




INTRODUCTION
STUDY BACKGROUND
Because the use of plant-derived drugs has become so widespread, there is a great need to develop an up-to-date base of market information about these products. More than 2 years have passed since BCC Research published its study of Plant-Derived Drugs: Products, Technology, Applications, which analyzed the key growth areas in plant-derived drugs and developed quantitative market projections.
Since then, there have been to our knowledge no broad-based quantitative market analyses that focus specifically on a new class of drugs called botanical drugs that are a subset of plant-derived drugs and formally defined by the U.S. Food and Drug Administration (FDA) in 2004.
STUDY GOAL AND OBJECTIVES
The present study meets this need by focusing on the global market for plant-derived drugs in light of the most recent available information. In addition to looking at future and current markets for a wide variety of new, reformulated, and established products, the study will analyze technological, environmental, legal/regulatory, and socioeconomic developments that may influence the market for plant-derived drugs.
This report provides an analysis of the emerging botanical drug industry and markets, geographically and by therapeutic area. The future of plant-derived drugs will also be discussed.
More specific objectives are as follows:
INTENDED AUDIENCE
The report has been written for the entire pharmaceutical community, but is tailored especially for readers with an interest in the marketing, management, and public policy dimensions of botanical drugs, including readers in the following:
The format of the study is organized around the following topics:
METHODOLOGY AND INFORMATION SOURCES
Both primary and secondary research methods were used in preparing this research report. The findings and conclusions contained in this report are based on information gathered from development companies and sales and manufacturers involved with primarily, botanical drugs as defined by the U.S. FDA, and secondarily, the larger world of plant-derived drugs, which encompasses botanical drugs as a sub-segment. Additional data were obtained from extensive reviews of secondary sources such as trade publications, trade associations, company literature, and online databases.
COMMERCIAL DRUGS
In the case of commercial drugs, the study starts by projecting the demand for various types of medical applications, such as chemotherapy drugs, asthma medicine, etc., which use plant-derived drugs as part of the therapy. The implied demand for plant-derived drugs is then estimated based on historical relationships, adjusted to reflect such factors as the availability of alternative, non-plant-derived drugs; price relationships; and other buyer criteria as well as other information from relevant companies.
DEVELOPMENTAL DRUGS
The approach described above is useful mainly for drugs that are already in commercial use. A somewhat different, approach is used to project demand for drugs that are still in the development or regulatory testing and approval process, but are expected to be commercialized in the 2008 to 2013 time frame.
In some cases, a new plant-derived drug’s developers or other industry analysts are projecting that the drug will be commercialized by a particular year (e.g., 2008). Where this is not the case, BCC uses the timeline for the U.S. FDA approval process as a yardstick for evaluating the likelihood that a particular plant-based drug will be commercialized in the next 5 years. (Even in cases where developers are projecting a particular year, BCC has used the FDA approval process timeline as a kind of reality check.)
In the United States, it takes 12 years, on average, for an experimental drug to complete clinical testing and receive FDA approval, as shown below.
TABLE 1
FDA APPROVAL PROCESS FOR NEW DRUGS
|
Stage
|
No. of
Years
|
Purpose
|
Success Rate
|
|
Pre-clinical testing
|
3.5
|
Assess safety and biological activity
|
5,000 compounds evaluated
|
|
Phase I clinical trials
|
1.0
|
Determine safety and dosage
|
Five enter trials
|
|
Phase II clinical trials
|
2.0
|
Evaluate effectiveness
Look for side effects
|
|
|
Phase III clinical trials
|
3.0
|
Verify effectiveness
Monitor adverse reactions from long-term use
|
|
|
FDA approval
|
2.5
|
Review process/approval
|
One approved
|
|
Total
|
12.0
|
|
|
Kim Johnson is a graduate of Mount Holyoke College with a degree in English Literature. She acquired experience as a healthcare journalist, including working for John Wiley & Sons for years as a print reporter, before serving as a research analyst in a small market research firm that focused on pharmaceuticals and biotechnology in the Research Triangle Park area of North Carolina. Before joining that firm, Kim published two reports on emerging and established diagnostics and therapeutics for benign and cancerous breast disease.
BCC is a leader in market research and consulting to the medical and pharmaceutical industries. Other BCC reports of potential interest to readers of this report include the following:




