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

Advancements in next-generation cell and gene therapies are fulfilling the promise of personalized medicine and attempting to cure and heal patients rather than ameliorating symptoms. Multiple approved products have been launched in global markets and the number of clinical trials continues to grow. A diverse set of scientific platforms are driving the industry, including CAR-T, stem cells, siRNA, oligonucleotides, gene editing (CRISPR, Zinc Fingers, TALENs) and viral transfection.

Over the next five years, Deloitte expects cell and gene therapy will continue to grow in importance.1  The US Food and Drug Administration (FDA) expects 200 cell and gene therapy IND applications each year by 2020 and 30-60 approvals by 2030.2  The global cell and gene therapy market, valued at $1 billion in 2018, is projected to grow at a compound annual growth rate (CAGR) of over 36 percent from 2019-2025, to ~$12 billion.3

As a snapshot in 2019, there are over 930 companies pursuing therapies and over 1,000 clinical trials globally representing a portfolio of smaller, venture-backed start-ups as well as global biopharmaceutical companies.4 The industry continues to add new players including for-profit companies as well as academic researchers, many of whom are using their institutions’ translational medicine capabilities to bring innovative therapies to human use.

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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Read our three part series on cell and gene therapies

Cell and gene therapies

Delivering scientific innovation requires operating model innovation

Potential disruption by cell and gene therapies calls for an overhaul of current operating models, with a focus on organizational structure, business processes, digital capabilities, risk tolerance, and reimbursement.  Explore these 5 five key elements of the operating model and some thinking on where solutions may lie.

Winning in the cell and gene therapies market in China

Leveraging local policy and innovation to shape a sustainable CGT ecosystem in China

In this article, we splice the key factors and trends defining the China CGT industry with the aim of enabling investors, companies, and researchers alike to shape—and benefit from—an increasingly innovative yet sustainable CGT sector in China.

Why Deloitte

  • We have executed 30+ cell therapy projects to date, leveraging our end-to-end capabilities and global footprint across the value chain.
  • We have delivered projects for cell therapy manufacturers in: Commercial, Patient Operations, Patient Services, Information Technology, Manufacturing & Supply Chain, Finance, Medical Affairs, Regulatory & Compliance, and Research & Development.
  • We combine our deep industry knowledge, specialized services and solutions, and innovative platforms to deliver actionable insights that can lead to greater patient access and engagement and higher-quality care.

1 “Estimating the Clinical Pipeline of Cell and Gene Therapies and Their Potential Economic Impact on the US Healthcare System” Value Health, Science Direct, 2019; 22(6):621–626

2 Deloitte analysis of data from database

3 “Global Cell and Gene Therapy Market to Reach $11.96 Billion by 2025,” Markets Insider, August 6, 2019, Also, Global Cell and Gene Therapy Market: Focus on Products, Applications, Regions and Competitive Landscape – Analysis and Forecast, 2019-2025, BIS Research,, accessed August 8, 2019.

4 Alliance for Regenerative Medicine, 2019 Q2 Global Regenerative Medicine Report.

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