What Japan BCG Laboratory does

Japan BCG Laboratory (日本ビーシージー製造株式会社) is a Tokyo-based, privately held pharmaceutical manufacturer founded in 1952 as a spin-off from the Japan Anti-Tuberculosis Association's production division. The company is the sole supplier of BCG vaccine in Japan and has manufactured more than 2.25 billion doses over six decades, exporting to over 50 countries under WHO prequalification granted in 1987. Its core technology is freeze-drying (lyophilization) of BCG vaccine using the proprietary Tokyo-172 strain — originally brought to Japan from the Pasteur Institute in 1924 and selected by WHO as the 1st Reference Reagent in 2009. The product portfolio spans freeze-dried BCG vaccines (percutaneous and intradermal formulations), purified tuberculin PPD for TB infection diagnosis, Immunobladder intravesical solution for bladder cancer (distribution transferred to Nippon Kayaku in 2013), FTA-ABS syphilis diagnostics, HISCL immunoassay reagents for Sysmex analyzers, and point-of-care tests including VeritFast H-FABP, VeritFast PCT, and IMM-FASTCHECK HIT-IgG.

The company operates a sales-led GTM primarily through direct supply to healthcare institutions and Japanese municipal governments for the national immunization program, with international export for global TB prevention and a dedicated Customer Center handling product inquiries. Its wholly owned subsidiary Japan Lyophilization Laboratory (日本凍結乾燥研究所), established in 1961 and restructured through the 2012 merger with Yurin Tokushu Kogyo, handles in vitro diagnostics and medical device manufacturing under ISO 13485:2016 certification. Recent strategic activity centers on a May 2026 exclusive U.S. Development and Supply Agreement with ImmunityBio for the Tokyo-172 BCG strain in non-muscle invasive bladder cancer treatment, addressing the chronic U.S. BCG shortage and signaling international commercial expansion of the company's biological assets beyond infectious disease prevention. The company holds no parent ownership and no evidence of external institutional investors, with ownership and operational control resting under President Seiichi Inoue.

Name

Japan BCG Laboratory

Legal name

日本ビーシージー製造株式会社

Website

https://bcg.gr.jp

Company type

Private

Founded year

1952

Operating status

Operating

Short description

Japan BCG Laboratory is a privately held, Tokyo-based pharmaceutical manufacturer founded in 1952 and the sole supplier of BCG vaccine in Japan. It produces freeze-dried BCG vaccines using the proprietary Tokyo-172 strain, tuberculin PPD diagnostics, and a portfolio of in vitro and point-of-care diagnostic reagents for domestic immunization programs and export to 50+ countries.

Ownership category

akta.pro rank

Product category

BCG Vaccine Manufacturing and Diagnostics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412), In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Travel & Tropical Disease Vaccines (HLAIAEAE)

akta.pro secondary industries

Immunization & Vaccine Delivery Programs (BPADAIAB), Vaccine Procurement, Tendering & Immunization Supply Programs (HLAIAEAN)

Keywords

• BCG vaccine manufacturing
• Tuberculosis prevention
• In vitro diagnostics
• Pharmaceutical manufacturing
• Freeze-dried vaccines

Headquarters

HQ city

Tokyo

HQ country

Japan

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. BCG Vaccine Sales: Sales of freeze-dried BCG vaccines for tuberculosis prevention to healthcare institutions, municipal governments, and for export to international markets. The company supplies over 2.25 billion doses globally over more than 60 years.
2. Diagnostic Product Sales: Sales of in vitro diagnostic products including purified tuberculin PPD, FTA-ABS test kits, HISCL reagents, and POCT reagents (H-FABP, PCT) to medical laboratories and healthcare facilities.
3. Immunobladder Sales: Sales of Immunobladder intravesical product for bladder cancer treatment, which was transferred to Nippon Kayaku Co., Ltd. for distribution from July 2013.

Go-to-market motion1 record

Distribution channels4 records

Marketing channels3 records

Core offering

Japan BCG Laboratory is the sole Japanese manufacturer of BCG vaccines for tuberculosis prevention, producing freeze-dried BCG vaccines (intradermal and percutaneous formulations) using the proprietary Tokyo-172 strain. The company also manufactures purified tuberculin PPD for TB infection diagnosis, the Immunobladder intravesical BCG product for bladder cancer treatment, and in vitro diagnostic reagents including the FTA-ABS syphilis test kit, HISCL automated immunoassay reagents, and point-of-care tests for cardiac and thrombocytopenia markers. Products are supplied to Japan's national immunization program, hospitals, clinics, and exported to over 50 countries.

Product overview

Japan BCG Laboratory is Japan's sole BCG vaccine manufacturer, producing a portfolio of vaccines, tuberculin diagnostics, and in vitro diagnostic reagents. Core products include the Tokyo 172 strain freeze-dried BCG vaccines for tuberculosis prevention (available in percutaneous and intradermal formulations), purified tuberculin PPD for infection testing, and Immunobladder for bladder cancer treatment. The company also manufactures a comprehensive range of diagnostic reagents including the FTA-ABS test for syphilis, HISCL automated immunoassay reagents for Sysmex instruments (covering hepatitis, tumor markers), and point-of-care tests (VeritFast H-FABP, VeritFast PCT, IMM-FASTCHECK HIT-IgG) for cardiac markers and thrombocytopenia screening. Associated company Japan Lyophilization Laboratory handles in vitro diagnostics and medical devices.

Differentiator

Problem solved

Functional benefit

Products and services

• Freeze-dried BCG Vaccine for Percutaneous Use (乾燥BCGワクチン（経皮用・1人用）) Freeze-dried BCG vaccine for percutaneous use via multi-puncture device for tuberculosis prevention. Contains the Tokyo-172 BCG strain. Pack of 1 dose with diluent. Used by healthcare institutions for routine infant BCG vaccination under Japan's national immunization program and exported internationally.
• Freeze-dried BCG Vaccine for Intradermal Use (乾燥BCGワクチン（皮内用）) Freeze-dried BCG vaccine for intradermal injection for tuberculosis prevention. Each ampoule contains 0.5 mg BCG (70% water content) plus 1.0 mL diluent, supplied in packs of 100 ampoules. Used for BCG vaccination by healthcare institutions and exported for international TB prevention programs.
• Purified Tuberculin PPD (一般診断用精製ツベルクリン（PPD）1人用) Purified Protein Derivative (PPD) tuberculin for intradermal Mantoux test for tuberculosis infection diagnosis. Each vial contains 1 µg PPD (equivalent to 50 tuberculin units). Used by hospitals, clinics, and medical laboratories for TB screening.
• Immunobladder Intravesical (イムノブラダー膀注用) BCG intravesical solution for treatment of TaT1 papillary tumors and carcinoma in situ (CIS) of the urinary bladder. Contains 80 mg BCG (70% water content) per vial. Used in oncology treatment for bladder cancer immunotherapy. Now sold and distributed by Nippon Kayaku Co., Ltd.
• FTA-ABS Test SG-KIT (トレポネーマ抗体检出用 FTA-ABSテスト-SG-KIT(KW)) Indirect fluorescent antibody absorption test kit for detecting Treponema pallidum antibodies in serum for syphilis diagnosis. Uses Nichol's antigen slides in packs of 100 tests. Japan's only diagnostic reagent for this immunostaining procedure.
• HISCL Immunoassay Reagents (HISCL™専用試薬) Reagent series for Sysmex HISCL fully automated immunoassay system. Includes TPAb, HBsAb, HBeAg, HBeAb, HBcAb, HBcAbII, CA15-3, and HBcIgM assay kits. Features 17-minute reaction time and 10-30 µL sample volume. Used by medical laboratories for hepatitis, syphilis, and cancer marker testing.
• VeritFast H-FABP (ヴェリファスト H-FABP) Point-of-care immuno-chromatographic test kit for detecting human heart-type fatty acid-binding protein (H-FABP) in plasma, serum, or whole blood, with a measurement time of 10 minutes. Used for early acute myocardial infarction diagnosis.
• VeritFast PCT (ヴェリファスト PCT) Point-of-care immuno-chromatographic test kit for measuring procalcitonin (PCT) in plasma, serum, or whole blood. Used for sepsis and bacterial infection diagnostics.
• IMM-FASTCHECK HIT-IgG (イムファストチェック HIT-IgG) Immuno-chromatographic test kit for detecting anti-platelet factor 4/heparin complex IgG antibodies (HIT antibodies), used for heparin-induced thrombocytopenia diagnosis. Measurement time: 15 minutes, with 3 tests per pack.
• CC-E Nichibi Pre-treatment Solution (抗酸菌検出用前処理液 CC-E ニチビー) Pre-treatment solution containing 2% sodium hydroxide for sputum liquefaction with NALC (N-acetyl-L-cysteine) for decontamination, used with phosphate buffer for mycobacterial culture. A subsidiary (Japan Lyophilization Laboratory) diagnostic reagent.
• Phosphate Buffer Nichibi (抗酸菌検出用緩衝液 リン酸緩衝液 ニチビー) Phosphate buffer solution (pH 6.8) for mycobacteria detection. Used for dilution and neutralization of alkali-treated specimens before mycobacterial culture. A subsidiary (Japan Lyophilization Laboratory) diagnostic reagent.
• Disposable Multi-Puncture Device for BCG Vaccination (ディスポBCG接種用管針) Disposable multi-puncture device for BCG vaccination. Used with the percutaneous BCG vaccine for tuberculosis prevention vaccination procedures. A medical device product of Japan Lyophilization Laboratory.

Quantifiable outcome

• More than 2.25 billion doses of BCG vaccine supplied globally
• +2 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Four partnerships are on record, tiered core and minor.

• ImmunityBiocoreStrategic or Co-development Partner · 16 May 2026ImmunityBio signed an exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory to develop, import, and commercialize the Tokyo-172 BCG strain for treating high-grade non-muscle invasive bladder cancer. The agreement is supported by positive Phase III data from the NCI-sponsored SWOG S1602 trial demonstrating non-inferiority of Tokyo-172 BCG compared to TICE BCG. ImmunityBio plans to engage with the FDA for regulatory pathway to approval, providing a second potential BCG source to address the over-decade-long chronic BCG shortage in the United States.
• Serum Institute of IndiaminorStrategic or Co-development PartnerJapan BCG Laboratory's partner ImmunityBio has an existing partnership with the Serum Institute of India for recombinant BCG, which serves as an additional potential BCG source for addressing the U.S. BCG shortage alongside the Japan BCG Laboratory Tokyo-172 strain agreement.
• 公益財団法人結核予防会 (Japan Anti-Tuberculosis Association)coreStrategic or Co-development PartnerJapan BCG Laboratory was originally established in 1952 as a spin-off from the Japan Anti-Tuberculosis Association's (公益財団法人結核予防会) manufacturing division. The company continues to collaborate with the association on tuberculosis prevention efforts and uses reference materials and expertise developed through this historical relationship.
• 株式会社日本凍結乾燥研究所 (Japan Lyophilization Laboratory)coreStrategic or Co-development PartnerJapan Lyophilization Laboratory is a subsidiary of Japan BCG Laboratory, established in 1961 to apply the company's freeze-drying technology to diagnostic agents and other products. The subsidiary merged with Yurin Tokushu Kogyo K.K. in 2012 and now focuses on in vitro diagnostics and medical devices. It manufactures diagnostic reagents for Sysmex HISCL automated immunoassay systems and other products.

Scale indicators4 records

Recent moves10 records

Expansion highlights4 records

Market position

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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

M&A

Investments1 record

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

Frequently asked questions about Japan BCG Laboratory