Botanical drugs have arrived, albeit slowly, as an official U.S. Food and Drug Administration (FDA)designation. Even though its outlook is optimistic for regulatory approvals and sales for botanical drugs, this report is more conservative compared to BCC’s previous forecast of the botanical market when it seemed that the economy might not be as much of a factor in companies’ progression and the regulatory pathway appeared to be more clearly understood. Going forward from 2012 to 2017, pharmaceutical companies and investors are still struggling with understanding and adhering to the requirements in the botanical regulatory pathway, slowing some of the progress here. As always, progress can be impeded through no
fault of anyone (e.g., data comes in that does not give management or investors the confidence to proceed).
This report groups plant-derived drugs and botanical drugs separately with the former considered single molecular entities and the latter mixtures (polymolecular) of vegetable materials that may include plant materials, algae, macroscopic fungi or combinations thereof. Botanicals may lack a distinct active ingredient. Certain processes can render the drug candidate unsuited for the pathway, including fermentation (but not always) and genetic engineering.
This report provides:
- An overview of the botanical drug industry, with the overall plant-derived drug industry as a backdrop and the global market for these drugs going forward
- Analyses of global market trends, with data from 2011, estimates for 2012, and projections of compound annual growth rates (CAGRs) through 2017
- A focus on legal, prescription-required therapeutic medicines sold in the open market; the study does not specifically cover herbals generally sold as dietary supplements (i.e., to promote overall "wellness" rather than to address a specific medical condition or symptoms)
- Examination of the industry structure, competition, and market drivers
- Discussion of market size and segmentation, including breakdowns of sales by therapeutic area and geographic area
- Observations and conclusions regarding the future of the botanical and plant-derived drug industry
- Forecast the market size for botanical and plant-derived drugs in terms of dollar and unit sales
- Classify the market size for botanical and plant-derived drugs by geographical region in terms of dollar and unit sal
- Receive infromation on the activities of influential companies and roles played by major stakeholders and players
- Examine crucial, innovative breakthroughs by means of a detailed patent analysis.
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