A biosimilar is a medical product which is identical to the reference product. There is no clinical difference between a biosimilar and a reference product. These clinical difference includes purity, potency and safety. In other words, biosimilars are alternatives to existing patented and approved biologics which possess similar medicinal properties as compared to the original biologics. The biosimilars vary a little from original biologics in terms of structure but must have similar safety and efficacy as compared to the originator biologics.
A biosimilar is a medical product which have an active substance of the reference product/innovator product. Biosimilars are not generic equivalent of the original product. Evaluation of biosimilars are done by using rigorous processes which includes, non-clinical examinations, functional studies, analytical studies and clinical trials. Biosimilars are extensively used for the treatment of neutropenia, growth hormone replacement and anemia which is directly related to cancer and kidney failure. Biosimilars may show a particular degree of dissimilarity on account of manufacturing process and variety of biological system.
The important products of the biosimilars industry includes erythropoietin, G-CSF, peptides and monoclonal antibodies. Biosimilars are alternatively called follow-on biologics or bio-pharmaceuticals. Biosimilars are produced in the laboratories by following two important processes which includes recombinant DNA technology (RDT) and controlled gene expression.
The global biosimilars market is observing robust growth on account of cost-effectiveness of biosimilars when compared to the innovator product, thereby driving the demand of biosimilars worldwide. The expiration of innovator products/drugs is also growing the market. Reduction in the healthcare expenditure and increment in the number of off patented drugs are anticipated to increase the biosimilars market. Private bodies and governments of different countries are actively supporting the use of biosimilars over the conventional drugs. Increase in the number of cancer patients globally can drive the growth of the global biosimilars market.
Biosimilars Market is anticipated to record a CAGR of 38.9% over the forecast period. The biosimilars market is expected to showcase a robust growth by the end of the forecast period. The market is segmented into technology such as bioassay technology, recombinant DNA technology and monoclonal antibody technology. Bioassay technology and monoclonal antibody technology are used for the validation and development of biosimilars as they are very important. CLICK TO DOWNLOAD SAMPLE REPORT
According to the World Health Organization (WHO), the cancer burden has enhanced to 18.1 million new cases and the number of death because of cancer is 9.6 million in the year 2018. If the patent of any cancer drug expires, the patient taking that particular cancer drug will have another alternative treatment option which will include a biosimilar drug such as trastuzumab (Herceptin). Thus, increase in the number of cancer patients across the globe is anticipated to drive the growth of the global biosimilars market.
Innovator original drugs including adalimumab (Humira) which is used to treat rheumatoid arthritis followed by epoetin which is responsible for the enhancement of red blood cells in the body are often expensive. The cost of biosimilars is 10-40% less than the original drug. These original drugs are discovered and developed through complicated time taking procedures and require high investment for the research and development. Biosimilar drugs are identical to the original drugs but, they are not the exact copies. Biosimilar drugs have the potential to produce exact clinical outcomes to that of the original drug. The economical cost of the biosimilar drugs will allow many patients to buy it, even in the low income countries. This effectiveness and cost effective price tag is anticipated to drive the growth of the global biosimilars market in the forecast period.
Biosimilars can give rise serious efficacy and safety concerns as they are developed to mimic human proteins. Therefore, many government regulatory bodies have made stringent guidelines for the approval and development of biosimilars. The U.S Food and Drug Administration have mentioned clearly in the guidelines which stipulate that the manufacturer of biosimilars must strictly perform extensive assessments based with regard to its similarity in order to demonstrate bio similarity with the innovator product to gain regulatory approval. Theses stringent guidelines from the government regulatory bodies may restrain the growth of global biosimilars market.
On the basis of regional analysis, global biosimilars market is segmented into five major regions including North America, Europe, Asia Pacific, Latin America and Middle East & Africa region.
European region is anticipated to lead the global biosimilars market as the first biosimilar was approved by the European Medicines Agencies (EMA) in the European Union. North America is also expected to experience a significant growth in the biosimilars market. Lower manufacturing cost of biosimilars, skilled labor force and less stringent regulatory measures by the government regulatory bodies in the Asia Pacific countries is anticipated to showcase high growth in the forecast period. Countries such as India, Korea and China is expected to experience vibrant growth in the forecast period.
Global stem cells market is further classified on the basis of region as follows:
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