市場調査レポート

再生医療と幹細胞治療:治癒の望みをもたらす未来の医薬品

Regenerative Medicine and Stem cell based Cell therapies-Drugs of the Future Offering Hope for Cure

発行 MP Advisors 商品コード 323218
出版日 ページ情報 英文 98 Pages
納期: 即日から翌営業日
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再生医療と幹細胞治療:治癒の望みをもたらす未来の医薬品 Regenerative Medicine and Stem cell based Cell therapies-Drugs of the Future Offering Hope for Cure
出版日: 2015年01月21日 ページ情報: 英文 98 Pages
概要

近年、世界各国で再生治療や細胞療法/幹細胞治療に関する研究が進み、医薬品上市の可能性が見えてきました。幹細胞治療などの活用により、これまで治療不可能とされた慢性疾患(糖尿病・肥満症・関節炎など)やがん、老化に伴う疾患(認知症など)が治療可能となる可能性があります。そして、巨大な市場機会をもたらすものと期待されています。

当レポートでは、世界各国における再生医療および細胞治療・幹細胞治療の最新の開発状況や今後の市場動向について分析し、幹細胞治療の概要や、世界各国での最新の開発・認可状況、現在上市済み/承認済みの医薬品を巡る情勢、今後の技術開発の方向性と市場成長の可能性、主要企業のプロファイルと技術開発状況といった情報を取りまとめてお届けいたします。

エグゼクティブ・サマリー

  • 再生医療/幹細胞治療の「黄金時代」の幕開け

イントロダクション

  • 幹細胞の種類
  • 間葉系肝細胞(MSC)
  • 難しい選択:「自己」移植治療か「同種異系」移植治療か

規制シナリオ

  • 日本とアジア諸国が先行
  • 日本の適応的な認可法令
  • 韓国の規制体制の現状
  • インドの規制体制の現状
  • 米国・EUの規制シナリオ

上市済みの細胞/幹細胞製品

  • 韓国や世界各国で認証済みの細胞/幹細胞製品
  • 認可済み治療法の治療費

進展と課題

  • 認証済み細胞治療にも医療費が償還される!

企業合併・買収(M&A):再生医療市場の活性化

特定の治療領域での進歩

  • 糖尿病
  • 心血管疾患
  • 筋骨格(MSD)関連の症状
  • 眼性疾患

再生医療・幹細胞治療の専業企業における、今後の代表的なマイルストーン(2015〜16年)

分析対象企業

  • CESCA Therapeutics Inc. (KOOL)
  • OCAtA Therapeutics Inc. (OCAT)
  • Orgenesis (ORGS)
  • TiGenix NV (TIG:BB)
  • Pluristem Therapeutics Inc (PSTI:IT)
  • Mesobalst Ltd (MSB:AU)
  • Medipost Co. Ltd (078160:KS)
  • JCRファーマ (4552:JP)
  • ジャパン・ティッシュ・エンジニアリング (7774:JP)

付録

目次
Product Code: 4473

Innovative Therapies for treating diseases are being sought after with fresh vigor as new targets, approaches and biology are discovered. Improved health care, nutrition and preventive medicine in the last few decades have all helped in increasing life expectancy WW. However, this has not translated in any reduction in the incidences or prevalence of chronic or critical illnesses! On the contrary, the incidence of chronic diseases like diabetes, obesity, arthritis etc. as well as cancer and the maladies associated with aging (dementia, Alzheimer's etc.) are on the rise!. Consequently the pharma industry continues to grow and is projected to achieve sales in excess of the trillion dollar mark by 2020. By the next decade, one field which is poised to bring a paradigm change in the way diseases are treated is the Stem cell therapy/Regenerative Medicine space. The number of companies and products in the clinic has reached a critical mass, warranting a close watch by those interested in keeping pace with the development of new medicines.

Therapy class report: "Regenerative Medicine and Stem cell based Cell therapies- Drugs of the Future Offering Hope for Cure".

This report describes the key growth drivers and reasons for why this sector is poised for the "golden dawn" and forecasts that in the coming years, the translation of stem cell research to the clinic and market and Stem Cell Technologies Will Begin to Break Through by 2017. The therapy class report highlights the future potential of this stream of medicine and the radical way in which diseases could be treated in the next few decades. This new stream of medicine is driven by landmark scientific discoveries and research (Nobel prize in 2012).

In recent years, the translation of research into the clinic has been spearheaded by Rising stars companies (RS). Some of them have come in the limelight because of their technology platform, clinical data, successful IPO, etc. We expect most of these home grown technologies/products developed by the RS/ Research collaborations to fuel the pipeline of large pharma through acquisition or collaboration when the drug is in late stage or approved. The Regenerative medicine Universe is large and new companies are rapidly becoming a part of this universe. . As a result, we have used some filters to select a few names for a detailed coverage in our Outlook this year. Needless to say, that this could just be the tip of the iceberg!

Key Criteria for Our Selection:-

  • Uniqueness of the Technology platform and the ability to scale up
  • Commercial value in case of positive outcome of the products in the pipeline
  • Pipeline and clinical data analysis
  • Marketed product and commercial tie up. Robustness of the Management, financial and business model.

Table of Contents

Table of Contents

Executive summary

  • Dawn of the Golden Era for Regenerative Medicine/Stem cell based therapies

Introduction

  • Stem cells Types
  • Mesenchymal stem cells (MSCs
  • Tough Choice- "Autologous vs. Allogenic " Therapies

Regulatory Scenario

  • Japan and Asia Lead the Way
  • Japanese Adaptive Licensing Legislation
  • South Korea Regulatory Update
  • India Regulatory Update
  • Regulatory Scenario in US and EU

Marketed Cell based/Stem Cell Products

  • Approved Cell-based / Stem Cell Therapies in Korea and WW
  • Cost of Treatment of Approved Therapies

Progress and Challenges

  • Reimbursement of Approved Cell based Therapies!

Merger and Acquisition- Gaining Momentum in Regenerative Space

Progress in Specific Therapy Areas

  • Diabetes
  • Cardiovascular Disease
  • Musculoskeletal (MSD) Related Conditions
  • Ocular Disease

SELECT UPCOMING MILESTONES IN REGENERATIVE MEDICINE/STEM CELL FOCUSED COMPANIES (2015-16)

COMPANY COVERAGE

  • 1. CESCA Therapeutics Inc. [KOOL]
  • 2. OCAtA Therapeutics Inc.[OCAT]
  • 3. Orgenesis [ORGS]
  • 4. TiGenix NV[ TIG:BB]
  • 5. Pluristem Therapeutics Inc [PSTI:IT]
  • 6. Mesobalst Ltd [MSB:AU]
  • 7. Medipost Co. Ltd [078160:KS]
  • 8. JCR Pharmaceuticals [4552:JP]
  • 9. Japan Tissue Engineering Co., Ltd [7774:JP]

Appendix

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