Our approach to R&D

The COVID-19 pandemic is only one example of the enormous burden that disease puts on society. From leading causes of death such as heart disease and cancer, to rare but debilitating genetic disorders, the disability and mortality associated with serious illness harms economic growth and exacerbates social inequality.

Finding solutions to these problems is why Novartis exists. Our more than 20 000 employees in research and development (R&D) work to discover and develop medicines for diseases with high unmet need. Our R&D teams have built depth in core disease areas including cardiovascular and renal, oncology, hematology, immunology and neuroscience, while we maintain innovative investigational and in-market programs in ophthalmology and respiratory-allergy. We are also advancing our pipeline of investigational medicines for malaria and other neglected diseases.

With our strong capabilities across five platforms – chemical biology, biotherapeutics (biologics), radioligand therapy, cell therapy and gene therapy – we have a unique foundation to address disease burdens faced by people around the world today and for decades to come.

20

Clinical data readouts

in 2021, paving the way for further launches in 2022 and beyond

34

Major submissions

in the US, the EU, Japan and China during 2021

Novartis continued to deliver transformative innovation to patients in 2021. We received 21 major approvals, including new treatments for high cholesterol and chronic myeloid leukemia, and made 34 major submissions. We advanced our diverse pipeline of investigational therapies, with three breakthrough therapy designations from the US Food and Drug Administration (FDA) and around 20 clinical data readouts paving the way for further launches in 2022 and beyond.

Our R&D efforts span two units. The Novartis Institutes for BioMedical Research (NIBR) leads drug discovery and development from concept to early clinical evaluation, and also partners with an external network of around 300 academic collaborators and 100 industry collaborators focused on areas of mutual scientific interest. Global Drug Development (GDD) leads the advanced clinical development of potential new medicines, running large clinical trials and steering the way to regulatory approval and access for patients.

50

Diseases

within the scope of our research and development programs

15+

Research and clinical programs

underway to identify and accelerate the next generation of radioligand therapies for cancer

These efforts have given Novartis one of the strongest discovery and development programs in the industry, with more than 275 research programs as well as 98 assets in development, spanning around 50 diseases and 71 new molecular entities. We invested USD 9.5 billion in R&D in 2021, or approximately 18.5% of our net sales, compared with USD 9.0 billion in 2020.

We prioritize projects with the potential to transform the standard of care for patients. Approximately 85% of our treatments in development have the potential to be first in class or first in a specific indication, while about 80% target areas of high unmet patient need.

We systematically integrate access into our discovery and development work. For example, we regularly review all drug development submissions and hold our clinical research teams accountable for acting on access opportunities. We also engage patients in how we research and develop our medicines, and we strive to include diverse patient populations in our studies to ensure we understand how patients everywhere might respond to a medicine.

Data science and digital technology

We use data and digital strategies across our R&D operations to open new paths to scientific discovery, improve patient outcomes and streamline the development process. Our investments in digital technology also helped to keep our clinical trials on track during the COVID-19 pandemic. For more information, please see the section “Go big on data and digital.”