Familial Chylomicronemia Syndrome (FCS) Treatment Market to Reach $18.32 Million by 2034

Vantage Market Research releases its latest comprehensive report on the ‘Global Familial Chylomicronemia Syndrome (FCS) Treatment Market’ with a forecast period of 2025-2034. In 2023, the global polypropylene compounds market size was USD 14.99 million, and is calculated at USD 15.30 million in 2024. The market is calculated to reach USD 18.32 million in 2034, and register a revenue CAGR of 2.1% over the forecast period (2025-2034).

 

Market Overview:

Familial Chylomicronemia Syndrome (FCS), also known as also known as type 1 hyperlipoproteinemia (T1HLP), Lipoprotein Lipase Deficiency (LPLD), and familial hypertriglyceridemia, is an inherited form of Severe Hypertriglyceridemia (sHTG). FCS is an extremely rare genetic or hereditary metabolic condition, with estimated prevalence being 1 in 1 to 2 million individuals. The condition is defined by poor triglyceride metabolism, which raises chylomicrons in blood, and mutations in the genes linked to lipoprotein lipase or its regulators prevent the body from breaking down fats consumed and in the blood. Symptoms include frequent attacks of pancreatitis along with extremely high triglyceride levels. Potential indicators can include high triglyceride blood count or hypertriglyceridemia, history of abdominal pain, acute or chronic pancreatitis, diabetes or other conditions that are known to cause hypertriglyceridemia.

Lipoprotein lipase deficiency can be diagnosed at any age and affects gender, race, and ethnicity equally, and currently no pharmacologic treatment is available for affected individuals. The first line of treatment is adherence to a strict, low-fat diet, change in lifestyle habits, and avoidance of certain medications and alcohol. Volanesorsen (brand name: Waylivra), which is an antisense oligonucleotide, may represent a new therapy to reduce plasma triglyceride levels. Waylivra is the sole drug approved for treating FCS in Europe, but has not been approved by regulators in the US for FCS treatment.

In recent years, the regulatory approval of new therapies for lipoprotein lipase deficiency or FCS (such as volanesorsen) has opened up avenues for patients and healthcare providers. Ongoing clinical trials and potential future approvals for novel therapies such as gene therapies and RNA-based treatments are also contributing to increased interest in treatment options. Companies are active in the Familial Chylomicronemia Syndrome (FCS) treatment market, though this number is limited, and some are engaged in development of therapies, and seeking approval. Some positive trends in the market include ongoing R&D initiatives in FCS and genetic research,  keen focus on breakthrough in drugs and therapeutics and regulatory approvals, improved diagnostics and accuracy, increasing effects of patient advocacy networks, and rising popularity of personalized medicine.

Some Key Takeaways:

• Among the regional markets, North America familial chylomicronemia syndrome treatment market is expected to lead in terms of revenue share over the forecast period.
• Europe familial chylomicronemia syndrome treatment market also accounts for significant revenue share, with Germany and the UK contributing in terms of revenue and adoption of treatments and therapies. 
• Asia Pacific familial chylomicronemia syndrome treatment market is gaining traction, with South Korea emerging at the forefront in genetic diagnostics and rare disease R&D and related initiatives.
• Revenue share incline of the North America polypropylene compounds market is driven majorly by contribution from the US.
• The genetic FCS therapies segment among the therapeutic approach segments in the global familial chylomicronemia syndrome treatment market is expected to account for largest revenue share.
• Among the patient age group segments, the adult segment is expected to account for largest revenue, attributable to more pronounced symptoms and higher rate of diagnosis in adults.
• The chronic management therapies segment is expected to account for largest revenue share among the treatment stage segments over the forecast period.
• The hospital pharmacies segment is expected to account for largest revenue share among the application segments over the forecast period.
• The competitive landscape in the global Familial Chylomicronemia Syndrome (FCS) treatment market is moderate as the segment is niche.

Company List:

• Ionis Pharmaceuticals
• Akcea Therapeutics (subsidiary of Ionis)
• Arrowhead Pharmaceuticals
• uniQure
• Aegerion Pharmaceuticals (subsidiary of Amryt Pharma)
• Visirna Therapeutics HK Limited
• Regeneron Pharmaceuticals
• Amgen Inc.
• Sanofi S.A.
• Novartis International AG

Recent Developments:

• September 26, 2023: Ionis Pharmaceuticals, Inc. announced positive topline results for the Phase 3 Balance study of olezarsen in individuals with familial chylomicronemia syndrome. In January 2023, Ionis had received US Food and Drug Administration (FDA) Fast Track designation for its olezarsen for FCS treatment, and on June 25, 2024 US FDA accepted priority review of olezarsen for the New Drug Application (NDA). In February 2024, olezarsen was granted orphan drug designation and breakthrough therapy designation. Ionis now plans additional regulatory filings for the treatment of FCS in the European Union by 2024 end. 
• September 10, 2024: Arrowhead Pharmaceuticals, Inc. announced being granted US Food and Drug Administration (FDA) breakthrough therapy designation for plozasiran as an adjunct to diet to reduce triglycerides in adults with FCS. The Phase 3 PALISADE study of investigational plozasiran in patients with FCS successfully met its primary endpoint and all multiplicity-controlled key secondary endpoint, and the incidence of acute pancreatitis (AP). The company plans to file a New Drug Application with the US Food and Drug Administration (FDA) by 2024 end, and seek regulatory approval with additional global regulatory authorities thereafter.