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Home > Market Research > Biotechnology > Botanical and Plant-Derived Drugs: Global Markets
This Report:
The global market for botanical and plant-derived drugs is expected to increase from $19.5 billion in 2008 to $32.9 billion in 2013, a compound annual growth rate (CAGR) of 11.0%.
Botanical drugs generated $127,000.0 in 2008. This segment should reach $2.4 billion in 2013 for a CAGR of 651.7%.
All other plant derived drugs generated $19.5 billion in 2008. This is expected to reach $30.5 billion in 2013, for a CAGR of 9.4%.
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.
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Table of Contents
CHAPTER 1: INTRODUCTION 1
STUDY BACKGROUND 1
STUDY GOAL AND OBJECTIVES 1
INTENDED AUDIENCE 2
SCOPE OF REPORT 2
METHODOLOGY AND INFORMATION SOURCES 3
COMMERCIAL DRUGS 4
DEVELOPMENTAL DRUGS 4
TABLE 1 FDA APPROVAL PROCESS FOR NEW DRUGS 4
ANALYST CREDENTIALS 5
RELATED BCC PUBLICATIONS 5
BCC ONLINE SERVICES 5
DISCLAIMER 6
CHAPTER 2: SUMMARY 7
SUMMARY TABLE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS, THROUGH 2013 ($ BILLIONS) 7
SUMMARY FIGURE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS, THROUGH 2013 ($ BILLIONS) 8
SUMMARY (CONTINUED) 9
SUMMARY (CONTINUED) 10
CHAPTER 3: OVERVIEW 11
BRIEF HISTORY OF PLANT-DERIVED MEDICINES 11
BRIEF HISTORY OF PLANT-? (CONTINUED) 12
TABLE 2 KEY DATES IN BOTANICAL MEDICINE 13
TABLE 3 WELL KNOWN PLANT-DERIVED DRUGS 13
OPPORTUNITY LIES BEYOND WHAT’S KNOWN 13
OPPORTUNITY LIES BEYOND ? (CONTINUED) 14
FIGURE 1 COMPOSITION OF FDA-APPROVED NATURAL-DERIVED COMPOUNDS IN US (2000–2005)* (%) 15
KEY DRIVERS 16
KEY CHALLENGES 16
SIGNS OF INDUSTRY INVESTMENT 17
TABLE 4 SWOT ANALYSIS ON BOTANICAL DRUG DEVELOPMENT 18
TABLE 5 KEY SIGNS OF INVESTMENT IN BOTANICAL AND OTHER PLANT-DERIVED DRUGS 19
TABLE 5 (CONTINUED) 20
BOTANICAL DRUGS DEFINED 20
UNDERSTANDING THE REGULATORY PROCESS 21
UNDERSTANDING THE REGULATORY ? (CONTINUED) 22
TABLE 6 DISTINCTIONS AMONG PRODUCTS THAT USE PLANTS MEDICINALLY 23
THE FIRST APPROVED BOTANICAL 23
A GROWING PIPELINE 24
FIGURE 2 INDS IN THE FDA BY THERAPEUTIC AREA (NUMBER) 25
OVERALL PHARMA LANDSCAPE 26
OVERALL PHARMA LANDSCAPE (CONTINUED) 27
TABLE 7 TOP PHARMA COMPANIES BY REVENUE, 2007 ($ BILLIONS) 28
MAJOR CLASSES OF PLANT DRUGS 28
Terpenes and Steroids 29
Terpenes 29
Steroids 29
Alkaloids and Glycosides 30
Alkaloids 30
Ergot Alkaloids 31
Morphine Alkaloids 31
Vinca Alkaloids 31
Glycosides 31
Cardiac Glycosides 32
Anthraglycosides 32
Phenols 32
E Cava Algae 32
Flavonoids 32
Resveratrol 33
Coumarin 33
Catechins 33
Proanthocyanidins 33
INTELLECTUAL PROPERTY 34
PRODUCTION 35
PRODUCTION (CONTINUED) 36
MOVING PRODUCTION FORWARD 37
ARTEMISININ: A CASE STUDY 38
SUPPLY AND LEGAL ISSUES 39
TABLE 8 MAJOR PRODUCERS OF RAW MATERIALS FOR PLANT-BASED MEDICINALS 40
DRUG DEVELOPMENT AND MANUFACTURE 40
Drug Development ? (Continued) 41
TABLE 9 KEY COMPANIES WITH NATURAL PRODUCT LIBRARIES 42
CHAPTER 4: MARKET SEGMENTATION 43
GEOGRAPHIC SEGMENTATION 43
SALES OF PLANT-DERIVED DRUGS BY REGION 43
TABLE 10 PLANT-DERIVED DRUG SALES FORECAST BY REGION, THROUGH 2013 (% TOTAL SALES) 43
FIGURE 3 GEOGRAPHIC SEGMENTATION FOR PLANT-DERIVED DRUGS, 2008 AND 2013 (%) 44
THERAPEUTIC AREA SEGMENTATION 45
NUMBER OF PLANT-DERIVED DRUGS BY THERAPEUTIC AREA 45
TABLE 11 FDA APPROVED BOTANICAL DRUGS FORECAST THROUGH 2013 (UNITS) 45
FIGURE 4 COMPOSITION OF FDA APPROVED BOTANICAL INDICATION FORECAST BY THERAPEUTIC AREA, 2008 AND 2013 (%)* 46
Value of Plant-Derived Drugs by Therapeutic Area 47
TABLE 12 RELATIVE VALUES OF FDA APPROVED BOTANICAL DRUGS FORECAST BY THERAPUETIC AREA, THROUGH 2013 ($ MILLIONS) 47
FIGURE 5 RELATIVE VALUES OF FDA APPROVED BOTANICAL DRUGS FORECAST BY THERAPEUTIC AREA, 2008 AND 2013 (%) 48
CHAPTER 5: THERAPEUTIC AREAS IN DETAIL FOR PLANT-DERIVED AND BOTANICAL DRUGS, THROUGH 2013 49
HORMONE THERAPY AND METABOLISM APPLICATIONS 49
TABLE 13 PLANT-DERIVED HORMONE THERAPY AND METABOLISM DRUGS IN LATE STAGE DEVELOPMENT 50
INFECTIOUS DISEASE APPLICATIONS 50
INFECTIOUS DISEASE ? (CONTINUED) 51
TABLE 14 PLANT-DERIVED INFECTIOUS DISEASE DRUGS IN LATE STAGE DEVELOPMENT 52
TABLE 14 (CONTINUED) 53
TABLE 14 (CONTINUED) 54
TABLE 14 (CONTINUED) 55
PAIN AND CENTRAL NERVOUS SYSTEM DISEASE APPLICATIONS 56
TABLE 15 BRAIN DISORDERS THAT ARE REFRACTORY TO SMALL MOLECULE DRUGS 57
TABLE 16 PLANT-DERIVED PAIN AND CNS DRUGS IN LATE STAGE DEVELOPMENT 57
TABLE 16 (CONTINUED) 58
TABLE 16 (CONTINUED) 59
TABLE 16 (CONTINUED) 60
CARDIOVASCULAR AND METABOLIC DISEASE 60
TABLE 17 PLANT-DERIVED CARDIOVASCULAR AND METABOLIC DRUGS IN LATE STAGE DEVELOPMENT 61
RESPIRATORY, INFLAMMATION, AND AUTOIMMUNE 62
TABLE 18 PLANT-DERIVED RESPIRATORY, INFLAMMATION, AND AUTOIMMUNE DRUGS IN LATE STAGE DEVELOPMENT 63
TABLE 18 (CONTINUED) 64
DERMATOLOGY APPLICATIONS 64
TABLE 19 PLANT-DERIVED DERMATOLOGY/WOUND CARE DRUGS IN LATE STAGE DEVELOPMENT 65
TABLE 19 (CONTINUED) 66
GASTROINTESTINAL APPLICATIONS 66
TABLE 20 PLANT-DERIVED GASTROINTESTINAL DRUGS IN LATE STAGE* DEVELOPMENT 66
TABLE 20 (CONTINUED) 67
ONCOLOGY APPLICATIONS 67
TABLE 21 ESTIMATED US CANCER CASES, 2007 67
TABLE 21 (CONTINUED) 68
TABLE 22 PLANT-DERIVED ONCOLOGY DRUGS IN LATE STAGE DEVELOPMENT 69
TABLE 22 (CONTINUED) 70
TABLE 22 (CONTINUED) 71
TABLE 22 (CONTINUED) 72
TABLE 22 (CONTINUED) 73
TABLE 22 (CONTINUED) 74
TABLE 22 (CONTINUED) 75
TABLE 22 (CONTINUED) 76
TABLE 22 (CONTINUED) 77
TABLE 23 BOTANICAL DRUGS IN LATE STAGE DEVELOPMENT WITH EXPECTED FDA-APPROVED COMMERCIALIZATION, THROUGH 2013* 77
TABLE 23 (CONTINUED) 78
CHAPTER 6: COMPANY PROFILES 79
ADVANCED LIFE SCIENCES 79
ARTECEF BV 79
AMERICAN ORIENTAL BIOENGINEERING 80
ANALYTICON DISCOVERY GMBH 81
AVESTHAGEN, LTD 81
BAYER SCHERING 82
BIONUMERIK PHARMACEUTICALS, INC 83
BIONOVO, INC 83
BIONOVO, INC (CONTINUED) 84
BOEHRINGER INGELHEIM 85
PHARMATON SA 85
BRISTOL MYERS SQUIBB 86
CARDAX PHARMACEUTICALS 87
CHONG KUN DANG PHARMACEUTICAL CORPORATION 88
CUBIST PHARMACEUTICALS, INC 88
CURAPHARM, INC 89
EISAI, INC 90
EKOMED, LLC 91
ELI LILLY 91
FYTOKEM PRODUCTS, INC 92
GALAPAGOS NV 93
GLAXOSMITHKLINE 94
GLOBAL PHARMATECH, INC 95
GW PHARMACEUTICALS, PLC 96
HETEROGENEITY, LLC 96
INDENA 97
INDENA (CONTINUED) 98
JOHNSON & JOHNSON 99
LIFEPHARMS, INC 100
LEO PHARMA 101
LUPIN, LTD 102
LUPIN PHARMACEUTICALS, INC 102
MADAUS GMBH 102
MERA PHARMACEUTICALS, INC 103
MERIDIAN MEDICAL TECHNOLOGIES, INC 103
KING PHARMACEUTICALS, INC (PARENT COMPANY) 103
MERLION PHARMACEUTICALS 104
MEDIGENE 105
MEDIGENE, INC 105
TABLE 24 MEDIGENE BOTANICAL PIPELINE 106
MERCK & CO, INC 107
MICROBIO 107
NAPO PHARMACEUTICALS, INC 108
NEUROGESX, INC 108
NOVARTIS INTERNATIONAL AG 109
PANACOS 110
PHYTOMEDICAL TECHNOLOGIES 111
PHYTOMEDICS, INC 111
PHYTOMEDICS, INC (CONTINUED) 112
PFIZER 113
POLYPHENON PHARMA 114
POLYPHENON PHARMA (CONTINUED) 115
PHYNOVA 116
TABLE 25 PHYNOVA PIPELINE 117
PHYTOCEUTICA, INC 117
PHYTOMYCO RESEARCH CORP 118
PHYTOPHARM, PLC 119
PIRAMAL ENTERPRISES, LTD 120
PUNISYN PHARMACEUTICALS, LTD 120
RANBAXY LABORATORIES, LTD 121
SANOFI-AVENTIS 121
SCHWABE PHARMACEUTICALS 122
SEQUOIA SCIENCES, INC 123
SIRTRIS 123
SOLVAY PHARMACEUTICALS 124
SUNTEN PHYTOTECH CO, LTD 124
TABLE 26 SUNTECH PHYTOTECH PIPELINE 125
TASLY PHARMACEUTICALS, INC 125
TCM BIOTECH INTERNATIONAL CORP 126
VEDIC LIFESCIENCES PVT, LTD 127
YAUPON THERAPEUTICS 127
WYETH PHARMACEUTICALS 128
ZHEJIANG KANGLAITE GROUP CO, LTD 129
ZHEJIANG KANGLAITE ? (CONTINUED) 130
APPENDIX 131
TABLE 27 PLANT-DERIVED DRUGS: THEIR ORIGIN AND ACTIONS 131
TABLE 27 (CONTINUED) 132
TABLE 27 (CONTINUED) 133
TABLE 27 (CONTINUED) 134
TABLE 27 (CONTINUED) 135
TABLE 28 USEFUL RESOURCES FOR THE BOTANICAL DRUG INDUSTRY 135
TABLE 28 (CONTINUED) 136
For full details, please email keithw@cmsinfo.com
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