Baseado em Kerry Ten, K & Laird, S A. 1999. The Commercial Use of Biodiversity. Access to genetic resources and benefit sharing. Routledge Library Editions: Ecology. Taylor and Francis.
In the pharmaceutical industry, average drug discovery and development times are between 10 and 15 years. The cost of this process varies widely, but estimates generally between US$231 million (Di Masi et al, 1991) and US$500 million (PhRMA, 1998). The odds of a successful commercial product arising from a single natural product sample are 1 in 5,000 to 1 in 10,000 (McChesney, 1996; PhRMA, 1998).
In the botanical medicine industry, the process of new product development includes standardisation of active compounds, quality control, and standards for safety and efficacy, can take less than two years, and the cost, which varies dramatically according to the nature of the research, processing and locations where these take place, is often less than US$1 million.
Within each sector, product research and development costs vary enormously. For example, it takes from 8 to 15 years to develop and release a new, modern variety of a major food crop. It costs in the range of US$1–2.5 million for a traditionally-bred variety, and US$35–75 million to genetically engineer and gain regulatory approval for a transgene for use in many different varieties ( Chapter 5 ). In crop protection, a biocontrol agent may take from two to five years to develop and cost US$l–5 million, whereas a new chemical pesticide can take from 8 to 14 years to develop and cost US$40–100 million ( Chapter 7 ).
Development and release of a new, modern variety typically takes 8–15 years, and costs in the range of US$1–2.5 million for a traditionally-bred variety, and between US$35 and US$75 million for a transgene used in many varieties, depending on its complexity and the number of regulatory ‘events’ ( Box 5.1 ). The research and development cycle of new seed varieties generally involves three overlapping phases: selection and pre-breeding; breeding; and product approval. These phases differ slightly where the research and development involves GMOs, since the high-technology biotechnological research tools needed for genetic engineering require extra investment, and the costs of regulatory approval are higher.
| Phase/Activities | Time (years) | Cost (US$ million) |
|---|---|---|
| (For GMO) Initial development of a transgene | ||
| Where Genetic Engineering of this kind is used at all, the cost and time to develop a genetically engineered transgenes depends on the individual trait in organism, and thus on the research and biosafety requirements. In phases I and II, a single transgene might be bred using traditional methods into anything from a few to over 100 varieties. | 4 | 30 to 50 |
| Phase I Generation of Genetic Material (Note: Phases I and II often overlap) | ||
| In traditional breeding, 100,000 of progeny are generated from 1,000 of crosses , often with the help of genetic markers (which accelerate phases I and II) and the use of controlled environmental facilities and/or alternate seasons in different hemispheres. Cost and time vary enormously depending on the individual traits and the crop in breeding method concerned. | 2 to 3 (for either thread bread or GM varieties) | Phase I and II: 1 to 2.5 per variety, including unsuccessful lines |
| Phase II evaluation and selection of progeny | ||
| (In a large company) Over several years, the breeder selects and develops some 5 to 20 prime cultivars from the initial 100,000 progenies. Cost and time vary enormously depending on the species and the nature of the cross. Wider cross with ‘exotic’ material increases the time in raises the cost. | Trad breeding - 5 to 6 years; GMO‘s - 3 to 6 years | |
| Phase III Submission of 5 to 20 prime cultivar to governmental authority for listing | ||
| In countries were seat certification is compulsory, test such as ‘distinct uniform and stable’ (DUS) and ‘value for cultivation and use’ (VCU) are undertaken to determine the potential of new varieties for certification. These includes tests for resistance and susceptibility to diseases, purity, use an yield potential. For GMO, additional environmental and humans safety tests.time thread breeding 2 to 3 years GMO’s 3 to 4 years cost thread breeding 1.500+ GMO’s one to | Trad breeding - 2 to 3 years; GMO‘s - 3 to 4 years | Trad breeding - 1,500+ ; GMO‘s - 1 to 7 per event for approval of a transgene (1) |
| Total | 8-15 | Trad breeding - 1-2.5 per variety; GMO‘s - 35 to 75 per transgene (2) |