Cecilia Van Cauwenberghe from Frost & Sullivan’s TechVision Group shares a perspective on the present status and potential evolution when it comes to cannabinoids for therapeutic purposes
The controversy concerning the use of cannabinoids for therapeutic purposes due to their psychoactive properties is present in many countries, the reason for which their prescription for medical and research purposes may be restricted. Nevertheless, most researchers all over the world strongly emphasise in their value as therapeutics for various severely underserved medical areas (Velmurugan, 2018).
The most studied extracts from cannabis are phytocannabinoids (naturally occurring cannabinoids), cannabidiol (CBD), cannabidivarin and delta-9-tetrahydrocannabinol (D9-THC), which are the unique compounds that interact with the endocannabinoid system (ECS) by modulating a broad spectrum of physiological systems influenced by the ECS (Maroon and Bost, 2018). Indeed, the therapeutic potential and applications of both phytocannabinoids and endocannabinoids, are beginning to demonstrate promising results in different disease conditions, including medically uncontrolled epilepsy and refractory epilepsy, childhood seizure disorders Lennox-Gastaut and Dravet syndromes, Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, chronic neuropathic pain, inflammation, glaucoma and even different types of cancers (Yasmin-Karim et al., 2018), as well as, psychiatric and mood disorders, such as schizophrenia, anxiety, depression, addiction, postconcussion syndrome and post-traumatic stress disorders. These observations have been substantiated by numerous studies. The National Academies of Sciences, Engineering and Medicine, for instance, conducted an exhaustive review of recent medical literature on The Health Effects of Cannabis and Cannabinoids (Abrams, 2018). This deep-dive work consisted of a systematic review process across over 10,000 studies.
Nevertheless, some concerns related to the healthy use of cannabinoids prevail among the clinical community. Although a variety of CBD products are available in several countries, including the U.S. Food and Drug Administration (FDA) approved Epidiolex and the EU’s European Medicines Agency (EMA) approved Sativex (also branded as Bedrocan, Marinol, and Cesanet), the legal status of the non-FDA/non-EMA approved products remains controversial. Moreover, non-FDA approved products present important variations among their consistency and quality, being in most cases difficult to establish whether their labelled CBD and D9-THC dosages are acceptable and to determine if the product is free of adulteration and contamination (White, 2019).
Potential therapeutics and business opportunities
Due to preclinical studies across a wide range of therapeutic areas suggest the anticonvulsant effects of phytocannabinoids mediated by the ECS, such as CBD and cannabidivarin, their antiseizure effects are a matter of very exciting discussions. Endocannabinoids are cannabinoids synthesised normally within the central nervous system (CNS). In particular, they play a key role in decreasing the release of excitatory neurotransmitter in CNS, hence proposed for preventing seizures (Sidra et al., 2018). Most scientists remark the fact that CDB, in contrast to D9-THC, does not produce any euphoric/intrusive psychoactive side effect. For that reason, CBD and cannabidivarin have been proposed as an adjunctive treatment for epilepsy (Stockings et al., 2018). In fact, there are more than 500 clinical trials in different stages of validation associated with the study of CBD in human health. Nine studies (active, not recruiting) are undergoing Phase 3 and Phase 4 clinical trials, whereas another 32 studies are planned to start late-stage clinical trials in 2019 and 2020 proposing CBD as adjunctive therapy for treatment-resistant pediatric and adult epilepsies.
Regarding business, more than 1.9 million U.S. residents have prescriptions for medical cannabis in 30 states and the District of Columbia. The revenue from California alone was $2.7 billion in 2017. The overall medical cannabis space is expected to grow at a CAGR of 13.6% from 2017 to 2022 to reach $10 billion by 2022. Globally, the United States, Canada and Western Europe are key markets (Das, 2018). “Due to preclinical studies across a wide range of therapeutic areas suggest the anticonvulsant effects of phytocannabinoids mediated by the ECS, such as CBD and cannabidivarin, their antiseizure effects are a matter of very exciting discussions.”
In October 2017, at Stanford University, the Cannabinoids in Epilepsy Therapy workshop was carried with the aim to open discussions about CBD based therapeutics among researchers, clinicians and patient advocates (Huizenga et al., 2018). The workshop facilitated a deeper knowledge around the current state of CBD, especially for the treatment of epilepsy, whereas aided the recognition of most concerning gaps that still needed to be addressed. Such scientific meetings engaging the community have gained increasing attention during the past two years. In parallel, the notorious augment of clinical trials advancing later stage status evidence the escalating interest in developing CBD preparations for the treatment of different conditions, mostly focused on epilepsy due to the observed efficacy without side effects. Big pharmaceutical companies working on the development of CBD-based drugs have the greatest potential to take the medical marijuana market to the next level because they have enormous amounts of capital, coupled with the regulatory process knowledge, to advance CBD-based therapeutics from clinical trial to marketed product.
I would like to thank all contributors from the industry involved with the development and delivery of this article from the TechVision Group at Frost & Sullivan.
1 Abrams, D.I., 2018. The therapeutic effects of Cannabis and cannabinoids: An update from the National Academies of Sciences, Engineering and Medicine report. European journal of internal medicine, 49, pp.7-11.
2 Das, R., 2018. US Medical Marijuana Market, Forecast to 2022 – Medical Cannabis Revenue will Overtake Recreational in the Next 4 Years. Frost & Sullivan Research Service, Growth Insights, K27E, Healthcare.
3 Huizenga, M.N., Fureman, B.E., Soltesz, I. and Stella, N., 2018. Proceedings of the Epilepsy Foundation’s 2017 Cannabinoids in Epilepsy Therapy Workshop.
4 Maroon, J. and Bost, J., 2018. Review of the neurological benefits of phytocannabinoids. Surgical neurology international, 9.
5 Sidra, Z., Kumar, D., Khan, M.T., Raj, G.P. and Kiran, F.N.U., 2018. Epilepsy and Cannabis: A Literature Review. Cureus, 10(9).
6 Stockings, E., Zagic, D., Campbell, G., Weier, M., Hall, W.D., Nielsen, S., Herkes, G.K., Farrell, M. and Degenhardt, L., 2018. Evidence for cannabis and cannabinoids for epilepsy: a systematic review of controlled and observational evidence. J Neurol Neurosurg Psychiatry, 89(7), pp.741-753.
7 Velmurugan, B.K., 2018. Therapeutic applications of cannabinoids. Chemico-biological interactions.
8 White, C.M., 2019. A Review of Human Studies Assessing Cannabidiol’s (CBD) Therapeutic Actions and Potential. The Journal of Clinical Pharmacology.
9 Yasmin-Karim, S., Moreau, M., Mueller, R., Sinha, N., Dabney, R., Herman, A. and Ngwa, W., 2018. Enhancing the therapeutic efficacy of cancer treatment with cannabinoids. Frontiers in oncology, 8.
Cecilia Van Cauwenberghe, PhD, MSc, BA
Associate Fellow and Senior Industry Analyst
TechVision Group, Frost & Sullivan