Rare NRG1 Fusion Market By Therapy Type (Monoclonal Antibodies, Tyrosine Kinase Inhibitors, RNA Therapies & Antibody-Drug Conjugates); By Cancer Type (Non-Small Cell Lung Cancer, Pancreatic Cancer, Others); By Diagnostic Method (CGP via NGS, FISH & RT-PCR); By Geography, Segment Revenue Estimation, Forecast, 2024–2030

Introduction And Strategic Context

The Global Rare NRG1 Fusion Market is projected to grow at a CAGR of 37.8% , with an estimated valuation of $ 187.0 million in 2024 , potentially reaching $1.42 billion by 2030 , based on strategic market assessments and extrapolated orphan oncology pipelines.

 

NRG1 fusions — short for Neuregulin 1 gene rearrangements — are exceptionally rare oncogenic drivers found in a small percentage of solid tumors , including lung adenocarcinoma, pancreatic cancer, and certain gastrointestinal malignancies. While the prevalence is low (estimated at <0.2% of all cancers), the biology is actionable — and that’s exactly where the opportunity lies.

 

This market doesn’t behave like traditional oncology segments. Here, it’s not about tumor type — it’s about molecular identity. That shift is driving a new kind of drug development model: basket trials, tumor -agnostic approvals, and molecular-first diagnostics.

 

So what’s fueling growth between now and 2030?

• Breakthrough approvals and fast-tracked pipelines: FDA’s accelerated approval of Zenocutuzumab (MCLA-128) marked a pivotal moment in 2023.

• Diagnostic advancements: Broader adoption of comprehensive genomic profiling (CGP) is making rare fusion detection more feasible in routine oncology.

• Investor enthusiasm: High pricing power for rare biomarkers, orphan drug incentives, and regulatory support have drawn strong backing.

• Targeted therapy fatigue: Oncologists are looking beyond EGFR, ALK, and KRAS. The NRG1 story is part of that next wave.

The stakeholder map here is tight but high-stakes. You’ve got biotech firms leading with ultra-niche therapies, diagnostic labs pushing for payer coverage of CGP, and oncology centers redesigning protocols around precision-first treatment.

 

To be honest, the NRG1 fusion market wouldn’t exist a decade ago. Now? It’s a model for what tumor -agnostic oncology could become — hyper-personalized, genomically defined, and no longer limited by organ boundaries.

 

Market Segmentation And Forecast Scope

The rare NRG1 fusion market isn’t segmented like traditional oncology categories. Instead of starting with tumor type, segmentation begins at the molecular level — then maps out how that biology plays out across therapeutic approaches, diagnostic platforms, and treatment settings.

Here’s how the market breaks down.

By Therapy Type

• Monoclonal Antibodies (mAbs)
  Currently led by Zenocutuzumab ( Zenzo ) , this subclass targets HER3 signaling activated by the NRG1 fusion. These agents are seeing the most momentum due to their specificity and early clinical success.

• Tyrosine Kinase Inhibitors (TKIs)
  Several multi-targeted TKIs — like afatinib — have shown modest activity, though off-label usage dominates here. Newer TKIs designed to hit HER3-HER2 dimers are in early development.

• Gene-Specific RNA Therapies and ADCs (Antibody-Drug Conjugates)
  Still in preclinical or Phase I stages, these hold potential for long-term pipeline expansion. ADCs targeting HER3 or pan- ErbB families may enter first-in-human trials by 2026.

Therapies targeting HER3 via mAbs account for over 72% of the 2024 market, driven primarily by Zenocutuzumab’s launch and off-label use of similar HER-targeting agents.

 

By Cancer Type

While NRG1 fusions occur across multiple tumors , a few have emerged as “hot zones”:

• Non-Small Cell Lung Cancer (NSCLC)
  The most validated indication, representing over 40% of known NRG1-positive cases. High tissue availability and routine genomic testing support early detection.

• Pancreatic Cancer
  A tougher space — limited biopsy material, aggressive progression — but targeted treatment here is seeing strong interest due to poor survival rates.

• Others (Breast, Gallbladder, Colorectal, Salivary Gland)
  Often uncovered incidentally via CGP. Treatment pathways remain fragmented, with some being routed through off-label use of HER-targeted therapies.

NSCLC is the dominant application segment in 2024, contributing nearly half of all treatment-linked revenues due to established testing protocols and trial enrollments .

 

By Diagnostic Method

• Comprehensive Genomic Profiling (CGP) via NGS
  The gold standard. Platforms like FoundationOne CDx and Caris are routinely identifying NRG1 fusions in advanced tumors .

• FISH and RT-PCR
  Occasionally used in academic or low-resource settings. However, these methods often miss rare or complex rearrangements, limiting market scalability.

NGS-based CGP accounts for over 85% of diagnostics-linked revenue in 2024 — but payer reimbursement remains uneven across regions.

 

By Region

• North America
  Dominates due to early access to Zenocutuzumab , broad CGP availability, and trial concentration in the U.S.

• Europe
  Uptake is slower, driven by country-level reimbursement decisions and centralized approvals through EMA.

• Asia Pacific
  Testing is growing fast in Japan and South Korea. China is ramping up NGS infrastructure, but drug access remains limited.

• LAMEA
  Largely untapped outside a few major cancer centers . Minimal testing volume, few NRG1-targeted therapy access points.

 

Scope Note

This segmentation reflects a molecular-first market model, not a conventional organ-specific framework. From biomarker discovery to therapy access, the success of this space will depend on how well precision medicine workflows integrate across both public and private oncology systems.

In other words: this market doesn’t scale with cancer prevalence — it scales with sequencing penetration.

 

Market Trends And Innovation Landscape

The rare NRG1 fusion market is being shaped by the confluence of two forces: precision oncology infrastructure catching up , and biotech innovation pushing the limits of what's “druggable.” While the patient pool is minuscule, the innovation pace is anything but.

Here’s what’s moving the needle in 2024 and beyond.

Tumor -Agnostic Therapy Models Are Going Mainstream

The approval of Zenocutuzumab in 2023 as a tumor -agnostic agent for NRG1 fusions set a new benchmark. For the first time, oncologists can treat a molecular signature — not a tissue type. It’s a big psychological shift. And regulators are supporting it with accelerated review programs similar to those seen for NTRK or RET fusions.

One oncology head at a U.S. research center put it this way: “We’re no longer asking where the tumor started. We’re asking what drives it. That’s the new starting point.”

 

HER3 Is Now a High-Priority Target

NRG1 fusions activate HER3 signaling — long considered “undruggable” due to its kinase-dead nature. That perception is changing fast. Companies are designing bispecific antibodies, HER3-targeted ADCs, and even HER2-HER3 dimer disruptors to shut down this pathway.

A few notable approaches:

• MCLA-128 ( Zenocutuzumab ) – HER2 x HER3 bispecific with ADCC properties

• Patritumab Deruxtecan (HER3-DXd) – under study in NRG1+ NSCLC

• AI-designed HER3 binders – still early stage, but emerging from platforms like Insilico and Recursion

This HER3 gold rush is attracting both big pharma partnerships and venture funding for platform biotechs .

 

Liquid Biopsy Integration Is Speeding Diagnosis

One major bottleneck has been detection. NRG1 fusions often fly under the radar in tissue-based testing — due to sample scarcity or intronic fusion complexity.

That’s changing with:

• cfDNA and RNA-based liquid biopsy panels

• Partnerships between liquid biopsy firms and major CGP labs

• Inclusion of rare fusions in pan-cancer early detection studies

Guardant Health and Tempus are both integrating NRG1 into their advanced panels. Meanwhile, RNA fusion detection via blood is expected to grow sharply between 2025–2027.

This could open the door for routine re-biopsy and earlier identification — especially in community oncology centers .

 

Basket Trials Are Becoming the New Gold Standard

Traditional trials by cancer type don’t work here. Instead, basket trials like eNRGy1 (for Zenocutuzumab ) are driving a new playbook: enroll by mutation, not organ.

This trial model is:

• Faster to enroll

• Cheaper to run

• More likely to generate statistically significant results for ultra-rare mutations

Expect more of these from sponsors like Merus , Elevation Oncology, and BridgeBio . Some are even pre-stratifying patients via national genomic databases before opening sites.

 

AI Is Being Used to Predict and Prioritize Rare Fusions

It’s one thing to detect a fusion. It’s another to know if it’s targetable. That’s where AI is starting to help.

• Bioinformatics pipelines are now scoring the oncogenic potential of rare NRG1 rearrangements.

• Decision-support tools are guiding oncologists on therapy selection even when data is sparse.

Startups like Owkin and PathAI are also partnering with diagnostic labs to triage fusion-positive cases for faster therapeutic intervention.

Bottom line? This isn’t just another oncology sub-market. It’s a pilot zone for future molecular medicine. Therapies, diagnostics, trial models, even regulatory frameworks — all of it is being redefined here.

What’s happening in NRG1 fusion today may become the blueprint for 50+ rare fusion-driven markets tomorrow.

 

Competitive Intelligence And Benchmarking

Unlike saturated oncology categories dominated by large pharmaceutical firms, the rare NRG1 fusion market is mostly led by biotech specialists, precision medicine startups , and a handful of strategic pharma partnerships. With low patient volume but high therapeutic margins, the space has attracted targeted investment rather than mass-market players.

Here’s a breakdown of key players and how their strategies are unfolding.

Merus N.V.

This Netherlands-based biotech is the clear front-runner, thanks to Zenocutuzumab ( Zenzo ) — the first and only targeted therapy approved specifically for NRG1 fusion–positive solid tumors . Their strategy hinges on:

• Tumor -agnostic development: Zenocutuzumab received accelerated approval across multiple cancers, allowing Merus to sidestep the organ-based regulatory model.

• Smart trial design: Their eNRGy1 basket trial helped demonstrate efficacy across NSCLC, pancreatic, and breast cancers — with a relatively small sample set.

• Strategic collaborations: Merus has engaged with major academic centers and NGS labs to fast-track biomarker identification.

They’ve built a playbook for how to launch and scale an ultra-rare oncology therapy.

 

Elevation Oncology

Positioning itself as a precision oncology pure-play, Elevation’s pipeline includes seribantumab , a HER3-directed monoclonal antibody initially tested in NRG1 fusion-positive tumors . While development has been slow compared to Merus , the company’s current focus is on combination strategies and second-line treatment settings.

• Pipeline diversification: Beyond NRG1, Elevation is targeting other actionable fusions like CLDN18.2 and RET.

• Partnership-first model: It’s a lean biotech that relies heavily on outsourced clinical ops and strategic licensing.

They’re not first to market, but they may find opportunity in resistant or refractory NRG1+ cases — especially if Zenocutuzumab shows early progression in some patients.

 

Daiichi Sankyo

Best known for its HER2-directed ADCs, Daiichi Sankyo is now testing patritumab deruxtecan (HER3-DXd) in multiple HER3-expressing tumors , including those with NRG1 rearrangements. While not developed specifically for NRG1, the compound’s mechanism could offer cross-pathway blockade.

Their strategy includes:

• ADC dominance: With Enhertu (HER2-DXd) already a blockbuster, Daiichi is repurposing the same scaffold for HER3.

• Big pharma scale: Robust manufacturing, regulatory infrastructure, and global market access are major advantages.

Expect this player to move quickly once proof-of-concept is confirmed in NRG1+ cohorts.

 

Guardant Health and Foundation Medicine (Diagnostics)

While not drug developers, these two control much of the diagnostic gateway to the NRG1 fusion market.

• Guardant Health is pushing liquid biopsy panels with NRG1 fusion detection via cfDNA and RNA hybrid approaches.

• Foundation Medicine includes NRG1 fusion identification in its FDA-approved FoundationOne CDx panel, which is now routinely used in NSCLC and GI cancers .

Their role is foundational: no diagnosis, no therapy. As the cost of CGP testing falls, these firms are expected to unlock broader access — especially in community cancer networks.

 

Others to Watch

• BridgeBio Pharma – Exploring small molecules against rare gene fusions; has signaled interest in ErbB targets.

• Turning Point Therapeutics (a Bristol Myers Squibb company) – May adapt pipeline to cover HER3 fusion or resistance mechanisms.

• Tempus – Uses AI and real-world data to identify rare fusions in under-tested patient cohorts, making them a key enabler on the diagnostic front.

What makes this market unique is that no single player “owns” the ecosystem. Drug developers, diagnostic labs, trial platforms, and even real-world evidence players all share influence — but from very different angles.

That fragmented setup creates white space for cross-industry partnerships, especially between biotechs and AI-enabled diagnostic firms.

 

Regional Landscape And Adoption Outlook

The rare NRG1 fusion market shows a distinctly asymmetric growth pattern across regions. That’s not due to prevalence — the incidence of NRG1 fusions is fairly consistent worldwide. What drives the difference is access to molecular diagnostics, drug approvals, clinical trial infrastructure, and reimbursement policy.

In short, this market grows where precision oncology is already embedded. And right now, that means a few countries are far ahead of the rest.

North America

This is the epicenter of market activity, responsible for nearly 68% of global revenue in 2024. Why?

• Widespread genomic profiling: Foundation Medicine, Caris, Tempus, and Guardant have strong footprints in the U.S.

• Regulatory flexibility: The FDA’s accelerated approval of Zenocutuzumab created a fast path to market. No equivalent exists yet in other regions.

• Trial access: Most NRG1 fusion basket trials are U.S.-based or U.S.-led, meaning patients here are more likely to be diagnosed and treated early.

• Payer dynamics: Major cancer centers (MD Anderson, MSK, UCSF) have established pathways for CGP reimbursement, making detection more routine.

Canada is somewhat behind due to limited CGP funding, but early adoption is visible in large academic centers like Princess Margaret and BC Cancer.

 

Europe

Adoption is steady but fragmented by country. While EMA has begun evaluating tumor -agnostic approvals, national health systems move slowly — and CGP access varies widely.

• Germany and the Netherlands are ahead, with solid trial enrollment and sequencing infrastructure.

• France and the UK are catching up, especially under initiatives like Genomics England.

• Southern and Eastern Europe lag significantly — not due to lack of patients, but lack of testing.

One challenge is that reimbursement for NGS in metastatic settings is not uniform, even in wealthy EU countries. As a result, NRG1 fusions are often missed entirely outside elite cancer centers .

Market expansion in Europe depends less on drug availability and more on diagnostics policy reform.

 

Asia Pacific

A mixed landscape — rapid growth in some countries, and near-zero activity in others.

• Japan and South Korea: These are the regional leaders, with national CGP programs and early participation in global trials. Japanese oncologists are especially proactive in testing rare fusions in lung and pancreatic cancers.

• China: NGS infrastructure is growing, and companies like Burning Rock and Genetron are scaling fusion panels. But access to NRG1-targeted therapies remains extremely limited due to local approval delays and restricted imports.

• Australia: Shows promise thanks to national genomics initiatives, but patient numbers are low.

Overall, APAC is a high-potential zone, but access remains tightly concentrated in urban tertiary care centers . Broader rollout will depend on liquid biopsy integration and real-world evidence validation.

 

Latin America, Middle East & Africa (LAMEA)

Right now, this is white space — not due to lack of interest, but due to structural gaps.

• Low NGS penetration

• High cost of targeted therapies

• No regulatory fast-track equivalents

A few institutions in Brazil, UAE, and South Africa are running CGP pilots, but these are mostly academic or grant-funded. For the most part, NRG1 fusions are neither tested nor treated here at scale.

That said, pan-cancer national sequencing programs are starting to emerge. Brazil’s Genomas Raros and Saudi Arabia’s Precision Medicine Vision 2030 could shift the landscape after 2026.

 

Regional Outlook Summary

Region	2024 Status	2030 Outlook
North America	Market leader	Plateau with high saturation
Europe	Fragmented growth	Moderate expansion via CGP mandates
Asia Pacific	Rapid in Japan/S. Korea	High CAGR in China post-2026
LAMEA	Minimal activity	Early-stage adoption via pilots

Bottom line: this market doesn’t grow evenly. It expands where there’s sequencing access, regulatory clarity, and a willingness to rethink how oncology is practiced.

 

End-User Dynamics And Use Case

The rare NRG1 fusion market is inherently specialist-driven. Because of the low prevalence and complex biology, this isn’t a space where general oncologists or community clinics can lead. Instead, most therapy decisions, diagnostic workflows, and clinical interventions are concentrated within a small but highly capable network of institutions.

Let’s break down who’s actually delivering care — and how.

1. Academic Medical Centers

These are the primary end users in 2024 — not just for therapy administration, but for driving diagnosis itself.

• Institutions like Memorial Sloan Kettering, MD Anderson, Dana-Farber, and UCSF routinely conduct comprehensive genomic profiling (CGP) for all stage IV solid tumor patients.

• These centers also lead or participate in basket trials, making them the most likely to encounter and treat NRG1+ patients.

• They act as referral hubs, taking in complex or fusion-positive patients from smaller hospitals.

Academic centers account for an estimated 62% of all NRG1-targeted therapy prescriptions in 2024.

 

2. Specialized Oncology Networks

Next come cancer centers that have adopted precision medicine workflows, even outside the academic world. Think large regional oncology networks or private hospital chains with in-house molecular pathology labs.

• In the U.S., this includes City of Hope, Moffitt Cancer Center , and Sarah Cannon.

• In Europe, groups like Gustave Roussy and Netherlands Cancer Institute are setting the pace.

These players are key for early commercial scaling — they’re not running trials, but they’re fast adopters of FDA- or EMA-cleared therapies and companion diagnostics.

 

3. Diagnostic Labs and Genomic Testing Providers

Interestingly, labs themselves are becoming de facto end users in some regions.

• Labs like Foundation Medicine, Caris, Tempus, Guardant, and Invitae don’t administer therapies — but they determine who even enters the market.

• Their CGP reports are increasingly integrated into EMRs and clinical decision support systems.

As payer coverage expands, especially for liquid biopsy, these labs will become even more influential in triaging patients toward NRG1-targeted options.

 

4. Payer-Linked Precision Medicine Programs

Some health systems — especially in the U.S. and Japan — are running payer-integrated programs that make CGP a prerequisite for treatment approval in advanced cancers.

While not “end users” in the traditional sense, these entities:

• Decide who gets tested

• Approve or deny therapy access

• Shape diagnostic volume and therapy penetration at scale

This trend is set to reshape the purchasing power in rare biomarker markets, pushing diagnostic quality and documentation to the forefront.

 

Use Case: Tertiary Hospital in South Korea

A 56-year-old female patient with stage IV pancreatic adenocarcinoma presented at a tertiary oncology center in Seoul in early 2024. Initial treatment failed, and CGP was ordered through a national pilot program. The report revealed an NRG1 fusion. Based on local trial availability and international guidelines, the patient was enrolled into a HER3- directed monoclonal antibody trial. Within 8 weeks, partial response was observed, with disease stabilization confirmed at 12-week follow-up.

This case illustrates the value of centralized genomic infrastructure and adaptive trial pathways — two pillars required to make NRG1-targeted therapy accessible at a national level.

End-user adoption here isn’t about volume — it’s about capability. And the real market drivers are not just doctors or hospitals — they’re systems that can coordinate diagnosis, access, and real-time clinical action across multiple stakeholders.

 

Recent Developments + Opportunities & Restraints

Recent Developments (Last 2 Years)

• FDA Accelerated Approval of Zenocutuzumab ( Merus N.V.) in mid-2023 marked the first tumor -agnostic treatment specifically targeting NRG1 fusion–positive solid tumors .

• Elevation Oncology halted development of seribantumab in late 2023 due to insufficient efficacy data in monotherapy trials, pivoting its strategy toward combination and fusion-agnostic assets.

• Foundation Medicine expanded its CGP panel to include higher-sensitivity RNA-based NRG1 fusion detection, improving diagnostic accuracy in pancreatic and breast tumors .

• Guardant Health announced successful detection of NRG1 fusions in cfRNA using liquid biopsy , enabling non-invasive testing across multiple cancer types.

• Patritumab Deruxtecan entered Phase II basket trials in HER3-driven cancers, including NRG1 fusion subsets, indicating growing pharma interest in HER3 as a druggable target.

 

Opportunities

• Expansion of CGP Reimbursement in Community Settings
  Wider insurance coverage for next- gen sequencing (NGS) — especially in U.S. and APAC — could unlock a significant untapped patient population currently undiagnosed.

• Liquid Biopsy Integration in Oncology Workflows
  With the emergence of RNA fusion detection via blood, testing access could spread beyond academic centers into regional hospitals and outpatient clinics.

• HER3-Targeted Therapy Combinations
  As resistance mechanisms emerge for existing HER2 or pan- ErbB inhibitors, HER3-targeted drugs may play a complementary role — opening new treatment lines and indications.

 

Restraints

• Low Awareness and Testing Rates in Non-Academic Settings
  Outside of major cancer centers , many oncologists remain unfamiliar with NRG1 fusions, and testing isn't routinely performed — severely limiting diagnosis.

• Payer Reluctance to Fund Ultra-Orphan Indications
  Despite clinical benefit, reimbursement hurdles persist due to small population size and high therapy cost — particularly in Europe and LAMEA.
   

This market’s future won’t be shaped by prevalence. It’ll be shaped by access: to testing, to trials, and to tumor -agnostic regulatory frameworks. Stakeholders who can bridge those gaps — whether they're biotech innovators or diagnostic networks — will define the next phase of growth.

 

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 187.0 Million
Revenue Forecast in 2030	USD 1.42 Billion
Overall Growth Rate	CAGR of 37.8% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Therapy Type, By Cancer Type, By Diagnostic Method, By Region
By Therapy Type	Monoclonal Antibodies, Tyrosine Kinase Inhibitors, RNA Therapies & ADCs
By Cancer Type	NSCLC, Pancreatic Cancer, Others (Breast, Colorectal, Salivary, etc.)
By Diagnostic Method	CGP via NGS, FISH & RT-PCR
By Region	North America, Europe, Asia Pacific, LAMEA
Country Scope	U.S., Canada, Germany, U.K., France, Japan, South Korea, China, Brazil, UAE
Market Drivers	- Increasing adoption of tumor-agnostic therapy models - Improved access to RNA-based CGP and liquid biopsy panels - Regulatory and commercial momentum post-Zenocutuzumab approval
Customization Option	Available upon request