MARKET SIZE
The healthcare digital twin market reached $500M in 2024 and is projected to grow at 28% CAGR to $8B by 2035. Digital twins create computational models of individual patients or populations, enabling virtual clinical trials, personalized treatment optimization, and regulatory-grade in silico evidence generation.
APPLICATION SEGMENTS
- In Silico Trials: 35% share—virtual patient populations for trial design and augmentation
- Organ Modeling: 25% share—heart, liver, kidney physiological simulations
- Drug Response: 20% share—PK/PD modeling, dose optimization
- Disease Progression: 12% share—longitudinal disease trajectory modeling
- Surgical Planning: 8% share—anatomical twins for procedure optimization
KEY PLAYERS
- Quris AI: Bio-AI platform combining organoids with digital twins
- Dassault Systèmes: Living Heart Project, virtual physiological human
- Siemens Healthineers: Digital twin for cardiac procedures and imaging
- Unlearn.AI: Digital twin control arms for clinical trials
- InSilico Trials: Virtual populations for regulatory submissions
REGULATORY ACCEPTANCE
FDA has accepted digital twin evidence for device approvals (cardiac devices, orthopedic implants) and is developing frameworks for drug applications. EMA's qualification of in silico methods and ICH M&S guidelines signal growing regulatory acceptance for computational evidence in marketing authorizations.