Verzögerte Marktzulassung durch regulatorische Hürden
Definition
Complex regulatory frameworks in Germany and EU cause multi-year delays in biotech technology licensing and commercialization, resulting in deferred market entry and revenue loss.
Key Findings
- Financial Impact: 2-3 years delay per product, equating to €10-50M lost revenue (based on €54.8B market, 6.3% CAGR)
- Frequency: Per licensing deal
- Root Cause: Superimposed regulations and lengthy approval timelines under EU directives and German Genetic Engineering Act
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Biotechnology Research.
Affected Stakeholders
Licensing Managers, Regulatory Affairs, CFOs
Deep Analysis (Premium)
Financial Impact
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Current Workarounds
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Methodology & Sources
Data collected via OSINT from regulatory filings, industry audits, and verified case studies.
Related Business Risks
Mangelnde Transparenz bei Schutzfristen
Betriebsprüfungsrisiken bei Lizenzierung
Hohe Bürokratiekosten in Klinikstudien-Verträgen
Kosten durch Datenqualitätsmängel in Experimenten
Kapazitätsverluste durch manuelle Datenprotokollierung
DSGVO-Risiken bei sensiblen Biotechnologie-Daten
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