Botanical and Plant-derived Drugs: Global Markets

NEW YORK, Nov. 28, 2017 /PRNewswire/ --

• The global market for botanical and plant-derived drugs will grow from $29.4 billion in 2017 to around $39.6 billion by 2022 with a compound annual growth rate (CAGR) of 6.1% for the period of 2017-2022.



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• Plant-derived drugs as a segment will grow from $29.3 billion in 2017 to around $39.2 billion by 2022 with a CAGR of 5.9% for the period of 2017-2022.
• Botanical drugs as a segment will grow from $57.0 million in 2017 to $425 million by 2022 with a CAGR of 49.5% for the period of 2017-2022.

Chapter 1: Introduction

Study Goals and Objectives
The use of plant-derived drugs has become widespread, so there is a great need to develop up-to-date market information about these products. BCC Research first published the previous version of this report over two years ago. This updated report analyzes the key growth areas in plant-derived drugs, develops quantitative market projections and discusses compliance within this category of drugs, created in 2004, which includes U.S. Food and Drug Administration (FDA) regulations, guidelines and review process.

Reasons for Doing This Study
This study focuses 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 analyzes technological, environmental, legal/regulatory and socioeconomic developments that may influence the market.
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 on plant-based drugs overall.
• Forecast the volume and value of botanical drugs through 2022.
• 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 could 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.

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.
• Competition.
• Observations and conclusions regarding the future of the botanical and plant-derived drug industry.


Information Sources
Both primary and secondary research methods were used in preparing this research report including, but not limited to, government and business officials, analysts, consultants and a variety of secondary research sources, such as peer-reviewed papers, investor presentations, analyst reports and companies' annual reports.

Methodology
Both primary and secondary research methods were used in preparing this research report. The findings and conclusions 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.

Geographic Breakdown
Geographic regions considered for market analysis include most developed markets of the world.

Botanical and Plant-derived Drugs, by Type
Botanical Drugs
Plant-derived Drugs

Chapter 2: Summary and Highlights
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 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.

They are not:
• Products that contain animals or animal parts (e.g., insects and annelids) and/or minerals, except when these are a minor component in a traditional botanical preparation (e.g., traditional Chinese medicine, Ayurvedic medicine).
• Materials derived from botanical species that are genetically modified with the intention of producing a single molecular entity (e.g., by recombinant DNA technology or cloning).
• Products produced by fermentation of yeast, bacteria, plant cells or other microscopic organisms, including plants used as substrates, if the objective of the fermentation process is to produce a single molecular entity (e.g., antibiotics, amino acids and vitamins).
• Highly purified substances, either derived from a naturally occurring source (e.g., paclitaxel) or chemically modified (e.g., estrogens synthesized from yam extracts).
Stakeholders have yet to absorb the full scope of this categorization because it was, in part, meant to open a pathway for many botanical products within traditional Chinese medicine, for example, that have years of research that show safe, and often effective, use.

Interest first emerged in botanicals as officials and others became aware of numerous plant-component compounds with a history of medicinal use that might need a separate evaluation process. The FDA, that had pathways that were historically built around a single chemical entity, recognized the need for different standards and modifications to its drug review to allow for a new type of drug candidate. Thus, the FDA created the botanical drug pathway in 2004, following a 1991 congressional mandate for the agency to be more vigilant concerning botanicals, in particular for products sold as supplements with medicinal claims.

Interest and activity have increased over time. In 2013, there were 51 Investigational New Drug (IND) applications, up from 21 in 2004. This compares with 516 botanical pre-INDs and INDs filed in December 2011, although only two drugs had been approved by 2012.
Over the last 10 years, interest from big pharma in botanicals has somewhat waned in terms of the establishment of a division or position in the natural products area—but interest is still selectively strong. For example, Abbott Laboratories (Lake Bluff, Ill.), Novartis AG (New York, N.Y.) and Pierre Fabre Laboratories (Paris, France) are active marketers of the Medigene botanical drug sold under the brand name Veregen.

The botanical drug category is still finding its market with big pharma companies often wary of large investment in the space. But many players continue to investigate the potential for commercialization. Larger pharmaceutical companies typically acquire startups after their innovative products have reached the final stages of successful clinical development.

This strategy will play out for botanicals and more likely for other plant-derived pharmaceuticals from marijuana-derived products (e.g., cannabinoids).
The FDA advises those seeking IND approvals to focus on medical conditions with unmet therapeutic need, identify active ingredients and develop a clinically relevant bioassay. Further, the FDA claims that compliance with the review process for botanical development is not too difficult as long as companies work within the framework.

Companies have realized that the pathways toward botanical-based commercialization have not necessarily been easy and in some cases, have opted to manufacture dietary supplements instead. This shift also likely shows that the drug candidate was not expected to exceed standard of care for a particular indication.

Indeed, many candidates are falling out of the clinical trial pipeline. Some of the casualties include: PhytoCeutica Inc's (Branford, CT) PHY906, known in China as Huang Qin Tang, that was being tested as an adjuvant treatment for diarrhea, nausea and vomiting as a result of chemotherapy; Hanmi Pharmaceutical's (South Korea) Phase 3 candidate ALS-L-1023 for abdominal obesity metabolic syndrome; TCM-700C that was being tested by TCM Biotech International Corp. (Taiwan) as an add-on treatment to the combination drug therapy (Peginterferon ?-2b plus Ribavirin) for patients with genotype 1 hepatitis C; Bionovo's (Emeryville, Calif.) Minerba or Biezelle which did not advance after testing for menopausal symptoms and breast cancer, respectively; and South Korea's Green Cross's Shinbaro capsule for osteoarthritis in the U.S.

BCC Research's previous forecasts were too optimistic about the growth prospects in this space, and also downplayed the impact of investment in botanical drugs overseas, particularly in Europe and Asia. In fact, it is likely some of the broadest investment in botanical drugs in the next decade will occur outside of the U.S.

But there is some investor wariness concerning patents for botanical compositions that do not come to fruition. Further, players in the market have sometimes failed to fully understand that products falling under the botanical designation may still require extensive studies which impact development costs. However, clinical development of botanicals is still a far less expensive proposition with costs at around one-10th of those for small molecule or biological drugs. In addition, botanical approval does not require the identification of active ingredients, a description of the product's mechanism of action, while the final product can be constituted from multiple botanicals.

The FDA's botanical review team contains experts in pharmacognosy and traditional Chinese medicine, in order to evaluate the various requirements needed for that particular drug candidate. Steps that are deemed unnecessary will be communicated to companies.

Reasons for the relatively slow pace in the botanical category include:
• Failure to show efficacy to a stated endpoint following completion of trials
• Unrealistic standards on meeting drug-level thresholds, particularly if a compound is already being used safely in humans
• insufficient planning or funding, particularly for companies that may have gained approval outside of the U.S. but then balk at the FDA's stringent process.
U.S. trials involve the disclosure of chemistry data (not including explanation for mechanism of action), nonclinical safety testing and clinical study databases. Companies may not have experience with this level of disclosure and typically are used to submitting summaries or expert opinion only in their home countries. In addition, progress can be impeded for any number of reasons not linked to stakeholders (e.g., data that does not give management or investors the confidence to proceed).
The two botanical drugs that have so far been approved as prescription drugs on the U.S. market are:
• Veregen (kunecatechins, or a partly purified extract from green tea leaves), a topical drug for the treatment of genital and perinatal warts (2006).
• Mytesi, previously branded Fulyzaq (crofelemer), an oral drug for control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy (2012).

Medigene's Veregen has moved forward at an increasing pace in part because the company has worked quickly to develop agreements with distributors and marketing partners in countries throughout the world. The botanical drug, used for genital and perianal warts from human papillomavirus types 6 and 11, had sales of $4.7 million in 2013 but dipped to $3.7 million in 2015 and $3.6 million in 2016. These figures reflect Medigene sales only minus royalties and sales from partners who also distributed the drug. The incidence of genital and perianal warts is reported in the range of 160 to 289 per 100,000 new cases each year, with a median of 194.5 per 100,000.1 The mechanism of action is virus-binding inhibition. It also works synergistically with the effects of antibiotics.

In 2017 Veregen was already approved in 21 countries with distribution partners including Fougera (part of Sandoz (itself part of Novartis)), and Women's Choice Pharmaceuticals in the U.S. market, Abbott Laboratories in Germany, Austria and Switzerland; Will-Pharma in the Netherlands; Bial in Spain; Pharmanova in Serbia; Paladin Labs (part of Endo International) in Canada; and Syncore in Taiwan and much of Asia. Veregen is also old by GC Rise Pharmaceuticals in China and Kolon Pharmaceuticals in South Korea.
Intellectual property (IP) around Veregen includes an expiring patent on its use for genital warts (expiring in 2020 in the U.S. and 2017 in Europe, although Germany will extend the patent to 2022). The formulation patent extends to 2022 in Europe and 2026 in the U.S.

On July 31, 2017, Napo Pharmaceuticals (South San Francisco, Calif.) and Jaguar Animal Health completed their merger to become Jaguar Health. The company produces crofelemer (now branded Mytesi and formerly Fulyzaq). Forecasts from when it was marketed by Salix (part of Valeant) and Glenmark were in the low double digits (approximately $20 million) in 2013 and 2014. However, Napo and Jaguar estimate the potential U.S. market for Mytesi to be approximately $100 million in gross annual sales not counting line extensions, including approvals for irritable bowel syndrome. Using its own sales force, Jaguar forecasts the drug will generate approximately $7 million in net sales in 2017.

Mytesi's generic name crofelemer refers to the proprietary extract of the blood-red latex of the South American croton tree. Peak sales are expected to be at least $200 million to $300 million in the U.S. alone.
There are many botanical drug products in development, with a few in late-stage clinical trials. Promising candidates for commercialization include: SAN 007 (5% East Indian sandalwood oil in a cream formulation) from Santalis Pharmaceuticals (San Antonio, Texas), Oneness Biotech's WH-1 formulation for diabetic foot ulcers in Phase 3 in Taiwan, and the Danshen dripping pill from Tasly Pharmaceutical (China) in Phase 3 for both stable angina and diabetic retinopathy.

Growth in the plant-derived market as a whole—excluding botanicals—is in line with the overall pharmaceutical market, given the presence of generics, including biosimilars. Further, the plant-derived market could account for 25% of the pharma market, according to one estimate. An area of growth for new plant-based drugs is marijuana cannabinoids or related compounds. Major players in this area are GW Pharmaceuticals (U.K.) that already sells the cannabinoid-based Sativex worldwide for spasticity from multiple sclerosis. The company is also developing an oral cannabinoid candidate called epidiolex for several epilepsy syndromes; AbbVie Inc.'s (North Chicago, Ill.) and Valeant Pharmaceuticals International Inc. (Canada) have Marinol (a form of dronabinol, an isomer of tetrahydrocannabinol, or THC), which is FDA-approved for nausea and wasting, and Cesamet (nabilone, or a synthetic form of cannabinoid) for nausea, respectively. Also in the marketplace is Syndros (liquid dronabinol) for nausea, vomiting or wasting made by Insys Therapeutics (Phoenix, Ariz.).

Inspyr Therapeutics' (San Antonio, Texas) mipsagargin in Phase 1 and Phase 2 for gastric and hepatocellular cancers, respectively, is an interesting example of what was initially considered a botanical drug instead of a plant-derived candidate. The compound would be considered plant-derived due to the nature of its development, including its chemical alteration into a prodrug, meaning it only releases at the tumor site to kill cancerous cells only. Derived from thapsigargin—a sesquiterpene lactone that is extracted from the plant Thapsia garganica—mipsagargin destroys tumor cells by breaking down their calcium balance.

Another example is Oseltamivir (branded Tamiflu) that was discovered from a natural substance called star anise, a native plant to China. Worldwide sales of Tamiflu have exceeded $3 billion.
Botanicals, as a subgroup of all plant-derived medications sold as prescription drugs, are expected to experience growth at higher levels relative to the entire pharmaceutical sector at a CAGR of 49.5% from 2017 to 2022.

Trends and Drivers for Botanical Drug Development Trends and/or drivers that are boosting the botanical drug market include:
• Interest in "natural" remedies with less toxicity or the perception of less toxicity in some instances.
• Patents that are expiring will necessitate compounds, other than single chemical entity drugs.
• Unmet need for new drugs that target certain indications. Many companies are realizing that, for some of these indications, a botanical may not only be more effective, but also could be as good as or the preferred option compared to the chemical-based drug.
• Established and emerging companies, including large pharma, are adopting a business model that includes development of innovative or first-in-class drugs, even if it means acquisitions or in-licensing.
• Public and private investment is continuing in botanical drug development. (For example, in addition to the U.S. National Institutes of Health (NIH) creating centers for botanical drug development as far back as 1999, grants specifically looking at plant-derived compounds are ongoing. A 2012 study that investigated the extracts of the Graviola plant and its effect on pancreatic cancer was supported by the following NIH funding mechanisms: NIH-NCI Cancer Biology Training Grant UNMC T32CA009479, R01 CA78590, U01EDRN CA111294, R01 CA131944, R01 CA133774, R01 CA 138791, P50 SPORE CA127297 and U54 CA160163.)
• Technology that helps to make possible outcomes and efficiencies, which support plant cultivation and botanical drug development.
• Increased awareness over the need to protect the environment while producing products.

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