Read the predictions of many leaders in the pharma industry, as we discuss what to expect in 2025!
There are so many sections in the pharma industry that are constantly growing each year, such as AI, sustainability and regulations - how do leaders in pharma see these progressing even further in 2025?
AI
Ana Pedro Jesuíno, associate director of marketed product safety, IQVIA:
In 2025, pharmacovigilance will undergo a bold transformation as AI and Machine Learning (ML) move beyond buzzwords to become the backbone of proactive safety management, reshaping how the pharmaceutical industry engages with real-world data and patient outcomes.
Chris Moore, European president of life sciences firm Veeva:
- European biopharmas that prioritise clean, harmonised data will unlock AI’s potential in 2025, leveraging regulatory frameworks like the EU AI Act to drive safe and scalable AI adoption.
- AI will revolutionise the review process of medical, legal, and regulatory (MLR) content that biopharmas produce, ensuring faster review cycles and better compliance.
- Adoption of advanced analytics AI will depend on investment in upskilling teams, and ensuring AI tools enhance decision-making rather than adding unnecessary complexities.
Simon Johns, director of medical information and marketed product safety, IQVIA:
In 2025, medical information (MI) will continue to adapt to the evolving needs of healthcare providers, patients, and consumers, particularly with the growing preference for self-service options through digital channels. This evolution will be driven by the integration of artificial intelligence (AI) technologies, enabling MI to become more responsive, efficient, and customer-centric.
Regulations
Marcela Miño, global head of lifecycle management and regulatory affairs, IQVIA:
In 2025, AI will reshape pharmacovigilance (PV) and regulatory affairs, transforming compliance into a proactive strategy that drives efficiency, enhances global agility, and redefines resource allocation.
Dr Philip Simister, head of science & entrepreneur advocate, OBN:
Approvals for biologics are on the increase, the cell and gene therapy areas have seen new modalities approved, with engineered TCR-T-cells and TILs for solid tumours and CRISPR-Cas9 gene-edited therapies passing regulatory approval in the last year or more, and highly relevant for rare disease treatment. Antibody-drug conjugates (ADCs) are a high-growth area and there is much interest in radiopharmaceuticals for precision oncology medicine, and cancer vaccines.
Sustainability
Louise Madden, CEO, H.E.L Group:
- 2025 marks a pivotal shift in industrial biotechnology as waste byproducts like CO2 and syngas emerge as preferred feedstocks for biomanufacturing. This transition, driven by mounting pressure for decarbonisation, will revolutionise how we produce sustainable aviation fuels (SAF), vaccines, and alternative proteins. High-pressure benchtop bioreactors which maximise substrate availability and volumetric productivity have opened opportunities for large-scale sustainable manufacturing.
- Biomass fermentation industries will lead this transformation, demonstrating that sustainable gaseous feedstocks and high-pressure fermentation can deliver both environmental and commercial benefits.
- Industries integrating advanced bioreactors into their process development will unlock enhanced carbon conversion efficiencies and titres, whilst reducing consumable costs with improved volumetric productivity. The utilisation of automation will play a crucial role in the safety and use of gaseous feedstocks, as smart control systems ensure reproducibility across scales. This technological convergence will significantly reduce production costs, making gaseous carbon-based biomanufacturing comparable and economically competitive with traditional methods.
Funding / Cost Saving
Stuart Rose, CEO, OBN:
Predictions from Jefferies of an increase in the public markets should see a several year stagnation of IPOs go into reverse. Probably not dramatic but the sentiment shift should bolster confidence and this, in turn, will create a helpful sentiment for private investment (boosting this also). The latter is critical lifeblood for the smaller companies and the sector needs it badly to leverage the excellent innovation that continues.
Richard J Cuthbert PhD, product manager, flow and antibody business, Bio-Rad Laboratories – Antibodies:
- The pharmaceutical and biopharmaceutical industries are undergoing significant restructuring efforts, driven by economic challenges and the need to adapt to evolving market conditions. Cost-saving and restructuring plans have focused on creating leaner, more agile organisations. Automation and outsourcing optimise costs and enhance scalability, allowing companies to adjust capacity with fluctuating demands without fixed costs.
- Outsourcing has also become a strategic approach to manage resource-intensive tasks more efficiently, particularly in complex and resource-intensive process such as antibody discovery. By outsourcing, companies can access cutting-edge technologies and expertise without the need for significant in-house investment.
Sabika Rizvi, director of aggregate reporting and benefit risk management services, IQVIA:
In 2025, the pharmacovigilance field will see technology’s role expand beyond cost-cutting to redefine operational efficiency and global compliance, but success will hinge on a bold recalibration of the human-machine balance.
Clinical Trials
Jim DiCesare, vice president, financial management solutions at IQVIA Technologies:
- To ensure participant satisfaction, retention, diversity and inclusivity is maintained to the highest levels, clinical trials will need to approach their participants with a “white glove” service mentality. To do so, clinical trials will leverage advanced digital technologies to ensure the payment process is done fairly and efficiently.
- Clinical trials must evaluate and ensure that their cybersecurity protocols are up-to-date and scalable as they involve more participants for larger and more complex studies.
Dr Brian Burke, chief commercial officer, Tozaro:
The effectiveness of autologous therapies for the treatment of cancer has been shown again and again. However, the number of patients successfully treated with these therapies is generally lower than most people assume - with only 30 to 40 thousand patients treated globally since the inception of CAR-T as a therapy modality. Two significant factors for this low figure are cost and logistics. As a result, allogeneic treatments have been heralded as a more cost-effective option, although progress towards routine use of allogeneic cell platforms has been slow. There is a possibility these therapies may be bypassed altogether by in vivo CAR-T treatments using viruses - with a record number of clinical trials already underway. One recent highlight in this space saw Interius Biotherapeutics announce the first use of durable in vivo CAR therapy in the clinic to treat B-cell malignancies using a lentiviral vector. It’s certainly an interesting race in this space!
Jeremiah McDole PhD, oncology segment manager, digital biology group, Bio-Rad Laboratories - Digital Biology Group:
- Tissue-based cancer biomarker detection has been a gold standard approach for the diagnosis and treatment of most kinds of solid tumour cancers. Unfortunately, the information provided only represents a momentary snapshot and narrow slice of the dynamic and heterogenous tumour progression cycle.
- The ability to detect circulating tumour DNA (ctDNA) with high sensitivity and precision in blood and other bodily fluids has enabled cancer investigators to monitor a tumour’s response to therapy, detect molecular residual disease (MRD) after curative-intent therapy, and track recurrence after a patient achieves remission.
- Perhaps, most exciting is the potential to detect and even treat early cancer occurrence well before the onset of clinical symptoms – something that can improve and save many lives.
- Further, the value of ctDNA has been recognised for clinical trials as the FDA has been building a guidance to utilise this biomarker as a potential endpoint. A move that could dramatically reduce required enrolment times for patients and impart significant saving to pharma companies.
Patrick Brady, global head of therapeutic innovation and regulatory science, IQVIA:
The regulatory landscape in 2025 will continue to reflect progress made by agencies like the FDA and EMA in fostering clinical trial innovation. Initiatives such as the FDA’s Center for Clinical Trial Innovation (C3TI) and the EMA’s Accelerating Clinical Trials (ACT EU) program have set the stage for global collaboration, aiming to make clinical research more efficient and attractive.
Drug Discovery
Dr Philip Simister, head of science & entrepreneur advocate, OBN:
- The success of GLP-1 receptor agonists for type 2 diabetes and obesity control could see competitor weight-loss drugs being pushed harder. Microbiome and healthspan/longevity research is expected to grow with more companies entering the space. Neurodegenerative research for major illnesses characterised by dementia (Alzheimer’s and Parkinson’s diseases) should be boosted by increased early-stage funding.
- Shortening of drug discovery pipelines, from early discovery to lead optimisation, will more likely be possible with the implementation of machine learning/deep learning methods in workflows. For comprehensive integration, this will necessitate better data capture and management practices, and a growth in end-to-end lab automation for standardised data acquisition.
Leadership
Stuart Rose, CEO, OBN:
The importance of a breadth of leadership skills will be more important than ever. Linked to investment, in a demanding market (and investors will be discerning as to where they put their cash), R&D SMEs will need to show an awareness of the full breadth of leadership accountabilities in their business plan (IP, regulatory, strategic, culture & strategy, clinical, commercial differentiation etc).
Automation
Richard J Cuthbert PhD, product manager, flow and antibody business, Bio-Rad Laboratories – Antibodies:
Automated high throughput flow cytometry instruments, focused on usability and efficiency can greatly improve lab productivity. They allow large volumes of samples to be processed with high precision and accuracy, significantly reducing the time and effort required for manual handling.
As the industry continues to evolve, the adoption of automation and outsourcing will play a crucial role in driving future growth and success.