Canada Car T-Cell Therapy Market

Canada Car T-Cell Therapy Market Executive Summary

Canada Car T-Cell Therapy Market valued at $232 Mn in 2022, projected to reach $393 Mn by 2030 with a 6.8% CAGR.

CAR T-cell therapy is an innovative immunotherapy used for specific cancers. It involves extracting T cells from the patient, modifying them in the lab to express a chimeric antigen receptor (CAR) targeting cancer cells, and reintroducing these modified T cells. Once infused, CAR T cells identify and destroy cancer cells with the targeted antigen. Successful in blood cancers like leukemia and lymphoma, ongoing research seeks to expand its use and enhance effectiveness for various cancers. The process takes weeks, involving T cell collection, genetic modification, and reintroduction into the patient's bloodstream.

The adoption of CAR T-cell therapy in Canada is on the rise, showcasing its increasing recognition for treating relapsed or refractory high-grade B-cell lymphomas and B-cell acute lymphoblastic leukemia (B-ALL). Following approval by Health Canada for axicabtagene ciloleucel and tisagenlecleucel, CAR T-cell therapy has shown encouraging results, such as a noteworthy 71% response rate in patients with relapsed/refractory diffuse large B-cell lymphoma, which is a notable improvement over standard regimen. An impressive 49.0% overall survival rate at 12 months is correlated with this increased response. However, challenges persist in ensuring widespread access, requiring concerted efforts to address logistical, cost-related, and infrastructure barriers. As Canada navigates the evolving landscape of CAR T-cell therapy, ongoing monitoring and collaborative initiatives among healthcare stakeholders will be crucial in optimizing its role and impact in the treatment of hematologic malignancies.

The Canadian Institutes of Health Research (CIHR) has awarded a substantial research grant of $1,667,700 to Dr. Kevin Hay of BC Cancer, Natasha Kekre of OHRI, and their collaborative team to conduct a phase I clinical trial for CLIC-2201, a CD22 CAR-T cell therapy intended to treat relapsed/refractory CD22 positive B-cell non-Hodgkin lymphoma. Funding from BioCanRx Enabling was first provided in September 2020 to support the development of this promising medicine.

Dr. Douglas Mahoney of the University of Calgary has been granted $125,000 by BioCanRx for an enabling study named "Personalized CAR T-cell therapy for a patient with a rare sarcoma," which strengthens the company's commitment to cancer research. This funding demonstrates the dedication to developing novel and individualized strategies for cancer treatments, especially in tackling the difficulties posed by uncommon and complicated disease forms.

Market Dynamics

Market Growth Drivers

Increasing Incidence of Cancer: The escalating frequency of cancer poses a significant public health challenge in Canada, with approximately 234,000 new cases identified annually. This growing prevalence expands the prospective pool of patients eligible for CAR T-cell therapies, especially in the context of specific indications such as hematological malignancies.

Increasing Clinical Achievements and Diversifying Applications: Early approvals of CAR T-cell treatments have shown promising results in the treatment of several cancers, demonstrating their potential to offer optimism to patients with limited treatment options. Ongoing clinical trials are aggressively exploring the possibility of CAR T-cell treatment for a wider range of cancer types, which could increase its market accessibility and effect.

Government Actions and Financial Support: The Canadian authorities acknowledge the promise of CAR T-Cell therapy and have dedicated resources to research, development, and infrastructure enhancement. In partnership with CADTH, the nation's Health Technology Assessment entity, and with partial funding from BioCanRx, Dr. William Wong from the University of Waterloo adopted a creative strategy to create a framework that aids in the decision-making processes related to the future reimbursement and integration of CAR T-cell therapy.

Market Restraints

Cost and Affordability: The high costs of CAR T-cell therapy, stemming from its personalized nature and complex manufacturing, pose a significant financial burden for patients and healthcare systems. Limited coverage by private and public insurance plans leads to substantial out-of-pocket expenses. Despite promising outcomes, concerns arise about its cost-effectiveness compared to alternative treatments, necessitating careful consideration of the balance between expense and potential benefits.

Manufacturing and Logistical Challenges: Currently, Canada has limitations due to a small number of specialized institutions that have the know-how to produce CAR T-cell treatments, creating bottlenecks that impede accessibility. The processing and transportation of CAR T-Cells necessitates temperature control and adherence to particular protocols, adding to the logistical complexity and costs. The personalized nature of the therapy contributes to the complexity of identifying eligible patients, posing a challenge in ensuring that they meet the stringent eligibility criteria.

Equity and Access Issues: Issues with equity and access related to CAR T-cell treatment are caused by variations in healthcare infrastructure and funding between provinces. Fair availability is a concern due to the treatment's high cost, which leaves low-income patients at a disadvantage. Moreover, limited awareness among patients and healthcare providers may hinder timely referrals and exacerbate accessibility issues.

Notable Recent Updates

• May 2023, Autolus Therapeutics plc disclosed that the summary of the crucial Phase 2 FELIX trial for obecabtagene autoleucel (obe-cel) in relapsed/refractory adult B-cell Acute Lymphoblastic Leukaemia (ALL) has been chosen for an oral presentation at the European Haematology Association (EHA) 2023 Congress.
• April 2022, Autolus Therapeutics plc has entered into a collaboration with Cardinal Health Inc. to assist in the introduction and marketing of its CAR T-cell therapies in the United States, contingent upon FDA approval.

Healthcare Policies and Regulatory Landscape

In Canada, several authorities are responsible for regulating and overseeing the administration of treatment medications. Health Canada, through its Pharmaceutical Drugs Directorate and Health Products and Food Branch, plays a significant role in pre-approval and approval processes for new pharmaceuticals, post-market safety monitoring, and pre-market evaluations. The Patented Medicine Prices Review Board independently regulates the market to ensure reasonable costs for patented medications. The Canadian Agency for Drugs and Technologies in Health provides evidence-based information on medication efficacy and cost-effectiveness. Additionally, each province and territory maintains its drug formulary, making selections based on considerations such as cost-effectiveness, safety, and efficacy to prevent excessive pricing of patented medications.

Competitive Landscape

Key Players

• Gilead Sciences (Kite Pharma)
• Novartis
• Bristol Myers Squibb
• Celgene
• Johnson & Johnson
• Cellectis
• Atara Biotherapeutics
• Adaptimmune Therapeutics
• Poseida Therapeutics
• UCAR-T