As every year, it’s time to review the latest developments in the pharmaceutical sector that are expected to define the near future. The transformation of the industrial environment is closer to completion: the focus of innovative medicines is mainly on biologics and advanced therapy medicinal products (ATMPs). Artificial intelligence is playing an increasingly fundamental role at every stage of the lifecycle, from discovery, preclinical and clinical development to production and post-marketing surveillance.
The regulatory landscape is also evolving to incorporate new technologies that offer the possibility to improve efficiency, such as the use of real-world data to inform regulatory decisions.
Here, we provide an overview of the expected trends for 2026, based on insights from various analysts in the pharmaceutical sector.
The evolution of the market
According to the Boston Consulting Group, almost 90% of biopharmaceutical sales in 2025 came from blockbuster and mega-blockbuster products. This trend is expected to continue, albeit with a shift from the CAR-T and gene therapies that characterised the period from 2010 to 2020, towards targeted therapies for broader populations. Examples include GLP-1 products for treating obesity and anti-Alzheimer’s monoclonal antibodies. Other potential targets attracting investment include high-potential pathways such as PCSK9 orals and siRNA for treating high cholesterol and hypertension, and PD-1×VEGF bispecific products for treating cancer.
According to BCG, the shift towards wider indications and validated targets is also the result of political decisions, such as the US Inflation Reduction Act of 2022, which reduced the pricing window for many new drugs. According to the analyst, interest in innovative personalised therapies requiring complex logistics, such as CAR-T and gene therapies, is decreasing due to constraints in manufacturing and market access. This trend is reflected in the the increasing number of M&A deals focusing on marketed assets. According to BCG, lower-risk or incrementally innovative therapies will represent the new targets for biotech companies, while the value of preclinical companies has decreased by around tenfold since 2021 ($500 million average vs $50 million today).
Another complicating factor is represented by China’s growing role as an innovation hub, with the country contributing around 30% to the global biotech pipeline. According to BCG, India is also strengthening its position, particularly with regard to AI, data and manufacturing capabilities. The analysis also highlights concerns about the situation in Europe, where access could in future be limited to more innovative and lucrative treatments, leaving a wide portion of the population without the medicines they need.
Deloitte’s 2026 outlook also highlights the expected impact of the EU new legislation (including the EU AI Act, Corporate Sustainability Reporting Directive and European Health Data Space regulation), as well as China’s volume-based procurement programme. Conversely, the growing availability of real-world data and AI applications tailored to the needs of regulators will streamline many regulatory processes and procedures.
AI to overcome the traditional limits of pharma development
According to the ISPE, implementing new technological approaches is key to overcoming limitations of traditional development in terms of both the time needed to reach the market and the ability to analyse large and complex amounts of data.
Artificial intelligence has become a reality in most pharmaceutical companies, enabling the rapid identification of therapeutic targets and candidate molecules for tackling them efficiently. Thanks to the integration of quantum computing, the ability to detect the multivariate properties of drug molecules so to optimise drug development is expected to increase exponentially.
Artificial intelligence is also transforming the design and performance of preclinical and clinical trials. In-silico organ or AI-based disease models are supporting the shift away from animal testing towards more sustainable methods of collecting preliminary data on the expected efficacy, toxicity and pharmacokinetic profile of molecules. The same applies to the design of clinical studies, which can benefit from the increasing availability of digital twins of the patients to predict the impact of drug candidates on biological and pathological processes. Real-world data will facilitate the rapid recruitment of patients and enable the remote monitoring of studies and treatments, eliminating the need for frequent hospital visits.
These trends are ushering in a whole new approach to clinical development. This includes decentralised and virtual trials, telemedicine for remote monitoring, and the use of biomarkers and adaptive designs to speed up the interpretation of results. Blockchain technologies support all these new applications as a way to ensure data traceability and integrity.
Smart factories and new procurement models
While reshoring of productions is the current objective to ensure the availability of medicines in both the EU and the US, according to BCG artificial intelligence will allow for the optimisation of every step of the manufacturing process from an integrated end-to-end perspective, including procurement, demand planning and process engineering.
Fully automated manufacturing sites represent the new paradigm. This is particularly evident in the production of sterile medicines, where cleanroom operations are largely independent of human intervention. However, as an article on the World Insurance Associates blog explains, elimination of the human risk may result in the introduction of new vulnerabilities, including system errors and cyber-trigged shutdowns of the plants. Benefits can arise from predictive maintenance or the use of digital twin models of the plants to replicate the production environment.
Artificial intelligence is also expected to support new procurement models to take into account the increasing complexity of supply chains, given that many treatments will be widely prescribed or administered in ambulatory settings or at patients’ homes. According to BCG, new direct-to-patient and direct-to-employer commercial models could emerge for certain kinds of medicinal products.
Business trends and drugs to watch
According to the PwC’s outlook, cardiometabolic, CNS, oncology, and immunology will continue to be the most dynamic areas of innovation, also in terms of mergers and acquisitions. The growing importance of Chinese’s biotech sector is evident in the increasing number of China-to-West licensing and co-development programmes. Meanwhile, private equity and structured financing are emerging as valuable tools to bridge the gap from late-stage development to commercialisation.
The Drugs to Watch 2026 report from Clarivate identified 11 medicinal products that have recently been launched or are close to reaching the market. These include two molecules (the GLP-1 agonist orforglipron and the GLP-1-GIP-GCGR agonist retatrutide) intended for the treatment of obesity and type 2 diabetes. Protein degraders such as BGB-16673 and mezigdomide are expected to transform targetability in oncology. Promising treatments for rare and chronic diseases include the anti-IL-5 monoclonal antibody depemokimab for asthma and the oral peptide JNJ-2113 for plaque psoriasis. The BTK oral inhibitor olebrutinib and the monoclonal antibody sibeprenlimab are targeted at treating IgA nephropathy and multiple sclerosis, respectively. Three other new treatments address women’s health, namely gedatolisib for breast cancer, relacorilant for ovarian cancer and hypercortisolism, and TAR-200 for bladder cancer.
