The global pharmaceutical cannabis market is poised for significant growth, projected to swell by 23% by 2027, mostly from one company but with other contenders battling to enter the market as the number of clinical trials surges.
In 2023, sales of prescription drugs containing cannabis are estimated to total US$1.11 billion, according to a new report by Prohibition Partners, with sales of currently approved drugs seen expanding to US$1.37 billion.
Epidiolex, the US-approved cannabidiol oral solution for rare forms of epilepsy first launched by GW Pharma in 2018 before it was bought by Jazz Pharmaceuticals PLC (NASDAQ:JAZZ) in 2021.
The drug is forecast to capture an anticipated 76% of the 2023 market share, according to the third edition of the Prohibition Partners Pharmaceutical Cannabis Report.
Thanks to Epidiolex, the US remains the epicentre of cannabis pharmaceutical sales, according to the report, which is expected to rake in over US$800 million sales this year.
Europe is gaining, with Germany leading the charge – representing a significant chunk of the continent's dronabinol and Sativex sales – and recent legal developments spurring hopes of much more to come.
Cannabis clinical trial trends
Looking to the next generation of revenue-generating drugs, the number of clinical trials using cannabis-based medicines has increased by 650%, from eight in 2010 to 60 in 2022.
So far in 2023, 49 clinical trials involving cannabis-based medicines have started, with more due to begin before the end of the year, the report noted.
While almost half of all clinical trials have targeted pain from various conditions, recent years have seen a marked increase in studies examining the potential benefits of cannabis and cannabinoids for various mental-related disorders, such as anxiety and depression.
Lawrence Purkiss, senior analyst at Prohibition Partners and co-author of the report, said: “Looking at the development of clinical trials in cannabis over the last decade gives great insight into the potential breakthroughs in the space in the coming years. From analysing the patent landscape in conjunction with the clinical trials record, it’s clear that the possibilities for further cannabinoid-based treatments are incredibly broad, with significant interest already in specific areas.”
Recent years have also witnessed a pivot towards mental health disorders, with trials exploring efficacy against anxiety, depression, and neurodegenerative ailments like Alzheimer's gaining momentum.
Oncologic complications, although still limited in trial numbers, are seeing growing interest, especially for conditions like glioblastoma. Further, cannabinoids' role in PTSD, epilepsy, metabolic disorders, and improving opioid-related disorders is coming under the spotlight.
There has been a notable shift towards CBD in isolation (like Epidiolex) from traditional combinations of THC + CBD (like Jazz's Sativex). Despite patented compounds leading phase 3 trials, success patterns remain elusive, the report said, with 34.5% of all trials analysed using a combination of these two most commonly-known cannabinoids.
The report suggests the industry's trajectory is upward, with developments in Germany and the industry shift towards later-phase trials poised to trigger a paradigm shift, while heavyweights like Jazz Pharmaceuticals and its rivals are likely to want to strengthen their patent arsenal.
Companies to watch
Among listed companies, Oxford Cannabinoid Technologies Holdings PLC (LSE:OCTP, OTCQB:OCTHF) recently received MHRA and REC 2 approval of the phase I clinical trial application in the UK of its lead pain relief drug candidate and dosed first patients in the study at the end of July.
Earlier this summer, MGC Pharmaceuticals PLC reported the delivery of first doses of its CannEpil formulation to UK patients to treat drug-resistant epilepsy, building on a safety study in Australia.
Kanabo Group PLC (LSE:KNB) has been telling investors that its cannabis inhaler is expected for European CE approval this year.
Ananda Developments Plc (AQSE:ANA) is set to begin two Phase 2 clinical trials for chronic pain conditions, it said earlier this year.
In the US, Avicanna Inc has entered into a research collaboration focused on the company’s proprietary formulations and pharmaceutical pipeline.
RespireRx Pharmaceuticals (OTC:RSPI) recently transferred its pharmaceutical cannabinoid program to an Australian subsidiary, ResolutionRx, which will focus on research and development, initially for the development of a new formulation of dronabinol for use in a Phase 3 clinical trial and the filing of regulatory approval for the treatment of obstructive sleep apnea.
Zygel, a CBD-containing gel applied to the skin, is being developed by Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) for the treatment of the rare Fragile X syndrome and has received Fast Track and Orphan Drug designations from the FDA.
Lenabasum, a synthetic cannabinoid drug, is being developed by Corbus Pharmaceutical Holdings (NASDAQ:CRBP) for the treatment of the rare autoimmune disease systemic sclerosis, is also currently in phase 3 clinical trials and has received Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the FDA.
Cannabics, a slow-release capsule that contains natural cannabinoids extracted from cannabis plants being developed by Cannabics Pharmaceuticals Inc (OTCQB:CNBX) for the treatment of cancer-related anorexia-cachexia syndrome, is in phase 2a clinical trials in Israel and has received Orphan Drug designation from the FDA. It is also being explored for other indications, such as colorectal cancer, glioblastoma, and ovarian cancer.