The biosimilars market was estimated at USD 3.1 billion in 2015. Since the guidelines on the similar biological medicinal products came into effect in Europe, in 2005, there has been a significant development in the field of biosimilars. These drugs are highly similar copies of a previously approved biologic (reference product) and may differ from the reference drug in terms of clinically inactive components without consequential clinical implications.
These drugs possess similar clinical properties in terms of safety, potency, and purity as compared to the original biologic drug. The global biosimilars market is expected to grow at a rapid pace as blockbuster biologics are approaching patent expiration; and thus, creating a huge potential for the similar biological medicinal products. The U.S. and APAC markets present profitable growth opportunities for the similar biological medicinal products industry, which is expected to grow at a significant rate in the coming years.
The key factors responsible for the growth of the industry are the cost-effectiveness of the dissimilar drugs and the increasing encumbrance to cut down expenditures across the healthcare systems in the world. Additionally, positive clinical evidential data obtained for the similar biological medicinal drugs have slowly led to the increased acceptance levels of these drugs by the regulatory bodies; and hence, the subsequent, higher approval rates of the biosimilars. However, high complexities and costs involved in the manufacturing of similar biological medicinal products, the presence of a rigorous regulatory framework governing their approval in countries around the world, and the presence of substitutes, such as non-original biologics and ‘bio-betters’ are likely to hinder the growth of this sector.
The biosimilars market by product is divided into recombinant non-glycosylated proteins and recombinant glycosylated proteins. The recombinant non-glycosylated proteins segment is categorized into insulin, human growth hormones, granulocyte colony-stimulating factor (G-CSF), and interferons; this segment captured the largest industry share in 2015 and is anticipated to grow at a healthy CAGR from 2016 to 2024.
On the other hand, recombinant glycosylated proteins segment is categorized into erythropoietin, monoclonal antibodies, and follitropin. As a result of the wide applicability of the products in oncology, blood, and other chronic disorders, this segment is expected to grow at a rapid pace.
The similar biological medicinal products market by application is segmented into oncology, blood disorders, growth hormone deficiency, chronic and autoimmune disorders, and others. The similar biological medicinal products find its application in the large range of blood disorders and the different oncology areas; these application segments are estimated to grow at a profitable rate due to the surging global cancer epidemic and the high incidence rates of blood disorders.
Cancer cases in the world were estimated to be approximately around 14.1 million in 2012. This estimate directly reflects the resultant increase in demand for these drugs for its application in oncology in the coming future.
The key regions taken into consideration in the biosimilars report are North America, Europe, Asia Pacific, and rest of the world. The European biosimilars sector is estimated to be the largest at a global level. In 2015, the German similar biological medicinal products market accounted for the maximum share in Europe. With respect to the growth rate, the industry in North America is anticipated to grow at the highest CAGR during the study period.
In the Asia Pacific region, India and China are expected to exhibit the highest growth and emerge as the leading players in the market. Asia-based biotech companies including Celltrion Healthcare Co., Ltd., Biocon Ltd., and Dr. Reddy’s Laboratories, Inc. are actively involved in building a stronghold in the industry, which is going to be a significant contributing factor in pushing forward the industry growth.
Some established players in this biosimilars market are Roche Diagnostics, Amgen, Inc., Biocon Ltd., Teva Pharmaceutical Industries Ltd., Merck & Co., Mylan, Inc., Dr. Reddy’s Laboratories, Inc., Sandoz, Inc., Celltrion Healthcare Co., Ltd., Abbvie, Inc., and Hospira, Inc.
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