Luye Pharma AG

Name

Luye Pharma AG

Legal name

Luye Pharma AG

Website

https://luyepharma.eu

Company type

Private

Founded year

1997

Operating status

Operating

Headcount range

101–250 employees

Ownership category

akta.pro rank

Product category

Pharmaceutical CDMO / Transdermal Drug Delivery

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

akta.pro secondary industries

Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO (HLAGABAB), Packaging, Labeling & Serialization (Clinical/Commercial) CDMO (HLAGABAJ)

Keywords

• Transdermal patches
• Pharmaceutical CDMO
• Contract manufacturing
• Drug delivery systems
• Contract development

Headquarters

HQ city

Miesbach

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Contract Manufacturing (CMO): Fee-for-service manufacturing of transdermal patches for pharmaceutical clients. Luye manufactures products according to client specifications using its state-of-the-art facilities, handling procurement of raw materials, technology transfer, production, secondary packaging, serialization, and market release.
2. Contract Development: R&D services including feasibility studies, product development (galenic, analytical, manufacturing process), analytical method validation, clinical trial material provision, and regulatory dossier preparation (CTD format).
3. Product Licensing: Licensing of self-developed transdermal patch products (Buprenorphine, Fentanyl, Rivastigmine) to pharmaceutical partners for marketing in regions where products are approved. Luye manufactures and handles regulatory/patent issues while partners market in target markets.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels4 records

Core offering

Luye Pharma AG operates as a Europe-based pharmaceutical CDMO (Contract Development and Manufacturing Organization) specializing in Transdermal Therapeutic Systems (TTS), particularly matrix patches. The company develops and manufactures transdermal patches containing proven active pharmaceutical ingredients, delivering them to global pharmaceutical clients through three integrated service lines: contract development (feasibility studies, formulation, analytical validation, clinical trial material supply, regulatory dossier preparation in CTD format), contract manufacturing (procurement, technology transfer, production, packaging, serialization, market release), and licensing of self-developed products (Buprenorphine, Fentanyl, Rivastigmine Single Day and Multi Day patches).

Product overview

Luye Pharma AG operates as a CDMO (Contract Development and Manufacturing Organization) specializing in Transdermal Therapeutic Systems (TTS/patches). Their portfolio includes four self-developed transdermal patch products: Buprenorphine (for pain management), Fentanyl (for chronic pain), Rivastigmine Single Day and Multi Day (for dementia). They offer integrated CDMO services including contract development, contract manufacturing, and licensing. The company provides complete services from feasibility and formulation development through clinical trial supply to full-scale manufacturing and market release.

Differentiator

Problem solved

Functional benefit

Products and services

• Buprenorphine Transdermal Patch Self-developed transdermal patch for moderate to severe cancer-related pain and severe pain unresponsive to non-opioid analgesics; available in 35, 52.5 and 70 μg/h dosage strengths with a 3-day application period. Licensed to pharmaceutical partners for marketing in approved regions.
• Fentanyl Transdermal Patch Self-developed transdermal patch for strong chronic pain requiring continuous, long-term opioid analgesia; available in 12.5, 25, 50, 75 and 100 μg/h dosage strengths.
• Rivastigmine Single Day Patch Self-developed transdermal patch for mild to moderate dementia from Alzheimer's or Parkinson's disease; available in 4.6, 9.5 and 13.3 mg/24h dosage strengths with a 1-day application period.
• Rivastigmine Multi Day Patch Self-developed transdermal patch for dementia with extended wear; available in 4.6 and 9.5 mg/24h dosage strengths with a 3-4 day application period.
• Contract Development Services Full-service pharmaceutical development for transdermal patches including new product ideation, feasibility studies, procurement of active substances, product development (galenic, analytical, manufacturing process), analytical method validation, supply of investigational medicinal products and clinical trial materials, clinical trial support, and preparation of EU regulatory dossiers.
• Contract Manufacturing Services Manufacturing of transdermal patches for pharmaceutical clients including procurement of raw materials, technology transfer, production under certified quality standards, production of bulk products, secondary packaging, logistics, serialization, and market release support.
• Licensing Services All-inclusive licensing package granting pharmaceutical partners rights to market Luye's self-developed transdermal patch products, including supply of approved products, regulatory dossiers for global applications, market-specific packaging, production, and lifecycle management.
• CDMO Services (Full-Service) Integrated CDMO offering including pharma project management, feasibility and formulation, upscaling, clinical trial material support, analytical services, blending and coating, converting and packaging, serialization, shipment, and regulatory dossier preparation.

Quantifiable outcome

• Europe's second-largest manufacturer of transdermal patches
• +2 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Scale indicators6 records

Recent moves9 records

Expansion highlights5 records

Direct peers

• AdhexPharma: France-headquartered transdermal patches and oral thin film CDMO serving global pharma customers. Direct European competitor with similar technology focus and contract development/manufacturing business model.
• Noven Pharmaceuticals (Hisamitsu Pharmaceutical): U.S. transdermal patch CDMO and drug delivery subsidiary of Japan's Hisamitsu. Competes head-to-head with Luye in the development, manufacturing, and licensing of transdermal patches including opioid and CNS products.
• Corium Inc. U.S. specialty CDMO focused on transdermal and topical drug delivery, now part of Lotte Biologics. Closely comparable to Luye in the small-molecule matrix/reservoir TTS CDMO space and customer mix of global pharma.
• Tapemark: U.S.-based contract developer and manufacturer of transdermal patches and topical drug delivery systems. Comparable to Luye as a specialist CDMO targeting pharmaceutical clients with similar TTS offerings.
• LTS LOHMANN Therapie-Systeme AG: Germany-based, family-owned CDMO that is the global market leader in transdermal therapeutic systems. Most direct comparable to Luye Pharma AG in technology (matrix and reservoir TTS), customer base (global pharma), and European manufacturing footprint.

Broad incumbents

• Catalent (Novo Holdings): Global, full-service CDMO with significant transdermal, oral, injectable, and biologic capabilities. Competes with Luye for the same global pharma customers but as a broad platform rather than a TTS specialist.
• 3M Drug Delivery Systems: Division of 3M supplying transdermal and inhalation drug delivery technologies and contract manufacturing to pharmaceutical clients. Overlaps with Luye's TTS CDMO offering as part of a much larger diversified industrial/medical platform.
• Kindeva Drug Delivery: Global CDMO (formerly 3M's Drug Delivery business, owned by Altaris) with transdermal patch and inhalation capabilities. Competes for the same large-pharma TTS outsourcing budgets as Luye, with broader delivery modalities.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 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 Luye Pharma AG