Looking ahead to 2026 in biopharma

As the biopharma industry heads into 2026, insights gained over the past year are set to be applied and scaled, especially in AI-driven drug development, advanced modalities, and cardiometabolic disease therapies.

These innovations will unfold amid shifting regulatory expectations and the rise of new digital tools, transforming how treatments are developed, delivered, and experienced.

Biopharma deals will remain active, but targeted

2025 saw several high-profile mergers and acquisitions, including Johnson & Johnson’s $14.6 billion purchase of Intra-Cellular Therapies to strengthen its neurological portfolio. These deals shone a spotlight on a key investor trend of prioritising therapy solutions that generate repeatable pipelines over one-off products, aiming to reduce risk and build long-term value.

As partnering and M&A continue to focus on differentiated late-stage assets and scalable platform technologies, companies with multi-asset potential are likely to attract a large share of capital and strategic interest.

Cardiometabolic disease will remain a major focus

Demand for next-generation incretin-based therapies, like GLP-1 receptor agonists (e.g., Ozempic) and DPP-4 inhibitors, is set to keep rising, as evidence of their effectiveness across obesity, diabetes, and cardiovascular risk reduction continues to grow.

As these therapies reshape treatment pathways, companies will increasingly reposition related assets to show clear, complementary value. Large outcomes trials will aim to clarify benefits in conditions such as heart failure, kidney disease, fatty liver disease, and sleep apnoea and, if these trials succeed, it could further expand both the clinical and commercial reach of these therapies.

The growing adoption of these treatments will also influence care pathways, health guidelines, and the way clinicians manage chronic diseases. Accessibility will remain a key consideration to attract later adopters, as seen with the introduction of new oral versions of GLP-1 therapies.

AI in drug discovery and development is set to pick up pace

Biopharma companies are moving past early exploratory AI projects and beginning to integrate AI across the entire drug development process. This shift promises shorter timelines, lower costs, and more personalised therapies.

AI is poised to transform target identification by quickly analysing vast biological and genomic datasets, uncovering new disease pathways, and prioritising targets based on their likelihood of success, work that previously took years of manual effort. In molecule design, generative models can speed up the creation and optimisation of candidates with the desired properties, cutting down synthesis cycles and reducing experimental failures.

Within clinical development, AI will support better patient selection, predict enrolment risks, inform adaptive trial designs, and help interpret interim data to enable faster, more informed decisions. Together, these applications show AI moving from a supportive tool to a key driver of R&D productivity.

As regulators begin to provide clearer guidance on using AI-generated evidence, adoption is expected to increase, and measurable productivity gains will start to appear. Clearer rules around regulation will reduce perceived risks and boost confidence in AI tools, opening the door to wider use and meaningful improvements across the sector.

Regulation will take a more central role

Regulation is set to play an increasingly important role in guiding development decisions, particularly in Europe, where updates on evidence requirements, unmet needs, and incentives are still in progress. Key examples include the rollout of EU joint HTA assessments, ongoing reforms under the EU pharmaceutical legislation, such as the Critical Medicines Act and EU Pharma Package, and the MHRA’s plans for sovereign marketing authorisation and point-of-care manufacturing frameworks in the UK.

These regulatory changes are largely a response to the rapid pace of innovation, as regulators work to adjust frameworks that can keep up with new therapies and technologies.

As a result, companies will focus more on trial design, endpoint selection, and real-world evidence to satisfy payer and health technology assessment (HTA) requirements. Access considerations will increasingly influence portfolio decisions, with companies carefully evaluating whether patients can actually obtain therapies, based on reimbursement, pricing, and coverage decisions by health systems.

A new digital landscape

Digital tools are continuing to become integrated with therapies, which are helping to support evidence generation and patient experience, rather than functioning as standalone offerings. Remote monitoring and digital biomarkers will provide continuous, real-world insights across clinical development and commercial use. Adherence solutions will expand, helping patients manage complex therapies while giving developers data on dosing, persistence, and usage patterns, which are insights that can influence pricing and access decisions.

Advanced modalities will face a test of scalability

Investment in advanced modalities, including cell therapy, mRNA, and protein degraders, is expected to grow, as next-generation treatments demand more bespoke and specialised approaches. If 2025 marked a breakthrough year for these modalities, driven by AI, gene editing and new therapeutic platforms, 2026 will be the year they are tested commercially, to determine whether they can produced reliably, at scale, and in a cost-effective way.

Investors and regulators will increasingly look for clearer proof points that advanced therapies offer durable benefits. Programmes with strong biological potential, but without a scalable delivery model, are likely to struggle to secure funding, with those combining science with solid plans for manufacturing, supply chains, and pricing standing out.

For customers, pricing will remain critical. Pushback against ultra-premium prices, especially for one-time treatments, has already begun, and payers are likely to scrutinise affordability even more closely in the coming year.

About the author

Simon Middleton is a partner at L.E.K. Consulting. He is a member of the Life Sciences practice and has worked for both clients and investors in the pharmaceutical, biotech, and medtech industries. Middleton has extensive experience across a range of therapeutic areas, including cardiovascular diseases, metabolic diseases, pain, and oncology. He holds a Masters in Biological Sciences from Oxford University, and an MPhil and PhD in Biological Anthropology from the University of Cambridge, where he specialised in molecular genetics.