Johnson & Johnson's strategic challenges in the mid-2020s center on four interconnected issues: navigating the Stelara biosimilar revenue transition, resolving the talc litigation overhang, maintaining MedTech competitive positioning against accelerating device innovation, and rebuilding Chinese MedTech revenues disrupted by government procurement reforms.
The Stelara Biosimilar Cliff is J&J's most acute near-term financial challenge. Stelara (ustekinumab), which generated approximately $10.8 billion in peak global net sales and served as J&J's highest-revenue pharmaceutical asset for multiple fiscal years, began facing biosimilar competition in the European Union in late 2023 and faces U.S. Market entry for multiple biosimilar manufacturers beginning in early 2025 per litigation settlements. The U.S. Component — approximately $6 billion in peak annual revenue — is expected to erode substantially as competing ustekinumab biosimilars from Amgen, Samsung Bioepis, Sandoz, and Fresenius Kabi enter the market at deep discounts to Stelara's list price and compete for formulary placement. Management has guided investors that growth in Darzalex, Tremfya, Spravato, and new pipeline launches will offset the Stelara headwind over a multi-year period, but the transition creates a near-term revenue and earnings growth gap that requires precise timing in the commercial launch cadence of next-generation assets. Investors and equity analysts have been skeptical that the bridge period — fiscal 2025 through 2026 — can be navigated without reported revenue declining in the Innovative Medicine segment, creating potential pressure on J&J's share price and making the Stelara cliff the most frequently cited near-term risk in J&J equity research.