Global market for cystic fibrosis therapeutics is projected to grow at a compound annual growth rate (CAGR) of 10% during the forecast period of 2023 to 2030. Cystic fibrosis, also known simply as CF, is a genetic condition that can be passed down through families. The secretion of proteins into particular body fluids is under the control of genes. Because of its effect on a variety of organs in the body, this tends to make mucus and perspiration more viscous. This disorder causes the electrolyte transport system to be altered, which in turn causes cells to absorb salt and water. This, in turn, leads to difficulties with the glands that are responsible for producing perspiration and mucus.
Individuals who have this condition and who suffer from an increased infection in both the upper and lower respiratory tracts are also contributing to the expansion of the market. A further factor that is contributing to the expansion of the market is the rising prevalence of conditions such as chronic cough, blood in sputum, and collapsed lungs. In addition, patients who have this disease also have issues with abnormalities of the gastrointestinal system as a result of difficulties in absorbing proteins, lipids, and vitamins, which is another factor that is affecting the expansion of the market. The availability of a variety of drugs for the treatment of respiratory and gastrointestinal infections as well as the availability of over-the-counter drugs for the treatment of reproductive system conditions is anticipated to have a positive impact on the growth of the market during the forecast period 2023 to 2030. As a result, the growing incidence of the disease will have an effect on the growth of the market during the period covered by the forecast.
Impact of Covid-19
During the course of the forecast, the influence of the COVID-19 pandemic around the globe is also having an effect on the growth of the market. The incidence of respiratory diseases is on the rise, which in turn drives up the risk of cystic fibrosis. This, in turn, is encouraging the key players that are already present throughout the world to focus on the formulation of new drugs for the purpose of accelerating the patients' recoveries and so lowering the global death rate.
Expanding Therapeutic Options is Expected to Drive Market Growth
The market has been triggered by an increase in the number of patients suffering from cystic fibrosis all over the world. The pharmacotherapy of cystic fibrosis has resulted in a number of improvements in the treatment of this ailment, which is having a beneficial impact on the expansion of the market. In addition, market trends that are now present in the treatment of the condition are the driving force behind the expansion of the market. This is because significant firms are producing a rising number of candidates for therapeutic care that are in the pipeline. Because of this, pharmaceutical companies are being encouraged to develop innovative treatments that address anomalies in the CFTR protein. In addition to this, the introduction of Ivacaftor/Lumacaftor, a potentiator that makes life better for those who are afflicted with the disease, is also contributing to the expansion of the market.
The Increasing Prevalence of CF
CF is quickly becoming the most prevalent genetic illness in every region of the world. According to the Cystic Fibrosis Patient Registry, more than 30,000 persons in the United States are currently afflicted with this ailment, and it is projected that approximately 70,000 people throughout the world are afflicted with this condition. In addition to this, it is also mentioned that each year there are roughly 1,000 new cases of the condition that are diagnosed. As a result, it is anticipated that the growing prevalence of respiratory issues, gastrointestinal complications, and reproductive diseases in patients with CF would also contribute to an increase in the demand for the treatment of the illness throughout the course of the projection period. In addition, the implementation of innovative treatment options for early detection is expanding the patient population for better treatment, which is expected to have an impact on the expansion of this market throughout the course of the projected period.
Strong Pipeline Candidates are the Key Market Enabler
The development of medicines that can be used in the treatment of cystic fibrosis is on the near horizon, which is contributing to the acceleration of market expansion. The development of new treatments that are targeting the deficiency in disease-affected people's cells is expected to boost the growth of the market during the forecast period. The fact that this treatment is expected to be transformative for a great number of patients is driving the expansion of the market. In addition, an increase in the number of people who are affected by the condition is believed to be the most important element driving the market. Because of this, the launch of novel pipeline candidates that are necessary for the treatment of very ill patients is gaining momentum. In addition to this, a great number of possible candidates are currently in the last stages of their development and are predicting the expansion of the market. For instance, Vertex Pharmaceuticals Incorporated recently revealed that its phase III clinical study on inhaled mannitol suggested for the treatment of mucociliary clearance had yielded favorable findings. In addition to this, technologically advanced devices used for a variety of serious situations such as airway clearance procedures, mucous thinners, and others are prepared to spike the cystic fibrosis therapeutics market over the forecast period.
Side Effects of Drugs to Impede the Market Growth
The fact that the medicines can cause undesirable side effects like infections of the upper respiratory tract, difficulties with the liver, chest pain, and an increase in blood pressure, amongst other issues, may impede the expansion of the market. In addition to this, the high expense of therapy among CF patients who are in need of a lung transplant, liver transplant, or any of the other types of transplants is another factor that is preventing the market from expanding. In addition, some of the factors that are having a negative impact on the cystic fibrosis market are extended FDA approvals, product recalls, severe regulations, and others.
CFTR Modulators Segment to Dominate the Market
According to a review of the market for cystic fibrosis therapies, the CFTR modulators segment held the majority share of the market in 2021 and is predicted to maintain its dominant position during the forecast period. This can be ascribed to an increase in the number of patients receiving therapy with these medications for cystic fibrosis. It is also anticipated that this sector will experience the most rapid expansion during the course of the time under consideration. In addition, the development of CFTR medicines such as Kalydeco, Orkambi, and Symdeko is an example of this type of innovation. These medications are now being used on a large scale to treat cystic fibrosis, and a large number of new CFTR therapies are now being tested in clinical trials. The primary objective of these medications is to lengthen the average life span of those who use them. In addition, developments in diagnostic procedures and treatment methods have led to a notable rise in the overall survival rate of patients. Patients with cystic fibrosis who also suffer from respiratory diseases and obstructive lung disease are the primary consumers of bronchodilators medications, which is driving the expansion of the market. In addition, it is anticipated that the category would record the greatest CAGR throughout the course of the projection period. As a result of the rising use of these medications in the treatment of a variety of conditions, including the relaxation of muscles and the clearing of airways, amongst others.
Oral Medication Leading the Market
Oral and parenteral administration are the two subsegments that constitute the market by route of administration. In 2021, the oral sector accounted for the majority of the market share in the cystic fibrosis therapeutics market. This was due to the increased formulation of medications in oral form, such as the development of CFTR drugs, which accounted for the majority of the market share in the oral segment. In addition, the Food and Drug Administration in the United States has granted approval for three different CFTR modulator medicines, all of which are in the form of oral tablets. Ivacaftor (also known as kalydeco), orkambi, and symdeko are some examples of these. As a result of the continuing clinical trials and research and development efforts aimed at the creation of oral CFTR medications, it is projected that the market for these oral drugs will expand at a rapid rate during the forecast period.
Retail Pharmacies & Drug Stores Dominate the Market by Distribution Channel
By distribution channel the market is segmented as retail pharmacies & drug stores, online pharmacies and hospital pharmacies. Retail pharmacies and drug stores make up the largest segment of the market. When compared to the internet pharmacies and hospital pharmacies segment, it is projected that the retail pharmacies and drug stores segment would be the one to dominate the industry during the forecast period. In addition to this, it is anticipated that the segment of online pharmacies will emerge as market with the highest rate of growth during the forecast period. The expansion of online pharmacies is expected to be fuelled over the period under consideration by an increase in the number of patients who place a higher priority on the simplicity of obtaining their medications, as well as by other factors.
North America Remains as the Global Leader
In 2021, the market for cystic fibrosis treatments and medications in North America accounted for the largest share in terms of market revenues. It is projected that North America would have the majority share of the market worldwide. The factors that are responsible for the dominance of the market in this region include an increase in the number of people diagnosed with cystic fibrosis (CF), an increase in the number of patients suffering from various respiratory disorders that influence CF, an increase in the number of R&D activities, an increase in the amount of money spent on healthcare, and other factors. During the forecast period, analysts opine that Europe will maintain a dominant second-place position, behind only North America. Because of factors such as rising disposable income, a growth in the number of people who have the condition, an increase in the use of more advanced treatments in an effort to improve patient outcomes, etc. In addition, various prospects for expansion are anticipated to present themselves in the Asia-Pacific industry. Because of factors such as an increase in the number of elderly people, an increase in the number of healthcare facilities, increased public awareness of treatment, and other factors. Latin America and the Middle East and Africa are both examples of regions that are considered to be part of the "rest of the globe." These regions are predicted to exhibit lower growth owing to the unmet demands of healthcare, low prevalence of the condition in the region, limited awareness linked with healthcare services, and others.
Vertex Pharma, The Market Leader
Vertex Pharmaceuticals Incorporated is the primary company that is now leading the market because of its extensive product portfolio and strong presence in the treatment of CF around the world. Vertex Pharmaceuticals is a biotechnology company that places a primary emphasis on the development of scientific advances in order to create game-changing medication for critical diseases. The company has more than one drug that has been granted approval for the treatment of CF. In addition to the many current clinical studies and research programme for therapy of the fundamental cause of cystic fibrosis, they have a solid pipeline of products for treatment of disorders such as sickle cell disease, type 1 diabetes mellitus, and other conditions. In addition, while looking at sales, Vertex Pharmaceuticals Incorporated is currently in the lead position among competitors. As a result of the high revenue-generating drugs it offers, such as Orkambi and Syddeko, both of which are prescribed for the treatment of cystic fibrosis. In addition, it is anticipated that Gilead Sciences, Inc. will experience significant growth throughout the world over the course of the forecast period. This is due to the fact that its products, such as CAYSTON, are primarily indicated to improve respiratory symptoms in people who have cystic fibrosis. The leading players in this market include Genentech, Inc., Novartis AG, Gilead Sciences, Inc., Vertex Pharmaceuticals Incorporated, AbbVie Inc., GlaxoSmithKline Plc., Johnson & Johnson, Allergan plc, Pharmaxis Ltd., and Mylan N.V. are the key players engaged in the therapeutic markets for cystic fibrosis.
Pipeline Review
Although Vertex is the only business that currently has drugs in the CFTR modulator drug class, other players stand out with products that are now on the market that belong to other drug classes. In addition to the mucolytic Bronchitol (mannitol) in the United States and the PERT product Pertzye (pancrelipase) in the United States, Chiesi possesses two inhaled antibiotic products: Bramitob/Bethkis (tobramycin) in the United States and five major European markets (5EU) (France, Germany, Italy, Spain and the United Kingdom) and Quinsair (levofloxacin) in the 5EU. Both TOBI (tobramycin) and TOBI Podhaler (tobramycin inhalation powder) are the most widely used inhaled antibiotic therapies. Two other important companies are Viatris (formerly Mylan), which owns the most popular inhaled antibiotic therapies, and Nestlé HealthScience, which owns two PERT products. Zenpep (pancrelipase) and Viokace are the PERT products (pancrelipase). Gilead, Teva, Genentech, AbbVie, Vivus, Horizon Therapeutics, and Pharmaxis are the other pharmaceutical companies that have medications currently on the market that are used for the treatment of cystic fibrosis.
Vertex is currently working to expand the label for Kalydeco in Canada to include paediatric CF patients aged 0 to less than 12 months, and they are working to expand the label for Trikafta/Kaftrio to include paediatric CF patients aged 2 to 5 years in the United States and 2 to 11 years in the European Union and Canada. Additionally, within the next five years, this company is anticipated to release not one, but two new products: VX-561 and VX-121 + tezacaftor + VX-561. At the moment, AbbVie is the company that sells Creon, which is the PERT that is utilised by CF sufferers the most. Both a CFTR potentiator known as ABBV-3067 and a CFTR corrector known as galicaftor (ABBV-2222) are now being tested in late-stage Phase II clinical trials for the company. ABBV-3067 is being tested alone and in conjunction with galicaftor. If AbbVie's attempt to enter the market for CFTR modulators is successful, Vertex will have a new competition.
By the year 2030, it is anticipated that Laurent Pharmaceuticals will be the only new participant in the CF space. It is now in the process of developing an anti-inflammatory medication known as LAU-7b (fenretinide) for the purpose of lowering the severity of lung infections caused by Pseudomonas aeruginosa as well as the levels of inflammation that they cause. Despite the fact that this agent in development has a novel mode of action and is a first-of-its-kind medication, the business developing it is still emerging in the CF field.
Historical & Forecast Period
This study report represents analysis of each segment from 2022 to 2032 considering 2023 as the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period of 2024 to 2032.
The current report comprises of quantitative market estimations for each micro market for every geographical region and qualitative market analysis such as micro and macro environment analysis, market trends, competitive intelligence, segment analysis, porters five force model, top winning strategies, top investment markets, emerging trends and technological analysis, case studies, strategic conclusions and recommendations and other key market insights.
Research Methodology
The complete research study was conducted in three phases, namely: secondary research, primary research, and expert panel review. key data point that enables the estimation of Cystic Fibrosis market are as follows:
Market forecast was performed through proprietary software that analyzes various qualitative and quantitative factors. Growth rate and CAGR were estimated through intensive secondary and primary research. Data triangulation across various data points provides accuracy across various analyzed market segments in the report. Application of both top down and bottom-up approach for validation of market estimation assures logical, methodical and mathematical consistency of the quantitative data.
| ATTRIBUTE | DETAILS |
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| Research Period | 2022-2032 |
| Base Year | 2023 |
| Forecast Period | 2024-2032 |
| Historical Year | 2022 |
| Unit | USD Million |
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Key questions answered in this report
