Cystic Fibrosis Market Size in the 7MM was approximately USD 18,743 million in the 2023, is expected to grow by 2034, estimates DelveInsight | Chiesi Farmaceutici S.p.A., Medidata Solutions, Bayer, Verona Pharmaceuticals, Eloxx Pharmaceuticals, Inc., Vert

DelveInsight's 'Cystic Fibrosis Market Insights, Epidemiology, and Market Forecast-2034' report deliver an in-depth understanding of the Cystic Fibrosis, historical and forecasted epidemiology as well as the Cystic Fibrosis market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

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Key Takeaways from the Cystic Fibrosis Market Report
• In February 2025:- Boehringer Ingelheim:- This study is open to adult men with cystic fibrosis and adult women with cystic fibrosis who cannot have children. People with cystic fibrosis can join if they are not eligible to receive cystic fibrosis transmembrane conductance regulator modulator therapy (CFTR-MT). The purpose of this study is to find out how well a medicine called BI 3720931 is tolerated and whether it improves lung function in people with cystic fibrosis. In this study, BI 3720931 is given to humans for the first time.
• In February 2025:- Vertex Pharmaceuticals Incorporated:- The purpose of this study is to evaluate the safety, and tolerability and efficacy of VX-522 in participants 18 years of age and older with cystic fibrosis and a cystic fibrosis transmembrane conductance regulator (CFTR) genotype not responsive to CFTR modulator therapy.
• As per DeveInsight analysis, in 2023, the estimated total diagnosed prevalent cases of cystic fibrosis in the 7MM were approximately 67,897 cases in 2023. This expanded genetic testing will facilitate the identification of more individuals with cystic fibrosis, contributing to the overall increase in reported cases.
• In 2023, among the 7MM, the US accounted for the highest diagnosed prevalent cases of cystic fibrosis with approximately 33,391 cases. These cases are expected to increase during the forecast period (2024-2034).
• Among the EU4 and the UK, the UK had the highest diagnosed prevalent cases of cystic fibrosis with nearly 11,275 cases, followed by France, and Germany with approximately 7,506, and 7,043 diagnosed prevalent cases respectively.
• According to DeveInsight analysis, males accounted for more diagnosed prevalent cases of cystic fibrosis than females. In 2023, there were approximately 17,363 males and 16,027 females diagnosed with prevalent cases of cystic fibrosis in the US.
• In the epidemiological model of cystic fibrosis, cases are categorized into age groups, namely children and adults. Within the EU4 and the UK, a larger proportion of cases are reported among adults, with approximately 14,651 cases observed in children and 19,801 cases in adults.
• In 2023, Japan reported an estimated 54 diagnosed prevalent cases of cystic fibrosis. Among these cases, there were approximately 2 cases of homozygous F508del, 2 cases of heterozygous F508del, and 50 cases of other mutation type-specific diagnosed prevalent cases of cystic fibrosis. These cases are expected to increase with the improved diagnosis and screening of the disease during the forecast period (2024-2034).
• The leading Cystic Fibrosis Companies such as Chiesi Farmaceutici S.p.A., Medidata Solutions, Bayer, Verona Pharmaceuticals, Eloxx Pharmaceuticals, Inc., Vertex Pharmaceuticals, Santhera Pharmaceuticals, Laurent Pharmaceuticals Inc., and others.
• Promising Cystic Fibrosis Pipeline Therapies such as Ciprofloxacin (Cipro Inhale), BAYQ3939, P-1037, Hypertonic Saline, VX-371 + HS, inhaled mannitol, and others.

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Cystic Fibrosis Epidemiology Segmentation in the 7MM
• Cystic Fibrosis Diagnosed Prevalent Cases
• Cystic Fibrosis Age-specific Diagnosed Prevalent Cases
• Cystic Fibrosis Gender-specific Diagnosed Prevalent Cases
• Cystic Fibrosis Mutation-specific Diagnosed Prevalent Cases

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Cystic Fibrosis Marketed Drugs
• TRIKAFTA: Vertex Pharmaceuticals
TRIKAFTA is a combination of ivacaftor-a CFTR potentiator-tezacaftor, and elexacaftor indicated for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the CFTR gene. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one F508del mutation. Elexacaftor and tezacaftor bind to different sites on the CFTR protein and have an additive effect in facilitating the cellular processing and trafficking of F508del-CFTR to increase the amount of CFTR protein delivered to the cell surface compared to either molecule alone. Ivacaftor potentiates the channel open probability (or gating) of the CFTR protein at the cell surface. Furthermore, the combined effect of elexacaftor, tezacaftor, and ivacaftor increases the quantity and function of F508del-CFTR at the cell surface, resulting in increased CFTR activity as measured by CFTR-mediated chloride transport.

• SYMDEKO: Vertex Pharmaceuticals
SYMDEKO (Symkevi) is a combination of tezacaftor and ivacaftor, indicated for the treatment of patients with cystic fibrosis ages 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the CFTR gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. If the patient's genotype is unknown, an FDA-cleared cystic fibrosis mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing. Tezacaftor facilitates the cellular processing and trafficking of normal and select mutant forms of CFTR (including F508del-CFTR) to increase the amount of mature CFTR protein delivered to the cell surface. Ivacaftor is a CFTR potentiator that facilitates increased chloride transport by potentiating the channel-open probability (or gating) of the CFTR protein at the cell surface. For ivacaftor to function CFTR protein must be present at the cell surface. Ivacaftor can potentiate the CFTR protein delivered to the cell surface by tezacaftor, leading to a further enhancement of chloride transport than either agent alone. The combined effect of tezacaftor and ivacaftor is increased quantity and function of CFTR at the cell surface, resulting in increases in chloride transport.

• KALYDECO: Vertex Pharmaceuticals
KALYDECO (ivacaftor; VX-770) is a CFTR potentiator indicated for the treatment of cystic fibrosis in patients aged 6 months and older who have one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use. Ivacaftor is a potentiator of the CFTR protein. The CFTR protein is a chloride channel present at the surface of epithelial cells in multiple organs. Ivacaftor facilitates increased chloride transport by potentiating the channel open probability (or gating) of CFTR protein located at the cell surface. The overall level of ivacaftor-mediated CFTR chloride transport is dependent on the amount of CFTR protein at the cell surface and how responsive a particular mutant CFTR protein is to ivacaftor potentiation.

Cystic Fibrosis Emerging Drugs
• VX-121/TEZ/ VX-561: Vertex Pharmaceuticals
VX-121 is an orally administered small molecule, CFTR corrector that helps fix and restore the function of defective CFTR protein. In people with certain types of mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the CFTR protein is not processed and cannot move through the cell normally. The triple combination of vanzacaftor/tezacaftor/deutivacaftor is being developed as an investigational once-daily treatment for people with CF with certain mutations in the CFTR gene. The drug candidate is currently undergoing evaluation in a Phase III clinical trial. Furthermore, Vertex Pharmaceuticals is conducting trials for another potential medication, VX-522. This drug involves CFTR mRNA delivery to the lung through lipid nanoparticles, aiming to target the root cause of cystic fibrosis.

• Ensifentrine: Verona Pharmaceuticals
Ensifentrine (RPL554) is a first-in-class, inhaled, dual inhibitor of the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes, and Verona Pharma's lead pipeline asset. This dual inhibition enables it to combine bronchodilator and anti-inflammatory properties in one compound, differentiating it from existing drug classes used to treat COPD, including corticosteroids, beta2-agonists, and anti-muscarinic. The drug candidate has demonstrated positive Phase II results, ensifentrine has been shown to activate the cystic fibrosis transmembrane conductance regulator, which is beneficial in reducing mucous viscosity and improving mucociliary clearance. This suggests ensifentrine has potential as a therapy for cystic fibrosis. Additionally, ensifentrine is being investigated in non-cystic fibrosis bronchiectasis, asthma, and other respiratory diseases.

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Cystic Fibrosis Drugs Market Insights
Cystic Fibrosis treatment encompasses various pharmacological options aimed at addressing the underlying genetic defect and managing associated symptoms. The use of cystic fibrosis transmembrane conductance regulator (CFTR) protein modulators is common. Potentiators, like ivacaftor (Kalydeco), enhance the function of defective CFTR protein that has reached the cell surface, thus improving chloride ion transport. Correctors, such as lumacaftor/ivacaftor (Orkambi) and tezacaftor/ivacaftor (Symdeko/Symkevi), aid in the processing and trafficking of CFTR protein to the cell surface, thereby increasing the amount of functional CFTR protein available.

Cystic Fibrosis Companies and Therapies
• Vertex Pharmaceuticals: VX-659
• Proteostasis Therapeutics Inc.: PTI-808
• Galapagos NV: GLPG2222 50 mg
• InterMune: Interferon Gamma-1b
• Verona Pharma PLC: RPL554
• PTC Therapeutics: Ataluren

Cystic Fibrosis Drugs Uptake
• ELX-02 (NB-124) is a synthetic aminoglycoside that acts as a ribosome protein modulator. It is a eukaryotic ribosomal selective glycoside (ERSG) that has designed to increase the read-through activity in patients with nonsense mutations which enables the production of sufficient amounts of full-length functional protein to restore activity. The US FDA granted FTD for ELX-02, Eloxx Pharmaceuticals, Inc., drug candidate intended to treat cystic fibrosis patients with nonsense mutations. In addition, the FDA and European Commission granted ELX-02, ODD for the Cystic Fibrosis treatment.
• Lonodelestat (previously known as POL6014), is a highly potent and selective peptide inhibitor of human neutrophil elastase (hNE), in development for the treatment of cystic fibrosis and other neutrophilic pulmonary diseases such as non-cystic fibrosis bronchiectasis (NCFB), alpha1 antitrypsin deficiency (AATD) and primary ciliary dyskinesia (PCD). Lonodelestat has ODD for the treatment of CF as well as for AATD and PCD in both EU and US.
• LAU-7b (fenretinide) is a novel oral form of fenretinide, an atypical retinoid that acts on certain cell membrane lipids involved in both viral replication and immune-inflammatory responses. Results from a Phase Ib clinical trial in adult patients with CF have shown LAU-7b to have good safety and pharmacokinetic profiles, coupled with promising pharmacodynamics on specific markers of inflammation. Currently, Laurent Pharma has completed two Phase II clinical studies with LAU-7b, a first-in-class pro-resolving drug candidate, in cystic fibrosis and COVID-19.

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Scope of the Cystic Fibrosis Market Research Report
• Coverage- 7MM
• Cystic Fibrosis Companies- Chiesi Farmaceutici S.p.A., Medidata Solutions, Bayer, Verona Pharmaceuticals, Eloxx Pharmaceuticals, Inc., Vertex Pharmaceuticals, Santhera Pharmaceuticals, Laurent Pharmaceuticals Inc., and others.
• Cystic Fibrosis Pipeline Therapies- Ciprofloxacin (Cipro Inhale), BAYQ3939, P-1037, Hypertonic Saline, VX-371 + HS, inhaled mannitol, and others.
• Cystic Fibrosis Market Dynamics: Cystic Fibrosis Market Drivers and Barriers
• Cystic Fibrosis Market Access and Reimbursement, Unmet Needs, and Future Perspectives

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Table of Content
1. Key Insights
2. Cystic Fibrosis Report Introduction
3. Cystic Fibrosis Market Overview at a Glance
4. Cystic Fibrosis Market: Future Perspective
5. Cystic Fibrosis Executive Summary
6. Key Events
7. Cystic Fibrosis Disease Background and Overview
8. Cystic Fibrosis Epidemiology and Patient Population
9. Patient Journey
10. Cystic Fibrosis Marketed Drugs
11. Cystic Fibrosis Emerging Drugs
12. Cystic Fibrosis: Seven Major Market Analysis
13. Key Opinion Leaders' View
14. Cystic Fibrosis Market Drivers
15. Cystic Fibrosis Market Barriers
16. Cystic Fibrosis SWOT Analysis
17. Cystic Fibrosis Unmet Needs
18. Reimbursement and Cystic Fibrosis Market Access
19. Appendix
20. DelveInsight Capabilities
21. Disclaimer
22. About DelveInsight

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