Innovation and Clinical Trial Tracking Factbook of the pharmaceutical industry. The market is highly research-intensive, being deeply reliant on a high level of R&D investment and a strong product pipeline to maintain growth and ensure long-term revenue generation. Without successful innovation, which can be broadly defined as the market launch of novel therapeutic molecules that cost-effectively treat or cure diseases, the industry would face a substantial long-term decline in revenue.
There has been a steady and growing stream of new chemical entity approvals by the FDA in the past decade, facilitated by the maintenance of a strong pharmaceutical pipeline. Although this growth in annual product approvals is a highly positive trend, there are numerous underlying challenges in the pharmaceutical industry associated with successfully developing a drug in the pipeline and achieving a return on investment with drugs that reach the market.
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An Assessment of the Pharmaceutical Pipeline is a comprehensive, granular analysis of the 25,522 products currently in the pharmaceutical industry pipeline, from the Discovery stage through to Pre-registration and split into therapy areas and key indications. This pipeline is also benchmarked against its size across each segment compared to 2015 and 2016, and an assessment of the level of first-in-class innovation is provided.
Notable exceptions include 1996 and 1997, when there was a peak in FDA approvals, and 2013, when there was a trough. The peak in 1996 was due to a substantial drug lag in the previous years, with new drug applications typically taking a number of years to review.
Following a substantial increase in the number of technical staff in the FDA and a shortening of drug review times from 31 to 16 months.
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In 2013, following a 15-year high in 2012, the number of new drug approvals declined from 39 to 27. The number of new drug applications from big pharma companies remained constant, while in spite of the creation of a breakthrough designation by the FDA in 2012, the contribution of new drug applications from smaller companies declined substantially, accounting for this drop.
Key Reasons to Access
- Achieve an up-to-date understanding of the landscape of the overall pharmaceutical pipeline, on both a broad and granular level; this also provides a highly accessible reference which is useful in any pharmaceutical strategic decision making process
- Benchmark key therapy areas and indications in terms of the number of pipeline products and level of innovation, and assess ones own strategic positioning against this backdrop
- Understand the contemporary role and importance of radical and incremental innovation within the various disease areas and indications
- Make key decisions about the role of innovation within ones own pipeline portfolio
- Understand and benchmark the risk of attrition, clinical trial duration and size across the pharmaceutical industry
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