Merck Drives Growth Amid Keytruda LoE Challenges with Strategic Investments and Expanding Pipeline
January 2025 — Merck continues to navigate the impending loss of exclusivity for its blockbuster cancer drug Keytruda by aggressively expanding its pipeline and diversifying its portfolio. Despite challenges in finding a direct replacement for Keytruda, the company has maintained a strong track record of execution since 2021, significantly advancing its research and development capabilities.
Strategic Investments Fuel Pipeline Growth: Merck has invested approximately $40 billion in strategic business development, focusing on acquisitions and partnerships to bolster its pipeline.
Notable acquisitions in 2024 include Harpoon Therapeutics, EyeBio, and Elanco Aqua, enhancing Merck's presence across multiple therapeutic areas.
Regulatory and Commercial Milestones in 2024: Merck achieved several key regulatory approvals and product launches across its diverse portfolio:
Cardiometabolic: Approval of WINREVAIR for pulmonary arterial hypertension (PAH) following the STELLAR trial.
Vaccines: Approval of CAPVAXIVE for pneumococcal disease in adults.
Oncology: Multiple new approvals for Keytruda in advanced cancers, including cervical cancer, endometrial carcinoma, and malignant pleural mesothelioma.
Positive Clinical Data Strengthens Pipeline: Key clinical data readouts in 2024 have reinforced Merck's future growth prospects:
Cardiometabolic: Positive results from the WINREVAIR ZENITH trial.
Infectious Disease: Promising data for Clesrovimab in preventing RSV in infants and islatravir-based regimens for HIV treatment.
Oncology: Encouraging results for subcutaneous pembrolizumab combined with berahyaluronidase alfa and early-stage Keytruda studies in head and neck squamous cell carcinoma (HNSCC), muscle-invasive urothelial carcinoma (MIUC), renal cell carcinoma (RCC), triple-negative breast cancer (TNBC), and cervical cancer.
Immunology: Positive outcomes for Tulisokibart in ulcerative colitis (UC) and Crohn's disease (CD).
Diversified and Expanding Pipeline:
Merck's late-stage development pipeline is set for substantial growth between 2026 and 2027, driven by key assets such as Bomedemstat, Ifinatamab deruxtecan, Pembrolizumab combined with Quavonlimab, Tulisokibart, Islatravir combined with Lenacapavir, MK-3000, Nemtabrutinib, Raludotatug deruxtecan, and Sacituzumab tirumotecan.
Navigating Keytruda's Loss of Exclusivity (LOE):
Merck has made substantial progress in mitigating the impact of Keytruda's LOE. From 2021 to 2024, company revenue grew to $64 billion. The number of unique assets in Phase 3 development tripled from 9 to 26, and early-stage assets in pre-clinical and Phase 1 grew from 36 to 52.
Merck's strategic investments and expanding pipeline reflect its commitment to sustained growth and innovation, positioning the company for long-term success in the evolving pharmaceutical landscape.
Novartis Unveils Growth Strategy with Strong Pipeline
January 14, 2025 — Novartis has solidified its transformation into a pure-play innovative medicines company, a strategic shift completed in 2023. The company focussed on four core therapeutic areas: Cardiovascular-Renal-Metabolic, Immunology, Neuroscience, and Oncology.
Market Leadership in Key Therapeutic Areas:
Kisqali leads approximately 50% market share in metastatic breast cancer and around 52% in early breast cancer.
Cosentyx commands about 60% of the hidradenitis suppurativa market.
Pluvicto holds nearly 35% share in post-taxane metastatic castration-resistant prostate cancer (mCRPC) across all treatment lines.
Scemblix leads with around 50% share in third-line and later (3L+) chronic myeloid leukemia (CML).
Robust Pipeline with Promising Readouts:
Novartis anticipates over 15 submission-enabling readouts in the next two years, reinforcing its position in innovative medicine development. Key upcoming milestones include:
OAV101: Positive readout for intrathecal spinal muscular atrophy (SMA) in December 2024.
IgAN Portfolio:
Atrasentan: Expected approval for IgA nephropathy (IgAN) in 2025.
Zigakibart: Readout for IgAN anticipated in 2026.
Fabhalta:
Approval for C3 glomerulopathy (C3G) in 2025.
Readouts for immune complex membranoproliferative glomerulonephritis (IC-MPGN) and atypical hemolytic uremic syndrome (aHUS) in 2026.
Remibrutinib:
Chronic spontaneous urticaria (CSU) submission in 2025.
Readouts for chronic inducible urticaria (CINDU) and multiple sclerosis (MS) in 2026.
Ianalumab:
Sjögren's syndrome (SjS) and second-line immune thrombocytopenia (2L ITP) readouts in 2025.
First-line ITP and warm autoimmune hemolytic anemia (wAIHA) readouts in 2026.
Pelacarsen: Cardiovascular risk reduction in lipoprotein(a) [CVRR-Lp(a)] readout in 2025.
Cosentyx: Readouts for giant cell arteritis (GCA) and polymyalgia rheumatica (PMR) in 2025.
Pluvicto:
Pre-taxane mCRPC approval expected in 2025.
Metastatic hormone-sensitive prostate cancer (mHSPC) readout in 2025.
Leqvio: Cardiovascular risk reduction in low-density lipoprotein cholesterol (CVRR-LDLC) readout in 2026
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