幹細胞市場展望

幹細胞市場展望 是由出版商Business Insights在2011年06月所出版的。 這份英文市場調查報告書包含Pages: 113 價格從美金3835起跳。

簡介

在幹細胞領域，優先使用於急性心肌梗塞、心衰竭、重症肢體缺血、肌萎縮性脊髓側索硬化症、脊髓損傷、以及缺血性中風等6種適應症。各家公司開發來自幹細胞的同種異體或是將自體骨髓在體外擴大的第1代治療方法，而近年來，以第1代產品的有效性為基礎的第2代產品已進入臨床實驗。預期將在高罹患率和高死亡率、且治療方法有限的疾病，以及自體骨髓單核細胞無法適用，或是無效的疾病上將會有大幅收益。

本報告，檢證針對損傷組織／內臟器官改善而移植至病患的幹細胞（主要來自成人組織）實用化，且詳細檢証6種的適應症，並彙整美國與歐洲等主要5國的業績預測，由下列摘要形式闡述。

報告摘要

市場概要

• 摘要
• 簡介
• 市場定義
• 幹細胞的種類
  • 成人幹細胞
  • ES細胞
• 臨床環境
• 法律規範
  • EU
  • 日本
  • 印度
  • 中國
• 業界概要
  • 市場價值
  • 授權與合併活動
• 結論

急性心肌梗塞

• 摘要
• 簡介
• 臨床檢視
• 產品線分析
  • 同種異體產品
  • 細胞加工裝置
• 市場潛力
  • 對應人口的計算
  • 市場導入情境
• 將來展望

心衰竭

• 摘要
• 簡介
• 臨床檢視
• 產品線分析
• 市場規模
• 將來展望

重症肢體缺血

• 摘要
• 簡介
• 臨床檢視
• 產品線分析
• 市場規模
• 將來展望

中樞神經系統疾病

• 摘要
• 簡介
• 肌萎縮性脊髓側索硬化症
• 脊髓損傷
• 缺血性中風
• 將來展望

其他適應症

• 摘要
• 簡介
• 移植體對抗宿主疾病
• 固體器官移植
• 糖尿病
• 慢性阻塞性肺部疾病
• 發炎性腸道疾病
• 急性腎損傷
• 阿茲海默症
• 帕金森氏症
• 多發性硬化症

商業模式與市場預測

• 摘要
• 簡介
• 主要的成功因子
  • 急性與選擇疾病
  • 法律規範
  • 幹細胞的品質
  • 製程
  • 臨床實驗設計
• 商業模式
  • 同種異體產品型號
  • 自我產品型號
  • 裝置型號
• 藥價與醫療報銷
• 至2025年的業績預測
• 將來展望

附錄

圖表

目錄

Abstract

Introduction

This report covers the commercialization of stem cells (primarily derived from adult tissues) which are transplanted into patients to improve the function of diseased/damaged tissues/organs. Six indications are covered in detail. Sales forecasts are estimated in the US and five major European markets (5EU), which include France, Germany, Italy, Spain and the UK.

Features and benefits

• Identify potential growth markets with sales forecasts by indication and expected timing of market entry.
• Compare the different business models for stem cell therapies.
• Evaluate which novel products offer the greatest potential clinical advances over the next several years and why.
• Assess potential clinical advances and how they address current unmet needs.
• Understand the drivers and resistors of the stem cell market.

Highlights

Six indications were prioritized based on likely commercial potential and adoption into clinical practice: acute myocardial infarction, heart failure, critical limb ischemia, amyotrophic lateral sclerosis, spinal cord injury and ischemic stroke.

Companies are developing first generation therapies primarily based on ex vivo expanded allogeneic or autologous bone marrow derived stem cells. Recently, a second generation of products has entered clinical development, which may build on the efficacy of first generation products.

The greatest potential revenues are forecast in diseases or conditions with significant mortality or morbidity and limited treatment options, for which autologous bone marrow mononuclear cells (BMMNCs) may not be applicable or ineffective and lower patient numbers can be offset by higher prices.

Your key questions answered

• What is the future commercial value of stem cell therapies?
• Which products are likely to be reimbursed and what price could be charged?
• Which indications offer the greatest sales potential?
• What are the competitive risks to commercialization and how can companies develop profitable business models?
• Which companies are attractive for investment?

Table of Contents

About the author

• Disclaimer

EXECUTIVE SUMMARY

• Market overview
• Acute myocardial infarction
• Heart failure
• Critical limb ischemia
• Central nervous system disorders
• Other indications
• Business models and market forecasts

Market overview

• Summary
• Introduction
• Market definition

• Stem cell types
  • Adult stem cells
  • Embryonic stem cells

• Clinical landscape

• Regulation
  • European Union
  • Japan
  • India
  • China

• Industry overview
  • Market value
  • Licensing and merger activity

• Conclusions

Acute myocardial infaction

• Summary
• Introduction
• Clinical review

• Pipeline analysis
  • Allogeneic products
  • Cell processing devices

• Market potential
  • Calculation of addressable population
  • Market adoption scenario

• Future outlook

Heart failure

• Summary
• Introduction

• Clinical review
  • Ongoing trials using BMMNCs or MSCs
  • Other stem cells types
  • Mechanism of action

• Pipeline analysis
  • Autologous products
  • Allogeneic products

• Market size

• Future outlook

Critical limb ischemia

• Summary
• Introduction
• Clinical review

• Pipeline analysis
  • Autologous products
  • Allogeneic products
  • Cell processing devices

• Market size

• Future outlook

Central nervous system disorders

• Summary
• Introduction
• Amyotrophic lateral sclerosis
• Spinal cord injury
• Ischemic stroke
• Future outlook

Other indications

• Summary
• Introduction
• Graft versus host disease
• Solid organ transplants
• Diabetes mellitus
• Chronic obstructive pulmonary disease
• Inflammatory bowel disease
• Acute kidney injury
• Alzheimer' s disease
• Parkinson' s disease
• Multiple sclerosis

Business models and market forecasts

• Summary
• Introduction

• Key success factors
  • Acute versus elective conditions
  • Regulatory considerations
  • Stem cell quality
  • Manufacturing process
  • Clinical trial design

• Business models
  • Allogeneic product models
  • Autologous product models
  • Device based models

• Pricing and reimbursement

• Sales forecasts to 2025

• Future outlook

Appendix

• Scope
• Methodology
• Abbreviations
• References

TABLES

• Table: Companies developing autologous products (US/Europe clinical trials)
• Table: Companies developing allogeneic products (US/Europe clinical trials)
• Table: Comparison of selected clinical trials in acute myocardial infarction
• Table: AMI clinical trials in the US or EU with proprietary stem cell products
• Table: Number of STEMI patients and percentage receiving PCI, US and 5EU
• Table: HF clinical trials with proprietary stem cell products (US/EU)
• Table: CLI clinical trials with proprietary stem cell products (US/EU)
• Table: ALS clinical trials with proprietary stem cell products (US/EU)
• Table: SCI clinical trials with proprietary stem cell products (US/EU)
• Table: Ischemic stroke clinical trials with proprietary stem cell products (US/EU)

FIGURES

• Figure: Number of stem cell clinical trials, allogeneic vs. autologous, 2002 - 10
• Figure: Number of stem cell clinical trials, by region, 2002 - 10
• Figure: Evolution of clinical applications of stem cell therapies, 2002 - 10
• Figure: Calculation of annual addressable AMI population for stem cell based therapy (US)
• Figure: Calculation of annual addressable CLI population for stem cell based therapy (US)
• Figure: Company landscape by business model (allogeneic, autologous, or device)
• Figure: Key inputs used in sales forecasts
• Figure: Drivers and resistors to stem cell therapy by indication
• Figure: Sales forecast 2010 - 25 (US/5EU)
• Figure: Market size, risk, and entry by indication (US/5EU)
• Figure: Ranking of companies developing proprietary stem cell based products

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