Market Overview
The Global Cystic Fibrosis Market reached US nbsp;10.96 billion in 2023 and is expected to reach USnbsp;26.58 billion by 2031, growing at a CAGR of 11.8% during the forecast period 2024-2031.
Cystic fibrosis (CF) is an genetic disorder that causes severe damage to the lungs, digestive system and other organs in the body. Cystic fibrosis influence the cells that produce mucus, sweat and digestive juices. These secreted fluids are usually thin and smooth. Some people who have the disease with few or no symptoms, while others witness severe symptoms or life-threatening complications. Symptoms of this disease depend on which organs are affected and the severity of the condition.
Executive Summary
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Market Dynamics: Drivers & Restraints
Increasing Prevalence of Cystic Fibrosis Disorder
The market is growing as cystic fibrosis grows more common. An increasing number of people with cystic fibrosis who require treatment and long-term management can be attributed to a mix of reasons including improved diagnosis and screening, increased public awareness, a longer lifespan, and genetics. The demographics of the patients with cystic fibrosis (CF) are changing as a result of better management, diet, and newborn screening that have prolonged the average lifespan of patients suffering from loneliness.
For instance, according to American Lung Association 2024, around 30,000 people in United States of America and 70,000 people worldwide suffer from cystic fibrosis out of which 1 in 30 Americans are a carrier.
Moreover, according to Cystic Fibrosis Trust, stated that, approximately 10,800 people in the UK suffering from cystic fibrosis; that's 1 in every 2,500 babies born. Cystic fibrosis influence around 100,000 people in the world. Cystic fibrosis is a genetic disease. One person in 25 carries the faulty CF gene, usually without knowing; that's over two Billion people in the UK. If two carriers have a baby, the child has a one-in-four chance of having cystic fibrosis.
High Cost of Cystic Fibrosis Treatment
The treatment costs of cystic fibrosis (CF), which includes CFTR modulators that are advanced drugs, is an issue that hampers the growth of the global market. This cost burden is more pronounced in the case of low- and middle-income countries, as it limits access to treatment therefore limiting the growth of the market. To illustrate, it could be noted that in high-income regions, despite having insurance, the amounts covered may be quite limited, and patients still incur considerable costs. These financial factors present a significant obstacle to the larger scale use of the newest and most effective treatments for CF, and this in turn, affects the whole system.
Market Segment Analysis
The global cystic fibrosis market is segmented based on drug class, route of administration, distribution channel and region.
Drug Class:
CFTR Modulators segment is expected to dominate the cystic fibrosis market share
The CFTR modulators segment are expected to hold a major portion of the cystic fibrosis market share. The global cystic fibrosis market has CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) modulators at their core since they act on the main pathology of the disease – mutations in the CFTR gene. These mutations result in the production of an ineffective or insufficient amount of the CFTR protein which helps to prevent excessive buildup of mucus in the lungs and the digestive system, which otherwise composes the major pathological symptoms in Cystic Fibrosis.
For instance, in July 2024, Vertex Pharmaceuticals has received FDA approval for the use of vanza triplie combo therapy in cystic fibrosis patients aged 6 years and above with at least one copy of F508del mutation or any CFTR mutation that is responsive. The FDA had earlier indicated a timeline of 10 months for a review of the application but later shortened it to 6 months and therefore the latest expected action date is January 2, 2025, in accordance with the Prescription Drug User Fee Act (PDUFA) provisions.
Antibiotics segment is the fastest-growing segment in the cystic fibrosis market share
Antibiotics are among the most important components in the treatment of chronic lung infections and the prevention of acute exacerbations in the cistic fibrosis global market. Thick mucus on the airways ecompasses several pathogenic bacteria causing lung infections and subsequent exacerbations in these patients. Infection by certaine bacteria, characterized by the presence of thick wrinkled scars of inflammatory tissue in the lungs is the hallmark of cystic fibrosis and ecompasses pathogens like Pseudomonas aeruginosa and Staphylococcus aureus. In cystic fibrosis, the patients have a chronic infection that is mostly associated with Pseudomonas aeruginosa and Staphylococcus aureus and it results to inflammatory process, destruction of lung tissues, and subsequent decrease in lung function.
Route of Administration:
Oral segment is expected to dominate the cystic fibrosis market share
The global market for cystic fibrosis drugs, the oral route of medication significantly contributes to the treatment of different aspects of the disease, mostly mild and moderate lung infections and the digestive system. For example, taking oral antibiotics is not only safe, but can be simply taken at home and it is practical in the open epidemiology of patients with constant infections and the need for therapy. Antibiotics in the form of oral liquid-azithromycin are quite popular for use in the treatment aimed at reducing the bacterial load and inflammation in the lungs to help in the preservation of lung functions. Other than antibiotics, oral pancreatic enzyme supplements are also very important for cystic fibrosis patients with pancreatic insufficiency as they help in nutrient absorption thereby promoting better health. The effectiveness of therapy can be heightened due to the convenience of taking medicine orally, especially in cases where there is a requirement for long-standing treatment which is often the case for this illness.
Parenteral segment is the fastest-growing segment in the cystic fibrosis market share
For patients suffering from cystic fibrosis, who experience severe exacerbations or infections, it is common to use parenteral routes of drug administration especially intravenous (IV) techniques. The use of parenteral routes allows for quick absorption of a high concentration of medication into the blood stream, making it possible to treat infections that are deep seated and difficult such as those caused by Pseudomonas aeruginosa, who is known to display resistance to most antibiotics. In the majority of cases where IV antibiotics are used, the patients are hospitalized or receiving transfusion therapy at home because of frequent recurrent episodes to enhance drug effectiveness especially in the management of lung exacerbations and also to protect the lungs from further damage. This route is especially useful where oral drugs are not adequate, making it a very important aspect of cystic fibrosis treatment where serious respiratory complications have developed.
Market Geographical Share
North America is expected to hold a significant position in the Cystic Fibrosis market share
North America is expected to hold a significant position in the global Cystic Fibrosis market during the forecast period due to the increasing government initiatives specifically in Canada, growing awareness, and increasing product approvals. Also, the supportive regulatory guidelines that promote cystic fibrosis and increasing healthcare disbursements are the factors driving the North America region growth.
For instance, according to the Cystic Fibrosis Canada article published in March 2023, the federal government released its strategy to improve access to medications for Canadians with rare diseases, meeting a commitment made in 2019 that coincides with Cystic Fibrosis Canada and the Canadian cystic fibrosis (CF) community's long-standing advocacy efforts.
Moreover, in September 2024, according to Cystic Fibrosis Foundation, Early identification of cystic fibrosis is fundamental in halting the spread of the disease and also enhancing a person’s overall wellbeing throughout his or her life. Newborn screening is a national program for the public health of screening affected infants’ patients for many illnesses at birth, where cystic fibrosis is one of the illnesses. However, these programs differ from state to state with roughly forty different algorithms used across the forty-eight states. This creates unintended disparities in health care among the population, especially the babies of color in whom delayed diagnoses are very high.
Europe is growing at the fastest pace in the cystic fibrosis market
Europe holds the fastest pace in the cystic fibrosis market and is expected to hold most of the market share due to increased research funding, advanced healthcare infrastructure, early diagnosis, personalized medicine, government initiatives, gene-based therapies, and patient advocacy groups. These factors contribute to improved patient outcomes and market growth.
For instance, in October 2024, The University of Liverpool is launched a new Cystic Fibrosis Innovation Hub to develop new tests and treatment approaches for lung infections and improve lung health management for people with cystic fibrosis (CF) in the UK. The hub is part of a £15 million Translational Innovation Hub Network funded by LifeArc and Cystic Fibrosis Trust. The network will consist of four Innovation Hubs led by Liverpool, Manchester, Cambridge, and Imperial College London.
Market Segmentation
By Drug Class
- CFTR Modulators
- Antibiotics
- Pancreatic Enzyme Supplements
- Mucolytics
- Bronchodilators
- Others
By Route of Administration
- Oral
- Inhaled
- Parenteral
By Distribution Channel
- Hospital Pharmacies
- Retail Pharmacies
- Online Pharmacies
By Region
- North America
- The U.S.
- Canada
- Mexico
- Europe
- Germany
- UK
- France
- Italy
- Spain
- Rest of Europe
- South America
- Brazil
- Argentina
- Rest of South America
- Asia-Pacific
- China
- India
- Japan
- South Korea
- Rest of Asia-Pacific
- Middle East and Africa
Market Competitive Landscape
The major global players in the market include Novartis AG, Vertex Pharmaceuticals Inc, F. Hoffmann-La Roche Ltd, Teva Pharmaceutical Industries Ltd, Gilead sciences, Alcresta Therapeutics Inc, Merck & Co. Inc, Pfizer Inc, Genentech, Chiesi Pharmaceuticals B.V. among others.
Key Developments
- In May 2024, Arcturus Therapeutics Holdings Inc., a global company focused on developing infectious disease vaccines and medicines for rare liver and respiratory diseases, has presented Phase 1 results in healthy volunteers and new Phase 1b interim data in CF patients for ARCT-032, an inhaled investigational mRNA therapeutic, at the 47th European Cystic Fibrosis Conference.
- In July 2024, Sionna Therapeutics has recently entered into a licensing agreement with AbbVie, who has been granted exclusive worldwide rights to the development and commercialization of a number of clinical stage compounds, including two in Phase 2, in order to improve on treatment by centralising the CFTR protein, which could revolutionize treatment for patients with cystic fibrosis.
Why Purchase the Report?
- To visualize the global cystic fibrosis market segmentation based on drug class, route of administration, distribution channel, and region as well as understand key commercial assets and players.
- Identify commercial opportunities by analyzing trends and co-development.
- Excel data sheet with numerous data points of cystic fibrosis market-level with all segments.
- PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
- Product mapping available as Excel consisting of key products of all the major players.
The global cystic fibrosis market report would provide approximately 70 tables, 69 figures, and 202 pages.
Target Audience 2024
- Manufacturers/ Buyers
- Industry Investors/Investment Bankers
- Research Professionals
- Emerging Companies
