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Institute Report
Strengthening Pathways for Cell and Gene Therapies: Current State and Future Scenarios
This report from the IQVIA Institute reflects on the current state of the end-to-end environment for cell and gene therapies
Mar 13, 2024
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Report Summary

Cell and gene therapies can provide transformative benefits to patients who are often left with no other treatment options. Recent years have seen record funding, clinical research, and new launches in this sector. Despite the increasing activity, the health system infrastructure needs and the complexities of the journey often required by patients to receive these therapies pose significant barriers to the future success and sustainability of these treatment modalities.  Significant uncertainty remains about the future trajectory of the sector, highlighting the need for a deep understanding of the current state and potential evolutionary paths over the coming years.

Cell and gene therapies are a broad group of medicines, including cell-based immunotherapies, cell therapies, gene therapies, and tissue-engineered products but do not include RNA therapeutics. In this report, we characterize the current state of these therapies across the product lifecycle, beginning with pre-commercial activities such as funding and clinical research. We also detail the hurdles to commercialization, including infrastructure needs, reimbursement, and patient access.

Reflecting on the current state of the end-to-end environment for cell and gene therapies, we provide potential future scenarios across eight indicators that can be monitored to understand the evolution of the sector through 2035 and beyond. We intend for this report to provide a foundation for meaningful discussions about the future of the sector and the role cell and gene therapies will play in healthcare.

 

Key findings:

  • Growing interest in the sector has resulted in increased funding and clinical activity.
  • As of the end of 2023, 76 cell and gene therapies have been launched globally, more than double the number of therapies that had been launched by 2013.
  • The treatment journey for patients who may be eligible for treatment with a cell and gene therapy is complex, and numerous barriers exist throughout the process.
  • Spending on cell and gene therapies is increasing rapidly and reached $5.9Bn in 2023, up 38% from 2022 although spending accounted for only 0.4% of the $1.6Tn spent on medicines globally in 2023.
  • Significant uncertainty still exists about the future trajectory and sustainability of the cell and gene therapy sector, with a range of future scenarios possible across eight key indicators which will define the future through 2035 and beyond.

Other findings:

Cell and gene therapy venture capital and public funding deal value in U.S.$$Mn and number of deals by type, 2014-2023

  • Venture capital activity and public transactions for cell and gene therapies have accelerated in the past three years. Following historic funding levels in 2021 and a retraction in 2022, nearly 100 deals and $3.4Bn of deal value occurred in 2023.
  • The total number of deals peaked at 127 in 2021 — 57% higher than in 2020 — dropped 24% in 2022 to 97 deals, and remained flat in 2023 at 96 deals, although still up 19% from 2020.
  • Later-stage venture capital deals, which typically bring in more dollars, grew in 2023 while earlier-stage deals declined; however, all remain above levels seen five years ago.

Cell and gene therapy clinical trial starts by type, 2013-2023

  • Cell and gene therapies developed by academic and research institutions and biopharma companies have gradually progressed from preclinical research to being evaluated in patients in clinical settings.
  • Over the last five years 3,285 trials were started to evaluate cell and gene therapies in patients across all sponsor types, including 631 in 2023.
  • Non-industry trials, which include those sponsored by academic institutions, non-profits, and governments with no biopharma involvement, represented 36% of trial starts in 2023, while industry-sponsored trials (with or without non-industry involvement) accounted for the other 64%.

Global cumulative cell and gene therapy launches by type

  • Cell and gene therapies include cell-based immunotherapies, cell therapies, gene therapies, and tissue-engineered products. The first of these therapies to receive regulatory approval and launch commercially was Transcyte, a tissue-engineered skin substitute for the treatment of epidermolysis bullosa, which launched in the U.S. in 1997.
  • Other early advanced therapies included tissue-engineered products, primarily skin substitutes and cartilage repair products.
  • The first gene therapy, Gendicine, was launched in China in 2004 for the treatment of head and neck cancer.

Status of cell and gene therapy reimbursement in Europe (Apr 2023) compared to GDP per capital 2022, current international dollars PPP

  • More significant variations in reimbursement rates emerge when looking outside of major markets. In Europe, wealthier countries generally reimburse cell and gene therapies more readily.
  • Similar correlations between access to medicines and GDP are observed for all novel medicines, not only cell and gene therapies. Countries in Western Europe, which generally have the highest GDP per capita, have an average reimbursement rate of 60% for cell and gene therapies, the highest among the European regions.
  • Within Western Europe, the wealthiest countries — Luxembourg and Switzerland — reimburse fewer therapies (42%) than Germany and France, which have lower GDP per capita but reimburse 75% or more of therapies.

Global cell and gene therapy spending and share by geography

  • The high cost per patient for cell and gene therapies has driven concern over spending on these products. Global spending on these therapies reached $5.9Bn in 2023.
  • Spending grew by 38% in 2023 from the prior year, and spending has averaged 65% annual growth over the last five years as more products are reaching the market. A majority (62%) of this spending is attributable to U.S. sales, compared to just 38% coming from other geographies. This could reflect the frequently higher prices seen in the U.S., though net prices — the amount paid to manufacturers after all discounts and rebates — in the U.S. may be more comparable to prices in other countries.
  • Higher spending in the U.S. likely reflects the broader acceptance of these therapies and a likely higher uptake, as more cell and gene therapies are available in the U.S. than in other countries.

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