Institute of Immunology

What Institute of Immunology does

Institute of Immunology Co., Ltd. (株式会社特殊免疫研究所) is a privately held Japanese biotechnology company founded in August 1979 in Koganei, Tokyo, that develops, manufactures, and sells diagnostic reagents, antigens, monoclonal antibodies, and animal and cell research tools. The company is organized around three business segments: antibody and diagnostic reagent production and sales; animal and cell services (Tg, KO/KI, CRISPR/Cas9 genome editing, and iPS cell generation); and proprietary R&D focused on antibody drug evaluation models. Its customers include pharmaceutical and biotechnology companies, in vitro diagnostics manufacturers, and academic research institutions, served via direct sales in Japan and a multi-region distributor network covering North America, Latin America, Europe, and China.

The company's technology stack centers on hybridoma-based monoclonal antibody production — with more than 1,000 projects completed since 1979 — augmented by CRISPR/Cas9 genome editing (licensed from the Broad Institute in April 2015) and iPS cell reprogramming and gene recombination (licensed from iPS Academia Japan in April 2015). Its most differentiated asset is the proprietary "Human Genome Mice" platform, the company's claim of world-first transgenic mice using large BAC vectors to express human target proteins, enabling in vivo evaluation of therapeutic antibodies. The company holds ISO 13485 certification (since August 2015) for medical device quality management, operates a Tochigi manufacturing plant expanded with a second factory building in July 2022, and is pursuing proprietary drug candidates including TKM-011, a humanized anti-CD20 antibody that completed a Phase I study in relapsed/refractory non-Hodgkin's lymphoma.

Institute of Immunology generates revenue through three primary streams: one-time sales of catalog antibodies, antigens, and IVD reagents (hepatitis, Helicobacter pylori, NASH-related kits); professional services including custom antibody production, contract animal model creation, and cell line development; and exclusive distribution of partner products (ABCRUX BioFactory services, GemPharmatech mouse models, Beacle HBV antigens, ARX Sciences raw materials). Pricing is project-based and not publicly disclosed. The company remains family-controlled, led by Chairman Ayumu Ito and President Yukio Ito, with no disclosed institutional investors, venture capital, or private equity backing across 46 years of independent operation.

Name

Institute of Immunology

Legal name

株式会社特殊免疫研究所

Website

https://tokumen.co.jp

Company type

Private

Founded year

1979

Operating status

Operating

Headcount range

251–500 employees

Short description

Institute of Immunology is a privately held Japanese biotech founded in 1979 that produces monoclonal antibodies, diagnostic reagents, humanized mouse models, and genome editing/iPS cell services for pharmaceutical firms, IVD manufacturers, and academic researchers, distributing via direct sales in Japan and a global partner network.

Ownership category

akta.pro rank

Product category

Life Sciences Reagents and Contract Research Services

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Biological Products, (No Disgnostic Substances) (2836), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI)

akta.pro secondary industries

Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering) (HLAAAIAB), Biomarker Assay & Reagent Development (LDT/IVD assay design, antibodies/standards/controls) (HLAAAMAL), Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB), mRNA & Nucleic Acid Manufacturing Services (mRNA/saRNA/Plasmid DNA) (HLAGAGAC)

Keywords

• Monoclonal antibody production
• In vitro diagnostic reagents
• Contract research services
• CRISPR genome editing
• Humanized mouse models

Headquarters

HQ city

Tokyo

HQ country

Japan

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Antibody and Diagnostic Reagent Sales: Sale of manufactured monoclonal antibodies, antigens, research reagents, and in vitro diagnostic reagents including hepatitis, Helicobacter pylori, and NASH-related products. Products are sold directly and through distributors.
2. Contract Manufacturing Services: Contract production of antibodies, antigens, and proteins including monoclonal antibody production, contract animal model creation (Tg, KO/KI, CRISPR), and cell line development (iPS cells, genome-edited cells).
3. Partner Services (ABCRUX): The company distributes ABCRUX BioFactory's contract services including microbial/animal cell cultivation, antibody/recombinant protein production, research-grade plasmid manufacturing, and ELISA assay development.

Go-to-market motion1 record

Distribution channels4 records

Marketing channels4 records

Core offering

Institute of Immunology manufactures and sells monoclonal antibodies, antigens, research reagents, and in vitro diagnostic reagents (including hepatitis, Helicobacter pylori, and NASH biomarker kits) and provides contract research services such as custom monoclonal antibody production, CRISPR/Cas9 genome editing for animals and cell lines, iPS cell reprogramming and editing, and proprietary Human Genome Mice for in vivo antibody drug evaluation. The company also distributes GemPharmatech mouse models and ABCRUX BioFactory contract services in Japan.

Differentiator

Problem solved

Functional benefit

Brands

• Immunis: Brand name for diagnostic reagent products including HGF EIA, HBV Genotype EIA, and CK-18F EIA
• MYCELL
• MR UREA
• Semi-Knockin Mouse

Products and services

• HBsAg Subtype EIA Enzyme immunoassay kit for hepatitis B surface antigen subtype detection, sold as a kit product (IVD/RUO) for clinical diagnostics laboratories and IVD manufacturers.
• Custom Monoclonal Antibody Production Service Contract monoclonal antibody production service covering immunization, cell fusion, hybridoma screening, cloning, ascites production, purification, and evaluation, delivered in project phases with termination rights between phases for pharmaceutical, biotech, and academic customers.
• Catalog Monoclonal Antibodies and Antigens Off-the-shelf monoclonal antibody and antigen catalog covering hepatitis viruses, cytokines, cancer markers, cardiac markers, blood typing, and transcription factors for research, diagnostic, and pharmaceutical customers.
• MYCELL HBsAg Diagnostic Reagent Diagnostic reagent product for hepatitis B surface antigen testing, manufactured under regulatory approval and marketed under the MYCELL brand for clinical diagnostics use.
• MR UREA Diagnostic Reagent Diagnostic reagent product for Helicobacter pylori detection using the urea method, sold under the MR UREA brand for clinical diagnostics use, with 15-test packaging introduced in April 2026.
• Immunis CK-18F EIA (Cytokeratin 18F EIA) Enzyme immunoassay diagnostic reagent for cytokeratin 18 fragment (CK-18F) used as a non-alcoholic steatohepatitis (NASH) biomarker, sold under the Immunis brand for clinical diagnostics use.
• Immunis HGF EIA and HBV Genotype EIA Enzyme immunoassay diagnostic reagents for hepatocyte growth factor (HGF) and hepatitis B virus (HBV) genotyping, sold under the Immunis brand for clinical diagnostics and research use.
• CRISPR/Cas9 Genome Editing Service for Animals Contract CRISPR/Cas9 genome editing service applied to animal model generation, with gRNA designed using CRISPRPOR and CRISPRdirect tools and RNP delivery performed via 4D-Nucleofector (LONZA), offered to pharmaceutical, biotech, and academic customers.
• Human iPS Cell Reprogramming and Editing Service Contract service for generation of human iPS cell lines from PBMCs using episomal vectors, combined with CRISPR/Cas9 genome editing including knockout, point mutations, and long-chain knock-in, offered to pharmaceutical, biotech, and academic customers.
• Knockout / Knock-in (KO/KI) Animal Contract Service Contract service for generating knockout and knock-in genetically engineered animal models for pharmaceutical, biotech, and academic research customers, including the proprietary Semi-Knockin Mouse approach for gene expression studies.
• Transgenic (Tg) Animal Production Service Contract transgenic animal production service using BAC vector technology for gene expression studies, offered to pharmaceutical, biotech, and academic customers.
• Human Genome Mice (Humanized Mouse Models for Antibody Drug Evaluation) Proprietary humanized mice that use huge BAC vectors to achieve accurate human target protein expression on a Balb/c background, enabling in vivo evaluation of therapeutic antibodies, discovery of best-in-class antibody therapies, and evaluation of new indications for therapeutic antibodies, sold to pharmaceutical and biotech drug discovery customers.
• Genome-Edited Cell Line Service Contract service for producing genome-edited cell lines using CRISPR/Cas9, with engineering capabilities including knockout, point mutations, and long-chain knock-in, for pharmaceutical, biotech, and academic customers.
• TKM-011 Humanized Anti-CD20 Antibody Proprietary humanized anti-CD20 antibody developed by the company for treatment of relapsed or refractory non-Hodgkin's lymphoma, with demonstrated potent cytotoxicity against Rituximab-resistant lymphoma cells and a Phase I study showing no dose-limiting toxicities.
• ABCRUX BioFactory Contract Services (Japan-exclusive distribution) Distribution in Japan of ABCRUX BioFactory's contract services including microbial and animal cell cultivation, antibody and recombinant protein production, research-grade plasmid manufacturing (endotoxin-free, animal-free), and ELISA assay development for research customers.
• GemPharmatech Genetically Engineered Mouse Models (Japan distribution) Distribution in Japan of GemPharmatech Co., Ltd.'s genetically engineered mouse models for life science research customers in the Japanese market.
• Beacle HBV Antigen Products (In-licensed distribution) In-licensed distribution of Beacle's hepatitis B virus antigen products — particle type (yeast), peptide type (E. coli), and core type (genetically modified E. coli) — for diagnostics and research customers.
• ARX Sciences IVD Raw Material Antibodies and HAMA Blockers (In-licensed distribution) In-licensed distribution of ARX Sciences' raw material antibodies and HAMA blockers for IVD assay development, including matched pair antibodies, cancer markers, cardiac markers, hormones, and infectious disease antibodies.
• Contract ELISA Development and Manufacturing Service Contract service for ELISA development, optimization, and contract manufacturing for diagnostics manufacturers and research customers, delivered through in-house capacity and the ABCRUX BioFactory partnership.

Quantifiable outcome

• Over 1,000 monoclonal antibody production projects completed since 1979
• +1 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Twelve partnerships are on record, tiered core and minor.

• ABCRUX BioFactory Inc.coreChannel Partner/ Reseller/ Distributor · 1 April 2024Institute of Immunology became the exclusive distributor for ABCRUX BioFactory Inc. in Japan from April 2024. ABCRUX provides contract services including microbial/animal cell cultivation, antibody/recombinant protein production, research-grade plasmid manufacturing (endotoxin-free, animal-free), and ELISA assay development. ABCRUX was founded in 2018 and operates at the Okinawa Life Science Research Center.
• Broad InstitutecoreTechnology or Integration · 1 April 2015Acquired patent licensing rights for CRISPR/Cas9 system from Broad Institute in April 2015 for use in animal genome editing, cell line editing, and human iPS cell genome editing services.
• iPS Academia JapancoreTechnology or Integration · 1 April 2015Acquired patent licensing rights for iPS cell establishment and gene recombination from iPS Academia Japan in April 2015, enabling the company to offer human iPS cell reprogramming and genome editing services.
• OYC Americas, Inc.coreChannel Partner/ Reseller/ DistributorExclusive distributor for Institute of Immunology products covering North America and Latin America, based in Vista, California.
• OYC EU B.V.coreChannel Partner/ Reseller/ DistributorExclusive distributor for Institute of Immunology products covering Europe, based in Rotterdam, Netherlands.
• Bio-Connect B.V.minorChannel Partner/ Reseller/ DistributorDistributor for Institute of Immunology products in Europe, based in Huissen, Netherlands.
• MBL Beijing Biotech Co., Ltd.coreChannel Partner/ Reseller/ DistributorDistributor for Institute of Immunology products covering China, based in Beijing.
• Ambigen Biotech Co., Ltd.minorChannel Partner/ Reseller/ DistributorDistributor for Institute of Immunology products in China, based in Nanjing.
• GemPharmatech Co., Ltd.coreChannel Partner/ Reseller/ DistributorInstitute of Immunology distributes GemPharmatech mouse models in Japan. A dedicated product page for GemPharmatech products was launched in May 2026. GemPharmatech specializes in genetically engineered mouse models.
• Beacle, Inc.minorChannel Partner/ Reseller/ DistributorInstitute of Immunology distributes Beacle's hepatitis B virus (HBV) antigen products as in-licensed products. Beacle develops HBV-related antigens in particle type (yeast), peptide type (E. coli), and core type (genetically modified E. coli).
• ARX SciencesminorChannel Partner/ Reseller/ DistributorInstitute of Immunology distributes ARX Sciences' raw material antibodies and HAMA blockers as in-licensed products. ARX specializes in supporting IVD assay development with matched pair antibodies, cancer markers, cardiac markers, hormones, and infectious disease antibodies.
• PhoenixBio Co., Ltd.minorOthersInstitute of Immunology contributed to the establishment of EpiPhoenix (now PhoenixBio) in 2002, a University of Hiroshima venture specializing in chimeric mice. In April 2014, the company acquired the Utsunomiya Office from PhoenixBio through corporate division.

Scale indicators3 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Cell Signaling Technology: Cell Signaling Technology is a US-based specialist in high-quality antibodies and reagents for signal transduction and disease research, overlapping directly with Institute of Immunology's catalog and academic/biopharma customer base.
• GenScript: GenScript is a global life sciences services and reagents company offering custom antibody production, gene synthesis, and cell engineering — directly competing with Institute of Immunology's contract services and antibody catalog offerings.
• Abcam: Abcam (now part of Danaher) is a global leader in antibody reagents and related life sciences research tools, with a much larger catalog and direct international distribution — the principal global benchmark for antibody-centric reagents businesses.
• FUJIFILM Wako Pure Chemical: FUJIFILM Wako is a major Japanese life sciences and chemical reagents supplier with a much broader catalog of diagnostic, research, and industrial chemicals, competing with Institute of Immunology in reagent categories but at significantly greater scale.

Direct peers

• PhoenixBio: PhoenixBio is a Japanese venture specializing in chimeric mice with humanized liver functions; Institute of Immunology contributed to its 2002 founding and acquired its Utsunomiya Office in 2014, making it a closely linked peer in animal model development.
• Nacalai Tesque: Nacalai Tesque is a Kyoto-based Japanese manufacturer and distributor of biochemical reagents, antibodies, and cell culture products serving academic, pharma, and diagnostics customers — a close comparable in scale and product scope.
• Taconic Biosciences: Taconic is a global provider of genetically engineered mouse and rat models for biomedical research, directly comparable to Institute of Immunology's Human Genome Mice and CRISPR-edited animal model offerings.
• Medical & Biological Laboratories (MBL): MBL is a Nagoya-based Japanese life sciences company that develops, manufactures, and sells monoclonal antibodies, diagnostic reagents, and research reagents — closely overlapping Institute of Immunology's product portfolio and customer base across pharma, diagnostics, and academic research.
• Cosmo Bio: Cosmo Bio is a Japanese distributor and manufacturer of life sciences research reagents, antibodies, and diagnostic kits, with a comparable catalog breadth and customer base in academic and pharma research institutions across Japan.

Regional players

• GemPharmatech: GemPharmatech is a leading Chinese provider of genetically engineered mouse models; Institute of Immunology distributes GemPharmatech products in Japan, making it both a partner and a regional peer in the model animal space.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Institute of Immunology