Biopharma predictions for 2026: thoughts from LEK Consulting’s Simon Middleton

18 December 2025

An Expert View piece looking forward to next year from the global strategy consultancy's Simon Middleton, head, Europe Life Sciences and partner.

Regulation will play an increasingly central role

Regulation will play a bigger role in shaping development decisions, especially in Europe, where efforts to update rules on evidence requirements, unmet needs, and incentives are ongoing. Examples include ongoing reforms to European Union (EU) pharmaceutical legislation, including the Critical Medicines Act and EU Pharma Package and Medicines and Healthcare products Regulatory Agency (MHRA) plans to install sovereign marketing authorization and point-of-care manufacturing frameworks in the UK.

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