文章

Market overview and Review on Semaglutide API - An Oral Glucagon-Like Peptide 1 Receptor Agonist

Mechanism of action:

Semaglutide is a glucagon-like peptide 1 (GLP-1) receptor agonist, with 94% sequence homology to human GLP-1 indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus

Semaglutide API Market Overview:

In 2019, 463 million people aged 20 - 79 years lived with diabetes worldwide, and this number will reach 700 million by the end of 2045 (According to data published in the 9th edition of diabetes atlas by the International Diabetes Federation (IDF) [1].

From 2020 to 2027, the global market size for GLP-1 receptor agonists is expected to grow at a compound annual growth rate (CAGR) of 6.1%. According to the GLP-1 receptor agonist market report, the market was valued at USD 11.3 billion in 2019 and it is projected to grow at a compound annual growth rate (CAGR) of 6.1% from 2020 to 2027 [1].

Globally, the Semaglutide API market is expected to grow due to an increasing prevalence of type 2 diabetes. In addition, Semaglutide will be in high demand worldwide due to the growing prevalence of diabetes and obesity, as it helps control blood sugar levels and improves insulin sensitivity. As a result, the Semaglutide market is estimated to grow at an average annual growth rate (CAGR) of 9% [2].

Our Manufacturing and Supply Assurance

We manufacture Semaglutide API at our cGMP API manufacturing facility, which was successfully inspected by international regulatory authorities. We have reliable KSM suppliers to ensure timely deliveries and adhere to stringent specifications. We are also multi-sourced on our KSMs to provide supply assurance.

The manufacturing facility is equipped with best-in-class peptide synthesizers and purification technologies, using different separation technologies of various capacities. We source the amino acid from the world’s leading amino acid manufacturer and have an in-house source for lysine-derivatized side chains.

Our quality control (QC) labs have the in-house capabilities to test and release all critical quality attributes (CQAs). We can customize the dispatches quantity to cater to customer needs. A complete characterization of API to establish the sameness with Innovator product (Following linear peptide synthesis).

Proven Track Record in Drug Product Development

Our in-house analysis lab complements our chemistry lab and has high-end capabilities to characterize the molecule comprehensively and prove its sameness. We applied multiple orthogonal techniques and extensive characterization tools as well as impurity profiling

With a proven track record in drug product development, we are well-positioned in peptide APIs, with extensive development capabilities supported by state-of-the-art process development facilities, formulation optimization platforms, and cGMP manufacturing capabilities. We filed our first drug master file (DMF) in August 2021 and have received “Available for reference status” from US FDA by Oct 2021 with “zero” screening deficiency.”

Our Unique end-to-end product Offerings

As a Semaglutide API manufacturer Dr. Reddy’s provides a unique end-to-end product offering where the customers can choose from the following business models:

The partnership a customer forms with Dr. Reddy’s goes beyond the supply of the final product. We provide our customers with the immunogenicity studies/data available, and a complete characterization data set to cater to regulatory requirements. In addition, our global regulatory affairs team assists our customers with assembly and filing requirements across various markets.

To know more about how we can meet your Semaglutide requirements please contact us at: api@drreddys.com

References: