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Market Overview

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The global NK cell therapeutics market is projected to reach $5,676 million in 2032, growing at a CAGR of 44.59% during the forecast period from 2024 to 2032. This growth can be attributed to the increasing number of clinical trials and the rising incidence and prevalence of cancer cases.

The pharmaceutical industry’s interest in cellular immunotherapy potential has been instrumental in driving the progress of the global NK cell therapeutics market. Currently, the industry is dominated by other immunotherapies such as CAR T-cell therapies, checkpoint inhibitors, and cytokines. However, the proportion of natural killer (NK) cell therapeutics is expected to increase due to their ability to address unmet medical needs, overcome limitations of existing immunotherapies, and target complex diseases. NK cell therapies offer advantages such as antigen non-specificity, easy isolation and ex vivo expansion, and low production cost.

The global NK cell therapeutics market is still in its early stages, with no approved NK cell therapy currently available. Many biopharmaceutical companies are actively researching and developing new immunotherapies, particularly NK cell therapies that can provide cost-effective next-generation treatment for cancer and other acute infectious diseases. Major players such as Affimed N.V., GC Cell (GC Biopharma corp.), Glycostem Therapeutics B.V., and Takeda Pharmaceutical Company Limited are heavily investing in clinical trials for therapeutic candidates targeting indications such as acute myeloid leukemia, B-cell non-Hodgkin’s lymphoma, hepatocellular carcinoma, and peripheral T-cell lymphoma. Increased funding and investments in research and development present significant opportunities in the global NK cell therapeutics market.

With growing global focus on researching NK cell therapies, major market players are developing novel therapeutics, including unmodified NK cells therapy, modified CAR-NK cells therapy, and NK cell engagers. Currently, there are 79 ongoing clinical trials for NK cell therapeutics targeting various indications such as acute myeloid leukemia, hematologic malignancies, hepatocellular carcinoma, and peripheral T-cell lymphoma.

Countries such as the U.S., the U.K., and South Korea are at the forefront of immunotherapy research. The presence of major market players in these countries, including Affimed N.V., Fate Therapeutics, Inc., Gamida Cell Ltd., GC Cell (GC Biopharma corp.), Nkarta, Inc., Sanofi S.A., and Takeda Pharmaceutical Company Limited, positively impacts the market growth.

However, the COVID-19 pandemic has significantly affected the research and clinical development of NK cell therapeutics. Lockdowns imposed by governments worldwide have hampered the progress of clinical trials and patient recruitment. As a result, the launch timelines of drugs have been impacted. Nevertheless, with the easing of restrictions after Q2 2021, the NK cell therapy market has regained momentum and is expected to grow during the forecast period from 2024 to 2032.

The COVID-19 pandemic has put immense strain on the research and clinical development of NK cell therapeutics. To contribute to the global effort against COVID-19, companies in the field of NK cell therapies have shifted their focus to developing drugs for COVID-19 treatment. This has led to delays in the launch of emerging therapies and diversion of financial resources towards COVID-19 drug development. These factors have collectively affected the development and launch of emerging NK therapies.

For example, Affimed N.V. faced challenges in patient enrollment for the investigation of AFM13 therapy due to the COVID-19 pandemic and decided to halt the trial for patients with transformed mycosis fungoides. Celularity Inc. also encountered difficulties in patient enrollment for its phase 1 clinical trial of CYNK-001 in acute myeloid leukemia. Nkarta, Inc. experienced enrollment restrictions for its clinical trials, and supply chain disruptions led to delays in gathering clinical sites for the trials of NKX101 and NKX019.

In terms of demand drivers, the global NK cell therapeutics market is fueled by the increasing number of clinical trials and the rising incidence and prevalence of cancer. However, the market also faces limitations such as the lack of specificity and poor in vivo survival of NK cells, as well as the high cost associated with immunotherapy treatment for cancer.

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Market Segmentation

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The market is segmented based on various factors, including therapy type, pipeline products, indication, and region.

Segmentation by Therapy Type
NK Cell Therapy (Unmodified)
CAR-NK Cell Therapy (Modified)
NK Cell Engagers

Segmentation by Pipeline Products
AFM13
MG4101
GTA002 (oNKordA)
TAK-007

Segmentation by Indication
Acute Myeloid Leukemia
Relapsed or Refractory (r/r) B-cell Non-Hodgkin’s Lymphoma (NHL)
Hepatocellular Carcinoma
Peripheral T-Cell Lymphoma

Segmentation by Region
U.S.
U.K
France
Spain
Italy
Germany
Japan
South Korea

The global NK cell therapeutics market is projected to be dominated by the NK cell therapy (unmodified) segment, which is expected to hold a share of 57.82% during the forecast period. This segment consists of pipeline NK cell therapeutics derived from allogenic or off-the-shelf cancer-killing immunotherapy, readily available from cord blood supplies. The market for NK cell therapeutics is categorized into three major segments: NK cell therapy (unmodified), CAR-NK cell therapy (modified), and NK cell engagers. However, the NK cell therapy (unmodified) segment is anticipated to dominate the market due to its inclusiveness of pipeline NK cell therapeutics utilizing allogenic or off-the-shelf cancer-killing immunotherapy, with no approved NK cell therapies made from allogeneic preparation currently available.

In 2032, MG4101 is expected to dominate the global NK cell therapeutics market, holding a 36.35% share, followed by TAK-007 with a market share of 24.20%. The global NK cell therapeutics market is projected to reach $5,676.1 million in 2032, exhibiting a CAGR of 44.59% during the forecast period of 2024-2032. The market includes four candidates: AFM13, MG4101, GTA002 (oNKordA), and TAK-007. Over the past three decades, NK cell therapeutics have gained recognition for their potential in addressing unmet medical needs and becoming a significant treatment option alongside or even surpassing other immunotherapies such as CAR T-cell therapy or checkpoint inhibitors.

The B-cell non-Hodgkin’s lymphoma – relapsed or refractory segment is expected to dominate the global NK cell therapeutics market in 2032, primarily due to the increasing number of B-cell lymphoma patients and the high unmet needs in this area. The global NK cell therapeutics market is categorized by indication into hepatocellular carcinoma (HCC), acute myeloid leukemia (AML), relapsed or refractory (r/r) B-cell non-Hodgkin’s lymphoma (NHL), and peripheral T-cell lymphoma (PTCL).

In 2024, the U.S. NK cell therapeutics market is estimated to be valued at $232 million and is projected to be the leading contributor to market growth, driven by increased research and development activities in the country. North America is anticipated to dominate the global NK cell therapeutics market by region during the forecast period, holding the largest share of 56.97%, followed by Europe with 30.80%.

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Competitive Landscape

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The selection of profiled companies is based on inputs obtained from primary experts, as well as an analysis of their company coverage, pipeline product portfolio, and market penetration.

Key companies profiled in this report include Affimed N.V., Century Therapeutics, Inc., Celularity Inc., Cytovac A/S, Dragonfly Therapeutics, Inc., Fate Therapeutics, Inc. , Gamida Cell Ltd., GC Cell (GC Biopharma corp.) , Glycostem Therapeutics B.V., ImmunityBio, Inc., Innate Pharma SA , Nkarta, Inc., Sanofi S.A., Takeda Pharmaceutical Company Limited , VaxCell Biotherapeutics Co., Ltd., Acepodia Inc., iCell Gene Therapeutics, Senti Biosciences, Shoreline Biosciences.

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Recent Industry Developments

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Affimed N.V. announced in April 2022 the findings of a dose-escalation study for its innate cell engager AFM24, which was conducted on patients with EGFR-positive solid tumors. The data revealed a well-managed safety profile for AFM24.

In April 2022, Nkarta, Inc. released positive preliminary data from phase 1 of their two cell therapy candidates, NKX101 and NKX019, which belong to the chimeric antigen receptor (CAR) natural killer (NK) cell therapy approach. The study demonstrated the safety advantages of using NK cells as an off-the-shelf modality, designed to enhance the benefits of cell therapy.

Affimed N.V. completed participant enrollment in January 2022 for a phase 2 study of its lead product AFM13 as a monotherapy for patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL).

In December 2021, Innate Pharma SA announced that the first patient had received treatment in a phase 1/2 clinical trial of IPH6101/SAR443579. This leading molecular target for NK cells focuses on NKp46/CD16 and is being tested in patients with chronic myelogenous leukemia (CRML), B-cell acute lymphoblastic leukemia (B-ALL), or high-risk myelodysplastic syndrome (HR-MDS). The trial is being conducted in collaboration with Sanofi S.A.

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Key Questions Answered

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What are the types of NK cell therapies and their applications?

What is the mechanism of action of NK cells?

What are the major drivers, challenges, and opportunities in the global NK cell therapeutics market?

What are the underlying factors contributing to emerging trends in the global NK cell therapeutics market?

How has the COVID-19 pandemic affected the global NK cell therapeutics market?

What are the key development strategies being implemented by major players to maintain competitiveness in the market?

What are the pricing and reimbursement scenarios in the field of NK cell therapeutics?

What are the regulatory implications in major regions regarding NK cell therapeutics?

What potential entry barriers would companies face when entering a specific country?

How is each segment of the market expected to grow from 2024 to 2032?

What revenue is anticipated for therapy type, indications, pipeline products, and countries?

What growth opportunities exist for companies operating in their respective countries?

Who are the leading players with significant offerings in the global NK cell therapeutics market?

Which companies are expected to be highly disruptive in the future and why?