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OUTSOURCING INSIGHTS REPORT Survey Methodology: The Nice Insight Pharmaceutical and Biotechnology Survey is deployed to outsourcing- facing pharmaceutical and biotechnology executives on an annual basis. The 2014-2015 report includes responses from 2,303 participants. The survey comprises 240+ questions and randomly presents ~35 questions to each respondent in order to collect baseline information with respect to customer awareness and customer perceptions of the top ~125 CMOs and ~75 CROs servicing the drug development cycle. Five levels of awareness, from "I've never heard of them" to "I've worked with them" factor into the overall customer awareness score. The customer perception score is based on six drivers in outsourcing: Quality, Innovation, Regulatory Track Record, Affordability, Productivity, and Reliability. In addition to measuring customer awareness and perception information on specifi c companies, the survey collects data on general outsourcing practices and preferences as well as barriers to strategic partnerships among buyers of outsourced services. LIFESCIENCELEADER.COM MARCH 2015 18 If you want to learn more about the report or how to participate, please contact Nigel Walker, managing director, or Kate Hammeke, director of marketing intelligence, at Nice Insight by sending an email to nigel@thatsnice.com or kate.h@thatsnice.com. N . W A L K E R was a 2 percent drop among the Emerging Biotech group (13 percent to 11 percent). For years industry experts have hoped India, an emerging economy, would become a major player in the global healthcare space. It has the ingredients for success and has demonstrated it with perhaps the most phenomenal growth the industry has shown in the past decade or so. It is encouraging to know the Indian government has taken up the issue of restoring the pharmaceutical industry's image by committing $511 million to dou- ble the number of inspectors at the central level and adding another 3,000 at the state level. The Central Drugs Standard Control Organization (CDSCO) has issued new guidelines for state regulators on how to conduct cGMP inspections ( Regulatory Affairs Professional Society , August 2014). But if India plans to export pharmaceu- ticals to the EU and U.S., it has to stick to the guidelines set by the FDA, EMA, and other specific regulatory agencies. On the flip side, the U.S. needs to stick to the rulebook and invite Indian officials during surprise visits. Along with the warnings and sanctions, it would be beneficial if the FDA channels the appropriate resources and has cohesive open conversations with all the involved stakeholders to ensure high standards are upheld. Along with steps taken so far, both must immedi- ately address one of the biggest concerns for both parties, cultural differences, as it seems to be creating a major hindrance. It's going to be a long way, but hopefully with some of the steps implemented in 2014, and with continued efforts, India can regain the lost trust and confidence it enjoyed in the developed markets over the years. L biotechnology industry. The biggest drop, of 6 percent, was observed amongst Big Pharma (17 percent to 11 percent) and Specialty Pharma (18 percent to 12 per- cent) followed by a drop of 4 percent amongst Emerging Pharma (14 percent to 10 percent). Interestingly, there wasn't any change in outsourcing to India among the Biotechnology firms; however, there see that the FDA warnings and shutdown of plants in India is reflected in the industry's outsourcing perspective toward India. The overall outsourcing to India fell from 13 percent in 2013-14 to 11 percent in 2014-15. If we further break down by industry category, we see that the pharmaceutical industry seems to have reacted more strongly than the By TJ Ladage WHAT DOES 2015 HOLD FOR THE INDIAN CMO INDUSTRY?