The pharmaceutical industry is witnessing a dramatic shift in R&D economics, with mounting pressure to reverse declining returns on investment through digital innovation. Recent data reveals a concerning trend: the mean cost of bringing a new asset to market has surged from $1.1 billion in 2010 to $2.1 billion in 2018, while projected returns have plummeted from 10.1% to 1.9%, according to Deloitte's analysis.
Digital Solutions Reshaping R&D Landscape
ICON's Chief Information Officer Tom O'Leary attributes this ROI decline to several factors, including increased capabilities costs and the shift toward more targeted therapies. "Gone are the days of blockbuster drugs. The efforts to identify those patients who are going to benefit most from a drug takes a considerable amount of time and effort," O'Leary explains.
A new report from ICON, "Digital Disruption in Biopharma," outlines how digital transformation could help reverse these concerning trends. The report emphasizes that while technologies like AI and Big Data offer tremendous potential, their successful implementation requires significant organizational changes.
Key Technologies Driving Change
Big Data and real-world data (RWD) are emerging as crucial tools, particularly in oncology research. The combination of electronic health records with imaging, genetic, and molecular test data is advancing the development of targeted treatments, including CAR-T and other cell therapies.
Artificial Intelligence is becoming increasingly vital as the engine that processes this wealth of data. AI applications in clinical trials range from:
- Automating study data entry
- Analyzing EHR data for patient recruitment
- Monitoring protocol compliance
- Adaptive dose-finding
- Drug discovery and molecular modeling
Industry Adoption and Implementation
The industry's embrace of digital transformation is accelerating rapidly. A survey of nearly 350 industry executives revealed that almost 80% of companies are either using or planning to implement AI or Big Data approaches in R&D, a significant increase from 36% in 2017.
Advanced analytics and AI were identified as the technologies with the highest potential for improving R&D productivity, followed by biomarker identification and EHR utilization. The survey also indicated that targeting biomarkers and gene therapies are the therapeutic approaches most likely to benefit from digital technologies.
Organizational Impact and Future Outlook
The digital transformation is catalyzing significant organizational change, with 70% of surveyed companies reporting the breakdown of internal silos or formal reorganization. However, O'Leary notes that widespread adoption may take time due to the lengthy nature of drug development processes.
"Companies aren't going to change their processes or technologies mid-stream on the development of other drugs. They're instead looking for new assets in the pipeline to try these new capabilities on," O'Leary explains.
Patient Engagement in the Digital Era
The success of digital transformation heavily relies on patient engagement. "The whole area of digital often requires the patient to engage via devices or sensors that capture the data needed," O'Leary emphasizes. Future success will depend on demonstrating that new drugs and devices are the best options for patients, incorporating their feedback throughout the development process.
