What Lyomark Pharma does

Lyomark Pharma GmbH is a privately held, German specialty pharmaceutical company founded in 1989 and headquartered in Oberhaching near Munich. It develops, manufactures, and distributes sterile pharmaceutical products — primarily lyophilized (freeze-dried) medicines and injectable solutions — for the international hospital market. Its portfolio is anchored in neonatology, with Alveofact (a bovine lung surfactant for treating respiratory distress syndrome in premature newborns, acquired from Boehringer Ingelheim in 2005), NeoKay (Vitamin K1 prophylaxis soft capsules, launched in Germany in 2014), and NEOFACT (an application aid for Less Invasive Surfactant Administration, launched in 2019). Beyond proprietary brands, Lyomark provides contract manufacturing from pilot to commercial scale, pharmaceutical active ingredient procurement with GMP-compliant storage, and regulatory services including eCTD dossier preparation, Product Quality Reviews and Periodic Safety Update Reports.

The company operates a dual go-to-market model: a direct sales organization in the German hospital market (established in 2006, selling since 2007) and an international licensing network of distribution partners that markets Lyomark products in more than 50 countries. It holds GMP and GDP certification and a manufacturing license from the Government of Upper Bavaria, with product approvals handled by the Federal Institute for Drugs and Medical Devices (BfArM). Its operating perimeter includes a majority stake in LYOCONTRACT GmbH (Ilsenburg, acquired August 2017), a licensed manufacturer of liquid and freeze-dried sterile products, and is grouped under shared ownership with sister company Bendalis GmbH (oncology medicines, founded 2005). Adjacent R&D is conducted through research partnerships with University Hospital Tübingen, University Medical Centre Hamburg-Eppendorf and University Hospital Bremen, and Lyomark holds a strategic development partnership with Aerogen Pharma for an inhalable surfactant form of Alveofact.

Lyomark generates revenue through four streams: contract manufacturing (professional services), pharmaceutical active ingredient supply (transactional), direct product sales in Germany (own brands), and international licensing royalties and co-distribution arrangements with foreign partners. As a privately held, self-described "mittelständisches Unternehmen" (medium-sized enterprise) with leadership transitions completed in 2021–2022 — Dr. Wolfgang Burger (from PharmaZell) and Dr. Dirk Hütten — Lyomark positions itself as a GMP-compliant, partner-oriented specialty manufacturer and licensor for the sterile hospital segment, with no disclosed institutional or private equity ownership.

Name

Lyomark Pharma

Legal name

Lyomark Pharma GmbH

Website

https://lyomark.com

Company type

Private

Founded year

1989

Operating status

Operating

Headcount range

11–50 employees

Short description

Lyomark Pharma GmbH is a privately held German specialty pharmaceutical company (founded 1989, Oberhaching near Munich) that develops, manufactures and licenses sterile lyophilized and injectable products — notably Alveofact, NeoKay and NEOFACT — for the international hospital market, serving neonatology, gastroenterology and oncology customers via direct German sales and licensing partners in 50+ countries.

Ownership category

akta.pro rank

Product category

Sterile Hospital Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Drugs and Druggists' Sundries Merchant Wholesalers (424210)

SIC

Pharmaceutical Preparations (2834), Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)

akta.pro primary industry

Generic Hospital & Institutional Products (HLAIABAL)

akta.pro secondary industries

Specialty Care Pharmaceuticals (HLAIAAAB), Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC) (HLAGAHAM), Specialty Pharmacy & Biologics Distribution (CRAOAHAD)

Keywords

• Sterile pharmaceuticals manufacturing
• Lyophilized injectable products
• Neonatal lung surfactant
• Contract pharmaceutical manufacturing
• Hospital pharmaceutical supply

Headquarters

HQ city

Oberhaching

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Contract Manufacturing Services: Development of pharmaceutical formulations from pilot scale to commercial production, manufacture and packaging of lyophilised products and injectable solutions for pharmaceutical clients
2. Pharmaceutical Active Ingredients Supply: Procurement of all active pharmaceutical ingredients and excipients, qualification of active pharmaceutical ingredient suppliers, GMP-compliant storage and on-time delivery
3. Direct Product Sales (Germany): Direct sales of own products in the German hospital market since 2007, including Alveofact, NeoKay, and related pharmaceutical products
4. International Licensing: International licensing and collaborations with distribution partners for worldwide distribution of Lyomark Pharma products, including co-distribution arrangements for selected products

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

Lyomark Pharma develops, manufactures, and distributes lyophilized (freeze-dried) and liquid sterile pharmaceutical products for the international hospital market. Its product portfolio is anchored in neonatology (Alveofact lung surfactant, NeoKay Vitamin K1 capsules, NEOFACT application aid), with additional specialty pharmaceuticals in gastroenterology and oncology. Beyond its own brands, the company offers contract manufacturing, regulatory dossier services (eCTD, PQR, PSUR), and active pharmaceutical ingredient supply to other pharmaceutical companies.

Product overview

Lyomark Pharma is a medium-sized pharmaceutical company specializing in sterile products for the hospital sector. The product portfolio centers on neonatology treatments including Alveofact® (bovine lung surfactant for respiratory distress syndrome), NEOFACT® (an innovative application aid for surfactant administration), and NeoKay® (Vitamin K1 prophylaxis). The company also provides contract manufacturing services for lyophilized and liquid sterile pharmaceuticals, pharmaceutical active ingredient procurement, regulatory services including PQR and PSUR creation, and international distribution partnerships. Products serve the hospital market across more than 50 countries.

Differentiator

Problem solved

Functional benefit

Brands

• Alveofact: Lung surfactant product for neonatal respiratory conditions
• NeoKay
• NEOFACT

Products and services

• Alveofact® Bovine lung surfactant derived from bovine lung lavage, used for the treatment of respiratory distress syndrome (RDS) in premature newborns. It contains phospholipids and surfactant proteins SP-B and SP-C and is supplied in 108 mg and 54 mg dosage forms.
• NEOFACT® Application Aid Medical device / application aid that enables simple and gentle surfactant administration without Magill forceps, designed to standardize the less invasive LISA technique in neonatal intensive care.
• NeoKay® 1 mg Soft Capsules Vitamin K1 (phytomenadione) prophylaxis in 1 mg soft capsule form for newborns and infants, used to prevent bleeding, particularly cerebral haemorrhage, due to vitamin K-dependent clotting factors.
• Contract Manufacturing Services for Sterile Pharmaceuticals Pharmaceutical formulation development from pilot scale to validated commercial batch size, plus manufacture and packaging of lyophilized products (freeze-dried medicines) and injectable solutions for the international hospital market, executed under GMP for pharmaceutical clients.
• Pharmaceutical Active Ingredients Supply Service Sourcing, qualification, and supply of active pharmaceutical ingredients and excipients including provision of CEP and EDMF documentation, GMP-compliant storage, and on-time delivery for pharmaceutical manufacturers.
• Regulatory Services (eCTD, PQR, PSUR) Creation of Product Quality Reviews (PQR), Periodic Safety Update Reports (PSUR), and Regulatory Dossiers in eCTD format, together with database queries and ongoing support for approval processes for pharmaceutical clients.

Quantifiable outcome

• NEOFACT showed 95% success rate in clinical feasibility study at University Hospital Tübingen
• +1 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature3 records

Partnerships

Six partnerships are on record, tiered core and minor.

• Aerogen PharmacoreStrategic or Co-development Partner · 14 December 2017Strategic partnership to develop an inhalable surfactant for the treatment of respiratory distress syndrome (RDS) in premature newborns, based on Lyomark's product Alveofact. Clinical studies were initiated with the new application form, with the first patients already recruited. The partnership aims to create a less invasive surfactant delivery method using Aerogen's aerosolized delivery technology.
• LYOCONTRACT GmbHcoreStrategic or Co-development Partner · 1 August 2017Lyomark Pharma acquired a majority stake in LYOCONTRACT GmbH (based in Ilsenburg), which received its manufacturing licence in 2012 for production of liquid and freeze-dried sterile medicinal products. The plant was built to the latest standards and is among the most modern in its sector. Both companies remain privately owned and independently managed, with the goal of developing LYOCONTRACT into a leading contract manufacturer for sterile products.
• Bendalis GmbHcoreStrategic or Co-development PartnerSister company founded in 2006, specializing in the development and marketing of high-quality oncology medicines for the treatment of cancer. Both companies are privately owned and work together under shared ownership.
• University Hospital TübingenminorStrategic or Co-development PartnerClinical trial partnership for NEOFACT feasibility study conducted at University Hospital Tübingen, where 20 preterm infants were administered surfactant using the NEOFACT application aid with 95% success rate.
• University Medical Centre Hamburg-EppendorfminorStrategic or Co-development PartnerResearch partnership with Dr. Julian Trah's research group studying immunomodulatory effects of surfactant products (Alveofact, Curosurf) on NET formation in neutrophil granulocytes.
• University Hospital BremenminorStrategic or Co-development PartnerResearch partnership with Professor Dr. Dr. Ursula Mirastschijski investigating topical application of Alveofact for wound healing and scar formation, resulting in published Nature Magazine study.

Scale indicators3 records

Recent moves10 records

Expansion highlights5 records

Broad incumbents

• Recipharm: European CDMO offering sterile fill-finish and lyophilization services; comparable to Lyomark's contract manufacturing business for pharmaceutical clients across formulation, scale-up, and commercial production.
• AbbVie: Global pharma incumbent with a historic neonatal surfactant franchise (Survanta) following the Abbott and Allergan acquisitions; broader respiratory and hospital portfolio overlaps with Lyomark's specialty hospital focus.
• Aurobindo Pharma: Large global generics manufacturer with a substantial hospital sterile injectables business; a relevant comparability anchor for Lyomark's generic hospital injectables pipeline and international distribution model.
• Curia Global: Global CDMO with sterile injectable manufacturing capabilities; competes for the same contract manufacturing and lyophilization work that Lyomark's LYOCONTRACT subsidiary targets.

Direct peers

• B. Braun Melsungen: German-headquartered medical and pharmaceutical company with a large sterile injectables and hospital solutions portfolio; a closely comparable private German player in sterile hospital injectables.
• Aenova Holding: German CDMO specializing in solid, semi-solid, and sterile liquid dosage forms; competes directly with Lyomark's contract manufacturing and lyophilization services for pharma clients.
• Chiesi Farmaceutici: Privately held Italian specialty pharma with Curosurf (poractant alfa), the global market-leading lung surfactant for neonatal RDS — directly competing with Lyomark's Alveofact in the same indication and customer base.
• Hikma Pharmaceuticals: Global manufacturer of generic injectable hospital products with a strong lyophilized injectables portfolio; directly comparable in hospital sterile injectables and contract manufacturing service offerings.

Regional players

• Stada Arzneimittel: German specialty and generics pharma with strong hospital presence in Europe; comparable in offering hospital sterile injectables and specialty products, though at significantly larger scale.

Emerging players

• Drägerwerk: German medical technology company with a strong neonatal care and respiratory product line (incubators, ventilators); comparable as a German specialty supplier into the same neonatal hospital customer base.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/lyomark-pharma

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries2 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 Lyomark Pharma