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Regulatory Trends in the US Pharma/Biotech Industry

Regulatory Trends in the US Pharma/Biotech Industry

In terms of the number of new molecular entities (NME) approved by the US Food and Drug Administration (FDA), 2014 marked a record year in the pharma/biotech industry, with the highest number of NMEs approved in the last decade. In terms of highest number of filings, regulatory submissions were at their peak in 2014, tied with 2011 and 2012.

The number of orphan drugs entering the US market grew by 􂀀% in 2014, compared to 2013, demonstrating that companies continue to target this market with its large unmet needs, fewer competitors, and a potentially higher return on investment.

The efficiency of the US FDA’s review of drug submissions continues to improve as a result of its expedited review designations: fast track, breakthrough, priority review, and accelerated approval.

The number of approved NMEs in the United States that was granted first-class designation increased significantly in 2014, compared to previous years, demonstrating that pharma and biotech companies are focusing on launching novel mechanism of actions (MOA) and are focusing on targeted therapies to treat medical conditions and specific populations.

Because of its benefits of convenience and overall safety, oral administration continues to be the dominant mode of administration for drugs approved in the United States.

The lack of a clear biosimilar regulatory pathway in the US market continues; no biosimilars were approved in the United States in 2014.

About this report

This market insight provides an analysis of the regulatory trends occurring in the US pharma/biotech industry for 2014. Included in this deliverable is an analysis of the new molecular entities (NME) approved by the US Food and Drug Administration in 2014 and predictions for 2015. Trends are showing that the US Food and Drug Administration is moving towards greater efficiency and expedited review periods, which will lead to faster access to care.


  • Executive Summary
    • Key Findings
  • Analysis of 2014 New Molecular Entities US FDA Filings and Approvals
    • NME Trends Show a Significant Increase in Regulatory Filings and Approvals
    • Increase in Orphan Drug Approvals
    • Increase in First-in-class Designation
    • Most Approved NMEs Evaluated as an Expedited Review
    • High Number of First Cycle Approval Continues
    • Oral Therapies Continue Dominating the Pharma/Biotech Industry
    • NMEs Approved in 2014
  • Frost & Sullivan Predictions for 2015

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