Gene Switch Market - Distribution by Application Area, Type of Target Therapy, Type of Payment Model Employed and Key Geographical Regions: Industry Trends and Global Forecasts, 2023-2035

Driven by numerous developmental breakthroughs and encouraging clinical trial results demonstrating the vast potential of adoptive cell therapies (ACT), including CAR-T cell therapies, TCR therapies, TILs and natural killer cell therapies, 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. In addition, over 1,200 cell therapies are currently being evaluated across various clinical stages of development. The recent approval of more than five CAR-T cell therapies have further fueled the interest in development of such cellular therapies. However, despite various advantages, adverse events associated with genetically modified gene and cell therapies, including neurotoxicity, cytokine release syndrome (CRS), on-target / off-tumor toxicity and graft-versus-host disease (GVHD), are some of the known limitations of such therapeutic modalities. As a result, the industry is actively seeking various tools / methods to mitigate this challenge. Among the various approaches to enhance the 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 processes) 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.

Key Market Insights

The Gene Switch Market - Distribution by Application Area (Management of Treatment Related Toxicity, Regulation of Gene Expression and Other Applications), Type of Target Therapy (CAR-T Cell Therapies, Gene Therapies and Other Therapies), Type of Payment Model Employed (Upfront Payments and Milestone Payments), and Key Geographical Regions (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, 2023-2035 report features an extensive study of the current market landscape and future opportunity for the players involved in the development of gene switch. The report answers many key questions related to this domain.

What is Gene Switching?

Gene switches are the sites on genes where regulatory molecules can bind to trigger the transcription and translational processes leading to the expression of that gene. Gene switching refers to reversible on / off switching of gene expression or switching of expression between two alleles of a gene. The expression of any gene is dependent on the rate at which it is transcribed into mRNA and translated into proteins. Certain regulatory proteins, or transcription factors, affect the transcription rate. Gene switches can be those regulatory proteins or specific DNA sequences that act to either switch on or off the expression of a gene.

What are the Applications of Gene Switch?

Gene switches, also known as suicide switches / genetic switches / safety switches / molecular switches, are important components of genetic circuits that have wide applications in synthetic biology, gene therapy, and developmental biology. Gene switch platforms are widely employed for enhancing the safety of engineered T-cell therapies by incorporating reversible ON / OFF safety switches. Currently, several studies are underway to evaluate small molecule-based safety switches for various cell-based interventions. In addition, gene switches are used for controlling the expression of transgenes in various gene therapies without the requirement of additional protein components and to enhance the effector cell proliferation and lifespan extension of activated cell therapies leading to durable patient responses to therapeutics.

What is the Current Market Landscape of Gene Switch Industry?

Presently, close to 50 industry and non-industry players are focused on the development / licensing of various types of gene switch platforms for an array of applications. The primary focus areas of these companies include management of treatment related toxicity, regulation of gene expression and other applications. The landscape features a mix of large, mid-sized and small companies. In addition, majority of the gene switch platforms are being used to mitigate the adverse events associated with CAR-T cell therapies.

What are the Upcoming Trends in the Gene Switch Market?

Many stakeholders in this domain have been making consolidated efforts to forge alliances with other industry / non-industry players for gene switch research, licensing and co-development. Moreover, this field is evolving continuously, as researchers and industry players alike aim to enhance the existing offerings in this domain. In this context, close to 150 articles focused on gene switch platforms have been published in high-impact journals, in the past five years. Furthermore, 350 patents related to gene switch platforms have been recently filed / granted, demonstrating the domain’s ongoing innovation.

What is the Global Market Size of Gene Switch Market?

The adoption of gene switch platforms to overcome the safety-related concerns associated with engineered cell therapies has increased in the recent past. The global gene switch market is anticipated to grow at an annualized growth rate (CAGR) of 14% during the period 2023-2035. It is worth highlighting that, in terms of target therapies, the gene switch market for CAR-T cell therapies is anticipated to grow at a relatively faster pace by 2035. Further, North America is anticipated to capture the major share of the gene switch market in 2035.

Who are the Key Players in the Gene Switch Market?

Examples of key players engaged in this domain (the complete list of players is available in the full report) include Autolus Therapeutics, aceRNA Technologies, Bellicum Pharmaceuticals, Kiromic Biopharma, Precigen, panCELLa and Sangamo Biosciences.

Scope of the Report

The study presents an in-depth analysis of the various firms / organizations that are engaged in this domain, across different segments.

The study presents detailed information on current market landscape and future opportunities of various stakeholders engaged in this domain. Amongst other elements, the report includes:

• An executive summary of the insights captured during our research, offering a high-level view on the current state of the gene switch market and its likely evolution in the mid-long term.
• A general overview of gene switches, highlighting details on the basic components of a gene switch and its mechanism of action. It also presents information on the applications and challenges associated with gene switches. In addition, it features a discussion on the future prospects within this domain.
• A detailed assessment of the overall market landscape of gene switch platforms, based on several relevant parameters, such as type of target gene switch (proteins, oligonucleotides, enzymes, small molecules and plasmids), switch activation (ON gene switches, OFF gene switches and ON / OFF gene switches), type of activator / repressor (small molecules, monoclonal antibodies, oligonucleotides, light, enzymes and oxygen), application area (management of treatment related toxicity, cell proliferation / cell persistence, regulation of gene expression and other applications), type of target therapies (CAR-T cell therapies, gene therapies, RNA therapies, T-cell therapies, CAR-NK cell therapies and cell therapies), highest phase of development (phase III, phase II, phase I/II, phase I and pre-clinical) and target therapeutic area (oncological disorders, immunological disorders, infectious diseases, neurological disorders and other therapeutic areas). In addition, it provides an in-depth analysis on the gene switch developers based on their year of establishment, company size (in terms of employee count), type of organization (industry and non-industry) and location of headquarters (North America, Europe and Asia-Pacific).
• A product competitiveness analysis of the gene switch platforms, based on supplier power (in terms of the experience of the developer) and product competitiveness (in terms of application area, target therapy, highest phase of development and target indication).
• Elaborate profiles of the prominent players (shortlisted based on proprietary scoring criteria) engaged in the gene switch market. Each company profile features a brief overview of the company, details related to its gene switch platform portfolio, recent developments and an informed future outlook.
• A detailed analysis of partnerships that have been inked by stakeholders engaged in this domain, since 2019, covering instances of technology licensing agreements, product development agreements, technology utilization agreements, research, development and commercialization agreements, mergers, product development and commercialization agreements, and research and development agreements. Further, the partnership activity in this domain has been analyzed based on several relevant parameters, such as year of partnership, type of partnership, application area, type of target therapy, type of partner, most active players (in terms of number of partnerships) and regional distribution of collaborations. 
• An in-depth analysis of the funding and investments that have been made into companies having proprietary gene switch platforms based on year of investment, type of funding (seed financing, venture series, initial public offering, secondary offering, grant, private placement, other equity and debt financing), type of investor, most active players and geography.
• A detailed analysis of peer-reviewed scientific articles related to research on gene switches, over the last five years, based on several relevant parameters, such as year of publication, type of article, most active publishers, most popular journals, popular focus area, most popular affiliations, and distribution by geography.
• An in-depth analysis of the patents that have been filed / granted related to gene switches, since 2017, taking into consideration several relevant parameters, such as type of patent, publication year, application year, patent jurisdiction, CPC symbols, type of applicant, patent age and leading players (in terms of number of patents filed / granted). It also features a detailed patent benchmarking analysis and an insightful patent valuation analysis, highlighting the leading patents (in terms of number of citations).
• A detailed analysis of various business models adopted by the firms developing gene switch platforms, including operational model, service centric model and product centric model.

One of the key objectives of the report was to estimate the current opportunity and the future growth potential of the gene switch market over the coming years. We have provided informed estimates on the likely evolution of the market for the period 2023-2035. Our year-wise projections of the current and forecasted opportunity have been further segmented based on relevant parameters, such as application area (management of treatment related toxicity, regulation of gene expression and other applications), type of target therapy (CAR-T cell therapies, gene therapies and other therapies), type of payment model employed (upfront payments and milestone payments) and key geographical regions (North America, Europe, Asia-Pacific And Rest of the World). In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic scenarios of the industry’s evolution.

All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What are gene switches?

Answer: Gene switches are regulatory proteins or specific DNA sequences that act to either switch on or off the expression of a gene.

Question 2: What are the applications of gene switches?

Answer: The primary applications of gene switches include management of treatment related toxicity, regulation of gene expression and cell proliferation / persistence.

Question 3: What is the likely compound annual growth rate (CAGR) of the gene switch market?

Answer: The global gene switch market is expected to grow at a CAGR of 14%, during the period 2023-2035.

Question 4: Which region captures the largest share of the gene switch market?

Answer: Currently, North America captures the largest share of the global gene switch market. Further, Asia-Pacific is likely to grow at a considerable pace during the forecasted period.

Question 5: Which type of target therapy currently accounts for the largest share in the gene switch market?

Answer: The CAR-T cell therapies segment currently captures the largest share (60%) of the overall gene switch market. This trend is unlikely to change during the forecasted period. 

Question 6: Which application area currently holds the largest share in the gene switch market?

Answer: Presently, the gene switches being used for the management of treatment related toxicity segment account for the largest share (56%) in the overall market. 

Question 7: How many patents have been filed / granted related to gene switches in recent years?

Answer: More than 360 patents have been filed / granted for gene switches by various stakeholders, since 2017, indicating an increase in research, and subsequently, the expansion of intellectual capital in this domain.