Cystic Fibrosis Market Analysis: Epidemiology Insights, Therapies, Companies, By Delveinsight Verona Pharmaceuticals, Eloxx Pharmaceuticals, Inc., Vertex Pharmaceuticals, Santhera Pharmaceuticals, L

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"Cystic fibrosis Market Analysis"Cystic Fibrosis Market Size in the 7MM was approximately USD 18,743 million in the 2023, out of which the US accounted for approximately USD 9,473 million.

Emerging therapies for cystic fibrosis (CF), including TRIKAFTA, SYMDEKO, KALYDECO, VX-121/TEZ/VX-561, Ensifentrine, and others, are expected to drive growth in the cystic fibrosis market in the coming years.

DelveInsight has released a new report titled“Cystic Fibrosis – Market Insights, Epidemiology, and Market Forecast–2034”, offering a detailed analysis of CF, covering historical and projected epidemiology as well as market trends across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

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Some of the key facts of the Cystic fibrosis Market Report:

In 2023, the cystic fibrosis (CF) market across the seven major markets (7MM) was estimated at approximately USD 18.7 billion, with the United States accounting for the largest share at around USD 9.5 billion. The U.S. market alone contributed roughly USD 7.05 billion. Market growth over the coming years is expected to be driven by the launch of new therapies and a rising prevalence of cystic fibrosis.

The increasing prevalence is influenced by greater awareness, genetic predispositions, and healthcare policy changes. As CF is caused by mutations in the CFTR gene, factors such as higher consanguinity rates may further contribute to growth between 2024 and 2034.

Existing treatments, including TRIKAFTA, SYMDEKO, and ORKAMBI (approved by the FDA and developed by Vertex Pharmaceuticals), have demonstrated clinical benefits but are not curative and may cause side effects. Combination therapies targeting multiple CFTR mutations are gaining attention to enhance outcomes. Nevertheless, high treatment costs and the absence of mutation-specific personalized therapies may constrain market expansion.

Several pipeline therapies are under investigation in the 7MM, such as Vertex Pharmaceuticals' VX-121, Verona Pharmaceuticals' Ensifentrine, and others. According to DelveInsight, the diagnosed prevalence of CF in 2023 was estimated at approximately 67,897 cases, with the U.S. reporting the highest number at around 33,391 cases, projected to increase during 2024–2034. Broader genetic testing access is expected to contribute to a rise in identified cases.

Key regulatory and developmental milestones include:

• March 2025: ReCode Therapeutics received FDA Orphan Drug Designation for RCT2100, an experimental mRNA therapy for CF.

• February 2025: Porosome Therapeutics secured FDA Orphan Drug Designation for a novel therapy targeting secretory defects in CF.

• January 2025: Lupin Limited announced tentative FDA approval for its generic Ivacaftor Oral Granules, a counterpart to Kalydeco.

• January 2025: FDA approved a new triple-combination CFTR modulator-vanzacaftor, tezacaftor, and deutivacaftor (Alyftrek)-for CF patients aged 6 and older with at least one responsive mutation, including F508del.

Key CF companies, including Verona Pharmaceuticals, Eloxx Pharmaceuticals, Vertex Pharmaceuticals, Santhera Pharmaceuticals, Laurent Pharmaceuticals, and others, are actively developing new therapies to improve the CF treatment landscape. Promising therapies include TRIKAFTA, SYMDEKO, KALYDECO, VX-121/TEZ/VX-561, Ensifentrine, among others.

Cystic fibrosis Overview

Cystic Fibrosis (CF) is a serious, life-shortening autosomal recessive genetic disorder caused by mutations in the CFTR gene on chromosome 7, which encodes an ion channel protein. The disease leads to the accumulation of thick, sticky mucus, primarily impacting the lungs and digestive system, and results in chronic respiratory infections, digestive problems, and other associated complications.

Cystic fibrosis Market Outlook

Cystic fibrosis (CF) treatment requires a comprehensive, multidisciplinary approach aimed at managing symptoms, preventing complications, and improving patients' quality of life. For respiratory challenges and bronchospasms, bronchodilators such as albuterol (Ventolin), a selective beta2-adrenoceptor agonist, are commonly prescribed to relax airway muscles and ease breathing. Other treatment strategies include airway clearance techniques, mucolytic agents, antibiotics to treat lung infections, nutritional support, and lung transplantation for advanced cases, along with innovative gene-based therapies like CFTR modulators.

The cystic fibrosis drug market is expected to grow as research progresses and new treatments emerge. Leading pharmaceutical companies in the 7MM actively developing CF therapies include Vertex Pharmaceuticals, Verona Pharma, and Eloxx Pharmaceuticals. Increased research efforts and upcoming therapeutic candidates indicate a transforming treatment landscape, with new therapies poised to deliver meaningful advancements for CF patients.

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Cystic fibrosis marketed drugs

• TRIKAFTA: Vertex Pharmaceuticals

• SYMDEKO: Vertex Pharmaceuticals

• KALYDECO: Vertex Pharmaceuticals

Cystic fibrosis Emerging Drugs

• VX-121/TEZ/ VX-561: Vertex Pharmaceuticals

• Ensifentrine: Verona Pharmaceuticals

Scope of the Cystic fibrosis Market Report

• Study Period: 2020-2034

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

• Key Cystic fibrosis Companies: Verona Pharmaceuticals, Eloxx Pharmaceuticals, Inc., Vertex Pharmaceuticals, Santhera Pharmaceuticals, Laurent Pharmaceuticals Inc., and others

• Key Cystic fibrosis Therapies: TRIKAFTA, SYMDEKO, KALYDECO, VX-121/TEZ/ VX-561, Ensifentrine, and others

• Cystic fibrosis Therapeutic Assessment: Cystic fibrosis current marketed and Cystic fibrosis emerging therapies

• Cystic fibrosis Market Dynamics: Cystic fibrosis market drivers and Cystic fibrosis market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies

• Cystic fibrosis Unmet Needs, KOL's views, Analyst's views, Cystic fibrosis Market Access and Reimbursement

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Key benefits of the Cystic fibrosis Market Report:

Cystic fibrosis market report covers a descriptive overview and comprehensive insight of the Cystic fibrosis Epidemiology and Cystic fibrosis market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).

The Cystic fibrosis market report provides insights into the current and emerging therapies.

The Cystic fibrosis market report provides a global historical and forecasted market covering drug outreach in 7MM.

The Cystic fibrosis market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Cystic fibrosis market.

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Table of Contents

1. Report Introduction

2. Executive Summary

3. SWOT analysis

4. Cystic fibrosis Patient Share (%) Overview at a Glance

5. Cystic fibrosis Market Overview at a Glance

6. Cystic fibrosis Disease Background and Overview

7. Cystic fibrosis Epidemiology and Patient Population

8. Country-Specific Patient Population of Cystic fibrosis

9. Cystic fibrosis Current Treatment and Medical Practices

10. Unmet Needs

11. Cystic fibrosis Emerging Therapies

12. Cystic fibrosis Market Outlook

13. Country-Wise Cystic fibrosis Market Analysis (2020–2034)

14. Market Access and Reimbursement of Therapies

15. Market drivers

16. Market barriers

17. Appendix

18. Cystic fibrosis Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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Cystic fibrosis Pipeline Insights, DelveInsight

"Cystic fibrosis Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Cystic fibrosis market. A detailed picture of the Cystic fibrosis pipeline landscape is provided, which includes the disease overview and Cystic fibrosis treatment guidelines.

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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