Landscape
Where biomarker drug development is busy, and where it is not
Every biomarker on marked.bio on one map: how many active trials select patients by it, how many companies run them, and how many approvals exist already.
- Biomarkers
- 23
- Active biomarker-selected trials
- 1,581
- Companies leading them
- 319
- Approved indications
- 223
132 FDA, 91 EU
Opportunity map
Each dot is a biomarker; bigger dots have more companies running trials. Bottom right means many trials but few approvals: drug developers are competing to be first. Top right is crowded and established; bottom left is early or niche. Click a dot to open the page.
Counts active trials that select patients by the biomarker itself (not a broader group). Approvals are FDA-approved indications that name the biomarker. Biomarkers marked New were added in v3.0 and have had fewer accuracy checks than the others.
Momentum
Trials started per year from 2016 to 2025, and the change in trial starts between 2022–2023 and 2024–2025. Click a column heading to sort.
| Biomarker | Active trials | Phase 3 | Companies | FDA | EU | Starts 2016–2025 | Change | Position |
|---|---|---|---|---|---|---|---|---|
| MSI-H / dMMR | 221 | 30 | 57 | 16 | 9 | 0% | Busy and established | |
| EGFR exon 19 deletion / L858R | 197 | 43 | 32 | 16 | 13 | -7% | Busy and established | |
| IDH1/2 mutation New | 139 | 21 | 23 | 8 | 3 | +28% | Busy and established | |
| BRCA1/2 mutation | 131 | 19 | 28 | 16 | 9 | -6% | Busy and established | |
| ALK fusion | 124 | 25 | 23 | 9 | 13 | -9% | Busy and established | |
| KRAS G12C | 123 | 25 | 33 | 4 | 2 | -10% | Busy and established | |
| HER2-low / ultralow (IHC 1+ or 2+/ISH-) | 114 | 17 | 27 | 2 | 2 | +49% | Busy, few approvals | |
| Claudin 18.2 expression New | 106 | 20 | 32 | 1 | 1 | +9% | Busy, few approvals | |
| BRAF V600E | 80 | 12 | 10 | 17 | 13 | +6% | Busy and established | |
| KRAS G12D New | 65 | 10 | 25 | 0 | 0 | +414% | Busy, few approvals | |
| PIK3CA activating mutation New | 59 | 14 | 22 | 3 | 3 | -52% | Busy and established | |
| ROS1 fusion | 48 | 11 | 13 | 5 | 3 | +60% | Busy and established | |
| HER2 (ERBB2) activating mutation New | 46 | 7 | 24 | 5 | 1 | +18% | Established, quieter | |
| EGFR exon 20 insertion New | 45 | 11 | 21 | 3 | 2 | -17% | Established, quieter | |
| FLT3 mutation (ITD/TKD) New | 43 | 7 | 12 | 3 | 3 | -33% | Established, quieter | |
| NPM1 mutation New | 37 | 5 | 11 | 2 | 0 | +125% | Early or niche | |
| RET fusion or mutation New | 31 | 9 | 11 | 5 | 4 | -77% | Established, quieter | |
| NTRK1/2/3 fusion | 27 | 1 | 10 | 3 | 3 | +33% | Established, quieter | |
| MET exon 14 skipping New | 21 | 2 | 12 | 2 | 2 | -38% | Early or niche | |
| FGFR2 fusion or rearrangement New | 18 | 2 | 11 | 3 | 2 | -58% | Established, quieter | |
| ESR1 mutation New | 9 | 3 | 4 | 5 | 2 | – | Established, quieter | |
| FGFR3 alteration (mutation or fusion) New | 9 | 0 | 5 | 1 | 1 | -50% | Early or niche | |
| NRG1 fusion New | 6 | 0 | 4 | 3 | 0 | – | Established, quieter |
Trial starts come from the registry's start date of trials that select the biomarker directly, whatever their current status. 2026 is left out because the year is not over.
Most active companies
Companies leading the most active biomarker-selected trials across all pages. See all 319 companies.