(Issue: CHEManager Europe 3/2013)             Regulatory Framework, Infrastructure Support and Discovery Funding Create an Environment Conducive to Growth

GBI Research has released a new report, "Biopharmaceutical Manufacturing in India, China and South Korea - Regulatory Framework, Infrastructure Support and Discovery Funding Create an Environment Conducive to Growth". The report provides an analysis of biopharmaceuticals approved in 2010 and 2011, operating dynamics in the biopharmaceutical industry, the current scenario in biopharmaceutical manufacturing, key stakeholders, the current market size (2011) of biopharmaceuticals, and forecasts to 2016 for India, China, South Korea and the global market.

The report also presents trends witnessed in biopharmaceutical manufacturing, preferred partnership pricing models, contract manufacturing partnerships, comparative analysis of biopharmaceutical manufacturing in India, China and South Korea, and the competitive landscape for the countries covered in the report.

Contract Manufacturing Organizations
Leading Contract Manufacturing Organizations (CMOs) offer manufacturing functions both upstream and downstream equally. In addition to manufacturing in biopharmaceutical production, they also offer clinical trials, logistics, packaging, and even marketing.
According to industry experts, almost 60% of the CMO market is dominated by manufacturing functions, out of which more than 50% is dominated by the downstream process. Many pharmaceutical companies are expected to outsource most parts of their R&D and biopharmaceutical manufacturing to emerging economies such as India and China.

Factors Facilitating Outsourcing
Cost rationalization and skilled labor are the main factors facilitating the outsourcing of processes to these countries. Contract manufacturing is experiencing an upsurge in these countries; outsourcing activities for biopharmaceutical manufacturing include secondary manufacturing such as fill and finish operations, mammalian cell culture, Active Pharmaceutical Ingredient (API) biologics, microbial fermentation and plant cells.

Biomanufacturing Capacities Expanding
Outsourcing analyses by pharmaceutical companies reveal that product characterization testing such as bio-manufacturing, toxicity, bioassays and analytical testing form the bulk of outsourcing to CMOs. With the increase in outsourcing, biomanufacturing capacities in emerging economies have been expanding. Although the U.S. continues to be a leader in biopharmaceutical production, with approximately 45% of the total production share, China's and India's shares have been continuously increasing, with 8% and 7% respectively. Sponsors are building strategic relationships with the contract players and progressively working towards homogenizing and simplifying manufacturing processes in order to ensure normalized products.

The Full Report
The report was published in October 2012, the report code is GBIHC255MR.
For more information call +44 1204 543 533 or visit www.gbiresearch.com.