Latest news with #DARZALEX
Yahoo
23-04-2025
- Business
- Yahoo
JNJ Q1 Earnings: Pipeline Progress and MedTech Execution Drive Guidance Above Expectations
Multinational healthcare company Johnson & Johnson (NYSE:JNJ) beat Wall Street's revenue expectations in Q1 CY2025, with sales up 2.4% year on year to $21.89 billion. The company's full-year revenue guidance of $92 billion at the midpoint came in 1.8% above analysts' estimates. Its non-GAAP profit of $2.77 per share was 7.3% above analysts' consensus estimates. Is now the time to buy JNJ? Revenue: $21.89 billion vs analyst estimates of $21.56 billion (2.4% year-on-year growth, 1.5% beat) Adjusted EPS: $2.77 vs analyst estimates of $2.58 (7.3% beat) Adjusted EBITDA: $9.16 billion vs analyst estimates of $8.39 billion (41.8% margin, 9.2% beat) The company slightly lifted its revenue guidance for the full year to $92 billion at the midpoint from $91.3 billion Management reiterated its full-year Adjusted EPS guidance of $10.60 at the midpoint Operating Margin: 28.3%, in line with the same quarter last year Free Cash Flow Margin: 43.2%, up from 13.3% in the same quarter last year Organic Revenue rose 3.3% year on year (5.2% in the same quarter last year) Market Capitalization: $380.2 billion Johnson & Johnson's latest quarter was shaped by ongoing growth in its innovative medicine and MedTech segments, as highlighted on the company's earnings call. CEO Joaquin Duato cited 4.2% operational sales growth in innovative medicine, despite the negative impact from biosimilar competition for STELARA, and emphasized the company's strong product launches and portfolio diversification. MedTech's growth was supported by contributions from recent acquisitions and new product introductions, offsetting short-term headwinds in orthopedics and procedure volumes. Looking ahead, management identified 2025 as a catalyst year, focusing on expanding key brands, advancing the pipeline, and executing on recently closed acquisitions. The company reaffirmed its full-year adjusted earnings guidance, while CFO Joe Wolk said the updated revenue outlook incorporates the addition of Caplyta from the IntraCellular acquisition. Management flagged the importance of mitigating new tariffs, navigating the loss of exclusivity for major products, and sustaining growth from its expanding medicine pipeline. Johnson & Johnson's management attributed the quarter's outperformance to both resilience in innovative medicine and robust execution in MedTech. Their remarks underscored the effects of biosimilar competition, new product launches, and strategic investments: STELARA biosimilar headwinds managed: Despite anticipated declines from biosimilar competition and U.S. Medicare Part D redesign, management emphasized that operational sales growth in innovative medicine was driven by double-digit expansion in eleven core brands, with Tremfya and DARZALEX noted for strong demand. Key launches in immunology and oncology: Tremfya's new indications in inflammatory bowel disease and Crohn's disease accelerated growth. Meanwhile, expanded European approval and new data for DARZALEX and riboflavin plus LASCRUZ in oncology highlighted the pipeline's contribution to sales. MedTech growth from acquisitions and new products: The acquisitions of Abiomed and Shockwave were cited as meeting expectations and broadening the MedTech portfolio. Newly launched devices, such as the Javelin Peripheral IVL catheter and expanded robotic surgery trials, contributed to segment growth. Operational and margin pressures addressed: Management discussed cost pressures from product mix, tariffs, and acquisition-related expenses, but pointed to spending discipline and a restructuring program in surgery as measures to improve profitability by 2027. Capital allocation and investment priorities: The company reiterated its commitment to R&D, announcing plans to invest over $55 billion in U.S. manufacturing and technology over four years, alongside a dividend increase for the sixty-third consecutive year. Management's outlook for 2025 anticipates operational sales growth between 3.3% and 4.3% (midpoint $92 billion) and maintains adjusted earnings per share guidance at a midpoint of $10.60, as the company integrates new assets and navigates market headwinds. Pipeline and new indications: The expansion of Tremfya, Caplyta, and upcoming filings for Ichotrochindra in autoimmune diseases are expected to offset the impact of lost exclusivity in other key products, supporting revenue growth. Tariffs and margin management: Newly imposed tariffs, particularly affecting MedTech exports to China, present a $400 million headwind; management is pursuing production shifts and advocating for favorable tax policies to mitigate this impact. MedTech portfolio optimization: Restructuring and exiting non-strategic product lines, combined with investment in higher-growth devices, are expected to support longer-term margin improvement and segment growth. Larry Biegelsen (Wells Fargo): Asked about the $400 million tariff impact and mitigation strategies; management said tariffs primarily hit MedTech exports to China and are seeking production adjustments rather than price increases. Chris Schott (JPMorgan): Inquired about gross margin drivers; CFO Joe Wolk cited product mix, STELARA's decline, and currency headwinds, and noted that consensus estimates were likely too optimistic. Asad Hader (Goldman Sachs): Requested quantitative detail on STELARA biosimilar erosion; management reiterated guidance based on the HUMIRA precedent and emphasized offsetting growth in other brands. Joanne Wuensch (Citibank): Questioned the orthopedics segment's underperformance and recovery timeline; management acknowledged competitive pressures and expected innovation and new launches to drive improvement. Matt Miksic (Barclays): Sought clarity on immunology opportunities, especially for Tremfya and Ichotrochindra; executives highlighted strong initial launches and market expansion potential for both products. In coming quarters, the StockStory team will be monitoring (1) the rollout and uptake of new indications for Tremfya and Caplyta, (2) the pace of MedTech's margin improvement and execution of the surgery restructuring plan, and (3) progress on upcoming regulatory submissions and product launches, especially for Ichotrochindra in autoimmune diseases. The handling of tariffs and biosimilar competition will also be key themes to watch. Could JNJ achieve its goals and exceed our expectations? See for yourself in our free research report. Market indices reached historic highs following Donald Trump's presidential victory in November 2024, but the outlook for 2025 is clouded by new trade policies that could impact business confidence and growth. While this has caused many investors to adopt a "fearful" wait-and-see approach, we're leaning into our best ideas that can grow regardless of the political or macroeconomic climate. Take advantage of Mr. Market by checking out our Top 5 Growth Stocks for this month. This is a curated list of our High Quality stocks that have generated a market-beating return of 175% over the last five years. Stocks that made our list in 2019 include now familiar names such as Nvidia (+2,183% between December 2019 and December 2024) as well as under-the-radar businesses like Comfort Systems (+751% five-year return). Find your next big winner with StockStory today. Sign in to access your portfolio
Yahoo
15-04-2025
- Business
- Yahoo
Genmab (CPSE:GMAB) Reports US$3 Billion DARZALEX Sales For Q1 2025
Genmab recently reported impressive first-quarter 2025 trade sales for DARZALEX, totaling USD 3,237 million, with strong performance both in the U.S. and internationally. Over the past week, the stock price increased by 1.93%, a movement aligned with broader market trends which saw a 6.8% rise. While Genmab's robust sales data for DARZALEX could have added weight to its market performance, the broader economic environment was influenced by tech and financial sectors leading U.S. indexes higher, despite ongoing U.S.-China trade tensions, with mixed results from mega-cap tech stocks influencing investor sentiment. Buy, Hold or Sell Genmab? View our complete analysis and fair value estimate and you decide. Outshine the giants: these 25 early-stage AI stocks could fund your retirement. The impressive first-quarter trade sales of US$3.24 billion for DARZALEX can significantly contribute to the positive narrative surrounding Genmab's growth strategy. With strong performance in the U.S. and internationally, the sale figures highlight potential boosts to revenue projections, further supported by investments in pipelines like EPKINLY, Rina-S, and Acasunlimab. Such data may drive confidence in the company's capacity to achieve its forecasted 15.1% annual revenue growth over the next three years. Despite this, Genmab's share price remains a considerable distance from the analysts' consensus price target of DKK2104.37, reflecting an opportunity for potential appreciation. Over the five-year period, Genmab's total shareholder return, including share price and dividends, saw a decline of 18.42%, contrasting with its recent weekly performance. When examining company performance over the past year, Genmab underperformed compared to the Danish Biotechs industry, which fell 32.4%. Despite short-term momentum, long-term investors have faced challenges, likely tied to market dynamics and competitive pressures that have influenced market perception. Nonetheless, the current pricing reflects a 44.5% discount relative to the price expectations of some analysts, revealing some optimism about future stock performance if key projects and expansions deliver as predicted. Our comprehensive valuation report raises the possibility that Genmab is priced lower than what may be justified by its financials. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include CPSE:GMAB. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
Yahoo
15-04-2025
- Business
- Yahoo
Genmab Announces Net Sales of DARZALEX® (daratumumab) for First Quarter of 2025
Company Announcement Net sales of DARZALEX® in the first quarter of 2025 totaled USD 3,237 million Genmab receives royalties on worldwide net sales from Johnson & Johnson (J&J, legal entity Janssen Biotech, Inc.) COPENHAGEN, Denmark; April 15, 2025 – Genmab A/S (Nasdaq: GMAB) announced today that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX ® in the U.S.), as reported by J&J were USD 3,237 million in the first quarter of 2025. Net trade sales were USD 1,829 million in the U.S. and USD 1,409 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to J&J to develop, manufacture and commercialize daratumumab. About Genmab Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For more than 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO) antibody medicines®. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and Marisol Peron, Senior Vice President, Global Communications & Corporate AffairsT: +1 609 524 0065; E: mmp@ Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: acn@ This Company Announcement contains forward looking statements. The words 'believe,' 'expect,' 'anticipate,' 'intend' and 'plan' and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on and the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO®. DARZALEX® and DARZALEX FASPRO® are trademarks of Johnson & Johnson. Company Announcement no. 20 CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122 Genmab A/SCarl Jacobsens Vej 302500 Valby Denmark Attachment 150425_CA20_DARZALEX Q1 2025 salesSign in to access your portfolio
Yahoo
23-03-2025
- Business
- Yahoo
DARZALEX Continues to Redefine Multiple Myeloma Treatment with Robust Market Performance
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 Related Reports Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies including Sanofi, Karyopharm Therapeutics, AbbVie, Takeda Pharmaceutical, Celgene, Bristol-Myers Squibb, RAPA Therapeutics, Pfizer, Array Biopharma, Cellectar Biosciences, BioLineRx, Celgene, Aduro Biotech, ExCellThera, Janssen Pharmaceutical, Precision BioSciences, Takeda, Glenmark (Ichnos Sciences SA), Poseida Therapeutics, Molecular Partners AG, Chipscreen Biosciences, AbbVie, Genentech (Roche), Janssen Biotech, Nanjing Legend Biotech, Merck Sharp & Dohme Corp., among others. Multiple Myeloma Pipeline Multiple Myeloma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key multiple myeloma companies, including CASI Pharmaceuticals, Carsgen Therapeutics, Cartesian Therapeutics, Gracell Biotechnology Shanghai Co., Ltd., Sorrento Therapeutics, TeneoOne, Karyopharma Therapeutics, Arcellx, Poseida Therapeutics, Ichnos Sciences, Nerviano Medical Sciences, Bristol Myers Squib, Ascentage Pharma, Ionis Pharmaceuticals, Chongqing Precision Biotech Co., Ltd., CRISPR Therapeutics, AstraZeneca, IGM Biosciences, Novartis, GlaxoSmithKline, Innovent Biologics, Keymed Biociences, Starton Therapeutics, Takeda, Fate Therapeutics, Gilead Sciences, Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd., Janssen Pharmaceutical, Nanjing IASO Biotechnology Co., Ltd., GPCR Therapeutics, Chimerix, among others. Relapsing Refractory Multiple Myeloma Market Relapsing Refractory Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key RRMM companies including AbbVie, Genentech, Amgen, Onyx Therapeutics Inc., Bristol-Myers Squibb, MedImmune LLC, Novartis Pharmaceuticals, Incyte Corporation, Takeda, among others. Relapsing Refractory Multiple Myeloma Pipeline Relapsing Refractory Multiple Myeloma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key RRMM companies, including Bristol-Myers Squibb, I-MAB Biopharma, Pfizer, Arcellx, Gilead Sciences, Novartis, Array Biopharma, Hrain Biotechnology Co., Ltd., Cartesian Therapeutics, Xencor, Takeda, Sorrento Therapeutics, Heidelberg Pharma AG, Ichnos Sciences, Allogene Therapeutics, Harpoon Therapeutics, Cellectis, Poseida Therapeutics, Regeneron Pharmaceuticals, ONK Therapeutics, TeneoOne, iTeos Therapeutics, Oricell Therapeutics, Anaveon AG, Luminary Therapeutics, Seagen Inc., Trillium Therapeutics Inc., Virtuoso BINco, Inc., Seagen Inc., Trillium Therapeutics Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakur info@ +14699457679 Logo: View original content: SOURCE DelveInsight Business Research, LLP Sign in to access your portfolio
Yahoo
18-03-2025
- Business
- Yahoo
Multiple Myeloma Market to Witness Substantial Growth -- Key Trends and Forecasts of Different Reports for the Next Decade
The multiple myeloma market is expected to grow in the upcoming years, owing to a rise in incident cases, label expansion and penetration of current therapies in earlier lines, high adoption of newer therapies, mainly CAR-T cell therapies and bispecific antibodies, a rich emerging pipeline, and an expected increase in investment in R&D activities. LAS VEGAS, March 18, 2025 /PRNewswire/ -- Multiple myeloma is a type of cancer characterized by the uncontrolled proliferation of clonal plasma cells, which leads to organ dysfunction and, eventually, death. There were more than 33,000 symptomatic incident cases in the US in 2024, and these cases are expected to grow with a moderate CAGR in the forecast period 2025–2034. The treatment landscape for multiple myeloma is rapidly evolving, particularly with the increasing use of monoclonal antibodies in newly diagnosed patients. DARZALEX has established a strong market position compared to its competitors. Many emerging therapies under evaluation are expected to complement DARZALEX rather than compete directly with it. Johnson & Johnson is actively exploring treatment sequences that combine DARZALEX with TECVAYLI, CARVYKTI, and TALVEY. SARCLISA, a newly approved CD38 antibody for multiple myeloma, is gaining traction quickly. However, DARZALEX maintains a significant head start. Both drugs are competing in quadruplet regimens for transplant-eligible and ineligible patients, with competition intensifying, particularly among non-transplant-eligible individuals, supported by evidence primarily from studies involving transplant-eligible groups. DARZALEX, from Johnson & Johnson, and EMPLICITI, from Bristol Myers Squibb and AbbVie, were both introduced in the same month. However, DARZALEX has outperformed EMPLICITI, achieving blockbuster status. In 2024, the US multiple myeloma market was valued at USD 15 billion. Significant growth is anticipated by 2034, driven by rising incidence rates, expanded indications, earlier adoption of existing therapies, increasing use of innovative treatments—such as CAR-T cell therapies and anti-BCMA—pipeline advancements, and greater investment in research and development. Discover more about the multiple myeloma market in detail @ Multiple Myeloma Market Report DelveInsight has expertise in the oncology market, and an experienced team handles the oncology domain proficiently. DelveInsight has recently released a series of epidemiology-based market reports on multiple myeloma including CAR T-Cell Therapy for Multiple Myeloma, Refractory Multiple Myeloma, Relapsing Refractory Multiple Myeloma, and Triple-refractory Multiple Myeloma. These reports include a comprehensive understanding of current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Additionally, the reports feature an examination of prominent companies working with their lead candidates in different stages of clinical development. Let's dive deep into the market assessment of these reports individually. CAR T-Cell Therapy for Multiple Myeloma Market CAR-T cell immunotherapy is emerging as a groundbreaking treatment for multiple myeloma, providing new hope for patients who have exhausted standard treatment options. Currently, only two CAR-T cell therapies are approved for multiple myeloma: ABECMA (idecabtagene vicleucel) from Bristol-Myers Squibb and CARVYKTI (ciltacabtagene autoleucel) from Johnson & Johnson Innovative Medicine. Their approval underscores the potential of CAR-T therapy as a transformative option for multiple myeloma. A major benefit of CAR-T therapies is their "one-and-done" approach, which requires just a single administration, unlike bispecific antibodies such as TECVAYLI and TALVEY, which require ongoing treatment. While current CAR-T treatments rely on a patient's own T cells (autologous), research is underway to develop allogeneic CAR-T cells sourced from healthy donors. Allogeneic CAR-T therapies could enable off-the-shelf treatments, improving accessibility and reducing costs. The approval of CAR-T therapies has created new opportunities for companies developing treatments for advanced-stage multiple myeloma (fourth line and beyond). Key players such as Arcellx (Anito-cel), Novartis (PHE885), Bristol-Myers Squibb (BMS-986393), CARsgen Therapeutics (Zevorcabtagene Autoleucel), and Galapagos (GLPG5301), among others, are advancing their CAR-T candidates at various stages of development. Overall, the CAR-T cell therapy market for multiple myeloma is expected to expand significantly between 2024 and 2034, driven by its strong efficacy and potential for broader use. Collaboration among pharmaceutical companies and research institutions, along with ongoing innovation, is expected to fuel market growth. However, challenges such as manufacturing complexities and pricing may need to be addressed to fully realize its potential. For a comprehensive view of the CAR T-cell therapy for multiple myeloma market, check out the CAR T-Cell Therapy for Multiple Myeloma Market Assessment Refractory Multiple Myeloma Market Refractory multiple myeloma refers to a form of multiple myeloma in which the disease no longer responds to treatment or relapses shortly after initial therapy. Multiple myeloma is a hematologic cancer caused by the proliferation of malignant plasma cells in the bone marrow, leading to bone damage, anemia, renal dysfunction, and immunodeficiency. Refractory multiple myeloma typically occurs after patients have been treated with standard therapies such as proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and monoclonal antibodies but fail to achieve a durable response. Patients with refractory multiple myeloma face a poor prognosis, with limited treatment options and shorter overall survival compared to newly diagnosed or relapsed cases. The complexity of refractory multiple myeloma stems from the disease's ability to develop resistance to multiple therapeutic classes, driving the need for novel treatment strategies. Several therapies have been approved for treating refractory multiple myeloma, including monoclonal antibodies like DARZALEX (Johnson & Johnson) and SARCLISA (Sanofi), proteasome inhibitors like KYPROLIS (Amgen) and VELCADE (Takeda), and IMiDs like REVLIMID (Bristol Myers Squibb) and POMALYST (Bristol Myers Squibb). The introduction of CAR-T therapies, such as ABECMA (Bristol Myers Squibb and bluebird bio) and CARVYKTI (Johnson & Johnson and Legend Biotech), has transformed the refractory multiple myeloma landscape by offering targeted, patient-specific treatments. Additionally, bispecific T-cell engagers (BiTEs) like TECVAYLI (Johnson & Johnson) and ADCs like BLENREP (GlaxoSmithKline) have emerged as promising therapies for refractory multiple myeloma. The refractory multiple myeloma market is growing rapidly, driven by increasing incidence rates, longer survival due to improved treatment options, and the rising number of patients progressing to refractory disease. The market is highly competitive, with major players including Johnson & Johnson, Bristol Myers Squibb, Amgen, Sanofi, and Takeda vying for market share. The growing adoption of CAR-T and BiTE therapies, combined with ongoing clinical trials investigating next-generation agents targeting BCMA, GPRC5D, and FcRH5, is expected to drive significant growth. However, high treatment costs, manufacturing complexity, and reimbursement challenges remain key barriers to widespread adoption. The introduction of novel modalities such as off-the-shelf CAR-T therapies and targeted ADCs is anticipated to further reshape the competitive landscape in the coming years. Discover more about refractory multiple myeloma drugs in development @ Refractory Multiple Myeloma Clinical Trials Relapsing Refractory Multiple Myeloma Market Relapsing refractory multiple myeloma (RRMM) refers to a stage of multiple myeloma where the disease either returns after a period of remission (relapse) or becomes resistant to existing therapies (refractory). RRMM poses a significant clinical challenge as patients often experience diminishing responses to successive lines of therapy, resulting in poor prognosis and limited treatment options. The high mutation rate and clonal evolution of myeloma cells contribute to treatment resistance, making RRMM a complex disease to manage. The current market offers a wide array of therapeutic options for treatment, including proteasome inhibitors, immunomodulators, HDAC inhibitors, monoclonal antibodies, chemotherapy, corticosteroids, nuclear export inhibitors, and CAR-T cell therapy across various treatment stages. Disease-targeted treatments typically involve medications such as targeted therapies and/or chemotherapy, with or without steroids. Bone marrow or stem cell transplantation may also be considered. Additionally, radiation therapy and surgery are employed in specific cases. Several promising drugs are in the pipeline, including Mezigdomide (Bristol Myers Squibb/Celgene), Linvoseltamab (Regeneron Pharmaceuticals), BGB-11417 (BeiGene), PHE885 (Novartis), Iberdomide (Bristol-Myers Squibb/Celgene), and CART-ddBCMA (Arcellx), among others. The RRMM market is experiencing rapid growth driven by the increasing incidence of multiple myeloma, the need for more effective treatments for relapsed and refractory cases, and the introduction of novel mechanisms of action. Challenges such as high treatment costs, access to CAR-T therapies, and the development of resistance to current treatments are influencing market dynamics. However, the pipeline remains robust, with a focus on next-generation CAR-T therapies, bispecific antibodies, and targeted small molecules, indicating a competitive and evolving landscape. To gain a deeper understanding of the RRMM market, be sure to explore the Relapsing Refractory Multiple Myeloma Market Outlook Triple-refractory Multiple Myeloma Market Triple-refractory multiple myeloma (TRMM) is a challenging form of the disease characterized by resistance to at least three different classes of therapies, including immunomodulatory drugs, proteasome inhibitors, and monoclonal antibodies. Patients with TRMM often face poor prognoses and limited treatment options, necessitating the development of novel therapeutic strategies. Recent advances in understanding the disease's biology have led to innovative approaches, including targeted therapies and combination regimens. The landscape of treatment for triple-refractory multiple myeloma is rapidly evolving, with a focus on innovative therapies that address the unique challenges posed by this aggressive disease. TRMM patients have exhausted standard treatment options, making them reliant on emerging therapies that target specific pathways involved in myeloma progression. The introduction of CAR-T therapies, such as idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel), has shown promising results in clinical trials, offering hope for improved outcomes in this difficult-to-treat population. Currently, several drugs have received approval for treating relapsed or refractory multiple myeloma, including pomalidomide and selinexor, which are used in various combinations to enhance efficacy. Companies like Amgen, Bristol-Myers Squibb, and Karyopharm Therapeutics are actively involved in developing new therapies for TRMM, focusing on novel agents such as BCMA-targeted treatments. The market dynamics are shaped by the increasing prevalence of multiple myeloma, increasing demand for effective treatments, the high cost of novel therapies, and the ongoing need for clinical trials to validate new treatment regimens. As research continues, the focus remains on improving patient outcomes and quality of life through personalized treatment strategies. Explore in-depth for a comprehensive understanding of the Triple-refractory Multiple Myeloma Clinical Trials About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakur info@ +14699457679 Logo: View original content: SOURCE DelveInsight Business Research, LLP
