What LaunchWorks does

LaunchWorks CDMO is a contract development and manufacturing organization (CDMO) specializing in molecular diagnostics and life science products, operating as a wholly-owned subsidiary of Integreon Global since its acquisition in 2017-2019. The company operates from a 30,000 ft2 ISO-13485:2016 and FDA-registered facility in Beverly, Massachusetts (established 2011-2012) and an MDEL-licensed clean room in Anjou, Quebec (established 2020 in partnership with Cryopak Canada), with engineering and microfluidic device R&D conducted through a Montreal-based collaboration with the National Research Council of Canada called the Laboratory of Industrial Fluidic Translation (LIFT). LaunchWorks is ISO-13485:2016 certified, FDA registered, and cGMP compliant, serving as a regulated manufacturing partner for RUO, POC, and IVD product developers.

The company's service portfolio is organized around a proprietary five-phase Product Manufacturing Plan covering design and development (including pilot lot production, lyophilization formulation, assay refinement, and stability testing), technology transfer and onboarding, precision manufacturing (formulation, automated and manual filling, custom labeling, kit assembly), product launch and fulfillment (including temperature-controlled storage at +4°C, -20°C, and -80°C, and cold-chain logistics via Mercury Logistics), and post-launch efficiency programs. Core product types manufactured include dry chemistry sample collection kits, complex NGS kits containing hundreds of oligonucleotides, and custom enzyme purification services. The QC testing stack includes library prep and quantification, enzyme activity assays, qPCR/PCR, gel electrophoresis, cell counting, oligo quantification, BL2 lab services, and contaminant testing.

Revenue is generated through project-based professional services contracts with quote-based (non-publicly-disclosed) pricing, governed by a Terms and Conditions document dated June 2023. Customers are primarily startup innovators without manufacturing infrastructure, high-volume dry kitting organizations, and diagnostic product companies at design freeze, each supported by a dedicated project manager through a consultative enterprise field sales motion. The company employs 11-50 staff and does not publicly disclose revenue, funding, or customer counts. Distribution is direct, supplemented by a web-based customer fulfillment portal for ordering, inventory, and shipment tracking.

Name

LaunchWorks

Legal name

LaunchWorks, LLC

Website

https://launchworkscdmo.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

11–50 employees

Short description

LaunchWorks CDMO is an ISO-13485:2016 certified, FDA-registered contract development and manufacturing organization specializing in molecular diagnostics. It serves diagnostic startups and commercial-scale life science companies with design, formulation, fill/finish, lyophilization, and cold-chain fulfillment services.

Ownership category

akta.pro rank

Product category

Contract Manufacturing (CDMO for Molecular Diagnostics)

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)

akta.pro primary industry

Lyophilization (Freeze-Drying) CDMO (HLAGABAI)

Keywords

• Contract manufacturing services
• Molecular diagnostics manufacturing
• Life sciences CDMO
• Lyophilization services
• Diagnostic kit assembly

Headquarters

HQ city

Beverly

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Manufacturing Services: Full-service CDMO providing molecular diagnostics manufacturing including formulation, filling, labeling, kit assembly, and quality control testing under cGMP and ISO 13485 standards. Revenue generated through project-based contracts with dedicated project management.
2. Design and Development Services: Product development services including raw material optimization, guard banding studies, pilot lot builds, final package and label design, and stability studies. Provided as part of the CDMO service offering.
3. Fulfillment and Storage Services: Order management, inventory management, kitting services, product tracking, carrier logistics, and temperature-controlled storage (+4°C, -20°C, -80°C) for finished diagnostic products.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels7 records

Core offering

LaunchWorks CDMO provides full-service contract development and manufacturing for molecular diagnostics and life science products, spanning design and development, technology transfer, cGMP/ISO-13485 manufacturing (formulation, automated and manual filling, lyophilization, kit assembly, labeling), quality control testing, and temperature-controlled fulfillment and storage. Its offerings are organized around a proprietary five-phase Product Manufacturing Plan that takes RUO, POC, and IVD products from pilot lot through commercial launch and post-launch optimization.

Product overview

LaunchWorks CDMO is a full-service Contract Development and Manufacturing Organization (CDMO) specializing in molecular diagnostics manufacturing. The company offers an integrated suite of services organized around its proprietary five-stage Product Manufacturing Plan: Design & Development (including lyophilization, stability testing, and QC specification development), Technology Transfer & Onboarding, Precision Manufacturing (formulation, filling, labeling, kitting), Product Launch & Fulfillment (including cold-chain logistics and storage), and Post-Launch Efficiencies. Key product types include dry chemistry sample collection kits, complex NGS kits containing hundreds of oligonucleotides, and custom enzyme purification services. The company is ISO-13485:2016 certified and FDA registered, serving startup innovators through high-volume commercial manufacturers in the RUO, POC, and IVD segments.

Differentiator

Problem solved

Functional benefit

Products and services

• Design & Development Services

Quantifiable outcome

• Reduced time to market through integrated design, development, and manufacturing services
• +2 more outcomes

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Five partnerships are on record, tiered core.

• Integreon Global (Parent Company)coreOthers · 1 January 2019Integreon Global acquired LaunchWorks in 2017. The parent company provides business relationships for lyophilization, precision plastic molding, and cold chain packing solutions. LaunchWorks rebranded from LaunchWorks Manufacturing Lab to LaunchWorks CDMO as part of the Integreon Global family of companies.
• Cryopak Canada (Sister Company)coreStrategic or Co-development Partner · 1 January 2019LaunchWorks Manufacturing Lab and Cryopak Canada collaborated with NRC to create LIFT (Laboratory of Industrial Fluidic Translation). Cryopak provides cold chain packaging solutions and together they established an MDEL licensed clean room lab facility in Montreal for CDMO projects.
• Laboratory of Industrial Fluidic Translation (LIFT)coreStrategic or Co-development Partner · 1 January 2019Joint collaboration between LaunchWorks, Cryopak Canada, and NRC to offer competitive capacity for microfluidic bio-device development. Design and development done at NRC in Montréal with manufacturing at LaunchWorks Beverly facility and future plans for additional manufacturing at Cryopak Canada.
• National Research Council of Canada (NRC)coreStrategic or Co-development PartnerNRC partners with Canadian industry to take research impacts from the lab to the marketplace. The NRC-LIFT collaboration combines NRC's expertise in nanofabrication and lab-on-a-chip technologies with LaunchWorks' cGMP and ISO 13485 manufacturing capabilities at clinical and industrial scale to accelerate creation, certification and deployment of microfluidic bio-devices.
• Mercury LogisticscoreChannel Partner/ Reseller/ DistributorOfficial LaunchWorks logistics partner specializing in time and temperature sensitive supply chain management. Creates customized shipping solutions and proactively tracks every package to ensure products reach destinations safely.

Scale indicators4 records

Recent moves9 records

Expansion highlights5 records

Direct peers

• GenScript: Global biotechnology CDMO offering gene synthesis, protein production, and custom reagent manufacturing with diagnostics industry focus. Comparable service portfolio including custom oligonucleotides, peptide synthesis, and diagnostic kit assembly.
• Curia (formerly AMRI): Contract development and manufacturing organization offering integrated services from drug discovery through commercial manufacturing. Similar CDMO business model to LaunchWorks, with comparable services in formulation, filling, and analytical testing, though broader therapeutic focus.
• Meridian Bioscience: Diagnostics-focused manufacturer of IVD test kits and reagents, including molecular diagnostics. Now part of Revvity/Sumitomo. Directly comparable to LaunchWorks in serving the molecular diagnostics manufacturing market with similar customer profiles of diagnostic developers and clinical labs.
• Bio-Techne: Manufacturer of reagents and diagnostic test kits for life sciences research and clinical diagnostics. Similar focus on molecular biology reagents, qPCR, and protein analysis. Overlapping customer segments of academic, biotech, and diagnostic companies requiring specialized reagent manufacturing.
• FUJIFILM Irvine Scientific: CDMO specializing in cell culture media, diagnostics reagents, and life sciences manufacturing. Comparable in serving diagnostic and biotech customers with custom manufacturing services, though focused on cell-based applications rather than purely molecular diagnostics.
• Aldevron: CDMO specializing in nucleic acids, proteins, and biological components for diagnostic and therapeutic applications. Now part of Danaher. Direct peer in serving molecular diagnostics customers with custom manufacturing of complex biological reagents, similar to LaunchWorks' NGS kit and enzyme purification services.

Broad incumbents

• Bio-Rad Laboratories: Major life sciences and diagnostics company with significant molecular diagnostics manufacturing capabilities, including digital PCR and qPCR products. Broader portfolio and global footprint than LaunchWorks, but overlapping customer base in IVD kit manufacturing and contract services.
• Eurofins Genomics: Part of Eurofins Scientific network, offering genomics services and custom oligo/kit manufacturing. Direct overlap in custom NGS kit manufacturing and oligonucleotide services. Significantly larger scale and broader geographic footprint than LaunchWorks.
• Thermo Fisher Scientific (CDMO Services): Global leader in life sciences with substantial CDMO capabilities through its Pharma Services division. Direct overlap in diagnostic kit manufacturing, custom reagent production, and analytical services. Significantly larger scale and resources than LaunchWorks.
• LGC Group (including SeraCare): Life sciences measurement and testing company with diagnostics manufacturing capabilities through SeraCare (now LGC Clinical Diagnostics). Provides reference materials, controls, and custom IVD manufacturing comparable to LaunchWorks' QC testing and diagnostic kit production services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

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 LaunchWorks