Talquetamab

As a BCMA-targeting CAR T-cell therapy, CARVYKTI addresses a high unmet need in relapsed or refractory multiple myeloma patients. With promising clinical efficacy, durable responses, and growing adoption in advanced treatment lines, CARVYKTI is poised for substantial revenue growth. LAS VEGAS, March 24, 2025 /PRNewswire/ -- DelveInsight's " CARVYKTI Market Size, Forecast, and Market Insight Report" highlights the details around CARVYKTI, a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient's T cells with a transgene encoding a CAR that identifies and eliminates cells that express BCMA. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of CARVYKTI. 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 CARVYKTI (ciltacabtagene autoleucel) Overview CARVYKTI is an autologous T-cell immunotherapy that targets B-cell maturation antigen (BCMA). It works by genetically modifying a patient's T cells with a transgene that encodes a chimeric antigen receptor (CAR). This CAR helps the T cells recognize and destroy cells expressing BCMA, which is primarily found in malignant multiple myeloma B-lineage cells, late-stage B cells, and plasma cells. The CARVYKTI CAR protein includes two single-domain antibodies designed to bind strongly to human BCMA, enhancing T-cell activation, proliferation, and the destruction of target cells upon binding. Currently, CAR-T cell therapies are only available to UK patients through clinical trials. Janssen recently decided not to proceed with seeking approval for cilta-cel (CARVYKTI) for myeloma patients in the UK through the National Institute for Health and Care Excellence (NICE). This decision means cilta-cel will not be available on the NHS for now, although it remains accessible through clinical trials. Janssen's decision does not impact ongoing trials. The drug is currently being evaluated in Phase III trials: CARTITUDE-6 for frontline multiple myeloma transplant eligible vs ASCT and CARTITUDE-5 for frontline multiple myeloma TNI. In 2024, CARVYKTI generated sales of USD 963 million across the world. CARVYKTI Dosage and Administration CARVYKTI is administered as a single infusion containing a suspension of CAR-positive, viable T cells in one infusion bag. The recommended dosage ranges from 0.5 to 1.0 × 10⁶ CAR-positive viable T cells per kilogram of body weight, with a maximum limit of 1 × 10⁸ CAR-positive viable T cells per infusion. Learn more about CARVYKTI projected market size for multiple myeloma @ CARVYKTI Market Potential CAR-T cell immunotherapy is emerging as a revolutionary treatment for multiple myeloma, offering new hope to patients who have exhausted conventional 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 highlights the potential of CAR-T therapy to transform multiple myeloma treatment. A key advantage of CAR-T therapies is their "one-and-done" nature, requiring a single administration, unlike bispecific antibodies such as TECVAYLI and TALVEY, which need ongoing dosing. Present CAR-T therapies use a patient's own T cells (autologous), but research is underway to develop allogeneic CAR-T cells derived from healthy donors. Allogeneic therapies could offer off-the-shelf solutions, enhancing accessibility and lowering costs. The approval of CAR-T therapies has created new opportunities for companies focused on advanced-stage multiple myeloma (fourth line and beyond). Several companies are progressing with their CAR-T candidates at different stages of development. The CAR-T cell therapy market for multiple myeloma is expected to grow significantly between 2024 and 2034, driven by its high efficacy and potential for expanded use. Collaboration between pharmaceutical companies and research institutions, along with ongoing innovation, is expected to accelerate market growth. However, challenges such as manufacturing complexity and pricing will need to be addressed to unlock the full potential of CAR-T therapies. Discover more about the CAR T-cell therapy for multiple myeloma market in detail @ CAR T-cell Therapy for Multiple Myeloma Market Report Emerging Competitors of CARVYKTI Some of the CAR-Ts in the multiple myeloma pipeline that will give fierce competition to CARVYKTI include Anito-cel (Arcellx), PHE885 (Novartis), BMS-986393 (Bristol-Myers Squibb), Zevorcabtagene Autoleucel (CARsgen Therapeutics), and GLPG5301 (Galapagos), among others In December 2024, Arcellx announced encouraging new data from its Phase II pivotal iMMagine-1 trial for anito-cel in multiple myeloma. The results were presented during an oral session at the 66th American Society of Hematology (ASH) Annual Meeting on Monday, December 9, 2024, at 5:30 p.m. PT. Also at ASH 2024, BMS shared the first overall survival (OS) and progression-free survival (PFS) results for arlo-cel in an oral presentation. The Phase I trial involved patients with relapsed or refractory multiple myeloma who had previously undergone at least three treatments, including a proteasome inhibitor, an immunomodulatory drug, and anti-CD38 therapy. Among 79 patients evaluable for efficacy, with a median follow-up of 16.1 months (range: 2.8–25.2), arlo-cel showed an overall response rate (ORR) of 87%, indicating durable responses. Minimal residual disease (MRD) was assessed as an exploratory measure, with 57% (48 of 84) of MRD-evaluable patients included. Of these, 46% (22 of 48) were MRD-negative and achieved a complete response (CR) or stringent CR (sCR). Across all treated patients, 27% (23 of 84) were MRD-negative and achieved a CR. Median PFS was 18.3 months (95% CI: 11.8–21.9), while the median OS had not yet been reached. To know more about the number of competing drugs in development, visit @ CARVYKTI Market Positioning Compared to Other Drugs Key Milestones of CARVYKTI In April 2024, Johnson & Johnson announced that the US FDA approved CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with RRMM who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. In March 2024, Johnson & Johnson announced that the US FDA Oncologic Drugs Advisory Committee (ODAC) recommends CARVYKTI for the treatment of adult patients with RRMM who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and who are refractory to lenalidomide. In February 2024, Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended the approval of a Type II variation for CARVYKTI for the earlier treatment of RRMM. In September 2022, Legend Biotech announced that Japan's Ministry of Health, Labour and Welfare (MHLW) had approved CARVYKTI (ciltacabtagene autoleucel) for the treatment of adults with relapsed or refractory multiple myeloma, limited to cases meeting both of the following conditions including patients having no history of CAR-positive T-cell infusion therapy targeting BCMA and patients who have received three or more lines of therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, and in whom multiple myeloma has not responded to or has relapsed following the most recent therapy. In May 2022, Janssen announced that the European Commission (EC) granted conditional marketing authorization for CARVYKTI for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. In February 2022, Janssen announced that the US FDA had approved CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. In August 2020, Legend Biotech announced that the China Center for Drug Evaluation, National Medical Products Administration (CDE, NMPA) had recommended BTD for ciltacabtagene autoleucel (cilta-cel; LCAR-B38M CAR-T cells) for the treatment of adults with relapsed or refractory multiple myeloma. In December 2019, Janssen announced receipt of a BTD from the US FDA for cilta-cel. In April 2019, the EMA granted a PRIME (PRIority MEdicines) designation for the company's investigational BCMA CAR-T therapy. In February 2019, the US FDA granted ODD for cilta-cel (JNJ-4528), and in February 2020, the European Commission also granted orphan designation for this drug. In December 2017, Janssen entered a worldwide collaboration and license agreement with Legend Biotech to jointly develop and commercialize LCAR-B38M in multiple myeloma Discover how CARVYKTI is shaping the multiple myeloma treatment landscape @ CARVYKTI CAR-T CARVYKTI Market Dynamics The market for CARVYKTI is driven by the increasing prevalence of multiple myeloma and the growing demand for innovative therapies that can address the limitations of existing treatments, such as proteasome inhibitors and immunomodulatory drugs. The competitive landscape includes other BCMA-targeting therapies, such as Bristol Myers Squibb's ABECMA (idecabtagene vicleucel), which was the first BCMA-directed CAR-T therapy approved for multiple myeloma. CARVYKTI's strong clinical efficacy, coupled with its potential for long-term remission, gives it a competitive edge, but challenges related to manufacturing scalability, logistical complexities, and high treatment costs could impact its market penetration and patient accessibility. Strategic partnerships and ongoing clinical development will play a key role in expanding CARVYKTI's market reach. Janssen and Legend Biotech are actively working to improve manufacturing processes to reduce vein-to-vein time and address supply chain bottlenecks. Furthermore, ongoing trials, such as CARTITUDE-4, are exploring CARVYKTI's use in earlier lines of therapy, which could significantly expand its patient base and market potential. If successful in earlier settings, CARVYKTI could shift the treatment paradigm for multiple myeloma and increase adoption among physicians and healthcare providers. Despite its promising clinical profile, CARVYKTI faces challenges related to reimbursement and healthcare infrastructure. The high cost of CAR-T therapies often limits patient access, particularly in markets with strict reimbursement policies. Moreover, the complex nature of CAR-T administration, which requires specialized centers and trained personnel, adds to the barriers. However, continued clinical success, regulatory support, and improvements in manufacturing and delivery infrastructure could strengthen CARVYKTI's market position and establish it as a cornerstone therapy in the multiple myeloma treatment landscape. Dive deeper to get more insight into CARVYKTI's strengths & weaknesses relative to competitors @ CARVYKTI Market Drug Report Table of Contents Related Reports 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. 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. 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 [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

iStock, leolintang Merck’s Keytruda holds on to the top spot while AbbVie’s Humira—once the world’s top-selling drug—continues to cede its market share to biosimilar competitors. For six years straight, AbbVie’s Humira reigned as the world’s best-selling drug. The anti-TNF antibody bowed only to Pfizer and BioNTech’s COVID-19 vaccine Comirnaty in 2021, and yet even in the throes of the pandemic—when anti-infectives saw a surge in demand—Humira stood its ground, staying in the top three earners of the year. In 2024, however, it became clear that Humira is no longer the dominant market force that it once was. Mounting biosimilar and competitive pressure have sent Humira’s sales steadily downward. The drug is no longer AbbVie’s biggest moneymaker and the pharma appears to no longer be investing in its growth. As per its latest pipeline update document , posted in January, AbbVie has no active studies or applications for Humira. Humira’s fall is emblematic of the typical life cycle of drugs. John Gagliano, senior director at BioPharmCatalyst, expects to see a similar pattern play out in the coming years, as the industry faces the strongest patent headwinds in more than a decade. “The overall landscape [of top drugs] is anticipated to become more diverse as emerging therapies gradually replace aging blockbusters,” he told BioSpace in an email. Companies can implement what Gagliano calls “defensive strategies” such as novel formulations, patent extensions and combination regimens to prolong the exclusivity of their drugs and “sustain their positions” in the market—but that only serves to delay the inevitable. “Many current top sellers face imminent loss of exclusivity (LOE), which will likely trigger rapid revenue declines,” Gagliano continued. In addition to Humira, Eliquis and Opdivo are likely to “drop out of the top ranks as biosimilars and generics enter the market,” predicts Gagliano’s colleague Olivia Tidwell, content coordinator at BioPharmCatalyst. Meanwhile, she continued, potentially rising to take their place are promising assets in emerging modalities, such as radioligand therapies, CAR Ts and gene therapies, among others. Here, BioSpace looks at the top 10 pharma products that brought in the biggest sales in 2024. The list is a mix of predictable and surprising. Novo Nordisk’s Ozempic, for instance, was pretty much a shoo-in for this list, while several drugs facing LOE concerns—and were therefore expected to suffer slower sales—managed to maintain their market dominance. Merck’s Keytruda Tops Again—But for How Long? 2024 Sales: $29.5 billion YOY Change: 18% For the second year in a row, Merck’s blockbuster PD-1 inhibitor Keytruda tops the list of pharma’s best-selling products. In 2024, Keytruda surged 18% year-on-year to hit $29.48 billion in sales . The feat comes as no surprise given how Keytruda has become a cornerstone cancer therapy with more than 40 indications under its belt, including various forms of lung and gynecological cancers. Most recently, the FDA approved Keytruda for the first-line treatment of pleural mesothelioma, giving Merck access to a market that could exceed $12 billion in value by 2034, as per an August 2024 IMARC report . But trouble could be brewing on Keytruda’s horizon. Key patents protecting Merck’s blockbuster are set to expire in 2028, opening it up to biosimilar competition and, in turn, eroding sales. There also appears to be growing regulatory apprehension regarding the widespread use of Keytruda—and PD-1 inhibitors more broadly. In September 2024, an FDA advisory panel overwhelmingly voted to narrow the label of Keytruda, along with Bristol Myers Squibb’s Opdivo and Yervoy, in stomach and esophageal cancers, restricting their use in patients with low PD-1 expression levels. The FDA has yet to put out a formal directive. Merck is doing what it can to maintain Keytruda’s market dominance. The pharma is developing a subcutaneous formulation of the PD-1 blocker that could help maintain an edge over potential copycats. “Unlike Humira’s steep post-LOE slide, Keytruda’s lifecycle management measures suggest it will retain significant market share, albeit potentially at a lower rank,” BioPharmCatalyst analyst Cristian Marulanda told BioSpace in an email. “Merck’s proactive strategies and continuous innovation may help Keytruda weather competitive pressures better than past examples.” IRA Threatens Rise of Novo’s Ozempic 2024 Sales: $16.9 billion YOY Change: 26% It comes as a surprise to no one that the widely popular type 2 diabetes drug Ozempic is among the top-performing drugs of 2024. In its full-year business report, Novo Nordisk revealed that the GLP-1 therapy made more than 120 billion Danish kroner last year, or approximately $16.9 billion. Ozempic was one of the highest-growth assets on this list—relative to 2023, Ozempic’s sales jumped 26%—and it is poised to see an even greater upward trend in coming years. Originally approved in 2017 to improve glycemic control, Ozempic secured additional approvals in 2020 to reduce cardiovascular risk and in January 2025 to lower the likelihood of chronic kidney disease. Getting in the way of Ozempic’s growth, however, is the Inflation Reduction Act (IRA). Earlier this year, the Centers for Medicare and Medicaid Services (CMS) selected the GLP-1 drug—alongside sister brand Rybelsus—for the second round of drug price negotiations. The move was not entirely unexpected . Over the past year, Novo was on the receiving end of several high-profile calls to lower the list price of Ozempic. Faced with the prospects of a price cap on Ozempic, Novo has asked the U.S. Court of Appeals for the Third Circuit to speed up proceedings regarding its ongoing complaint against the IRA. Novo alleges that the price negotiations are in violation of its constitutional rights—an argument that has so far failed to convince judges. Biktarvy Sales Symbolize Gilead’s Strong Standing 2024 Sales: $13.4 billion YOY Change: 13% Building off the size of the HIV market is Gilead’s antiretroviral drug Biktarvy, which in 2024 jumped 13% to bring in $13.42 billion in sales, growth that the pharma attributed to “higher demand” for the drug. Biktarvy is currently the cornerstone of Gilead’s HIV business. It “commands over 50% share of the U.S. market” and is the “regimen of choice” across many markets, commercial chief Johanna Mercier said during the company’s fourth-quarter investor call. Unlike Keytruda and Ozempic, there are no clear headwinds in Biktarvy’s immediate future. Key patent protections for the drug will remain intact in the coming years and will keep generic competitors off the market until 2033. Biktarvy also escaped the CMS’s list for the second cycle of drug negotiations. Still, Biktarvy isn’t a completely risk-free asset for Gilead, and the prospects of price control problems remain on the horizon. In a note to investors in February 2025, analysts at BMO Capital Markets said that they are wary of the drug’s “likely inclusion” in the 2028 cycle of IRA negotiations. BMS, Pfizer Brace for Eliquis LOE 2024 Sales: $13.3 billion YOY Change: 9% The blood thinner Eliquis—developed and commercialized through the powerhouse partnership between Bristol Myers Squibb and Pfizer— made $13.3 billion in 2024, representing a 9% year-on-year increase in sales. The drug has long been a prized asset for both companies, but that may soon be coming to an end. Eliquis is set to lose market exclusivity in 2026—with several generics already lined up, eager to enter the U.S. market and eat into the drug’s earnings. Among these are copycats from Mylan Pharmaceuticals and Micro Labs Limited, which the FDA approved as early December 2019 . Eliquis was also in the first batch of drugs that underwent the CMS drug price negotiations last year. The final maximum fair price of $231 for a 30-day supply, set to take effect in 2026, is a 56% discount from the original cost, though it was already selling below list price . To cope with the potential loss of revenue from Eliquis, BMS has kicked a multibillion-dollar savings initiative into motion, targeting $1.5 billion in cost-cuts by the end of 2025 and another $2 billion through 2027. Pfizer is taking a similar approach, setting a $3.5 billion savings goal in 2024 and tacking on another $1.5 billion by the end of 2027. Sanofi, Regeneron Rely on Robust Dupixent Figures 2024 Sales: $13 billion YOY Change: 23% Sanofi and Regeneron are jointly commercializing the immunology heavy-hitter Dupixent, which last year bagged $13.072 billion , representing 23% year-on-year growth. Like Biktarvy, Dupixent appears to have no patent- and IRA-related issues on its horizon. The drug will retain market exclusivity until 2031 and is looking at promising market prospects, too. The FDA in September 2024 approved Dupixent for the treatment of chronic obstructive pulmonary disease, for which launch is expected this year . Still, analysts at William Blair in a January 2025 report cautioned that Regeneron and Sanofi are “extremely reliant on Dupixent,” with “little else to be excited about” in their pipelines. Regeneron, for instance, has been trying to get its high-dose Eylea brand off the ground with limited success so far. In the fourth quarter, Eylea HD brought in $305 million, below the projected $336 million consensus. Sanofi, meanwhile, is a “bit of a one-trick pony with respect to near-term growth drivers,” according to the William Blair report. Vaccines account for around 15% of its revenue and this space faces considerable exposure due to volatility linked to changes in government policies, the firm wrote. AbbVie’s Skyrocketing Skyrizi 2024 Sales: $11.7 billion YOY Change: 50.9% AbbVie’s answer to Humira’s fall, the anti-IL-23 therapy Skyrizi, is the fastest-growing asset on this list. With a 50.9% year-on-year increase in sales, Skyrizi raked in $11.718 billion for the Illinois pharma in 2024, easily surpassing Humira’s nearly $9 billion earnings. That Skyrizi finds itself on this list is evidence of how well AbbVie handled the lapsed protections for Humira, which for years was the world’s top-selling drug. In the third quarter of 2024, sales of Skyrizi—alongside the JAK inhibitor Rinvoq—helped AbbVie narrowly beat analysts’ expectations , despite continued erosion of Humira’s sales. This trend continued into the fourth quarter. In a Feb. 1 note from BMO Capital Markets, in reaction to the pharma’s full-year business report, analysts said that Skyrizi and Rinvoq are set to “usher in a new era of growth” for AbbVie, which has “finally fully moved on from the narrative of the Humira LOE.” Skyrizi’s immediate future is clear of patent concerns. Market exclusivity is set to last until 2031, as per the January William Blair report. Likewise, Rinvoq’s protections will remain intact into 2033. J&J Offsets Stelara Losses With Darzalex Growth .tg {border:none;border-collapse:collapse;border-spacing:0;} .tg td{border:none;border-collapse:collapse;border-spacing:0;font-family:Arial, sans-serif;font-size:14px;overflow:hidden; padding:10px 5px;word-break:normal;} .tg th{border:none;border-collapse:collapse;border-spacing:0;font-family:Arial, sans-serif;font-size:14px;font-weight:normal; overflow:hidden;padding:10px 5px;word-break:normal;} .tg .tg-ej4a{border:none;border-collapse:collapse;border-spacing:0;font-family:Arial, Helvetica, sans-serif !important;font-size:18px;text-align:left; vertical-align:top} Darzalex 2024 Sales: $11.6 billion YOY Change: 20% Stelara 2024 Sales: $10.4 billion YOY Change: -4.6% J&J had two top-selling drugs in 2024: one on its way in, the other on its way out. Stelara, an anti-IL-12 and IL-23 antibody indicated for various inflammatory diseases, lost key patent protections in September 2023 . Biosimilars have since entered the U.S market and, while not yet completely unseating Stelara, have eroded its sales. In 2023, the biologic made $10.86 billion . Last year, sales were down 4.6% to $10.34 billion. To make up for lost revenue, J&J is leaning on its cancer drug Darzalex, an anti-CD38 cytolytic antibody approved for multiple myeloma. In 2024, Darzalex brought in $11.67 billion, representing nearly 20% year-on-year growth. According to the William Blair report, Darzalex will help drive J&J’s cancer franchise—including its CAR T therapy Carvykti and bispecific antibodies Tecvayli and Talvey—to 15.3% compounded annual growth, hitting $27.1 billion in sales by 2029. J&J continues to work on expanding Darzalex’s label, including a September 2024 FDA filing that would allow the drug’s use in patients with newly diagnosed multiple myeloma who are ineligible for stem cell transplantation, as well as a November 2024 submission for high-risk smoldering multiple myeloma. Darzalex will retain key patent protections until 2029, as per William Blair. Humira: On its Way Out? 2024 Sales: $9 billion YoY Change: -37.6% Sustaining a 37.6% year-on-year decline in sales, Humira is now clearly beyond its prime. In 2024, the once-dominant anti-inflammatory therapy brought in $8.993 billion for AbbVie. The obvious culprit for Humira’s fall from grace is growing biosimilar competition. Since the drug lost key patent protections in 2023, several copycats have hit the market, including Amgen’s Amjevita, Celltrion’s Yuflyma, Cordavis and Sandoz’s Hyrimoz and Boehringer Ingelheim’s Cyltezo. Another major driver of Humira’s market erosion is CVS Caremark’s move in April 2024 to remove the branded drug from its major national formularies in favor of biosimilars, including its own adalimumab brand Hyrimoz. Cordavis is a CVS Caremark subsidiary launched in August 2023. Humira is putting up a commendable fight, though. In the first-quarter 2025 edition of Samsung Bioepis’ Biosimilar Market Dynamics report , Humira remains the top adalimumab brand, controlling 72% of the market. In the third-quarter 2024 edition of the same report, Humira still had 82% market share . Merck’s Gardasil Hangs On Amid Controversy 2024 Sales: $8.6 billion YoY Change: -3% The only vaccine on this list, Merck’s human papillomavirus shot Gardasil saw a 3% drop in sales in 2024, bringing in $8.58 billion . The jab’s prospects don’t look good. Key patent protections are set to expire in 2028, according to William Blair, though there appear to be no notable biosimilars on the horizon. More importantly for Merck and Gardasil are questions surrounding how U.S. health authorities will handle vaccines moving forward with Robert F. Kennedy Jr.—a known vaccine critic—as Secretary of Health and Human Services . In addition, last month, Merck announced that Gardasil shipments to China would be suspended amid stubbornly high inventories of the vaccine, a result that CEO Rob Davis blamed on “increased pressure on discretionary consumer spending” on the pharma’s most recent earnings call. Gardasil was recently approved for males in China.