Gene switches have garnered significant attention from drug developers owing to their ability to control the activity of genetically modified cell products in vivo

The global gene switch market size is estimated to grow from USD 795 million in 2025 to USD 2,478 million by 2035, representing a CAGR of 12.03% during the forecast period till 2035.

Driven by numerous developmental breakthroughs and encouraging study results demonstrating the vast potential of adoptive cell therapies (ACT), including CAR-T cell therapies, TCR therapies, TILs and natural killer cell therapies, in the treatment of various complex disorders, this therapeutic modality has garnered considerable attention from the players engaged in the pharmaceutical industry. In fact, in the past few years, close to 30 cell and gene therapies have been approved by the US FDA.

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Moreover, over 1,220 cell therapies are currently being evaluated across various clinical stages of development. Further, the recent approvals of more than five CAR-T cell therapies have further fueled the interest in the broader development of such cellular therapies.
However, despites several advantages, adverse events associated with genetically modified T-cell therapies, including neurotoxicity, cytokine release syndrome (CRS), on-target / off-tumor toxicity and graft-versus-host-disease (GVHD), form the major limitation of such therapeutic modality. As a result, the industry is actively seeking various tools / methods to mitigate this challenge. Amongst the various approaches to enhance safety profiles of ACTs, safety switch / gene switch / kill switch systems (which are the regulatory sites on genes capable of switching on / off transcription and translation process) have gained sufficient attention from drug developers owing to their ability to control the activity of genetically modified cell products in vivo while sparing host immune activity.

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Type of Payment Model Employed
1. Upfront Payments
2. Milestone Payments

Application Area
1. Management of Treatment Related Toxicity
2. Regulation of Gene Expression
3. Other Applications

Type of Target Therapy
1. CAR-T Cell Therapies
2. Gene Therapies
3. Other Therapies

Gene switch platform developers - developer landscape
It is worth mentioning that the number of gene switch developers has gradually increased over the past decades. The current market landscape is fragmented, featuring the presence of both new entrants and established players. Examples of some mid-sized players include (in alphabetical order) Aptamer Group, Creative Biolabs, Kiromic BioPharma and MeiraGTx. Further, majority (57%) of the companies are based in North America, followed by those located in Asia pacific (26%). This can be attributed to the favorable environment and regulatory landscape for gene switch-based immunotherapies in these geographies.

Specifically, post 2010, around 30% companies have been established, indicating the growing interest of stakeholders in this field and presence of several start-ups in this domain. Examples of some recently established players include (in alphabetical order; established post 2015) aceRNA Technologies (2018), IASO Bio (2017), Lyell Immunopharma (2018) and Oncoinsight (2017).

Gene switch platforms - current market landscape
At present, close to 50 gene switch platforms are under development for their various applications in adoptive cell therapies (ACT), including CAR-Ts, TCRs and gene therapies. It is worth mentioning that majority of them are protein-based gene switches.

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Various small molecules, including rimiducid, rapamycin and dasatinib, are being investigated to design safety switches for ACTs. Majority (54%) of the gene switches are developed for CAR-T cell therapies. This is followed by gene therapies (27%) and RNA Therapies (11%). Further, majority (48%) of the gene switches are proteins, followed by oligonucleotide (36%).
Close to 50% of the gene switches are being developed for management of treatment related toxicity. This can be attributed to the fact that gene and cell therapies often result in cytokine release syndrome and neurotoxicity. Therefore, gene switch platforms are being developed to prevent such adverse events.

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