Neurofibromatosis Type 1-Associated Plexiform Neurofibromas (NF1-PN) Market Poised for Transformation with FDA Approvals and Expanding Pipeline, Finds DelveInsight

Neurofibromatosis Type 1-Associated Plexiform Neurofibromas (NF1-PN) Market Summary
NF1-PN Market Set to Grow Beyond USD 380 Million by 2034 driven by rising diagnosed cases, better awareness, advanced diagnostics, and genetic testing. In the US alone, ~97,000 diagnosed NF1 cases were reported in 2023, expected to increase by 2034. Treatment remains challenging-surgery is often complex, risky, and prone to recurrence, leaving significant unmet needs, especially in pediatric patients with inoperable PNs. Current care is limited, with KOSELUGO approved only for children, creating a treatment gap for adults.

The FDA's approval of SpringWorks' Gomekli (mirdametinib) marks progress, showing promise as a first-in-class adult therapy and a best-in-class pediatric option. Multiple companies, including AstraZeneca, Merck, Healx, and Fosun Pharma, are advancing MEK inhibitors and next-generation candidates like FCN-159 and PAS-004. This evolving pipeline underscores urgent demand for safer, more effective, and widely accessible NF1-PN therapies.

The Neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) market is entering a new growth phase, driven by improved diagnosis, recent FDA approvals, and an expanding pipeline of therapies designed to address a long-standing unmet need. According to DelveInsight's "NF1-PN Market Insights, Epidemiology, and Market Forecast 2034" report, the total NF1-PN market across the 7MM (United States, EU4, UK, and Japan) was valued at around USD 380 million in 2023 and is expected to grow steadily throughout the forecast period (2020-2034).

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Key facts of the Neurofibromatosis Type 1-Associated Plexiform Neurofibromas (NF1-PN) Market Report are:
• NF1-PN Market Set to Grow Beyond USD 380 Million by 2034
• Leading Neurofibromatosis Type 1-Associated Plexiform Neurofibromas (NF1-PN) companies working in the market are AstraZeneca, Merck, SpringWorks Therapeutics, Pasithea Therapeutics, Healx, Fosun Pharmaceutical, and others.
• Key NF1-PN Therapies expected to launch in the market are HLX-1502, Mirdametinib, KOSELUGO (selumetinib), FCN-159, Mirdametinib (PD-0325901), PAS-004, and others.
• In September 2025, the FDA approved selumetinib (KOSELUGO, AstraZeneca) granules and capsules for pediatric patients aged 1 and older with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PN). Previously, selumetinib capsules were approved for children aged 2 and older with the same condition.
• In February 2025, Springworks Therapeutics Inc. received its second FDA approval since spinning out of Pfizer in 2017. The company aims to position Gomekli (mirdametinib), approved for neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) that cannot be fully resected, as a first-in-class treatment for adults and a potential best-in-class option for children.
• In November 2024, AstraZeneca and Merck announced positive topline results from the Phase III KOMET trial in adults with NF1 who have symptomatic, inoperable plexiform neurofibromas, and the companies plan to share these findings with regulatory authorities and present them at an upcoming medical meeting.

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Neurofibromatosis Type 1-Associated Plexiform Neurofibromas (NF1-PN) Epidemiology
In 2023, the US reported the highest number of NF1-PN cases among the 7MM, with ~39,000 diagnosed prevalent cases, projected to rise over time. Within the EU4 and the UK, Germany recorded the highest burden, while the UK had the lowest. In the US, around 30% of NF1-PN cases were children and 70% were adults in 2020. Japan reported 5,500 operable and 3,900 inoperable NF1-PN cases in 2023, both expected to increase during the forecast period.

Rising Burden of NF1-PN across Key Markets
• In 2023, approximately 97,000 diagnosed prevalent cases of NF1 were reported in the US.
• NF1 prevalence is expected to rise through 2034, driven by greater awareness, improved imaging, and access to genetic testing.
• Plexiform neurofibromas (PNs) occur in 30-50% of NF1 patients, often identified via whole-body MRI.
• The disease significantly impacts children transitioning to adult care, posing challenges in continuity, access, and multidisciplinary management.

Neurofibromatosis Type 1-Associated Plexiform Neurofibromas (NF1-PN) Epidemiology Segmentation
• Total Diagnosed Prevalent Cases of NF1
• Diagnosed Prevalent Cases of NF1 Manifestations
• Age-specific Diagnosed Prevalent Cases of NF1-PN
• NF1-PN Cases by Clinical Symptoms
• NF1-PN Cases Eligible for Surgery

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Neurofibromatosis Type 1-Associated Plexiform Neurofibromas (NF1-PN) Competitive Landscape
Marketed NF1-PN Drug
• KOSELUGO (selumetinib) - AstraZeneca & Merck
KOSELUGO, a MEK1/2 inhibitor, blocks overactive enzymes driving tumor growth in NF1, thereby slowing tumor progression. Approved by the FDA in April 2020 for children aged 2+ with symptomatic, inoperable plexiform neurofibromas, it later received conditional approval in the EU (2021) and approval in Japan (2022) for pediatric patients aged 3+. The drug holds ODD, BTD, and Rare Pediatric Disease designations. In November 2024, AstraZeneca and Merck reported positive Phase III KOMET trial results in adults with symptomatic, inoperable PN, with regulatory submissions planned.

Emerging NF1-PN Drugs
• Mirdametinib (SpringWorks Therapeutics):
An oral MEK1/2 inhibitor in development for NF1-PN, low-grade glioma, and select solid tumors. The FDA accepted its NDA in July 2024, granting Priority Review with a PDUFA date of February 28, 2025. European approval is also targeted for 2025.
• HLX-1502 (Healx):
An oral therapy offering a differentiated approach for NF1 patients with inoperable plexiform neurofibromas. Healx received FDA IND clearance to begin Phase II trials and, in October 2024, secured Fast Track Designation (FTD) for HLX-1502.

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NF1-PN Market Outlook
In 2023, the NF1-PN market size across the 7MM was USD 380 million, with the US leading at USD 230 million. Germany held the largest EU share. By 2034, mirdametinib is projected to dominate the NF1-PN market.
The NF1-PN treatment landscape has traditionally relied on surgery, including complete resection or debulking. However, around 50% of tumors are inoperable due to size, invasiveness, or location near vital structures, limiting options to symptomatic management. Even when surgery is possible, complete removal is rare, and recurrence is common.
A major breakthrough came in 2020 with the FDA approval of KOSELUGO, a MEK1/2 inhibitor, as the first targeted therapy for pediatric patients with symptomatic, inoperable NF1-PN. This shifted the paradigm from solely surgical management to targeted drug therapies.
The pipeline is now expanding with promising drugs like mirdametinib (SpringWorks Therapeutics), HLX-1502 (Healx), and FCN-159 (Fosun Pharmaceutical), expected to transform outcomes further.

Neurofibromatosis Type 1-Associated Plexiform Neurofibromas (NF1-PN) Unmet Needs and Market Opportunities
Despite progress, several gaps remain:
• Limited therapies for adults (until mirdametinib approval).
• High economic burden and geographic disparities in care.
• Challenges in transitioning pediatric patients to adult care.
• Psychosocial struggles including pain, cognitive difficulties, and stigma.
This opens avenues for novel therapies, digital health tools, and multidisciplinary care models to redefine patient outcomes.

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Expert Insights on NF1-PN Treatment Advances
"Novel targeted therapies, including MEK inhibitors and cabozantinib, have revolutionized NF1-PN treatment-not only by inducing tumor shrinkage but also by improving pain and quality of life with manageable toxicity," said a leading oncology expert from Spain.
In Germany, a neuro-oncologist added:
"Effective targeted therapies are now available, but their use requires careful multidisciplinary evaluation to ensure patient-specific decisions and equitable access."

About the Report: NF1-PN Market Insights, Epidemiology and Market Forecast - 2034
The report offers:
• Comprehensive market analysis across 7MM (US, EU4, UK, Japan).
• Epidemiology trends segmented by manifestations, age groups, clinical symptoms, and surgical eligibility.
• Current treatment practices and evolving guidelines.
• Drug profiles and pipeline analysis (KOSELUGO, mirdametinib, HLX-1502, FCN-159, PAS-004).
• Qualitative insights: SWOT, conjoint analysis, patient journey mapping.
• Market access & reimbursement dynamics.
• KOL interviews and expert validation to ensure real-world insights.

Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679

About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

This release was published on openPR.