What notable changes are expected in the pharmaceutical industry in 2026, and what should pharmaceutical companies focus on?

Welcome to AdisInsight’s new report, 'Key Forces Shaping the Pharmaceutical Industry in 2026: New Drug Launches and Patent Expirations', for deeper insights into breakthrough drug launches. Hyaluronidase/Pembrolizumab (Keytruda QLEX) Mechanism of Action: Antibody-dependent cellular cytotoxicity; PD-1 receptor antagonist; T-cell stimulator Drug Class: Monoclonal antibody; Small molecule Developer: Merck & Co. Indications: Solid tumors; Bladder cancer Approval Dates: September 19, 2025 and November 21, 2025 Clinical Trials: MK-3475A-D77 and KEYNOTE-905 Solid tumors refer to abnormal tissue masses forming in organs such as the lung, breast, colon, or prostate—without involving blood or bone marrow. They account for 90% of adult cancers and are classified as either benign or malignant. Thanks to advances in targeted therapy, immuno-oncology, and precision medicine, clinical outcomes for patients with solid tumors are steadily improving. Why is hyaluronidase/pembrolizumab expected to have a major impact in 2026? Hyaluronidase/pembrolizumab (Keytruda QLEX) is a fixed-dose combination therapy developed by Merck & Co., combining the programmed cell death protein 1 (PD-1) receptor antagonist pembrolizumab with recombinant human hyaluronidase (MK-5180). It is intended for treating multiple tumor types, including malignant melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, squamous cell carcinoma, and other solid tumors. In September 2025, Keytruda QLEX received FDA approval for most of the solid tumor indications previously approved for intravenous Keytruda. The market widely expects QLEX sales to approach $900 million in 2026, pushing Keytruda’s total annual revenue beyond $33.5 billion. Benefits for patients and healthcare systems: This subcutaneous formulation enables administration within one to two minutes—significantly shorter than the 30-minute intravenous infusion time. This improves treatment convenience, facilitates broader adoption in monotherapy and oral combination regimens, reduces patient chair time, and alleviates pressure on healthcare resources. Merck’s strategic advantage: The U.S. patent for intravenous Keytruda expires in 2028; developing Keytruda QLEX helps extend patent protection. This launch represents a key strategic move by Merck to address impending patent expiry and sustain its market leadership. Pipeline expansion: In 2026, Merck is poised to achieve sustained revenue growth through new indication approvals and market expansion. In April 2026, the FDA reviewed Merck’s application for Keytruda/Keytruda QLEX in combination with Padcev (enfortumab vedotin) for treating specific patients with muscle-invasive bladder cancer—addressing a substantial unmet medical need. Lynkuet (Elinzanetant) Mechanism of Action: Neurokinin-1 receptor antagonist; Neurokinin-3 receptor antagonist Drug Class: Small molecule Developer: Bayer Indication: Vasomotor symptoms Launch Date: November 2025 (U.S.) Clinical Trials: OASIS 1, OASIS 2, and OASIS 3

What is the mechanism of action and approved indications of Keytruda (pembrolizumab)?

Keytruda (pembrolizumab) is an immunotherapy drug approved for the treatment of at least 19 different types of cancer, including melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), classical Hodgkin lymphoma, endometrial cancer, triple-negative breast cancer, and certain colorectal cancers. 1. Keytruda may be used as monotherapy or in combination with other agents—including chemotherapy—depending on the specific type of cancer. Keytruda’s mechanism of action involves blocking the PD-1 protein on T cells, thereby preventing its interaction with PD-L1 expressed on cancer cells. This inhibition effectively ‘releases the brakes’ on the immune system, enabling T cells to more efficiently recognize and attack cancer cells. By enhancing the body’s natural defenses, Keytruda elicits a targeted immune response against tumors. Keytruda belongs to the class of immune checkpoint inhibitors and is also categorized as a monoclonal antibody. [Indications] Melanoma [Manufacturer] Merck & Co., Inc., U.S. [Available Strengths] 100 mg/4 mL [Mechanism of Action] Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interactions with both PD-L1 and PD-L2, thereby releasing PD-1 pathway–mediated inhibition of immune responses—including antitumor immunity. [Indications] • In combination with enfortumab vedotin for the treatment of adults with locally advanced or metastatic urothelial carcinoma. • As monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in patients who are ineligible for any platinum-containing chemotherapy; or whose disease progressed during or after platinum-containing chemotherapy, or within 12 months following neoadjuvant or adjuvant platinum-containing chemotherapy. • As monotherapy for the treatment of adult patients with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors, who are ineligible for or have elected not to undergo cystectomy. • In combination with axitinib or lenvatinib for first-line treatment of advanced renal cell carcinoma (RCC). • As adjuvant treatment for patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. [Keytruda Dosage and Administration] Adults Administered via intravenous infusion over 30 minutes. Dosing options: 200 mg every 3 weeks or 400 mg every 6 weeks. • For urothelial carcinoma and BCG-unresponsive NMIBC: Continue treatment until disease progression, unacceptable toxicity, or—for patients without disease progression—for up to 24 months; (and/or until persistent or recurrent high-risk NMIBC). • For adjuvant RCC treatment: Continue treatment until disease recurrence, unacceptable toxicity, or for up to 12 months. • For advanced RCC: Administer in combination with axitinib (5 mg twice daily) or lenvatinib (20 mg once daily). Axitinib dose escalation may occur every 6 weeks or longer.

Halozyme wins court order to block Merck's injected Keytruda in select European markets

4 days ago

A Dutch patent court ruled in favor of Halozyme against Merck, ordering the halt of injectable Keytruda sales in eight European markets due to infringement on Halozyme's MDASE delivery technology. This ruling impacts Merck's subcutaneous drug growth strategy ahead of key patent expirations.

reuters

2026-10-07

Halozyme wins court order to block Merck's injected Keytruda in select European markets

Halozyme wins court order to block Merck's injected Keytruda in select European markets

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