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神経学における幹細胞療法

Stem Cell Therapies in Neurology

発行 GlobalData 商品コード 721737
出版日 ページ情報 英文 67 Pages
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神経学における幹細胞療法 Stem Cell Therapies in Neurology
出版日: 2018年09月11日 ページ情報: 英文 67 Pages
概要

当レポートでは、神経学における幹細胞療法市場について調査し、幹細胞・疫学の概要、規制、治験と主なディベロッパー、パイプライン、市場アクセスと市場展望などについて詳細に分析しています。

第1章 イントロダクション

第2章 エグゼクティブサマリー

第3章 神経学・疫学向け幹細胞の概要

  • 再生医療
  • 現在のパイプライン製品に用いられている幹細胞の一般的なタイプ
  • 神経学向け幹細胞
  • 監査防戦略を決定する際に検討される要因
  • 神経学的症状の疫学

第4章 幹細胞療法の規制

  • 米国・EUにおける規制当局
  • FDAと再生医療
  • 日本における規制当局
  • 中国における規制当局

第5章 パイプライン評価・幹細胞療法のプロファイル

  • 神経学のパイプライン概要
  • 神経学における幹細胞療法の発展
  • 神経疾患を標的にしたパイプライン幹細胞療法
  • パイプライン製品:NurOwn
  • パイプライン製品:ANGES-003
  • パイプライン製品:NSI-566
  • 臨床データが限られるいくつかの初期段階の治療法

第6章 治験マッピング

  • 治験の概要
  • 治験マッピング
  • 神経学において幹細胞の治験を実施する際の課題
  • 主要企業

第7章 市場アクセス:医療費償還・料金・アンメットニーズ

  • 市場アクセス
  • 医療費償還
  • アンメットニーズ
  • パイプライン製品のプロファイル

第8章 市場展望

  • BrainStorm Therapeutics' NurOwn
  • Shanghai Angecon's ANGES-003
  • Neuralstem's NSI-566
  • 神経学における幹細胞療法向けの予測される主なイベント

第9章 付録

目次
Product Code: GDHCHT012

"Stem Cell Therapies in Neurology", is an evolving field. The current pipeline of products feature different types of stem cells and these therapies have the potential to target a range of neurological diseases. However, there are challenges associated with the development of these therapies, including the need to demonstrate strong safety and efficacy data.

Biotechnology companies currently dominate in this field and are expected to lead the development of different pipeline products.

The current pipeline consists of 16 products (Phase 1,2, and 3), and the most common indications for which these products are being evaluated include Amyotrophic Lateral Sclerosis (ALS), Alzheimer's Disease and Parkinson's Disease. The most commonly understood mechanism of action underlying stem cells therapy in neurology is the potential ability of these therapies to secrete trophic factors that help in neuronal survival and growth.

As research in this field progresses, it is expected to help further improve the understanding of how these therapies work and, potentially address unmet needs in the field of neurology.

Key Questions Answered

  • What are the key unmet needs clinically and in research? What do KOLs identify as the key unmet needs? Will the products in the stem cells pipeline fill these unmet needs?
  • When are the pipeline products expected to launch? What are the key features of the products in the pipeline?
  • What are some of the factors that need to be considered for market access of these products?
  • What are the challenges associated with development of stem cell therapies in neurology?
  • What are the regulatory frameworks in the 8MM that oversee the development of stem cell therapies?

Scope

  • Overview of Stem Cells and Epidemiology: focuses on different types of stem cells for neurology, factors to be considered when deciding a stem cell strategy, and epidemiology of different neurological diseases.
  • Regulatory Oversight: focuses on regulatory agencies in the 8MM (US, France, Germany, Italy, Spain, UK, China, Japan).
  • Clinical Trials and Key Developers: overview of ongoing clinical trials, mapping of clinical trials, and challenges of conducting clinical trials for stem cells in neurology.
  • Pipeline Analysis: comprehensive data assessing emerging products and mechanisms of action under development for stem cells therapy in neurology. The most promising candidate in Phase III (and Phase II/III) development is profiled.
  • Market Access and Market Outlook: factors affecting the access of these therapies, along with focus on unmet needs in neurology which can be potentially addressed by stem cell therapies. Market potential for some of the pipeline drugs are also addressed along with anticipated key events.

Reasons to buy

The report will enable you to -

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the stem cells market for neurology.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the neurology stem cells market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

  • 1. Introduction
  • 1.1 Related Reports 5
  • 1.2 Upcoming Related Reports 6
  • 2. Executive Summary 7
  • 2.1 Key Findings 8
  • 2.2 KOL Insights on Stem Cell Therapy Competitive Landscape 9
  • 3. Overview of Stem Cells for Neurology and Epidemiology 10
  • 3.1 Regenerative Medicine 12
  • 3.2 Common Types of Stem Cells Employed in Current Pipeline Products 13
  • 3.3 Stem Cells for Neurology 14
  • 3.4 Factors to Be Considered When Deciding Stem Cell Strategy 15
  • 3.5 Epidemiology of Neurology Indications 16
  • 4. Regulatory Oversight of Stem Cell Therapies 22
  • 4.1 Regulatory Agencies in the US and EU 24
  • 4.2 The FDA and Regenerative Medicine 25
  • 4.3 Regulatory Agencies in Japan 26
  • 4.4 Regulatory Agencies in China 27
  • 5. Pipeline Assessment, Profiled Stem Cell Therapies 28
  • 5.1 Pipeline Overview for Neurology 30
  • 5.2 Neurology Stem Cell Therapy Development 33
  • 5.3 Pipeline Stem Cell Therapies Targeting Neurology Diseases 34
  • 5.4 Pipeline Product: NurOwn 35
  • 5.5 Pipeline Product: ANGES-003 36
  • 5.6 Pipeline Product: NSI-566 37
  • 5.7 Some Early-Stage Therapies with Limited Clinical Data 38
  • 6. Clinical Trials and Key Developers 40
  • 6.1 Overview of Clinical Trials 42
  • 6.2 Clinical Trial Mapping 43
  • 6.3 Challenges of Conducting Stem Cell Clinical Trials in Neurology 44
  • 6.4 Key Players 45
  • 7. Market Access: Reimbursement, Pricing, Unmet Need 46
  • 7.1 Market Access 48
  • 7.2 Stem Cell Therapy Reimbursement 49
  • 7.3 Unmet Need Within Neurology 50
  • 7.4 Stem Cell Therapy Reimbursement for Some Profiled Pipeline Products 51
  • 8. Market Outlook 52
  • 8.1 Market Outlook for BrainStorm Therapeutics' NurOwn 54
  • 8.2 Market Outlook for Shanghai Angecon's ANGES-003 55
  • 8.3 Market Outlook for Neuralstem's NSI-566 56
  • 8.4 Anticipated Key Events for Stem Cell Therapies in Neurology 57

9. Appendix 58

  • 9.1 Sources 59
  • 9.2 Methodology 60
  • 9.3 Primary Research 61
  • 9.4 About the Authors 62
  • 9.5 About GlobalData 65
  • 9.6 Contact Us 66
  • 9.7 Disclaimer 67
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