IGES panel at Bio Europe Spring: independent commercialisation is becoming increasingly important for biotech start-ups

Pharmaceutical companies with only one drug on the market face particular challenges when launching their products. Independent commercialisation is increasingly taking its place alongside the out-licensing model, especially when it comes to orphan drugs. This is the conclusion of a panel discussion organised by the IGES Group at the BIO-Europe Spring 2025 congress

Berlin, March 18, 2025 (IGES Institut) - In the European Union, the number of companies marketing a single pharmaceutical product has risen from four in 2014 to 33 in 2024. Arguments for and against independent marketing instead of out-licensing were the focus of the panel. Under the moderation of Dr Tilo Mandry (Lead International Liaison Manager at the IGES Institute), Thomas Ballotti (Scientific Officer, European Medicines Agency), Delphine Bourdon (Vice President, Head of International Finance, Blueprint Medicines) and Daniël Ghyssels (Vice President Commercial Europe, Immunocore) discussed the topic.

Blueprint Medicines and Immunocore are single-product companies that shared their experiences with the panellists. Thomas Ballotti is responsible at the EMA for advising and supporting small and medium-sized companies in the EU authorisation procedure. These are often single-product companies that are regularly unfamiliar with the EU authorisation procedure and therefore face particular challenges.

The discussion showed that single-product companies are much more challenged with the successful launch of a drug in Europe than established pharmaceutical companies. One reason for this is that they cannot draw on experience from the launch of earlier products. In addition, they often lack an established team that can confidently launch products in the individual European countries. On the other hand, single-product companies have an advantage because their small size allows them to act faster and more flexibly than established pharmaceutical companies.

During the discussion, it became clear that despite the increasing number of single-product companies, independent marketing is not replacing the out-licensing model, but is taking its place: almost exclusively orphan drugs and niche products are marketed by single-product companies, as these do not require a broad-based sales force. All other drug segments are better off being out-licensed.

All panel participants agreed that early planning is crucial for sole distribution: dialogue with the EMA on planning and structuring the marketing authorisation process as well as forward planning and coordination of reimbursement and pricing procedures in European countries are essential.

BIO-Europe Spring 2025 took place in Milan from 17 to 19 March. Around 3,700 visitors from more than 2,000 companies from the field of innovative biotechnological pharmaceuticals were in attendance. The IGES Group took part in the congress with experts from three European countries. Discussions with researchers, companies and associations centred on international market access and reimbursement strategies for medical innovations in Europe.

IGES Italy Pharma was present for the first time as a new company in the IGES Group. Founded in 2025, the company specialises in strategic and health economic consulting services for developers and manufacturers of pharmaceuticals who want to launch products on the Italian market.

The IGES Group as a whole offers a wide range of research and consulting services for global developers and manufacturers of pharmaceuticals, medical devices and digital health applications. The services support almost all phases of the product life cycle management of new developments. They are focussed on the most important European healthcare markets.

IGES has been present at the event, which is one of the largest life sciences trade fairs of its kind in Europe, for many years.

Panel discussion:

A work of art: Success as a first-time launcher in Europe

Tue, March 18 2025, 10:00 - 10:45 (MEZ, UTC/GMT +2 Stunden)
Exhibit Hall Stage
Location: Allianz MiCo, Central Building, Entrance via Gate 5
Corner of Viale Teodorico & Viale Lodovico Scarampo
20149 Mailan, Italien

Panelists

  • Thomas Ballotti (Scientific Officer, European Medicines Agency)
  • Delphine Bourdon (VP, Head of International Finance, Blueprint Medicines)
  • Daniël Ghyssels (VP, Commercial Europe, Immunocore)
  • Moderator: Dr. Tilo Mandry (Lead International Liaison Manager, IGES)