Regenerative Medicine Market in Japan 2016-2020

Regenerative Medicine Market in Japan 2016-2020

About Regenerative Medicine

Regenerative medicine deals with the process of using therapeutically induced or laboratory-grown human tissue to treat damaged or diseased human cells, tissues, or organs. It focuses on repairing, replacing, or regenerating damaged cells, and thus offers a paradigm shift in healthcare treatment. The three main technologies used in regenerative medicine are small molecules and biologics, gene therapy, and cell therapy. Small molecules and biologics help in the regeneration of diseased cells and tissues, whereas cell therapy helps in treating the functioning of existing cells.

Technavio’s analysts forecast the regenerative medicine market in Japan to grow at a CAGR of 35.3% during the period 2016-2020.

Covered in this report

The report covers the present scenario and the growth prospects of the regenerative medicine market in Japan for 2016-2020. To calculate the market size, the report considers the revenue generated from the sales of various types of regenerative medicine products to end-users like hospitals, ambulatory surgical centers (ASCs), and clinical research laboratories.

The market is divided into the following segments based on product:

  • Tissue Scaffold
  • Cell Therapy
Technavio's report, Regenerative Medicine Market in Japan 2016-2020, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market.

Key vendors
  • CellSeed
  • JCR Pharmaceuticals
  • Japan Tissue Engineering
  • Terumo
  • Astellas
  • Caladrius Biosciences
  • Healios
  • Fujifilm
  • Rohto Pharmaceuticals
Other prominent vendors
  • FUJISOFT Tissue Engineering
  • MediBIC
  • MEDI NET
  • Nikon
  • TAKARA
  • CMIC
  • EPS
  • Cyfuse Biomedical
  • Irvine Scientific
  • Kaken
  • Regience
  • Sumitomo Dainippon
  • Takeda
  • Alfresa
  • MEDIPAL Holdings
  • TOHO
Market driver
  • Growing partnerships of MNCs with local vendors in Japan
  • For a full, detailed list, view our report
Market challenge
  • High cost and failure rate in clinical trials coupled with inadequate clinical evidence
  • For a full, detailed list, view our report
Market trend
  • Strong pipeline portfolio of regenerative medicines
  • For a full, detailed list, view our report
Key questions answered in this report
  • What will the market size be in 2020 and what will the growth rate be?
  • What are the key market trends?
  • What is driving this market?
  • What are the challenges to market growth?
  • Who are the key vendors in this market space?
  • What are the market opportunities and threats faced by the key vendors?
  • What are the strengths and weaknesses of the key vendors?


Press Release

Technavio Announces the Publication of its Research Report – Regenerative Medicine Market in Japan 2016-2020

Technavio recognizes the following companies as the key players in the regenerative medicine market in Japan: CellSeed, JCR Pharmaceuticals, Japan Tissue Engineering, Terumo, Astellas, Caladrius Biosciences, Healios, Fujifilm, and Rohto Pharmaceuticals.

Other Prominent Vendors in the market are: FUJISOFT Tissue Engineering, MediBIC, MEDI NET, Nikon, TAKARA, CMIC, EPS, Cyfuse Biomedical, Irvine Scientific, Kaken, Regience, Sumitomo Dainippon, Takeda, Alfresa, MEDIPAL Holdings, and TOHO.

Commenting on the report, an analyst from Technavio’s team said: “The vendors in the market are pursuing inorganic growth strategies to expand their presence and expertise. This trend is likely to have a positive impact shortly. In March 2015, Fujifilm and CDI, the leading developers and manufacturers of functioning human cells in industrial quantities, entered into a definitive agreement under which Fujifilm will acquire CDI. In February 2016, Astellas Pharma acquired Ocata Therapeutics, which is a developer of regenerative medicines for eye diseases. In November 2015, ReproCELL completed the acquisition of the Biopta. The acquisition enables the ReproCELL to expand its drug discovery services.”

According to the report, recent product approvals is a key driver which will fuel the market growth. The market has been witnessing new product approvals, which are expected to drive the growth. The new product approvals have the potential to generate substantial revenue in the market. For instance, in September 2015, Mesoblast's partner JCR Pharmaceuticals received approval of its product TEMCELL for the treatment of pediatric acute GVHD in Japan. This was the first product to be approved under the Japanese regenerative medicine law that enables cell therapy treatment to go directly from the first phase to commercialization. In the same month, Terumo Corporation received conditional approval for manufacturing and commercialization of its product HeartSheet autologous skeletal myoblast sheets.

Further, the report states that currently, the regenerative medicine market in Japan is lagging behind the other developed nations such as the US and few European countries such as Germany and the UK. The Japanese market has witnessed only four product approvals in 2014, which constitute a serious challenge to compete with other Western markets. On the other hand, by 2012 itself, the governments in Europe have approved 20 regenerative medicines, followed by South Korea with 14, and the US with nine. The low rate of product approval is due to the old regulatory system in Japan. Further, the less technological expertise of local vendors for the development of innovative regenerative medicine is another reason for a low competitive edge.

Companies Mentioned

CellSeed, JCR Pharmaceuticals, Japan Tissue Engineering, Terumo, Astellas, Caladrius Biosciences, Healios, Fujifilm,Rohto Pharmaceuticals, FUJISOFT Tissue Engineering, MediBIC, MEDI NET, Nikon, TAKARA, CMIC, EPS, Cyfuse Biomedical, Irvine Scientific, Kaken, Regience, Sumitomo Dainippon, Takeda, Alfresa, MEDIPAL Holdings, and TOHO.

  • Executive summary
    • Highlights
  • Scope of the report
    • Market overview
    • Top-vendor offerings
      • Table Product offerings
  • Market research methodology
    • Research methodology
    • Economic indicators
  • Introduction
    • Key market highlights
      • Table Regenerative medicine application in various therapeutics
      • Table Major applications of regenerative medicine in Japan
  • Healthcare reforms in Japan
  • Regulatory landscape in Japan
    • Table Regenerative medicine legislation acts in Japan
    • Table Product approval and regulatory characteristics in Japan
    • Table Overview of regenerative medicine regulation acts
    • Table Landscape of regenerative medicine in Japan
    • ASRM
      • Table Risk categories of regenerative medical technologies
      • Table Regenerative medicine approval process in Japan under the ASRM
    • PMD Act
      • Table Regenerative medicine approval process in Japan under PMD Act
      • Table Comparison of traditional and new product approval process under the PMD Act
      • Table Conditional approvals for regenerative medical products versus regular approval for pharmaceuticals
  • Reimbursement scenario
    • Reimbursement scenario for regenerative medicine in Japan
      • Table Japan's NHI pricing methods
      • Table NHI pricing calculation for TEMCELL HS
      • Table NHI pricing calculation for HeartSheet A kit
      • Table NHI pricing calculation for HeartSheet B kit
  • Gene therapy: An emerging field in regenerative medicine
    • Table Gene therapy research by sponsorship
  • Pipeline portfolio
    • Table Regenerative medicine pipeline products in Japan
    • Table Pipeline analysis of regenerative medicine in Japan 2015
    • Table Pipeline products of regenerative medicine for cell therapy in 2015
  • Market landscape
    • Market overview
      • Table Key developments in regenerative medicine market in Japan 2015
      • Table Regenerative medicine market in Japan 2015-2020 ($ millions)
      • Table Regenerative medicine market in Japan: Optimistic and pessimistic analyses 2015-2020
      • Table Optimistic and pessimistic market analysis of regenerative medicine in Japan 2015-2020
    • Five forces analysis
      • Table Five forces analysis
  • Market segmentation by product
    • Table Regenerative medicine market in Japan by product 2015 and 2020
    • Table Positioning of segments (by product type) in regenerative medicine market in Japan 2015
    • Table Regenerative medicine market in Japan: Lifecycle analysis by product 2015
    • Cell therapy
      • Table Cell therapy overview
      • Table Ethical issues involved in different cell therapy research category
      • Table Stem cell research policies in Japan
      • Table Key cell therapy products marketed in Japan
    • Cell therapy regenerative medicine market in Japan
      • Table Cell therapy regenerative medicine market in Japan 2015-2020 ($ millions)
      • Table Opportunity analysis of cell therapy regenerative medicine market in Japan
    • Tissue scaffold
      • Table Collaborations for R&D of tissue scaffold
    • Tissue scaffold regenerative medicine market in Japan
      • Table Tissue scaffold regenerative medicine market in Japan 2015-2020 ($ millions)
      • Table Opportunity analysis of tissue scaffold in Japan regenerative medicine market
      • Table Regenerative medicine market in Japan by product type 2015-2020 ($ millions)
      • Table Regenerative medicine market in Japan 2015-2020 (%)
  • Market segmentation by application
    • Dermatology
      • Table Overview of the regenerative medicine dermatology market in Japan
      • Table Pipeline of regenerative medicine for dermatology
    • Musculoskeletal
      • Table Overview of musculoskeletal regenerative medicine market in Japan
    • Cardiovascular
      • Table Overview of cardiovascular regenerative medicine market in Japan
    • Other
  • Market drivers
    • Transformation of regulatory landscape fostering quick approval of regenerative medicines
      • Table Regulatory guidelines in Japan
      • Table Approval process of SAKIGAKE assignment system
    • Growing partnerships of MNCs with local vendors in Japan
      • Table Partnerships of MNCs with local vendors in Japan
    • Recent product approvals fuel the market growth
    • Government initiatives driving regenerative medicine market in Japan
      • Table MHLW budget on drug discovery using iPS cells ($ millions)
  • Impact of drivers
    • Table Impact of drivers
  • Market challenges
    • Ethical challenges involved in regenerative medicine
    • High cost and failure rate in clinical trials coupled with inadequate clinical evidence
    • Low competitive edge of Japanese regenerative medicine market over other developed nations
      • Table Force field analysis of regenerative medicine market in Japan
  • Impact of drivers and challenges
    • Table Impact of drivers and challenges
  • Market trends
    • Strong pipeline portfolio of regenerative medicines
      • Table Regenerative medicine pipeline portfolio 2015
    • Entry of new players expanding the applications of regenerative medicine
      • Table Current applications of regenerative medicine
      • Table Future applications of regenerative medicine
    • Strategic collaborations and acquisitions
      • Table Major strategic collaborations and acquisitions in Japan
    • Advent of 3D tissue bioprinters for the development of regenerative medicines
      • Table Impact of trends in regenerative medicine in Japan 2015-2020
  • Vendor landscape
    • Competitive scenario
      • Table Presence of vendors in regenerative medicine
    • Key news
    • Product approvals
    • Partnerships
    • Mergers and acquisitions
    • Other
  • Key vendor analysis
    • CellSeed
      • Table CellSeed: Profile
      • Table CellSeed: Strength analysis
      • Table CellSeed: Growth strategy matrix
      • Table CellSeed: Opportunity assessment
    • JCR Pharmaceuticals
      • Table JCR Pharmaceuticals: Profile
      • Table JCR Pharmaceuticals: Strength analysis
      • Table JCR Pharmaceuticals: Growth strategy matrix
      • Table JCR Pharmaceuticals: Opportunity assessment
    • Japan Tissue Engineering (J-TEC)
      • Table J-TEC: Profile
      • Table J-TEC: Strength analysis
      • Table J-TEC: Growth strategy matrix
      • Table J-TEC: Opportunity assessment
    • Terumo
      • Table Terumo: Profile
      • Table Terumo: Strength analysis
      • Table Terumo: Growth strategy matrix
      • Table Terumo: Opportunity assessment
    • Upcoming vendors
    • Other prominent vendors
  • Appendix
    • List of abbreviations
  • Explore Technavio

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