NEW YORK, Dec. 19, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Botanical and Plant-Derived Drugs: Global Markets

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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 four years have passed since BCC Research published its first version of Botanical and Plant-Derived Drugs: Global Markets. This report is an update of that one. Both analyze the key growth areas in plant-derived drugs, develop quantitative market projections and discuss compliance with the requirements for the botanical category of drugs, created in 2004, with its own U.S. FDA regulations, guidelines and review process.

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 as a whole is 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 2017.Describe botanical drugs that are currently in clinical testing or the approval stage and assess the probability that they will be commercialized successfully in the next five 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 five years.Assess the long-term outlook for the plant-derived drug 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 pharmaceutical 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 both botanicals as well as other approved drugs that contain a mixture of natural plant-derived and synthetic or semisynthetic 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 the breakdown of sales by therapeutic area and geographic area.

Market drivers.

Market projections through 2017.

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 subsegment. 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 and medicine, 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 processes, but are expected to be commercialized in the 2012 to 2017 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., 2017). 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 five 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.)

Since the market projections in this report include only products that are likely to be commercialized in the five-year period of 2012 to 2017, the projections are limited to plant-derived drug candidates that are likely to receive FDA approval by 2017. This in turn generally limits the field of drugs that are in Phase III clinical trials or in the final FDA approval process.

ANALYST CREDENTIALS

Kim Lawson 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. Ms. Lawson has authored several market research reports for BCC Research.

TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 1

STUDY BACKGROUND 1

STUDY GOAL AND OBJECTIVES 1

INTENDED AUDIENCE 1

SCOPE OF REPORT 2

METHODOLOGY AND INFORMATION SOURCES 3

COMMERCIAL DRUGS 3

DEVELOPMENTAL DRUGS 3

TABLE A FDA APPROVAL PROCESS FOR NEW DRUGS 3

ANALYST CREDENTIALS 4

RELATED BCC PUBLICATIONS 4

BCC ONLINE SERVICES 4

DISCLAIMER 5

CHAPTER 2 SUMMARY 7

SUMMARY TABLE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS,

THROUGH 2017 ($ BILLIONS) 8

SUMMARY FIGURE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS,

2010-2017 ($BILLIONS) 8

CHAPTER 3 OVERVIEW 12

BRIEF HISTORY OF PLANT-DERIVED MEDICINES 12

TABLE 1 KEY DATES IN BOTANICAL MEDICINE 13

TABLE 2 WELL KNOWN PLANT-DERIVED DRUGS 14

OPPORTUNITY LIES BEYOND WHAT IS KNOWN 14

FIGURE 1 TYPE OF NATURAL PRODUCT DRUGS SUBMITTED AS IND APPLICATIONS TO THE

FDA, 2008 (% SHARES) 14

GETTING STARTED 16

KEY DRIVERS 17

KEY CHALLENGES 18

U.S. GOVERNMENT INVESTMENT 19

INDUSTRY INVESTMENT 20

TABLE 3 SWOT ANALYSIS OF BOTANICAL DRUG DEVELOPMENT 24

TABLE 4 KEY INVESTMENTS IN BOTANICAL AND OTHER PLANT-DERIVED DRUGS 25

BOTANICAL DRUGS DEFINED 27

UNDERSTANDING THE REGULATORY PROCESS 29

TABLE 5 DISTINCTIONS AMONG PRODUCTS THAT USE PLANTS MEDICINALLY 30

INVESTIGATIONAL NEW DRUG APPLICATIONS 30

CLINICAL TRIALS 30

NEW DRUG APPLICATION 31

THE FIRST APPROVED BOTANICAL 31

ADVICE FROM FDA BASED ON VEREGEN APPROVAL 33

BOTANICAL CANDIDATES IN THE PIPELINE 33

CROFELEMER 33

FEMARELLE AND MENERBA 35

SHINBARO CAPSULE 36

DANSHEN DRIPPING PILL (CARDIOTONIC PILL) 37

EISO (EAST INDIAN SANDALWOOD OIL) 37

FAHF-2 39

TABLE 6 BOTANICAL COMPOSITION OF MENERBA (MF 101) 40

A GROWING PIPELINE 40

FIGURE 2 THERAPEUTIC AREAS OF FDA DRUG APPROVALS, 2011 (NO. OF DRUG

APPROVALS) 41

FIGURE 3 SNAPSHOT OF U.S. FDA BOTANICAL PIPELINE, 2011 42

OVERALL PHARMA LANDSCAPE 42

TABLE 7 TOP PHARMA COMPANIES BY SALES, 2011 ($BILLIONS) 44

TABLE 8 MAJOR UPCOMING U.S. PATENT EXPIRIES, 2012-2016 44

FIGURE 4 PHARMA DRUG SALES BY REGION, 2011 AND 2016 (% OF MARKET SHARE) 45

MAJOR CLASSES OF PLANT DRUGS 45

Terpenes and Steroids 46

Terpenes 46

Steroids 46

Alkaloids and Glycosides 47

Alkaloids 47

Ergot Alkaloids 47

Morphine Alkaloids 48

Vinca Alkaloids 48

Glycosides 48

Cardiac Glycosides 48

Anthraglycosides 48

Phenols 48

E. Cava Algae 49

Flavonoids 49

Resveratrol 49

Coumarin 49

Catechins 49

Proanthocyanidins 49

INTELLECTUAL PROPERTY 50

PRODUCTION 51

A NEW TYPE OF PRODUCTION: PLANT-MADE DRUGS 53

MOVING PRODUCTION FORWARD 53

ARTEMISININ: A CASE STUDY 55

SUPPLY AND LEGAL ISSUES 55

TABLE 9 MAJOR PRODUCERS OF RAW MATERIALS FOR PLANT-BASED MEDICINALS 56

DRUG DEVELOPMENT AND MANUFACTURE 57

TABLE 10 KEY COMPANIES WITH NATURAL PRODUCT LIBRARIES 58

CHAPTER 4 MARKET SEGMENTATION 61

GEOGRAPHIC SEGMENTATION 61

SALES OF PLANT-DERIVED DRUGS BY REGION 61

THERAPEUTIC AREA SEGMENTATION 61

NUMBER OF PLANT-DERIVED DRUGS BY THERAPEUTIC AREA 61

TABLE 11 FDA APPROVED BOTANICAL DRUGS FORECAST, THROUGH 2017 (NO.) 61

FIGURE 5 COMPOSITION OF FDA APPROVED BOTANICAL INDICATIONS FORECAST BY

THERAPEUTIC AREA, 2012 AND 2017 (% OF TOTAL BOTANICALS) 62

Value of Plant-Derived Drugs by Therapeutic Area 63

TABLE 12 RELATIVE VALUES OF FDA APPROVED BOTANICAL DRUGS FORECAST BY

THERAPEUTIC AREA, THROUGH 2017 ($BILLIONS) 63

FIGURE 6 RELATIVE VALUES OF FDA APPROVED BOTANICAL DRUGS FORECAST BY

THERAPEUTIC AREA, 2012 AND 2017 (% OF MARKET SHARE BY DOLLAR VALUE) 64

CHAPTER 5 THERAPEUTIC AREAS FOR PLANT-DERIVED AND BOTANICAL DRUGS 66

HORMONE THERAPY AND METABOLISM APPLICATIONS 66

TABLE 13 PLANT-DERIVED HORMONE THERAPY AND METABOLISM DRUGS IN LATE STAGE

DEVELOPMENT 67

INFECTIOUS DISEASE APPLICATIONS 67

TABLE 14 PLANT-DERIVED INFECTIOUS DISEASE DRUGS IN LATE STAGE DEVELOPMENT 68

PAIN AND CENTRAL NERVOUS SYSTEM DISEASE APPLICATIONS 72

TABLE 15 BRAIN DISORDERS THAT ARE REFRACTORY TO SMALL MOLECULE DRUGS 73

TABLE 16 PLANT-DERIVED PAIN AND CNS DRUGS IN LATE STAGE DEVELOPMENT 74

CARDIOVASCULAR AND METABOLIC DISEASE 75

TABLE 17 PLANT-DERIVED CARDIOVASCULAR AND METABOLIC DRUGS IN LATE STAGE

DEVELOPMENT 76

RESPIRATORY, INFLAMMATION (BOTH NON-RELATED AND RELATED TO ORTHOPEDIC)

AND AUTOIMMUNE 77

TABLE 18 PLANT-DERIVED RESPIRATORY, INFLAMMATION (BOTH NON-RELATED AND

RELATED TO ORTHOPEDIC) AND AUTOIMMUNE DRUGS IN LATE STAGE DEVELOPMENT 78

DERMATOLOGY APPLICATIONS 79

TABLE 19 PLANT-DERIVED DERMATOLOGY/WOUND CARE DRUGS IN LATE STAGE

DEVELOPMENT 80

GASTROINTESTINAL APPLICATIONS 81

TABLE 20 PLANT-DERIVED GASTROINTESTINAL DRUGS IN LATE STAGE* DEVELOPMENT 81

ONCOLOGY APPLICATIONS 82

TABLE 21 ESTIMATED U.S. CANCER CASES BY GENDER, 2012 83

TABLE 22 PLANT-DERIVED ONCOLOGY DRUGS IN LATE STAGE DEVELOPMENT 85

TABLE 23 BOTANICAL DRUGS IN LATE STAGE DEVELOPMENT WITH POSSIBLE

FDA-APPROVED COMMERCIALIZATION, THROUGH 2017* 89

CHAPTER 6 COMPANY PROFILES 94

ABBOTT LABORATORIES 94

SOLVAY PHARMACEUTICALS 94

ADVANCED LIFE SCIENCES 95

AMAREX CLINICAL RESEARCH 95

AMERICAN ORIENTAL BIOENGINEERING 95

ANALYTICON DISCOVERY GMBH 96

ARTECEF BV 97

AVESTHAGEN INC. 97

BAYER HEALTHCARE PHARMACEUTICALS 98

BEIJING PEKING UNIVERSITY WBL BIOTECH CO. LTD. 99

BIONORICA SE 99

BIONUMERIK PHARMACEUTICALS INC. 99

BIONOVO INC. 100

BOEHRINGER INGELHEIM 101

PHARMATON SA 102

BOTANICAL DRUG CORP. 102

BRISTOL MYERS SQUIBB 103

CARDAX PHARMACEUTICALS 103

CHI-MED 104

CHINA BOTANIC PHARMACEUTICAL 104

CHONG KUN DANG PHARMACEUTICAL CORP. 105

CUBIST PHARMACEUTICALS INC. 106

CURAPHARM INC. 106

EISAI INC. 107

EKOMED LLC 107

ELI LILLY 108

FYTOKEM PRODUCTS INC. 108

GALAPAGOS NV 109

GENSPERA INC. 110

GLAXOSMITHKLINE 110

GREEN CROSS CORP. 112

GW PHARMACEUTICALS PLC 112

HANMI PHARM CO. LTD. 113

HETEROGENEITY LLC 114

INDENA 114

INDUS BIOTECH 116

JOHNSON & JOHNSON 116

LANZHOU FOCI PHARMACEUTICALS CO. LTD. 117

LIFEPHARMS INC. 117

LEO PHARMA 118

LUPIN LTD. 118

LUPIN PHARMACEUTICALS INC. 119

ROTTAPHARM|MADAUS 119

MADAUS GMBH 119

MEDICUS RESEARCH 120

MERLION PHARMACEUTICALS 120

MEDIGENE 121

MEDIGENE INC. 121

MERCK & CO. INC. 122

MICROBIO CO. LTD. 122

MYREXIS, INC 123

NAPO PHARMACEUTICALS INC. 123

NEUROGESX INC. 124

NOVARTIS INTERNATIONAL AG 124

PFIZER 125

PHARMANUTRIENTS BOTANICAL CORP. 127

PHYNOVA 127

TABLE 24 PHYNOVA PIPELINE 127

PHYTOCEUTICA INC. 128

PHYTOMYCO RESEARCH PVT. LTD. 129

PHYTOPHARM PLC 129

PHYTOPHARMACON INC. 130

PHYTRIX 130

PIRAMAL LIFE SCIENCES 131

PUNISYN PHARMACEUTICALS LTD. (RIMONEST LTD.) 131

PURGENESIS 132

RANBAXY LABORATORIES LTD. 132

SALIX PHARMACEUTICALS, INC 132

SANOFI 134

SCHWABE PHARMACEUTICALS 135

SE-CURE PHARMACEUTICALS LTD. 135

SEQUOIA SCIENCES INC. 136

SIRTRIS 136

SUNTEN PHYTOTECH CO. LTD. 137

TABLE 25 SUNTECH PHYTOTECH PIPELINE 137

TASLY PHARMACEUTICALS INC. 138

TCM BIOTECH INTERNATIONAL CORP. 138

VEDIC LIFESCIENCES PVT. LTD. 139

VIROXIS 140

VR LABORATORIES LLC 140

ZHEJIANG KANGLAITE GROUP CO LTD. 141

CHAPTER 7 APPENDIX 143

TABLE 26 PLANT-DERIVED DRUGS: THEIR ORIGIN AND ACTIONS 143

TABLE 27 USEFUL RESOURCES FOR THE BOTANICAL DRUG INDUSTRY 148

LIST OF TABLES

TABLE A FDA APPROVAL PROCESS FOR NEW DRUGS 3SUMMARY TABLE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS,THROUGH 2017 ($ BILLIONS) 8TABLE 1 KEY DATES IN BOTANICAL MEDICINE 13TABLE 2 WELL KNOWN PLANT-DERIVED DRUGS 14TABLE 3 SWOT ANALYSIS OF BOTANICAL DRUG DEVELOPMENT 24TABLE 4 KEY INVESTMENTS IN BOTANICAL AND OTHER PLANT-DERIVED DRUGS 25TABLE 5 DISTINCTIONS AMONG PRODUCTS THAT USE PLANTS MEDICINALLY 30TABLE 6 BOTANICAL COMPOSITION OF MENERBA (MF 101) 40TABLE 7 TOP PHARMA COMPANIES BY SALES, 2011 ($BILLIONS) 44TABLE 8 MAJOR UPCOMING U.S. PATENT EXPIRIES, 2012-2016 44TABLE 9 MAJOR PRODUCERS OF RAW MATERIALS FOR PLANT-BASED MEDICINALS 56TABLE 10 KEY COMPANIES WITH NATURAL PRODUCT LIBRARIES 58TABLE 11 FDA APPROVED BOTANICAL DRUGS FORECAST, THROUGH 2017 (NO.) 61TABLE 12 RELATIVE VALUES OF FDA APPROVED BOTANICAL DRUGS FORECAST BYTHERAPEUTIC AREA, THROUGH 2017 ($BILLIONS) 63TABLE 13 PLANT-DERIVED HORMONE THERAPY AND METABOLISM DRUGS IN LATE STAGEDEVELOPMENT 67TABLE 14 PLANT-DERIVED INFECTIOUS DISEASE DRUGS IN LATE STAGE DEVELOPMENT 68TABLE 15 BRAIN DISORDERS THAT ARE REFRACTORY TO SMALL MOLECULE DRUGS 73TABLE 16 PLANT-DERIVED PAIN AND CNS DRUGS IN LATE STAGE DEVELOPMENT 74TABLE 17 PLANT-DERIVED CARDIOVASCULAR AND METABOLIC DRUGS IN LATE STAGEDEVELOPMENT 76TABLE 18 PLANT-DERIVED RESPIRATORY, INFLAMMATION (BOTH NON-RELATED ANDRELATED TO ORTHOPEDIC) AND AUTOIMMUNE DRUGS IN LATE STAGE DEVELOPMENT 78TABLE 19 PLANT-DERIVED DERMATOLOGY/WOUND CARE DRUGS IN LATE STAGEDEVELOPMENT 80TABLE 20 PLANT-DERIVED GASTROINTESTINAL DRUGS IN LATE STAGE* DEVELOPMENT 81TABLE 21 ESTIMATED U.S. CANCER CASES BY GENDER, 2012 83TABLE 22 PLANT-DERIVED ONCOLOGY DRUGS IN LATE STAGE DEVELOPMENT 85TABLE 23 BOTANICAL DRUGS IN LATE STAGE DEVELOPMENT WITH POSSIBLEFDA-APPROVED COMMERCIALIZATION, THROUGH 2017* 89TABLE 24 PHYNOVA PIPELINE 127TABLE 25 SUNTECH PHYTOTECH PIPELINE 137TABLE 26 PLANT-DERIVED DRUGS: THEIR ORIGIN AND ACTIONS 143TABLE 27 USEFUL RESOURCES FOR THE BOTANICAL DRUG INDUSTRY 148

LIST OF FIGURES

SUMMARY FIGURE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS,

2010-2017 ($BILLIONS) 8

FIGURE 1 TYPE OF NATURAL PRODUCT DRUGS SUBMITTED AS IND APPLICATIONS TO THE

FDA, 2008 (% SHARES) 14

FIGURE 2 THERAPEUTIC AREAS OF FDA DRUG APPROVALS, 2011 (NO. OF DRUG APPROVALS) 41

FIGURE 3 SNAPSHOT OF U.S. FDA BOTANICAL PIPELINE, 2011 42

FIGURE 4 PHARMA DRUG SALES BY REGION, 2011 AND 2016 (% OF MARKET SHARE) 45

FIGURE 5 COMPOSITION OF FDA APPROVED BOTANICAL INDICATIONS FORECAST BY

THERAPEUTIC AREA, 2012 AND 2017 (% OF TOTAL BOTANICALS) 62

FIGURE 6 RELATIVE VALUES OF FDA APPROVED BOTANICAL DRUGS FORECAST BY

THERAPEUTIC AREA, 2012 AND 2017 (% OF MARKET SHARE BY DOLLAR VALUE) 64

To order this report: Drug_and_Medication Industry: Botanical and Plant-Derived Drugs: Global Markets

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