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Data updated: Nov 8, 2026

Roche

Big Pharma
OncologyImmunologyNeurology Execution: Good

Swiss pharma-diagnostics leader known for oncology and diagnostics integration. Key franchises include Tecentriq, Hemlibra, and Ocrevus. Pioneer in personalized medicine.

$66.4B
Revenue (2024)
$240.0B
Market Cap
-
Trials
1
New Drugs (2yr)
Modality:
9 Small Molecules 31 Biologics

FDA Novel Drug Designations

(2016-2024)
13 Novel 7 First-in-Class 7 Orphan 8 Breakthrough 5 Accelerated 10 Priority Review 5 Fast Track
See 13 novel approvals →
2024 ITOVEBI (INAVOLISIB) Breakthrough · Priority Review
2024 PIASKY (CROVALIMAB-AKKZ) Orphan
2023 COLUMVI (GLOFITAMAB-GXBM) Priority Review · Accelerated · Fast Track
2022 VABYSMO (FARICIMAB-SVOA)
2022 LUNSUMIO (MOSUNETUZUMAB-AXGB) First-in-Class · Orphan · Breakthrough · Priority Review · Accelerated
2020 EVRYSDI (RISDIPLAM) Orphan · Priority Review · Fast Track
2020 ENSPRYNG (SATRALIZUMAB) First-in-Class · Orphan · Breakthrough · Fast Track
2019 ROZLYTREK (ENTRECTINIB) Orphan · Breakthrough · Priority Review · Accelerated
2019 POLIVY (POLATUZUMAB VEDOTIN-PIIQ) First-in-Class · Orphan · Breakthrough · Priority Review · Accelerated
2018 XOFLUZA (BALOXAVIR MARBOXIL) First-in-Class · Priority Review
2017 OCREVUS (OCRELIZUMAB) First-in-Class · Breakthrough · Priority Review · Fast Track
2017 HEMLIBRA (EMICIZUMAB) First-in-Class · Orphan · Breakthrough · Priority Review
2016 TECENTRIQ (ATEZOLIZUMAB) First-in-Class · Breakthrough · Priority Review · Accelerated · Fast Track

Roche at a Glance

  • Leading 21 drug targets across portfolio
  • Fast trial execution (30 months median completion)

Upcoming FDA Decisions

Full Calendar →
Nov 30, 2026 — Giredestrant
17d
Dec 18, 2026 — Giredestrant + everolimus

Roche's Recent FDA Approvals

Roche secured 1 new FDA approval for novel drugs (NDA/BLA) in the last two years.

Roche's Therapeutic Areas

Roche's approved drugs and pipeline span 5 therapeutic areas, led by Oncology and Immunology, across 31 biologic and 9 small-molecule drugs. Weighted by commercial stage — approved drugs count most, then late-stage trials.

Oncology 62%
20 drugs Phase 3: 176 Phase 2: 204 Phase 1: 334
Immunology 16%
3 drugs Phase 3: 75 Phase 2: 26 Phase 1: 43
Neurology 9%
2 drugs Phase 3: 36 Phase 2: 22 Phase 1: 27
Metabolic 7%
0 drugs Phase 3: 31 Phase 2: 14 Phase 1: 15
Ophthalmology 6%
3 drugs Phase 3: 22 Phase 2: 11 Phase 1: 15

Roche's Top Competitors

Roche's closest competitors by therapeutic-area and drug-target overlap include AbbVie, Eli Lilly, and Pfizer. Ranked by overlap in therapeutic areas and drug targets across approved drugs and pipeline.

Roche Pipeline Snapshot

Roche has 1051 active clinical programs from ClinicalTrials.gov — 340 Phase 3, 277 Phase 2 and 434 Phase 1.

340
Phase 3
277
Phase 2
434
Phase 1

Phase 3 Readout Calendar Pro

8 Phase 3 trials with confidence-graded primary completion dates.

Full calendar →
Q4 2026
Satralizumab
NMDAR Autoimmune Encephalitis
Estimated · aging NCT05503264
Q4 2026
Alectinib
Non-Small Cell Lung Cancer
Estimated · aging NCT05170204
Q4 2026
Pertuzumab
Solid Tumors
Estimated · aging NCT02320435
Unlock 5 more readouts with confidence-graded estimates
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Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.

Pro Intelligence Preview

Deep insights for investors and analysts

Revenue Insights

  • • OCREVUS leads revenue
  • • 5 key drugs tracked
View revenue breakdown →

Trial Catalysts

  • • Oncology pipeline focus
  • • 8 Phase 3 readouts tracked
View readout calendar →

Patent Risk

  • • Patent expiration timeline
  • • Revenue at risk analysis
View patent timeline →

Compare Companies

  • • Side-by-side pipeline analysis
  • • Revenue & market share comparison
Compare with competitor →

Execution Intelligence

  • • Phase 3: 281/420 completed
  • • Speed: 30 months avg
Unlock Full Intelligence

Revenue forecasts • Trial milestones • Patent risk modeling

How We Calculate These Metrics

Execution Quality Score

Measures trial completion rates weighted by phase importance. Phase 3 trials count 4x more than Phase 1 because late-stage completion is harder and more valuable.

What counts as "completed": A trial that reached its planned endpoint and reported results. Trials that were terminated early, withdrawn, or suspended are not counted as completed—these often indicate safety issues, lack of efficacy, or strategic pivots.

  • Excellent (80%+): Top-tier execution, most trials reach planned endpoints
  • Good (60-79%): Strong execution with occasional early terminations
  • Fair (40-59%): Average execution, notable rate of terminated/withdrawn trials
  • Needs Improvement (under 40%): High termination rates, execution challenges