India biopharmaceutical companies' adherence to Intellectual Property (IP) is a big attraction for international companies to enter into co-development and production alliances.
Over the last four years, since the beginning of the new patent regime in 2005, global companies have been watching Indian pharma companies and are impressed by the compliance to IP. This is because prevalence of strong IP environment has seen an improvement in research and manufacture.
This has led several global majors to off-load many of the early stage proof-of-concept studies to Indian companies, Dr Rolf G Werner, corporate senior vice-president, corporate division biopharmaceuticals, Boehringer Ingelheim told Pharmabiz in an interaction.
Indian pharma companies have strengthened IP competence and regulatory expertise. They are supported by a large, competent scientific pool with which is resulting in time line deliveries. These factors have impressed Western world, added Dr Werner, who was in India for the Kemwell Biologics plant set up with in association with Boehringer Ingelheim.
In the last few years, Indian companies have been able to bag impressive contract research and manufacture orders. This has ensued out of the highest quality standards, impressive production and research infrastructure and product development efforts. All these factors have convinced European customers to depend on India's scientific strength and capability. Not only that the region is home to the highest number of US FDA approved plants outside the US which is a recognition of its systematically documented dossiers for international submissions, pointed out Dr Werner.
In Europe, it is becoming difficult to invest further into pharmaceuticals because of an excess capacity. Companies have begun to move towards bio pharma therapies which cover insulin, erythropoietin, Factor 8, G-CSF, tPA, monoclonal antibodies and antibody mimetics. Of the 400 drugs under various stages of clinical development, 300 are monoclonal antibodies. The new areas of product development are tumour receptors and targets in immunotherapy.
For established pharmaceutical companies, investment into large scale cGMP manufacturing is often a financial risk due to the attrition rate of the biopharmaceuticals during the clinical trials.
India's vast pool of scientific talent and Indo- German relations can facilitate several strategic collaborations. "This has led to Boehringer Ingelheim teaming up with the Bangalore-based Kemwell to set up a biologicals unit for which process IP and know-how for high quality cGMP manufacturing are provided by us," said Werner.
Worldwide biopharmaceuticals is valued at $70 billion with an annual growth 16 per cent as against the pharmaceuticals market size of $600 billion growing at 8 per cent.