The Neurofibromatosis type 1-associated Plexiform Neurofibromas market across the 7MM is expected to surge owing to an increased awareness, advancements in diagnostic techniques, greater accessibility to genetic testing, and the emergence of new transformative treatments such as KOSELUGO (AstraZeneca and Merck), Mirdametinib (SpringWorks Therapeutics), HLX-1502 (Healx), FCN-159 (Fosun Pharmaceutical), and AS-004 (Pasithea Therapeutics).

DelveInsight’s report titled “Neurofibromatosis Type 1-associated Plexiform Neurofibromas (NF1-PN): Market Insights, Epidemiology, and Market Forecast – 2034” offers comprehensive epidemiological data along with insights into market trends, an analysis of the competitive landscape, current and emerging therapeutic approaches, and assessments of the patient journey concerning NF1-PN, a rare disease.

The report forecasts that the NF1-PN market across the 7MM, which includes the United States, the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan, will grow from ~USD 380 million in 2023 at a considerable CAGR by 2034. This anticipated growth is attributed to ongoing research into the genetic underpinnings of these tumors, the availability of medical therapy as an alternative to surgery, improvements in administration ease, and a decrease in side effect profiles of emerging therapies.

According to the report, the United States consistently holds the highest market share among the 7MM, with around USD 230 million in 2023.

The report provides a detailed epidemiological analysis and forecasts up to 2034, segmented by total NF1 diagnosed prevalent cases, diagnosed cases of NF1 manifestations, age-specific NF1-PN diagnosed cases, NF1-PN cases by clinical symptoms, and NF1-PN cases eligible for surgery in the 7MM. In 2023, the majority of diagnosed NF1-PN patients were estimated to be in the US, followed by Germany.

Current NF1-PN treatment practices, emerging drugs, market shares of individual therapies, and unmet medical needs from 2020 to 2034 are also addressed in the report. While surgery remains a standard treatment for many patients, it is often complex, not always feasible, carries inherent risks, and has a high possibility of tumor recurrence. A multidisciplinary approach involving genetics, neurology, radiology, and surgery, is vital for effectively managing the disease’s physical and emotional impacts.

With an improved understanding of the genetic basis of plexiform neurofibromas, targeted therapies like the MEK inhibitor KOSELUGO (AstraZeneca and Merck) have emerged as promising options, especially for pediatric patients with inoperable NF1-PN. Building on this progress, researchers are exploring other MEK inhibitors for potential use in both pediatric and adult patients.

The current NF1-PN developmental pipeline includes additional MEK inhibitors such as Mirdametinib (SpringWorks Therapeutics), FCN-159 (Fosun Pharmaceutical), and PAS-004 (Pasithea Therapeutics). Another emerging drug, HLX-1502 (Healx), offers a unique investigational treatment option for NF1 patients. In October 2024, the US FDA granted Fast Track Designation (FTD) to HLX-1502 for the treatment of NF1.

Recent developments include findings for PAS-004, which demonstrated no dose-limiting toxicities in Phase 1 clinical trials. An external Safety Review Committee recommended proceeding with its higher doses without modification in February 2025, highlighting the potential of these emerging therapies to revolutionize NF1-PN treatment.

Although NF1-PN presents significant challenges due to its highly individualized treatment needs—including multidisciplinary teamwork, tumor regrowth, and complications arising from tumors developing in critical areas like the head, neck, chest, or spine—the emergence of novel therapies as an alternative to surgery, improving administration ease and minimize side effects, is expected to broaden treatment options and enhance market growth.

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