The global engineered T cells market size was estimated at USD 26.87 billion in 2023 and is projected to hit around USD 348.9 billion by 2032, growing at a CAGR of 32.96% from 2023 to 2032. The engineered T cells market lies in the remarkable advancements achieved through strategies like CAR-T cell therapy and TCR-T cell therapy in clinical trials globally.

Market Overview

The engineered T cells market is experiencing rapid growth, driven by advancements in immune cell engineering targeting cancer. Commercial products like chimeric-antigen receptor (CAR) T cells have gained approval for hematologic malignancies, marking a significant milestone in this field. CAR T cells are produced by isolating T cells from patients and modifying them in the laboratory to express chimeric antigen receptors (CARs) on their surface. These receptors are designed to recognize and bind to specific proteins (antigens) present on cancer cells. With a growing number of CAR T-cell therapies undergoing development and clinical testing, the market landscape is evolving dynamically.

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Variations among specific therapies that can influence their efficacy, they generally share common components. Each CAR consists of extracellular domains, typically fragments of lab-made antibodies, which determine the receptor’s ability to recognize and bind to tumor antigens. Additionally, internal signaling and co-stimulatory domains within the CAR facilitate cellular activation and tumor cell destruction. The strategic modification of T cells, including CAR T cell therapy and T cell receptor (TCR) T cell therapy, has significantly advanced the treatment of malignant tumors. T cells play a pivotal role in cell-mediated immunity, making them an attractive target for genetic modification. As these therapies continue to demonstrate clinical efficacy and safety, the engineered T cells market is poised for continued expansion, offering promising avenues for cancer treatment.

• In January 2022, Immunocore announced FDA approval of KIMMTRAK (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma
• In February 2024, BioNTech and A utolus announced a strategic alliance aimed at strengthening their CAR-T cell pipeline

Key Insights

• North America is projected to have a highest market share during the forecast period.
• By Type, the chimeric antigen receptor (CAR) modified T cells segment generated over 78% of revenue share in 2022.
• By End-user, the hospitals segment registered the maximum market share of 58% in 2022.
• By Application, the lung cancer segment is expected to captured the biggest revenue share over the forecast period.

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Regional Stance

North America dominated the engineered T cells market and is poised to maintain this position in the foreseeable future. Canada, in particular, emerges as a robust center for CAR-T manufacturing, boasting a comprehensive array of capabilities spanning upstream and downstream processing, automated systems, closed system bioreactors, and unwavering commitment to regulatory compliance. The nation’s collaborative ethos, combined with a focus on sustainability, positions Canada as a global leader in cellular therapy, offering clients a dependable and innovative partner for the development and production of advanced CAR-T therapies. Canada’s dedication to sustainability is evident in its CAR-T manufacturing practices, with facilities prioritizing environmentally conscious approaches and integrating green technologies to minimize waste in alignment with evolving sustainability standards.

In Mexico, CAR T-cell therapy presents a cost-effective alternative compared to some other countries. The country’s proximity to the United States and Canada facilitates convenient travel options for patients seeking CAR T-cell therapy, ensuring easier access to treatment without significant logistical hurdles. However, it’s crucial to acknowledge that the accessibility and affordability of CAR T-cell therapy may vary based on individual circumstances. Hence, consulting with medical professionals and the specialized team at institutions like the Immunotherapy Institute is recommended to understand the specifics of accessing and financing CAR T-cell therapy in Mexico. Mexico’s burgeoning reputation as a destination for medical tourism, particularly for advanced treatments like CAR T-cell therapy, underscores its significant strides in medical infrastructure and expertise. Specialized centers such as the Immunotherapy Institute offer top-notch medical facilities, cutting-edge treatments, and personalized care, cementing Mexico’s position as a preferred choice for international patients seeking advanced healthcare solutions.

• In February 2024, Astellas and Kelonia Therapeutics entered into a research and license agreement to develop novel immuno-oncology therapeutics.
• In December 2023, the FDA granted priority review to Amgen’s Tarlatamab application for advanced small cell lung cancer.

The Asia Pacific region is poised to experience rapid growth in the engineered T cells market, emerging as the fastest-growing region during the forecasted period. In India, the landscape of cancer treatment has evolved significantly, transcending conventional methods like surgery, chemotherapy, and radiation therapy. The focus has shifted towards targeted therapies, which are specifically tailored to combat cancer cells by targeting unique molecular changes within these cells. Among the array of targeted therapies, CAR T-cell therapy has emerged as a notable contender, garnering considerable attention from researchers and oncologists in India. While immune checkpoint inhibitors have been more extensively utilized, CAR T-cell therapies have showcased remarkable efficacy in eliminating advanced leukemias and lymphomas, thereby offering prolonged remission for numerous patients.

This burgeoning interest in CAR T-cell therapy reflects India’s commitment to embracing innovative approaches in cancer treatment. With a growing emphasis on precision medicine and personalized therapies, the country is witnessing a paradigm shift towards adopting cutting-edge immunotherapies to combat cancer effectively. The dynamic landscape of cancer treatment in India, characterized by advancements in targeted therapies and the increasing adoption of CAR T-cell therapy, underscores the region’s potential as a significant growth hub in the engineered T cells market. As research and development efforts continue to flourish, India is poised to play a pivotal role in shaping the future of cancer immunotherapy within the Asia Pacific region and beyond.

• In October 2023, India’s equivalent to the US Food and Drug Administration, the Central Drugs Standard Control Organization, granted approval to NexCAR19, marking India’s first approved CAR-T cell therapy. The approval was granted based on findings from two small clinical trials conducted in India involving 64 individuals with advanced lymphoma or leukaemia.

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Report Highlights

The engineered T cells market is anticipated to be dominated by the segment of chimeric antigen receptor (CAR) modified T cells throughout the predicted period. CAR T-cell therapy represents a groundbreaking advancement in cancer treatment, offering a potent tool for combating the disease. CAR T therapy begins with the extraction of a patient’s immune cells, which are then genetically modified to recognize the patient’s own tumor cells. Subsequently, these re-engineered cells are reintroduced into the patient’s body in substantial quantities through adoptive cell transfer. This personalized approach enables the modified T cells to specifically target and eliminate cancer cells. The therapy has demonstrated remarkable efficacy, particularly in patients with certain types of advanced cancers such as acute lymphoblastic leukemia (ALL) and lymphoma, both in pediatric and adult populations. However, it’s essential to note that the personalized nature of CAR T therapy necessitates significant infrastructure and expertise to ensure safe and successful treatment delivery.

Given its transformative potential in cancer care, CAR T-cell therapy is poised to drive substantial growth in the engineered T cells market. As healthcare providers continue to invest in infrastructure and expertise to support the delivery of CAR T therapy, the market is expected to witness sustained expansion, offering renewed hope to patients battling advanced cancer worldwide.

• In April 2024, Ginkgo Bioworks acquired Modulus Therapeutics’ cell therapy assets in order to enhance next-generation CAR designs

The T cell receptor (TCR) modified T cells segment is poised for significant growth in the engineered T cells market during the forecast period. TCR-T therapy represents a promising avenue in cellular immunotherapy for cancer treatment, offering advantages such as independence from the surface antigen expression limitations of target cells. The therapy’s potential in treating solid tumors has piqued researchers’ interest, building on significant advancements in hematologic malignancies treatment. However, while TCR-T cell immunotherapy has shown promise in hematological cancers, its overall efficacy in solid tumors has been comparatively lower.

Key steps in TCR-T cell therapy include patient screening, leukapheresis for cell collection, generation of transduced TCR products, lymphodepletion to enhance therapeutic efficacy, and infusion of the TCR-based adoptive therapy. The success of this process relies on careful patient selection, identification of suitable tumor targets, and rigorous clinical management. As research continues to refine TCR-T cell therapy and address its challenges, the segment is anticipated to witness significant growth in the engineered T cells market. Investments in innovation and clinical development aimed at enhancing the therapy’s efficacy and accessibility are expected to drive its adoption in cancer treatment, offering new hope to patients battling solid tumors globally.

• In June 2023, CERo Therapeutics, Inc. and Phoenix Biotech Acquisition Corp. announced a merger agreement to form a public company focused on advancing next-generation engineered T cell therapeutics

By Application

The lung cancer segment is poised to dominate the engineered T cells market during the forecasted period. Lung cancer stands as one of the most prevalent cancers globally and is the leading cause of cancer-related mortality. Traditional treatment modalities such as surgery, chemotherapy, radiotherapy, and targeted therapy have long been the mainstays of lung cancer treatment. The emergence of chimeric antigen receptor (CAR)-T cell immunotherapy represents a paradigm shift, offering a novel approach and renewed hope in the fight against lung cancer. However, leveraging CAR-T cell therapy for eradicating solid tumors presents significant challenges. CAR-T cells, a groundbreaking adoptive immunotherapy strategy, have demonstrated success in hematological tumors and are now paving the way for innovative immunotherapy approaches in solid tumors, including lung cancer. Nevertheless, the complexity of targeting lung cancer-specific antigens using engineered CAR-T cells is underscored by several obstacles.

The breast cancer segment is projected to experience rapid growth in the engineered T cells market during the forecast period. Globally, breast cancer accounts for a significant disease burden, with millions of women diagnosed and a substantial number of deaths reported annually. As the most commonly diagnosed cancer in women and the second leading cause of cancer-related death, breast cancer presents a critical healthcare challenge. Chimeric antigen receptor (CAR) T cell therapy emerges as a promising immunotherapeutic approach developed from adoptive T cell transfer. This innovative therapy harnesses patients’ own immune cells to target and destroy cancer cells. CAR-T cells are equipped with specific antibodies that recognize antigens present on tumor cells, triggering cytotoxic effects to eliminate them.

As research and development efforts continue to advance, and clinical trials progress, CAR-T cell therapy holds immense potential to transform the landscape of breast cancer treatment. Its application underscores the importance of personalized medicine and innovative immunotherapeutic approaches in addressing the complexities of breast cancer management, ultimately offering new hope for patients and driving growth in the engineered T cells market.

The hospitals segment is projected to maintain dominance in the engineered T cells market throughout the forecast period. CAR T cell therapy, a cutting-edge cancer immunotherapy treatment, relies heavily on hospital settings for its delivery and administration. CAR T cell therapy involves the genetic modification of T cells in a laboratory setting, enhancing their ability to locate and destroy cancer cells with greater precision and efficacy. Hospitals serve as the primary infrastructure for conducting these complex procedures, providing the necessary expertise, facilities, and resources for the successful implementation of CAR T cell therapy.

Hospitals serve as the primary point of care for cancer patients, making them the natural choice for the administration of CAR T cell therapy. Their established infrastructure, advanced medical technologies, and comprehensive healthcare services make hospitals the preferred end-use setting for patients seeking innovative cancer treatments like CAR T cell therapy. As hospitals continue to invest in expanding their capabilities and expertise in cellular immunotherapy, they are poised to drive significant growth in the engineered T cells market. Their central role in delivering CAR T cell therapy underscores their importance as key stakeholders in advancing cancer care and improving patient outcomes.

The cancer research centers segment is poised for attractive growth in the engineered T cells market during the forecast period. CAR T-cell therapy, an innovative treatment approach, represents a significant advancement in cancer care by harnessing the body’s immune system to target and eliminate cancer cells. Cancer cells possess mechanisms to evade the immune system, but CAR T-cell therapy reprograms the body’s defenses to recognize and attack these malignant cells effectively. This therapy holds promise for patients with various types of blood cancer, offering a potential lifeline for those with relapsed or refractory non-Hodgkin lymphoma, multiple myeloma, and B-cell acute lymphoblastic leukemia (ALL).

These specialized cancer research centers serve as the primary hubs for CAR T-cell therapy delivery, offering comprehensive clinical care, state-of-the-art facilities, and a multidisciplinary team of experts trained in cellular immunotherapy. Their advanced capabilities and focus on research and development make them ideal settings for patients seeking access to innovative treatments like CAR T-cell therapy. As cancer research centers continue to expand their expertise and infrastructure in cellular therapies, they are positioned to drive growth in the engineered T cells market. Their role in advancing the field of cancer immunotherapy underscores their importance as key stakeholders in shaping the future of cancer care and improving outcomes for patients worldwide.

Market Dynamics

Driver

Rapid Treatment Time and Enhanced Recovery

The accelerated treatment timeline and improved recovery associated with CAR T-cell therapy are emerging as key drivers shaping the engineered T cells market. Unlike traditional stem cell transplants that necessitate aggressive chemotherapy, CAR T-cell therapy offers a streamlined approach with a single infusion, typically requiring only up to two weeks of inpatient care. This efficiency not only minimizes treatment duration but also facilitates a quicker patient recovery compared to stem cell transplants. As a result, CAR T-cell therapy holds the potential to eventually replace conventional transplants in certain scenarios. Currently approved for patients for whom transplant is unlikely to provide a cure or for those who relapse post-transplant, CAR T-cell therapy’s effectiveness and streamlined administration are fueling its adoption, thus propelling growth in the engineered T cells market.

• In April 2023, BioNTech and DualityBio formed a global strategic partnership to accelerate the development of antibody-drug conjugate therapeutics for solid tumors.

Restraint

Risk of Infections and Uncertainty Surrounding Long-Term Effects

The engineered T cells market faces constraints due to the heightened risk of infections associated with CAR-T cell therapy, particularly in the initial weeks post-treatment when the immune system is intensely engaged in combating cancer. Individuals with compromised white blood cell counts are particularly susceptible to infections and require vigilant monitoring for symptoms such as fever, chills, and general malaise. Furthermore, the nascent stage of CAR-T cell therapy limits its widespread adoption, as healthcare professionals remain uncertain about its full spectrum of long-term side effects. This uncertainty poses a restraint on market growth, underscoring the need for continued research and monitoring to better understand the safety profile of CAR-T cell therapy.

Opportunity

Innovative CAR-T Cell Therapeutic Designs

Advanced technologies and computational tools are driving opportunities in the engineered T cells market, particularly in the realm of chimeric antigen receptor (CAR) T-cell therapy. With the success of CAR-T cell therapy in treating hematological malignancies, evidenced by FDA approval of six CAR-T cell products, the stage is set for further advancements in oncology treatment. Despite obstacles hindering widespread adoption, innovative CAR-T cell therapeutic designs are emerging from preclinical and clinical trials, showcasing significant potential for development. This evolving landscape presents a ripe opportunity for growth in the engineered T cells market, as the discovery of optimal targets, novel CAR binding domains, and predictive biomarkers promises to revolutionize cancer therapy akin to the advent of synthetic pharmaceuticals with arsphenamine.

• In February 2024, BioNTech and Autolus announced a strategic collaboration on CAR-T cell therapy to advance their pipeline and expand late-stage programs

Recent Developments

• In December 2023, Shinobi Therapeutics launches after completing a $51M Series A funding round to further develop its hypoimmune iPS-T cell therapy platform Source:
• In March 2023, Adaptimmune Therapeutics plc and TCR² Therapeutics Inc. announced a definitive agreement to merge in an all-stock transaction, creating a leading cell therapy company focused on treating solid tumors
• In January 2024, Adaptimmune announced that the U.S. FDA had accepted the Biologics License Application for Afami-cel, prioritizing its review for the treatment of advanced synovial sarcoma

Key Players in the Engineered T Cells Market

• Amgen Inc
• Bellicum Pharmaceuticals Inc.
• Bristol-Myers Squibb
• Precision Biosciences Inc.
• Eli Lilly And Company
• Gilead Sciences, Inc.
• Novartis Ag
• AthenexInc
• Oxford BiomedicaPlc
• Pfizer Inc.

Market Segmentation

• By Type
  • Chimeric Antigen Receptor (CAR) Modified T Cells
  • T Cells Receptor (TCR) Modified T Cells
  • Tumor Infiltrating Lymphocytes
• By Application
  • Lung Cancer
  • Colorectal Cancer
  • Melanoma
  • Breast Cancer
  • Leukemia
• By End-user
  • Hospitals
  • Cancer Research Centers
  • Clinics
• By Geography
  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa

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