Gene Switch Market

Gene Switch / Molecular Switch Overview

The global gene switch / molecular switch market is estimated to be USD 670 million in 2023 and is anticipated to grow at a CAGR of 11.5% during the forecast period. Driven by numerous developmental breakthroughs and encouraging clinical trial results demonstrating the vast potential of adoptive cell therapy, including CAR T cell therapy, TCR therapy, TIL and natural killer cell therapy, 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 therapy products 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 therapy have further fueled the interest in development of such cellular therapies. However, despite various advantages, adverse events associated with gene therapy, 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 adoptive cell therapy, safety switch / molecular switch / gene switch / suicide switch / safety 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.  Further, we have considered the ongoing activity and existing trends in the gene switch market / molecular switch market to anticipate the global market opportunity. The molecular switch market growth is expected to directly relate to the growth in adoptive cell therapy market during the forecast period.

Key Market Insights

The Gene Switch / Molecular 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 Therapy, Gene Therapy 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 market report features an extensive analysis of the current market landscape of companies developing gene switch / molecular switch platforms, gene switch market size and likely future potential associated with the industry, during the forecast period. The research report answers many key questions related to this market.

Gene Switching, A Safety System for Adoptive Cell Therapy

Gene switch is the site 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 switch can be those regulatory proteins or specific DNA sequences that act to either switch on or off the expression of a gene.  The molecular switch have proved helpful in overcoming the adverse events witnessed with adoptive cell therapy.

Applications of Gene Switch

Gene switch, also known as suicide switch / molecular switch / safety switch / safety switch, 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, such as CAR T cell therapy, by incorporating reversible ON / OFF safety switch. Currently, several studies are underway to evaluate small molecule-based safety switches for various cell-based interventions. ,  In addition, gene switch platforms are used for controlling the expression of transgenes in various gene therapies without the requirement of additional protein components. In synthetic biology, molecular switch technologies are also used to enhance the effector cell proliferation and lifespan extension of adoptive cell therapy leading to durable patient responses in multiple indications, including breast cancer, ovarian cancer and graft-versus-host disease. ,   The multiple applications of molecular switch will drive the market growth during the forecast period.

Competitive Landscape Analysis: Molecular Switch Companies

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 gene switch / molecular switch market 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 therapy products. It is worth highlighting that several big pharma companies are also using gene switch / molecular switch for the development of safe and effective adoptive cell therapy candidates. For instance, Autolus Therapeutics uses its proprietary gene switch platforms, Rituximab Safety Switch (RQR8) and Rapamycin Safety Switch (RQR9), for the development of CAR T therapy programs against various oncological disorders. Examples of some gene switch platforms include CaspaCIDe® Safety Switch (Bellicum Pharmaceuticals), RheoSwitch Therapeutic System® (RTS®) (Precigen) and FailSafe® (panCELLa).

Partnership and Collaboration Analysis: Technology Licensing and Product Development Agreements Have Fueled Gene Switch Market Growth

Many stakeholders in this industry have been making consolidated efforts to forge alliances with other industry / non-industry players for gene switch research, licensing and co-development. It is worth highlighting that, since 2019, close to 25 strategic partnerships have been inked in the gene switch / molecular switch market. A notable example of partnership inked in 2023 includes technology licensing agreement between Autolus Therapeutics and Cabaletta Bio for the use of Autolus’ safety switch system in cell therapies for autoimmune disease. Big pharmaceutical companies are also evaluating the CAR-T switch technology, with BMS paying an undisclosed upfront amount to Autolus Therapeutics in October 2022 for access to its RQR8 safety switch for its cell therapy programs. With the rising clinical pipeline of cell therapy programs, the market is likely to witness more such collaborations, driving the gene switch market revenues during the forecast period.

Market Trends Analysis: Increase in Publications and Intellectual Property Landscape Reflect the Rising Interest in Gene Switch / Molecular Switch Market

The growing interest in gene switch market can be validated by the fact that in the last five years, close to 150 articles focused on gene switch platforms have been published in high-impact journals. Interestingly, the patent filing activity in the industry has also witnessed a growth rate of over 50%, in the last decade. Over 360 patent applications related to gene switch platforms have been recently filed / granted, demonstrating the industry’s ongoing innovation. 

Market Analysis: Global Gene Switch Market Size

The global gene switch / molecular switch market is estimated to be worth USD 670 million in 2023. Currently, the global market of gene switch is likely to be driven by two business models; the first involves the out-licensing of proprietary gene switch platforms to interested clients and the second involves product development agreements using gene switch / safety switch platforms. As the promise of gene switch platforms to develop successful safer and effective gene therapies is realized, the business models will become more collaborative in nature. The presence of big pharmaceuticals will play a major role in establishing the confidence of the industry in gene switch platforms. It is worth highlighting that, in terms of target therapies, the gene switch market for CAR T cell therapy is anticipated to grow at a relatively faster pace by 2035. The market size is expected to grow at a CAGR of 11.5% during the forecast period, mainly driven by the increasing adoption of such safety switch to overcome the safety-related concerns associated with engineered cell therapies.

Regional Analysis: North America to Hold the Largest Gene Switch Market Share

In the past few years, several well-funded start-ups / small companies, offering gene switch platforms have been established. Of these, the majority of companies are headquartered in North America. Consequently, more than 50% of the global market of gene switch / safety switch / molecular is anticipated to be captured by players based in North America, in 2035. These companies will support the drug development initiatives of adoptive cell therapy developers, generating revenues through out-licensing model.

Leading Gene Switch / Molecular Switch Companies

Examples of key gene switch companies (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. This market report also includes an easily searchable excel database of all the gene switch companies worldwide.

Recent Developments in Gene Switch Market

Several recent developments have taken place in the field of gene switches. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

• In July 2023 Pluristyx announced the closing of an equity investment and strategic partnership with Stem Genomics. Further, the companies aim to offer a unified pathway allowing customers to evaluate the genomic stability of Pluristyx’s pluripotent stem cell (PSC) lines by using Stem Genomics’ iCS-digital™ PSC assay. 
• In June 2023, Sangamo Therapeutics entered into definitive licensing agreement with Voyager Therapeutics for the potential treatment of prion diseases by using its proprietary epigenetic regulation platform and zinc finger transcriptional regulators developed by Sangamo Therapeutics. 
• In January 2023, Autolus Therapeutics announced collaboration with Cabaletta Bio for using Autolus’ Safety switch system in cell therapies for the treatment of autoimmune disease.

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 as defined in the below table:

The research report presents an in-depth analysis, highlighting the capabilities of various stakeholders in this market, across different geographies. Amongst other elements, the market 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 market.
• 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 therapy, gene therapy, RNA therapy, T-cell therapy, CAR-NK cell therapy 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 industry, 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 industry 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 this market report was to estimate the current market size, opportunity and the future growth potential of the gene switch / molecular market over the forecast period. We have provided informed estimates on the likely evolution of the market for the forecast 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 therapy, gene therapy 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 is gene switch?

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

Question 2: What is an example of a gene switch?

Answer: CaspaCIDe® Safety Switch, a proprietary platform of Bellicum Pharmaceuticals, is an example of gene switch.

Question 3: What is the purpose of molecular switch?

Answer: Gene switch platforms are widely employed for enhancing the safety of engineered T-cell therapies, such as CAR T therapy, 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 switch platforms are used for controlling the expression of transgenes in various gene therapies without the requirement of additional protein components. In synthetic biology, molecular switch technologies are also used to enhance the effector cell proliferation and lifespan extension of adoptive cell therapy leading to durable patient responses in multiple indications, including breast cancer, ovarian cancer and graft-versus-host disease.

Question 4: 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 5: 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 11.5%, during the forecast period 2023-2035.

Question 6: 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 7: Which type of target therapy currently accounts for the largest share in the gene switch market?

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

Question 8: Which application area currently holds the largest share in the gene switch market?

Answer: Presently, the gene switch being used for the management of treatment related toxicity segment account for the largest share (58%) in the overall market. 

Question 9: 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 industry.