Market Outlook
The biosimilars market size was $6.0 billion in 2018, and it is expected to advance at a CAGR of 29.6% during 2019–2024. The major factors behind the industry growth include the increasing aging population, soaring cases of chronic diseases, rising investments by pharmaceutical companies in research and development (R&D), higher affordability of biosimilars in comparison to reference drugs, and extensive pipeline of biosimilars.
Biosimilars refer to U.S. Food and Drug and Administration (FDA)-approved biological products that are extremely similar to reference drugs. They might have tiny differences in their inactive products, but they are highly similar to the reference products in terms of efficiency, purity, and safety.
In 2018, the recombinant glycosylated proteins category, within the product segment, held the largest market share, of nearly 54.3%. This can be ascribed to the less complexity and easy approval process for these products owing to the glycosylation process, which increases the stability of the proteins.
The recombinant glycosylated proteins category is further classified into erythropoietin (EPO), follitropin, and monoclonal antibodies (mAbs). Among these, mAbs are expected to generate the highest revenue in the coming years due to the high requirement for such biosimilars for treating chronic diseases, such as diabetes and cancer.
Further, the recombinant non-glycosylated proteins category of the biosimilars market is categorized into interferons, insulin, granulocyte-colony stimulating factor (G-CSF), and recombinant human growth hormone. In 2018, insulin accounted for the major share, of 48.9%, owing to the growing prevalence of diabetes worldwide.
In 2018, the contract category held the larger market share, of 60.5%, within the manufacturing type segment. This was due to the increasing outsourcing of non-core activities by major biopharmaceutical companies to contract organizations.
The intravenous category, under the route of administration (ROA) segment, dominated the biosimilars industry in 2018, by accounting for a 48.7% share. This is because of the rapid onset of action of the drug in case of intravenous administration. Moreover, the category is expected to witness the fastest growth, at a CAGR of 31.0%, in the foreseeable future.
During 2014–2018, the oncology category, within the indication segment, dominated the market due to the rising prevalence of cancer. According to the World Health Organization (WHO), in 2018, approximately one in every six deaths was caused due to cancer.
Market Dynamics
The escalating geriatric population, surging R&D investments by pharmaceutical firms, growing prevalence of chronic illnesses, inexpensive nature of biosimilars, and extensive pipeline of such drugs will drive the biosimilars market in the coming years.
The large population of old people leads to a high prevalence of age-related diseases. The National Institutes of Health states that in 2015, 8.5% of the global population was aged 65 years or above, and this share is estimated to reach around 17% by 2050.
The increasing cases of chronic diseases are another growth driver for the market. According to the WHO, in 2016, cardiovascular diseases (CVDs) led to 31% of the global deaths, and cancer emerged as the second-most-devastating illness, resulting in around 9.6 million deaths worldwide.
Another growth driver for the market for biosimilars is the spurring R&D investment by pharmaceutical companies for the development of such drugs. Several pharmaceutical firms have biosimilars that are either being marketed or in the pipeline. For example, Teva Pharmaceuticals Industries Limited has rituximab injection (Truxima) and trastuzumab biosimilar (CT-P62) in its pipeline.
Moreover, the Pharmaceuticals Journal states that the cost of biosimilars is 10–70% lower than branded biologics. For example, the cost of a six-month treatment through the rituximab biologic is $6.7 million, whereas the same treatment through biosimilars costs $3.3 million. Thus, the low cost of biosimilar drugs is another major factor facilitating the biosimilars market growth.
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.
