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Neurofibromatosis Type 1-Associated Plexiform Neurofibromas (NF1-PN) Market to Reach USD 2.3 Billion by 2034

09-10-2025 02:20 PM CET | Health & Medicine

Press release from: Exactitude Consultancy

Neurofibromatosis Type 1-Associated Plexiform Neurofibromas (NF1-PN)

Neurofibromatosis Type 1-Associated Plexiform Neurofibromas (NF1-PN)

Neurofibromatosis type 1 (NF1) is a rare, genetic tumor predisposition disorder caused by mutations in the NF1 gene. Among its manifestations, plexiform neurofibromas (PNs) are one of the most severe complications. These benign but often disfiguring and painful tumors can cause neurological impairment, airway obstruction, spinal deformities, and malignant transformation in rare cases.

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Until recently, management relied on surgery, which is often risky and incomplete. The approval of MEK inhibitors has transformed the treatment landscape, offering the first targeted therapies for NF1-PN. Combined with genetic testing, patient advocacy, and growing clinical research, the NF1-PN market is set for strong expansion over the next decade.

Market Overview
• Market Size (2024): USD 1.05 billion
• Forecast (2034): USD 2.3 billion
• CAGR (2025-2034): 8.1%

The NF1-PN market is entering a growth phase as MEK inhibitors such as selumetinib (Koselugo) gain adoption, supported by global rare disease programs and increased clinical trial activity.

Key Highlights:
• Selumetinib is the first FDA- and EMA-approved therapy for NF1-PN.
• Strong pipeline of MEK inhibitors and other targeted therapies.
• Expanding genetic diagnostics improving early detection.
• Patient advocacy groups driving awareness and trial recruitment.

Segmentation Analysis
By Product Type:
• Targeted Therapies
o MEK Inhibitors (Selumetinib, Mirdametinib, Trametinib - pipeline/repurposed)

• Surgical Interventions
o Tumor Resection (limited use due to complexity)

• Supportive Care
o Pain Management
o Physiotherapy & Rehabilitation

• Genetic Testing & Counseling Services

By Platform:
• Small Molecules
• Biologics
• Genetic Testing Platforms

By Technology:
• Molecular Targeted Therapy Platforms
• AI-Driven Imaging & Tumor Monitoring
• Next-Gen Genetic Sequencing

By End Use:
• Hospitals
• Specialty Oncology & Neurology Clinics
• Research Institutes
• Genetic Counseling Centers

By Application:
• Pediatric NF1-PN Patients
• Adult NF1-PN Patients
• Clinical Research

Segmentation Summary:
Targeted therapies, led by MEK inhibitors, dominate the current market. Genetic testing and AI imaging technologies are expanding patient identification and monitoring, while supportive care remains essential in comprehensive management.

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Regional Analysis
North America
• Largest market with ~49% share in 2024.
• U.S. leads with FDA approval of selumetinib and strong insurance coverage for rare diseases.
• Well-developed patient registries and advocacy networks.
Europe
• Holds ~30% share.
• EMA approval of selumetinib driving adoption in Germany, UK, and France.
• Strong role of rare disease research initiatives and clinical trials.
Asia-Pacific
• Fastest-growing region with CAGR of ~9.4%.
• Japan, China, and India expanding genetic diagnostics and rare disease care.
• Growing clinical research participation and registry development.
Middle East & Africa
• Smaller market due to limited infrastructure.
• Gradual expansion of tertiary oncology centers.
Latin America
• Brazil and Mexico drive regional demand.
• Expanding access to MEK inhibitors and diagnostic tools.
Regional Summary:
North America and Europe dominate due to early therapy approvals and established rare disease frameworks, while Asia-Pacific represents the fastest growth opportunity with expanding awareness and healthcare access.

Market Dynamics
Key Growth Drivers:
• FDA/EMA approval of selumetinib creating a new treatment paradigm.
• Rising investment in MEK inhibitor pipelines.
• Expansion of genetic testing and counseling programs.
• Patient advocacy groups accelerating awareness and support.

Key Challenges:
• High cost of targeted therapies limiting access.
• Lifelong management required due to tumor recurrence risk.
• Limited availability of treatments in emerging economies.
• Small patient pool restricting large-scale commercial investment.

Latest Trends:
• Development of next-generation MEK inhibitors with improved tolerability.
• AI-assisted MRI for tumor growth monitoring.
• Research into combination regimens for NF1-PN management.
• Increasing collaboration between biotech firms and academic centers.

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Competitor Analysis
Major Players in the Market:
• AstraZeneca plc (Selumetinib/Koselugo)
• SpringWorks Therapeutics (Mirdametinib - pipeline)
• Novartis AG (Trametinib - repurposed research)
• Roche Holding AG
• Pfizer Inc.
• Bristol Myers Squibb (BMS)
• Eli Lilly and Company
• Amgen Inc.
• Illumina, Inc. (genetic diagnostics)
• Quest Diagnostics

Competitive Summary:
AstraZeneca leads the NF1-PN market with selumetinib, the first approved targeted therapy. SpringWorks is advancing mirdametinib in late-stage trials, while Novartis explores trametinib's potential. Diagnostics players like Illumina and Quest support patient identification. Competition is focused on next-gen MEK inhibitors, combination therapies, and global expansion.

Conclusion
The Neurofibromatosis Type 1-Associated Plexiform Neurofibromas (NF1-PN) Market, valued at USD 1.05 billion in 2024, is projected to reach USD 2.3 billion by 2034, growing at a CAGR of 8.1%. The market is being reshaped by targeted therapies, genetic diagnostics, and patient advocacy, offering new hope to patients worldwide.

Key Takeaways:
• Selumetinib has established a new treatment standard for NF1-PN.
• North America and Europe dominate, while Asia-Pacific grows fastest.
• Genetic testing and AI imaging are improving diagnosis and monitoring.
• Next-gen MEK inhibitors and combination regimens represent the future.

The next decade will see NF1-PN management evolve from surgical reliance to precision-targeted therapies and AI-driven monitoring, creating strong opportunities for pharmaceutical innovators, diagnostics firms, and healthcare providers.

This report is also available in the following languages : Japanese (神経線維腫症1型関連叢状神経線維腫(NF1-PN)市場), Korean (1형 신경섬유종증 관련 총상신경섬유종(NF1-PN) 시장), Chinese (1 型神经纤维瘤病相关丛状神经纤维瘤 (NF1-PN) 市场), French (Marché des neurofibromes plexiformes associés à la neurofibromatose de type 1 (NF1-PN)), German (Markt für plexiforme Neurofibrome (NF1-PN) im Zusammenhang mit Neurofibromatose Typ 1), and Italian (Mercato dei neurofibromi plessiformi associati alla neurofibromatosi di tipo 1 (NF1-PN)), etc.

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About Us
Exactitude Consultancy is a market research & consulting services firm which helps its client to address their most pressing strategic and business challenges. Our market research helps clients to address critical business challenges and also helps make optimized business decisions with our fact-based research insights, market intelligence, and accurate data.
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