Analysis

Cell and gene therapy

Opportunities and challenges to personalized medicine

Cell, gene, and other emerging therapies are distinctly different from traditional biopharma products. How can life sciences companies address challenges along key stages of the product life cycle?

Growth in cell and gene therapy

Cell and gene therapies (CGTs) have quickly emerged as one of the most transformative innovations in biopharmaceuticals in recent times. CGTs are being tested in therapeutic areas beyond their initial oncology focus to include neurology, ophthalmology, and COVID-19 treatment. With more than 900 firms globally focused on these advanced therapies and over 1,000 cell and/or gene therapy clinical trials currently underway, the industry could see a tsunami of approvals1 - experts predict within 10 years up to 60 new CGTs could be launched, treating about 350,000 patients in the United States alone2.

Despite all this clinical and commercial promise, as with any new and innovative disruptive technology, cell and gene therapy developers face challenges along several key dimensions—enabling patient access, managing supply chain and manufacturing operations, and developing a health care provider network.

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1 Commissioner of Food and Drugs - Food and Drug Administration Scott Gottlieb M.D., “Evaluation and research on new policies to advance development of safe and effective cell and gene therapies,” US FDA, press release, January 15, 2019.

2 Estimating the Clinical Pipeline of Cell and Gene Therapies

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