Biosimilars is a biological product designed to have similar active properties to the one that has been previously licensed and has no clinically significant differences in terms of safety and effectiveness. Biosimilars insulin is a type of biosimilars where it is indistinguishable to the reference insulin product and is already been approved by FDA or licensed. The producers of biosimilars use the similar manufacturing techniques as of the patented product but not likely identical to that used by the patent holder. Due to increasing insulin manufacturers from the developed and developing countries, the patents for insulin formulations had neared expiry or were ended. This created a necessity to seek approvals on biosimilar insulin for the not yet established companies in the highly regulated markets such as Europe and United States. In 2014, The European Commission (EC) first granted insulin treatment through the biosimilars pathway to Eli Lilly and Company and Boehringer Ingelheim GmbH. Lilly/Boehringer Ingelheim developed a biosimilar insulin called ÒInsulin glargineÓ and was the fourth diabetes product which was approved from Lilly-Boehringer Ingelheim Alliance in Europe. Basaglar is the first ÒbiosimilarÓ insulin product to be approved and launched in U.S. which was developed by the alliance of Lilly/Boehringer Ingelheim.
Scope of the Report:This report focuses on the Biosimilars Insulin in global market, especially in North America, Europe and Asia-Pacific, South America, Middle East and Africa. This report categorizes the market based on manufacturers, regions, type and application.
Increasing prevalence of Type I diabetes, higher cost of existing insulin drugs are expected to drive growth of insulin biosimilars market. Government authorities are also focusing on the approval of insulin biosimilars owing to substantial financial burden in terms of reimbursements. Recently, the U.S. FDA has approved new insulin glargine Basaglar, for type 1 and type 2 diabetes which is Biosimilar version of SanofiÕs basal insulin Lantus (insulin glargine). Additionally, Lilly and Boehringer Ingelheim's biosimilar insulin glargine has got approval through European Medicines Agency's (EMA's) Biosimilar pathway. Such ongoing approvals by the respective authorities are expected to drive the growth of insulin Biosimilar market. However, Insulin patent protection rights and strong retaliation from the branded manufactures has restricted the growth of insulin biosimilar development.
The worldwide market for Biosimilars Insulin is expected to grow at a CAGR of roughly xx% over the next five years, will reach xx million US$ in 2026, from xx million US$ in 2020, according to a new study.
Market Segment by Manufacturers, this report covers Eli Lilly
Boehringer Ingelheim
Merck
Pfizer
Biocon
Mylan
Market Segment by Regions, regional analysis covers North America (United States, Canada and Mexico)
Europe (Germany, France, UK, Russia and Italy)
Asia-Pacific (China, Japan, Korea, India and Southeast Asia)
South America (Brazil, Argentina, Colombia etc.)
Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)
Market Segment by Type, covers Insulin Glargine Basaglar
Insulin Lantus
Market Segment by Applications, can be divided into Type I Diabetes
Type II Diabetes
There are 15 Chapters to deeply display the global Biosimilars Insulin market.
Chapter 1, to describe Biosimilars Insulin Introduction, product scope, market overview, market opportunities, market risk, market driving force;
Chapter 2, to analyze the top manufacturers of Biosimilars Insulin, with sales, revenue, and price of Biosimilars Insulin, in 2018 and 2019;
Chapter 3, to display the competitive situation among the top manufacturers, with sales, revenue and market share in 2018 and 2019;
Chapter 4, to show the global market by regions, with sales, revenue and market share of Biosimilars Insulin, for each region, from 2015 to 2020;
Chapter 5, 6, 7, 8 and 9, to analyze the market by countries, by type, by application and by manufacturers, with sales, revenue and market share by key countries in these regions;
Chapter 10 and 11, to show the market by type and application, with sales market share and growth rate by type, application, from 2015 to 2020;
Chapter 12, Biosimilars Insulin market forecast, by regions, type and application, with sales and revenue, from 2020 to 2026;
Chapter 13, 14 and 15, to describe Biosimilars Insulin sales channel, distributors, traders, dealers, Research Findings and Conclusion, appendix and data source
Frequently Asked Questions
The base year for the study has been considered 2019, historic year 2014 and 2018, the forecast period considered is from 2020 to 2027. The regions analyzed for the market include North America, Europe, South America, Asia Pacific, and Middle East and Africa. These regions are further analyzed at the country-level. The study also includes attractiveness analysis of type, application and regions which are benchmarked based on their market size, growth rate and attractiveness in terms of present and future opportunity for understanding the future growth of the market.
Market is segmented on the basis:
- By Type
- By Application
- By Region
- By Country
- By Manufacturer
The report offers in-depth analysis of driving factors, opportunities, restraints, and challenges for gaining the key insight of the market. The report emphasizes on all the key trends that play a vital role in the enlargement of the market from 2019 to 2026.
The report provides company profile of the key players operating in the market and a comparative analysis based on their business overviews industry offering, segment market share, regional presence, business strategies, innovations, mergers & acquisitions, recent developments, joint venture, collaborations, partnerships, SWOT analysis, and key financial information.
