Japan Tissue Engineering

Basic Information

Stock Code
7774
Industry
Precision Instruments
Category Detail
Biotechnology & Pharmaceuticals
Prefecture
Aichi Prefecture
Establishment Year
February 1999
Listing Year
December 2007
Official Website
https://www.jpte.co.jp/
TSE Information
TSE Information
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Other Companies
GNI Group, Heartseed, BlueMeme, AnGes, Nexera Pharma, Kids Bio, PeptiDream, SanBio, Helios, Rena Science, QualiPs, Takara Bio, ReproCELL

Overview

Japan Tissue Engineering is Japan's only commercial production company for regenerative medicine products, established in 1999, and a precision instrument manufacturer specializing in the regenerative medicine field.

Current Situation

Japan Tissue Engineering recorded net sales of 2.1 billion yen in the fiscal year ended March 2022, but posted operating and net losses. It develops, manufactures, and sells major regenerative medicine products such as autologous cultured epidermis 'JACE' and cartilage 'JACK', and possesses the only QMS-compliant facility in Japan. As a member of the Teijin Group, it aims for stable business development through capital and business alliances. Technologically, it focuses on advanced medical research such as CAR-T cell therapy and is expanding indications for rare disease products. Amid short-term performance stagnation due to product approval delays, expanding business areas and strengthening the product lineup are key challenges. Expectations are high for market expansion due to government regenerative medicine promotion policies, and it continues to strengthen R&D and regulatory compliance for sustainable growth. Looking ahead, it has commercialization of new treatments such as CAR-T cell products in view.

Trivia

Interesting Facts

  • The only company in Japan engaged in commercial manufacturing of regenerative medicine products.
  • Autologous cultured epidermis JACE was a pioneer among insurance-covered regenerative medicine products.
  • Currently part of Teijin Group after investments from Teijin and Fujifilm.
  • Autologous cultured cartilage JACK is the second domestically approved regenerative medicine product.
  • Researching and developing advanced immune therapies such as CAR-T cell therapy.
  • Headquarters located in Gamagori City, Aichi Prefecture, as a locally rooted company.
  • Listed on Tokyo Stock Exchange Growth Market, aiming for continuous growth.
  • Active collaboration with bio ventures through contract manufacturing services.
  • Pioneer in epidermal regeneration products for burn treatment.
  • Manufacturing facilities certified as high-standard QMS-compliant.
  • Obtained MHLW designation as medical device for rare diseases.
  • Capital of approximately ¥5 billion with solid financial base.
  • Regenerative medicine products expanding from free-access to insurance coverage.
  • Provides products for rare diseases such as epidermolysis bullosa.
  • Established with venture capital from Central Capital and others.

Hidden Connections

  • Backed by major group capital from Teijin, Fujifilm, Nidec, and others.
  • Has joint research agreements with companies such as CellSeed in regenerative medicine.
  • Active regional contributions through collaboration with local Gamagori City and Tokai area medical/educational institutions.
  • Receives administrative support through MHLW designation as rare disease medical device.
  • Plays a role in supporting growth of bio ventures through outsourcing services.
  • Challenging acute lymphoblastic leukemia treatment through CAR-T cell therapy development.
  • Manufacturing quality management system for regenerative medicine products is a domestic standard model case.
  • Deep trust relationship with medical institutions due to long years of product development experience.

Future Outlook

Growth Drivers

  • Rapid increase in domestic and international demand for regenerative medicine.
  • Successful commercialization of advanced treatments such as CAR-T cell therapy.
  • Expansion of new approvals for rare disease treatment products.
  • Utilization of government regenerative medicine promotion policies and subsidies.
  • Market strengthening through business collaboration with Teijin Group.
  • Stable revenue from expansion of contract manufacturing services.
  • Increasing needs for chronic disease treatments amid aging society.
  • Improved manufacturing efficiency and cost reduction through technological innovation.
  • Entry into overseas new markets through international collaboration.
  • Expansion of digitalization and AI utilization in R&D.
  • Strengthening clinical data collaboration with medical institutions.
  • Continuous technological innovation through successor talent development.

Strategic Goals

  • Achieve over 30% market share in major regenerative medicine products.
  • Commercialize and launch CAR-T cell therapy domestically and internationally.
  • Triple current sales of contract manufacturing services.
  • Maintain R&D expense ratio at over 15% of sales.
  • Establish sustainable manufacturing system and reduce environmental impact.
  • Strengthen and accelerate domestic and international regulatory compliance.
  • Further advance regional and social contribution activities.
  • Enhance employee development programs and promote diversity.
  • Realize digital transformation.
  • Expand markets and transfer technology through international partnerships.

Business Segments

Regenerative Medicine Product Manufacturing Outsourcing

Overview
Provides contract services for other companies' regenerative medicine product manufacturing and cell culture.
Competitiveness
Possesses advanced QMS-compliant manufacturing facilities for high-quality production.
Customers
  • Regenerative Medicine Ventures
  • Pharmaceutical Companies
  • Universities and Research Institutions
  • Medical Institutions
Products
  • Cell Culture Outsourcing
  • Product Manufacturing Support
  • Quality Management Support

R&D Support Services

Overview
Provides technical support services for regenerative medicine R&D.
Competitiveness
Strength in highly experienced support by specialized engineers.
Customers
  • Biopharmaceutical Companies
  • Academia
  • Regenerative Medicine-Related Companies
Products
  • Technical Consulting
  • Testing and Evaluation Support
  • Development Planning Support

Clinical Application Support

Overview
Supports manufacturing and other aspects for clinical trials of regenerative medicine products.
Competitiveness
Abundant experience in regulatory compliance and medical device collaboration.
Customers
  • Medical Institutions
  • Clinical Research Institutions
  • Pharma Ventures
Products
  • Formulation Manufacturing Support
  • Clinical Trial Cell Manufacturing
  • Regulatory Compliance Support

Manufacturing Technology Development

Overview
Supports development and optimization of manufacturing technologies for regenerative medicine products.
Competitiveness
Utilizes proprietary technology know-how and manufacturing expertise.
Customers
  • Regenerative Medicine Companies
  • Pharmaceutical Companies
  • Universities
Products
  • Process Development
  • Manufacturing Technology Evaluation
  • Manufacturing Equipment Design

Quality Assurance Support

Overview
Provides QMS compliance support and quality assurance system development.
Competitiveness
Deep expertise in QMS and strong regulatory compliance capabilities.
Customers
  • Regenerative Medicine Manufacturers
  • Medical Device Manufacturers
  • Clinical Trial Institutions
Products
  • Quality Management System Development
  • Document Management Support
  • Regulatory Compliance Support

Raw Materials Procurement and Management

Overview
Handles procurement and management of raw materials necessary for regenerative medicine product manufacturing.
Competitiveness
Stable securing of high-quality materials and traceability management.
Customers
  • Pharmaceutical Companies
  • Regenerative Medicine-Related Companies
Products
  • Cell Culture Media
  • Cell Materials
  • Other Supplies

Regulatory Review Measures

Overview
Support for compliance with the Pharmaceuticals and Medical Devices Act and Regenerative Medicine Safety Act.
Competitiveness
Advanced specialized knowledge responsive to regulatory trends.
Customers
  • Regenerative Medicine Companies
  • Pharmaceutical Companies
  • Government Agency Response Companies
Products
  • Approval Application Support
  • Clinical Trial Management
  • Regulatory Information Provision

Education and Training Services

Overview
Provides various education and training programs related to regenerative medicine.
Competitiveness
Specialized curriculum tailored to practical needs.
Customers
  • Healthcare Professionals
  • Researchers
  • Corporate Employees
Products
  • Technical Training
  • Regulatory Training
  • Production Management Training

Technology Licensing

Overview
Business of licensing proprietary regenerative medicine technologies.
Competitiveness
Revenue model backed by high technological capabilities.
Customers
  • Bio Ventures
  • Pharmaceutical Companies
  • Research Institutions
Products
  • Cell Culture Technology
  • Regenerative Medicine Formulation Technology

Equipment Sales and Maintenance

Overview
Sales and maintenance services for equipment related to regenerative medicine manufacturing.
Competitiveness
Rapid response closely tied to medical sites.
Customers
  • Medical Institutions
  • Manufacturing Outsourcing Companies
  • Research Institutions
Products
  • Cell Culture Equipment
  • Quality Management Equipment
  • Consumables

Data Management and Analysis Services

Overview
Data management services for regenerative medicine product manufacturing and clinical trials.
Competitiveness
Balance of high-precision analysis and legal compliance.
Customers
  • Pharmaceutical Companies
  • Research Institutions
  • Medical Institutions
Products
  • Manufacturing Data Management
  • Clinical Data Analysis
  • Quality Traceability

Logistics and Storage Services

Overview
Logistics management specialized in maintaining quality of regenerative medicine products.
Competitiveness
Strict temperature control to guarantee product quality.
Customers
  • Regenerative Medicine Manufacturers
  • Medical Institutions
Products
  • Product Transportation
  • Low-Temperature Storage
  • Inventory Management

Competitive Advantage

Strengths

  • Japan's only commercial regenerative medicine product production facility
  • Stable management through capital and business alliance with Teijin Group
  • Advanced cell culture technology and QMS-compliant quality management
  • Diverse lineup of regenerative medicine products
  • Technological strength in R&D support
  • Market superiority from rare disease treatment products
  • Advanced initiatives in CAR-T cell therapy development
  • Close collaboration system with medical institutions
  • Track record of MHLW-approved medical device production
  • Provision of contract cell culture manufacturing services
  • Robust regulatory compliance capabilities
  • Possession of specialized personnel in regenerative medicine
  • Strong brand recognition in the domestic market
  • Diversified R&D investments
  • Solid QMS system ensuring product safety

Competitive Advantages

  • Possesses the only QMS-compliant facility in Japan capable of commercial production of regenerative medicine products, achieving high quality
  • Financial stability and market expansion base from support by major Teijin Group
  • Able to broadly meet market needs through approvals for diverse regenerative medicine products
  • Maintains markets difficult for competitors to enter due to superiority in rare disease products
  • Strengthens competitiveness of next-generation products through CAR-T cell therapy research
  • Accelerates clinical applications through close ties with medical and research institutions
  • Flexible response to customer needs with abundant contract manufacturing services
  • Efficient product approvals and legal compliance due to high regulatory response capabilities
  • Rapid business adaptability to amendments in regenerative medicine laws
  • Strength in integrated system from drug discovery to manufacturing and post-marketing
  • Contributes to local revitalization with regionally rooted R&D structure
  • Strength in providing advanced technical solutions by specialized engineers
  • Abundant experience in administrative responses such as insurance coverage applications
  • Strict quality management standards highly evaluated for medical safety
  • Thick customer trust due to abundant technical track record

Threats

  • Performance pressure from product approval delays hindering market entry
  • Risk of fluctuations in regenerative medicine-related regulations
  • Acceleration of new technology development by competitors
  • Risk of reduced R&D investment due to changes in funding environment
  • Potential growth slowdown from domestic market maturity
  • Intensified competition from low-price strategies of new entrants
  • Market contraction risk from healthcare cost containment policies
  • Intensified technological competition with overseas companies
  • Increased response costs from diversification of global regulatory standards
  • Delays in product adoption by medical institutions due to infectious disease outbreaks
  • Instability in raw material procurement and supply chains
  • Labor competition from difficulties in employee acquisition

Innovations

2022: Capital and Business Alliance Concluded with Teijin Group

Overview
Joined the group through Teijin's tender offer for shares, strengthening management base.
Impact
Successfully enhanced funding and stabilized operations.

2023: Advancing R&D on CAR-T Cell Therapy

Overview
Started development of autologous CAR-T cell formulation targeting acute lymphoblastic leukemia.
Impact
Expectations for business expansion in next-generation regenerative medicine.

2024: Expansion of Regenerative Medicine Contract Manufacturing Services

Overview
Improved contract capacity through facility expansion and quality management enhancement.
Impact
Contributes to increased contracts and sales growth.

2021: Indication Expansion for Autologous Cultured Cartilage Product 'JACK'

Overview
Successfully expanded indications beyond traumatic cartilage defects.
Impact
Improved market competitiveness and increased sales.

2020: QMS Enhancement for Improved Manufacturing Quality Management

Overview
Advanced manufacturing process management and quality monitoring systems.
Impact
Improved product safety and reliability.

Sustainability

  • Proper treatment and reduction of bio-waste
  • Energy-saving in manufacturing processes
  • Material procurement policy aiming to reduce environmental impact
  • Strengthening quality assurance system to ensure medical safety
  • Building sustainable development structure through talent development
  • Strengthening regional collaboration with Aichi Prefecture
  • Community support through social contribution activities
  • Establishment of long-term stable product supply system