Biocon - Growth Drivers

Growth Drivers

Today, biologics, with revenues of $125 billion in 2008, are outperforming the global pharma market. The growth rate of biologics—which include biosimilar MAbs, biosimilar insulin and novel biotherapeutics, among others—is projected to increase at double-digit levels. Moreover, even as mature markets have a single-digit growth rate of 4.3%, the growth essential to the industry’s survival is coming from emerging markets that are expected to expand by $90 billion during 2009-13 and contribute 48% of annual market growth in 2013. In such a scenario, Biocon has the structures to engage these growth drivers.

Monoclonal Antibodies (MAbs): These are one of the fastest growing categories of the biopharmaceuticals industry with sales expected to reach $67.6 billion by 2015, a CAGR of 13.8% between 2008 and 2015. Biocon has the expertise required to develop MAbs as seen with its product, BIOMAb-EGFR – it has the manufacturing facilities required for MAb research and has developed expertise in process development, formulation development and characterization as well as manufacturing and clinical development. Biocon has entered into sales and marketing agreements with Mylan to develop and commercialize molecules globally.

Biosimilar insulin: With the worldwide insulin market expected to be worth over $11 billion by 2011 and an estimated 246 million people affected by diabetes worldwide, according to The World Health Organization, the demand for insulin in expected to increase greatly over the next decade. Biocon has expertise in developing cost-effective Pichia-derived insulin. It has a rich insulin portfolio—comprising recombinant human insulin, insulin glargine (a long-acting basal insulin analogue), insulin aspart (short-acting, in pre-clinical), and insulin lispro (another short-acting analogue, in pre-clinical)—covering the analog space.

Novel licensing program: Biocon has programs to out-license two molecules IN-105 and T1h. With a positive safety and clearance profile, IN-105 is an orally delivered conjugated insulin drug that is expected in the market soon. IN-105 is currently undergoing Phase 3 clinical studies in India. An investigational new drug application (IND) with the US Food and Drug Administration was filed in December. T1h is a novel humanized monoclonal antibody that blocks CD6. In clinical trials in the autoimmune segment, T1h is the only Class I novel biological being tested in India for rheumatoid arthritis (RA) and psoriasis. Two Phase II clinical trials have been started one in RA and one in psoriasis, and are expected to be completed this year.

Emerging markets: With the dynamics of the pharma world shifting, emerging markets—the 17 high-growth pharmaceutical markets, including the 7 primary pharmerging markets of India, Brazil, Russia, China, Mexico, Turkey and South Korea—present an important opportunity for biotechnology firms. Emerging markets including India already contribute about 40% of Biocon’s sales. Biocon has entered into partnerships with companies around the world to gain access in emerging markets.