Home » About Microbicides » Economics » Funding Needs
Funding Needs
On average, it costs roughly $57 million to take a single microbicide lead through the entire process of testing required to license it for sale.
The vast majority of these costs involve the expense of mounting the large-scale trials necessary to test efficacy (whether the product works for its intended purpose). Each phase 3 trial is estimated to cost over $46 million. Many products never make it to this final stage because they encounter problems somewhere along the way. (Table on average costs)
The resource needs of the field are expanding exponentially now, as 4 products get ready to enter phase III trials over the next few years.
| Costs of Microbicide Development | |
|---|---|
|
Total development costs per product: |
$56.9 million (post discovery) |
|
Average cost of pre-clinical development: |
4.5 million (not including basic research or discovery) |
|
Average cost of phase I safety trial: |
2.5 million |
|
Average cost of phase II trial |
3 million |
|
Projected cost of each phase III trial |
46.4 million |
|
Cost of registration |
1 million |
Resource needs to ensure success
Projections developed by the International Partnership for Microbicides (IPM), the Alliance for Microbicide Development and the Global Campaign for Microbicides estimate that the global annual investment to ensure timely development of a safe and effective microbicide must re-double to at least $280 million per year over the next five years. And remain at approximately $280 million a year until satisfactory microbicides are licensed.
The $280 estimate assumes that:
$130 million a year is needed for research (discovery and pre-clinical development)
$120 million a year is need for clinical trial site development (for 5 years only)
$10 million a year is needed for advocacy and policy (this represents more than a tripling of the annual investment in this category)
Significantly, these figures do not include any funding for purchase or distribution of a microbicide once it is licensed. That will represent an additional cost.
According to the Tufts Center for the Study of Drug Development, the average cost in private industry to develop a new drug, including failures, is $802 million.
