Familial Chylomicronemia Syndrome Treatment Market Size in the 7MM was ~USD 15 Million in 2022, estimated DelveInsight

Familial Chylomicronemia Syndrome Treatment Market is projected to witness substantial growth over the next few years, driven by advancements in treatment modalities and increasing awareness of the condition. The pipeline for Familial Chylomicronemia Syndrome Therapeutics includes promising candidates that aim to not only treat acute attacks but also prevent recurrence.

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Key Takeaways from the Familial Chylomicronemia Syndrome Market Report

* In August 2024:- Arrowhead Pharmaceuticals- The purpose of AROAPOC3-3001 is to evaluate the efficacy and safety of ARO-APOC3 plozasiran) in adult participants with familial chylomicronemia syndrome (FCS). Participants who have met all eligibility criteria will be randomized to receive 4 doses of plozasiran or matching placebo administered subcutaneously. Participants who complete the randomized period will continue in a 2-year open-label extension period where all participants will receive plozasiran.
* According to DelveInsight's analysis, the US reported approximately 1,359 diagnosed prevalent cases of FCS in 2023, a figure projected to rise significantly from 2024 to 2034. This increase in prevalence is driven by several factors, including greater awareness of the condition, advancements in diagnostic methods, and a deeper understanding of its clinical manifestations. Additionally, broader societal trends such as the rising incidence of metabolic disorders, an aging population, and lifestyle changes like increased substance misuse contribute to this upward trend. Enhanced diagnostic capabilities have also led to a more accurate representation of FCS prevalence.
* In 2023, the US accounted for the highest diagnosed prevalent cases of FCS with approximately 1,359 cases. These cases are anticipated to increase during the forecast period.
* In 2023, there were approximately 883 diagnosed cases of FCS among individuals aged 0-17 years and nearly 476 cases among those aged 18 years and above in the US. These numbers are expected to increase by 2034.
* The leading Familial Chylomicronemia Syndrome Companies such as Ionis Pharmaceuticals Inc., Akcea Therapeutics, Novartis Pharmaceuticals, Arrowhead Pharmaceuticals, UniQure Biopharma B.V. , and others.
* Promising Familial Chylomicronemia Syndrome Therapies such as Plozasiran, VSA001, Olezarsen , and others.

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Familial Chylomicronemia Syndrome Epidemiology Segmentation in the 7MM

* Total Familial Chylomicronemia Syndrome Diagnosed Prevalent Cases in the US
* Familial Chylomicronemia Syndrome Age-specific Diagnosed Prevalent Cases

Familial Chylomicronemia Syndrome Market Insights

FCS cannot be cured, but it can be effectively managed. Treatment options for FCS can be categorized into two areas: addressing acute crises associated with pancreatitis and providing chronic management of hypertriglyceridemia to lower the risk of future episodes. Dietary modification serves as the cornerstone for managing FCS. While lifestyle changes are crucial, they are typically not enough on their own and are often complemented by lipid-lowering therapies, including fibrates, nicotinic acid, omega-3 fatty acids, and statins. Unfortunately, the lipid-lowering efficacy of these treatments in FCS often falls short of expectations and may be ineffective for many patients.

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Familial Chylomicronemia Syndrome Marketed Drugs

* WAYLIVRA (volanesorsen): Akcea Therapeutics Ireland Limited/ Ionis Pharmaceuticals

WAYLIVRA (volanesorsen) is a self-administered SC injection with a prefilled syringe with a dosage for one-time use. In February 2019, the European Medicines Agency (EMA) gave conditional marketing authorization for the drug for patients with confirmed FCS at high risk of pancreatitis. There is an inadequate response to TG reduction therapy.

Familial Chylomicronemia Syndrome Emerging Drugs

* Olezarsen: Ionis Pharmaceuticals

Olezarsen, formerly known as IONIS-APOCIII-LRx and AKCEA-APOCIII-LRx, is a ligand-conjugated (LICA) investigational antisense medicine designed to inhibit the production of Apoc-III in the liver. In January 2023, Ionis Pharmaceuticals, Inc. received FTD from the US FDA for olezarsen to treat FCS. Olezarsen is patent protected in the US and Europe until at least 2034. Olezarsen is far ahead in its clinical development and may face competition with ARO-APOC3. WAYLIVRA is another drug approved in Europe for FCS, which will compete with Olezarsen in capturing the market. The clinical trials ongoing for Olezarsen have not yet produced concrete results to predict its future.

Familial Chylomicronemia Syndrome Market Outlook

There is a lack of approved therapies for FCS in the market. Currently, no drug is approved by the United States FDA for managing FCS. Likewise, no therapy is approved in Japan as well. However, the EMA granted marketing authorization to WAYLIVRA (Volanesorsen) in the EU in May 2019. The drug has also been granted ODD by the US FDA and EMA but failed to get approval in the US. As per the ClinicalTrials.gov and additional secondary domain searches, the pipeline of FCS is not very robust. Not many companies have taken the initiative to meet the high medical requirement of this condition. But contrary to this, companies like Akcea Therapeutics, Ionis Pharmaceuticals, and Arrowhead Pharmaceuticals stepped into this field.

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Scope of the Familial Chylomicronemia Syndrome Market Report

* Coverage- 7MM
* Familial Chylomicronemia Syndrome Companies- Ionis Pharmaceuticals Inc., Akcea Therapeutics, Novartis Pharmaceuticals, Arrowhead Pharmaceuticals, UniQure Biopharma B.V., and others.
* Familial Chylomicronemia Syndrome Therapies- Plozasiran, VSA001, Olezarsen, and others.
* Familial Chylomicronemia Syndrome Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
* Familial Chylomicronemia Syndrome Unmet Needs, KOL's views, Analyst's views, Familial Chylomicronemia Syndrome Market Access and Reimbursement

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Table of Content

1 Key Insights

2 Report Introduction

3 Familial Chylomicronemia Syndrome Market Overview at a Glance

4 Epidemiology and Market Methodology

5 Executive Summary of Familial Chylomicronemia Syndrome (FCS)

6 Key Events

7 Disease Background and Overview Familial Chylomicronemia Syndrome (FCS)

8 Epidemiology and Patient Population of Familial Chylomicronemia Syndrome (FCS)

9 Patient Journey

10 Marketed Drugs

11 Emerging Drugs

12 Familial Chylomicronemia Syndrome (FCS): Seven Major Market Analysis

13 SWOT Analysis

14 Unmet Needs

15 Key Opinion Leaders' Views

16 Market Access and Reimbursement

17 Appendix

18 DelveInsight Capabilities

19 Disclaimer

20 About DelveInsight

About Us

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