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희귀 NRG1 융합 : 대상 집단, 경쟁 구도 및 시장(2036년)

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

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 151 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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희귀 NRG1 융합에 대한 인사이트와 동향

  • 인간의 뉴레그린(NRG)은 상피성장인자(EGF) 계열에 속하는 소분자 리간드입니다. 이들은 4개의 서로 다른 유전자(NRG1-4)에 의해 암호화되며, ErbB 수용체의 활성화에 관여하여 생리적 및 종양성 과정 모두를 조절합니다.
  • NRG1은 신경계, 심장, 유방의 정상적인 생리 기능에 중요한 역할을 할 뿐만 아니라, 암을 포함한 일부 질환에서 병리학적 역할도 담당하고 있습니다.
  • NRG1 유전자 융합은 췌장암, 담관암, 폐암 등 여러 가지 다른 종류의 암에서 발생할 가능성이 있습니다. NRG1 유전자 융합은 침윤성 점액성 선암이라고 불리는 비소세포폐암(NSCLC)의 하위 유형에서 빈번하게 관찰됩니다.
  • NRG1 융합은 폐암의 드물고 침습성이 높은 ‘침윤성 점액성 선암(IMA)’이라는 아형에서 유의미하게 많이 관찰되며, 보고된 빈도는 10%에서 30% 이상에 이릅니다.
  • 췌장암에서 NRG1 융합은 드문 소견으로, 환자의 약 0.5%에서 관찰됩니다.
  • NRG1 융합은 비교적 드물며, 검사 대상 검체의 약 0.2%에서만 확인되기 때문에 이를 검출하거나 특이적인 치료법을 개발하기가 어렵습니다. 발병률이 낮기 때문에 많은 의료 종사자들이 이러한 병합 증상에 대해 정기적인 검사를 실시하지 않고 있을 가능성이 있으며, 그 결과 표적 치료의 기회를 놓치고 있을 수 있습니다.
  • NRG1 융합 양성 암은, 그러한 융합이 없는 경우에 비해 전체 생존율이 낮은 경향을 보입니다. 효과적인 치료법을 통해 이러한 미충족 의료 수요를 해결할 수 있다면, 환자의 예후와 삶의 질을 크게 개선할 수 있을 뿐만 아니라 시장 수요를 더욱 촉진하게 될 것입니다.
  • GILOTRIF(아파티닙)은 NRG1 융합 양성 질환에서 효능을 보여주는 사례 보고 및 소규모 코호트 연구를 바탕으로 한 적응증 외 사용이 주요 요인이 되어, 시장 점유율은 작지만 기여하고 있습니다. 플래티넘 제제를 기반으로 한 화학요법 ± 면역요법 ± 베바시주맙은, 널리 이용 가능한 표적 치료 옵션이 없는 상황에서 여전히 기본 표준 치료법으로 자리 잡고 있어, 주요 7개국 전체 시장 매출에서 가장 큰 비중을 차지하고 있습니다.
  • BIZENGRI(제노쿠츠주맙-zbco)는 비소세포폐암(NSCLC) 또는 췌장 선암 환자의 NRG1 융합에 대해 FDA가 승인한 유일한 약물입니다.
  • 과학적 관심이 높아지고 있음에도 불구하고, 개발 파이프라인이 비교적 부족하고 개발 중인 약물도 적기 때문에 NRG1 융합 양성 암 분야에서 충족되지 않은 의료 수요가 얼마나 큰지가 여실히 드러나고 있습니다.

G7 국가에서 비소세포폐암(NSCLC)의 희귀 NRG1 융합 사례 시장 규모 및 전망

  • 2025년 희귀 NRG1 융합 비소세포폐암(NSCLC) 시장 규모 전망 : 약 700만 달러
  • 희귀 NRG1 융합 비소세포폐암의 성장률(2026-2036년) : 연평균 성장률(CAGR) 27%

이 희귀 NRG1 융합 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 상황에 대한 종합적인 분석을 제공합니다. 또한, 희귀 NRG1 융합 환자의 부담 동향, 수익 및 시장 점유율 동향, 피크 시기의 환자 점유율 및 치료 도입률 분석을 평가하고, 전 세계 각 지역의 시장 규모에 대한 상세한 평가와 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제시합니다. 본 보고서에서는 희귀 질환인 NRG1 융합증의 주요 미충족 의료 수요에 초점을 맞추어, 경쟁 구도와 임상 현황을 분석함으로써 고부가가치의 성장 기회를 도출하고, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

희귀 질환인 NRG1 융합 관련 시장의 주요 촉진요인

NRG1 융합 관련 적응증의 유병률 및 발생률 증가

NRG1 융합 양성 암의 발생 건수는 여전히 낮은 수준이지만, 분자진단법의 발전과 유전체 검사의 보급에 따라 서서히 증가하고 있습니다. 이러한 증가는 특히 비소세포폐암(NSCLC), 췌장암, 기타 고형암 등의 적응증에서 두드러지게 나타나며, 치료 대상 환자 수의 증가로 이어지는 동시에 효과적인 표적 치료의 필요성을 부각시키고 있습니다. 미국에서는 2025년에 NRG1 융합 양성 비소세포폐암(NSCLC)의 신규 사례가 약 800건 발생할 것으로 예상되며, 2036년까지 그 수가 증가할 것으로 전망됩니다.

희귀 NRG1 융합 암 치료 기회의 확대

NRG1 융합의 희귀성에 더해, 치료 파이프라인이 극히 제한적이라는 점과 첨단 유전체 검사를 통한 검출률 향상이 맞물리면서, 표적 치료 및 정밀 종양학 분야에서 혁신을 이룰 수 있는 큰 기회가 열리고 있습니다. NRG1 융합은 치료 선택지가 제한적인, 치료가 가능한 희귀 종양학 분야이지만, 울혈성 심부전(CHF)과 같은 비종양학적 적응증으로의 연구 확대를 통해 치료 개발을 위한 새로운 길이 열리고 있습니다. 암(HER3 신호전달을 매개로)과 심혈관 회복 메커니즘 모두에서 NRG1의 생물학적 중요성은 혁신을 위한 더 광범위한 기회를 부각시키고 있으며, 이를 통해 NRG1을 표적으로 하는 치료법의 전반적인 임상적 및 상업적 잠재력이 향상되고 있습니다.

희귀 NRG1 융합 돌연변이에 대한 이해와 치료 알고리즘

희귀 NRG1 융합의 개요

NRG1(뉴레글린 1) 유전자 융합은 일부 고형 종양에서 발견되며, 치료 가능성이 있는 발암성 드라이버입니다. NRG1 융합은 ErbB를 매개로 하는 신호 전달 경로의 활성화를 유발하며, 이는 합리적인 치료 표적이 됩니다. NRG1의 발암성 융합은 세포 표면에서 NRG1 융합 단백질의 과도한 축적을 유발할 가능성이 있습니다. 이로 인해 ErbB 수용체 티로신 키나아제가 지속적으로 활성화되어 mTOR 및 MAPK 경로의 과도한 활성을 유발하고, 종양 형성을 촉진합니다. NRG1 유전자는 ERBB2(HER2)-ERBB3 이종 이량체 수용체 티로신 키나제의 리간드를 암호화합니다. CD74-NRG1 및 SLC33A2-NRG1과 같은 NRG1 유전자 융합은 폐암, 유방암, 대장암, 난소암, 췌장암 등 다양한 종류의 암에서 여러 융합 파트너와 함께 낮은 빈도로 관찰됩니다.

희귀 NRG1 융합의 진단

NRG1 융합은 첨단 분자진단 기술을 통해 확인됩니다. 그중에서도 RNA 기반 차세대 염기서열 분석(NGS)은 유전자 재조합 및 다양한 융합 파트너를 검출하는 데 있어 가장 신뢰할 수 있는 방법으로 여겨집니다. 이러한 희귀 변이의 검출률을 높이고, 환자를 보다 정확하게 분류하며 표적 치료에 대한 접근성을 높이기 위해 임상 현장에서는 점점 더 광범위한 유전체 프로파일링이 활용되고 있습니다.

희귀 NRG1 융합의 치료

NRG1 융합 양성 종양의 현재 치료법은 주로 HER3-HER2 신호전달 경로의 표적 억제에 기반을 두고 있습니다. HER2-HER3 이중특이성항체인 제녹츠주맙은 현재 이용 가능한 주요 표적 치료제 중 하나로, 여러 종류의 종양에서 임상적으로 유의미한 반응을 보이고 있습니다. 또한, 임상적 활용 가능성에 따라 일부 환자에게는 적응증 외 또는 임상시험 단계에 있는 항HER3 약물이 투여될 수 있으며, 치료 방침의 결정은 주로 분자 프로파일링 및 정밀 종양학 옵션에 대한 접근 가능 여부에 근거하여 이루어집니다.

희귀 NRG1 융합의 역학

희귀 NRG1 융합에 관한 역학 분석 및 예측의 주요 결과

  • 2025년 미국의 NRG1 융합형 비소세포폐암(NSCLC) 신규 환자 수는 약 850건으로 추정됩니다.
  • SEER(2025년)에 따르면, 2025년에는 췌장암 신규 환자가 6만 7,440명에 달할 것으로 추정됩니다.
  • 미국 국립암연구소(2024년)에 따르면, 미국 내 난소암 신규 발병률은 여성 10만 명당 연간 10.2건이었습니다.
  • G7 국가 중 2025년 심부전 진단을 받은 환자 수는 미국이 가장 많을 것으로 예상되며, 약 748만 3,000명에 달할 것으로 전망됩니다.
  • 담관암의 경우, 전체 사례의 약 0.8%에서 NRG1 융합이 확인되었습니다.
  • 유방암 발생률은 상승 추세를 유지하며, 2012년부터 2021년까지 연간 1%의 속도로 증가했으나, 이러한 증가는 주로 국소기 및 호르몬 수용체 양성 사례에 국한되었습니다.

희귀 NRG1 융합 유전자 시장의 전망

희귀 NRG1 융합 유전자 시장은 정밀 종양학 분야에서 새롭게 부상하고 있으며 아직 거의 개척되지 않은 분야로, 종합적인 유전체 프로파일링의 보급과 치료 대상이 되는 저빈도 돌연변이의 검출 정확도 향상에 힘입어 성장하고 있습니다. 이러한 희귀성(검사 대상 검체의 약 0.2%)에도 불구하고, 비소세포폐암(NSCLC), 췌장암, 담관암 및 기타 고형암에서 NRG1 융합 유전자의 확인 사례가 증가하고 있어, 해당 검사의 대상이 될 수 있는 환자층은 점차 확대되고 있습니다.

현재 이 시장에서는 여전히 화학요법을 기반으로 한 치료법이나, HER 경로 억제제의 적응증 외 사용이 주류를 이루고 있지만, 제녹츠주맙(BIZENGRI)은 NRG1 융합 양성 비소세포폐암(NSCLC) 및 췌장암에 대해 FDA 승인을 받은 유일한 표적 치료제로 자리매김하고 있으며, 정밀 치료로의 큰 전환을 보여주고 있습니다. 그러나 전반적인 치료 옵션은 여전히 제한적이며, 임상 개발 파이프라인도 부족하기 때문에 충족되지 않은 의료 수요가 크게 부각되고 있습니다.

희귀 NRG1 융합 유전자 시장은 여전히 극히 제한적이고 취약한 임상 파이프라인에 직면해 있으며, 일부 프로그램은 초기 단계에 있거나 G7 국가 이외의 지역으로 한정되어 있습니다. 이는 이 돌연변이의 희귀성과 개발상의 과제 모두를 반영하고 있습니다. 이러한 기존의 제약 외에도, 허밍버드 바이오사이언스(Hummingbird Biosciences)가 개발 중인 임상시험용 신약 HMBD-001(도세탁셀과 병용)은 항-HER3 단일클론 항체로, NRG1 융합/ HER3 변이를 가진 비소세포폐암(NSCLC)의 2차 치료 이후(제Ib상)에서 평가가 진행되고 있습니다. 특히 주목할 점은, 이 프로그램이 주요 7개국(G7) 이외의 지역에서 연구되고 있으며, 호주를 거점으로 한 임상시험(예 : NCT05919537 및 NCT05057013)도 포함되어 있다는 점으로, 이는 그 지리적 범위가 제한적임을 더욱 부각시키고 있습니다.

동시에, 파이프라인은 더욱 축소되고 있습니다. 그 원인 중 하나로, Elevation Oncology사가 후원하던 NRG1 융합 양성 진행성 고형암을 대상으로 한 세리반타맙(NCT04383210) 임상시험이 경영상의 판단에 따라 중단된 점을 들 수 있으며, 이로 인해 이 분야의 전반적인 경쟁 구도가 약화되고 있습니다.

전반적으로, 최초의 치료제 출시, 진단 기법의 개선, 그리고 해당 질환에 대한 인식 제고에 힘입어 2022년부터 2036년까지 주요 7개국 규모의 희귀 NRG1 융합 시장은 꾸준한 성장을 이룰 것으로 예상되며, 이는 시판 제품과 신약 파이프라인 모두에 큰 상업적 영향을 미칠 것으로 전망됩니다.

  • 추산에 따르면, 희귀 NRG1 융합 비소세포폐암(NSCLC) 시장의 규모가 가장 큰 곳은 미국이며, 2025년에는 약 400만 달러에 달할 것으로 전망됩니다.
  • 2036년에는 희귀 NRG1 융합 비소세포폐암에 대한 모든 치료법 중에서, 미국에서 BIZENGRI가 가장 높은 매출을 올릴 것으로 추정됩니다.
  • EU4 국가 및 영국 중에서 2025년 희귀 NRG1 융합 비소세포폐암(NSCLC)의 시장 규모가 가장 컸던 곳은 독일이었으며, 그 다음으로 영국과 프랑스가 뒤를 이었습니다.
  • HER2-HER3를 표적으로 하는 이중특이성항체인 제녹츠즈마브(BIZENGRI)는 NRG1에 기인하는 신호 전달 및 다운스트림의 발암 경로를 억제하는, 동종 최초의 HER2-HER3 이중특이성항체입니다. 희귀 NRG1 융합 양성 암에 대해 유일하게 승인된 표적 치료제로서의 입지를 확립했으며, 이 극히 드문 종양학 분야에서 정밀 바이오로직스의 유효성을 입증하고 있습니다.
  • 재조합 HER3/NRG1 경로 조절제 : SAL007/JK07은 NRG1-HER 신호전달 축을 선택적으로 조절하도록 설계된 재조합 융합 단백질로, HER4를 통한 유익한 효과를 강화하는 동시에, HER3에 기인한 발암성 신호 전달을 억제함으로써, 종양학 및 심혈관질환 두 적응증 모두에서 그 잠재력을 입증하고 있습니다.

자주 묻는 질문

  • 희귀 NRG1 융합 비소세포폐암(NSCLC) 시장 규모는 어떻게 예측되나요?
  • NRG1 융합 양성 암의 발생률은 어떻게 되나요?
  • NRG1 융합에 대한 현재의 치료법은 무엇인가요?
  • NRG1 융합의 진단 방법은 무엇인가요?
  • NRG1 융합 관련 치료 기회는 어떻게 확대되고 있나요?
  • NRG1 융합 양성 암의 생존율은 어떻게 되나요?

목차

제1장 주요 인사이트

제2장 소개

제3장 희귀 NRG1 융합 : 시장 개요

제4장 주요 요약

제5장 희귀 NRG1 융합 : 역학 및 시장 조사 방법

제6장 주요 사건

제7장 희귀 NRG1 융합 배경과 개요

제8장 주요 7개국의 희귀 NRG1 융합 역학 및 환자 인구

제9장 환자 경과

제10장 시판 치료제

제11장 새로운 치료법

제12장 희귀 NRG1 융합 : 주요 7개국 분석

제13장 희귀 NRG1 융합 : 미충족 수요

제14장 희귀 NRG1 융합 : SWOT 분석

제15장 희귀 NRG1 융합 : KOL의 견해

제16장 희귀 NRG1 융합 : 시장 진입 및 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight 소개

KSM 26.07.20

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.

Table of Contents

1. Key Insights

2. Report Introduction

3. Rare NRG1 Fusion Market Overview at a Glance

  • 3.1. Market Share (%) Distribution of Rare NRG1 Fusion in 2025
  • 3.2. Market Share (%) Distribution of Rare NRG1 Fusion in 2036

4. Executive Summary

5. Epidemiology and Market Methodology of Rare NRG1 Fusion

6. Key Events

7. Background and Overview of Rare NRG1 Fusion

  • 7.1. Introduction
  • 7.2. Treatment

8. Epidemiology and Patient Population of Rare NRG1 Fusion in 7MM

  • 8.1. Key Findings
  • 8.2. Assumptions and Rationale: The 7MM
  • 8.3. Total Cases in Selected Indications for Rare NRG1 Fusion in the 7MM
  • 8.4. The United States
    • 8.4.1. Total Cases in Selected Indications for Rare NRG1 Fusion in the United States
    • 8.4.2. Total Eligible Patient Pool for Rare NRG1 Fusion in Selected Indications in the United States
    • 8.4.3. Total Treated Cases in Selected Indications for Rare NRG1 Fusion in the United States
  • 8.5. EU4 and the UK
    • 8.5.1. Total Cases in Selected Indications for Rare NRG1 Fusion in EU4 and the UK
    • 8.5.2. Total Eligible Patient Pool for Rare NRG1 Fusion in Selected Indications in EU4 and the UK
    • 8.5.3. Total Treated Cases in Selected Indications for Rare NRG1 Fusion in EU4 and the UK
  • 8.6. Japan
    • 8.6.1. Total Cases in Selected Indications for Rare NRG1 Fusion in Japan
    • 8.6.2. Total Eligible Patient Pool for Rare NRG1 Fusion in Selected Indications in Japan
    • 8.6.3. Total Treated Cases in Selected Indications for Rare NRG1 Fusion in Japan

9. Patient Journey

10. Marketed Therapies

  • 10.1. Marketed Competitive Landscape of Rare NRG1 Fusion
  • 10.2. Zenocutuzumab-zbco (BIZENGRI): Merus and Partner Therapeutics
    • 10.2.1. Drug Description
    • 10.2.2. Regulatory Milestones
    • 10.2.3. Other Developmental Activities
    • 10.2.4. Summary of Pivotal Trials
    • 10.2.5. Clinical Development
      • 10.2.5.1. Clinical Trial Information
    • 10.2.6. Safety and Efficacy
    • 10.2.7. Analyst Views

11. Emerging Therapies

  • 11.1. Emerging Competitive Landscape of Rare NRG1 Fusion
  • 11.2. SAL007/JK07: Salubris Pharmaceuticals
    • 11.2.1. Drug Description
    • 11.2.2. Other Developmental Activities
    • 11.2.3. Clinical Development
      • 11.2.3.1. Clinical Trials Information
    • 11.2.4. Analyst Views

12. Rare NRG1 Fusion: 7MM Analysis

  • 12.1. Key Findings
  • 12.2. Market Outlook of Rare NRG1 Fusion
  • 12.3. Key Market Forecast Assumptions
    • 12.3.1. Cost Assumptions
    • 12.3.2. Pricing Trends
    • 12.3.3. Analogue Assessment
    • 12.3.4. Launch Year and Therapy Uptakes
  • 12.4. Conjoint Analysis of Rare NRG1 Fusion
  • 12.5. Total Market Size of Rare NRG1 Fusion in the 7MM
  • 12.6. Total Market Size of Rare NRG1 Fusion by Therapies in the 7MM
  • 12.7. The United States
    • 12.7.1. Total Market Size of Rare NRG1 Fusion by Indications in the United States
    • 12.7.2. Total Market Size of Rare NRG1 Fusion by Therapies in the United States
  • 12.8. EU4 and the UK
    • 12.8.1. Total Market Size of Rare NRG1 Fusion by Indications in EU4 and the UK
    • 12.8.2. Total Market Size of Rare NRG1 Fusion by Therapies in EU4 and the UK
  • 12.9. Japan
    • 12.9.1. Total Market Size of Rare NRG1 Fusion by Indications in Japan
    • 12.9.2. Total Market Size of Rare NRG1 Fusion by Therapies in Japan

13. Unmet Needs of Rare NRG1 Fusion

14. SWOT Analysis of Rare NRG1 Fusion

15. KOL Views of Rare NRG1 Fusion

16. Market Access and Reimbursement of Rare NRG1 Fusion

  • 16.1. The United States
  • 16.2. EU4 and the UK
    • 16.2.1. Germany
    • 16.2.2. France
    • 16.2.3. Italy
    • 16.2.4. Spain
    • 16.2.5. United Kingdom
  • 16.3. Japan
  • 16.4. Summary and comparison of Market Access and Pricing Policy Developments in 2025
  • 16.5. Market Access and Reimbursement of Rare NRG1 Fusion Therapies

17. Appendix

  • 17.1. Bibliography
  • 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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