Antidiabetic Biosimilars Market - Global Industry Insights 2024

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Antidiabetic Biosimilars Market - Global Industry
Insights, Trends and Opportunity Analysis, 2016-2024
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Report Description
Antidiabetic biosimilars market overview
Antidiabetics help control blood glucose levels in diabetic patients. Various types of antidiabetics include
biguanides, thiazolidinediones, DPP-IV inhibitors, α-glucosidase Inhibitors, sulfonylureas, insulin, and
GLP-1 receptor agonists such as exenatide. A biosimilar product is biological product that is approved on
the basis that it is highly similar to a FDA approved biological product known as a reference product.
Biosimilar manufacturers need to generate data from lab testing and clinical testing to demonstrate that
the biosimilar developed provides the same therapeutic benefit to patients as the reference product.
Patent expiries to drive growth of the global antidiabetic biosimilars market
The global antidiabetic biosimilars market is driven by increasing number of diabetes mellitus patients.
According to World Health Organization (WHO) the number of people suffering from diabetes stood at
422 million in 2014. The global prevalence of diabetes among adults above 18 years increased to 8.5%
in 2014 from 4.7% in 1980. Increasing incidence of lifestyle disorders such as obesity, increases the risk
of diabetes and in turn drives growth of the antidiabetic biosimilars market. In June 2014, the European
Medicines Agency authorized the first biosimilar of insulin Glargine, Abasaglar from Eli Lilly and Company
and Boehringer Ingelhim International Gmbh, for treatment of diabetes mellitus. The biosimilar received
U.S. FDA approval in 2016, which would fuel growth of the antidiabetic biosimilars market.
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Furthermore patent expiry of insulin aspart and insulin lispro is projected to propel growth of antidiabetic
biosimilars market. Biosimilar insulin have potential to reduce diabetes treatment costs, increase
accessibility of insulin treatment and expand the number of insulin brands. Some antidiabetic biosimilars
which are approved or are in approval process include:
Product
SB9/MK-1293
Company
Status
Samsung
Bioepis/Merck
Submitted to FDA for approval in August 2016 and to EMA in
December 2015. Approved by EMA in November 2016.
Eli
Lilly/Boehringer
Ingelheim
Approved by EMA in September 2014, by US FDA in August
2014, by Australia in May 2015 and by Japan in January 2015
Glaritus
Wockhardt
‘Similar biologic’ launched in India in March 2009
Basalog
Biocon/Mylan
‘Similar biologic’ launched in India in March 2009. Received
approval in Japan in March 2016 and launched in July 2016.
EMA regulatory submission in November 2016
Abasaglar/
Basaglar/
LY2963016
Constraints for growth of the antidiabetic biosimilars market
Biosimilars would have to face stringent regulatory requirements that would focus on their production
before entering into major markets such as the U.S. While biosimilars have marked successful entry in
the European markets, entry in the U.S. market is still a challenge due to stringent regulatory norms.
Furthermore, biosimilars would need to gain favorable reimbursement to gain market traction.
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Increasing number of diabetes patients driving the antidiabetic biosimilars market globally
Increasing incidence of diabetes, complexities in alternative diabetic therapies, and government incentives
for introduction of low cost therapies are collectively creating a conducive environment for growth of the
market. According to the International Diabetes Federation (IDF), there were around 59.8 million diabetic
patients in Europe in 2015. The market for antidiabetic biosimilar is expected to be high in near future in
Asia Pacific due to increase in research activities related to antidiabetic products and supportive
government funding. North America region is projected to represent a lucrative market for antidiabetic
biosimilar in the near future, as prevalence of diabetes is increasing in this region. According to the
International Diabetes Federation, in 2015, over 29.1 million people in the U.S. suffered from diabetes.
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Antidiabetics help control blood glucose levels in diabetic patients. Various types of antidiabetics include biguanides, thiazolidinediones, DPP-IV inhibitors, α-glucosidase Inhibitors, sulfonylureas, insulin, and GLP-1 receptor agonists such as exenatide. A biosimilar product is biological product that is approved on the basis that it is highly similar to a FDA approved biological product known as a reference product. Biosimilar manufacturers need to generate data from lab testing and clinical testing to demonstrate that the biosimilar developed provides the same therapeutic benefit to patients as the reference product.