Late last month we reported on Indian contract manufacturing organization (CMO) Kemwell Biopharma signing its first contract from its new facility in Bangalore, India, to develop and manufacture monoclonal antibodies (mAbs) for a Western client.
The region’s low costs has led it to become a hotbed for API and small molecule drug manufacturing but though Kemwell told us it hopes to open the doors to Western biomanufacturing outsourcing, Biopharma-Reporter.com spoke to Indian manufacturer Biocon - whose India-centric Branded Formulations business accrues approximately 50% of revenue from biologics - about the industry.
“Biomanufacturing vis-a-vis pharma is more complex and a capital-intensive business with longer gestation periods,” spokesman Rumman Ahmed told us, adding “uninterrupted power supply, potable water, high quality talent and an enabling policy regime are some of the pre-requisites for the success of this sector.
“Unfortunately, in India the biomanufacturing sector faces numerous challenges in terms of infrastructure, access to capital and an uncertain and complex regulatory process.”
Ahmed’s comments were supported by Ronald Rader, Senior Director of Research at BioPlan Associates, a US research and publishing group whose 10th Annual Report and Survey of Biomanufacturing indicated only 12.9% of US drugmakers would consider india as a biomanufacturing outsourcing partner.
According to Rader, India is being held back by a number of issues, including: inadequate infrastructure, transport, and storage, slow development of regulations and procedures to US and EU standards, a lack of training and hiring of required bioprocessing professionals, and concerns about foreign patents and prices of biopharmaceuticals.
“Based on our 15 years review of the market, we find no U.S.-approved biologics/biopharmaceuticals, manufactured in India,” Rader said.
However, Rader added things are changing, and in the near-term “India will likely become the major single source for lesser-developed country biopharmaceuticals,” compelling greater manufacturing standards and moving “India’s efficiencies and quality processes forward.”
Biosimilars have Eastern Promise…
“Despite challenges, India has contributed effectively in addressing some of the growing healthcare needs of various governments across the world by offering affordable generics, biosimilars and vaccines,” Ahmed told us.
Just as India is a key region for small molecule generic manufacturing, biosimilars may lead the way forward for Indian biomanufacturing.
“Some Indian companies are targeting US/EU markets, with biogenerics and biosimilars,” said Rader, with India gearing up its biomanufacturing as a source of these copies.
However, Aiswariya Chidambaram - a Senior analyst at Frost & Sullivan - told Biopharma-Reporter.com Indian biosimilar development would most likely be hindered by “tedious approval processes,” the requirement of a cold chain distribution “and will be largely dependent on the transparency of approval process and government support.”
She continued: “Generally, China is a larger generic market than India and hence this is being reflected in the uptake of biosimilars as well.”
Ahmed also conceded that for now “China has a better edge in terms of infrastructure, funding and regulatory policies, which has worked in its favour.”