Rare NRG1 Fusion - Target Population, Competitive Landscape, and Market - 2036

Rare NRG1 Fusion Insights and Trends

• Human neuregulins (NRGs) are small ligands belonging to the epidermal growth factor (EGF) family proteins. They are encoded by four different genes (NRG1-4) and are implicated in the activation of ErbB receptors to modulate both physiologic and neoplastic processes.
• NRG1 has an essential role in normal physiology of the nervous system, heart and breast, in addition to a pathologic role in some diseases, including cancer.
• NRG1 gene fusions can occur in several different types of cancer, including pancreatic cancer, cholangiocarcinoma, lung cancer, and others. NRG1 gene fusions are often found in a subtype of non-small cell lung cancer (NSCLC) called invasive mucinous adenocarcinoma.
• NRG1 fusions are significantly enriched in the rare, aggressive invasive mucinous adenocarcinoma (IMA) subtype of lung cancer, with reported frequencies ranging from 10% to over 30%
• NRG1 fusions are an uncommon finding in pancreatic cancer, present in roughly 0.5% of patients.
• NRG1 fusions are relatively rare, occurring in about 0.2% of tested specimens, which complicates their detection and the development of specific treatments. The low incidence means that many healthcare providers may not routinely test for these fusions, leading to missed opportunities for targeted therapy.
• NRG1 fusion-positive cancers often face poorer overall survival rates compared to those without such fusions. Addressing this unmet need through effective therapies could significantly improve patient outcomes and quality of life, further driving market demand.
• GILOTRIF (afatinib) contributes a small share, largely driven by off-label use supported by case reports and small cohorts showing activity in NRG1 fusion positive disease. Platinum-based chemotherapy +- immunotherapy +- bevacizumab continues to account for the largest portion of market revenue across the 7MM, as it remains the default standard of care in the absence of widely available targeted options.
• BIZENGRI (zenocutuzumab-zbco), is the only FDA approved drug for NRG1 fusion in patients with NSCLC or pancreatic adenocarcinoma.
• Despite growing scientific interest, the pipeline is relatively sparse, with few active assets, emphasizing the considerable unmet need in NRG1 fusion positive cancers.

Rare NRG1 Fusion Market Size and Forecast in the 7MM for NSCLC

• 2025 Projected Rare NRG1 Fusion NSCLC Market Size: ~USD 7 million
• Rare NRG1 Fusion NSCLC Growth Rate (2026-2036): 27% CAGR

DelveInsight's 'Rare NRG1 Fusion - Target Population, Competitive Landscape, and Market Metadata-2036' report delivers an in-depth understanding of the rare NRG1 fusion, historical and forecasted epidemiology, as well as the rare NRG1 fusion market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The Rare NRG1 fusion market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates rare NRG1 fusion patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in rare NRG1 fusion and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Rare NRG1 Fusion Market

Rising Prevalence and Incidence of NRG1 Fusion-Associated Indications

The increasing of NRG1 fusion positive cancers remains low but is gradually increasing due to improved molecular diagnostics and broader genomic testing. This rise is particularly observed in indications such as NSCLC, pancreatic cancer, and other solid tumors, leading to a growing identifiable patient population and highlighting the need for effective targeted therapies. In the US, there were ~800 incident cases of NRG1 fusion NSCLC in 2025, which is projected to increase by 2036.

Rising Opportunities in Rare NRG1 Fusion

The rarity of NRG1 fusions, coupled with a highly limited treatment pipeline and increasing detection through advanced genomic testing, is creating significant opportunities for targeted therapies and innovation in precision oncology. While NRG1 fusions represent a rare but actionable oncology segment with limited treatment options, expanding research into non-oncology indications like congestive heart failure (CHF) is opening additional avenues for therapeutic development. The dual relevance of NRG1 biology in both cancer (via HER3 signaling) and cardiovascular repair mechanisms highlights broader opportunities for innovation, thereby increasing the overall clinical and commercial potential of NRG1-targeted therapies.

Emerging Rare NRG1 Fusion Competitive Landscape

The NRG1 Fusion pipeline is constrained, with some potential drugs in development including SAL007/JK07 (Salubris Pharmaceuticals), HMBD-001 (Hummingbird Bioscience), and others.

Rare NRG1 Fusion Understanding and Treatment Algorithm

Rare NRG1 Fusion Overview

NRG1 (Neuregulin 1) gene fusions are potentially actionable oncogenic drivers that are present in some solid tumors. NRG1 fusions result in ErbB-mediated pathway activation and present a rational therapeutic target. Oncogenic fusions of NRG1 may cause excess accumulation of the NRG1-fusion protein at the cell surface. This causes persistent activation of ErbB receptor tyrosine kinases that drive excess activity in the mTOR and MAPK pathways and promote tumorigenesis. The NRG1 gene encodes ligands for the ERBB2 (HER2)-ERBB3 heterodimeric receptor tyrosine kinase. Gene fusions of NRG1 such as CD74-NRG1 and SLC33A2-NRG1 have been found at low frequency in a wide range of carcinomas including lung, breast, colorectal, ovarian, and pancreatic cancers and with a wide range of fusion partners.

Rare NRG1 Fusion Diagnosis

NRG1 fusions are identified using advanced molecular diagnostic techniques, with RNA-based next-generation sequencing (NGS) considered the most reliable approach for detecting gene rearrangements and diverse fusion partners. Broader genomic profiling is increasingly used in clinical practice to improve detection rates of these rare alterations, enabling more accurate patient stratification and access to targeted therapies.

Rare NRG1 Fusion Treatment

The current management of NRG1 fusion-positive tumors is primarily based on targeted inhibition of the HER3-HER2 signaling pathway. The HER2-HER3 bispecific antibody zenocutuzumab represents the key available targeted therapy, demonstrating clinically meaningful responses across multiple tumor types. In addition, some patients may receive off-label or investigational anti-HER3 agents depending on clinical availability, with treatment decisions largely guided by molecular profiling and access to precision oncology options.

Rare NRG1 Fusion Unmet Needs

The section "unmet needs of Rare NRG1 Fusion Unmet Needs" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Limited approved targeted therapies available

2. Sparse and early-stage clinical pipeline

3. Challenges in routine detection and diagnosis

4. Lack of standardized treatment guidelines, and others.....

Comprehensive unmet needs insights in rare NRG1 fusion and their strategic implications are provided in the full report.

Rare NRG1 Fusion Epidemiology

Key Findings from Rare NRG1 Fusion Epidemiological Analysis and Forecast

• The total incident cases related to of NRG1-Fusion NSCLC were estimated to be ~850 in the US in 2025.
• As per SEER (2025), it is estimated that there would be 67,440 new cases of pancreatic cancer in 2025.
• As per National Cancer Institute (2024), the incidence rate of new cases of ovarian cancer was 10.2 per 100,000 women per year in the US.
• In the 7MM, the US accounted for the highest number of diagnosed prevalent cases of heart failure, with nearly 7,483,000 in 2025.
• In cholangiocarcinoma, NRG1 fusions have been observed in approximately 0.8% of cases.
• Breast cancer incidence continued an upward trend, rising by 1% annually during 2012-2021, largely confined to localized-stage and hormone receptor-positive disease.

Rare NRG1 Fusion Drug Chapters & Competitive Analysis

The rare NRG1 fusion drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the rare NRG1 fusion treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the rare NRG1 fusion therapeutics market.

Approved Therapy for Rare NRG1 Fusion

Zenocutuzumab-zbco (BIZENGRI): Merus and Partner Therapeutics

Zenocutuzumab-zbco is a bispecific antibody that binds to the extracellular domains of HER2 and HER3 expressed on the surface of cells, including tumor cells, inhibiting HER2:HER3 dimerization and preventing NRG1 binding to HER3. BIZENGRI decreased cell proliferation and signaling through the phosphoinositide 3-kinase-AKT-mammalian target of rapamycin pathway. In addition, it mediates antibody-dependent cellular cytotoxicity. BIZENGRI showed antitumor activity in mouse models of NRG1+ lung and pancreatic cancers. The approval of BIZENGRI is based on data from the eNRGy trial, a multicenter, open-label clinical trial that enrolled patients with NRG1+ pancreatic adenocarcinoma or NRG1+ NSCLC that is advanced unresectable or metastatic and had disease progression on or after prior systemic therapy.

In December 2024, Merus and Partner Therapeutics announced the license agreement of zenocutuzumab in NRG1 fusion-positive cancer in which Merus had exclusively given licensed to Partner Therapeutics to commercialize zenocutuzumab for the treatment of NRG1+ fusion cancer in the US.

Rare NRG1 Fusion Pipeline Analysis

SAL007/JK07: Salubris Pharmaceuticals

SAL007/JK07 is a recombinant fusion protein consisting of a fully IgG1 monoclonal antibody and an active polypeptide fragment of the human growth factor NRG-1. The HER4 pathway appears to be responsible for the regenerative effects in the heart, while the HER3 pathway appears primarily responsible for safety and tolerability limitations of recombinant NRG-1. By blocking HER3 signaling with an antibody fusion design, JK07 selectively stimulates the HER4 pathway with a favorable pharmacokinetic profile, which has the potential to significantly widen the therapeutic window of NRG-1 and yield better clinical effects.

Rare NRG1 Fusion Key Players, Market Leaders and Emerging Companies

• Merus
• Partner Therapeutics
• Salubris Pharmaceuticals
• Hummingbird Bioscience, and others

Rare NRG1 Fusion Key Players Drug Updates

• In February 2026, Partner Therapeutics announced that the US FDA has granted Orphan Drug Designation (ODD) to zenocutuzumab zbco for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma.
• In February 2026, Partner Therapeutics announced findings from a post hoc analysis of the eNRGy trial evaluating treatment beyond progression with zenocutuzumab in patients with advanced NRG1+ NSCLC at the 2026 International Association for the Study of Lung Cancer (IASLC) Targeted Therapies of Lung Cancer (TTLC) meeting.
• In January 2026, Partner Therapeutics announced new data from a post hoc analysis of the eNRGy trial, evaluating zenocutuzumab in patients with advanced NRG1+ pancreatic adenocarcinoma (PDAC) and cholangiocarcinoma (CCA) at the 2026 ASCO Gastrointestinal Cancers.
• In October 2025 Partner Therapeutics announced that the FDA has awarded Breakthrough Therapy designation to zenocutuzumab-zbco (BIZENGRI) for the treatment of adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a NRG1 gene fusion.
• In September 2025, Salubris Biotherapeutics announced the completion of enrollment for the HFrEF cohort in the Phase IIb RENEU-HF study evaluating JK07, with topline results anticipated in the first half of 2026.

Drug Class Insights

Rare NRG1 Fusion Market Outlook

The rare NRG1 fusion market is an emerging but highly underserved segment of precision oncology, driven by the increasing adoption of comprehensive genomic profiling and improved detection of low-frequency actionable alterations. Despite its rarity (~0.2% of tested specimens), the growing identification of NRG1 fusions across NSCLC, pancreatic cancer, cholangiocarcinoma, and other solid tumors is gradually expanding the addressable patient pool.

Currently, the market remains dominated by chemotherapy-based regimens and off-label use of HER pathway inhibitors, while zenocutuzumab (BIZENGRI) stands as the only FDA-approved targeted therapy for NRG1 fusion-positive NSCLC and pancreatic cancer, marking a major shift toward precision treatment. However, overall treatment options remain limited, and the clinical pipeline is sparse, highlighting significant unmet need.

The rare NRG1 fusion market continues to face a highly limited and fragile clinical pipeline, with several programs either early-stage or restricted to non-7MM geographies, reflecting both the rarity of the alteration and development challenges. Alongside existing constraints, the investigational asset HMBD-001 (in combination with docetaxel), developed by Hummingbird Bioscience, is an anti-HER3 monoclonal antibody being evaluated in NRG1 fusion/HER3-altered NSCLC in second-line and beyond settings (Phase Ib). Notably, this program is being studied outside the 7MM, including Australia-based clinical trials (e.g., NCT05919537 and NCT05057013), further highlighting its limited geographic footprint.

At the same time, the pipeline has contracted further due to discontinuations, including the termination of the seribantumab study (NCT04383210) in NRG1 fusion-positive advanced solid tumors, sponsored by Elevation Oncology, due to a business decision, which has reduced overall competitive momentum in this space.

Overall, the launch of first therapy, improved diagnostic approaches, and increasing disease awareness are expected to drive steady growth in the 7MM rare NRG1 fusion market from 2022-2036, with strong commercial implications for both marketed products and emerging pipelines.

• According to the estimates, the largest market size of rare NRG1 fusion NSCLC was captured by the United States, i.e., ~USD 4 million in 2025.
• In 2036, among all the therapies for rare NRG1 fusion NSCLC, the highest revenue is estimated to be generated by BIZENGRI, in the United States.
• Among the EU4 countries and the UK, Germany accounted for the largest market size of rare NRG1 fusion NSCLC in 2025, followed by the UK and France.

Drug Class/Insights into Leading Emerging and Marketed Therapies in Rare NRG1 Fusion (2022-2036 Forecast)

The rare NRG1 fusion market comprises HER2-HER3 targeted bispecific antibodies and recombinant NRG1 pathway modulators, alongside limited chemotherapy and off-label targeted options, each addressing distinct mechanisms of aberrant NRG1-driven signaling and downstream oncogenic pathways underlying tumor growth in NRG1 fusion-positive cancers.

• HER2-HER3 targeted bispecific antibodies: Zenocutuzumab (BIZENGRI) is a first-in-class HER2-HER3 bispecific antibody that inhibits NRG1-driven signaling and downstream oncogenic pathways, establishing itself as the only approved targeted therapy in rare NRG1 fusion-positive cancers and validating precision biologics in this ultra-rare oncology segment.
• Recombinant HER3/NRG1 pathway modulators: SAL007/JK07 is a recombinant fusion protein designed to selectively modulate the NRG1-HER signaling axis, enhancing beneficial HER4-mediated effects while limiting HER3-driven oncogenic signaling, supporting its potential in both oncology and cardiovascular indications.

Rare NRG1 Fusion Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the rare NRG1 fusion market's uptake by drugs, patient uptake by therapy, and sales of each drug.

The introduction of BIZENGRI the first tumor-agnostic targeted therapy for NRG1 fusions is expected to progressively reshape the market, with uptake varying by region based on regulatory timelines, access, and biomarker testing penetration.

Rare NRG1 Fusion Therapies Price Scenario & Trends

Pricing and analogue assessment of rare NRG1 fusion therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.

Further details are provided in the final report....

Industry Experts and Physician Views for Rare NRG1 Fusion

To keep up with rare NRG1 fusion market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the Rare NRG1 Fusion emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in Rare NRG1 Fusion, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as the University of North Carolina at Chapel Hill, Berlin Institute of Health at Charite, and the University of Nottingham, etc. were contacted. Their opinion helps understand and validate current and emerging Rare NRG1 Fusion therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in Rare NRG1 Fusion.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of rare NRG1 fusion, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report:

• The report covers a segment of key events, an executive summary, a descriptive overview of rare NRG1 fusion, explaining its causes, signs and symptoms, pathogenesis, and currently available treatments.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the rare NRG1 fusion market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM rare NRG1 fusion market.

Report Insights

• Rare NRG1 Fusion Patient Population Forecast
• Rare NRG1 Fusion Therapeutics Market Size
• Rare NRG1 Fusion Pipeline Analysis
• Rare NRG1 Fusion Market Size and Trends
• Rare NRG1 Fusion Market Opportunity (Current and forecasted)

Report Key Strengths

• Epidemiology-based (Epi-based) Bottom-up Forecasting
• Artificial Intelligence (AI)-enabled Market Research Report
• 11-year forecast
• Rare NRG1 Fusion Market Outlook (North America, Europe, Asia-Pacific)
• Patient Burden Trends (by geography)
• Rare NRG1 Fusion Treatment Addressable Market (TAM)
• Rare NRG1 Fusion Competitive Landscape
• Rare NRG1 Fusion Major Companies Insights
• Rare NRG1 Fusion Price Trends and Analogue Assessment
• Rare NRG1 Fusion Therapies Drug Adoption/Uptake
• Rare NRG1 Fusion Therapies Peak Patient Share analysis

Report Assessment

• Rare NRG1 Fusion Current Treatment Practices
• Rare NRG1 Fusion Unmet Needs
• Rare NRG1 Fusion Clinical Development Analysis
• Rare NRG1 Fusion Emerging Drugs Product Profiles
• Rare NRG1 Fusion Market Attractiveness
• Rare NRG1 Fusion Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

• What was the rare NRG1 fusion market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
• What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
• What can be the future treatment paradigm of rare NRG1 fusion?
• What are the disease risks, burdens, and unmet needs of rare NRG1 fusion? What will be the growth opportunities across the 7MM concerning the patient population with rare NRG1 fusion?
• Who is the major future competitor in the market, and how will the competitors affect their market share?
• What are the current options for the treatment of rare NRG1 fusion? What are the current guidelines for treating rare NRG1 fusion in the US, Europe, and Japan?

Reasons to Buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the rare NRG1 fusion market.
• Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
• This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets within the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.