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Botanical and Plant-Derived Drugs: Global Markets

Botanical and Plant-Derived Drugs: Global Markets

The global market for botanical and plant-derived drugs was valued at $23.2 billion in 2013 and $24.4 billion in 2014. This total market is expected to reach $25.6 billion in 2015 and nearly $35.4 billion in 2020, with a compound annual growth rate (CAGR) of 6.6% from 2015 to 2020.

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 2013 and 2014, estimates for 2015, and projections of CAGRs through 2020.
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


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).
Nonmedicinal 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 2020.
Competition.
Observations and conclusions regarding the future of the botanical and plant-derived drug industry.

CHAPTER 1 INTRODUCTION
STUDY BACKGROUND
STUDY GOAL AND OBJECTIVES
INTENDED AUDIENCE
SCOPE OF REPORT
METHODOLOGY AND INFORMATION SOURCES
COMMERCIAL DRUGS
DEVELOPMENTAL DRUGS
TABLE A FDA APPROVAL PROCESS FOR NEW DRUGS
ANALYST'S CREDENTIALS
RELATED BCC RESEARCH REPORTS
BCC RESEARCH WEBSITE
DISCLAIMER
CHAPTER 2 SUMMARY
SUMMARY TABLE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS, THROUGH 2020 ($ MILLIONS)
SUMMARY FIGURE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS, 2013-2020 ($ MILLIONS)
CHAPTER 3 OVERVIEW
BRIEF HISTORY OF PLANT-DERIVED MEDICINES
TABLE 1 KEY DATES IN BOTANICAL MEDICINE
TABLE 2 WELL KNOWN PLANT-DERIVED DRUGS
OPPORTUNITY LIES BEYOND WHAT IS KNOWN
FIGURE 1 TYPE OF NATURAL PRODUCT DRUGS SUBMITTED AS IND
APPLICATIONS TO THE FDA, 2008 (% SHARES)
GETTING STARTED
KEY DRIVERS
KEY CHALLENGES
U.S. GOVERNMENT INVESTMENT
INDUSTRY INVESTMENT
TABLE 3 SWOT ANALYSIS OF BOTANICAL DRUG DEVELOPMENT
TABLE 4 KEY INVESTMENTS IN BOTANICAL AND OTHER PLANT-DERIVED
DRUGS
NUTRITION SCIENCE PARTNERS LTD. (NESTLE HEALTH): A CASE STUDY
BOTANICAL DRUGS DEFINED
UNDERSTANDING THE REGULATORY PROCESS
TABLE 5 DISTINCTIONS AMONG PRODUCTS THAT USE PLANTS MEDICINALLY
INVESTIGATIONAL NEW DRUG APPLICATIONS
CLINICAL TRIALS
NEW DRUG APPLICATION
THE FIRST AND SECOND APPROVED BOTANICAL
VEREGEN (CHINESE GREEN TEA CATECHINS)
Advice from FDA Based on Veregen Approval
FULYZAQ (CROFELEMER)
BOTANICAL CANDIDATES IN THE PIPELINE
SAMITAL AND PANAX GINSENG
TCM-700C
FEMARELLE AND BRIZO
SHINBARO CAPSULE
DANSHEN DRIPPING PILL (CARDIOTONIC PILL)
EISO (EAST INDIAN SANDALWOOD OIL)
MICROBIO AND WH-1, MB-6, AND OB318
TABLE 6 BOTANICAL COMPOSITION OF MENERBA (MF 101)*
A GROWING PIPELINE
FIGURE 2 TOP THERAPEUTIC AREAS OF FDA DRUG APPROVALS*, 2014 (NO. OF DRUG APPROVALS)
FIGURE 3 SNAPSHOT OF U.S. FDA BOTANICAL PIPELINE IN 2012
OVERALL PHARMA LANDSCAPE
TABLE 7 TOP PHARMA COMPANIES BY SALES, 2014 ($ BILLIONS)
TABLE 8 MAJOR UPCOMING U.S. PATENT EXPIRIES, 2014-2019
FIGURE 4 PHARMA DRUG SALES BY REGION, 2014 AND 2019 (% OF MARKET SHARE)
MAJOR CLASSES OF PLANT DRUGS
Terpenes and Steroids
Terpenes
Steroids
Alkaloids and Glycosides
Alkaloids
Ergot Alkaloids
Morphine Alkaloids
Vinca Alkaloids
Glycosides
Cardiac Glycosides
Anthraglycosides
Phenols
E. Cava Algae
Flavonoids
Resveratrol
Coumarin
Catechins
Proanthocyanidins
INTELLECTUAL PROPERTY
PRODUCTION
A NEW TYPE OF PRODUCTION: PLANT-MADE DRUGS
MOVING PRODUCTION FORWARD
ARTEMISININ: A CASE STUDY
SUPPLY AND LEGAL ISSUES
TABLE 9 MAJOR PRODUCERS OF RAW MATERIALS FOR PLANT-BASED
MEDICINALS
DRUG DEVELOPMENT AND MANUFACTURE
TABLE 10 KEY COMPANIES WITH NATURAL PRODUCT LIBRARIES
CHAPTER 4 MARKET SEGMENTATION
GEOGRAPHIC SEGMENTATION
SALES OF PLANT-DERIVED DRUGS BY REGION
THERAPEUTIC AREA SEGMENTATION
NUMBER OF PLANT-DERIVED DRUGS BY THERAPEUTIC AREA
TABLE 11 NUMBER OF FDA APPROVED BOTANICAL DRUGS, THROUGH 2020 (NUMBER)
FIGURE 5 COMPOSITION OF FDA APPROVED BOTANICAL INDICATIONS FORECAST BY THERAPEUTIC AREA, 2015 AND 2020 (%)
VALUE OF PLANT-DERIVED DRUGS BY THERAPEUTIC AREA
TABLE 12 RELATIVE VALUES OF FDA APPROVED BOTANICAL DRUGS FORECAST BY THERAPEUTIC AREA, THROUGH 2020 ($ MILLIONS)
FIGURE 6 RELATIVE VALUE SHARE OF FDA APPROVED BOTANICAL DRUGS FORECAST BY THERAPEUTIC AREA, 2015 AND 2020 (%)
CHAPTER 5 THERAPEUTIC AREAS FOR BOTANICAL AND PLANT-DERIVED
DRUGS
HORMONE THERAPY AND METABOLISM APPLICATIONS
TABLE 13 PLANT-DERIVED HORMONE THERAPY AND METABOLISM DRUGS
IN LATE STAGE DEVELOPMENT
INFECTIOUS DISEASE APPLICATIONS
TABLE 14 PLANT-DERIVED INFECTIOUS DISEASE DRUGS IN LATE STAGE
DEVELOPMENT
PAIN AND CENTRAL NERVOUS SYSTEM DISEASE APPLICATIONS
TABLE 15 BRAIN DISORDERS THAT ARE REFRACTORY TO SMALL MOLECULE
DRUGS
TABLE 16 PLANT-DERIVED PAIN AND CNS DRUGS IN LATE STAGE
DEVELOPMENT
CARDIOVASCULAR AND METABOLIC DISEASE APPLICATIONS
TABLE 17 PLANT-DERIVED CARDIOVASCULAR AND METABOLIC DRUGS IN LATE STAGE DEVELOPMENT
RESPIRATORY, INFLAMMATION (BOTH NONRELATED AND RELATED TO
ORTHOPEDIC) AND AUTOIMMUNE APPLICATIONS
TABLE 18 PLANT-DERIVED RESPIRATORY, INFLAMMATION (BOTH NON-RELATED AND RELATED TO ORTHOPEDIC) AND AUTOIMMUNE DRUGS IN LATE STAGE DEVELOPMENT
DERMATOLOGY APPLICATIONS
TABLE 19 PLANT-DERIVED DERMATOLOGY/WOUND CARE DRUGS IN LATE
STAGE DEVELOPMENT
GASTROINTESTINAL APPLICATIONS
TABLE 20 PLANT-DERIVED GASTROINTESTINAL DRUGS IN LATE STAGE
DEVELOPMENT
ONCOLOGY APPLICATIONS
TABLE 21 ESTIMATED U.S. CANCER CASES BY GENDER, 2015
TABLE 22 PLANT-DERIVED ONCOLOGY DRUGS IN LATE STAGE
DEVELOPMENT
BOTANICAL DRUGS IN LATE STAGE DEVELOPMENT
TABLE 23 BOTANICAL DRUGS IN LATE STAGE DEVELOPMENT WITH POSSIBLE FDA-APPROVED COMMERCIALIZATION, THROUGH 2020
CHAPTER 6 COMPANY PROFILES
ABBOTT LABORATORIES
ACORDA THERAPEUTICS, INC.
AMAREX CLINICAL RESEARCH
ANALYTICON DISCOVERY GMBH
ARTECEF BV
AVESTHAGEN LTD.
BAYER HEALTHCARE PHARMACEUTICALS
BEIJING PEKING UNIVERSITY WBL BIOTECH CO. LTD.
BIONORICA SE
BIONUMERIK PHARMACEUTICALS INC.
BOEHRINGER INGELHEIM
PHARMATON SA
BOTANICAL DRUG CORP.
BRISTOL MYERS SQUIBB
CARDAX PHARMACEUTICALS
CHI-MED
CHONG KUN DANG PHARMACEUTICAL CORP.
CURAPHARM INC.
DONG-A-ST
DONGWHA PHARM CO. LTD.
EISAI INC.
EISAI, INC. U.S.
EKOMED LLC
ELI LILLY
FYTOKEM PRODUCTS INC.
GALAPAGOS NV
GENSPERA INC.
GLAXOSMITHKLINE
GLENMARK PHARMACEUTICALS LIMITED
GREEN CROSS CORP.
GREEN LABORATORIES, LLC
GW PHARMACEUTICALS PLC
HAMIDA PHARMA INC.
HANMI PHARMA CO. LTD.
HETEROGENEITY LLC
INDENA
INDUS BIOTECH
IZUN PHARMACEUTICALS CORP.
JOHNSON & JOHNSON
LANZHOU FOCI PHARMACEUTICALS CO. LTD.
LEO PHARMA
LUPIN LTD.
LUPIN PHARMACEUTICALS INC.
MEDIGENE
MEDIGENE INC. (U.S. DIVISION)
MERCK & CO. INC.
MERLION PHARMACEUTICALS
MICROBIO CO. LTD.
MYCOSYNTHETIX, INC.
NAPO PHARMACEUTICALS INC.
NOVARTIS INTERNATIONAL AG
PFIZER
THE PHARMACEUTICAL PLANT CO.
PHARMANUTRIENTS BOTANICAL CORP.
PHYNOVA
PHYTOCEUTICA INC.
PHYTOMYCO RESEARCH PVT. LTD.
PHYTOPHARMACON INC.
PIRAMAL PHYTOCARE LTD.
PRAIRIE PLANT SYSTEMS INC.
PUNISYN PHARMACEUTICALS LTD. (RIMONEST LTD.)
PURAPHARM INTERNATIONAL LTD.
PURGENESIS TECHNOLOGIES INC.
QUERCEGEN PHARMACEUTICALS LLC
ROTTAPHARM (MADAUS)
SANOFI
SCHWABE PHARMACEUTICALS
SE-CURE PHARMACEUTICALS LTD.
SEQUOIA SCIENCES INC.
SUN PHARMACEUTICAL INDUSTRIES LTD.
SUN TEN PHARMACEUTICAL CO. LTD.
TASLY PHARMACEUTICALS INC.
TCM BIOTECH INTERNATIONAL CORP.
TFS CORPORATION LTD.
VALEANT PHARMACEUTICALS INTERNATIONAL INC.
SALIX PHARMACEUTICALS INC.
VEDIC LIFESCIENCES PVT. LTD.
VIROXIS
XIANGXUE PHARMACEUTICALS, CO. LTD.
ZHEJIANG KANGLAITE GROUP
KANGLAITE USA
CHAPTER 7 APPENDIX
TABLE 24 PLANT-DERIVED DRUGS: THEIR ORIGIN AND ACTIONS
TABLE 25 USEFUL RESOURCES FOR THE BOTANICAL DRUG INDUSTRY

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