LONDON & BOSTON & SAN FRANCISCO & TOKYO--(BUSINESS WIRE)--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, the editorial team of Evaluate Ltd., explores how much of an advantage it will be for 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 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 analyzes 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 assessed is another big issue for all CAR-T projects – lack of persistence. Even in acute lymphoblastic leukaemia, where studies have shown remissions of 90 percent 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.”
Plieth argues that complex manufacturing procedures for some of the most advanced CAR-T products could hinder take up. “Manufacturing 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 $1 billion. 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 free report – Shifting CAR-Ts into a Higher Gear, 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 2022. Our services include EvaluatePharma, EvaluateClinical Trials and EvaluateMedTech. Our award-winning editorial team, EP Vantage, leverages our strategic analysis to cut through the noise, giving you daily opinion and insights. The Evaluate services enable the life science community to make sound business decisions about value and opportunity. For more information please visit www.evaluategroup.com. On Twitter: @evaluatepharma, @evaluatemedtech, @epclinicaltrial, @epvantage.