Cystic Fibrosis Therapeutics Market

Cystic Fibrosis Therapeutics Market Snapshot (2023 to 2033)

The global Cystic Fibrosis Therapeutics Market size is expected to be valued at US$ 12.5 Billion in 2023. With the implementation of innovative treatment options for early detection, the overall demand for Cystic Fibrosis is projected to grow at a CAGR of 25.0% between 2023 and 2033, totaling around US$ 116.42 Billion by 2033.

According to Netwellness, a community service provider, 3 to 4% of babies are born with genetic disorders. This number is expected to increase in the coming years, especially in the emerging economies of Asia pacific such as India and China, owing to the high birth rate observed in these regions.

Cystic Fibrosis is emerging as the leading genetic disease globally. This often affects multiple organ systems of the body. As per the Cystic Fibrosis Patient Registry, it is estimated that more than 30,000 people are currently suffering from this condition in the US and it is estimated that about 70,000 people are suffering from it across the globe.

Moreover, it is also noted that approximately 1,000 new cases of CF are diagnosed every year. Hence, the rising prevalence of respiratory problems, gastrointestinal complications, as well as reproductive disorders in patients with Cystic Fibrosis is also anticipated to augment the demand for the treatment of the condition over the analysis period.

Additionally, the adoption of advanced treatment options for early detection is raising the patient population for better treatment, which in turn is projected to propel the growth of the cystic fibrosis therapeutics market in the near future.

Cystic Fibrosis Demand Analysis (2018 to 2022) Vs Market Outlook (2023 to 2033)

The global demand for Cystic Fibrosis Therapeutics is projected to increase at a CAGR of 25.0% during the forecast period between 2023 and 2033, reaching a total of US$ 116.42 Billion in 2033, according to a report from Future Market Insights (FMI). From 2018 to 2022, sales witnessed significant growth, registering a CAGR of 12.4%.

According to Future Market Insights, a market research and competitive intelligence provider, the Cystic Fibrosis Therapeutics Market was valued at US$ 10.0 Billion in 2022.

The increasing incidence of cystic fibrosis (CF), and the rising treatment rate, are the major factors that are expected to augment the market growth during the forecast period. Also, other factors such as the rise in the number of initiatives undertaken by nonprofit organizations, the rise in Research and Development funding by both private and public organizations, as well as supportive government legislation are also anticipated to accelerate the revenue share of the cystic fibrosis therapeutics market in the forthcoming years.

As per the data published by the Cystic Fibrosis Foundation, the incidence of these hereditary disorders is constantly growing. In 2019, there were more than 70,000 patients living with cystic fibrosis. Increasing year-on-year growth in the number of patients further results in surging demand for efficient and effective CF therapeutics.

Furthermore, a surge in the number of potential clinical pipeline candidates is another factor that is likely to fuel the market growth. In addition, an increase in the number of clinical trials to expand its target patient base with the existing drug portfolio is also among some of the drivers of this market.

The presence of various nonprofit organizations, such as Cystic Fibrosis Worldwide, Cystic Fibrosis Foundation, Cystic Fibrosis Canada, South African Cystic Fibrosis Trust, and South African Cystic Fibrosis Association, which are consistently involved in the activities related to CF is also one of the pivotal factors that can be accounted for surging demand. These organizations are investing huge amounts of funds to find various therapeutics for CF, and to support the research and developmental activities by prominent players.

Which Drivers underpin Cystic Fibrosis Industry Expansion?

Availability of Potential Pipeline Candidates to Fuel the Market Growth

The advent of drugs for the treatment of Cystic Fibrosis is on the new horizon, which is a major factor that is expected to escalate the growth of the market during the analysis period. The emergence of drugs that are targeting the defect in the cells of people suffering from diseases is enhancing market growth. This treatment is projected to be life-changing for many patients, which in turn is influencing the market growth.

Additionally, a surge in the prevalence of the disease is another major factor that is considered to fuel the demand of the market. This, in turn, is propelling the launch of newly formulated pipeline drugs required for the treatment of serious patients. Moreover, many potential candidates are in their final stages of development and are expected to boost the market growth over the forecast period.

Presence of Advanced Treatment Options to Accelerate the Market Growth

The Cystic Fibrosis Therapeutics Market has been triggered, owing to an increasing number of patients suffering from CF globally. Pharmacotherapy of CF has come up with various advancements in the treatment of this condition, which in turn is positively impacting the market growth. In addition, market trends present in the treatment of the disease are fueling the market growth, attributed to the increasing number of pipeline candidates from major companies aiming toward therapeutic care. This in turn is influencing manufacturers to introduce advanced medication targeting CFTR protein abnormalities. Moreover, the launch of Ivacaftor / Lumacaftor, a potentiator that improves the lives of people suffering from the disease, is also stimulating market growth.

Further, the technological improvement by major companies, along with rising Research and Development activities is also aiding this market growth by introducing new products. For instance, the National Research Council launched cystic fibrosis diagnostic smart patch for early diagnosis of the condition. This patch is digitally powered by wireless technology.

Sabyasachi Ghosh

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Which Factors are limiting the Growth of Cystic Fibrosis Therapeutics Market?

Side Effects Associated with CF Drugs to Restrain the Market Growth

Although the growth of the market is observed to be projecting over the years, due to a surge in awareness of the treatment options, an increase in the prevalence of the disease worldwide, an increase in the launch of new drugs, and other developments there are some of the factors that are expected to hinder the market growth.

The products have adverse effects such as upper respiratory tract infection, liver problems, chest pain, increase in blood pressure, and others that might impede the market growth. Moreover, the high cost of the treatment among Cystic Fibrosis patients suffering from a lung transplant, liver transplant, and others is also restraining the market growth.

In addition, prolonged FDA approvals, product recalls, stringent regulations, and others are some of the other factors that are anticipated to limit the Cystic Fibrosis Therapeutics Market.

Existence of Inadequate Income Opportunities Limits the Market Growth

The existence of inadequate income opportunities, as well as high expenditures connected with the treatment, are the major factors that are anticipated to impede the growth of the Cystic Fibrosis Therapeutics Market during the analysis period. Besides, the outline of the generic drugs and patient expiration is expected to further challenge the market growth in the near future.

Moreover, due to the limited information available, extensive research is essential as CF is a rare disease. The research and development cost for CF is very high, leading to the enormous prices of the end products. The high cost of drugs and treatment is another major factor that will limit the growth of the Cystic Fibrosis Therapeutics Market.

Region-wise Insights

Will North America Continue Dominance in the Global Cystic Fibrosis Therapeutics Market?

The surge in Patients Suffering from CF in the Region to Fuel the Market Growth

The Cystic Fibrosis Therapeutics Market in North America is expected to accumulate the highest market share of 48% in 2023.

Factors such as an increase in CF cases, a surge in patients suffering from various respiratory disorders influencing CF, a rise in Research and Development activities, and a rise in healthcare expenditure are expected to fuel the growth of the cystic fibrosis market during the forecast period. Also, the increasing healthcare expenses, coupled with advanced medical amenities which in turn will further propel the regional market growth in the forthcoming years.

As per the cystic fibrosis foundation (CFF), there are close to 40,000 children and adults living with cystic fibrosis in the United States (and an estimated 105,000 people have been diagnosed with CF across 94 countries), and CF can affect people in every racial and ethnic group. In addition, as per the CFF's national patient registry, the median age of a person with CF is currently 33.4 years. The average life expectancy of CF patients has increased significantly compared to the patients 30 years back. Thus, the increasing prevalence of CF has boosted North America's share in the global Cystic Fibrosis Therapeutics Market.

Additionally, Hopkins University and Medicine researchers developed a novel treatment for a pathogen in December 2020. Mycobacterium abscesses are a pathogen that is drug-resistant and harmful to persons with lung diseases or cystic fibrosis. Hence, all these factors are likely to fuel the regional market growth during the forecast period. The region is expected to hold the highest CAGR of 24.8% during the forecast period.

How Will the Growth of the Cystic Fibrosis Therapeutics Market unfold in Asia Pacific?

Growing Geriatric Patients in the Region to Fuel the Market Growth

The Cystic Fibrosis Therapeutics Market in Asia Pacific is expected to accumulate the highest market share of 47% in 2023.

The Asia Pacific hypophosphatasia market is anticipated to register significant growth during the analysis period, attributed to factors such as an increase in geriatric patients, and high awareness associated with treatment.

Moreover, enlightening of the healthcare amenities will permit the development, which in turn are expected to boost the growth of the Cystic Fibrosis Therapeutics Market in the region in the forecast period. The region is expected to hold the highest CAGR of 24.7% during the forecast period.

Category-wise Insights

By Drug Class, which Cystic Fibrosis Category will remain prominent?

Cystic Fibrosis Transmembrane Conductance (CFTR) Segment to beat Competition in Untiring Market

On the basis of drug class, the global Cystic Fibrosis Therapeutics Market is dominated by the Cystic Fibrosis Transmembrane Conductance (CFTR) Segment, which accounts for a share of 48%. The segment is expected to hold a CAGR of 24.8% over the analysis period.

CFTR is considered to be a dominating market, attributed to its functions such as it improves the body’s function at the cellular level, which is considered to be slow, improving the function of CFTR protein, and others. Moreover, advanced therapies of triple combination drugs are also fueling the segment’s growth during the forecast period.

Additionally, factors such as increased usage of CFTR drugs in the treatment of muscle relaxation, airway clearance, and others are other factors that are likely to boost the growth of the CFTR segment. Mucolytics are considered to be important inhaled medications known as mucous thinners, which in turn are augmenting the segment’s growth over the analysis period.

By Route of Administration, which Cystic Fibrosis Category to dominate?

Oral Segment to Drive the Cystic Fibrosis Therapeutics Market

Based on the Route of Administration, the oral segment is expected to witness a significant growth of 47% in 2022, and the trend is expected to continue during the forecast period, expanding at a rapid rate of 24.7% CAGR over the analysis period.

This growth is attributed to factors such as the rise in the adoption of oral drugs globally, and the advent of new formulation drugs that can be consumed easily without the risk of invasive procedures to obtain effective treatment.

Moreover, the parenteral drug segment is anticipated to register significant growth, over the analysis period, attributed to an increased usage of parenteral drugs which include inhaled and injections. Thus, inhaled drugs are widely used by medical practitioners for patients suffering from high-risk respiratory disorders coupled with CF.

The Start-Up Ecosystem: How key Players are opening Frontiers for Future Growth?

Cystic Fibrosis Therapeutics Market startup players are adopting various marketing strategies such as new product launches, geographical expansion, mergers and acquisitions, partnerships, and collaboration to identify the interest of potential patients and create a larger customer base. For instance,

• Founded in 2011, Translate Bio is a leading mRNA therapeutics company, that develops a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction.
• Galecto Biotech started in 2011, develops galectin modulators for the treatment of severe diseases, including cystic fibrosis and cancer. The company builds on more than 10 years of research into galectins and galectin modulators, which combined with a strong patent estate gives Galecto Biotech a unique platform.
• Established in 2019, Sionna Therapeutics, a developer of a batch of small molecules will be the first to fully restore function to the cystic fibrosis transmembrane conductance regulator (CFTR) protein.

Who are the Leading Players in the Cystic Fibrosis Therapeutics Market?

Prominent players in the Cystic Fibrosis Therapeutics Market are Novartis AG, Vertex Pharmaceuticals Incorporated, AbbVie Inc., Gilead Sciences, Inc., Mylan N.V., Pfizer Inc., Bayer AG, Genentech, Inc., and AstraZeneca, among others.

Recent Developments:

• In December 2022, Vertex Pharmaceuticals Incorporated announced that the US Food and Drug Administration has cleared its Investigational New Drug (IND) application for VX-522, a messenger ribonucleic acid (mRNA) therapy targeted at treating the underlying cause of cystic fibrosis (CF) lung disease for the approximately 5,000 people with CF who cannot benefit from a cystic fibrosis transmembrane conductance regulator (CFTR) modulator. Vertex plans to initiate a single ascending dose clinical trial for VX-522 in people with CF in the coming weeks.
• In October 2020, Roche and Abbvie announced the partnership and acquired the TMEM 16A product portfolio. It is used in cystic fibrosis with a rare type of CFTR genotype and concerned respiratory illnesses. It helped the firm boost its product of offerings.
• In April 2019, the US Food and Drug Administration (FDA) approved Vertex Pharmaceuticals Incorporated’s KALYDECO (ivacaftor) with an aim of expanding the range of treatment options for the millions of children living with cystic fibrosis (CF). This allows physicians to begin treating the underlying cause of CF in eligible infants as young as six months of age for the first time, with the potential to modify the course of the disease.

Report Scope

Key Segments Covered in the Cystic Fibrosis Industry Analysis

Cystic Fibrosis Therapeutics Market by Drug Class:

• Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)
• Bronchodilators
• Mucolytic
• Pancreatic Enzyme Supplement
• Others

Cystic Fibrosis Therapeutics Market by Route of Administration:

• Oral
• Parenteral

Cystic Fibrosis Therapeutics Market by Distribution Channel:

• Retail Pharmacies & Drug Stores
• Online Pharmacies
• Hospital Pharmacies

Cystic Fibrosis Therapeutics Market by Region:

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa (MEA)