Chronic Refractory Cough - Market Insight, Epidemiology And Market Forecast - 2032

This ‘Chronic Refractory Cough-Market Insights, Epidemiology, and Market Forecast-2032' report deliver an in-depth understanding of the Chronic Refractory Cough, historical and forecasted epidemiology as well as the Chronic Refractory Cough market trends in the United States, the EU-5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

The Chronic Refractory Cough market report provides current treatment practices, emerging drugs, market share of the individual therapies, and the current and forecasted 7MM Chronic Refractory Cough market size from 2019 to 2032. The Report also covers current Chronic Refractory Cough treatment practice, market drivers, market barriers, SWOT analysis, reimbursement, market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• The EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2019-2032

Chronic Refractory Cough Understanding and Treatment Algorithm

Chronic Refractory Cough Overview

Chronic Refractory Cough (CRC) is defined as a cough lasting more than 8 weeks despite guidelines-based treatment and which may be treated only by different medical specialties. Individuals with CRC have impaired quality of life and interruption of activities of daily living. It also results in depression and can persist for many months or years, despite systematic investigation and treatment of known causes. The infection can also be referred to as chronic cough (CC), chronic idiopathic cough (CIC), unexplained chronic cough (UCC), and cough hypersensitivity syndrome (CHS).

Recurrent incidence of CC results in CRC. The symptoms and indications of CRC are similar to those of CC. One of the first and most important symptoms that may indicate respiratory involvement is a persistent or chronic cough. Key symptoms include a dry irritated cough localized around the laryngeal region. Symptoms are not restricted to cough and can include globus, dyspnea, and dysphonia. CRC has factors in common with laryngeal hypersensitivity syndromes and chronic pain syndromes, and these similarities help to shed light on the pathophysiology of the condition.

Laryngopharyngeal reflux (LPR) is a common cause of CRC and may be present without symptoms of classic GERD, including heartburn (silent reflux). Obstructive sleep apnoea syndrome (OSAS) is also an independent risk factor for CC and a risk factor for LPR/GERD recalcitrant to medical therapy. ACE inhibitors are another common cause of CRC, which can occur spontaneously even after many years on this medication without previous problems.

CC is more prevalent in women, and there are various complications associated with it which include negative psychological, social, and physical outcomes. It causes an interruption of daily activities, social embarrassment, and physical exhaustion secondary to frequent coughing episodes.

Chronic Refractory Cough Diagnosis

CRC can be diagnosed when patients have no identified causes of CC or when the cough persists after investigation and treatment of cough-related conditions.

The diagnosis of the disease is either done by primary or secondary assessment. The initial assessment for protracted or chronic cough is intended to characterize the condition based on history, to elicit any alarm symptoms or findings that may indicate a serious underlying disease, and to identify whether there is a specific disease present that is associated with CC.

The first step in evaluating individuals with CRC is performing a correct and complete anamnesis, followed by a physical examination. While the second stage of investigation is considered to further characterize the condition of the disease. These include nasendoscopy and 24-hour pH monitoring. Laryngeal examination using flexible nasendoscopy identifies the presence of laryngeal lesions or abnormal motor patterns that might be contributing to the cough symptoms and laryngeal discomfort.

Some of the common tests that are performed to examine chronic cough are chest radiograph, spirometric and peak expiratory flow measurements, bronchoprovocation testing, sinus imaging, etc.

Chronic Refractory Cough Treatment

According to the recent guidelines published by the American College of Chest Physicians (ACCP) four categories of treatment can be implemented which include nonpharmacologic therapies, ICS, neuromodulatory therapies, proton pump inhibitors, and other therapies.

The market for CRC is mainly dominated by nonpharmacologic therapies, which include Speech Therapy and Physiotherapy. The first step in Speech Pathology Management of CRC patients is to evaluate the pathophysiological features of the condition, including cough characteristics, urge to cough, Paradoxical vocal fold movement (PVFM), and voice symptoms.

After nonpharmacological therapies, the market holds various types of pharmacologic therapies which include neuromodulators, proton pump inhibitors, ICS, and other treatment options. Neuromodulators include opiates (morphine, codeine, tramadol, etc.), gabapentin, pregabalin, morphine, amitriptyline, and baclofen, which act on the heightened neural sensitization that is involved in the pathogenesis of CRC. Combined therapy can also be employed to treat patients with CRC. This includes the use of nonpharmacologic and pharmacologic interventions together.

Recently in 2022, Japan's MHLW approved Merck's LYNFUA (gefapixant), an orally-administered, selective P2X3 receptor antagonist for the treatment of adults with RCC or UCC.

Chronic Refractory Cough Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by 12 month Prevalent Cases of Chronic Cough, Gender-specific Cases of Chronic Cough, Total Diagnosed Prevalent Cases of Chronic Refractory Cough, and Diagnosed Prevalent Cases of Chronic Cough in IPF scenario of Chronic Refractory Cough in the 7MM covering the United States, the EU-5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2019 to 2032.

Key Findings

• In 2021, the 12-month prevalent cases of CC were estimated to be 30,625,209 cases in the 7MM. These cases are expected to increase by 2032 at a CAGR of 0.4% during the study period (2019-2032).
• Among the 7MM, the United States accounted for nearly 42% of the 12-month prevalent cases of CC with 12,782,168 cases in 2021 which are expected to increase further by 2032.
• Assessments as per the analysts show that the total diagnosed prevalent cases of CRC in the 7MM were 12,250,084 cases in 2021. Among the 7MM, in 2021, the US accounted for nearly 41.7% of the total diagnosed prevalent cases of CRC. The prevalent population for CRC was derived from the prevalent patient pool of CC.
• In the US, the gender-specific cases of CC were 5,061,738 and 7,720,429 cases for males and females, respectively in the year 2021, which are expected to increase by 2032.
• Among the EU-5, Germany accounted for the highest number of total diagnosed prevalent cases of CRC (1,383,684), followed by Italy with 1,034,973 cases in 2021. In contrast, Spain accounted for the least of the total diagnosed prevalent cases of CRC in the EU-5.
• In 2021, Japan accounted for 1,812,612 cases of total diagnosed prevalent cases of CRC, which is approximately 15% of the 7MM total diagnosed prevalent cases of CRC.
• In the US, the diagnosed prevalent cases of CC in IPF were 75,537 cases in 2021 which are expected to increase by 2032.

Chronic Refractory Cough Epidemiology

The epidemiology segment also provides the Chronic Refractory Cough epidemiology data and findings across the United States, the EU-5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

Chronic Refractory Cough Drug Chapters

The drug chapter segment of the Chronic Refractory Cough report encloses the detailed analysis of Chronic Refractory Cough marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the Chronic Refractory Cough clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug, and the latest news and press releases.

Chronic Refractory Cough Emerging Drugs

MK-7264 (gefapixant): Merck & Co/ Kyorin Pharmaceuticals

MK-7264 (gefapixant), is being developed by Merck & Co for the treatment of RCC or UCC. Also known as AF-219, it is an investigational, non-narcotic, orally-administered, selective P2X3 receptor antagonist that prevents ATP binding. In 2020, Merck completed Phase III trials for MK-7264 and based on its result submitted an NDA for the approval of MK-7264. In January 2022, the FDA issued a CRL regarding Merck's NDA for MK-7264 and requested additional information related to the measurement of efficacy. Currently, Merck is performing additional analyses and anticipates submitting this information to the FDA in the first half of 2023 in response to the CRL. The review period in the EU has also been extended pending the receipt of additional information from the Company. The Company plans to submit the information to the EMA in the first half of 2023.

BLU-5937: Bellus Health

BLU-5937 (formerly known as NEO5937), being developed by Bellus Health, is a potent, highly selective, orally bioavailable small molecule antagonist of the P2X3 receptor, a clinically validated target for CC. BLU-5937 has the potential to be a best-in-class therapeutic for CRC patients. In July 2022, Bellus Health completed an End-of-Phase II meeting with the US FDA. Based on the positive feedback from the FDA, Bellus Health plans a Phase III CALM trial consisting of two pivotal trials (CALM-1 and CALM-2), with a primary efficacy endpoint of 24-hour cough frequency measured at 12 and 24 weeks, respectively. It is expected to enroll its first patient in the fourth quarter of 2022 with topline data expected by 2024. Besides this, it also plans to initiate a Phase I clinical trial investigating a once-daily, extended-release formulation of BLU-5937.

S-600918 (sivopixant): Shionogi

S-600918 (sivopixant) is an oral, P2X3 receptor antagonist, an antitussive agent that is being developed by Shionogi for RCC or UCC. It has high selectivity for P2X3 homomer compared with P2X2/3 heteromer, which could reduce coughs with minimal taste-related side effects. The company has already completed a Phase IIb dose-finding study and plans for Phase III trials in the future to determine a clinically optimal dose for RCC.

AX-8: Axalbion

AX-8, being developed by Axalbion, is a potent, selective transient receptor potential melastatin 8 (TRPM8) agonist, for the treatment of CC. TRPM8 is expressed in many of the sensory fibers innervating the upper airways and can treat RCC by counterbalancing CHS by decreasing or abolishing pathological coughing, and limiting or suppressing abnormal sensations associated with cough. Recently, Axalbion announced positive Phase II results from a proof-of-concept study of AX8 in patients with RCC or UCC.

List of products to be continued in the report…

Chronic Refractory Cough Market Outlook

CRC proves to be a huge burden on the patients who are fighting this debilitating condition. It is typically nonproductive and there is often a preceding history of viral respiratory tract infection. Patients frequently describe a dry, irritating cough that may be localized to the laryngeal region. It significantly impairs patients' quality of life. Unfortunately, in many situations, patients continue to experience CRC despite following the published guidelines for diagnosis and treatment.

Currently, the market holds no approved therapy to treat CRC. According to the recent guidelines published by the American College of Chest Physicians (ACCP) four categories of treatment can be implemented which include nonpharmacologic therapies, ICS, neuromodulatory therapies, proton pump inhibitors, and other therapies.

The market for CRC is mainly dominated by nonpharmacologic therapies, which include Speech Therapy and Physiotherapy. The main strategies that are followed by the speech therapists include education (Cough can be triggered by irritation, controlling the urge to cough, etc.), symptom control techniques, such as cough suppression swallow, cough control breathing, PVFM release breathing, and release of laryngeal restriction, reduction in laryngeal irritation (behavioral management of reflux, reduction in phonotraumatic behaviors, patients should remain hydrated and minimizing exposure to the irritating substances.

After nonpharmacological therapies, the market holds various types of pharmacologic therapies which include neuromodulators, proton pump inhibitors, ICS, and other treatment options. Neuromodulators include opiates (morphine, codeine, tramadol, etc.), gabapentin, pregabalin, morphine, amitriptyline, and baclofen, which act on the heightened neural sensitization that is involved in the pathogenesis of CRC.

ICS are effective in eosinophilic airway inflammation. An assessment of airway eosinophilia (induced sputum, bronchoalveolar lavage) or exhaled NO is followed before subjecting patients with ICS in case of CRC. These mainly include mometasone, budesonide, and beclometasone. Treatment with ICS can significantly reduce cough but regress analyses are required to address the exact treatment regimen of these drugs.

Combined therapy can also be employed to treat patients with CRC. This includes the use of nonpharmacologic and pharmacologic interventions together, i.e., combining speech therapy with drugs to provide relief to the patients. Patients on speech therapy can be advised to opt for drugs, such as pregabalin or gabapentin. Recently Japan's MHLW approved Merck's LYNFUA (gefapixant), an orally-administered, selective P2X3 receptor antagonist for the treatment of adults with RCC or UCC
The market holds a critical unmet need with no approved curative definitive therapy for CRC. The pharmacologic therapies that are employed cannot be used in a long term due to various adverse events associated with them. Expected launch of potential therapies that include orvepitant maleate (Nerre Therapeutics), BLU-5937 (Bellus Health), MK-7264 (gefapixant) (Merck), AX-8 (Axalbion), S-600918 (Shionogi), and NP-120 (ifenprodil) (Algernon Pharmaceuticals) may address this unmet need, increase the market size in the coming years, assisted by an increase in the diagnosed prevalent population of CRC during the forecast period [2022-2032].

According to the publisher, the overall dynamics of the CRC market is anticipated to change in the coming years owing to the expected launch of emerging therapies.

Key Findings

• The market size of Chronic Refractory Cough in the seven major markets was USD 8,740.2 million in 2021, which is further expected to increase by 2032 at a Compound Annual Growth Rate (CAGR) of 3.9% for the study period (2019-2032).
• The launch of potential therapies, MK-7264 (gefapixant), BLU-5937, S-600918 (sivopixant), AX-8, and Orvepitant Maleate is expected to increase the market size in the coming years, assisted by the increase in the diagnosed prevalent population of CRC.
• The United States accounts for the largest market size for Chronic Refractory Cough, in comparison to the EU-5 (Germany, Italy, France, Spain, and the United Kingdom) and Japan.
• Among the EU5 countries, Germany had the highest market size with approximately USD 837.4 million in 2021. This is expected to further increase, with Germany estimated to capture the maximum market followed by the UK in 2032.
• The market size for Chronic Refractory Cough in Japan was valued at approximately USD 1,097.0 million in 2021. It is expected that the market will increase mainly due to the launch of upcoming therapy during the forecast period (2022-2032).

The United States Market Outlook

This section provides the total Chronic Refractory Cough market size and market size by therapies in the United States.

The EU-5 Market Outlook

The total Chronic Refractory Cough market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total Chronic Refractory Cough market size and market size by therapies in Japan are provided.

Chronic Refractory Cough Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the Chronic Refractory Cough market or expected to get launched in the market during the study period 2019-2032. The analysis covers the Chronic Refractory Cough market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, and the reasons behind the maximal use of new drugs and allows, the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Chronic Refractory Cough Development Activities

The report provides insights into different therapeutic candidates in phase II, and phase III stages and also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions, mergers, licensing, and patent details for Chronic Refractory Cough emerging therapies.

Reimbursement Scenario in Chronic Refractory Cough

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

The publisher performs competitively and market Intelligence analysis of the Chronic Refractory Cough market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of Chronic Refractory Cough, explaining its etiology, signs and symptoms, pathophysiology, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the Chronic Refractory Cough epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Chronic Refractory Cough is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the Chronic Refractory Cough market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Chronic Refractory Cough market.

Report Highlights

• The robust pipeline with novel MOA and oral ROA and increasing incidence will positively drive the Chronic Refractory Cough market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Chronic Refractory Cough R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for Chronic Refractory Cough. The launch of emerging therapies will significantly impact the Chronic Refractory Cough market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Chronic Refractory Cough Report Insights

• Patient Population
• Therapeutic Approaches
• Chronic Refractory Cough Pipeline Analysis
• Chronic Refractory Cough Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Chronic Refractory Cough Report Key Strengths

• 11-Years Forecast
• The 7MM Coverage
• Chronic Refractory Cough Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Chronic Refractory Cough Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• SWOT analysis

Key Questions Answered

Market Insights:

• What was the Chronic Refractory Cough market share (%) distribution in 2019 and how it would look like in 2032?
• What would be the Chronic Refractory Cough total market size as well as market size by therapies across the 7MM during the forecast period (2022-2032)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Chronic Refractory Cough market size during the forecast period (2022-2032)?
• At what CAGR, the Chronic Refractory Cough market is expected to grow at the 7MM level during the forecast period (2022-2032)?
• What would be the Chronic Refractory Cough market outlook across the 7MM during the forecast period (2022-2032)?
• What would be the Chronic Refractory Cough market growth till 2032 and what will be the resultant market size in the year 2032?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What are the disease risk, burdens, and unmet needs of Chronic Refractory Cough?
• What is the historical Chronic Refractory Cough patient pool in the United States, the EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
• What would be the forecasted patient pool of Chronic Refractory Cough at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Chronic Refractory Cough?
• Out of the above-mentioned countries, which country would have the highest incidence population of Chronic Refractory Cough during the forecast period (2022-2032)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2022-2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Chronic Refractory Cough along with the approved therapy?
• What are the current treatment guidelines for the treatment of Chronic Refractory Cough in the US and Europe?
• What are the Chronic Refractory Cough marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of Chronic Refractory Cough?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Chronic Refractory Cough?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and licensing activities related to the Chronic Refractory Cough therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Chronic Refractory Cough and their status?
• What are the key designations that have been granted for the emerging therapies for Chronic Refractory Cough?
• What is the 7MM historical and forecasted market for Chronic Refractory Cough?

Reasons to Buy

• The report will help in developing business strategies by understanding trends shaping and driving Chronic Refractory Cough.
• To understand the future market competition in the Chronic Refractory Cough market and an Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Chronic Refractory Cough in the US, the EU-5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Chronic Refractory Cough market.
• To understand the future market competition in the Chronic Refractory Cough market.