SOURCE: Cutting Edge Information

Cutting Edge Information

July 20, 2016 08:17 ET

Study Finds 88% of Pharma Companies Base Global Launch Planning on Regulatory Affairs Guidance

Various Tools Help Drug Companies Establish Successful Global Launch Plans

RESEARCH TRIANGLE PARK, NC--(Marketwired - July 20, 2016) - A new benchmarking study published by Cutting Edge Information discovered that regulatory guidance is the most common tool that pharmaceutical companies use when developing their global launch strategies.

In fact, the majority, 88% of surveyed firms, look to regulatory guidance to inform global launch planning. Furthermore, 83% of large pharmaceutical companies and 80% of small pharmaceutical companies that participated in the study rely on regulatory guidance to establish a launch sequence. Regulatory guidance educates market access teams regarding potential requirements that companies may face when entering specific markets.

The study, Pharmaceutical Launch Sequencing: Establishing Patient Access and Understanding Global Pricing, researched the impact of various functional departments on launch sequence planning. For example, the study found that 63% of surveyed companies use market research to help their launch sequences. Surveyed drug companies used both in-house and outsourced market research to make decisions. Companies used other when developing launch sequences, such as pricing studies, payer discussions, commercial strategic plans, and computerized optimizers.

"Preparing a successful global launch is a challenge for any multinational drug company," said Adam Bianchi, senior director of research at Cutting Edge Information. "That's why it is important to use regulatory guidance and market research throughout the process."

Adequately staffed cross-functional boards are able to compile key commercial, regulatory and market access insights which influence these plans. Companies must also be able to resource these teams with adequate launch sequencing budgets and the tools necessary to make informed decisions.

Pharmaceutical Product Launch Sequencing: Maximizing Revenue and Achieving Global Market Access, available at, helps companies maximize their margins when launching products around the world. The report identifies key trends in how companies approach launch sequences and what drives decision making among internal and external stakeholders. The report's key findings include:

  • Assign final launch sequencing decisions to C-level executives.
  • Incorporate guidance from regulatory affairs to drive global launch decisions.
  • Prepare for the growing importance of BRIC markets as second wave launch targets.
  • Engage with regulatory teams throughout launch sequencing planning and execution

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