We recently supported the EU launch strategy of a complex fixed-combination OTC product across seven countries. The project required navigating diverse regulatory expectations, bioequivalence challenges, and promotional constraints.
Key insights included the strategic choice of an oral solution to reduce regulatory risk, the need for country-specific dossier strategies, and the grey areas surrounding direct-to-consumer promotion.
This initiative illustrates how regulatory expertise and strategic foresight can unlock access in high-risk, high-complexity environments.
On February 12, 2025, International Drug Development (IDD) attended the presentation of the France HealthTech 2024 Panorama report by France Biotech. The report outlines key trends and challenges in the sector:
- Sector Growth: 2,700 companies, 75,600 employees, +21% revenue growth, and €1.4 billion in R&D investments (+10%).
- Challenges: Despite high startup rates, business failures are increasing. Financing remains critical, with strong support from Bpifrance.
- Employment: Slight decline in 2024, but 83% of companies plan to hire in 2025 (+2,000 jobs).
- Tech Focus: Digital health and AI are booming, with 450 companies using AI and 76% in the commercialization phase.
- Government Support: €682 million allocated by Bpifrance, focusing on mental health and prevention. Tax incentives like CIR and JEI benefit 86% of companies.
- Sector Insights: Biotech focuses on oncology, neurology, and infectious diseases. Medtech faces MDR challenges. Digital health is advancing diagnostics and patient monitoring.
- Outlook: The sector is set for growth, driven by innovation, partnerships, and public support, though financing and regulatory compliance remain key hurdles.