Biosimilars are therapeutically similar copies of biologic drugs. The European Medicines Agency (EMA) defines biosimilars as drugs that claim to be 'similar' to their reference biological medicinal products. The active drug substance of biosimilars is derived from a living organism by means of recombinant DNA or controlled gene expression methods. In the coming years, biosimilars will continue to act as a catalyst for the biopharmaceutical industry. The most significant reason for the increasing adoption of biosimilars is their cost benefits to patients as these products are available in the market at 10% to 30% lower prices compared to their parent products. The global market is estimated to reach $2.0 billion by 2018 at a CAGR of more than 20% between 2013 and 2018.
The biosimilar products market is segmented into recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. The recombinant non-glycosylated proteins market is further segmented as insulin, granulocyte colony-stimulating factor (G-CSF), interferons, and human growth hormone, whereas the recombinant glycosylated proteins market is further broken down into erythropoietin, monoclonal antibodies, and follitropin. Recombinant peptide market is divided into Calcitonin and Glucagon.
Of all the segments, the key traction segment that is estimated to grow at a faster rate of 25% by 2018 is the recombinant glycosylated proteins segment. This growth can mainly be attributed to investments by drug manufacturers to develop biosimilar versions of monoclonal antibodies (more than 50 biosimilars of monoclonal antibodies are in the pipeline), the introduction of the new biosimilar drug 'Ovaleap' (follitropin) to treat infertility, and the growing demand for erythropoietin and monoclonal antibodies to treat cancer.
Monoclonal antibody is one of the lucrative markets for drug manufacturers, for x future investment to develop MAb at a large scale and is also estimated to be the fastest growing market at an estimated CAGR of 41.9% from 2013 to 2018. About eight biologic MAb drugs are expected become off-patent products from 2013 to 2018. The drugs that are expected to lose their patent protections are Rituxan/MabThera, Remicade, Herceptin, Humira, Avastin, Synagis, Erbitux, and Lucentis. The three most targeted products for biosimilars are Rituximab, Infliximab, and Adalimumab due to their high worldwide sales and approvals for multiple indications. Various key industry players of the generics market have started working on the manufacturing and clinical trial activities of MAbs. At present, approximately 50 biosimilar MAbs are in the pipeline. Bioexpress Therapeutic (Switzerland) has 16 biosimilar candidates of MAbs that are in the pipeline. The other players that have invested in the production of MAbs are GeneTechno Science (Japan), Celltrion (South Korea), Zydus-Cadila (India), Biocon (India), and Samsung Biologics (South Korea).
Following monoclonal antibodies, insulin will be the fastest growing segment and is estimated to grow at a CAGR of 35.6% from 2013 to 2018. The growth is attributed to the rise in incidences of diabetes, on-going patent expirations of biologic drugs such as Lantus, Humalog, and Novorapid, and the cost effectiveness of the biosimilars of insulin. Other factors that drive the global market is the rise in the number of off-patented biologic drugs, rise in incidences of chronic disorders, growing pressure to cut healthcare expenditure, rise in aging populations, and government support and initiatives.
On the other hand, the factors that restrict the growth of the market are high manufacturing complexities and costs, the stringent regulatory environment in the U.S. and Europe, innovative strategies used by biologic drug manufacturers to protect their intellectual property, costly purifi
