Leaders in Pharma: 2026 predictions

With 2026 on the horizon, pharma leaders are already looking ahead. European Pharmaceutical Manufacturer asked industry voices what they think 2026 will bring, from innovation and AI to regulation and resilience. Here’s what they had to say.

Ross Meyercord, CEO, Propel Software

Next year will mark the tipping point for connected intelligence. Software platforms that extend data and workflows across the enterprise will dominate, while isolated tools will fade into irrelevance. Agentic AI is already proving that productivity breakthroughs come from collaboration, between systems as much as people.

The next generation of AI agents won’t live inside individual apps. They’ll communicate, coordinate, and act across entire tech ecosystems, turning fragmented processes into fluid, intelligent networks. In this new era, standalone software simply won't be able to compete. The demise of remaining on-premise software will accelerate, leaving just 15% of those companies over the next three years.

Updesh Dosanjh, practice leader for the Pharmacovigilance Technology Solutions, IQVIA

The next frontier for safety is proactive pharmacovigilance: preventing harm before it happens. At present, the industry relies heavily on a retrospective model. Pharmaceutical professionals analyse cases, submit reports on time, and update labels in an effort to prevent past mistakes from repeating themselves.   

Looking ahead to 2026, advances in artificial intelligence combined with strong governance can dramatically shorten the time between the detection of a safety signal and the corresponding action. This shift has the potential to bring decision-making close to real time, a concept I call “instant PV.” Achieving this requires a new way of measuring outcomes. The focus should expand beyond merely meeting service level agreements to include tracking reductions in adverse events per 10,000 patients, decreasing hospitalisations, and accessing the reach and adoption of safety communications among prescribers.   

Governance is the silver bullet that unlocks this future. It is the essential mechanism that makes this vision achievable and ensures that proactive pharmacovigilance becomes the standard for patient safety.

Miao Li, PhD, market development manager, Pioneer Antibody Library Discovery Platform, Life Science Group, Bio-Rad Laboratories

Breakthroughs in structural biology and high-resolution epitope mapping are opening access to previously hidden binding sites on established cancer targets like HER2, PD-1, and TNF-α. By targeting these cryptic regions, therapeutic antibodies can stay effective even in the presence of mutations or adaptive signalling changes, reducing the risk of treatment failure.

In parallel, advances in nanomembrane protein stabilisation and conformational analysis are making once “undruggable” targets, such as transmembrane (TMEM) protein domains, more accessible. These nanomembranes preserve native protein conformations and increase protein stability, enabling researchers to present GPCRs and other TMEM proteins in fully functional states during screening. At the same time, modern phage display platforms, enhanced by synthetic biology and next-generation sequencing, now allow deep epitope screening under diverse physiological conditions, enabling the design of microenvironment-specific antibodies, from hypoxic tumors to inflamed tissues. Importantly, the technology’s non-animal basis supports the industry’s shift toward more ethical and sustainable R&D practices.

Looking toward 2026, integrating a customised phage display platform with nanomembrane technologies could accelerate antibody discovery, streamline characterisation, and unlock novel antibody-based drugs against crucial signalling TMEM proteins that drive cancer progression and therapeutic resistance.

Mike Daniels, chief commercial officer, SynGenSys

The cell and gene therapy landscape is a rapidly evolving and growing space, with a surge of clinical trials and approvals throughout 2025. As we move into 2026, we anticipate continued growth in the sector, but with an increased focus on custom genetic components including promoters and signal peptides, alongside continued vector design development.

It is critical that cell and gene therapies are tissue type-specific to avoid adverse off-target effects, but many natural promoters currently used in the development of these therapeutics are limited in terms of activity profiles and size. Libraries of synthetic promoters, such as those designed to target liver or muscle tissue, will help to overcome key challenges in cell and gene therapy development, allowing for tuneable transgene expression with minimal off-target activity, facilitating development and subsequent commercialisation of safer and more effective therapeutics. The technology behind these libraries will also provide opportunity for the design of promoters tailored to a specific therapeutic need, enabling development of therapeutics for a much wider range of diseases where treatment options are currently limited.

Steve Gens, CEO, Gens & Associates

As AI becomes more integral to the work people are doing, the priority extends beyond matters of governance. We’re at a point now where companies need AI-performance-toolkit skills. Just as Excel, Word, and PowerPoint skills became critical to work 20 years ago and, during the pandemic, people suddenly had to become proficient in Teams or Zoom – it’s the same with AI now. People will need to be able to use it effectively in their daily working lives.

Renato Rjavec, VP Regulatory, ArisGlobal

The biggest theme for regulatory affairs will be associated with the realisation that strategic investment in digitisation has become an inevitable prerequisite for successful regulatory operations. Accelerated pace of evolving regulatory requirements in the area of electronic submissions (expansion of eCTD 3.x regions, adoption of eCTD 4.0), electronic exchange of product data (PMS, UDI), electronic labelling (ePI) and advanced technologies (generative and agentic AI) will leave behind anyone who has not so far observed the trends and invested in digital platforms to unify regulatory data and ensure its quality and compliance.

This trend has been so obvious over the last years that for me a real surprise is that so many life sciences companies are still caught by surprise.

John Cogan, COO, Qinecsa

The real impact of AI will be the biggest strategic theme for 2026 - which use cases will bring actual ROI so we can get away from the smoke and mirrors and focus on the reality. This does not surprise me as we’ve had 18 months of hype and PoCs, and now it’s time to do the math on investment vs return.

Michelle Bridenbaker, COO, Unbiased Science

In pharma all teams from manufacturing to medical affairs are going to be working to embed and expand the use of AI in their organisations. We have seen a massive move to transform the way we work starting in 2025, but in 2026, those of us that have begun in earnest the journey towards AI are beyond pilots and finding ways to build better use cases for AI, running more successful project pilots and moving towards more sustainable, AI driven solutions and transformation of how we work. This trend is here to stay, and we all must embrace this change as our resourcing & staffing models are getting leaner, our profit margins tighter, and our workloads are expanding – we must do more with less and AI is the only foreseeable way forward.

Megha Sinha, Kamet Consulting

I think the dominant strategic theme for 2026 will be orchestration of work across functions and platforms.

Life sciences companies now have plenty of point solutions — RIM, PLM, QMS, ERP, label tools, workflow apps — but the real struggle is how work actually flows between them. The differentiator will be the ability to:

  • see the end-to-end work graph (products, SKUs, markets, tasks, owners);
  • apply consistent, codified business rules; and
  • coordinate execution across regulatory, manufacturing, quality, supply and commercial.

It doesn’t really surprise me that I’m not simply saying “AI” is the theme. AI is critical, but its real value is as an engine within a work-orchestration fabric — not as yet another standalone tool or dashboard.

Lidia Garcia Martin, MSAT & new productions head, Recipharm

2026 is set to be a defining year for high-potency API (HPAPI) manufacturing. With precision medicine and disease indications like oncology and immunology relying increasingly on highly active compounds, manufacturers are under pressure to deliver safe and scalable solutions of these therapies. The next wave of progress is likely to be shaped by three major factors: automation, digitalisation, and sustainability.

Automation and robotics can reduce manual handling and the associated exposure risks when working with HPAPIs, strengthening operator protection while also improving process robustness. Containment systems are becoming more sophisticated, including closed systems, isolators, and advanced heating, ventilation, and air conditioning (HVAC) infrastructure. These technologies enable primary and secondary controls to work together more seamlessly.

In parallel, digitalisation can transform high-potency operations. Real-time monitoring and data-driven process control will enhance data availability and process understanding and will help organisations make science-based and fact-based decisions, refine risk management strategies, validate containment performance, and accelerate technical transfer and scale-up activities.

Dr Petra Dieterich, SVP & scientific leader, Abzena

In 2025, we saw a marked shift from Antibody-drug conjugates (ADCs) to Antibody-Oligonucleotide Conjugates (AOCs) in clinical development activities, and we expect this to continue to grow through 2026 and beyond. 

ADCs have seen extraordinary progress in oncology research, and innovators are building on this success by leveraging the precise targeting mechanism of antibodies in conjugation with other therapeutic agents, specifically RNA drugs, also called oligonucleotides.

Existing oligonucleotide drugs improve the health of cells by modifying protein production caused by defective genes. However, oligonucleotides have limited bioavailability, often requiring direct injection into the eye or spinal cord.  One solution to this problem is through covalent linkage of the oligonucleotide to a targeting protein to form Antibody Oligo-Conjugates (AOCs).  These are amenable to systemic delivery, which is far more patient-friendly. 

Dr. Matthew Lakelin, head of consultancy services & co-founder, TrakCel

The cell and gene therapy (CGT) sector is entering its next critical phase, shifting focus from scientific discovery to large-scale commercial delivery. Following the projected surge in regulatory approvals, 2026 will be defined by the industry's response to operational growing pains that now extend beyond scientific complexity.

The fundamental challenge lies in the fragmented digital ecosystem. Unlike traditional biologics, CGTs require highly individualised supply chains with precise logistics and close coordination across many different stakeholders. Historically, reliance on bespoke, siloed orchestration platforms has led to a proliferation of systems with inconsistent data structures, resulting in operational inefficiency and reduced scalability for treatment centres. Inefficiency is exacerbated when considering that each hospital will request data security assessments before using new portals and annual data security assessments thereafter. The requirement to be trained and use multiple different portals has led to a phenomenon known as “portal fatigue.”

Consequently, CGT portal trends are moving toward industry-wide collaboration, standardisation and data interoperability, which is a prerequisite for global scalability. The focus must be on adopting unified, standards-based platforms that can seamlessly integrate manufacturing, logistics and clinical systems, effectively reinforcing critical processes like chain of identity (COI) and chain of custody (COC) management.

Christian Dowdeswell, managing director, Arcinova, a Quotient Sciences company

More complex synthetic pathways driven by AI enabled drug discovery. The number of synthetic steps to get to a Small Molecule is set to increase dramatically, with drug discovery enabled by AI leading to more complex molecules constructed from non-existent building blocks. The emergence of tools such as digital twins to accelerate process development are critical in responding to this.

Personalised medicine will continue to make advances, with drug manufacturing at niche scales being an area where Arcinova is experiencing high demand, which we expect to continue  to grow during the next 12 months.

Return to investment in BioPharma, perhaps more of a prediction than a trend. Interest rates are widely expected to fall during 2026, which should see the return of investment into BioPharma. However, I fully expect that good clinical data & strong CMC packages will remain essential to securing funding in what will remain a competitive environment.

Renato Azevedo, sr. director, global product management - bioprocess, Ecolab Life Sciences

Three interconnected trends will define much of the bioprocessing industry’s focus in 2026: process intensification, cost efficiency, and partnership-driven innovation.

Process intensification remains paramount. Manufacturers are under pressure to do more with less, increasing productivity while reducing footprint and costs. We're developing next-generation chromatography resins that deliver higher performance without requiring facility redesigns or massive capital investment. The goal is seamless integration into existing infrastructure.

Cost pressures continue intensifying across the industry. Purification represents one of the highest cost areas in drug manufacturing, making it a critical focus for efficiency gains. From biosimilar competition to margin pressure on established products, manufacturers must find ways to enhance economic efficiency without compromising quality. Our purification technologies address this directly, targeting the area where meaningful cost reductions can be achieved.

Marinus Bouma, business development, Ofichem

Despite the rise of biologics, there is a continued but evolving role of small-molecule CDMOs. Even as biologics, cell therapies, and ADCs attract interest, small molecules will remain foundational. This includes not just the generic production, but also innovator drug manufacturing, meaning CDMOs focusing on small molecules will still have robust demand and strategic importance.

Many pharmaceutical companies continue to outsource small-molecule API manufacturing and formulation development rather than maintaining their own facilities, driven by cost-effectiveness, flexibility, and the desire to stay asset-light.

We expect that the outsourced development services will grow, for example in early-stage synthesis, scale-up, route scouting and optimization and more (both generics and innovative) small-molecule drugs are entering development pipelines that rely on CDMOs.

For 2026 we expect faster, more efficient delivery of small-molecule drugs to market. Thanks to better manufacturing processes (for example using continuous manufacturing), small-molecule drug developers outsourcing to CDMOs may see shorter development timelines, cost savings, and more reliable yields.

Jeremy Skillington, CEO, Poolbeg Pharma

I expect the deal momentum seen in late 2025 to continue well into 2026 and beyond, as the industry approaches one of the largest patent cliffs in its history. With substantial revenue at risk, Big Pharma, who have significant cash reserves, is racing to refill pipelines with assets that can deliver meaningful value for both their businesses and patients alike. Given its impressive efficacy, cancer immunotherapy will remain a major area of focus as more treatments reach the market, but the conversation is evolving: enhancing the safety and overall patient experience of these therapies is becoming just as critical as improving efficacy. Additionally, the influence of China across innovation, capital flow and global competitive dynamics is set to accelerate in 2026 and beyond. It will be fascinating to watch how this momentum shapes the next phase of biopharma development that will ultimately benefit patients across a host of different diseases.

Dr. Mark Lambrecht, global head of health care & life sciences, SAS

Data orchestration harmonises life sciences. As life sciences moves toward personalised medicine, we are no longer dealing with isolated data points. Instead, in 2026 and beyond we will orchestrate high-quality, continuous data streams from digital biomarkers, genomics, imaging and clinical laboratories. The promise of multimodal analysis – from genome-wide association studies to polygenic risk scores – depends on robust data engineering that can harmonise and contextualise these complex signals. Expect to see significant investment in the joining of the discovery and clinical analytical data fields.