According to DelveInsight’s analysis, the growth of the NRG Fusion market is expected to be mainly driven by the expected launch of various emerging therapies, including zenocutuzumab, HMBD-001, JK07, and others along with increased awareness and incorporation of NRG fusion detection testing in clinical practice.
LAS VEGAS, Sept. 2, 2024 /PRNewswire/ — DelveInsight’s NRG Fusion Market Insights report includes a comprehensive understanding of current treatment practices, emerging NRG fusion, market share of individual therapies, and current and forecasted NRG fusion 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 NRG Fusion Market Report
- As per DelveInsight’s analysis, the total market size of NRG fusion in the 7MM is expected to rise significantly by 2034 owing to the first expected approval of Merus’ Zenocutuzumab by 2025 in the US resulting in more adoption of NRG fusion testing.
- Biomarker testing for NRG1 fusions is not routinely followed, therefore, the testing rate remains low currently, which is expected to increase post-launch of the first targeted therapy.
- The NRG1 rare fusions occur in various solid tumors in a range of 0.1%-0.5%, however, the contribution is larger in cancers such as NSCLC and pancreatic cancers. Delveinsight epidemiology assessment provides NRG1 fusion patient burden in multiple cancers including Cholangiocarcinoma, Pancreatic cancer, Renal Cell Carcinoma, Ovarian Carcinoma, NSCLC, Breast, Bladder, and Colorectal cancer.
- In 2023, the total incident cases of NRG1 fusion were over 3,000 cases in the US, which is expected to grow during the forecast period.
- Leading NRG fusion companies such as Merus, Hummingbird Bioscience, Salubris Biotherapeutics, and others are developing novel NRG fusion therapies Some of the key NRG1 fusion therapies in the pipeline include Zenocutuzumab, HMBD-001, and others. Seribantumab development is currently paused.
- In 2023, Elevation Oncology paused the development of Seribantumab for NRG1 fusions (CRESTONE trial), intending to continue development only in collaboration with a partner, which makes the continuation of the trial a bit uncertain at this moment.
- In May 2024, the FDA accepted a Biologic Licensing Application (BLA) for zenocutuzumab, for non-small cell lung cancer and pancreatic cancer patients. The FDA’s target action date is in December 2024.
- Multiple prior designations (FTD for solid tumors and BTD for NSCLC and Pancreatic cancer) had paved the way for Zenocutuzumab’s priority and accelerated review.
- Even though in the early stage of development, Hummungbird Bioscience is also focussing on pancreatic cancer and NSCLC patients harboring NRG1 fusions along with solid tumors harboring NRG1 fusion and HER3 extracellular mutation in a Phase 1B trial.
Discover which therapies are expected to grab the NRG fusion market share @ NRG Fusion Market Report
NRG Fusion Market Dynamics
NRG fusions have been found in more than 10 types of solid tumors, suggesting they are a promising target for a broad, tumor-agnostic therapeutic approach. Increasing awareness and research in this area make it an appealing opportunity for major industry players. Various ERBB3 inhibitors with encouraging preclinical results are progressing through different stages of clinical trials, including combinations with ERBB2-targeting drugs for ERBB2-positive breast and gastric cancers.
Currently, there are no approved targeted therapies specifically for NRG fusions. For advanced tumors with NRG1 fusions, the standard treatment remains chemotherapy, immunotherapy, or novel anti–PD–1 or anti–PD-L1 agents, though these options often yield suboptimal responses in these patients. NRG fusions are rare but significant oncogenic events seen across several tumor types, including non-small cell lung cancer, breast cancer, colon cancer, pancreatic cancer, and cholangiocarcinoma.
Various strategies to target the HER3 pathway, such as monoclonal antibodies, bispecific T-cell engagers, and antibody-drug conjugates, are under investigation. Early results indicate poor outcomes for patients with NRG1 fusions, highlighting the need for new therapeutic options. Among emerging treatments, Merus’s zenocutuzumab is at the forefront, with the FDA having accepted a BLA for this drug in May 2024 to treat non-small cell lung cancer and pancreatic cancer. The FDA is expected to decide by December 2024.
NRG Fusion Treatment Market
Currently, there are no approved targeted therapies specifically for NRG fusions. For advanced tumors with NRG fusions, standard treatments involve chemotherapy and/or immunotherapy or newer anti–PD–1 or anti–PD-L1 agents. However, these therapies often yield suboptimal responses for patients with NRG1 fusions. While developing new drugs for rare conditions is challenging, repurposing existing drugs approved for other uses is a practical approach. In the case of NRG1 fusion-driven tumors, existing ErbB-targeted therapies show promise. Since NRG1 proteins are ligands for ErbB receptors, treatments like the monoclonal antibody zenocutuzumab and small molecules such as afatinib are particularly noteworthy.
Learn more about the FDA-approved NRG fusion therapies @ NRG Fusion Drugs
Key Emerging NRG Fusion and Companies
Several key players, including Elevation Oncology, Merus, Hummingbird Bioscience, Salubris Biotherapeutics, and others, are involved in developing drugs for NRG fusion for various indications.
Seribantumab (MM-121) is a fully human monoclonal antibody developed by Elevation Oncology. It targets and inhibits HER3 signaling, which supports tumors with NRG1 gene fusions. By binding to HER3, Seribantumab prevents the NRG1 fusion protein from over-activating it. The antibody is being pursued as a targeted therapy for tumors driven by NRG1 fusions. In May 2022, Seribantumab received fast-track designation from the FDA for the treatment of advanced solid tumors with NRG1 gene fusions. Elevation Oncology is now looking for a partnership to secure further investment for the drug.
Zenocutuzumab (MCLA-128), an experimental drug developed by Merus, targets and inhibits the growth factor NRG1, which can become excessive due to NRG1 fusions and interfere with HER3 binding. This bispecific antibody can recognize and bind to both HER2 and HER3. Its mechanism involves first attaching to HER2, which subsequently prevents HER3 from interacting with NRG1. Zenocutuzumab is currently undergoing Phase II clinical trials for treating solid tumors with NRG1 fusions. The FDA has granted priority review for its Biologics License Application (BLA) for use in treating NRG1 fusion-positive NSCLC and pancreatic cancer.
The anticipated launch of these emerging therapies are poised to transform the NRG fusion market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the NRG fusion market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about NRG fusion therapies clinical trials, visit @ NRG Fusion Treatment Drugs
NRG Fusion Overview
Neuregulins (NRG) are a group of epidermal growth factor (EGF) ligands commonly found in solid tumors. There are four genes—NRG-1, NRG-2, NRG-3, and NRG-4—that produce over 32 different NRG isoforms. NRGs function by interacting with the ErbB/HER family of receptor tyrosine kinases. In mammals, four ErbB/HER receptors have been identified: ErbB1/HER1/EGFR, ErbB2/HER2/neu, ErbB3/HER3, and ErbB4/HER4. These receptors and their ligands are well-studied in cancer research due to their role in oncogenic transformation and are targeted by various therapies, including monoclonal antibodies like trastuzumab and pertuzumab for HER2, cetuximab for EGFR, and tyrosine kinase inhibitors such as lapatinib for both EGFR and HER2.
NRG Fusion Epidemiology Segmentation
Among the 7MM, the US accounted for the highest incident cases of NRG Fusion in 2023. The NRG fusion market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
- Total Incident Cases of Selected Indication For NRG Fusion
- Total Eligible Patient Pool for NRG Fusion In Selected Indication
- Total Treated Cases in Selected Indication For NRG Fusion
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NRG Fusion Report Metrics |
Details |
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Study Period |
2020–2034 |
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NRG Fusion Report Coverage |
7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
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Key NRG Fusion Companies |
Merus, Hummingbird Bioscience, Salubris Biotherapeutics, Elevation Oncology, and others |
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Key NRG Fusion Therapies |
Zenocutuzumab, HMBD-001, Seribantumab and others |
Scope of the NRG Fusion Market Report
- NRG Fusion Therapeutic Assessment: NRG Fusion current marketed and emerging therapies
- NRG Fusion Market Dynamics: Conjoint Analysis of Emerging NRG Fusion Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL’s views, Analyst’s views, NRG Fusion Market Access and Reimbursement
Discover more about NRG fusion drugs in development @ NRG Fusion Clinical Trials
Table of Contents
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1. |
Key Insights |
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2. |
Report Introduction |
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3. |
Executive Summary of NRG Fusion |
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4. |
Key Events |
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5. |
Market Forecast Methodology |
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6. |
NRG Fusion Market Overview at a Glance in the 7MM |
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6.1. |
Market Share (%) Distribution by Therapies in 2020 |
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6.2. |
Market Share (%) Distribution by Therapies in 2034 |
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7. |
NRG Fusion: Background and Overview |
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7.1. |
Introduction |
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7.2. |
Treatment |
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8. |
Target Patient Pool |
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8.1. |
Key Findings |
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8.2. |
Assumptions and Rationale: 7MM |
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8.3. |
Epidemiology Scenario in the 7MM |
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8.3.1. |
Total Cases in Selected Indications for NRG Fusion in the 7MM |
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8.3.2. |
Total Eligible Patient Pool for NRG Fusion in Selected Indications in the 7MM |
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8.3.3. |
Total Treated Cases in Selected Indications for NRG Fusion in the 7MM |
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9. |
Emerging Therapies |
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9.1. |
Key Competitors |
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9.2. |
Zenocutuzumab (MCLA-128): Merus |
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9.2.1. |
Product Description |
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9.2.2. |
Other developmental activities |
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9.2.3. |
Clinical development |
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9.2.4. |
Safety and efficacy |
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9.3. |
Zenocutuzumab (MCLA-128): Hummingbird Biosciences |
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9.3.1. |
Product Description |
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9.3.2. |
Other developmental activities |
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9.3.3. |
Clinical development |
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9.3.4. |
Safety and efficacy |
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10. |
NRG Fusion: Seven Major Market Analysis |
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10.1. |
Key Findings |
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10.2. |
Market Outlook |
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10.3. |
Conjoint Analysis |
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10.4. |
Key Market Forecast Assumptions |
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10.4.1. |
Cost Assumptions and Rebates |
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10.4.2. |
Pricing Trends |
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10.4.3. |
Analogue Assessment |
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10.4.4. |
Launch Year and Therapy Uptakes |
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10.5. |
Total Market Size of NRG Fusion in the 7MM |
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10.6. |
Market Size of NRG Fusion by Indication in the7MM |
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10.7. |
The United States Market Size |
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10.7.1. |
Total Market Size of NRG Fusion in the United States |
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10.7.2. |
Market Size of NRG Fusion by Indication in the United States |
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10.7.3. |
Market Size of NRG Fusion by Therapies in the United States |
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10.8. |
EU4 and the UK Market Size |
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10.8.1. |
Total Market Size of NRG Fusion in EU4 and the UK |
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10.8.2. |
Market Size of NRG Fusion by Indication in EU4 and the UK |
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10.8.3. |
Market Size of NRG Fusion by Therapies in EU4 and the UK |
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10.9. |
Japan Market Size |
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10.9.1. |
Total Market Size of NRG Fusion in Japan |
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10.9.2. |
Market Size of NRG Fusion by Indication in Japan |
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10.9.3. |
Market Size of NRG Fusion by Therapies in Japan |
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11. |
Market Access and Reimbursement |
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12. |
SWOT Analysis |
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13. |
KOL Views |
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14. |
Unmet Needs |
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15. |
Appendix |
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16. |
Bibliography |
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17. |
Report Methodology |
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18. |
DelveInsight Capabilities |
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19. |
Disclaimer |
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20. |
About DelveInsight |
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