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Each year, millions of farmers around the world plant biotech crops for higher yields, improved crop quality and the ability to use sustainable farming practices such as no-till. Getting these innovative new traits from the lab to their fields requires a tremendous investment.
- The cost of discovery, development and authorization of a new plant biotechnology trait introduced between 2008 and 2012 is US$136 million.
- The time from the initiation of a discovery project to commercial launch is 13.1 years on average for all relevant crops.
- The time associated with registration and regulatory affairs is increasing from a mean of 3.7 years for an event introduced before 2002, to the current (2011) estimated 5.5 years.
- Regulatory science, registration and regulatory affairs account for the longest phase in product development, estimated at 36.7% of total time involved.
- The trend in the number of units (candidate genes, constructs or genetic events) being screened in order to develop one trait is increasing.
From discovering new genetic traits, field testing and meeting intense regulatory requirements that ensure environmental and human safety, the overall plant biotech R&D process is costly and time-consuming. To determine the relative cost and duration of this process, Phillips McDougall conducted a research survey based on information provided by six of the industry’s largest biotech crop developers – BASF, Bayer CropScience, Dow AgroSciences, DuPont/Pioneer Hi-Bred, Monsanto and Syngenta AG.
The September 2011 survey entitled, “The cost and time involved in the discovery, development and authorization of a new plant biotechnology derived trait”, focused on biotech traits in large scale commodity crops that had received cultivation approval in two countries and import approvals from at least five countries.
Key findings of the survey included:
The cost of discovery, development and authorization of a new plant biotechnology trait introduced between 2008 and 2012 is US$136 million
Overall Time to Commercialization
The time from the initiation of a discovery project to commercial launch is 13.1 years on average. This does not include the time required to develop and obtain regulatory approval for stacked trait varieties which are the final product in most crops today.