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1007448

先端医療医薬品 (ATMP) の市場動向・市場シェア・市場規模の予測 (2021-2028年):治療区分 (CAR-T・遺伝子・細胞・幹細胞治療)・地域別

Advanced Therapy Medicinal Products Market Size, Share & Trends Analysis Report By Therapy Type (CAR-T, Gene, Cell, Stem Cell Therapy), By Region (North America, Europe, APAC, ROW), And Segment Forecasts, 2021 - 2028

出版日: | 発行: Grand View Research, Inc. | ページ情報: 英文 225 Pages | 納期: 2-10営業日

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価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=111.41円
先端医療医薬品 (ATMP) の市場動向・市場シェア・市場規模の予測 (2021-2028年):治療区分 (CAR-T・遺伝子・細胞・幹細胞治療)・地域別
出版日: 2021年05月04日
発行: Grand View Research, Inc.
ページ情報: 英文 225 Pages
納期: 2-10営業日
  • 全表示
  • 概要
  • 図表
  • 目次
概要

世界の先端医療医薬品 (ATMP) の市場規模は予測期間中13.2%のCAGRで推移し、2028年には212億米ドルの規模に成長すると予測されています。

ATMPは従来の治療法では得られない画期的なメリットをもたらすことから市場成長が見込まれています。Zolgensma、Kymriah、Yescarta、Tecartus、Abecmaの承認により、この分野への投資が活発化し、収益の増加につながっています。

当レポートでは、世界の先端医療医薬品 (ATMP) の市場を調査し、市場の定義と概要、新型コロナウイルス感染症 (COVID-19)およびその他の市場影響因子の分析、法規制環境、特許動向、パイプラインの分析、市場規模の推移・予測、治療区分・地域など各種区分別の内訳、競合環境、主要企業のプロファイルなどをまとめています。

第1章 調査手法・調査範囲

第2章 エグゼクティブサマリー

第3章 市場可変因子・動向・展望

  • 市場の分類
  • 市場力学
  • 規制状況:地域別
  • 価格設定モデル
  • 特許情勢
  • 取引・資金調達・提携・協力
  • パイプライン分析
  • SWOT分析
  • ポーターの分析

第4章 COVID-19:影響分析

第5章 市場予測・動向分析:治療区分別

  • 細胞治療
  • 遺伝子治療
  • CAR-T療法
  • 組織工学製品

第6章 市場予測・動向分析:地域別

  • 北米
  • 欧州
  • アジア太平洋
  • その他の地域

第7章 企業プロファイル

  • 戦略的枠組み
  • Market Participants Categorization
  • F. Hoffmann-La Roche Ltd.
  • Bluebird Bio, Inc.
  • Novartis AG
  • UniQure N.V.
  • Bristol-Myers Squibb Company
  • Gilead Lifesciences, Inc.
  • Kolon TissueGene, Inc.
  • JCR Pharmaceuticals Co., Ltd.
  • MEDIPOST
  • Vericel Corporation
  • PHARMICELL Co., Ltd.
  • Organogenesis Inc.
図表

List of Tables

  • Table 1 Approved therapies that are considered in the revenue modeling
  • Table 2 Gene therapy buyouts and associated premiums
  • Table 3 Suggested payment models for innovative therapies
  • Table 4 Pipeline analysis: Cell therapy
  • Table 5 Pipeline analysis: Gene therapy
  • Table 6 Pipeline analysis: CAR-T therapy
  • Table 7 Pipeline analysis: NK Cell therapy
  • Table 8 Pipeline analysis: Tissue engineered products
  • Table 9 CAR-T cell resources and potential disruptions during a pandemic
  • Table 10 Ongoing regenerative medicine clinical trials to treat COVID-19 & related complications, as of April 14, 2020
  • Table 11 Collaborations between Japanese players and global (Mesenchymal Stem Cell) MSC biotechs
  • Table 12 North America Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
  • Table 13 North America cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
  • Table 14 U.S. Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
  • Table 15 U.S. cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
  • Table 16 Canada Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
  • Table 17 Canada cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
  • Table 18 Europe Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
  • Table 19 Europe cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
  • Table 20 Asia Pacific Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
  • Table 21 Asia Pacific cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
  • Table 22 Collaborations between Japanese players and global (Mesenchymal Stem Cell) MSC biotechs:
  • Table 23 China Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
  • Table 24 China cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
  • Table 25 Japan Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
  • Table 26 Japan cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
  • Table 27 Russia Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
  • Table 28 Russia cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
  • Table 29 Australia Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
  • Table 30 Australia cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
  • Table 31 India Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
  • Table 32 India cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
  • Table 33 RoW Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
  • Table 34 RoW cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)

List of Figures

  • Fig. 1 Key stakeholders constituting the ATMP ecosystem
  • Fig. 2 Classification of companies
  • Fig. 3 Market segmentation & scope
  • Fig. 4 Gene therapy market snapshot, 2019 (USD Million)
  • Fig. 5 Market research process
  • Fig. 6 Information procurement
  • Fig. 7 Industry pyramid analysis
  • Fig. 8 Industry pyramid analysis
  • Fig. 9 Market research approaches
  • Fig. 10 Value-chain-based sizing & forecasting
  • Fig. 11 Industry pyramid analysis
  • Fig. 12 Industry pyramid analysis
  • Fig. 13 Definition of ATMP by EU regulatory body
  • Fig. 14 Definition of ATMP by the U.S. FDA
  • Fig. 15 Revenue model for ATMP market
  • Fig. 16 Commodity flow analysis for historic and base year estimates
  • Fig. 17 Commodity flow analysis for forecast analysis
  • Fig. 18 Initiatives by Vericel Corporation to sustain market and boost revenue through its ATMPs
  • Fig. 19 Market trends & outlook
  • Fig. 20 Advanced Therapy Medicinal Products (ATMP) therapy market driver impact
  • Fig. 21 Conventional therapies versus ATMP Advanced Therapy Medicinal Products (ATMP)
  • Fig. 22 ATMPs' value to healthcare systems, patients, & society
  • Fig. 23 Key strategies by market players to drive success in gene therapy arena
  • Fig. 24 Number of ongoing clinical trials, 2017 & 2018
  • Fig. 25 Some major industry sponsors of CAR T cell clinical trials, as of September 2019
  • Fig. 26 Distribution of the sponsors of ATMP clinical trials, 2016
  • Fig. 27 Distribution of the non-commercial sponsors of ATMP clinical trials, 2016
  • Fig. 28 Gene therapies in clinical trials at the end of 2019 globally
  • Fig. 29 Advanced Therapy Medicinal Products (ATMP) market restraint impact
  • Fig. 30 Uncertainties identified in this field with respect to magnitude and effect duration
  • Fig. 31 Global financings for ATMPs
  • Fig. 32 U.K. cell and gene therapy manufacturing capacity, 2016 to 2019
  • Fig. 33 Number of gene therapy sites across gene therapy and multifunctional facilities in the U.K., 2019
  • Fig. 34 Challenges in gene therapy arena by degree of difficulty to overcome
  • Fig. 35 Number of gene and cell therapy patents, 2003 - 2017
  • Fig. 36 CAR T-cell patent landscape, by Derwent World Patents Index (DWPI), 2018
  • Fig. 37 Major players in CAR T space with respect to patent filing, by Derwent World Patents Index (DWPI)
  • Fig. 38 Number of CAR T-Cell patent by operating players, by Derwent World Patents Index (DWPI), 2018
  • Fig. 39 Patents for CAR T-cell therapy, 2016 - 2019
  • Fig. 40 Total M&A transactions values in cell therapy, gene therapy, & tissue engineered products, by year
  • Fig. 41 SWOT analysis, by factor (Political & legal, economic, and technological)
  • Fig. 42 Porter's Five Forces Analysis
  • Fig. 43 Advanced Therapy Medicinal Products (ATMP) market: Therapy type outlook and key takeaways
  • Fig. 44 Advanced Therapy Medicinal Products (ATMP) market: Therapy type movement analysis (USD Million)
  • Fig. 45 Cell therapy clinical trials, 2018
  • Fig. 46 Global financings in cell therapy, 2016 - 2018
  • Fig. 47 Global cell therapy market, 2017 - 2028 (USD Million)
  • Fig. 48 Global stem cell therapy market, 2017 - 2028 (USD Million)
  • Fig. 49 Global non-stem cell therapy market, 2017 - 2028 (USD Million)
  • Fig. 50 Volume of gene therapies in development, by companies; as of August 2018
  • Fig. 51 Global gene therapy market, 2017 - 2028 (USD Million)
  • Fig. 52 Annual investment in CAR T space
  • Fig. 53 Number of CAR-T related publications from 2015 to 2018
  • Fig. 54 Global CAR-T therapy market, 2017 - 2028 (USD Million)
  • Fig. 55 Global tissue-engineered products market, 2017 - 2028 (USD Million)
  • Fig. 56 ATMP market: Regional outlook and key takeaways
  • Fig. 57 Advanced Therapy Medicinal Products (ATMP) market: Regional movement analysis
  • Fig. 58 North America ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
  • Fig. 59 U.S. ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
  • Fig. 60 Canada ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
  • Fig. 61 Registered cell therapy contract manufacturing organization (CMO) locations in the EU
  • Fig. 62 Europe ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
  • Fig. 63 Drivers for rapid growth of cell therapy in Asia Pacific
  • Fig. 64 Asia Pacific ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
  • Fig. 65 Japan ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
  • Fig. 66 China ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
  • Fig. 67 Russia ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
  • Fig. 68 Australia ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
  • Fig. 69 India ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
  • Fig. 70 Rest of World (RoW) ATMP market estimates and forecast, 2017 - 2028 (USD Million)
  • Fig. 71 Strategy framework
  • Fig. 72 Market participants categorization
目次
Product Code: GVR-3-68038-855-8

Advanced Therapy Medicinal Products Market Growth & Trends

The global advanced therapy medicinal products market size is expected to reach USD 21.2 billion by 2028, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 13.2% from 2021 to 2028. The ATMPs (Advanced Therapy Medicinal Products) exhibit the potential to cure diseases by addressing their root cause rather than symptomatic treatment. Thus, ATMPs help deliver transformative advantages which are not offered by conventional treatments. These factors are expected to drive the market over the forecast period.

The breakthrough approvals of Tecartus and Abecma post-approval of Zolgensma, Kymriah, and Yescarta have bolstered the exceptional advancements in this space. These approvals have spurred the investment flow in this arena thereby driving revenue growth. Key companies are adopting various operation models to accelerate the product manufacturing process.

Furthermore, the market witnessed several acquisitions by players that intended to enter or expand their existing business in this field. Acquisitions of Kite Pharma by Gilead Life Science, AveXis by Novartis, and Juno Therapeutics by Celgene are some major & recent examples. These acquisitions depict the increasing interest of well-established pharma companies in this market. Increasing competition for gene therapy buyouts can lead to hefty premiums.

On the other hand, with the growing consumer demands, the ATMP manufacturers are outsourcing their product manufacturing thereby creating lucrative opportunities for the contract manufacturing organizations. Thus, several CDMOs have expanded their facilities. For instance, in January 2021, FUJIFILM Diosynth Biotechnologies invested USD 40 million for the establishment of a new process development and manufacturing facility for advanced therapies and viral vectors.

Advanced Therapy Medicinal Products Market Report Highlights

The cell therapy segment accounted for the largest revenue share in 2020 owing to the presence of a high number of approved products in this segment

Increased investment flow to sponsor clinical trials has also spurred the revenue share of the cell therapy segment

Introduction of effective guidelines to support cell therapy manufacturing and the recent approval of advanced therapies further aid in the dominance of the segment

The geographical expansion of Yescarta and Kymriah in Japan and Europe has encouraged the investors to support the development in this space

Recent approvals of gene therapies have significantly accelerated the clinical trials in this segment

COVID-19 pandemic has opened new areas for key players to invest in T-cell research for viral infections

The research community is actively evaluating the potential of advanced therapies in COVID-19 patients, thereby aiding in market growth

North America accounted for the largest revenue share in 2020 owing to the exponential rise in clinical trials pertaining to advanced therapies

Strong pipeline of ATMPs in the U.S. accelerated revenue generation in the region

Also, the shifting focus of U.S.-based companies from conventional drug development to ATMPS is driving regional growth

In Asia Pacific, the market is expected to witness the fastest CAGR owing to expanding ATMP landscape in emerging markets such as China at the forefront

Expanding business of China-based CDMOs has driven regional market growth

Key companies are undertaking various strategic initiatives to maintain their market position. Collaboration between ViGeneron GmbH and Biogen Inc. in January 2021 is one of the notable examples of collaboration in this space

The companies collaborated on the development of an AAV-based gene therapy product for the treatment of inherited eye diseases

Table of Contents

Chapter 1 Executive Summary

  • 1.1 Market Outlook
  • 1.2 Competitive Milieu
  • 1.3 Segment Outlook
  • 1.4 Market Summary

Chapter 2 Research Methodology

  • 2.1 Information Procurement
  • 2.2 Information or Data Analysis
  • 2.3 Market Scope & Definition
    • 2.3.1 ATMP definition as per EU regulatory body:
    • 2.3.2 ATMP definition as per the U.S. FDA:
  • 2.4 Market Model
    • 2.4.1 Historic and base year estimates
    • 2.4.2 Forecast analysis
      • 2.4.2.1 Case study
      • 2.4.2.1.1 MACI (Vericel Corporation):
      • 2.4.2.1.2 LAVIV (Azficel-T) (Fibrocell Technologies):

Chapter 3 Market Variables, Trends, & Scope

  • 3.1 Market Segmentation
  • 3.2 Market Dynamics
    • 3.2.1 Market driver analysis
      • 3.2.1.1 Benefits over conventional therapies
      • 3.2.1.2 Growing competition among market players
      • 3.2.1.3 Increase in number of clinical trials for ATMP
    • 3.2.2 Market Restraint Analysis
      • 3.2.2.1 Absence of effective diagnosis framework
      • 3.2.2.2 Affordability and financial sustainability
    • 3.2.3 Market Opportunity Analysis
      • 3.2.3.1 Increased financing for gene and cell therapy
      • 3.2.3.2 Facility expansion for cell and gene therapies
      • 3.2.3.3 Technological advancements in manufacturing vectors
    • 3.2.4 Market Challenge analysis
      • 3.2.4.1 Challenges in developing generics/biosimilar market for ATMPs
      • 3.2.4.2 Current challenges of on-market gene therapies
  • 3.3 Regulatory Landscape, by Geography
    • 3.3.1 U.S.
    • 3.3.2 Europe
    • 3.3.3 China
    • 3.3.4 Japan
  • 3.4 Payment & Pricing Models
    • 3.4.1 Payment models for innovative therapies
  • 3.5 Patent Landscape
  • 3.6 Deals, Funding's, Partnerships and Collaborations
    • 3.6.1 Merger & acquisition deals
    • 3.6.2 Collaboration & partnerships
  • 3.7 Pipeline Analysis
  • 3.8 Advanced Therapy Medicinal Products (ATMP) Market-SWOT Analysis, by Factor (Political & Legal, Economic, and Technological)
  • 3.9 Industry Analysis - Porter's

Chapter 4 COVID-19 Impact Analysis

  • 4.1 COVID-19 Impact Analysis
  • 4.2 Challenges Analysis
    • 4.2.1 Manufacturing & supply challenges
    • 4.2.2 Other challenges
  • 4.3 Opportunities analysis
    • 4.3.1 Need for development of new therapies against SARS-CoV-2
      • 4.3.1.1 T-cell Therapy
      • 4.3.1.2 Cell Therapy
      • 4.3.1.3 Gene Therapy
      • 4.3.1.4 Tissue engineering
    • 4.3.2 Rise in demand for supply chain management solutions
  • 4.4 Challenges in Manufacturing T-cell Therapies Against COVID-19
  • 4.5 Clinical Trial Analysis
  • 4.6 Key Market Initiatives
  • 4.7 Conclusion

Chapter 5 Therapy Type Business Analysis

  • 5.1 Advanced Therapy Medicinal Products (ATMP) Market: Therapy Type Movement Analysis
  • 5.2 Cell Therapy
    • 5.2.1 Global cell therapy market, 2017 - 2028 (USD Million)
    • 5.2.2 Stem cell therapy
      • 5.2.2.1 Global stem cell therapy market, 2017 - 2028 (USD Million)
    • 5.2.3 Non-stem cell therapy
      • 5.2.3.1 Global non-stem cell therapy market, 2017 - 2028 (USD Million)
  • 5.3 Gene Therapy
    • 5.3.1 Global gene therapy market, 2017 - 2028 (USD Million)
  • 5.4 CAR-T Therapy
    • 5.4.1 Global CAR-T therapy market, 2017 - 2028 (USD Million)
  • 5.5 Tissue-Engineered Products
    • 5.5.1 Global tissue-engineered products market, 2017 - 2028 (USD Million)

Chapter 6 Regional Business Analysis

  • 6.1 Market: Regional Movement Analysis
  • 6.2 North America
    • 6.2.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
    • 6.2.2 U.S.
      • 6.2.2.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
    • 6.2.3 Canada
      • 6.2.3.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
  • 6.3 Europe
    • 6.3.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
  • 6.4 Asia Pacific
    • 6.4.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
    • 6.4.2 Japan
      • 6.4.2.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
    • 6.4.3 China
      • 6.4.3.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
    • 6.4.4 Russia
      • 6.4.4.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
    • 6.4.5 Australia
      • 6.4.5.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
    • 6.4.6 India
      • 6.4.6.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
  • 6.5 Rest of World (RoW)
    • 6.5.1 Market estimates and forecast, 2017 - 2028 (USD Million)

Chapter 7 Company Profiles

  • 7.1 Strategy Framework
  • 7.2 Market Participants Categorization
  • 7.3 F. Hoffmann-La Roche Ltd.
    • 7.3.1 Company overview
    • 7.3.2 Financial performance
    • 7.3.3 Spark Therapeutics, Inc.
      • 7.3.3.1 Company overview
      • 7.3.3.2 Financial performance
    • 7.3.4 Product benchmarking
    • 7.3.5 Strategic initiatives
  • 7.4 Bluebird Bio, Inc.
    • 7.4.1 Company overview
    • 7.4.2 Financial performance
    • 7.4.3 Product benchmarking
    • 7.4.4 Strategic initiatives
  • 7.5 Novartis AG
    • 7.5.1 Company overview
    • 7.5.2 Financial performance
    • 7.5.3 AveXis, Inc.
      • 7.5.3.1 Financial performance (AveXis, Inc.)
    • 7.5.4 Product benchmarking
    • 7.5.5 Strategic initiatives (Novartis AG)
      • 7.5.5.1 Strategic initiatives (AveXis, Inc.)
  • 7.6 UniQure N.V.
    • 7.6.1 Company overview
    • 7.6.2 Financial performance
    • 7.6.3 Product benchmarking
    • 7.6.4 Strategic initiatives
  • 7.7 Bristol-Myers Squibb Company
    • 7.7.1 Company overview
    • 7.7.2 Financial performance
    • 7.7.3 Celgene Corporation
      • 7.7.3.1 Company overview
      • 7.7.3.2 Financial performance
    • 7.7.4 Product benchmarking
    • 7.7.5 Strategic initiatives
  • 7.8 Gilead Lifesciences, Inc.
    • 7.8.1 Company Overview
    • 7.8.2 Financial Performance
    • 7.8.3 Product Benchmarking
    • 7.8.4 Strategic initiatives
  • 7.9 Kolon TissueGene, Inc.
    • 7.9.1 Company overview
    • 7.9.2 Financial performance
    • 7.9.3 Product benchmarking
    • 7.9.4 Strategic initiatives
  • 7.10 JCR Pharmaceuticals Co., Ltd.
    • 7.10.1 Company overview
    • 7.10.2 Financial performance
    • 7.10.3 Product benchmarking
    • 7.10.4 Strategic initiatives
  • 7.11 MEDIPOST
    • 7.11.1 Company overview
    • 7.11.2 Financial performance
    • 7.11.3 Product benchmarking
    • 7.11.4 Strategic initiatives
  • 7.12 Vericel Corporation
    • 7.12.1 Company overview
    • 7.12.2 Financial performance
    • 7.12.3 Product benchmarking
    • 7.12.4 Strategic initiatives
  • 7.13 PHARMICELL Co., Ltd.
    • 7.13.1 Company overview
    • 7.13.2 Financial performance
    • 7.13.3 Product benchmarking
    • 7.13.4 Strategic initiatives
  • 7.14 Organogenesis Inc.
    • 7.14.1 Company overview
    • 7.14.2 Financial performance
    • 7.14.3 Product benchmarking
    • 7.14.4 Strategic initiatives