NK Cell Therapy Market on Track for Exponential Growth Amid Rising Pipeline Developments | DelveInsight
The NK cell therapy market is experiencing significant growth, driven by rising interest in immuno-oncology and advancements in cell engineering technologies. Increasing clinical trials, strategic collaborations, and regulatory support are accelerating the development of NK cell-based therapies. The market is expected to expand further with improvements in scalability, off-the-shelf availability, and enhanced efficacy against solid tumors. Key players are investing in innovative approaches, including combination therapies and gene-modified NK cells, to improve clinical outcomes.
New York, USA, Feb. 28, 2025 (GLOBE NEWSWIRE) -- NK Cell Therapy Market on Track for Exponential Growth Amid Rising Pipeline Developments | DelveInsight
The NK cell therapy market is experiencing significant growth, driven by rising interest in immuno-oncology and advancements in cell engineering technologies. Increasing clinical trials, strategic collaborations, and regulatory support are accelerating the development of NK cell-based therapies. The market is expected to expand further with improvements in scalability, off-the-shelf availability, and enhanced efficacy against solid tumors. Key players are investing in innovative approaches, including combination therapies and gene-modified NK cells, to improve clinical outcomes.
DelveInsight’s NK Cell Therapy Market Insights report includes a comprehensive understanding of current treatment practices, emerging NK cell therapy, market share of individual therapies, and current and forecasted NK cell therapy market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Key Takeaways from the NK Cell Therapy Market Report
- As per DelveInsight’s analysis, the NK cell therapy market is anticipated to grow at a significant CAGR by 2034.
- As per the DelveInsight analysis, the total number of incident cases of multiple myeloma in the US was 30,000 in 2023, which is expected to increase during the forecast period.
- Leading NK cell therapy companies such as Artiva Biotherapeutics, Glycostem, Fate Therapeutics, Indapta Therapeutics, Senti Biosciences, and others are developing novel NK cell therapies that can be available in the NK cell therapy market in the coming years.
- Some of the key NK cell therapies in the pipeline include AlloNK, oNKord, FT522, IDP-023, SENTI-202, and others.
- In April 2024, Ingenium Therapeutics announced that its investigational therapy IGNK001 (Gengluecel) has been granted Orphan Drug Designation by the US FDA for the treatment of AML.
- In May 2024, NKGen Biotech announced the publication of its Phase I interim analysis results for SNK02 for advanced solid tumors. These results will be presented at the 2024 ASCO Annual Meeting, held in Chicago from May 31 to June 4, 2024.
- In May 2024, Fate Therapeutics announced that a late-breaking abstract featuring preclinical data from its FT522 program for autoimmune diseases will be featured at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting.
Discover which therapies are expected to grab the NK cell therapy market share @ NK Cell Therapy Market Report
NK Cell Therapy Market Dynamics
The NK cell therapy market is experiencing significant momentum as it emerges as a promising avenue in cancer immunotherapy and other disease treatments. FT522, an off-the-shelf cell therapy, offers a unique therapeutic approach for autoimmune diseases by targeting CD19+ B cells and other pathogenic cell types without the need for conditioning chemotherapy.
NK cells, known for their innate cytotoxicity against tumor cells, are being increasingly explored in clinical applications, with promising trial results supporting their potential in cancer treatment. CAR NK cells further enhance this potential by enabling pre-manufacturing and storage, allowing immediate off-the-shelf use, which can improve patient access, shorten treatment timelines, and reduce therapy costs.
Furthermore, many potential therapies are being investigated, and it is safe to predict that the treatment space will significantly impact the NK cell therapy market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate is expected to drive the growth of the NK cell therapy market in the 7MM.
However, challenges remain, including the heterogeneity of NK cells affecting treatment consistency, limited clinical evidence compared to CAR-T therapies, regulatory and manufacturing complexities, and concerns regarding off-target effects and adverse events.
Moreover, NK cell therapy treatment poses a significant economic burden and disrupts patients’ overall well-being and QOL. Furthermore, the NK cell therapy market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the NK cell therapy market growth.
Despite these hurdles, the growing investment in NK cell therapy development and the progression of CAR NK therapies toward clinical use highlight substantial opportunities in this emerging field.
NK Cell Therapy Treatment Market
Natural killer (NK) cells exist in multiple subsets, and their functions can vary across different organs due to their dynamic nature. Harnessing their cytotoxic potential through therapeutic approaches like adoptive NK cell therapy and bispecific killer cell engagers (BiKEs) holds significant promise. While adoptive NK cell therapy offers a favorable safety profile, improving combination strategies by gaining deeper insights into NK cell-specific mechanisms could enhance therapeutic outcomes. For instance, integrating cytokine-induced memory-like NK cells with chimeric antigen receptor (CAR) or BiKE expression has demonstrated enhanced responses. NK cells present immense potential as innovative therapeutic agents against various diseases, including HER2-positive solid tumors, B-cell lymphoma, acute myeloid leukemia, and more.
Current clinical applications of NK cells include both autologous and allogeneic NK-cell-based therapies. To date, most clinical trials involving NK cells have primarily targeted hematologic malignancies. However, recent preclinical studies provide strong evidence supporting their evaluation in solid tumors and non-oncological conditions.
Although many strategies have centered on CAR-NK cells, their activation requires a relatively high antigen threshold. In contrast, T-cell receptor (TCR)-engineered NK cells offer distinct advantages, enabling the recognition of intracellular antigens with lower activation thresholds and eliminating the risk of receptor mispairing. Despite the promise NK cells hold in cancer therapy, challenges remain, such as their limited persistence and proliferation in vivo, which may impact their therapeutic efficacy.
Learn more about the NK cell therapy @ NK Cell Therapy Drugs
Key Emerging NK Cell Therapy and Companies
Some of the potential drugs in the pipeline include AlloNK (Artiva Biotherapeutics), oNKord (Glycostem), FT522 (Fate Therapeutics), IDP-023 (Indapta Therapeutics), SENTI-202 (Senti Biosciences), among others.
AlloNK (also known as AB-101) is an allogeneic, cryopreserved NK cell therapy candidate that is not genetically modified. It is designed to enhance the effectiveness of B-cell-targeting monoclonal antibodies, promoting B-cell depletion. As an off-the-shelf therapy, AlloNK is intended for use in combination with monoclonal antibodies and can be administered in community healthcare settings.
Currently, AlloNK combined with rituximab is being assessed in a Phase I/II clinical trial for patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The FDA has granted Fast Track designation to AlloNK in combination with rituximab or obinutuzumab for the treatment of lupus nephritis, as well as AlloNK with rituximab for relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).
Additionally, Artiva is collaborating with Affimed on a Phase II clinical trial (NCT05883449, LuminICE-203) to evaluate a combination therapy of AlloNK and the innate cell engager AFM13 for patients with relapsed or refractory CD30-positive lymphomas.
Glycostem develops innovative therapies for hematological conditions and solid tumors, with its first-generation NK cell-based immunotherapy, oNKord. This therapy was granted orphan drug designation for AML by the EMA in 2014 and the FDA in 2016. Currently, oNKord is undergoing Phase I/IIa clinical trials for acute myeloid leukemia. Glycostem envisions oNKord not only as an effective treatment for AML but also as a foundation for developing NK cell-based therapies targeting multiple myeloma, various hematological malignancies, and solid tumors such as colorectal, head and neck, lung, and breast cancers.
FT522 is an innovative, off-the-shelf CAR NK cell therapy designed to target multiple pathogenic cell types while eliminating the need for patient lympho-conditioning in the treatment of systemic autoimmune diseases. Currently, it is being evaluated in a Phase I trial for relapsed/refractory B-cell lymphoma, with plans to expand its clinical development for autoimmune disorders.
Interim results from a Phase I study (NCT05950334) indicated that FT522 led to rapid, profound, and sustained B-cell depletion in the periphery, showing improved persistence compared to an earlier generation of CD19-targeted CAR NK cells in treating relapsed/refractory B-cell lymphoma.
The anticipated launch of these emerging NK cell therapies are poised to transform the NK cell therapy market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the NK cell therapy market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about NK cell therapy clinical trials, visit @ NK Cell Therapy Treatment Drugs
NK Cell Therapy Overview
Natural Killer (NK) cell therapy is an emerging form of immunotherapy that harnesses the innate immune system to target and destroy cancer cells. Unlike T-cell therapies, NK cells do not require antigen priming, allowing them to recognize and eliminate tumor cells more rapidly. NK cells exert their cytotoxic effects through direct cell lysis, antibody-dependent cellular cytotoxicity (ADCC), and cytokine secretion, making them a versatile tool in cancer treatment. Researchers are developing various strategies to enhance NK cell therapy, including genetic modifications, cytokine activation, and combination approaches with checkpoint inhibitors or monoclonal antibodies to improve efficacy and persistence.
One of the key challenges in NK cell therapy is ensuring robust expansion, persistence, and activity within the tumor microenvironment. Autologous NK cell therapies, derived from a patient’s own cells, face issues of immune suppression, while allogeneic NK cells from healthy donors or induced pluripotent stem cells (iPSCs) offer scalability but may require engineering to enhance function and reduce the risk of rejection. Companies and research groups are exploring chimeric antigen receptor (CAR)-NK cells, which combine NK cells’ innate targeting abilities with the specificity of CAR-T therapy. As advancements in NK cell manufacturing, delivery, and in vivo persistence continue, NK cell therapy is gaining traction as a promising alternative or complement to existing immunotherapies.
NK Cell Therapy Epidemiology Segmentation
AML is one of the most common types of leukemia in adults. Still, AML is fairly rare overall, accounting for only about 1% of all cancers. AML is slightly more common among men than women, but the average lifetime risk of getting AML for both sexes is about ½ of 1%. The NK cell therapy market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
- Total Incident Cases of Selected Indications for NK Cell Therapy
- Total Eligible Patient Pool for NK Cell Therapy in Selected Indications
- Total Treated Cases in Selected Indications for NK Cell Therapy
Download the report to understand what epidemiologists are saying about NK cell therapy patient trends in 7MM @ NK Cell Therapy Patient Pool
| NK Cell Therapy Report Metrics | Details |
| Study Period | 2020–2034 |
| NK Cell Therapy Report Coverage | 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
| Key NK Cell Therapy Companies | Artiva Biotherapeutics, Glycostem, Fate Therapeutics, Indapta Therapeutics, Senti Biosciences, and others |
| Key NK Cell Therapies | AlloNK, oNKord, FT522, IDP-023, SENTI-202, and others |
Scope of the NK Cell Therapy Market Report
- NK Cell Therapy Therapeutic Assessment: NK Cell Therapy current marketed and emerging therapies
- NK Cell Therapy Market Dynamics: Conjoint Analysis of Emerging NK Cell Therapy Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL’s views, Analyst’s views, NK Cell Therapy Market Access and Reimbursement
Discover more about NK cell therapies in development @ NK Cell Therapy Clinical Trials
Table of Contents
| 1. | NK Cell Therapy Market Key Insights |
| 2. | NK Cell Therapy Market Report Introduction |
| 3. | Executive Summary of NK Cell Therapy |
| 4. | Key Events |
| 5. | NK Cell Therapy Market Forecast Methodology |
| 6. | NK Cell Therapy Market Overview at a Glance in the 7MM |
| 7. | NK Cell Therapy: Background and Overview |
| 8. | NK Cell Therapy Target Patient Pool |
| 9. | NK Cell Therapy Emerging Drugs |
| 10. | Seven Major NK Cell Therapy Market Analysis |
| 11. | NK Cell Therapy Market Access and Reimbursement |
| 12. | SWOT Analysis |
| 13. | KOL Views |
| 14. | Unmet Needs |
| 15. | Appendix |
| 16. | DelveInsight Capabilities |
| 17. | Disclaimer |
| 18. | About DelveInsight |
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