Cystic Fibrosis Market Poised for Growth During the Forecast Period (2026-2036) as CFTR Modulators Transform Treatment Landscape | DelveInsight
DelveInsight's analysis predicts significant growth in the cystic fibrosis market from 2026 to 2036, driven by the launch of emerging therapies such as Lonodelestat (Spexis), LAU-7b (Laurent Pharmaceuticals), ARCT-032 (Arcturus Therapeutics), 4D-710 (4D Molecular Therapeutics), KB407 (Krystal Biotech), and others, and increased global healthcare spending. The introduction of new treatments and rising healthcare investments will expand market opportunities and improve patient outcomes.
LAS VEGAS, Oct. 21, 2026 /PRNewswire/ -- Recently published Cystic Fibrosis Market Insights report includes a comprehensive understanding of current treatment practices, cystic fibrosis emerging drugs, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Cystic Fibrosis Market Summary
Discover the future of the cystic fibrosis therapeutics market @ https://www.delveinsight.com/report-store/cystic-fibrosis-market
Key Factors Driving the Growth of the Cystic Fibrosis Market
Shikha Bhardwaj, Associate Consultant of Forecasting & Analytics at DelveInsight, said, "ALYFTREK demonstrates strong clinical and commercial value, with the potential to deliver improved patient outcomes and convenient once-daily dosing, supported by rapid NHS access and reimbursement agreements that are enhancing adoption."
Cystic Fibrosis Market Analysis
Cystic Fibrosis Competitive Landscape
Some of the cystic fibrosis drugs under development include Lonodelestat (Spexis), LAU-7b (Laurent Pharmaceuticals), ARCT-032 (Arcturus Therapeutics), 4D-710 (4D Molecular Therapeutics), KB407 (Krystal Biotech), SPL84 and SPL23 (SpliSense), RCT2100 (ReCode Therapeutics), Ivacaftor (Vertex Pharmaceuticals), and others.
Spexis' Lonodelestat is an investigational inhaled therapy designed to inhibit neutrophil elastase, an enzyme associated with pulmonary inflammation and tissue damage in patients with cystic fibrosis. By blocking neutrophil elastase activity, Lonodelestat is intended to reduce lung inflammation and potentially preserve or improve pulmonary function. The therapy is currently being evaluated in Phase II clinical trials to assess its safety and efficacy in cystic fibrosis. Findings from these studies will help determine its potential for further development, regulatory approval, and clinical use.
Laurent Pharmaceuticals' LAU-7b (fenretinide) is a novel oral formulation of fenretinide, an atypical retinoid that modulates specific cell membrane lipids involved in viral replication and immune-inflammatory pathways. As the company's lead drug candidate, LAU-7b is a patent-protected oral formulation designed to support a convenient once-daily, low-dose treatment regimen. The candidate has completed Phase II clinical development for cystic fibrosis.
Arcturus Therapeutics' ARCT-032 is an investigational inhaled mRNA therapy delivered using LUNAR, a lipid-mediated delivery platform that encapsulates mRNA within lipid nanoparticles. In February 2024, the European Commission granted Orphan Medicinal Product Designation to ARCT-032 for the treatment of cystic fibrosis following a positive opinion from the European Medicines Agency. The candidate had previously received Rare Pediatric Disease Designation from the FDA in October 2023 and Orphan Drug Designation in November 2023. In October 2025, the company reported interim results from its ongoing Phase II clinical trial evaluating ARCT-032 in patients with cystic fibrosis.
4D Molecular Therapeutics' 4D-710 is an investigational genetic medicine candidate that utilizes the A101 vector to target the underlying cause of cystic fibrosis lung disease. The candidate is being evaluated in a Phase 1/2 clinical study in patients with cystic fibrosis who are ineligible for CFTR modulator therapy or have discontinued treatment because of adverse effects. 4D-710 is designed for single-dose aerosol administration to deliver a corrective CFTRΔR transgene throughout the airways and alveoli. Its mutation-agnostic approach is intended to provide a disease-modifying effect regardless of the patient's specific CFTR mutation.
The anticipated launch of these emerging therapies are poised to transform the cystic fibrosis market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the cystic fibrosis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about the cystic fibrosis treatment pipeline @ Cystic Fibrosis Drug Pipeline
Cystic Fibrosis Epidemiology Segmentation
The cystic fibrosis epidemiology section provides insights into the historical and current cystic fibrosis patient pool and forecasted trends for the leading markets. Recent trends in cystic fibrosis indicate that Staphylococcus aureus and Pseudomonas aeruginosa remain the most prevalent pathogens, driving a large share of infections.
The cystic fibrosis treatment market report proffers epidemiological analysis for the study period 2022–2036 in the leading markets, segmented into:
Cystic Fibrosis Market Report Metrics
Details
Study Period
2022–2036
Coverage
7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Cystic Fibrosis Epidemiology Segmentation
Diagnosed Prevalent Cases of Cystic Fibrosis, Gender-specific Diagnosed Prevalent Cases of Cystic Fibrosis, Age-specific Diagnosed Prevalent Cases of Cystic Fibrosis, Mutation-specific Diagnosed Prevalent Cases of Cystic Fibrosis, and Microorganism-specific Diagnosed Prevalent Cases of Cystic Fibrosis
Key Cystic Fibrosis Companies
Spexis, Laurent Pharmaceuticals, Arcturus Therapeutics, 4D Molecular Therapeutics, Krystal Biotech, SpliSense, ReCode Therapeutics, Vertex Pharmaceuticals, and others
Key Cystic Fibrosis Therapies
Lonodelestat, LAU-7b, ARCT-032, 4D-710, KB407, SPL84, SPL23, RCT2100, Ivacaftor, ALYFTREK, TRIKAFTA, SYMDEKO, ORKAMBI, and others
Scope of the Cystic Fibrosis Market Report
Download the report to understand the cystic fibrosis pipeline @ Cystic Fibrosis Clinical Trials
Table of Contents
1
Cystic Fibrosis Market Key Insights
2
Cystic Fibrosis Market Report Introduction
3
Executive Summary
4
Key Events
5
Epidemiology and Market Forecast Methodology
6
Cystic Fibrosis Market Overview at a Glance
6.1
Clinical Landscape Analysis (By Mechanism of Action [MoA] and Molecule Type)
6.2
Market Share (%) Distribution of Cystic Fibrosis in 2025
6.3
Market Share (%) Distribution of Cystic Fibrosis in 2036
7
Disease Background and Overview
7.1
Introduction
7.2
Signs and Symptoms
7.3
Causes
7.4
Related Conditions
7.5
Etiology
7.6
Risk Factors
7.7
Pathophysiology
7.8
Complications
7.9
Diagnosis
7.10
Management and Treatment
8
Epidemiology and Patient Population
8.1
Key Findings
8.2
Assumptions and Rationale: The 7MM
8.3
Total Diagnosed Prevalent Cases of Cystic Fibrosis in the 7MM
8.4
The US
8.4.1
Diagnosed Prevalent Cases of Cystic Fibrosis in the US
8.4.2
Gender-specific Diagnosed Prevalent Cases of Cystic Fibrosis in the US
8.4.3
Age-specific Diagnosed Prevalent Cases of Cystic Fibrosis in the US
8.4.4
Mutation-specific Diagnosed Prevalent Cases of Cystic Fibrosis in the US
8.4.5
Microorganism-specific Diagnosed Prevalent Cases of Cystic Fibrosis in the US
8.5
EU4 and the UK
8.6
Japan
9
Patient Journey of Cystic Fibrosis
10
Marketed Cystic Fibrosis Drugs
10.1
Marketed Key Cross
10.2
ALYFTREK: Vertex Pharmaceuticals
10.2.1
Product Description
10.2.2
Regulatory Milestones
10.2.3
Other Developmental Activities
10.2.4
Clinical Trial Information
10.2.5
Safety And Efficacy
10.3
TRIKAFTA: Vertex Pharmaceuticals
10.4
SYMDEKO: Vertex Pharmaceuticals
10.5
ORKAMBI: Vertex Pharmaceuticals
List to be continued in the report
11
Emerging Cystic Fibrosis Drugs
11.1
Key Cross Competition
11.2
LAU-7b: Laurent Pharmaceuticals
11.2.1
Product Description
11.2.2
Other Development Activities
11.2.3
Clinical Trial Information
11.2.4
Safety And Efficacy
11.2.5
Analyst's Views
11.3
Lonodelestat: Spexis
11.4
ARCT-032: Arcturus Therapeutics
List to be continued in the report
12
Cystic Fibrosis Market Analysis
12.1
Key Findings
12.2
Key Cystic Fibrosis Market Forecast Assumptions
12.3
Cystic Fibrosis Market Outlook
12.4
Conjoint Analysis
12.5
Total Market Size of Cystic Fibrosis in the 7MM
12.6
Total Market Size of Cystic Fibrosis by Therapies in the 7MM
12.7
Market Size of Cystic Fibrosis in the US
12.7.1
Total Market Size of Cystic Fibrosis
12.7.2
The Market Size of Cystic Fibrosis by Therapies
12.8
Market Size of Cystic Fibrosis in EU4 and the UK
12.9
Market Size of Cystic Fibrosis in Japan
13
KOL Opinion Leaders' Views of Cystic Fibrosis
14
SWOT Analysis of Cystic Fibrosis
15
Unmet Needs of Cystic Fibrosis
16
Market Access and Reimbursement
16.1
The US
16.2
In EU4 and the UK
16.3
Japan
16.4
Summary and Comparison of Market Access and Pricing Policy Developments in 2025
16.5
Market Access and Reimbursement of Cystic Fibrosis Therapies
17
Bibliography
18
Acronyms and Abbreviations
19
Cystic Fibrosis Market Report Methodology
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