Gene Switch Market-Distribution by Application Area (Management of Treatment Related Toxicity, Regulation of Gene Expression & Others), Type of Target Therapy & Payment Model Employed, Industry Trends & 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.

SCOPE OF THE REPORT

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 Domain?

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.

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.

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:

Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts' views

While the focus has been on forecasting the market till 2035, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

KEY QUESTIONS ANSWERED

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.

CHAPTER OUTLINES

Chapter 1 is a preface providing an introduction to the full report, Gene Switch Market, 2023-2035.
Chapter 2 is an executive summary of the key insights captured in our report. It offers a high-level view on the likely evolution of the gene switch market in the short to mid-term, and long term.
Chapter 3 provides a general overview of gene switch, highlighting details on its basic components and mechanism of action. Further, it presents detailed information on applications of gene switch. Additionally, it features a discussion on the future prospects within this domain.
Chapter 4 includes information of around 50 gene switch platforms currently available. The chapter features an elaborate analysis 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), 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 details on the gene switch platform developers, along with analysis 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).
Chapter 5 presents 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).
Chapter 6 features detailed profiles of the prominent gene switch developers (shortlisted based on proprietary scoring criteria). 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.
Chapter 7 features an analysis of the various collaborations and partnerships inked between stakeholders engaged in this domain, since 2018. Further, the partnership activity in this domain has been analyzed based on various parameters, such as year of partnership, type of partnership (technology licensing agreements, product development agreements, technology utilization agreements, research, development and commercialization agreements, merger agreements, product development and commercialization agreements and research and development agreements), application area (management of treatment related toxicity, regulation of gene expression and other applications), type of target therapy (CAR-T cell therapies, gene therapies, mRNA therapies, stem cell therapies and other therapies), type of partner (industry and non-industry), most active players (in terms of number of partnerships inked) and regional distribution (continent and country-wise) of partnership activity.
Chapter 8 provides details on the various investments and grants that have been awarded to players focused on gene switch development. It includes a detailed analysis of the funding instances that have taken place during the period 2019 to 2023 (till January), highlighting the growing interest of venture capital (VC) community and other strategic investors in this domain.
Chapter 9 features a detailed review of peer-reviewed, scientific articles related to research on gene switch on the basis of several relevant parameters, such as year of publication, type of article, most active publisher, emerging focus areas, active affiliated institutes and geography. The chapter also highlights the top journals (in terms of number of articles published and impact factor).
Chapter 10 provides an insightful analysis of the patents that have been filed / granted related to gene switch, since 2019, 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 patent benchmarking analysis and a detailed patent characteristics and patent valuation analysis.
Chapter 11 presents a business model analysis to understand the operational model adopted by the firms developing gene switch platforms, including service centric model and product centric model.
Chapter 12 features a comprehensive market forecast analysis, highlighting the likely growth of the gene switch market, till 2035. We have segregated the current and future opportunity based on 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).
Chapter 13 summarizes the entire report. It presents the key takeaways from the report and expresses our independent opinion of the gene switch market, based on the research and analysis described in the previous chapters.
Chapter 14 is an appendix, which contains tabulated data and numbers for all the figures included in this report.
Chapter 15 is an appendix, which contains a list of companies and organizations mentioned in this report.

Product Code: RA100428

1. PREFACE

1.1. Introduction
1.2. Key Market Insights
1.3. Scope of the Report
1.4. Research Methodology
1.5. Key Questions Answered
1.6. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

3.1. Chapter Overview
3.2. Emergence of Gene Switch
- 3.2.1. Basic Components of Gene Switch
- 3.2.2. Mechanism of Action of Gene Switch
- 3.2.3. Type of Gene Regulation
3.3. Applications of Gene Switch
- 3.3.1. Endogenous Gene Regulation
- 3.3.2. Exogenous Gene Regulation
3.4. Challenges Associated with Gene Switch
3.5. Concluding Remarks

4. MARKET LANDSCAPE

4.1. Chapter Overview
4.2. Gene Switch Platforms: Overall Market Landscape
- 4.2.1. Analysis by Type of Target Gene Switch
- 4.2.2. Analysis by Switch Activation
- 4.2.3. Analysis by Type of Activator / Repressor
- 4.2.4. Analysis by Application Area
- 4.2.5. Analysis by Type of Target Therapies
- 4.2.6. Analysis by Highest Phase of Development
- 4.2.7. Analysis by Target Therapeutic Area
4.3. Gene Switch Platform Developers: Developer Landscape
- 4.3.1. Analysis by Year of Establishment
- 4.3.2. Analysis by Company Size
- 4.3.3. Analysis by Type of Organization
- 4.3.4. Analysis by Location of Headquarters

5. PRODUCT COMPETITIVENESS ANALYSIS

5.1. Chapter Overview
5.2. Assumptions and Key Parameters
5.3. Methodology
5.4. Product Competitiveness Analysis: Gene Switch Platforms

6. COMPANY PROFILES

6.1. Chapter Overview
6.2. aceRNA Technologies
- 6.2.1. Company Overview
- 6.2.2. Gene Switch Platform Portfolio
- 6.2.3. Recent Developments and Future Outlook
6.3. Autolus Therapeutics
- 6.3.1. Company Overview
- 6.3.2. Gene Switch Platform Portfolio
- 6.3.3. Recent Developments and Future Outlook
6.4. Bellicum Pharmaceuticals
- 6.4.1. Company Overview
- 6.4.2. Gene Switch Platform Portfolio
- 6.4.3. Recent Developments and Future Outlook
6.5. Cellectis
- 6.5.1. Company Overview
- 6.5.2. Gene Switch Platform Portfolio
- 6.5.3. Recent Developments and Future Outlook
6.6. Kiromic BioPharma
- 6.6.1. Company Overview
- 6.6.2. Gene Switch Platform Portfolio
- 6.6.3. Recent Developments and Future Outlook
6.7. panCELLa
- 6.7.1. Company Overview
- 6.7.2. Gene Switch Platform Portfolio
- 6.7.3. Recent Developments and Future Outlook
6.8. Precigen
- 6.8.1. Company Overview
- 6.8.2. Gene Switch Platform Portfolio
- 6.8.3. Recent Developments and Future Outlook
6.9. Sana Biotechnology
- 6.9.1. Company Overview
- 6.9.2. Gene Switch Platform Portfolio
- 6.9.3. Recent Developments and Future Outlook
6.10. Sangamo Therapeutics
- 6.10.1. Company Overview
- 6.10.2. Gene Switch Platform Portfolio
- 6.10.3. Recent Developments and Future Outlook

7. PARTNERSHIPS AND COLLABORATIONS

7.1. Chapter Overview
7.2. Partnership Models
7.3. Gene Switch Platforms: Partnerships and Collaborations
- 7.3.1. Analysis by Year of Partnership
- 7.3.2. Analysis by Type of Partnership
- 7.3.3. Analysis by Application Area
- 7.3.4. Analysis by Year of Partnership and Application Area
- 7.3.5. Analysis by Type of Target Therapy
- 7.3.6. Analysis by Type of Partner
- 7.3.7. Most Active Players: Analysis by Number of Partnerships
- 7.3.8. Analysis by Geography
  - 7.3.8.1 Intercontinental and Intracontinental Agreements
  - 7.3.8.2 International and Local Agreements

8. FUNDING AND INVESTMENT ANALYSIS

8.1. Chapter Overview
8.2. Type of Funding
8.3. Gene Switch Platforms: Funding and Investments Analysis
- 8.3.1. Analysis of Instances by Year of Investment
- 8.3.2. Analysis of Amount Invested by Year of Investment
- 8.3.3. Analysis of Instances by Type of Funding
- 8.3.5. Analysis of Amount Invested by Type of Funding
- 8.3.6. Analysis of Instances by Type of Investor
- 8.3.7. Most Active Players: Analysis by Number of Instances
- 8.3.8. Most Active Players: Analysis by Amount Invested
- 8.3.9. Analysis of Amount Invested by Geography
  - 8.3.9.1. Analysis by Region
  - 8.3.9.2. Analysis by Country

9. PUBLICATION ANALYSIS

9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Gene Switch Platforms: Recent Publications
- 9.3.1. Analysis by Year of Publication
- 9.3.2. Analysis by Type of Article
- 9.3.3. Most Active Publishers: Analysis by Number of Publications
- 9.3.4. Most Popular Journals: Analysis by Number of Publications
- 9.3.5. Analysis by Journal Impact Factor
- 9.3.6. Most Popular Journals: Analysis of Journal Impact Factor
- 9.3.7. Analysis by Key Focus Areas
- 9.3.8. Analysis by Affiliated Organization of Author
- 9.3.9. Most Popular Affiliation: Analysis by Number of Publications
- 9.3.10. Analysis by Geography

10. PATENT ANALYSIS

10.1. Chapter Overview
10.2. Scope and Methodology
10.3. Gene Switch Platforms: Patent Analysis
- 10.3.1. Analysis by Patent Publication Year
- 10.3.2. Analysis by Patent Application Year
- 10.3.3. Analysis by Annual Number of Granted Patents and Patent Applications
- 10.3.4. Analysis by Patent Jurisdiction
- 10.3.5. Analysis by CPC Symbols
- 10.3.6. Analysis by Type of Applicant
- 10.3.7. Leading Industry Players: Analysis by Number of Patents
- 10.3.8. Leading Non-Industry Players: Analysis by Number of Patents
- 10.3.9. Leading Individual Assignees: Analysis by Number of Patents
10.4. Gene Switch Platforms: Patent Benchmarking Analysis
- 10.4.1. Analysis by Patent Characteristics
10.5. Gene Switch Platforms: Patent Valuation
10.6. Leading Patents: Analysis by Number of Citations

11. BUSINESS MODEL ANALYSIS

11.1. Chapter Overview
11.2. Gene Switch Platform Developers: Business Model Analysis
- 11.2.1. Analysis by Operational Model
- 11.2.2. Analysis by Service Centric Model
- 11.2.3. Analysis by Product Centric Model
11.3. Concluding Remarks

12. MARKET FORECAST AND OPPORTUNITY ANALYSIS

12.1. Chapter Overview
12.2. Key Assumptions and Forecast Methodology
12.3. Global Gene Switch Platform Market, 2023-2035
- 12.3.1. Gene Switch Platform Market: Analysis by Application Area, 2023 and 2035
  - 12.3.1.1. Gene Switch Market for Management of Treatment Related Toxicity, 2023-2035
  - 12.3.1.2. Gene Switch Market for Regulation of Gene Expression, 2023-2035
  - 12.3.1.3. Gene Switch Market for Other Applications, 2023-2035
- 12.3.2. Gene Switch Platform Market: Analysis by Type of Target Therapy, 2023 and 2035
  - 12.3.2.1 Gene Switch Platform Market for CAR-T Cell Therapies, 2023-2035
  - 12.3.2.2 Gene Switch Platform Market for Gene Therapies, 2023-2035
  - 12.3.2.3 Gene Switch Platform Market for Other Therapies, 2023-2035
- 12.3.3. Gene Switch Platform Market: Analysis by Type of Payment Model Employed, 2023 and 2035
  - 12.3.3.1. Gene Switch Platform Market for Upfront Payments, 2023-2035
  - 12.3.3.2. Gene Switch Platform Market for Milestone Payments, 2023-2035
- 12.3.4. Gene Switch Platform Market: Analysis by Geography, 2023 and 2035
  - 12.3.4.1. Gene Switch Platform Market in North America, 2023-2035
  - 12.3.4.2. Gene Switch Platform Market in Europe, 2023-2035
  - 12.3.4.3. Gene Switch Platform Market in Asia Pacific, 2023-2035
  - 12.3.4.4. Gene Switch Platform Market in Rest of the World, 2023-2035

13. CONCLUDING REMARKS

14. APPENDIX 1: TABULATED DATA

15. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS