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世界の放射性医薬品市場動向

Global Radiopharmaceuticals Market Outlook 2020

発行 KuicK Research 商品コード 302597
出版日 ページ情報 英文 600 Pages
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世界の放射性医薬品市場動向 Global Radiopharmaceuticals Market Outlook 2020
出版日: 2016年04月20日 ページ情報: 英文 600 Pages
概要

世界の放射性医薬品市場は北米地域が最大のシェアを占めており、欧州市場が続きます。核医学検査に欠かせないMo-99がカナダで生産されていることや、米国でも活発に研究活動が行われていることなどから、今後も北米市場が安定した成長を続けるものと思われます。また中国・インド・日本・韓国・ブラジル・南アフリカなどの有望で潜在力のある国々とともに、アジア太平洋地域も将来的に大きな成長が期待されています。 これらの新興国では政府主導でアイソトープを国内生産していることが成長の牽引となっています。

当レポートでは、世界の放射性医薬品市場の概要と市場動向、欧州、米国およびカナダにおける放射性医薬品に対するガイドライン、放射性医薬品の治験動向とともに、参入する企業の競合環境をまとめております。

第1章 世界の放射性医薬品市場見通し

  • 市場概要
  • 診断および治療用放射性医薬品
  • 臨床開発段階における放射性医薬品

第2章 世界の放射性医薬品の市場力学

第3章 放射性医薬品に用いられる放射性元素

第4章 放射性医薬品に対する欧州医薬品庁(EMA)のガイドライン

  • 医薬品の物理化学的、生物学的、または微生物学的検査
  • 毒性学・薬理学検査
  • 臨床文書化
  • 線量測定
  • 表示・包装

第5章 放射性医薬品に対する米国食品医薬品局(FDA)のガイドライン

  • 臨床適応
  • 安全性評価のための一般的配慮
  • 医療用造影剤の臨床評価

第6章 放射性医薬品に対するカナダのガイドライン

  • 基礎研究における陽電子放出放射性医薬品(PER)の使用
  • 人間を介入させる基礎研究における陽電子放出放射性医薬品(PER)の使用
  • 既存の薬剤および製品の安定性検査
  • 陽電子放出放射性医薬品(PER)に関するGMP

第7章 企業、適応、相別の世界の放射性医薬品治験動向

第8章 適応別の上市済み放射性医薬品

第9章 適応、国、相別の中止・中断された放射性医薬品プロファイル

  • 開発報告のないもの
  • 中止されたもの
  • 市場から撤退したもの
  • 停止中のもの

第10章 競合環境

  • Avid Radiopharmaceuticals
  • Actinium Pharmaceuticals
  • AREVA Med
  • Bayer HealthCare Pharmaceuticals
  • Cardinal Health
  • Immunomedics
  • Lantheus Medical Imaging
  • Merck
  • Navidea
  • Nordion
  • Lantheus Medical Imaging
  • GE Healthcare
  • Ion Beam Applications
  • PETNET Solutions(Siemens Healthcare Global)

図表

目次

Radioisotopes are radioactive isotopes having an unstable balance of atomic nucleus. Radioisotopes are produced either by using nuclear research reactor or by using cyclotron. These isotopes emit energy in the form of alpha, beta or gamma when changed to a stable nature. The gamma rays, thus emitted are used in Nuclear medicine, specifically in medical diagnostics. In this field, the radiation is used to provide diagnostic information about a human body's functioning. Radiotherapy is also used to treat some life-threatening diseases like cancer. Also, it has been observed that the increasing use of radioisotopes is one of the major reasons for a fall in deaths caused by cancer across the globe. It is because of this feature that the demand for radioisotopes or otherwise called radiopharmaceuticals is increasing significantly.

The global radiopharmaceuticals market is dominated by the North American region followed by the European region. Owing to the production of Mo-99 by the Canada and continuous research activities in different clinical institutes in USA such as National Cancer Institute, the North American market is headed for a strong growth in the future. Other markets in the Asia-Pacific region are also expected to show a significant growth in the future, with China, India, Japan, South Korea, Brazil, and South Africa being the most promising and potential regions. The major driver of growth in these countries is the domestic production of isotopes by reactors coupled with supportive government initiatives.

The radiopharmaceuticals market can be segmented into diagnostic & therapeutic radiopharmaceuticals. Close to 90% of the global radiopharmaceuticals market is dominated by diagnostic segment wherein SPECT accounts for major market share. The SPECT market is dominated by Tc-99m isotopes and F-18 accounts for majority of share in PET segment.

"Global Radiopharmaceuticals Market Outlook 2020" Report Highlight:

  • Global Radiopharmaceutical Market Overview
  • Global Radiopharmaceuticals Market Dynamics
  • FDA & EMA Guidelines for Radiopharmaceuticals
  • Global Radiopharmaceuticals Clinical Pipeline Insight by Company, Indication & Phase
  • Global Radiopharmaceuticals Clinical Pipeline: 133 Radiopharmaceuticals
  • Majority Radiopharmaceuticals in Preclinical Phase: 44 Radiopharmaceuticals
  • Marketed Radiopharmaceuticals: 19 Radiopharmaceuticals

Table of Contents

1. Global Radiopharmaceutical Market Overview

  • 1.1 Current Market Scenario
  • 1.2 Diagnostic & Therapeutic Radiopharmaceuticals
  • 1.3 Global Radiopharmaceticals Clinical Pipeline Overview

2. Global Radiopharmaceuticals Market Dynamics

3. Radioisotopes Used in Radiopharmaceuticals

4. EMA Guidelines for Radiopharmaceuticals

  • 4.1 Physico-Chemical, Biological or Microbiological Tests of Medicinal Products
  • 4.2 Toxicological & Pharmacological Tests
  • 4.3 Clinical Documentation
  • 4.4 Radiation Dosimetry
  • 4.5 Labelling & Packaging

5. FDA Guidelines for Radiopharmaceuticals

  • 5.1 Clinical Indication
  • 5.2 General Considerations for Safety Assessments
  • 5.3 Clinical Evaluation of Medical Imaging Agents

6. Canada Guidelines for Radiopharmaceuticals

  • 6.1 Use of Positron Emitting Radiopharmaceuticals (PERs) in Basic Research
  • 6.2 Use of Positron Emitting Radiopharmaceuticals in Basic Research involving Humans
  • 6.3 Stability Testing of Existing Drug Substances and Products
  • 6.4 Good Manufacturing Practices (GMP) for Positron Emitting Radiopharmaceuticals (PERs)

7. Global Radiopharmaceuticals Clinical Pipeline Insight by Company, Indication & Phase

  • 7.1 Unknown
  • 7.2 Research
  • 7.3 Preclinical
  • 7.4 Phase-0
  • 7.5 Phase-I
  • 7.6 Phase-I/II
  • 7.7 Phase-II
  • 7.8 Phase-II/III
  • 7.9 Phase-III
  • 7.10 Preregistration

8. Marketed Radiopharmaceuticals Clinical Insight by Indication

  • 8.1 Florbetapir F 18 (Amyvid)
  • 8.2 Iobenguane I-123 (AdreView)
  • 8.3 Ibritumomab Tiuxetan (Zevalin & Zevamab)
  • 8.4 Radium-223 Chloride (Alpharadin & Xofigo)
  • 8.5 Tc 99m Tilmanocept (Lymphoseek)
  • 8.6 Florbetaben F18 (NeuraCeq)
  • 8.7 Capromab (ProstaScint)
  • 8.8 Pentetreotide (Oktreotid & 111In)
  • 8.9 Iodine I 131 Derlotuximab Biotin (Cotara)
  • 8.10 Tc 99m Besilesomab (Scintimun)
  • 8.11 Samarium 153 lexidronam (Quadramet)
  • 8.12 Technetium Tc 99m Sulfur Colloid Injection
  • 8.13 Tc 99m Apcitide (AcuTect)
  • 8.14 DW 166HC (Milican)
  • 8.15 Tc 99m Sulesomab (LeukoScan)
  • 8.16 Satumomab (OncoScint CR/OV)
  • 8.17 Pentetreotide (OctreoScan & SomatoTher)
  • 8.18 Tc 99m ior cea1
  • 8.19 Tc 99m Nofetumomab Merpentan (VerLuma)

9. Discontinued & Suspended Radiopharmaceuticals by Indication & Phase

  • 9.1 No Development Reported
  • 9.2 Discontinued
  • 9.3 Market Withdrawal
  • 9.4 Suspended

10. Competitive Landscape

  • 10.1 Avid Radiopharmaceuticals
  • 10.2 Actinium Pharmaceuticals
  • 10.3 AREVA Med
  • 10.4 Bayer HealthCare Pharmaceuticals
  • 10.5 Cardinal Health
  • 10.6 Immunomedics
  • 10.7 Lantheus Medical Imaging
  • 10.8 Merck
  • 10.9 Navidea
  • 10.10 Nordion
  • 10.11 Lantheus Medical Imaging
  • 10.12 GE Healthcare
  • 10.13 Ion Beam Applications
  • 10.14 PETNET Solutions (Siemens Healthcare Global)

List of Figures

  • Figure 1-1: Global Radiopharmaceuticals Market (US$ Billion), 2014-2020
  • Figure 1-2: Global Radiopharmaceuticals Market by Region (%), 2014 & 2020
  • Figure 1-3: Global Radiopharmaceuticals Market by Region (US$ Billion), 2014 - 2020
  • Figure 1-4: Target Patient Base for Radiopharmaceuticals (Million), 2014-2020
  • Figure 1-5: Target Patient Base for Radiopharmaceuticals by Region (%), 2014 & 2020
  • Figure 1-6: Target Patient Base for Radiopharmaceuticals by Region (Million), 2014 - 2020
  • Figure 1-7: Global Radiopharmceutical Pipeline by Phase (%), 2016
  • Figure 1-8: Global Radiopharmceutical Pipeline by Phase (Numbers), 2016
  • Figure 1-9: Suspended & Discontinued Radiopharmceutical Pipeline (%), 2016
  • Figure 1-10: Suspended & Discontinued Radiopharmceutical Pipeline (Number), 2016
  • Figure 8-1: Lantheus Medical Imaging Product Pipeline

List of Tables

  • Table 1-1: Calcium-47 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-2: Carbon-11 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-3: Carbon-14 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-4: Chromium-51 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-5: Cobalt-57 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-6: Cobalt-58 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-7: Erbium-169 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-8: Fluorine-18 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-9: Gallium-67 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-10: Gallium-68 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-11: Hydrogen-3 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-12: Indium-111 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-13: Iodine-123 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-14: Iodine-125 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-15: Iodine-131 Diagnostic Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-16: Iodine-131 Therapeutic Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-17: Iron-59 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-18: Krypton-81m Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-19: Nitrogen-13 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-20: Oxygen-15 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-21: Phosphorus-32 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-22: Radium-223 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-23: Rubidium-82 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-24: Samarium-153 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-25: Selenium-75 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-26: Sodium-22 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-27: Sodium-24 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-28: Strontium-89 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-29: Technetium-99m Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-30: Thallium-201 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-31: Xenon-133 Investigation Properties as Radiopharmaceuticals Drug
  • Table 1-32: Yttrium-90 Investigation Properties as Radiopharmaceuticals Drug
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