Gene-Circuit Cell Therapy Market Report 2025

The gene-circuit cell therapy market size has grown exponentially in recent years. It will grow from $1.14 billion in 2024 to $1.38 billion in 2025 at a compound annual growth rate (CAGR) of 21.3%. Growth in the historic period was driven by rising demand for targeted and programmable therapies, increased investment in cell and gene therapy research and development, higher prevalence of cancer and genetic disorders, and the expansion of clinical trials for engineered cell therapies.

The gene-circuit cell therapy market size is expected to see exponential growth in the next few years. It will grow to $2.95 billion in 2029 at a compound annual growth rate (CAGR) of 20.9%. Growth in the forecast period is expected to result from greater adoption of in-vivo delivery and non-viral platforms, stronger regulatory support with streamlined approval processes, increasing investment from pharmaceutical companies and venture capital, rising demand for off-the-shelf allogeneic cell therapies, and the expansion of manufacturing capacity and gene synthesis services. Key trends projected for the forecast period include advancements in synthetic gene circuit design, the development of safety switches and programmable control systems, progress in automated and scalable manufacturing, and integration of technologies for real-time monitoring and bioinformatics.

The increasing incidence of genetic diseases is expected to drive the growth of the gene-circuit cell therapy market in the future. Genetic diseases are disorders caused by changes or mutations in DNA that can be inherited or arise spontaneously, impacting health, development, or bodily functions. The growing prevalence of these diseases is linked to heightened awareness and improvements in diagnostic technologies, which facilitate earlier and more accurate identification of previously undiagnosed conditions. Gene-circuit cell therapy aids in managing genetic diseases by providing highly targeted and programmable treatments, making it suitable for conditions involving complex or previously untreatable genetic defects. It improves patient outcomes by precisely modifying or controlling cellular functions, reducing disease symptoms, and potentially offering functional cures. For example, the Cystic Fibrosis Trust reported in September 2023 that 11,148 people were diagnosed with cystic fibrosis in 2022, a rise from 10,908 in 2021. This growing incidence of genetic diseases is thus contributing to the expansion of the gene-circuit cell therapy market.

The increasing use of personalized medicine is anticipated to boost the growth of the gene-circuit cell therapy market moving forward. Personalized medicine is a healthcare approach that customizes treatments and prevention strategies according to an individual’s unique genetic makeup, lifestyle, and environment. The rising adoption of personalized medicine is largely due to advancements in genomics, which allow for precise identification of genetic variations and the development of tailored treatments. Gene-circuit cell therapy supports this approach by enabling targeted and programmable treatments, making it ideal for managing complex and chronic diseases. It improves therapeutic precision by tailoring interventions to meet the specific needs of individual patients, leading to better treatment effectiveness and overall health outcomes. For instance, the Personalized Medicine Coalition (PMC) reported in February 2024 that the U.S. Food and Drug Administration (FDA) approved 26 new personalized medicines in 2023, a significant increase from 12 approvals in 2022. Therefore, the growing adoption of personalized medicine is driving the growth of the gene-circuit cell therapy market.

Key players in the gene-circuit cell therapy market are focusing on developing advanced therapeutic platforms, such as CRISPR-based gene editing systems, to enhance treatment precision, improve outcomes, and address genetic diseases that were once deemed incurable. CRISPR-based gene editing technologies enable precise modifications to the genome, allowing for the correction of genetic defects or the introduction of therapeutic genes into cells. For example, in December 2023, Vertex Pharmaceuticals Inc., a U.S.-based biopharmaceutical company, partnered with CRISPR Therapeutics Inc., a U.S.-based biotechnology company, to receive conditional marketing authorization from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for CASGEVY (exagamglogene autotemcel, exa-cel). This therapy is designed for patients aged 12 and older with sickle cell disease (SCD) and recurrent vaso-occlusive crises or transfusion-dependent beta thalassemia (TDT). CASGEVY works by editing hematopoietic stem cells to reactivate fetal hemoglobin production, reducing or eliminating disease symptoms and offering a potential functional cure for these conditions.

Major players in the gene-circuit cell therapy market are Tmunity Therapeutics Inc., Ginkgo Bioworks Holdings Inc., Arcellx Inc., Beam Therapeutics Inc., CRISPR Therapeutics AG, Intellia Therapeutics Inc., Orchard Therapeutics plc, Fate Therapeutics Inc., Rubius Therapeutics Inc., BlueRock Therapeutics LP (a subsidiary of Bayer AG), Precigen Inc., SparingVision, Alaunos Therapeutics Inc., Cartesian Therapeutics Inc., Lyell Immunopharma Inc., Synlogic Inc., Senti Biosciences Inc., Autolus Therapeutics plc, Cellectis S.A., and Sotio Biotech.

North America was the largest region in the gene-circuit cell therapy market in 2024. The regions covered in gene-circuit cell therapy report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the gene-circuit cell therapy market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.

Gene-circuit cell therapy is an advanced approach to cell therapy in which engineered cells are designed with synthetic gene circuits that enable them to detect, process, and respond to specific biological signals in the body. This allows for controlled, targeted, and adaptable therapeutic actions such as drug release, immune modulation, or correction of dysfunctional cellular behavior, offering greater precision and safety compared to conventional cell therapies.

The main product types of gene-circuit cell therapy are autologous and allogeneic. Autologous therapy involves collecting a patient’s own cells, engineering them with synthetic gene circuits to sense and react to specific biological signals, and reinfusing them into the same patient. This therapy uses advanced technologies such as clustered regularly interspaced short palindromic repeats, transcription activator-like effector nucleases, zinc finger nucleases, and others. It is applied in the treatment of oncology, genetic disorders, infectious diseases, and additional conditions. The primary end users include hospitals and clinics, research institutions, biotechnology companies, pharmaceutical companies, and others.

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The gene-circuit cell therapy consists of revenues earned by entities by providing services such as cell engineering and programming, patient monitoring, therapeutic response customization, and clinical trial support services. The market value includes the value of related goods sold by the service provider or included within the service offering. The gene-circuit cell therapy also includes sales of engineered therapeutic cells, synthetic gene circuit constructs, cell therapy kits, reagents, and supporting delivery systems or devices. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values and are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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