1. Market Research
  2. > Biotechnology Market Trends
  3. > Regulatory Trends in the US Pharma/Biotech Industry : Efficiency of the FDA Review Process Expedites Access to Care

Regulatory Trends in the US Pharma/Biotech Industry : Efficiency of the FDA Review Process Expedites Access to Care

  • February 2015
  • -
  • Frost & Sullivan
  • -
  • 37 pages

Summary

Table of Contents

Key Findings

•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 x % 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.

Most Approved NMEs Evaluated as an Expedited Review

Key Takeaway: While the percentage of expedited reviews declined between 2013 and 2014, the overall number increased, showing that companies are continuing to innovate and fulfill large unmet needs.

•Fast track is assigned to drugs with the potential to fulfill an unmet need. These drugs are reviewed in an expedited fashion by being part of a rolling review process and increased level of communication between the FDA and the manufacturer.
•Breakthrough is assigned to drugs showing early evidence that there is significant improvement, compared to alternative therapies.
•Priority review is assigned to drugs with the potential to fulfill a significant unmet medical need. In this instance, the drug review process can end as soon as x months, compared to the standard x months.
•Accelerated approval is assigned to drugs with the potential to treat a life threatening condition.
•Compared to x out of 27 ( x %) in 2013, an impressive x out of x ( x %) approved NMEs were assigned at least 1 of 4 expedited regulatory review designations in 2014, compared to the standard review.

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 60 Million searchable statistics with tables, figures & datasets
  • More than 25,000 trusted sources
Get This Report
24/7 Customer Support

Talk to Veronica

+1 718 514 2762

Purchase Reports From Reputable Market Research Publishers
Global Markets for Nanocomposites, Nanoparticles, Nanoclays, and Nanotubes

Global Markets for Nanocomposites, Nanoparticles, Nanoclays, and Nanotubes

  • $ 6650
  • Industry report
  • January 2017
  • by BCC Research

Use this report to: - Analyze nanocomposites that are in commercial use or under development, associated technologies and applications. - Provide suppliers of advanced materials, entrepreneurs, investors ...

Sample Preparation in Genomics, Proteomics, and Epigenomics: Global Markets

Sample Preparation in Genomics, Proteomics, and Epigenomics: Global Markets

  • $ 6650
  • Industry report
  • January 2017
  • by BCC Research

Use this report to: - Assess current market dynamics and estimate future demand for sample preparation in genomics, proteomics and epigenomics. - Gain insight into existing products as well as new developments ...

Global Markets for Protein Labeling

Global Markets for Protein Labeling

  • $ 6650
  • Industry report
  • February 2017
  • by BCC Research

Use this report to: - Identify key market dynamics and the factors impacting the global protein-labeling market and its subsegments. - Gain insight into global protein-labeling market and its market segments, ...

Synthetic Biology: Global Markets

January 2017 $ 6650

ref:plp2015

Reportlinker.com © Copyright 2017. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.