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
NRG Fusion Report
Metrics
|
Details
|
Study Period
|
2020–2034
|
NRG Fusion
Report Coverage
|
7MM [the United States,
the EU4 (Germany, France, Italy, and Spain), the United Kingdom,
and Japan]
|
Key NRG Fusion
Companies
|
Merus, Hummingbird
Bioscience, Salubris Biotherapeutics, Elevation Oncology, and
others
|
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
1.
|
Key Insights
|
2.
|
Report
Introduction
|
3.
|
Executive Summary of
NRG Fusion
|
4.
|
Key Events
|
5.
|
Market Forecast
Methodology
|
6.
|
NRG Fusion Market
Overview at a Glance in the 7MM
|
6.1.
|
Market Share (%)
Distribution by Therapies in 2020
|
6.2.
|
Market Share (%)
Distribution by Therapies in 2034
|
7.
|
NRG Fusion: Background
and Overview
|
7.1.
|
Introduction
|
7.2.
|
Treatment
|
8.
|
Target Patient
Pool
|
8.1.
|
Key Findings
|
8.2.
|
Assumptions and
Rationale: 7MM
|
8.3.
|
Epidemiology Scenario
in the 7MM
|
8.3.1.
|
Total Cases in Selected
Indications for NRG Fusion in the 7MM
|
8.3.2.
|
Total Eligible Patient
Pool for NRG Fusion in Selected Indications in the 7MM
|
8.3.3.
|
Total Treated Cases in
Selected Indications for NRG Fusion in the 7MM
|
9.
|
Emerging
Therapies
|
9.1.
|
Key
Competitors
|
9.2.
|
Zenocutuzumab
(MCLA-128): Merus
|
9.2.1.
|
Product
Description
|
9.2.2.
|
Other developmental
activities
|
9.2.3.
|
Clinical
development
|
9.2.4.
|
Safety and
efficacy
|
9.3.
|
Zenocutuzumab
(MCLA-128): Hummingbird Biosciences
|
9.3.1.
|
Product
Description
|
9.3.2.
|
Other developmental
activities
|
9.3.3.
|
Clinical
development
|
9.3.4.
|
Safety and
efficacy
|
10.
|
NRG Fusion: Seven Major
Market Analysis
|
10.1.
|
Key Findings
|
10.2.
|
Market
Outlook
|
10.3.
|
Conjoint
Analysis
|
10.4.
|
Key Market Forecast
Assumptions
|
10.4.1.
|
Cost Assumptions and
Rebates
|
10.4.2.
|
Pricing
Trends
|
10.4.3.
|
Analogue
Assessment
|
10.4.4.
|
Launch Year and Therapy
Uptakes
|
10.5.
|
Total Market Size of
NRG Fusion in the 7MM
|
10.6.
|
Market Size of NRG
Fusion by Indication in the7MM
|
10.7.
|
The United States
Market Size
|
10.7.1.
|
Total Market Size of
NRG Fusion in the United States
|
10.7.2.
|
Market Size of NRG
Fusion by Indication in the United States
|
10.7.3.
|
Market Size of NRG
Fusion by Therapies in the United States
|
10.8.
|
EU4 and the UK Market
Size
|
10.8.1.
|
Total Market Size of
NRG Fusion in EU4 and the UK
|
10.8.2.
|
Market Size of NRG
Fusion by Indication in EU4 and the UK
|
10.8.3.
|
Market Size of NRG
Fusion by Therapies in EU4 and the UK
|
10.9.
|
Japan Market
Size
|
10.9.1.
|
Total Market Size of
NRG Fusion in Japan
|
10.9.2.
|
Market Size of
NRG Fusion by Indication in Japan
|
10.9.3.
|
Market Size of NRG
Fusion by Therapies in Japan
|
11.
|
Market Access and
Reimbursement
|
12.
|
SWOT
Analysis
|
13.
|
KOL Views
|
14.
|
Unmet Needs
|
15.
|
Appendix
|
16.
|
Bibliography
|
17.
|
Report
Methodology
|
18.
|
DelveInsight
Capabilities
|
19.
|
Disclaimer
|
20.
|
About
DelveInsight
|
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