錄
Product Code: GBI050CBR

Although pediatrics represent around two-fifths of the global population the market for pediatric medicines remains relatively small (accounting for <10% of global pharmaceutical sales). Until pediatric legislation was introduced in the US (1997) and EU (2007) there has been little incentive for the pharma industry to evaluate drugs in children due to the low medical need of chronic illnesses and the high off-label use of generic drugs (Milne & Bruss, 2008).

Since the introduction of pediatric legislation there has been a substantial investment in pediatric research and the number of clinical trials performed in children has increased significantly. In the US more than 350 product labels include new pediatric information and more than 130 products have undergone a pediatric focused post-labelling safety review. In Europe there has been 221 changes regarding the safety and efficacy of medicines from the submission of old or new studies in children and 89 additions of dosing information for children as a direct consequence of Paediatric Investigation Plans (PIPs).

Despite the apparent success of the pediatric regulation, the submission of pediatric information is complex and the incentives are often insufficient to encourage industry innovation (Rose & Della Pasqua, 2011). No new drugs can be registered in the EU without a detailed PIP being approved by the EMA's Pediatric Committee (PDCO) (Rose, 2014). Without a PIP, the registration process for a new drug can be blocked. In the US, the FDA has adopted a more pragmatic approach to pediatric drug development, providing voluntary and mandatory routes for pediatric evaluation.

Many experts agree that there is significant room to improve the EU pediatric regulations and a revision of the legislation is scheduled to take place in 2018. In the meantime, there is considerable potential for the industry to develop pediatric formulations and doses of approved and generic medicines, particularly for use in transition countries where access to high quality pediatric formulation is improving. In addition, new commercial opportunities exist to develop medicines that target pediatric specific conditions in neonates as well as rare and neglected diseases and pediatric vaccines.

Scope

  • Pediatric medicines: an overview
  • The pediatric population
  • Underlying/key issues for pediatric drug development
  • Unmet clinical needs
  • Current landscape
  • Regulation and legislation
  • Global harmonization
  • Strategic considerations for developing pediatric medicines
  • Clinical trial considerations
  • Pediatric formulation issues
  • Pediatric networks
  • Patient access
  • Commercial opportunities
  • Generic formulations and dosage forms
  • Rare and neglected diseases
  • Pediatric vaccines

Key Reasons to Purchase

  • Reviews the current regulatory landscape and helps sponsors to understand the potential impact of FDA SIA regulations and the variations between EU regulation on global pediatric plans;
  • Identifies the key challenges associated with pediatric drug development and the ways to overcome these hurdles;
  • Assesses what issues need to be addressed in order to improve access to pediatric medicines and commercial opportunities in transition countries based on KOL insights;
  • Analyses different strategies to develop age-appropriate medicines in niche therapeutic fields in neonates, rare and neglected pediatric diseases and pediatric vaccines.

Table of Contents

  • Executive summary
  • How commercially attractive is pediatric drug development
  • Why should pharma invest in pediatric medicines
  • Methodology
  • Pediatric medicines: an overview
  • The pediatric population
  • Underlying/key issues for pediatric drug development
  • Unmet clinical needs
  • Current landscape
  • Regulation and legislation
  • Global harmonization
  • Strategic considerations for developing geriatric medicines
  • Clinical trial considerations
  • Pediatric formulation issues
  • Pediatric networks
  • Patient access
  • Commercial opportunities
  • Generic formulations and dosage forms
  • Rare and neglected diseases
  • Pediatric vaccines
  • Appendix
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