DARZALEX has significant market potential as a leading monoclonal antibody for multiple myeloma treatment. Its approval in various combinations for both newly diagnosed and relapsed/refractory patients has expanded its reach. The multiple myeloma market is expected to grow steadily, with DARZALEX contributing significantly due to its strong clinical efficacy and growing adoption.
LAS VEGAS, March 20, 2025 /PRNewswire/ -- DelveInsight's "DARZALEX Market Size, Forecast, and Market Insight Report" highlights the details around DARZALEX, a human IgG1k monoclonal antibody that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of DARZALEX. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Janssen's DARZALEX (daratumumab, JNJ-54767414) Overview
DARZALEX (daratumumab) is a prescription medication used to treat multiple myeloma, a type of blood cancer. It is not a chemotherapy drug but a human IgG1k monoclonal antibody that binds strongly to the CD38 molecule, which is highly expressed in multiple myeloma cells. Daratumumab works by activating the immune system to target and destroy cancer cells, leading to rapid tumor cell death through various immune-mediated mechanisms and immunomodulatory effects. It also induces direct tumor cell death through apoptosis (programmed cell death). Janssen Biotech develops and commercializes DARZALEX under an exclusive global license from Genmab. As the first CD38-targeting monoclonal antibody, DARZALEX has received Orphan Drug and Breakthrough Therapy designations for multiple myeloma, helping to accelerate its approval process.
DARZALEX is approved for the treatment of adult patients with multiple myeloma in various combinations and settings:
Newly Diagnosed Patients (Ineligible for Autologous Stem Cell Transplant): In combination with lenalidomide and dexamethasone, or with bortezomib, melphalan, and prednisone.
Newly Diagnosed Patients (Eligible for Autologous Stem Cell Transplant): In combination with bortezomib, thalidomide, and dexamethasone.
Relapsed or Refractory Multiple Myeloma:
- In combination with lenalidomide and dexamethasone for patients who have received at least one prior therapy.
- In combination with bortezomib and dexamethasone for patients who have undergone at least one previous treatment.
- In combination with carfilzomib and dexamethasone for patients who have received one to three prior lines of therapy.
- In combination with pomalidomide and dexamethasone for patients who have undergone at least two prior therapies, including lenalidomide and a proteasome inhibitor.
As Monotherapy: For patients who have received at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent, or those who are double-refractory to both classes of drugs.
Apart from this, DARZALEX FASPRO is a subcutaneous (SC) formulation that combines daratumumab, a CD38-targeting cytolytic antibody, with hyaluronidase, an enzyme that aids in drug absorption. It is indicated for the treatment of adult patients with multiple myeloma in various scenarios:
Newly Diagnosed Patients (Ineligible for Autologous Stem Cell Transplant):
- In combination with bortezomib, melphalan, and prednisone.
- In combination with lenalidomide and dexamethasone.
Newly Diagnosed Patients (Eligible for Autologous Stem Cell Transplant):
- In combination with bortezomib, thalidomide, and dexamethasone.
Relapsed or Refractory Multiple Myeloma:
- In combination with lenalidomide and dexamethasone for patients who have received at least one prior therapy.
- In combination with bortezomib and dexamethasone for patients who have undergone at least one previous treatment.
- In combination with carfilzomib and dexamethasone for patients with one to three prior lines of therapy.
- In combination with pomalidomide and dexamethasone for patients who have received at least one prior therapy, including lenalidomide and a proteasome inhibitor.
As Monotherapy: For patients who have received at least three prior therapies, including a proteasome inhibitor and an immunomodulatory agent, or those who are double-refractory to both drug classes.
DARZALEX is currently being investigated in multiple clinical trials for multiple myeloma including PERSEUS for frontline multiple myeloma transplant eligible, CEPHEUS for frontline multiple myeloma transplant ineligible, and AQUILA for smoldering multiple myeloma. In 2024, DARZALEX generated sales of USD 11.6 billion across the world.
Drug Name | DARZALEX (daratumumab, JNJ-54767414) |
Molecule type | Monoclonal antibody |
Developer | Johnson & Johnson (Janssen) |
First Approval Year | US: 2015; EU: 2016; JP: 2017 |
Primary Indication | Adult patients with multiple myeloma |
Mechanism of action | Binds to CD38 and inhibits the growth of CD38-expressing tumor cells |
Route of administration | DARZALEX: IV infusion; DARZALEX FASPRO: SC injection |
DARZALEX Dosage and Administration
Monotherapy and in combination with Lenalidomide (D-Rd) or Pomalidomide (D-Pd) and Dexamethasone
The DARZALEX dosing schedule for combination therapy (4-week cycle regimens) and monotherapy is as follows:
- Combination therapy with lenalidomide and low-dose dexamethasone for newly diagnosed patients ineligible for autologous stem cell transplant (ASCT) and in patients with relapsed/refractory multiple myeloma.
- Combination therapy with pomalidomide and low-dose dexamethasone for patients with relapsed/refractory multiple myeloma.
- Monotherapy for patients with relapsed/refractory multiple myeloma.
The recommended dose of DARZALEX is 16 mg/kg actual body weight administered as an IV infusion according to the following dosing schedule:
Weeks | Schedule |
Weeks 1–8 | Weekly (total of eight doses) |
Weeks 9–24a | Every 2 weeks (total of eight doses) |
Week 25b onwards until disease progression | Every 4 weeks |
aFirst dose of the every-2-week dosing schedule is given at Week 9 bFirst dose of the every-4-week dosing schedule is given at Week 25 | |
In combination with Bortezomib, Melphalan, and Prednisone (D-VMP)
The DARZALEX dosing schedule for combination therapy with bortezomib, melphalan, and prednisone (6-week cycle regimen) for patients with newly diagnosed multiple myeloma ineligible for ASCT. The recommended dose of DARZALEX is 16 mg/kg actual body weight administered as an IV infusion according to the following dosing schedule:
Weeks | Schedule |
Weeks 1–6 | Weekly (total of six doses) |
Weeks 7–54a | Every 3 weeks (total of 16 doses) |
Week 55b onwards until disease progression | Every 4 weeks |
aFirst dose of the every-3-week dosing schedule is given at Week 7 bFirst dose of the every-4-week dosing schedule is given at Week 55 | |
In Combination with Bortezomib, Thalidomide, and Dexamethasone (D-VTd)
The DARZALEX dosing schedule for combination therapy with bortezomib, thalidomide, and dexamethasone (4-week cycle regimen) for patients with newly diagnosed multiple myeloma eligible for ASCT. The recommended dose of DARZALEX is 16 mg/kg actual body weight administered as an IV infusion according to the following dosing schedule:
Treatment Phase | Weeks | Schedule |
Induction | Weeks 1–8 | Weekly (total of 8 doses) |
Weeks 9–16a | Every 2 weeks (total of four doses) | |
Stop for High Dose Chemotherapy and ASCT | ||
Consolidation | Week 1-8b | Every 2 weeks (total of four doses) |
aFirst dose of the every-2-week dosing schedule is given at Week 9 bFirst dose of the every-2-week dosing schedule is given at Week 1 upon re-initiation of treatment following ASCT | ||
In combination with Bortezomib and Dexamethasone (D-Vd)
The DARZALEX dosing schedule for combination therapy with bortezomib and dexamethasone (3-week cycle regimen) for patients with relapsed/refractory multiple myeloma. The recommended dose of DARZALEX is 16 mg/kg actual body weight administered as an IV infusion according to the following dosing schedule:
Weeks | Schedule |
Weeks 1–9 | Weekly (total of nine doses) |
Weeks 10–24a | Every 3 weeks (total of five doses) |
Week 25b onwards until disease progression | Every 4 weeks |
aFirst dose of the every-3-week dosing schedule is given at Week 10 bFirst dose of the every-4-week dosing schedule is given at Week 25 | |
In combination with Carfilzomib and Dexamethasone (DKd)
The recommended dosage for DARZALEX, combined with carfilzomib and dexamethasone (4-week cycle) for patients with relapsed/refractory multiple myeloma.
Weeks | DARZALEX Dosec | Schedule |
Week 1 | 8 mg/kg | Days 1 and 2 (total two doses) |
Weeks 2–8 | 16 mg/kg | Weekly (total of seven doses) |
Weeks 9–24a | 16 mg/kg | Every 2 weeks (total of eight doses) |
Week 25b onwards until disease progression | 16 mg/kg | Every 4 weeks |
aFirst dose of the every-2-week dosing schedule is given at Week 9 bFirst dose of the every-4-week dosing schedule is given at Week 25 cBased on actual body weight | ||
Learn more about DARZALEX projected market size for multiple myeloma @ DARZALEX Market Potential
Multiple myeloma is a cancer caused by the uncontrolled growth of clonal plasma cells, leading to organ dysfunction and eventually death. In 2024, the US saw over 33,000 new symptomatic cases, with moderate growth expected at a steady CAGR from 2025 to 2034.
The treatment landscape for multiple myeloma is evolving rapidly, with monoclonal antibodies playing an increasingly important role, especially in newly diagnosed patients. DARZALEX has secured a strong market position over its competitors, and many emerging therapies are expected to complement rather than directly challenge it. Johnson & Johnson is actively evaluating treatment sequences combining DARZALEX with TECVAYLI, CARVYKTI, and TALVEY.
SARCLISA, a newly approved CD38 antibody for multiple myeloma, is quickly gaining market share, but DARZALEX maintains a significant advantage due to its early market entry. Both drugs are competing in quadruplet regimens for both transplant-eligible and non-eligible patients, with the competition heating up in the non-transplant-eligible segment, supported by data from transplant-eligible trials.
DARZALEX, developed by Johnson & Johnson, and EMPLICITI, from Bristol Myers Squibb and AbbVie, were introduced simultaneously, but DARZALEX has emerged as a blockbuster therapy, outperforming EMPLICITI in market uptake.
The US multiple myeloma market was valued at USD 15 billion in 2024, with significant growth expected by 2034. This growth will be fueled by rising incidence rates, expanded indications, earlier adoption of existing therapies, increased use of innovative treatments like CAR-T and anti-BCMA therapies, pipeline developments, and greater research and development investments.
Discover more about the multiple myeloma market in detail @ Multiple Myeloma Market Report
Emerging Competitors of DARZALEX
Some of the drugs in the multiple myeloma pipeline include Mezigdomide (Bristol Myers Squibb/Celgene), Linvoseltamab and REGN7945 (Regeneron Pharmaceuticals), BGB-11417 (BeiGene), Cevostamab (Roche), and CART-ddBCMA (Arcellx), among others.
In February 2025, Regeneron Pharmaceuticals announced that the CHMP of the EMA has recommended the conditional marketing authorization of linvoseltamab for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 3 prior lines of therapy. The positive CHMP opinion is supported by data from the pivotal LINKER-MM1 trial, which evaluated linvoseltamab in adults with RRMM. Earlier this month, the FDA accepted for review the Biologics License Application for linvoseltamab. The target action date for the FDA decision is July 10, 2025.
To know more about the number of competing drugs in development, visit @ DARZALEX Market Positioning Compared to Other Drugs
Key Milestones of DARZALEX
- In February 2025, Johnson & Johnson's DARZALEX subcutaneous-based regimen received a positive CHMP opinion for patients with newly diagnosed multiple myeloma, regardless of transplant eligibility.
- In November 2024, Johnson & Johnson submitted regulatory applications to the FDA and the EMA for the approval of a new indication for DARZALEX FASPRO in the US and the DARZALEX subcutaneous (SC) formulation in the European Union (EU).
- In October 2024, Janssen-Cilag International NV, a Johnson & Johnson company, announced that the EC has approved an expanded indication for the SC formulation of DARZALEX. It is now approved for use in combination with bortezomib, lenalidomide, and dexamethasone in patients with NDMM who are eligible for ASCT. This approval allows patients to receive the daratumumab SC-based quadruplet therapy at the time of initial diagnosis, offering a new treatment option that has demonstrated significant improvements in patient outcomes.
- In November 2021, the US FDA approved DARZALEX FASPRO in combination with KYPROLIS (carfilzomib) and dexamethasone (Kd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
- In July 2021, the US FDA approved DARZALEX FASPRO in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.
- In June 2021, the European Commission approved DARZALEX SC in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor (PI) and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a PI and have demonstrated disease progression on or after the last therapy.
- In May 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending DARZALEX IV in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy.
- In March 2021, Janssen announced the approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for the SC formulation of DARZALEX (known as DARZQURO) for the treatment of multiple myeloma
- In November 2020, Ono Pharmaceutical announced that an additional twice-weekly regimen has been available for KYPROLIS for IV injections of 10 mg and 40 mg (KYPROLIS), a proteasome inhibitor, in Japan, in combination with dexamethasone plus DARZALEX IV infusion for the approved indication of relapsed or refractory multiple myeloma.
- In August 2020, the FDA approved DARZALEX and carfilzomib in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
- In June 2020, the European Commission granted marketing authorization for DARZALEX SC formulation for treating adult patients with multiple myeloma. Daratumumab SC is administered as a fixed dose, significantly reducing treatment time from hours to approximately 3–5 min, compared to the daratumumab IV formulation.
- In May 2020, the US FDA approved DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a new SC formulation of daratumumab. DARZALEX Faspro is approved in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible, and relapsed or refractory patients.
- In January 2020, the European Commission granted marketing authorization for DARZALEX (daratumumab) in combination with bortezomib, thalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).
- In December 2019, daratumumab, with a new dosage, was indicated for treating multiple myeloma.
- In November 2019, the European Commission granted marketing authorization for DARZALEX in combination with lenalidomide and dexamethasone (Rd) as a treatment for adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
- In September 2019, DARZALEX received approval with bortezomib, thalidomide, and dexamethasone to treat newly diagnosed patients eligible for autologous stem cell transplants.
- In August 2019, DARZALEX was approved in combination with bortezomib, melphalan, and prednisone for treating patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant in Japan.
- In June 2019, DARZALEX received approval with lenalidomide and dexamethasone for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
- In February 2019, Janssen Biotech got approval from the US FDA for a split-dosing regimen for DARZALEX, providing healthcare professionals and patients with multiple myeloma an option to split the first infusion over 2 consecutive days.
- In December 2018, Janssen Biotech got approval from the European Commission for the marketing authorization of a split first infusion of DARZALEX over 2 consecutive days for patients with multiple myeloma.
- In August 2018, the European Commission granted marketing authorization for DARZALEX (daratumumab) in combination with bortezomib, melphalan, and prednisone (VMP), for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
- In May 2018, DARZALEX received approval in combination with Bortezomib, Melphalan, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT), making it the first monoclonal antibody approved for newly diagnosed patients with this disease.
- In September 2017, the Ministry of Health, Labor and Welfare (MHLW) in Japan approved the use of DARZALEX daratumumab) in combination with lenalidomide, dexamethasone, bortezomib, and dexamethasone for treating adults with relapsed or refractory multiple myeloma.
- In June 2017, DARZALEX was combined with pomalidomide and dexamethasone for treating patients with multiple myeloma who have received at least two prior therapies, including lenalidomide (an immunomodulatory agent) and a PI.
- In April 2017, the European Commission approved DARZALEX for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
- In November 2016, DARZALEX was used in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treating patients with multiple myeloma who have received at least one prior therapy.
- In November 2016, Amgen entered into a collaboration with Janssen Biotech to evaluate the combination of Amgen's KYPROLIS (carfilzomib) and Janssen's DARZALEX (daratumumab) in multiple clinical studies in patients with multiple myeloma. Under the terms of the agreement, the companies elected to supply drugs only or supply drugs and share development costs on a study-by-study basis.
- In May 2016, the European Commission granted conditional approval to DARZALEX for monotherapy of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
- In November 2015, DARZALEX first received US FDA approval as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent.
- In July 2013, orphan designation (EU/3/13/1153) was granted by the European Commission to Janssen-Cilag International, Belgium, for Daratumumab to treat plasma-cell myeloma.
- In August 2012, Janssen Biotech and Genmab entered a global license and development agreement, which granted Janssen an exclusive license to develop, manufacture, and commercialize DARZALEX for patients with multiple myeloma
Discover how DARZALEX is shaping the multiple myeloma treatment landscape @ DARZALEX Injection
DARZALEX Patent Details
The latest licensed US patent for DARZALEX is set to expire in 2029, while the latest licensed European patent will expire in 2031 or 2032. Additionally, Janssen Biotech holds a distinct patent portfolio covering DARZALEX FASPRO.
DARZALEX Market Dynamics
Approved by the FDA in 2015, DARZALEX has significantly changed the treatment landscape for multiple myeloma, particularly for patients who have relapsed or are refractory to prior therapies. Its market success has been driven by strong clinical efficacy, demonstrated by improved progression-free survival (PFS) and overall survival (OS) in combination with other standard-of-care therapies such as lenalidomide, bortezomib, and dexamethasone. The introduction of a subcutaneous formulation (DARZALEX FASPRO) in 2020 further strengthened its market position by offering a faster, more convenient administration option compared to the original intravenous formulation.
The multiple myeloma market has seen robust growth, with DARZALEX playing a key role due to its expanding label across different lines of therapy. Its use has progressed from treating heavily pre-treated patients to frontline therapy in combination regimens, broadening its addressable patient population. Janssen's strategic partnerships and combination studies with immunomodulatory agents, proteasome inhibitors, and corticosteroids have further enhanced its positioning. The growing preference for combination therapies in multiple myeloma, supported by real-world evidence and updated treatment guidelines, has sustained strong demand for DARZALEX despite increasing competition from other CD38-targeting therapies like isatuximab (SARCLISA) from Sanofi.
Pricing and reimbursement dynamics have also shaped the market landscape. DARZALEX commands a premium price, justified by its strong clinical benefits and expanded label indications. However, reimbursement challenges and pricing pressures from healthcare payers and governments, especially in Europe, have required Janssen to adopt targeted pricing and patient assistance programs. The availability of the subcutaneous version, which reduces administration time and healthcare resource utilization, has helped mitigate cost concerns and strengthen market adoption.
The competitive landscape in the multiple myeloma market remains intense, with new entrants targeting CD38 and other novel mechanisms, such as BCMA-targeting therapies and T-cell engagers. However, DARZALEX has maintained a strong foothold through first-mover advantage, long-term clinical data, and established physician familiarity. Ongoing clinical trials exploring combinations with emerging agents and potential indications beyond multiple myeloma could further enhance its market longevity and competitive edge.
Dive deeper to get more insight into DARZALEX's strengths & weaknesses relative to competitors @ DARZALEX Market Drug Report
Table of Contents
1 | Report Introduction |
2 | DARZALEX: Johnson & Johnson (Janssen) |
2.1 | Product Overview |
2.2 | Other Development Activities |
2.3 | Clinical Development |
2.4 | Clinical Trials Information |
2.5 | Safety and Efficacy |
2.6 | Product Profile |
2.7 | Market Assessment |
2.7.1 | The 7MM Analysis |
2.7.1.1 | Cost Assumptions and Rebate |
2.7.1.2 | Pricing Trends |
2.7.1.3 | Analogue Assessment |
2.7.1.4 | Launch Year and Therapy Uptake |
2.7.2 | The United States Market Analysis |
2.7.3 | EU4 and the United Kingdom Market Analysis |
2.7.3.1 | Germany |
2.7.3.2 | France |
2.7.3.3 | Italy |
2.7.3.4 | Spain |
2.7.3.5 | UK |
2.7.4 | Japan Market Analysis |
2.8 | Market Drivers |
2.9 | Market Barriers |
2.10 | SWOT Analysis |
3 | Key Cross of Marketed Competitors of DARZALEX |
4 | Key Cross of Emerging Competitors of DARZALEX |
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