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Shifting CAR-Ts into a Higher Gear
Industry on the brink of first CAR-T approval, but big obstacles remain, says EP Vantage
LONDON, BOSTON, TOKYO (June 3, 2016) — Chimeric antigen receptor T cell (CAR-T) therapy has indisputably become one of the industry’s hottest topics and the next 18 months could see the first CAR-T drugs filed for US approval. But behind the excitement for all things CAR-T lie a number of obstacles in their path to approval.
In its second deep-dive into the CAR-T space EP Vantage explores how much of an advantage it will be for to be the first company to achieve approval in a market that has never been tested and the ability to charge premium pricing can only be guessed at.
In this comprehensive report EP Vantage also examines:
- The complexity and expense of manufacturing
- The poor durability of many current CAR constructs
- The growing ways by which tumour cells can become resistant to CAR-T therapy
- The fear of severe toxicities
- The cost and reimbursement questions surrounding CAR-T treatments
The report also looks at the problems many CAR-T therapies face when trying to deal with solid tumours including the lack of tumour-specific cell-surface antigens that can be targeted with CAR-T therapy and what steps are being taken to overcome this, including the addition of new features to CAR-T treatments to make them more effective.
Also examined is another big issue for all CAR-T projects - lack of persistence. Even in acute lymphoblastic leukaemia where studies have shown remissions of 90% or more, many patients relapse within a year.
Alongside duration of efficacy the eventual price of treatment and manufacturing is explored.
Report author Jacob Plieth claims that there could be payer pushback for many CAR-T treatments: “Estimates are that the cost will be around $500,000 per procedure – that looks hard to sustain given that in most cases these treatments have been used as a mere bridge to stem cell transplant."
He also argues that complex manufacturing procedures for some of the most advanced CAR-T products could hinder take up: “Manufacturing this remains the single biggest stumbling block to the widespread adoption of CAR-T as a commercial product.”
On the commercial side the report shows that to date Novartis and Celgene have been some of the most active big companies in CAR-T with Celgene striking a deal with Juno worth up to $1bn. The other big players in the space and what their investment strategies have been, is looked at with specific focus on licensing deals and M&A.
To download the complimentary Shifting CAR-Ts into a Higher Gear Review report, please visit www.evaluategroup.com/CART2016.
About Evaluate Ltd.
Evaluate is the trusted source for life science market intelligence and analysis with exclusive consensus forecasts to 2020. We support life science and healthcare companies, financial institutions, consultancies and service providers in their strategic decision-making. Our services include EvaluatePharma, EvaluateClinical Trials and EvaluateMedTech. Our global team of dedicated healthcare analysts employs rigorous methodologies to deliver strategic commercial analysis. We make our services valuable by combining superior quality content, user-friendly reporting tools and outstanding customer service to solve client problems.
For more information visit: www.evaluategroup.com. On Twitter: @evaluatepharma, @evaluatemedtech, @epclinicaltrial, @epvantage.
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