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United States Cystic Fibrosis Market NEWS 2025: FDA Approval of VX-548 by Vertex Pharmaceuticals Expands Treatment Eligibility for Cystic Fibrosis Patients with Rare Mutations

09-24-2025 02:50 PM CET | Health & Medicine

Press release from: DataM Intelligence 4market Research LLP

Cystic Fibrosis Market

Cystic Fibrosis Market

The Global Cystic Fibrosis Market reached USD 10.96 billion in 2023 and is expected to reach USD 26.58 billion by 2031, growing at a CAGR of 11.8% during the forecast period 2024-2031.

The cystic fibrosis market is centered on therapies, diagnostics, and devices that manage this genetic disorder affecting the lungs and digestive system. Treatments include gene modulators, mucus-thinning drugs, and antibiotics to control infections. Diagnostic tools support early detection and personalized treatment plans. Increasing prevalence and awareness of cystic fibrosis drive market demand. Research into novel therapies and improved patient care continues to expand the market.

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β˜› Cystic Fibrosis Market Recent Developments 2025:

United States: Recent Industry Developments

βœ… In August 2025, Vertex Pharmaceuticals announced FDA approval for VX-548, a next-generation CFTR modulator for cystic fibrosis patients with rare mutations. The therapy is expected to expand treatment eligibility to thousands of patients previously lacking options.

βœ… In July 2025, Proteostasis Therapeutics initiated Phase 3 trials for PTI-428, targeting improved lung function in cystic fibrosis patients with advanced disease stages. Early Phase 2 data demonstrated significant improvements in FEV1 and reduced pulmonary exacerbations.

βœ… In June 2025, Moderna began development of an mRNA-based therapy for cystic fibrosis, aiming to correct CFTR gene expression. Preclinical results show potential for long-term restoration of lung function, representing a novel approach in CF management.

Europe: Recent Industry Developments

βœ… In July 2025, AstraZeneca and CF Foundation Therapeutics launched a multi-center European study on triple combination CFTR modulators, focusing on children aged 6-11. The study aims to assess safety and efficacy in younger populations.

βœ… In May 2025, Vertex Pharmaceuticals expanded its European access program, providing VX-770/tezacaftor/elexacaftor therapy to underserved cystic fibrosis populations. The initiative includes patient support, education, and reimbursement assistance.

Japan: Recent Industry Developments

βœ… In July 2025, Takeda Pharmaceutical initiated clinical trials for a next-generation CFTR modulator targeting Japanese cystic fibrosis patients with rare mutations. The study focuses on safety and efficacy in adolescent and adult populations.

βœ… In June 2025, Chugai Pharmaceutical partnered with Vertex Pharmaceuticals to expand access to triple combination CFTR therapy in Japan. The collaboration aims to accelerate patient enrollment in post-marketing programs.

βœ… In May 2025, Astellas Pharma launched a patient support initiative providing comprehensive care programs for cystic fibrosis, including home therapy monitoring and genetic counseling, addressing gaps in rare disease management.

β˜› Cystic Fibrosis Market Trends:

Targeted therapies such as CFTR modulators dominate the market trend. Gene therapy and mRNA-based treatments are emerging for more permanent solutions. Personalized treatment plans based on genetic profiling are increasing patient outcomes. Digital health tools are being adopted for monitoring lung function and adherence. Rising awareness and screening programs in newborns are contributing to early diagnosis.

Recent Pipelines:

New-generation CFTR modulators are under late-stage trials. mRNA therapies aiming to correct CFTR protein expression are being evaluated. Inhaled antibiotics and anti-inflammatory agents are in clinical studies. Gene editing technologies like CRISPR-Cas9 are in preclinical development. Adjunct therapies for mucus clearance and lung function improvement are progressing in trials.

β˜› Cystic Fibrosis Market Competitve Landscape:

Vertex Pharmaceuticals Inc., AbbVie Inc, F. Hoffmann-La Roche Ltd, Novartis AG, Teva Pharmaceutical Industries Ltd, Gilead sciences, Genentech Inc, AstraZeneca, Alcresta Therapeutics Inc., Merck & Co. Inc.

Research Methodology

We follow a hybrid research approach, combining qualitative insights with rigorous quantitative analysis to deliver reliable and comprehensive market intelligence. Our process begins with extensive secondary research, drawing on trusted industry reports, proprietary databases, and credible market sources. This is then reinforced through targeted primary research, including structured surveys and in-depth interviews with industry leaders, subject matter experts, and key market participants.

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β˜› Segment Covered in the Cystic Fibrosis Market:

By Therapeutic drug class: CFTR modulators, Pancreatic enzyme supplements, Mucolytics, Bronchodilators.

By Route of administration: Oral, Inhaled, Parenteral.

By End-user: Hospitals, Clinics, Cancer centers, Others.

β˜› This Report Includes:

βœ” Comprehensive go-to-market strategies with actionable insights.

βœ” Unbiased evaluation of overall market performance.

βœ” Deep-dive analysis into development trends, competitive landscape, supply-demand dynamics, YoY growth, benchmarking, vendor mapping, market access, and overall progress.

βœ” Tailored regional and country-level reports with detailed localized analysis available on request.

βœ” Identification of niche segments and high-growth regions presenting strong opportunities.

βœ” Accurate regional forecasts using both top-down and bottom-up approaches.

πŸ“Œ Get Corporate Access to Live Cystic Fibrosis Industry Intelligence Database: https://www.datamintelligence.com/buy-now-page?report=cystic-fibrosis-market

β˜› Regional Analysis for Cystic Fibrosis Market:

β‡₯ North America (U.S., Canada, Mexico)

β‡₯ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

β‡₯ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

β‡₯ South America (Colombia, Brazil, Argentina, Rest of South America)

β‡₯ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

β˜› Frequently asked questions:

➠ What is the global sales, production, consumption, import, and export value of the Cystic Fibrosis Market?
➠ Who are the key global manufacturers, and what is their operational performance?
➠ What are the major opportunities and threats in the global Cystic Fibrosis Market?
➠ Which product types or end-users show the most growth potential and market share?
➠ What challenges and constraints are impacting the Cystic Fibrosis Market?
➠ What sales, marketing, and distribution channels are used globally?

πŸ“Œ Request for 2 Days FREE Trial Access: https://www.datamintelligence.com/reports-subscription

β˜› Power your decisions with real-time competitor tracking, strategic forecasts, and global investment insights all in one place.

βœ… Competitive Landscape
βœ… Sustainability Impact Analysis
βœ… KOL / Stakeholder Insights
βœ… Unmet Needs & Positioning, Pricing & Market Access Snapshots
βœ… Market Volatility & Emerging Risks Analysis
βœ… Quarterly Industry Report Updated
βœ… Live Market & Pricing Trends
βœ… Import-Export Data Monitoring

β˜› Have a look at our Subscription Dashboard: https://www.youtube.com/watch?v=x5oEiqEqTWg

Contact Us -

Company Name: DataM Intelligence
Contact Person: Sai Kiran
Email: Sai.k@datamintelligence.com
Phone: +1 877 441 4866
Website: https://www.datamintelligence.com

About Us -

DataM Intelligence is a Market Research and Consulting firm that provides end-to-end business solutions to organizations from Research to Consulting. We, at DataM Intelligence, leverage our top trademark trends, insights and developments to emancipate swift and astute solutions to clients like you. We encompass a multitude of syndicate reports and customized reports with a robust methodology.

Our research database features countless statistics and in-depth analyses across a wide range of 6300+ reports in 40+ domains creating business solutions for more than 200+ companies across 50+ countries; catering to the key business research needs that influence the growth trajectory of our vast clientele.

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