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Darzalex

(daratumumab)

Darzalex (daratumumab) is a human IgG1k monoclonal antibody targeting CD38 on multiple myeloma cells. It is the backbone of multiple myeloma therapy across all treatment lines, from newly diagnosed to relapsed/refractory.

Oncology$9.0B RevenueGrowth blockbuster — Multiple myeloma franchise leader
MM Regimen Share
>70%
SC Admin Time
5 minutes
Approved Combinations
8+
Patients Treated
300K+

Drug Overview

Generic Name
daratumumab
Company
Johnson & Johnson
Mechanism
CD38 monoclonal antibody
Drug Class
Monoclonal antibody — Anti-CD38
Route
IV infusion / Subcutaneous injection
Approval Year
2015
Peak Sales Estimate
$12B+ by 2027
Patent Expiry
2029-2031 (estimated)

How It Works

Darzalex binds CD38 on myeloma cells, inducing death through CDC, ADCC, ADCP, and direct apoptosis. Also depletes immunosuppressive regulatory T and B cells.

Revenue History ($B)

Annual revenue trajectory

Competitor Revenue Comparison ($B)

Revenue of competing drugs in the same class

Approved Indications

4 indications

Key Indications

All approved therapeutic uses

Multiple Myeloma (newly diagnosed)
Relapsed/Refractory MM
Smoldering MM
AL Amyloidosis

Market Position

Darzalex is the backbone of MM therapy, used in >70% of regimens across all lines. Subcutaneous formulation (5-min vs 7-hr IV) dramatically improved convenience. Direct competitor Sarclisa has minimal share.

Future Outlook

Projected to reach $12B+ by 2027, driven by earlier treatment lines (smoldering MM), SC adoption, and geographic expansion. J&J also developing bispecifics (teclistamab) to complement the franchise.

Competitive Landscape

DrugCompanyRevenue
Revlimid (lenalidomide)BMS$6.0B (declining)
Pomalyst (pomalidomide)BMS$3.5B
Kyprolis (carfilzomib)Amgen$2.0B
Sarclisa (isatuximab)Sanofi$0.4B

Approval Timeline

Nov 2015
R/R MM (monotherapy)
FDA4th line+
Oct 2015
R/R MM (combination)
FDAWith Rd or Vd
May 2020
Newly diagnosed MM (D-Rd)
FDATransplant-ineligible
Apr 2021
Newly diagnosed MM (D-VRd)
FDATransplant-eligible
May 2020
Subcutaneous formulation
FDA5-minute administration

Key Clinical Trials

NCT03601120Completed
PERSEUS (D-VRd)
Phase 3709 patients
PFS benefit confirmed
NCT04071157Completed
CASSIOPEA (D-VTd)
Phase 31,234 patients
Improved CR rate
NCT04975955Ongoing
AJUSTICE (smoldering MM)
Phase 3360 patients
Awaiting readout
Data Sources

Revenue figures from company annual reports (FY2023). Clinical trial data from ClinicalTrials.gov. Competitive intelligence from Evaluate Pharma World Preview 2024 and IQVIA MIDAS. Market analysis by Medifirm Intelledge Global.