What are next year’s big trends? Simon Middleton, Head, Europe Life Sciences and Partner at L.E.K. Consulting, shares his predictions.
The biopharma industry is at an inflection point going into 2026. Discoveries from the past year will be scaled, particularly across AI-enabled drug development, advanced modalities and cardiometabolic disease treatment. Evolving regulatory expectations and newly developed digital tools will reshape how therapies are developed, delivered, and experienced.
AI-enabled drug discovery and development will accelerate
Companies are moving beyond exploratory AI pilots and beginning to embed AI across the entire drug development value chain, enabling shorter timelines, lower costs, and more personalised therapies.
AI will reshape target identification by rapidly analysing large biological and genomic datasets to uncover new disease pathways and rank targets by success probability, which would have previously required years of manual effort.
In molecule design, generative models will accelerate the creation and refinement of candidates with desired properties, reducing synthesis cycles and experimental failures. Within clinical development, AI will enhance patient selection, forecast enrolment risks, support adaptive trial design, and interpret data to enable faster decision-making. Collectively, these applications show AI shifting from a supportive capability to a core driver of R&D productivity.
As regulators offer clearer guidance on the use of AI-generated evidence, adoption is expected to increase, and measurable productivity gains will start to emerge. Regulatory clarity will reduce perceived risk and increase confidence in AI tools, paving the way for broader deployment and productivity gains across the sector.
Regulation will play a more central role
Speaking of regulation, this 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 still underway.Examples include EU joint HTA assessments, EU pharmaceutical legislation reform, such as the Critical Medicines Act or EU Pharma Package, and MHRA plans to install sovereign marketing authorisation and point-of-care manufacturing in the UK.
This regulation is largely driven by how quickly new therapies and technologies are advancing, which is forcing regulators to adjust their frameworks so they can keep pace with innovation.
As a result, companies will place greater emphasis on trial design, endpoint selection, and real-world evidence to meet payer and health technology assessment (HTA) requirements. Access considerations will increasingly drive portfolio choices, as companies require a closer assessment of whether patients can actually obtain therapy, dependent on reimbursement, pricing, and coverage decisions by health systems.
Advanced modalities will enter a test of scalability
Investment in advanced modalities such as cell therapy, mRNA and protein degraders, is likely to rise as next-generation therapies require more bespoke and specialised methods of treatment. If 2025 saw a breakthrough in advanced modalities thanks to developments in artificial intelligence, gene editing, and new therapeutic platforms, 2026 will put these therapies to the commercial test to see if they can be made reliably, at scale and at minimal cost.
Investors and regulators will expect clearer proofpoints that advanced therapies deliver long-lasting usage benefits, meaning programmes with strong biology but no scalable delivery model will struggle to attract funding. Those that balance breakthrough potential with robust plans for manufacturing, supply chain, regulatory strategy, and pricing will stand out.
From a customer perspective, pricing will be key. We’ve already seen a sharp push back on ultra-premium pricing, particularly for treatments that only have a one-time usage, and this is likely to become even more front-of-mind for payers next year.
Cardiometabolic disease will remain a major area of focus
Demand for next-generation incretin-based therapies, like GLP-1 Receptor Agonists (e.g. Ozempic) and DPP-4 Inhibitors, will continue to surge as their effectiveness across obesity, diabetes, and cardiovascular risk reduction is evidenced. The global GLP-1 drug market’s size grew by approximately 18% in 2025, with market values reaching over $60 billion USD, according to a Towards Healthcare Report.
As these drugs reshape treatment pathways, companies will increasingly reposition adjacent assets to demonstrate clear, complementary value. We’ll see large outcomes trials aiming to clarify benefits in areas such as heart failure, kidney disease, fatty liver disease, and even sleep apnoea. If these trials succeed in proving a link between incretin-based therapies, it will permit a further widening of the clinical and commercial scope of these therapies.
The widespread popularisation of these therapies in the biopharma market will also have an impact on treatment pathways, reshaping health guidelines and how medical professionals approach chronic disease management. Accessibility will be front of mind to attract delayed adopters, as we’ve seen already with companies introducing different oral forumulations for GLP-1 drugs.
Biopharma dealmaking is set to remain selective but active
There were a number of high-profile mergers and acquisitions that occurred in 2025, including Johnson & Johnson’s $14.6 billion USD acquisition of Intra-Cellular Therapies to boost its neurological portfolio. From these deals, we can see investors are prioritising therapy solutions that generate repeatable pipelines rather than one-off products to improve risk diversification and long-term value creation.
As partnering and M&A continue to concentrate on differentiated late-stage assets and scalable platform technologies, companies with multi-asset potential are positioned to attract a disproportionate share of capital and strategic interest.
New digital landscape
Digital tools will increasingly support evidence and patient experience rather than sitting alongside therapies as standalone offerings. Remote monitoring and digital biomarkers will play a bigger role, enabling more continuous and real-world insights for therapies across clinical development and commercial usage. Adherence solutions will also expand to help patients manage complex therapies and give developers data on dosing, persistence, and patterns that can influence pricing and access negotiations.
