Regeneron's Potential to Disrupt the Multiple Myeloma Market: A Threat to Johnson & Johnson's Dominance?

Johnson & Johnson (J&J) has long dominated the multiple myeloma market, with its flagship drug Darzalex generating $11.6 billion in 2024 sales and projected to reach $14.7 billion by 2030Analysts predict myeloma market will hit $33B by 2030^[1]. However, the landscape is shifting. Regeneron's linvoseltamab (Lynozyfic), a BCMAxCD3 bispecific antibody, has recently secured FDA accelerated approval for relapsed/refractory multiple myeloma (R/R MM) and is now advancing into high-risk smoldering multiple myeloma (HR-SMM), a niche where J&J's Darzalex is seeking regulatory approval. This article examines how Regeneron's innovation could disrupt J&J's market share, particularly in HR-SMM, and what this means for investors.

Johnson & Johnson's Market Fortification

J&J's oncology portfolio is a cornerstone of its growth strategy. Darzalex, a CD38-targeting monoclonal antibody, has been a blockbuster, with $3.54 billion in Q2 2025 salesJohnson & Johnson Raises 2025 Outlook as Oncology Portfolio Drives 24% Growth^[2]. Complementing this is Carvykti, the leading CAR-T therapy, and Tecvayli, a bispecific antibody. Together, these products have positioned J&J to capture 91% of the myeloma market in 2023, with analysts predicting it will surpass Bristol-Myers Squibb to dominate by 2030Multiple Myeloma Market Is Going to Boom | Major Giants^[3].

However, J&J's dominance is not without vulnerabilities. The Inflation Reduction Act's pricing pressures and the emergence of next-generation therapies like bispecifics and CAR-Ts could erode margins. Yet, J&J's strength lies in its diversified portfolio and early mover advantage in HR-SMM, where Darzalex FASPRO is pending FDA approval as the first therapy to delay progression to active myelomaFDA ODAC Votes in Support of DARZALEX FASPRO for High-Risk Smoldering Multiple Myeloma^[4].

Regeneron's Linvoseltamab: A New Contender

Regeneron's linvoseltamab received FDA accelerated approval in July 2025 for R/R MM patients who have failed at least four prior therapiesFDA grants accelerated approval to linvoseltamab-gcpt for ...^[5]. The drug's pivotal LINKER-MM1 trial demonstrated a 70% objective response rate (ORR), with 46.9% achieving complete responsesLynozyfic™ (linvoseltamab-gcpt) Receives FDA Accelerated Approval^[6]. More notably, in HR-SMM, linvoseltamab's Phase 2 LINKER-SMM1 trial showed 100% response rates in 19 patients, with 84% achieving complete remission and molecular negativity in 12 of 19 casesCan Regeneron Change The Paradigm In Multiple Myeloma?^[7]. These results outpace Darzalex's 63.4% ORR in HR-SMM trialsDaratumumab or Active Monitoring for High-Risk Smoldering Multiple Myeloma^[8], suggesting a potential paradigm shift in early intervention.

Linvoseltamab's response-adapted dosing—starting with weekly infusions and extending to monthly for responders—also offers a logistical advantage over J&J's Tecvayli and Pfizer's Elrexfio, which require more frequent administrationRegeneron gets long-awaited FDA okay for myeloma drug^[9]. This flexibility could enhance patient adherence and broaden market adoption.

Competitive Dynamics in HR-SMM: A Niche Under Siege

HR-SMM represents a critical battleground. Approximately 50% of HR-SMM patients progress to active myeloma within 2–3 years, creating a $32.5 billion market by 2033Multiple Myeloma Market Report and Company Analysis^[10]. J&J's AQUILA trial for Darzalex FASPRO showed a 51% reduction in progression risk compared to active monitoring, earning a 6-2 FDA ODAC vote in favor of approvalU.S. FDA Oncologic Drugs Advisory Committee votes in favor of the benefit-risk profile of DARZALEX FASPRO for high-risk smoldering multiple myeloma^[11]. However, linvoseltamab's superior response rates and molecular remission data in HR-SMM could challenge J&J's first-mover status.

While J&J's portfolio remains robust, linvoseltamab's entry into HR-SMM introduces a direct competitor. If approved, linvoseltamab could capture a significant share of this niche, particularly among patients seeking deeper remissions. However, J&J's broader market presence—Darzalex's $14.7 billion 2030 sales forecast versus linvoseltamab's projected $3.0 billion—suggests J&J's dominance in the overall myeloma space is unlikely to waneAnalysts predict myeloma market will hit $33B by 2030^[12].

Investment Implications

For investors, the key question is whether linvoseltamab's niche success in HR-SMM will meaningfully erode J&J's broader market share. While Regeneron's drug offers compelling clinical data, J&J's diversified portfolio, including Carvykti and Tecvayli, provides a buffer against single-product disruptions. Additionally, J&J's pending HR-SMM approval for Darzalex FASPRO could solidify its leadership in early intervention.

However, linvoseltamab's emergence underscores the importance of innovation in a rapidly evolving market. Regeneron's ability to scale production and manage the drug's REMS program will be critical to its long-term success. For J&J, maintaining its edge will require continued investment in next-generation therapies and strategic partnerships.

Conclusion

Regeneron's linvoseltamab is a formidable entrant in the multiple myeloma space, particularly in HR-SMM. While it may not displace J&J's dominance in the broader market, its clinical advantages and dosing flexibility position it as a disruptive force in specific segments. Investors should monitor J&J's regulatory progress in HR-SMM and Regeneron's commercialization strategy for linvoseltamab, as both will shape the competitive landscape in the coming years.