QIAGEN GmbH - Global Manufacturing & R&D Hub for Sample to Insight Solutions

📢 Key Milestones (2025):
   QIAGEN GmbH's Hilden facility completed ISO 50001 energy management certification and received $201.0 million in group capital expenditures (up from $167.2 million in 2024) to support automated production equipment, energy efficiency initiatives, and manufacturing capacity expansion. The site remains the largest of QIAGEN's four primary global consumAble manufacturing locations.

Company Profile (Updated April 2026)

QIAGEN GmbH is the primary German operating subsidiary of QIAGEN N.V., serving as the global manufacturing and research headquarters for the QIAGEN Group. The company is headquartered at QIAGEN Strasse 1, 40724 Hilden, North Rhine-Westphalia, Germany. Founded in 1984 as Diagen GmbH by scientists from Heinrich Heine University Düsseldorf, QIAGEN GmbH originally functioned as the sole corporate entity before the 1996 reorganization into the Dutch holding structure of QIAGEN N.V.

Today, QIAGEN GmbH remains the operational heart of the group, responsible for the design, development, manufacturing, distribution, servicing, and administration of instruments and reagents that power molecular diagnostics and life Sciences research worldwide. The Hilden facility operates under a three-shift production system and spans approximately 91,000 m² (979,500 sq. ft.) of production, laboratory, and administrative space.

Historical Note: Prior to April 29, 1996, references to "QIAGEN" and the "Company" in corporate filings meant QIAGEN GmbH and its consolidated subsidiaries. The 1996 IPO and Dutch reorganization established QIAGEN N.V. as the publicly listed holding company, with QIAGEN GmbH continuing as the core German operating entity.

Core Mission: To manufacture and develop high-quality sample and assay technologies that enable customers worldwide to extract, process, and analyze DNA, RNA, and proteins with precision, reliability, and regulatory compliance.

Hilden Manufacturing & Operations Hub

Facility Overview

Address: QIAGEN Strasse 1, 40724 Hilden, Nordrhein-Westfalen, Germany

Total Area: ~91,000 m² (~979,500 sq. ft.)

Workforce: ~1,360 FTE (full-time equivalents), operating across three shifts

Primary Functions:

- Design and development of instruments and reagents

- Large-scale manufacturing of consumable products (nucleic acid purification kits, PCR reagents, diagnostic assays)

- Global distribution and logistics coordination

- Technical service and customer support for RNA/DNA isolation, genome amplification, PCR, and sequencing analysis

- Administrative management of European and global operations

Production Capabilities

The consumable products manufactured at QIAGEN GmbH include:

- Sample Preparation Kits: Silica membrane and magnetic bead-based nucleic acid purification systems (QIAamp, DNeasy, RNeasy series)

- PCR & qPCR Reagents: QuantiTect, QuantiFast, and RT-PCR enzyme master mixes

- Diagnostic Consumables: QuantiFERON-TB assay components, QIAstat-Dx test panels, and companion diagnostic reagents

- Instruments: QIAcube, QIAsymphony, and Rotor-Gene Q system components

Manufacturing operations are highly integrated, utilizing SAP R/3 and S/4HANA enterprise resource planning systems for sophisticated inventory control, production planning, and global subsidiary integration.

Quality Management & Certifications

QIAGEN GmbH maintains rigorous quality standards compliant with international medical device and diagnostic regulations:

- ISO 9001:2015 — Quality management systems

- ISO 13485:2016 — Medical device quality management

- ISO 50001 — Energy management standard (completed implementation in 2025)

- MDSAP (Medical Device Single Audit Program) — Multi-jurisdictional regulatory compliance

- FDA cGMP (current Good Manufacturing Practice) — Special cGMP production areas built within the Hilden facility for molecular diagnostic consumables

These certifications form part of QIAGEN's Total Quality Management system, ensuring that products are produced and tested in accordance with FDA Quality System Regulations and EU IVDR requirements.

Capital Investments & Sustainability (2024-2025)

QIAGEN GmbH's Hilden facility has received significant infrastructure investments:

- 2024 Capital Expenditure: $167.2 million (group-wide, with major allocations to Hilden for automation and facility upgrades)

- 2025 Capital Expenditure: $201.0 million (group-wide), continuing investments in automated production equipment and energy efficiency

- Green Energy Investment: Installation of an emergency power supply system and renewable heating systems to decrease reliance on carbon-based energy and lower carbon emissions

- Operational Efficiency: Continued investment in automated and interchangeable production equipment to improve manufacturing efficiency and supply chain resilience

- ISO 50001 Certification: Completed in 2025, supporting group-wide net-zero carbon goals by 2050

Corporate Structure & Governance

Legal Form: GmbH (German limited liability company)

Handelsregister: AMTSgericht Düsseldorf HRB 45822

USt-IdNr.: DE 121386819

Parent Company: QIAGEN N.V. (naamloze vennootschap), a Dutch public limited liability company and holding company listed on NYSE (QGEN) and Frankfurt Stock Exchange (QIA)

Corporate Seat of Parent: Hulsterweg 82, 5912 PL Venlo, The Netherlands

Role within Group: QIAGEN GmbH is one of more than 50 consolidated subsidiaries under QIAGEN N.V. While N.V. serves as the legal holding and financial reporting entity, QIAGEN GmbH functions as the primary operating subsidiary responsible for core European manufacturing, R&D, and global supply chain coordination.

Also DBA: PEAK-Service Europe (providing field service outsourcing and operational support across 31 countries)

Geschäftsführer (Managing Directors)

- Thierry Bernard — Chief Executive Officer & Managing Director

- Roland Sackers — Chief Financial Officer & Managing Director

- Antonio Santos — Managing Director

Key Technologies Produced at Hilden

Sample Technologies

- Silica Membrane Technology: Spin-column based DNA/RNA purification

- MagAttract Magnetic Bead Technology: Automated high-throughput nucleic acid isolation

- Stabilization Chemistry: PAXgene and AllProtect reagents for sample preservation

Assay Technologies

- PCR Enzymes & Master Mixes: HotStarTaq, QuantiNova, and RT-PCR formulations

- QuantiFERON Components: Latent tuberculosis blood test reagents

- QIAstat-Dx Panel Reagents: Syndromic infectious disease testing consumables

Automation & Instruments

- QIAcube Connect: Automated purification instrument manufacturing

- QIAsymphony: High-throughput sample-to-result system components

- Rotor-Gene Q: Real-time PCR cycler production

Global Manufacturing Network

While QIAGEN GmbH in Hilden is the largest facility, QIAGEN N.V. operates four primary consumable manufacturing sites:

- Germany (Hilden): ~91,000 m², ~1,360 FTE, 3 shifts — flagship R&D and manufacturing hub

- United States (Germantown, MD): ~29,260 m², ~280 FTE, 2 shifts — instruments, IVD, medical devices

- Spain (Barcelona): ~2,880 m², ~230 FTE, 1 shift — QIAstat-Dx commercialization and manufacturing

- China (Shanghai): ~1,594 m², ~173 FTE, 1 shift — life sciences and molecular diagnostics distribution

Additional specialized facilities include enzyme production in Gdansk (Poland) and Beverly (MA, USA), oligonucleotide synthesis in Vasteras (Sweden), and NGS development in Frederick (MD, USA).

Supply Chain & Global Distribution

QIAGEN GmbH in Hilden serves as the central European distribution hub, supplying products to:

- European Markets: Direct distribution to Germany, France, UK, Italy, Spain, and Nordic countries

- Global Export: Coordination with regional subsidiaries including QIAGEN Sciences LLC (Maryland, USA), QIAGEN Manchester Ltd. (UK), QIAGEN Gdansk (Poland), and QIAGEN china (Shanghai)

- Integrated Logistics: SAP-based production planning and inventory control systems linking Hilden manufacturing with global sales channels

2026 Operational Outlook

- Digital Manufacturing: Continued S/4HANA ERP implementation to enhance operational visibility and efficiency

- Sustainability Targets: Leverage ISO 50001 certification to advance group-wide net-zero carbon goals by 2050

- Capacity Utilization: Support global demand growth for QIAstat-Dx, QIAcuity, and QuantiFERON product lines

- Quality Excellence: Maintain cGMP and MDSAP compliance amid evolving EU IVDR and FDA regulatory landscapes

- Automation Expansion: Continue capital investments in interchangeable production equipment to improve efficiency and reduce carbon footprint

Contact Information

QIAGEN GmbH Headquarters

Address: QIAGEN Strasse 1, 40724 Hilden, Nordrhein-Westfalen, Germany

Phone: +49 (2103) 29-0

Orders: 02103-29-12000

Fax: 02103-29-22000

Email: info@qiagen.com

Website: www.qiagen.com

Parent Company (Investor Relations)

QIAGEN N.V.

Address: Hulsterweg 82, 5912 PL Venlo, The Netherlands

Investor Relations: corporate.qiagen.com/investors

Email: ir@qiagen.com

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