ARCALIS

What ARCALIS does

ARCALIS, Inc. is a Japanese Contract Development and Manufacturing Organization (CDMO) founded in February 2021 as a joint venture between Axcelead, Inc. (a Japanese drug discovery platform group backed by Whiz Partners and Takeda) and Arcturus Therapeutics Holdings, Inc. (NASDAQ:ARCT, a US-based late-stage clinical mRNA medicines company). It is Japan's first and only mRNA-specialized CDMO, providing fully integrated services from drug discovery through commercial cGMP manufacturing at a single site. Its service portfolio spans discovery plasmid DNA template synthesis, discovery mRNA synthesis, LNP formulation, analytical services for mRNA/LNP, GLP toxicology, GMP plasmid DNA manufacturing, GMP mRNA manufacturing (up to 100g/batch, 5kg/year), GMP LNP formulation, and fill-finish for mRNA-LNP drug products. The company leverages Arcturus-licensed proprietary platform technologies, including LUNAR lipid nanoparticle delivery and STARR self-amplifying RNA, alongside its own organ-selective LNP platform, optimized T7 RNA polymerase (minimizing dsRNA impurities), and the HARNA machine learning-based codon optimization technology co-developed with Hitachi. Its primary customers are pharmaceutical companies developing mRNA vaccines and therapeutics (with Meiji Seika Pharma as the anchor commercial customer for the KOSTAIVE self-amplifying mRNA COVID-19 vaccine), biotech firms requiring integrated discovery-to-GMP support, and academic/research institutions including the National Cancer Center Japan and Fukushima Medical University. Revenue is generated through project-based professional services (discovery and CMC development) and long-term managed services contracts for cGMP manufacturing, with no public pricing disclosed; technology licensing from Arcturus and additional government/METI subsidy funding support capital expenditure. ARCALIS is headquartered in Minamisoma, Fukushima, Japan (relocated from Kashiwa in July 2023), operates an R&D and early development office in Kashiwanoha (Chiba), has approximately 55 employees as of March 2026, and is expanding its physical footprint with a drug product facility completed in March 2026 and a manufacturing technology development facility planned for November 2027.

Name

ARCALIS

Legal name

ARCALIS, Inc.

Website

https://corp.arcalis.co.jp

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

51–100 employees

Short description

ARCALIS is a Japanese mRNA-focused CDMO founded in 2021 as a JV between Axcelead and Arcturus Therapeutics, providing fully integrated services from mRNA design through cGMP manufacturing and fill-finish for pharmaceutical companies, biotech firms, and academic institutions, with Meiji Seika Pharma as its anchor commercial customer.

Ownership category

akta.pro rank

Product category

Pharmaceutical CDMO Services

NAICS

Pharmaceutical and Medicine Manufacturing (3254), Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414), Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

mRNA/LNP & Nucleic Acid Therapeutics CDMO (HLAGABAF)

akta.pro secondary industries

mRNA & Nucleic Acid Manufacturing Services (mRNA/saRNA/Plasmid DNA) (HLAGAGAC), Plasmid DNA & mRNA Manufacturing Services (HLAAAKAE), RNA Manufacturing & CMC (oligo synthesis, IVT, purification, formulation, QC) (HLAAADAF)

Keywords

• MRNA contract manufacturing
• Pharmaceutical CDMO services
• Lipid nanoparticle formulation
• GMP mRNA manufacturing
• Drug substance development

Headquarters

HQ city

Kashiwa

HQ country

Japan

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. mRNA Drug Discovery Services: Integrated drug discovery support services including plasmid DNA template synthesis, discovery mRNA synthesis, LNP formulation, and in vitro/vivo expression evaluation. Revenue is earned through project-based service fees for research-stage work.
2. CMC Development Services: CMC (Chemistry, Manufacturing and Controls) development including analytical method development, process development, and technical transfer for mRNA and LNP manufacturing.
3. cGMP Manufacturing (Drug Substance & Drug Product): cGMP-compliant manufacturing of mRNA drug substance (up to 100g/batch, 5kg/year) and LNP drug product including fill-finish. Revenue generated through long-term manufacturing contracts with pharmaceutical and biotech clients. ARCALIS serves as the domestic manufacturing site for Meiji Seika Pharma's self-amplifying mRNA vaccine KOSTAIVE (ARCT-154).
4. Technology Licensing (from Arcturus): Licensed technologies from parent Arcturus (LUNAR, STARR) are deployed in customer projects; ARCALIS serves as Arcturus's manufacturing base for its pipeline.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

ARCALIS is a Japan-based mRNA-focused Contract Development and Manufacturing Organization (CDMO) that delivers fully integrated services from early-stage drug discovery through commercial-scale cGMP manufacturing. Its offerings span discovery plasmid DNA template synthesis, discovery mRNA synthesis, LNP formulation, analytical services for mRNA/LNP, GLP toxicology, GMP plasmid DNA manufacturing, GMP mRNA drug substance manufacturing (up to 100g per batch / 5kg annually), GMP LNP formulation, and fill-finish for mRNA-LNP drug products. The company serves pharmaceutical firms, biotech companies, and academic institutions seeking integrated mRNA capabilities, and serves as the domestic Japan manufacturing site for Arcturus's self-amplifying mRNA COVID-19 vaccine KOSTAIVE (ARCT-154).

Product overview

ARCALIS is an mRNA-focused Contract Development and Manufacturing Organization (CDMO) providing fully integrated services from mRNA design to large-scale GMP manufacturing. The company offers a comprehensive suite of services including: discovery services (plasmid DNA synthesis, mRNA synthesis, LNP formulation), analytical services for mRNA/LNP characterization, GLP toxicology studies, and GMP manufacturing (plasmid DNA templates, mRNA API up to 100g/batch, LNP formulation, and fill-finish). Specialized technology platforms include organ-selective LNP delivery, self-amplifying RNA (saRNA), HARNA codon optimization, and optimized T7 polymerase. The Minamisoma facility provides drug substance manufacturing (5kg/year capacity) while the Kashiwanoha site handles discovery and CMC development services.

Differentiator

Problem solved

Functional benefit

Quantifiable outcome

• End-to-end development from discovery to GMP supply in as fast as 3 months for discovery-stage projects
• +3 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature7 records

Partnerships

Ten partnerships are on record, tiered minor, important and core.

• Synplogen, Inc.minorStrategic or Co-development Partner · 1 April 2025ARCALIS and Synplogen entered a business alliance agreement to promote the development and manufacturing of mRNA therapeutics and vaccines. The partnership combines Synplogen's genetic engineering and synthetic biology capabilities with ARCALIS's mRNA CDMO services.
• Fukushima Medical University and Fukushima Translational Research FoundationimportantStrategic or Co-development Partner · 26 November 2024ARCALIS signed a comprehensive MOU with Fukushima Medical University and its translational research foundation for collaboration on mRNA pharmaceutical and vaccine R&D and manufacturing. Leverages the Fukushima Innovation Coast Framework to advance regional biotech ecosystem.
• National Cancer Center Japan (NCC)importantStrategic or Co-development Partner · 30 July 2024ARCALIS and the National Cancer Center Japan signed a collaboration agreement for the research, development, and manufacturing of mRNA pharmaceuticals. Activities include joint seminars (held October 2024, December 2024, and February 2025), technology exchange, and potential co-development of mRNA-based cancer immunotherapies.
• PassPort Technologies, Inc.minorStrategic or Co-development Partner · 22 February 2024PassPort Technologies and Arcturus Therapeutics (parent) initiated collaborative research. ARCALIS may serve as the manufacturing partner for any resulting mRNA therapeutic candidates. The collaboration involves microbrewery-based delivery technology for mRNA.
• CSL SeqirusminorChannel Partner/ Reseller/ Distributor · 13 December 2023CSL Seqirus entered a strategic alliance with Arcturus (parent) for global distribution and sales of self-amplifying mRNA vaccines. ARCALIS, as Arcturus's manufacturing subsidiary, may supply product for CSL Seqirus's global distribution network.
• Hitachi, Ltd.minorStrategic or Co-development Partner · 22 May 2023ARCALIS and Hitachi entered a joint research agreement on mRNA sequence design technology. The collaboration developed HARNA (HARNATM), a machine learning-based mRNA codon optimization technology that predicts and enhances mRNA stability and protein expression. Hitachi contributes AI/ML expertise; ARCALIS contributes mRNA biology and manufacturing domain knowledge.
• Meiji Seika Pharma Co., Ltd.coreStrategic or Co-development Partner · 25 August 2022Meiji Seika Pharma and ARCALIS agreed to collaborate on domestic production and supply of ARCT-154/KOSTAIVE, a self-amplifying mRNA COVID-19 vaccine developed by Arcturus. Meiji Seika Pharma holds manufacturing/marketing approval for KOSTAIVE in Japan and designated ARCALIS as the domestic manufacturing site. Meiji Seika Pharma invested in ARCALIS (November 2024 announcement) and holds a strategic equity stake. ARCALIS also manufactures KOSTAIVE under METI's dual-use facility subsidy program.
• Axcelead Drug Discovery Partners (Axcelead DDP)coreStrategic or Co-development Partner · 20 July 2022ARCALIS and Axcelead DDP jointly offer an integrated mRNA drug discovery service. Axcelead DDP provides LNP formulation, in vitro/vivo evaluation, pharmacodynamics, pharmacokinetics, and toxicology studies, while ARCALIS provides mRNA design, synthesis, and CMC/GMP manufacturing. The integrated service delivers lead mRNA/LNP candidates in as fast as 3 months.
• Axcelead, Inc.coreStrategic or Co-development Partner · 27 May 2021Axcelead, Inc. is the parent company and co-founding JV partner of ARCALIS, together with Arcturus. Axcelead is a Japanese drug discovery platform group company that inherited Takeda's drug discovery platform in 2017. ARCALIS was established as an Axcelead subsidiary. Axcelead provides corporate infrastructure, management, and strategic guidance to ARCALIS. The companies share the Axcelead DDP subsidiary for integrated drug discovery services.
• Arcturus Therapeutics Holdings, Inc.coreStrategic or Co-development Partner · 27 April 2021Arcturus Therapeutics (NASDAQ: ARCT), a San Diego-based late-stage clinical mRNA medicines company, is the co-founding joint venture partner of ARCALIS. ARCALIS licenses Arcturus's proprietary mRNA platform technologies including LUNAR LNP delivery, STARR self-amplifying RNA, and mRNA manufacturing know-how. Arcturus's development pipeline (including ARCT-154/KOSTAIVE) uses ARCALIS as its primary manufacturing base. ARCALIS also serves as Arcturus's manufacturing subsidiary in Japan.

Scale indicators10 records

Recent moves11 records

Expansion highlights6 records

Broad incumbents

• Lonza: One of the world's largest CDMOs with broad biologics and mRNA manufacturing services, including IVT mRNA, LNP formulation, and fill-finish. Comparable as a global end-to-end mRNA CDMO competing for similar customers.
• Wuxi Biologics: Large-scale Asia-based biologics CDMO offering end-to-end services from discovery through commercial manufacturing. Comparable end-to-end platform with significant Asia-Pacific presence competing for biotech customers.
• Samsung Biologics: Large-scale biologics CDMO with growing mRNA contract manufacturing capabilities and Asia-Pacific presence. Competes with ARCALIS for regional and global mRNA manufacturing contracts.

Direct peers

• TriLink BioTechnologies (Maravai LifeSciences): Specialist CDMO focused on nucleic acid and mRNA manufacturing including IVT mRNA, LNP formulation, and GMP-grade plasmid DNA. Most directly comparable mRNA-specialized CDMO peer to ARCALIS.
• AGC Biologics: Global CDMO with mammalian and microbial biologics manufacturing, with expanding mRNA/LNP service offerings. Highly comparable given overlapping CDMO scope and Japanese parent (AGC) — ARCALIS's CEO Takamatsu previously led CDMO business at AGC.
• Catalent (Novo Holdings): Major global biologics CDMO with established mRNA/LNP formulation and fill-finish capabilities, including a partnership with Moderna. Directly comparable to ARCALIS as a cGMP mRNA contract manufacturer serving pharma and biotech.
• Aldevron (Danaher): CDMO specializing in plasmid DNA, mRNA, and protein manufacturing for therapeutic and vaccine developers. Directly comparable nucleic-acid-focused CDMO with overlapping mRNA manufacturing and GMP capabilities.

Emerging players

• BioNTech: mRNA therapeutics developer with proprietary manufacturing capabilities and CDMO partnerships. Comparable as a leading mRNA platform company; competes for mRNA talent and customer relationships in Japan/Asia.
• CureVac: mRNA therapeutics company with proprietary platform and contract manufacturing partnerships (including with GSK). Comparable as a specialized mRNA platform developer/manufacturer with technology stack overlap.

Regional players

• Takara Bio: Japan-based CDMO/biotech with capabilities in nucleic acid production, gene therapy, and cell engineering. Comparable as a Japan-headquartered nucleic acid and biologics CDMO with overlapping technology and customer base.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInjp.linkedin.com/company/linkedin.com-company-corp-arcalis-co-jp

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds1 record

Investors1 record

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 ARCALIS