Report Overview
This report gives a clear and detailed account of all activity involving cannabis and cannabinoids in the landscape of pharmaceutical medicine, at a global level. The main topics covered include an analysis of the relevant landscape in clinical trials, patents and innovation. As well as this, a market-sizing forecast for the global pharmaceutical cannabis industry for the period 2023-2027 is presented, with accompanying commentary, and a short analysis of the recent M&A activity and research funding activity relevant to the sector is included.
Discussion of the topics covered is informed and supported by extensive data produced during research for the report. Throughout the main sections, this data is visualised in order to provide evidence and clarification to analysis. Whenever possible, context is provided to explain the factors that have brought about the current circumstances in the relevant sphere of activity, and what constraints face those operating within it. Recent developments and trends are highlighted in order to draw attention to the most significant dynamics in each area.
Key Findings
- Global sales within the pharmaceutical cannabis industry are estimated to reach approximately US$1.11 billion in 2023, with projected growth to US$1.37 billion by 2027.
- Epidiolex (Epidyolex in Europe) is the dominant player in the market, with an estimated market share of around 76% projected for 2023.
- In the pharmaceutical cannabis industry, the only drug to generate significant sales (of approximately €160 million annually) apart from Epidiolex and Sativex is dronabinol.
- There is growing interest in research around non-cannabinoid compounds targeting the endocannabinoid system. Jazz Pharmaceuticals dominated the patent landscape for the medical application of cannabinoids, and has a patent portfolio which dwarfs that of any other company involved in patenting activity around the medical application of cannabinoids.
- CBD and THC are still seeing the majority of patent activity versus other cannabinoids, as they have historically. A large amount of activity is also focused on cannabinoids and compounds that are closely related to these cannabinoids, for example CBDV, THCV, CBDA, and relevant prodrugs and analogues.
- There is a wide variation in the costs associated with each stage of the clinical trials process, but even at the lowest end, bringing a medicine to the market is going to cost US$20 million or more.
- Pharmaceutical cannabis sales are concentrated in two regions globally - North America and Europe. Within these regions, sales are not evenly distributed but are concentrated in key markets.
What's Included:
A digital copy of the report which includes an assessment of the market size within the pharmaceutical cannabis industry, which primarily consists of three cannabinoid treatments: Epidiolex, dronabinol, and Sativex. The impact of Syndros, Marinol, nabilone and Cesamet/Canemes on the overall figures is of little significance - collectively, these medications are projected to contribute less than US$3 million in 2023, representing less than 0.3% of the global sales. For this reason, they have not been included in the charts in this section
Table of Contents
- Executive Summary
- Introduction
- Overview
- Drug Development - Costs & Relevant Factors
- Main Players
- Geographies
- Clinical Trials
- Expert Interviews
- Patents
- Innovation
- M&A Activity
- Market Sizing
- Conclusion
Executive Summary
The use of cannabinoids in the treatment of medical conditions offers major opportunities, but also challenges to anyone operating in the space. Research on the endocannabinoid system is one of the most promising avenues for new therapeutics in medicine at the moment. However, regulations are constantly shifting beneath the feet of operators and their ability to serve patients depends on their capacity to navigate a changing landscape of governance. This report has been compiled to assist interested parties in understanding the market for the medical use of cannabinoids and where it may be heading.
The majority of medicinal cannabis is currently being prescribed in a medically non-traditional manner, with short patient-doctor interactions and approximate dosing of the active pharmaceutical ingredients e.g. via inhalation of com- busted flower. In both Europe and the United States (US), the sales of unapproved canna- bis products such as smoked flower and full- spectrum oils dwarfs those of approved pharmaceuticals like Epidiolex®, Marinol®, Sativex® and Cesamet® which have been guided through the traditional approvals process. In Europe however, there is a clear trend towards the use of more precise formulations of unapproved cannabis products as well as approved pharmaceutical products. In the US, sales of medical flower and vaporised products remain dominant amongst unapproved medicines, but there is also an increase in sales of pharmaceuticals, mainly Epidiolex®.
Epidiolex® is currently the poster child for a successful cannabinoid pharmaceutical; garnering over €430 million in sales in 2020 and serving an estimated patient population of more than 20,000. The story of GW Pharmaceuticals, the producers of Epidiolex ® , is instructive regarding the challenges and opportunities of operating in the pharmaceutical cannabis space; taking over 20 years to generate considerable sales and facing several set - backs in clinical trials. The fruits of GW’s strategy are obvious however, with sales increasing at a rapid pace, and the recent acquisition of the company by Jazz Pharmaceuticals for over €6 billion.
The author estimates the market size for the three most widely used cannabinoid pharmaceuticals (Epidiolex ®, Sativex ®, dronabinol) to be worth just under €900 million as of 2021, growing to €1.8 billion by 2025. These figures have much room for growth, as and when, any new cannabinoid therapeutic is approved, or existing medicines become used in new conditions or regions.
The current medical cannabis market is bursting with innovation. The author has identified at least 30 late-stage clinical trials using cannabinoid therapeutics, any of which could have a large impact on the medicinal cannabis space. Products with new routes of administration, such as metered inhalers and transdermal products, are currently making their way through the approval’s process. Research and development on minor cannabinoids such as Cannabigerol (CBG) and Cannabichromene (CBC) is just beginning, with a lot of therapeutic promise but still with a lack of hard evidence. The market for synthetic cannabinoids produced outside the cannabis plant, is now beginning to gain some maturity, with chemosynthetic products already on the market and several firms producing commercial amounts of Tetrahydrocannabinol (THC) and Cannabidiol (CBD) through biosynthetic processes.
Many in the medical cannabis space are developing portfolios of patents to protect products and their methods of production. The industry is yet to see a considerable amount of litigation, but this may soon change, as signalled by the case between GW Pharmaceuticals and Canopy Growth over proprietary methods of cannabinoid extraction. In the realm of patents, the looming expiration of market exclusivity on Epidiolex ® could soon offer opportunities to potential producers of generics to supply cheaper alternatives to patients suffering from rare forms of epilepsy.
Overall, the total potential for the use of medical cannabinoids in the pharmaceutical space has barely been scratched. In the medium to long term, the publisher expects to see the development of a range of new cannabinoid therapeutics approved across the globe. Operators in the space can expect to see these products gradually taking up more of the market share at the expense of unapproved flower and full-spectrum oils over the next 10 years. This will coincide with the liberalisation of adult-use cannabis across North America and Europe which will further distil the use of medical products from flower to more precise formulations.
