Biosimilars Market Overview
The global biosimilars market generated $6.0 billion revenue in 2018, and is expected to witness 29.6% CAGR during the forecast period. The growth of the market can primarily be attributed to several factors, including growing geriatric population, rising prevalence of chronic diseases, inexpensive nature of biosimilars as compared to reference drugs, increasing investment in research and development (R&D) by biopharmaceutical companies, and extensive pipeline of biosimilars.
Biosimilars are the U.S. Food and Drug Administration (USFDA) approved biologic products, which are highly similar to reference drugs. They may have small differences in their inactive products, but are similar to reference products in terms of safety, efficacy, and purity.
Recombinant glycosylated proteins, recombinant non-glycosylated proteins, and recombinant peptides are the products available in the biosimilars market. Among these, recombinant glycosylated proteins held the largest market share, of 54.3%, in 2018. This can be attributed to the easy approval and less complexity of these products due to the process of glycosylation, which makes the protein more stable. Recombinant glycosylated proteins are further classified into monoclonal antibodies (mAbs), erythropoietin, and follitropin. Among these, mAbs is expected to hold the largest market share during the forecast period, mainly on account of increased requirement of biosimilars for the treatment of various chronic diseases such as cancer and diabetes.
Further, recombinant non-glycosylated proteins are sub-categorized into insulin, recombinant human growth hormone, granulocyte-colony stimulating factor (G-CSF), and interferons. Out of these, insulin held the largest market share, of 48.9%, in 2018, owing to the increasing incidence of diabetes among the population.
Key players operating in the biosimilars market manufacture these products either in-house or opt for contract manufacturing. In 2018, contract manufacturing held the largest market share, of 60.5%, owing to the increasing out-sourcing of non-core activities to contract organizations.
Based on route of administration (ROA), the biosimilars market is categorized into intravenous, subcutaneous, intranasal, and others. Biosimilars administered through intravenous route occupied the largest market share, of 48.7%, in 2018, owing to the rapid onset of action in case of intravenous administration. The category is also expected to undergo fastest growth, registering a CAGR of 31% during the forecast period.
Oncology, rheumatology, blood-related disorders, auto-immune diseases, chronic diseases, infectious diseases, growth hormone deficiency (GHD), and others are some prominent application areas for biosimilars. Among these, oncology was the largest category in the biosimilars market during the historical period. This is attributed to the increasing incidence of cancer worldwide. According to WHO, approximately one in every six deaths occurred due to cancer in 2018.
Biosimilars Market Dynamics
Some of the key factors driving the growth of the biosimilars industry are growing geriatric population, increasing prevalence of chronic diseases, increasing R&D investment by biopharmaceutical companies, extensive pipeline of biosimilars, and inexpensive nature of biosimilars.
Growing geriatric population is a major issue in the world. According to the National Institutes of Health, 8.5% of the total population, globally, was aged 65 years and above in 2015, and this is expected to reach 17% by 2050. The geriatric population implies the emergence of old age-related diseases.
Moreover, increasing prevalence of chronic diseases is another factor that positively impacts the growth of the biosimilars market. For instance, according to the World Health Organization (WHO), cardiovascular disease resulted in 31% of all deaths, globally, and cancer constituted the second-most devastating disease, causing approximately 9.6 million deaths worldwide in 2016.
Besides, increasing R&D investment by biopharmaceutical companies to develop biosimilars is also an important factor for the growth of the biosimilars market. Many biopharmaceutical companies have biosimilars either being marketed or in pipeline. For instance, Teva Pharmaceuticals Industries Limited has two biosimilars in its pipeline, which include trastuzumab biosimilar (CT-P62), and rituximab injection (Truxima).
Furthermore, low cost of biosimilar drugs is another factor affecting the growth of the biosimilars market. For instance, Pharmaceuticals Journal mentions that biosimilars cost 10–70% lesser than branded biologics. For instance, cost of a six-months treatment through rituximab biologics is $6.7 million, while the same treatment from biosimilar costs $3.3 million.
Biosimilars Market Competitive Landscape
Rapid product launches are expected to have a positive impact on the growth of the biosimilars market. For instance, Amgen Inc., Sandoz International GmbH, Samsung Bioepis, and Mylan N.V. launched adalimumab as a joint venture in 2018 in the European market. These companies are further expected to launch this biosimilar in the U.S. market by 2023.
Besides increasing number of collaborations and partnerships also tend to have a positive impact on the biosimilars market growth. For instance, in June 2018, Biocon India Private Limited declared a global collaboration with Sandoz International GmbH for the development, production, and marketing of next generation biosimilars, including Etanercept.
Some of the key players in the global biosimilars market are AMEGA Biotech, Samsung Bioepis Co. Ltd., Coherus BioSciences Inc., Synthon Holding B.V., BIOCAD, Zydus Cadila, Celltrion Inc., Dr. Reddy’s Laboratories Ltd., Teva Pharmaceutical Industries Limited, Novartis AG, Pfizer Inc., and Mylan N.V.