According to FutureWise analysis, the market for biosimilar therapeutic peptides in 2025 is US$ 3.92 billion and is expected to reach US$ 17.33 billion by 2033 at a CAGR of 20.42%. The market is experiencing strong growth due to rising demand for affordable alternatives to branded peptide drugs and the increasing prevalence of chronic diseases such as cancer, diabetes, and metabolic disorders. Biosimilar therapeutic peptides are preferred for their high specificity, safety, and efficacy. Additionally, supportive regulatory frameworks and advancements in peptide synthesis technologies are driving their global adoption.
Therapeutic peptides, consisting of short chains of 2 to 50 amino acids, are designed to offer high specificity and potency in the treatment of various conditions, including diabetes, cancer, osteoporosis, and cardiovascular diseases. These peptides can be chemically synthesized or produced through recombinant methods, providing several advantages over larger biologics, such as enhanced stability, reduced immunogenicity, and precise targeting capabilities. Notable examples of therapeutic peptides include insulin, introduced in 1921, glucagon-like peptide-1 (GLP-1) agonists such as exenatide and liraglutide for managing type 2 diabetes, and teriparatide for the treatment of osteoporosis.
Biosimilar therapeutic peptides are versions of originator peptides whose patents have expired. They are engineered to closely match the reference product in terms of structure, purity, bioactivity, and clinical effectiveness, often at a lower cost. Unlike small-molecule generics, biosimilars of peptides must demonstrate analytical similarity due to potential variations in synthesis methods, impurities, or folding of the peptides. Regulatory pathways, such as those established by the European Medicines Agency (EMA) since 2006 and the U.S. Food and Drug Administration (FDA) through the 505(b)(2) or Abbreviated New Drug Application (ANDA) for certain peptides, focus on comparative physicochemical characterization (using techniques like HPLC, mass spectrometry, and NMR) and bioassays.
The development process includes solid-phase peptide synthesis (SPPS) or hybrid recombinant-chemical methods, followed by thorough purification to manage truncation, deamidation, or oxidation variations. For example, the biosimilar glatiramer acetate, used in the treatment of multiple sclerosis, needs to replicate the originator’s intricate mixture of random polypeptides. Meanwhile, biosimilar teriparatide must ensure it mirrors the identical 34-amino-acid sequence and maintains comparable affinity for parathyroid hormone receptors. Clinical studies typically confirm pharmacokinetic equivalence and immunogenic similarity, and extrapolation across different indications is permitted when the mechanisms of action align.
FutureWise Market Research has instantiated a report that provides an intricate analysis of Biosimilar Therapeutic Peptides Market trends that shall affect the overall market growth. Furthermore, it includes detailed information on the graph of profitability, SWOT analysis, market share and regional proliferation of this business. Moreover, the report offers insights on the current stature of prominent market players in the competitive landscape analysis of this market.
According to the research study conducted by FutureWise research analysts, the Biosimilar Therapeutic Peptides Market is anticipated to attain substantial growth by the end of the forecast period. The report explains that this business is predicted to register a noteworthy growth rate over the forecast period. This report provides crucial information pertaining to the total valuation that is presently held by this industry and it also lists the segmentation of the market along with the growth opportunities present across this business vertical.