Biosimilar drugs are copy drugs similar to the biological drugs that have been already authorized, hence similar but not identical. Biosimilar can be manufactured if the patent of the original product is expired and original innovator officially approved for the development of drugs. It includes medicine derived from biological sources such as bacterium, yeast or blood. Biological medicine is very expensive as the manufacturing process is very complex and requires a huge investment. They are different in structure but have the same mode of action as of original product. In Europe, since 2006, the European medicine agency allowed the commercialization of biosimilar drugs while FDA started it in 2015.
The higher cost of biological medicines, increasing prevalence of chronic diseases, and government initiatives to approve commercialization of biosimilars drives the growth of the market. As per the Forbes projection in near future, around 20% of GDP will be spent on healthcare. Companies producing biosimilar drugs have a profit margin of around 30% and are cost effective. Abbvie’s Humira (adalimumab) is one of the products having the highest sale in 2016 & 2017 and contribute higher share in revenue, which is now available in biosimilar as Cyltezo of Boehringer Ingelheim’s & Amjevita of Amgem’s.
Growing market share of biological drugs in overall pharmaceutical medicines consumption creates an opportunity for biosimilar drugs market. Lack of FDA guidelines, fewer pharmacopeia monographs, huge investment required in setting up biosimilar manufacturing plant, complex process of manufacturing, and lack of economy of scale in production due to low demand can restrain the growth of the market.
Factors influencing the growth of the biosimilar market:
Rising aging population, growing use of biological products to treat a chronic condition, and dependency of health decision on cost supports the market to grow exponentially. Rising prescription of biosimilar drugs by doctors expand the market. According to the Forbes, biosimilars have made it possible to lower the prices of biological drugs by 30% in European Union. Increasing number of firms losing patent protection, government support to use biosimilars, and manufacturer strategy to team up with drug delivery devices companies are boosting the market growth.
Europe is expected to hold the major share in the market, owing to the early commercialization of biosimilar medicines, large product portfolio in biosimilar, liberal government guidelines, and developed healthcare infrastructure. During the last few years, there is a significant increase in the prevalence of different chronic disease in Europe, which has increased the demand for better treatment. North America is expecting a sound growth in near future due to newly formed yielding regulation by FDA to approve biosimilars, growing demand for biological drugs, and higher penetration of players of the market. Presence of huge diabetic population in Americas will drive the market in America. According to the WHO, in 2015, 30.1 million people in America were suffering from diabetes. Increasing numbers of companies indulged in R&D & manufacturing of biosimilar, rising demand of cost-effective biological medicines, and growing awareness of these alternatives to branded drugs stimulate the growth of the market in Asia-Pacific. According to the WHO, over 55% of total global diabetes population is present in Asia-Pacific. The Middle East & Africa hold the least share, owing to the limited development in the healthcare sector and the presence of poor economies in Africa region. The Middle East holds the major share in LAMEA biosimilar market due to the presence of well-developed economies, high health spending, and well-developed healthcare infrastructure.
Major players profiled in this market are:
• Teva Pharmaceuticals
• Dr. Reddy’s Laboratories
• samsung Biologics
• STADA Arzneimittel
In January 2018, Biocon, one of the leader players in biosimilar market, signed a deal with Sandoz, the arm company of Novartis to jointly invest, develop, and market new product portfolio of biosimilar in cancer and immunology for global market.
In March 2016, Dr Reddy's and TR-Pharm entered into a strategic collaboration agreement for production and commercialisation of biosimilar drugs in Turkey.
In December 2017, First biosimilar called trastuzumab used for breast and stomach cancer was developed by Mylan-Biocon and approved by FDA in US.
Strategic agreement between pharmaceutical companies to develop biosimilar drugs is widely adopted strategy use by players in this market.
• Human growth hormone
• Monoclonal antibodies
• Granulocyte-Colony Stimulating Factor
By Type of Manufacturing:
• Contract Manufacturing
• In-house Manufacturing
By Diseases type:
• Blood Disorder
• Autoimmune Diseases
• Growth Hormone Deficiency
• Infectious Diseases
• North America
o Rest of Europe
o South Korea
o Rest of Asia-Pacific
o Saudi Arabia
o South Africa
o Rest of LAMEA