Medical Marijuana – Innovative Pipeline Shows Promise for Treating more than 80 Indications

GlobalData’s Medical Marijuana Thematic Analysis report combines key opinion leader insight, interviews with industry experts and surveys of prescribing physicians and consumers in the US, France, Germany, Italy, Spain, the UK, Canada, Israel and Australia to provide an in-depth review of the medical marijuana market. The medical marijuana market is expected to grow at a CAGR of 81.3% between 2018 and 2025. Growth in the medical marijuana market will be driven by the approval of marketed drugs in additional markets. For example, Epidiolex is approved in the US and recently launched in France, Germany and the UK. The drug, which is used to treat refractory childhood-onset epilepsies is expected to launch in Spain and Italy, among other markets in 2020. Similarly, GW Pharma's Sativex is approved for muscle spasticity in patients with multiple sclerosis in many European markets and is at the pre-registration stage in the US. Launching in this market will drive sales. Furthermore, label expansion opportunities and the launch of novel agents in the coming years will lead to explosive growth making the market value worth an estimated $3.2B by 2025.

The report includes an assessment of ongoing clinical trials, the geographical location of trial sponsors, discussion of the key players in the medical marijuana space as well as insights from industry experts discussing market challenges and considerations of stakeholders in the arena.

Key Questions Answered in This Report

What was the value of the medical marijuana market in 2018?

What challenges do biopharmaceutical companies developing medical marijuana therapeutics face that are unique to this field?

Which patients do prescribing physicians think are most likely to benefit from treatment with medical marijuana?

What are the concerns and perceptions of prescribers and potential consumers of medical marijuana across the nine markets covered in this report?

What are the unmet needs in the medical marijuana market and what opportunities remain for industry players?

Scope

Overview of the potential applications of medical marijuana including SWOT analysis of marketed and late-stage pipeline agents

In-depth analysis of diseases where at least one medical marijuana product is used in clinical practice

Key topics covered include assessment of strategic consolidations, unmet needs, clinical trial mapping, examination of market opportunities and challenges

Discussion of late-stage pipeline products including a sales forecast from 2018-2025

Pipeline analysis: comprehensive data and discussion of emerging trends, the significance of the endocannabinoid system in various conditions, the route of administration of pipeline agents and the markets in which the drugs are expected to launch.

Analysis of the current and future market competition in the global medical marijuana therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

The medical marijuana market is expected to grow at a CAGR of 81.3% from 2018 to 2025. The launch of pipeline agents Zygel and lenabasum will add to the number of products in the market which will reaching a global value of $3.2 billion in 2025.

There are currently five approved medical marijuana therapies across the countries discussed in this report (US, France, Germany, Italy, Spain, UK, Canada, Israel and Australia). The products are Epidiolex, Marinol, Sativex, Nabilone and Syndros. The main issues presented are the fact that Epidiolex and Sativex are unaffordable without coverage from health insurance policies. The THC-content of products like Marinol also presents a barrier to approval in markets other than the US. This is because of its psychoactive properties. Another clinical obstacle is the tolerability of oromucosal sprays as pediatric patients can have difficulty with the taste of these therapies.

Other unmet needs include updating treatment guidelines and conducting more clinical research into the safety and efficacy of medical marijuana products for chronic diseases.

KOLs were impressed by the diversity of the medical marijuana pipeline and emphasized the need for more research as an urgent unmet need.

There is widespread diversity in the size and geographical location of companies investigating medical marijuana. Additionally, an active deals landscape between non-profit research organizations, academic institutions and biopharmaceutical companies presents opportunities for more comprehensive studies in the field.

Refining dosing arrangements and gaining marketing authorization in various markets is expected to be a challenge that will persist in the market as well as the enforcement of good manufacturing practices that meet the standards set by different regulatory bodies such as the FDA, the Therapeutic Goods Administration (TGA) in Australia and the European Medicines Agency (EMA).

Rapid uptake of therapeutics is anticipated due to the refractory nature the conditions for which products are being developed. Patients with Dravet syndrome and Lennox-Gastaut syndrome are likely to have hundreds of seizures every two weeks which causes significant disruption to the quality of life of patients and their carers.

High costs of therapy associated with products treating orphan indications are expected to remain an unmet need in the foreseeable future.

Reasons to buy

The report will enable you to:

Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

Develop business strategies by understanding the trends shaping and driving the global medical marijuana market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global medical marijuana market in the future.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Companies mentioned

Albany Molecular Research

Almirall

Axim Biotechnologies

Bionorica

Cannabis Science

Ci Therapeutics

Corbus Pharma

Eli Lilly

Emerald Bioscience

Emerald Health Sciences

GW Pharma

Insys Therapeutics

Ipsen

LTS Lohmann Therapie-Systeme

Neopharm

Novaliq

One World Cannabis

Panaxia

RespireRx

STERO Biotechs

SUDA Pharma

Tetra-Bio Pharma

Teva

Therapix Biosciences

Unimed Pharma

Veritas

Yom Chai

Zynerba Pharma

Table of Contents

Table of Contents

1. Preface

1.1 Table of Contents

1.2 Abbreviations

1.3 Related Reports

2. Executive Summary

2.1 Key Findings

2.2 KOL Insights

3. Introduction to Medical Marijuana

3.1 Defining Medical Marijuana

3.2 Overview of Cannabinoids

3.3 Overview of Cannabinoid Receptors

3.4 The Endocannabinoid System

4. Medical Marijuana: The Global Picture

4.1 The History of Medical Marijuana

4.2 Medical Marijuana in the US

4.3 Medical Marijuana in France

4.4 Medical Marijuana in Germany

4.5 Medical Marijuana in Italy

4.6 Medical Marijuana in Spain

4.7 Medical Marijuana in the UK

4.8 Medical Marijuana in Canada

4.9 Medical Marijuana in Israel

4.10 Medical Marijuana in Australia

4.11 Medical Marijuana in the Media

5. Marketed Products

5.1 Marketed Products by Indication

5.2 Marketed Product Profiles

5.3 Dosing

5.4 SWOT Analysis of Marketed Products

6. Pipeline Assessment

6.1 Overview of Late-Stage Pipeline Products

6.2 Late-Stage Pipeline Products by Indication

6.3 Phase II Pipeline Products

6.4 Phase III Pipeline Products

6.5 SWOT Analysis of Pipeline Products

7. Clinical Trials

7.1 Overview of Marijuana Products in Clinical Development

7.2 Ongoing Clinical Trials

7.3 Innovative Early-Stage Approaches

7.4 Leading Industry Sponsors

8. R&D Strategies

8.1 Receiving Permission to Conduct Clinical Trials

8.2 Companies in the Late-Stage Pipeline

8.3 Clinical Trial Design

8.4 Pipeline by Route of Administration

9. Early-Stage Pipeline Products

9.1 Indications in the Early-Stage Pipeline

10. Focus Indication: Anorexia Nervosa

10.1 Introduction to Anorexia Nervosa

10.2 Complications of Anorexia

10.3 Treatment Strategies

10.4 The Endocannabinoid System in Anorexia

10.5 Medical Marijuana Products for Anorexia

11. Focus Indication: Muscle Spasticity

11.1 Introduction to Muscle Spasticity

11.2 Muscle Types

11.3 Muscle Contraction

11.4 Etiology of Muscle Spasticity

11.5 Treatment Algorithm for Muscle Spasticity

11.6 Medical Marijuana Products for Muscle Spasticity

12. Focus Indication: Pain

12.1 Introduction to Pain

12.2 Types of Pain

12.3 Neuropathic Pain

12.4 Cancer Pain

12.5 Medical Marijuana Products for Pain

13. Focus Indication: Epilepsy

13.1 Introduction to Epilepsy

13.2 The Pathophysiology of Seizures

13.3 Types of Seizures

13.4 Childhood-Onset Epilepsies

13.5 Medical Marijuana Products for Epilepsy

14. Case Study: Charlotte’s Web

14.1 The Story of Charlotte Figi

14.2 KOL Perspectives

15. Industry Insights

15.1 Considerations of Stakeholders

16. Deals Landscape

16.1 Strategic Consolidations

16.2 Mergers and Acquisitions

17. Pricing and Reimbursement Strategy

17.1 Pricing and Reimbursement in the US

17.2 Pricing and Reimbursement in the EU and France

17.3 Drug Prices in Germany

17.4 Drug Prices in Italy

17.5 Pricing in Spain, the UK and Australia

17.6 Pricing in Canada and Israel

17.7 KOL Perspectives

18. Unmet Needs

18.1 Overview of Unmet Needs

18.2 KOL Perspectives

19. Market Challenges and Opportunities

19.1 Challenges for Medical Marijuana Pharmacotherapy

19.2 Opportunities for Medical Marijuana Pharmacotherapy

20. Prescriber Perspectives

20.1 Take-Home Messages from the Prescriber Survey

20.2 Key Messages from US Prescribers

20.3 Key Messages from 5EU Prescribers

20.4 Key Messages from Canadian Prescribers

20.5 Key Messages from Israeli Prescribers

20.6 Key Messages from Australian Prescribers

21. Consumer Perspectives

21.1 Take-Home Messages from the Consumer Survey

21.2 Consumer Perspectives in North America

21.3 Consumer Perspectives in the 5EU

21.4 Consumer Perspectives in Israel

21.5 Consumer Perspectives in Australia

22. Market Outlook

22.1 The Future of Medical Marijuana

22.2 Market Drivers

22.3 Market Barriers

22.4 Market Potential

22.5 Take-Home Messages

22.6 Closing Statements from Industry Experts and KOLs

23. Appendix

23.1 Sources

23.2 Study Design

23.3 Methodology

23.4 Primary Research

23.5 About the Authors

23.6 About GlobalData

23.7 Contact Us

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