Biosimilars are complex biological agents made from living organisms, including microorganisms such as bacteria, yeast, humans and animals. They are compared to biological reference products and approved by the different government bodies. Patent expiration of biological standards is a key factor in the development of biosimilars. They consist of complex molecules such as monoclonal antibodies and human insulin. The most advanced techniques involve the development and manufacture of biosimilars, including monoclonal antibody (MAb) technology, nuclear magnetic resonance (NMR) technology, recombinant DNA technology (rDNA), electrophoresis and biological assays. Monoclonal antibody technology and bioassays are the most important technologies for the development and validation of biosimilars. Most biological agents, such as monoclonal antibodies, anticoagulants, and vaccines, are large molecules that must be administered parenterally to achieve the desired therapeutic effect.
Europe Biosimilars Market Size Growth Rate:
According to the research report, Europe Biosimilars Market size was valued at USD 1 million in 2018 and this figure estimated to cross USD 11.6 Million by the end of 2025, and it is growing at a CAGR of 32.35% during the forecast period 2019-2025.
Europe Biosimilars Market Growth Drivers and Restraints:
The increase in the elderly population is one of the important factors that has been identified to promote the biosimilar market. The emergence of non-patented organic products is another key factor that will drive the growth of the biosimilars market in Europe. Biosimilars are widely used to treat a variety of chronic diseases, including diabetes, different types of cancers, cardiovascular disease, autoimmune disease, rheumatoid arthritis, kidney failure, growth hormone deficiency, and hematologic and infectious diseases. Demand is expected to increase significantly over the next few years for these products in all the local nations. In addition, the European market is expected to see an increase in the growth of other diseases, and several successful biopharmaceutical patents have expired or will expire. This leads mainly to the growth of the biosimilars industry in this region.
The need for complex infrastructure for biosimilars production and the long-term clinical trials required to obtain regulatory approval are some of the key factors that will hinder the European market growth. Changes in regulatory guidelines and substantial biosimilar approval processes have a major impact on the commercial growth of the local biosimilars market. In addition, the biosimilars market in Europe is expected to face a series of challenges during the forecast period such as the high manufacturing costs and complexity in its production. Also, the use of affordable generic drugs in the market can hinder sales of these biosimilars. The major limitation of the manufacturer is to establish bioequivalence through in-depth analysis.
It is also believed that the innovative strategy developed by the biopharmaceutical manufacturer inhibits the development of the Europe biosimilars market, especially new market participants. Also, large-scale investments in large-scale R & D, long development processes, and cost-effectiveness requirements significantly limit the growth of the biosimilars market in Europe. Incorporating development plans into regulatory guidelines and adopting optimal commercial strategies will play a crucial role in the commercial growth of the biosimilars market in Europe.
Europe Biosimilars Market Regional Presence:
Geographically, the European market is analyzed in several regions, namely the United Kingdom, Spain, Italy, Germany and France. Europe should be in second place in the global biosimilars market and will offer an important contribution to overall market in the years to come. The strong growth of this region can be attributed to the presence of several biosimilar drugs, including binocysts, tevagrastim and omnitrope. In addition, it is estimated that the strict regulatory framework and the increase in the number of products in progress will significantly contribute to the development of the biosimilars market in Europe in the coming years. The European market is further fueled by the increased prevalence of chronic diseases and by various initiatives taken by the EMA and the government to raise awareness of new approaches and the use of biosimilars.
Some of the prominent companies leading the Europe Biosimilars Market:
- 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 Europe Biosimilars Market size and forecast until 2025:
Europe Biosimilars Market – By Type:
- Human Growth Hormones
- Granulocyte Colony-stimulating Factor (G-CSF)
- Recombinant Glycosylated Proteins
- Monoclonal Antibodies
- Recombinant Peptides
Europe Biosimilars Market – By Technology:
- Mass Spectroscopy
- Monoclonal Antibody Technology
- Recombinant DNA Technology
- Nuclear magnetic resonance (NMR) technology
Europe Biosimilars Market – By Application:
- Oncology diseases
- Blood disorders
- Growth hormone deficiencies
- Chronic and autoimmune diseases
Europe Biosimilars Market – By Regional Segmentation:
- United Kingdom
- Rest of Europe