What PharmaBio does

PharmaBio Corporation (ファーマバイオ株式会社) is a privately held Japanese healthcare company founded in 1978 and headquartered in Kawasaki, Kanagawa Prefecture, with operating sites in Kawasaki (Tokyo Head Office and Kawasaki Plant) and Nagoya. The company operates as Japan's first Contract Development and Manufacturing Organization (CDMO) for regenerative medicine products, a service line launched in 2011. PharmaBio provides GCTP-compliant contract manufacturing and development services for cell and tissue-derived pharmaceuticals, alongside biological safety testing services including comprehensive pathogen genetic testing (real-time PCR covering 50+ viruses and microorganisms), sterility testing, flow cytometry, ELISA, and SARS-CoV-2 PCR testing.

The company's proprietary technology platform centers on cell sheet products. Its lead asset, PAL-222, is a human allogeneic subcutaneous adipose tissue-derived mesenchymal stem cell sheet in Phase 1/2a clinical trials for myopic chorioretinal atrophy (PAMyCA Study, initiated March 2023) and neovascular age-related macular degeneration (PRESERVE Study, initiated April 2025). The mechanism involves M2 macrophage polarization for wound healing, validated through a December 2025 publication in Scientific Reports with Kyoto University. A complementary human autologous iris pigment epithelial cell sheet is also in clinical development at Nagoya City University Hospital. In February 2026, PharmaBio obtained a Regenerative Medicine Product Manufacturing and Marketing License from Kanagawa Prefecture, enabling commercial sales of regenerative medicine products.

PharmaBio operates a dual business model: (1) professional services revenue from CDMO contracts and testing services to global pharmaceutical companies, regenerative medicine developers, and cell therapy companies, and (2) proprietary drug development with future licensing/royalty potential from PAL-222 and other pipeline assets. Go-to-market is B2B enterprise sales through direct engagement, supported by a June 2020 capital and distribution alliance with Alfresa Corporation (a subsidiary of TSE-listed Alfresa Holdings) for logistics infrastructure. The company is led by President and CEO Hitoshi Kusano with Chairman Kaoru Miyauchi and Scientific Advisor Dr. Tetsuo Nagano (former PMDA Executive Director).

Name

PharmaBio

Legal name

PharmaBio Corporation

Website

https://pharmabio.co.jp

Company type

Private

Founded year

1978

Operating status

Operating

Headcount range

11–50 employees

Short description

PharmaBio Corporation is Japan's first regenerative medicine CDMO, providing GCTP-compliant contract manufacturing, biological safety testing, and proprietary cell sheet drug development (PAL-222 MSC sheet) for global pharmaceutical companies and academic institutions.

Ownership category

akta.pro rank

Product category

Regenerative Medicine CDMO Services

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836), Services-Medical Laboratories (8071)

akta.pro primary industry

Cell Therapy CDMO (HLAGABAD)

akta.pro secondary industries

Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK), Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

Keywords

• Regenerative medicine CDMO
• Contract manufacturing services
• Cell sheet development
• Stem cell therapy
• Biological safety testing

Headquarters

HQ city

Tokyo

HQ country

Japan

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Infrastructure, Operations, Supply Chain

Revenue model

1. Contract Manufacturing and Development Services: PharmaBio provides contract manufacturing and development of regenerative medicine products including cell and tissue-based products, complying with GMP/GCTP standards.
2. Biological Safety and Sterility Testing Services: Various contract testing services including microbial testing of cells, comprehensive pathogen microbial gene testing, sterility testing, flow cytometry, and ELISA testing.
3. SARS-CoV-2 Testing Services: COVID-19 testing services added to the company's contracted testing lineup.
4. Development of New Regenerative Medicine Products: Proprietary drug development of regenerative medicine products including PAL-222 for myopic chorioretinal atrophy and age-related macular degeneration.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

PharmaBio provides GCTP-compliant contract development and manufacturing services (CDMO) for regenerative medicine products including cell and tissue-based pharmaceuticals. The company also develops proprietary cell sheet products (PAL-222 MSC sheet and iris pigment epithelial cell sheet) and offers contract biological safety testing services including pathogen genetic testing, sterility testing, SARS-CoV-2 testing, flow cytometry, and ELISA.

Product overview

PharmaBio is Japan's first CDMO (Contract Development and Manufacturing Organization) for regenerative medicine products, established in 1978. The company offers a portfolio of core cell sheet products and contract services. Core products include PAL-222 (human allogeneic subcutaneous adipose tissue-derived mesenchymal stem cell sheet) for ophthalmologic conditions and iris pigment epithelial cell sheet for myopic chorioretinal atrophy. The service portfolio comprises manufacturing development contract services (GCTP-compliant), safety testing services (biological safety, virus/bacteria testing, sterility testing), and specialized testing services (comprehensive pathogen genetic testing, SARS-CoV-2 testing, flow cytometry, ELISA). The company also pursues proprietary drug discovery development leveraging accumulated manufacturing expertise.

Differentiator

Problem solved

Functional benefit

Quantifiable outcome

• First-in-human clinical trials successfully initiated for PAL-222 in myopic chorioretinal atrophy (PAMyCA Study) and neovascular AMD (PRESERVE Study)
• +1 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Eight partnerships are on record, tiered major and minor.

• Kyoto UniversitymajorStrategic or Co-development Partner · 26 December 2025Joint research on PAL-222 MSC sheet resulting in publication in Scientific Reports journal. Research demonstrated wound healing mechanism through M2 macrophage polarization.
• Yamaguchi UniversitymajorStrategic or Co-development Partner · 11 April 2025Clinical trial agreement for PRESERVE Study - Phase 1/2a clinical trial of PAL-222 transplantation for neovascular age-related macular degeneration resistant to existing treatments.
• Rohto Pharmaceutical Co., Ltd.majorStrategic or Co-development Partner · 9 January 2024Joint research agreement with Rohto Pharmaceutical (headquartered in Osaka, President: Masafumi Sugimoto) for development of novel cell sheets.
• Aize Healthcare CorporationmajorStrategic or Co-development Partner · 26 July 2023Joint R&D agreement for human allogeneic subcutaneous adipose tissue-derived mesenchymal stem cell sheet (PAL-222) for patients with myopic chorioretinal atrophy.
• Nitta CorporationminorStrategic or Co-development Partner · 12 December 2022Joint development of manufacturing equipment and materials for cell sheets used in ophthalmologic disease transplantation treatments.
• Nagoya City UniversitymajorStrategic or Co-development Partner · 9 February 2021Clinical trial collaboration for human autologous iris pigment epithelial cell sheet transplantation for myopic chorioretinal atrophy; continued partnership for PAMyCA Study with allogeneic MSC sheet PAL-222.
• Janssen Pharmaceutical K.K.majorStrategic or Co-development Partner · 19 July 2019Agreement for cell therapy material processing including cell preparation and processing related to clinical trial products.
• Cell Therapies Pty LtdminorStrategic or Co-development PartnerService provision alliance with Cell Therapies, a leading CDMO in the Asia Pacific region for cell/tissue derived medicine, to provide development manufacturing consignment for global studies.

Scale indicators5 records

Recent moves8 records

Expansion highlights6 records

Broad incumbents

• Lonza Group AG: Lonza is the global leading CDMO with extensive cell and gene therapy manufacturing services worldwide. Comparable business model (CDMO services for cell/tissue-based therapeutics) at far greater scale; poses competitive pressure on inbound global programs that could route to PharmaBio.
• AGC Biologics: AGC Biologics (AGC Inc.'s CDMO arm) offers cell therapy and gene therapy contract manufacturing globally, including mammalian and microbial biologics. Comparable CDMO services for cell-based therapies at larger global scale.
• Catalent, Inc. Catalent is a global CDMO with biologics and cell therapy capabilities serving pharmaceutical developers worldwide. Operates in the same broad CDMO category for advanced therapies, competing for similar global sponsor contracts.
• CMIC Group Co., Ltd. CMIC is a leading Japanese CRO and CDMO providing drug development and manufacturing services. Overlaps with PharmaBio's contract development offering and pharmaceutical manufacturing customer base within Japan.

Emerging players

• Healios K.K. Healios is a Japanese regenerative medicine company developing stem cell therapies (e.g., MultiStem) for inflammatory and ophthalmic indications. Adjacent in Japanese cell therapy R&D but more biotech than CDMO; uses contract manufacturers like PharmaBio.

Direct peers

• MEDINET Co., Ltd. MEDINET provides immune cell therapy and regenerative medicine contract manufacturing services in Japan. Comparable as a Japanese cell therapy CMO serving pharma/biotech sponsors under similar GMP/GCTP frameworks.
• Cell Therapies Pty Ltd: Cell Therapies is an Australian cell and tissue CDMO that is itself a PharmaBio service-provision alliance partner. Same business model of cell therapy contract manufacturing and development, regional anchor for Asia-Pacific studies.
• Japan Tissue Engineering Co., Ltd. (J-TEC): J-TEC (FUJIFILM subsidiary) is Japan's leading regenerative medicine products company, commercializing autologous cell sheets and cultured cartilage under Japanese regulation. Same vertical (cell/tissue-based therapeutic products, GCTP manufacturing, Japan-based), making it the closest direct comparable to PharmaBio's CDMO and PAL-222 pipeline.
• Nikon CeLL innovation Co., Ltd. Nikon CeLL innovation operates a Japanese cell therapy CDMO with contract cell processing and manufacturing services for regenerative medicine. Direct overlap with PharmaBio's contract manufacturing and development offering for cell and tissue-based products.

Others

• Alfresa Corporation (Alfresa Holdings): Alfresa Corporation (subsidiary of TSE-listed Alfresa Holdings) is PharmaBio's strategic capital alliance partner for distribution infrastructure for regenerative medicine products. Not a CDMO but a key ecosystem stakeholder enabling downstream commercialization.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds3 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about PharmaBio