North America Biosimilars Market Overview:
Biosimilar is a biopharmaceutical product similar to the previous or existing original product manufactured by a company. Biosimilars are complex biological products made from living organisms including micro-organisms such as bacteria and yeasts, humans and animals. Biosimilars are compared to biological reference products and are licensed by the USFDA. The patent expiry of the biological reference product is the key factor leading to the development of biosimilars. These are composed of complex molecules such as monoclonal antibodies and human insulin. State-of-the-art technologies are involved in the development and manufacture of biosimilars including monoclonal antibody (MAb) technology, nuclear magnetic resonance (NMR) technology, recombinant DNA technology (rDNA), electrophoresis and biological tests.
Monoclonal antibody technology and bioassays are the most important technologies for the development and validation of biosimilars. Most biological products, such as monoclonal antibodies, anticoagulants and vaccines, are large molecules that must be administered parenterally to achieve the desired therapeutic effects.
North America Biosimilars Market Size Growth Rate:
According to the research report, North America Biosimilars Market size was valued at USD 2 million in 2018 and this figure estimated to cross USD 13 Million by the end of 2025, and it is growing at a CAGR of 31.19% during the forecast period 2019-2025.
Growth Drivers and Restraints:
Biosimilars are widely used in the prevention and treatment of various chronic diseases, such as diabetes, cancers, cardiovascular diseases, autoimmune diseases, rheumatoid arthritis, kidney failure, growth hormone deficiency, hematological and infectious diseases, and the demand for biosimilars is likely to pick up speed in the years to come. The growth of the geriatric population is an important factor identified to primarily promote the biosimilars market. The appearance of non-patented organic products is one of the main factors likely to foster the growth of the North American biosimilars market in the coming years. These drugs are comparatively profitable, as demand is expected to increase significantly in the coming years. In addition, the increasing prevalence of different diseases in the North American is expected to fuel market growth. Patents for a number of successful biopharmaceutical products have expired or are about to expire, resulting primarily in the growth of the biosimilar industry.
Changes to regulatory guidelines and practical approval processes for biosimilars have a major impact on the commercial growth of the North American biosimilars market. In addition, the regional market is expected to face a number of challenges over the forecast period. The need for a complex infrastructure for biosimilar production and the lengthy clinical trials required to gain regulatory approval are some of the important factors that may hinder the growth of the market in the years to come. However, high manufacturing costs and complexity may remain longstanding hurdles to overall biosimilar production. In addition, the availability of affordable generic drugs on the market may also hinder sales of biosimilars. The main restriction for manufacturers is to establish the similarity through in-depth analytical characterization.
In addition, it is believed that the innovative strategies developed by biopharmaceutical manufacturers are stopping the development of the North American biosimilar market, especially new market players. Moreover, large investments in research and development, longer development processes and cost-efficiency requirements in scale significantly limit the growth of the North American market. The integration of the development plan into regulatory guidelines and the adoption of optimal business strategies would play a crucial role in the commercial growth of the biosimilars market in this region.
Depending on the geography, the North American market is analyzed in the regions of the United States and Canada. North America is expected to post a high CAGR during the forecast period due to increasing efforts by manufacturers to take advantage of growth opportunities in the United States and Canada. The United States biosimilar regulatory route was created in March 2009 and since then the region has gained significant momentum, presenting new opportunities and challenges. The FDA in the USA approved the first biosimilar product, Zarxio (filgrastim-sndz), in March 2015.
Some of the Promising Companies leading the North America Biosimilars Market Profiled in the Report are:
- Amgen Inc
- F. Hoffmann-La Roche Ltd
- Sandoz International GmbH
- Dr. Reddy's Laboratories Ltd
- Teva Pharmaceutical Industries Ltd
- Pfizer Inc
- Samsung Bioepis
- Mylan N.V
This research report includes following segmentation for the North America Biosimilars Market size and forecast until 2026:
North America Telemedicine Market – By Type:
- Human Growth Hormones
- Granulocyte Colony-stimulating Factor (G-CSF)
- Recombinant Glycosylated Proteins
- Monoclonal Antibodies
- Recombinant Peptides
North America Telemedicine Market – By Technology:
- Mass Spectroscopy
- Monoclonal Antibody Technology
- Recombinant DNA Technology
- Nuclear magnetic resonance (NMR) technology
North America Biosimilars Market – By Application:
- Oncology diseases
- Blood disorders
- Growth hormone deficiencies
- Chronic and autoimmune diseases
North America Biosimilars Market – By Regional Segmentation:
- United States
- Rest of North America