2017 GLOBAL DRUG DELIVERY & FORMULATION REPORT – Notable Technologies, Approvals, Transactions, Pipelines & Perspectives
The third annual Drug Delivery & Formulation Report, a collaborative effort between team members at Drug Development & Delivery and PharmaCircle, provides a look back at 2016 in terms of approvals and developments in the area of drug delivery and formulation.
The report continues to cover the following significant key points of interest, with the belief that understanding the past, even the recent past, can provide insights to what is possible:
1. Drug Delivery & Formulation Technologies
2. Drug Delivery & Formulation Approvals
3. Drug Delivery Related Transactions
4. Drug Delivery Formulation Pipeline
5. Notable Drug Device Approvals
6. Combination Product Approvals
Technologies, irrespective of industry sector, see periods where there are bursts of innovation and creativity, interspersed with longer periods of technology adoption and optimization. The Pharma industry may be one of these periods where considerable attention is being placed on technology application to new and existing products.
It seems that 2016 looked back more than it looked forward in terms of drug delivery and formulation enhanced and enabled product approvals. While there were a similar number of new products approved in 2016 using drug delivery and formulation technologies as 2015, these products for the most part did little to push forward the state-of-the-art. 2016 was also a little unique in that there were no blockbuster drug delivery and formulation deals or transactions to suggest there was any shift in the industry’s general strategic direction.
An overview of the current global pipeline for drug delivery and formulation enabled and enhanced products provides a sense of what is out there and what we might expect. Drug-Device enhancements over the past few years have generally been incremental and largely predictable in terms of features and performance. Prefilled syringes and autoinjectors accounted for the largest number of 2016 approvals (16/43), followed somewhat surprisingly by nasal drug-delivery products.
Combination pharmaceutical products represent an important source of commercial and therapeutic opportunity by expanding eligible patient populations, improving efficacy and safety, and extending market exclusivity. This engine of development seems to be winding down as evidenced by New Combination approvals in Europe and the U.S. for the past few years. A total of 162 new Combination Products were approved in the period between 2007 and 2016, an average of about 16 per year. Click here to download/view the full report.
As always, we would love to get your comments on the report and suggestions for improvements in the future.
Ralph Vitaro, Publisher & President
Drug Development & Delivery
Tugrul Kararli, President & Founder
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