The U.S. Food and Drug Administration’s (FDA) botanical drug pathway is still being refined as further drug candidates continue to enter the clinical development pipeline under what many consider an easier path to commercialization. FDA approval, a relatively stringent process by global standards, generally clears the path for approval in other countries. Further, the U.S. is seen as a gold standard for regulatory review.
The global market for botanical and plant-derived drugs Expected to grow around $39.6 billion by 2022 with a compound annual growth rate (CAGR) of 6.1% for the period of 2017-2022.
The FDA defines botanicals drug candidates as:
– Heterogenous compositions (not well characterized) that include plant materials, algae, macroscopic fungi, or combinations thereof being tested or subsequently sold that are safe and that have clinically proven therapeutic effects.
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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 2022.
– Observations and conclusions regarding the future of the botanical and plant-derived drug industry.
Mentioned Key Player Profiles :-
Acorda Therapeutics Inc.
Amarex Clinical Research
Analyticon Discovery Gmbh
Bayer Healthcare Pharmaceuticals
Bionumerik Pharmaceuticals Inc.
Chong Kun Dang Pharmaceutical Corp.
Chung Mei Biopharma Co Ltd
Dongwha Pharm Co. Ltd.
Fytokem Products Inc.
Glenmark Pharmaceuticals Limited
Green Cross Corp.
Green Laboratories Llc
Gw Pharmaceuticals Plc
Hamida Pharma Inc.
Hanmi Pharma Co. Ltd.
Inspyr Therapeutics Inc.
Insys Therapeutics Inc
Izun Pharmaceuticals Corp.
Johnson & Johnson
Kanglaite Usa Inc.
Lanzhou Foci Pharmaceuticals Co. Ltd.
Lupin Pharmaceuticals Inc.
Merck & Co. Inc.
Microbio Co. Ltd.
Napo Pharmaceuticals Inc.
Novartis International Ag
Pharmaceutical Plant Co.
Phytomyco Research Pvt. Ltd.
Piramal Phytocare Ltd.
Prairie Plant Systems Inc.
Punisyn Pharmaceuticals Ltd. (Rimonest Ltd.)
Purapharm International Ltd.
Quercegen Pharmaceuticals Llc
Se-Cure Pharmaceuticals Ltd.
Sequoia Sciences Inc.
Sun Pharmaceutical Industries Ltd.
Sun Ten Pharmaceutical Co. Ltd.
Tasly Pharmaceuticals Inc.
Tcm Biotech International Corp.
United Cannabis Corp.
Valeant Pharmaceuticals International Inc. (Salix Pharmaceuticals Inc.)
Vedic Lifesciences Pvt. Ltd.
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