01 Expansion of Biosimilars & Interchangeable Insulin Analogs A trend in the protein therapeutics market is the shift from exclusive branded insulin analogues to biosimilar and interchangeable formulations, which improves access and lower cost for patients. For example, in July 2025, the U.S. FDA approved Kirsty (Insulin Aspart-xjhz), the first interchangeable rapid-acting insulin aspart biosimilar to Novolog, enabling substitution at the pharmacy level without prescriber intervention.These developments highlighted the growing shift towards biosimilars and interchangeable insulin analogs, boosting affordability, competition, and patient access in diabetes care.
02 Expansion of Indications for Monoclonal Antibodies in Rare Diseases & Immune Disorders A growing trend in the global market is the shift from using monoclonal antibodies (mAbs) mainly for common diseases (cancer, arthritis, etc.) to targeting rare diseases and immune disorders, which supports increasing drug indications and patient access. Recently, Amgen Inc.’s UPLIZNA (inebilizumab cdon) was approved by the U.S. FDA as the first treatment for Immunoglobulin G4-related disease (IgG4 RD), a rare, chronic immune-mediated condition, expanding its use beyond its prior indication for NMOSD.These expansions of mAb indications for rare immune-mediated diseases are boosting market growth through unmet demands, which further broaden the therapeutic application.
March 2026 Amgen expanded its protein therapeutics portfolio with advancements in biologic medicines and targeted therapies designed for oncology, inflammation, and chronic disease management.
January 2026 Roche expanded its protein-based therapeutics portfolio with new biologic treatment developments, focusing on oncology, immunology, and personalized healthcare applications.
October 2025 Eli Lilly expanded its protein therapeutics pipeline with continued development of biologic medicines, peptide-based therapies, and innovative treatments for metabolic and chronic diseases.
August 2025 AbbVie expanded its biologics portfolio with advanced protein therapeutics targeting autoimmune diseases, oncology, and other specialty care areas.