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Market Overview
- The Global Cystic Fibrosis Market is expected to grow at a CAGR of 13.2% during the forecasting period (2020-2027).
- Cystic fibrosis (CF) is a life-limiting autosomal recessive genetic disorder, which causes severe damage to secretory glands of the body like lungs, pancreas, liver, and intestines. It is more common in the lungs. The disease is caused by the mutation of a gene that encodes a chloride-conducting transmembrane channel called the cystic fibrosis transmembrane conductance regulator (CFTR).
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Market Dynamics
- The major driving forces are the increasing prevalence, rising demand for pipeline drugs, increasing awareness among healthcare fraternity about cystic fibrosis therapy, favorable initiatives undertaken by nonprofit organizations.
- The rising prevalence of CF is one of the dominating factors, propelling the global cystic fibrosis market. As per the Cystic Fibrosis Foundation Patient Registry, about 30,000 people in the United States have cystic fibrosis. The disease affects about 1 in 2,500 to 3,500 white newborns. Also, approximately 1,000 new cases of CF are diagnosed each year. It affects about 1 in 17,000 African-Americans and 1 in 100,000 Asian-Americans. It is estimated that 10,500 people in the United Kingdom have the disease. About 4,000 Canadians have it, and Australia reports about 3,300 cases. Thus, the growing prevalence of CF is boosting the market.
- Rising demand for pipeline drugs is due to the rising prevalence of cystic fibrosis, which is uplifting the market. The key players are operating in the market in collaboration with nonprofit organizations focus on the development of novel therapeutics for the treatment. Some of the drugs that are in clinical trials are SYMDECO (tezacaftor (VX-661) + ivacaftor, VX-445 + tezacaftor + ivacaftor, VX-659 + tezacaftor + ivacaftor. Others include
- Further, favorable initiatives taken by the regional and national nonprofit organizations is one of the major factors propelling growth. These initiatives ensure support for CF patients. These organizations aid in research & development activities of these therapeutics and help improve the quality of life of these patients. For instance, the North American Cystic Fibrosis Conference (NACFC) provides a collaborative and educational forum to cystic fibrosis professionals to share advances in R&D related to CF therapeutics. Also, a five-year deal was announced on 12 September 2019, according to which the NHS Scotland has decided to provide £100,000-per-year for cystic fibrosis drugs like Orkambi and Symkevi. Thus, favorable initiatives are driving the market.
- However, as CF is a rare disease, and due to the limited information available, extensive research is essential. The research and development cost for the CF is very high, leading to the enormous prices of the end products. The high cost of drugs and treatment is one of the factors that hamper the growth of the cystic fibrosis market. For instance, in June 2016, the National Institute for Health and Care Excellence (NICE) estimated that it would cost around £104,000 per patient per year to provide Orkambi to CF patients.
Segmentation Analysis
- The global cystic fibrosis market can be segmented by therapeutic drug class as CFTR modulators, pancreatic enzyme supplements, mucolytics, and bronchodilators.
- The CFTR modulators segment is expected to grow at a high rate throughout the forecast. This is owing to the increased number of US FDA approvals of the drugs. For instance, Ivacaftor (KALYDECO), a CFTR modulator introduced by Vertex pharmaceuticals, is developed in conjunction with Cystic fibrosis foundation (CFF). Also, on June 21, 2019, the US FDA has approved SYMDEKO (tezacaftor/ivacaftor and ivacaftor) of Vertex pharmaceuticals to treat the Cystic fibrosis in children ages 6-11 years with specific mutations in the CFTR gene. Further, on August 7, 2018, the US FDA has approved Vertex pharmaceuticals Orkambi, which is a combination of lumacaftor and ivacaftor is the first medicine to treat the underlying cause for children of 2-5 years. Thus, the presence of an increased number of FDA approvals is driving the market.
- By route of administration, the market is segmented as oral drugs and inhaled drugs.
- The oral route of administration is expected to share a significant market share due to the ease of administration and convenience. This is owing to the use of several antibiotics like penicillins, cephalosporins, and macrolides.
Geographical Analysis
- Geographically, the global cystic fibrosis market is segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.
- North America is dominating the global cystic fibrosis market in 2018 and is estimated to hold significant market size over the forecast period (2019-2026) owing to the rising prevalence of cystic fibrosis, and the presence of government initiatives.
- The rising prevalence is expected to drive the market over the forecast period. For instance, according to the cystic fibrosis foundation (CFF), more than 30,000 patients are living with cystic fibrosis in the US. Nearly 1000 new CF cases are diagnosed each year. According to the CFF's national patient registry, the median age of the person with CF is currently 33.4 years. The average life expectancy of CF patients has increased significantly as compared to the patients 30 years back. Thus, the increasing prevalence of CF has boosted North America's share in the global cystic fibrosis market.
- Further, Government initiatives are expected to share a significant market share. In 2018, the cystic fibrosis foundation announced $100 million to the Infection Research Initiative, a comprehensive approach to improve the results associated with infections through enhanced diagnosis, prevention, and treatment. The Foundation is also actively pursuing and funding a broad portfolio of new therapies for other complications of the disease, like inflammation, excessive mucus, gastrointestinal problems, and cystic fibrosis-related diabetes. The Foundation has spent over $72 million to the Nonsense and Rare Mutations Research and Therapeutics Initiative.
- However, over the forecast period, the prevalence of cystic fibrosis is expected to grow at a significant rate in Australia when compared to other Asian countries, where cystic fibrosis is sporadic. According to Cystic Fibrosis Foundation (CFA), every four days, a baby is born in Australia with cystic fibrosis, and more than one million Australians are carriers of cystic fibrosis. Cystic Fibrosis Australia (CFA) is committed to improving clinical practice and patient results through its quality improvement programmer and research to extend life expectancy from 37 to 50 years by 2025.
Competitive Landscape
- The key players operating in the global cystic fibrosis market are Vertex Pharmaceuticals Inc., AbbVie Inc., F. Hoffmann-La Roche Ltd., Novartis AG, Teva Pharmaceutical Industries Ltd, Gilead Sciences, Allergan, AstraZeneca, Alcresta Therapeutics Inc., and Merck & Co. Inc.
- The key players are adopting various strategies such as product launches, mergers & acquisitions, partnerships, and collaborations, which are contributing to the growth of the cystic fibrosis market globally. For instance,
- On June 21, 2019, The US FDA has approved SYMDEKO (tezacaftor/ivacaftor and ivacaftor) to treat the underlying cause of Cystic fibrosis in children ages 6-11 years with specific mutations in the CFTR gene.
- On April 30, 2019, FDA approved Kalydeco (ivacaftor) as the first and only CFTR modulator to treat infants with CF as early as 6 months of age.
- In December 2018, Alcresta Therapeutics, Inc. announced the issuance of a permanent and unique billing code by the Centers for Medicare and Medicaid Services (CMS) for RELiZORB. RELiZORB is an in-line digestive enzyme cartridge and is intended for use in the pediatric patients (ages 5 years and above) and adults to hydrolyze fats in enteral formula.
- On August 15, 2018, FDA approved Kalydeco (Ivacaftor) for cystic fibrosis in children ages 12 to <24 months with mutations in the CFTR gene.
- On August 7, 2018, The US FDA approved ORKAMBI (lumacaftor/ivacaftor) as the first medicine to treat cystic fibrosis for children ages 2-5 years with the most common form of the disease.
- On August 1, 2017, FDA approved Kalydeco (ivacaftor) for people of ages two and older with CF who have specific residual function mutations.
- On May 17, 2017, FDA expanded approved the use of Kalydeco to treat additional mutations of cystic fibrosis.
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Key Players:The global Cystic Fibrosis Market consist of players such as AbbVie, Allergan plc, Chiesi Farmaceutici S.p.A., F. Hoffmann-La Roche AG, Gilead Sciences, Inc., Novartis AG, Pharmaxis Ltd, PTC Therapeutics, and Vertex Pharmaceuticals Incorporated are some of the prominent players at the forefront of competition in the global cystic fibrosis market and are profiled in MRFR Analysis report.Get Sample Report at https://www.marketresearchfuture.com/sample_request/1825Global Cystic Fibrosis Market - Overview:According to a recent study report published by the Market Research Future analysts, the global Cystic Fibrosis Market Growth Analysis is growing at a double digit CAGR.
CF being the rare disease, and due to the limited information available, the extensive research is required.
As these products help patients in managing the cystic fibrosis symptoms and are consumed daily, these companies have fair amount of share in the market.
Additionally, there are other companies which such as Pharmaxis, PTC therapeutics, Janssen Pharmaceuticals, Inc which are involved in the development of the treatments for the symptoms of cystic fibrosis.Global Cystic Fibrosis Market - Regional Analysis;Cystic fibrosis can occur in both genders as well as in all ethnic groups and races.
However cystic fibrosis can also affect Latinos, American Indians, African, and Middle Eastern population.North America is one of the majorly affected region by the deadly disease cystic fibrosis.
Among the CF patients in Europe, 51.8% were adults with age 18 years or more and 48.2% were less than 18 years old.
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