Importance of Fast Time to Market
When I first started working in the pharmaceutical industry roughly 28 years ago, I learned the phrase “Fast Time to Market” (to bring a new drug to market as quickly as possible).
Fast Time to Market is important in drug development.
It is possible that a product in general may be premature. It could be necessary to bring a product to market in a timely manner.
In the case of pharmaceuticals, however, development must be completed and new drugs brought to market as quickly as possible.
Suppose a researcher discovers a new compound. However, perhaps as many as 100 other researchers around the world have noticed the same thing.
New drug development costs 10 to 20 billion yen and takes 10 to 15 years.
In launching a drug, there could be a significant difference in the drug price if the order of launch is No. 1 and No. 2.
The process of bringing a new drug to market includes both the research and development period (preparation of the application) on the part of the pharmaceutical company and the regulatory review period, and there is an urgent need to shorten both of these periods.
In the above figure, A is the area under R&D (before market launch) and B is the area after market launch; the area of B (sales) minus the area of A (R&D expenses) is the profit of the pharmaceutical company.
Shortening the development period is very important to maximize profits.
For example, for a drug that sells 36 billion yen a year, a one-day reduction in R&D time would lead to a profit of 100 million yen.
In other words, Fast Time to Market is important. (see above).
The process of bringing a new drug to market includes both the research and development period (preparation of the application) on the part of the pharmaceutical company and the regulatory review period, and there is an urgent need to shorten both of these periods.
（1）Research and development reduces the time period over which various reports are prepared.
・Compliance with various laws and regulations (guidelines)
i.e. GLP、GCP、GMP
・Document Management
（2）Reduction in the time it takes for a new drug application to be prepared
・Management of Dossier (application materials)
・publish
・Simultaneous worldwide application
・Electronic Submission
・eCTD
（3）The period during which new drugs are reviewed by the authorities
・Fewer inquiries, quicker responses to inquiries
Challenges to overcome in the pharmaceutical industry
However, there are many challenges in developing new drugs.
・The time to market for generic products is becoming shorter.
・Erosion by generics is accelerating.
・New generations of therapies are being developed one after another.
Profits continue to be squeezed by these changing conditions.
The current patent law stipulates that the duration of an acquired patent right is 20 years from the filing of the application. Since patent applications are usually filed at the stage before clinical trials are conducted, if one subtracts the 10-15 years of subsequent development and examination, the period during which a pharmaceutical company can actually market a new drug exclusively is only about 5-10 years.
(However, in consideration of the considerable time required to develop and examine new drugs to ensure safety and other factors, the government allows pharmaceutical companies, upon application, to extend patents for up to five years, the “period during which the patented invention may not be worked.)
After the substance patent of a new drug expires, generic drug makers usually launch so-called “generic drugs,” which have the same active ingredients, efficacy, and dosage and administration as the new drug and are less expensive than the new drug.
Fast Time to Peak Sales
Today, the strategy of many pharmaceutical companies has shifted from Fast Time to Market to Fast Time to Peak Sales. In other words, it is about how to achieve maximum sales as quickly as possible.
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