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Cell and Gene Therapy
Opportunities and challenges of precision medicine in Europe
Cell, gene and other emerging therapies are distinctly different from traditional one-size-fits-all medicinal products. How can life sciences companies address challenges along key stages of the product life cycle?
The cell and gene therapy market is exploding globally
Ground-breaking developments in next-generation cell and gene therapies (CGTs) offer curative value for patients with few to no other therapeutic interventions for either maintenance or cure within specific disease areas, many of which include rare and ultra-rare diseases. The largest therapeutic area is cancer, followed by musculoskeletal diseases and eye diseases.1 Multiple approved products have been launched in global markets and the number of clinical trials continues to grow. In Europe, these therapies are classified under Advanced Therapeutic Medicinal Products (ATMPs) and are driven by a diverse set of scientific advancements including CAR-T, TCR-T, stem cells, siRNA, oligonucleotides, gene editing (CRISPR, Zinc Fingers, TALENs) and viral transfection.
The global CGT market is projected to grow at a compound annual growth rate of over 36 percent from 2019-2025, to ~ €10 billion.2 With more than 900 companies globally focusing on CGTS and over 1,000 clinical trials being conducted, the industry could see numerous approvals—as many as 10 to 20 new advanced therapies per year starting in 2025.3 Moreover, 33% of these clinical trials is being conducted in Europe.1
Global biopharma companies as well as smaller, venture backed-up start-ups are rapidly investing in this complex space. In 2018, about $13 billion has been invested globally in advanced therapies such as cell, gene and gene modifying therapies. In 2019, 19 CGT-related M&A deals worth over $156 billion were completed.3
As with any innovative and disruptive technology, CGT developers face challenges along several key stages of the product life cycle. Compared to chemical-based pharmaceuticals, key success factors such as enabling patient access, managing supply chain and manufacturing operations, evidencing compliance with increasingly complex regulatory requirements and alternate business models impose a greater burden.
Our cell and gene experience across the cell and gene therapy (CGT) value chain
The NextGen Therapies practice at Deloitte has been supporting all the major industry players involved in developing new treatment modalities, like cell and gene modifications, to develop curative therapies.
We have helped both small and large industry players identify and resolve critical business and operational challenges across the cell and gene therapies value chain. Within the cell and gene therapies practice, we gained extensive experience across business functions by supporting clients in their clinical to commercial evolution for launch readiness.