Introducing new drugs, small molecules and biologics to the U.S. market expands patient treatment options, gives consumers greater choice, and encourages healthcare innovation. However, getting a new pharmaceutical drug approved and into the market is a lengthy and expensive process. According to Medicine Net:
“It takes an average of 12 years for an experimental drug to travel from the laboratory to your medicine cabinet. That is, if it makes it. Only 5 in 5,000 drugs that enter preclinical testing progress to human testing. One of these 5 drugs that are tested in people is approved. The chance for a new drug to actually make it to market is thus only 1 in 5,000.”
Drug Development and Approval
While the approval process for new drugs is complex, this helps ensure that drugs are safe and effective for patients. To ensure compliance with regulations, the Food and Drug Administration (FDA) oversees the approval process. In particular, the FDA's Center for Drug Evaluation and Research (CDER) monitors and supports drug development initiatives.
Before approving a new drug, the FDA requires successful completion of the following stages:
- Preclinical Testing
- Investigational New Drug Application (IND)
- Phase I Clinical Trials
- Phase II Clinical Trials
- Phase III Clinical Trials
- New Drug Application (NDA) Review
- Phase IV Studies
Launch Marketing Strategies
Months before commercial launch, pharma teams will create and execute a brand marketing plan. They'll need to model evidence requirements that payers may use to determine market access.
Phase II and Phase III launch teams may examine how emerging commercial models impact launch planning and understand what steps can be taken to prepare earlier by leveraging market access intelligence. The launch phase is critical for driving consumer adoption and brand loyalty.
A successful drug launch requires financial resources, a developed sales team, established brand messaging and reliable market access data. Many pharma leaders lean on MMIT’s launch solutions for timely data and industry insights.
Subscribe to the MMIT blog for more pharma, provider, and payer perspectives on key topics that affect the healthcare network.