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:
- Identify and classify the botanical and plant-derived drugs that have been commercialized to date
- Identify and evaluate the impact of factors that will drive future demand for botanical drugs with a focus too on plant-based drugs overall
- Forecast the volume and value of shipments of botanical drugs through 2013
- Describe botanical drugs that are currently in the clinical testing or approvals stage and assess the probability that they will be commercialized successfully in the next 5 years
- Forecast the potential market for these drug candidates, weighted to reflect the estimated probability that they will be commercialized
- Identify the leading manufacturers of plant-derived drugs and the firms that may become important players in the next 5 years
- Assess the long-term outlook for the plant-derived drugs industry, taking into account market opportunities as well as technological, environmental, legal/regulatory and socioeconomic factors
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 pharmaceuticals industry, especially companies supplying bulk or formulated plant-derived drugs, or companies that are planning to enter this field
- Medical research institutions
- International organizations and governmental organizations with relevant responsibilities such as health, drug safety, conservation and the environment, and foreign trade
- Investors
- The financial and analyst community
SCOPE OF REPORT
This report is an analytical business tool whose primary purpose is to describe the botanical drug industry with the overall plant-derived drug industry as a backdrop and the global market for these drugs going forward.
For the purposes of this report, botanicals are those drugs that are FDA approved under the botanical drug pathway, while plant-derived drugs are those under the FDA’s new classification, which includes both botanicals as well as other approved drugs that contain a mixture of natural plant-derived and synthetic substances.
The study’s main focus is 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). While there is a substantial market for these products, the medical value of many of these substances has not been demonstrated conclusively.
The study also does not cover the following:
- Underground or illicit drugs
- Home remedies
- Tribal medicines
- Drugs derived from archaea, bacteria, and fungi (molds and yeasts)
- Non-medicinal plant substances such as laxative cellulose and pectin fiber
- Intravenously delivered nutrients of plant origin, such as dextrose
- Plant-derived substances serving as pharmaceutical excipients, such as starch, methylcellulose, guar gum, vegetable oils, fatty acids, cocoa butter, and candelilla wax
- Plant substances serving in cosmetics, toiletries, and personal care products
- Microbial fermentation products, even those made with culture media incorporating corn steep liquor, starch, or other plant-derived nutrients
- Marine life
The format of the study is organized around the following topics:
- Major types and applications of botanical drugs with plant-derived drugs as their backdrop
- Industry structure
- Market size and segmentation, including breakdown of sales by therapeutic area and geographic area
- Market drivers
- Market projections through 2013
- Competition
- Observations and conclusions regarding the future of the botanical and plant-derived drug industry
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
|
|
|
Source: U.S. FDA
Since the market projections in this report include only products that are likely to be commercialized in the 5-year period (2008 to 2013), the projections are limited to plant-derived drug candidates that are likely to receive FDA approval by 2013. This in turn generally limits the field drugs that are in Phase III clinical trials or in the final FDA approval process.
ANALYST CREDENTIALS
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.
Report Code: BIO022E, Published: February 2009, Analyst: Kim Lawson
