US Cough Hypersensitivity Syndrome Therapeutics Market Analysis

US Cough Hypersensitivity Syndrome Therapeutics Market Analysis Executive Summary

The US Cough Hypersensitivity Syndrome Therapeutics Market is at around $3.402 Bn in 2022 and is projected to reach $4.620 Bn in 2030, exhibiting a CAGR of 3.9% during the forecast period.

Cough Hypersensitivity Syndrome (CHS) is defined as an enhanced coughing reaction to stimuli such as temperature fluctuations, mechanical forces, or chemical exposure. Common underlying causes of CHS include asthma, upper airway cough syndrome (UACS), gastroesophageal reflux disease (GERD), rhinitis, chronic obstructive pulmonary disease (COPD), and pulmonary fibrosis. Its risk factors include increased sensitivity to cough-inducing stimuli such as citric acid or capsaicin. Available treatment options include antitussive medications, inhaled corticosteroids (ICS), short-acting beta2-agonists (SABA), anticholinergics, antihistamines, P2X3 receptor antagonists, and neurokinin-1 receptor antagonists. Johnson & Johnson, Bayer AG, and other major pharmaceutical companies produce therapies for CHS.

More than 5%-20% of Americans are affected by a chronic cough that can result in CHS. Several factors contribute to market expansion such as the surge in the prevalence of Cough Hypersensitivity Syndrome and subsequently its risk factors like smoking, growing awareness, and high unmet medical needs. However, conditions such as high costs of treatment, high development costs of new therapeutics, and limited understanding of the disease restrict the growth and potential of the market.

Market Dynamics

Market Growth Drivers

Increasing prevalence of Cough Hypersensitivity Syndrome: CHS frequently arises from chronic respiratory conditions such as asthma, COPD, and allergic rhinitis. Chronic cough affects an estimated 5% to 20% of the American population. The increased prevalence of these diseases in the US population drives the market for CHS treatments, with factors such as air pollution, smoking, and higher life expectancy contributing to this trend.

Unmet medical need: Currently, CHS has no FDA-approved drugs. Existing therapies, such as cough suppressants or inhaled corticosteroids, provide little relief and have adverse effects. This gap in treatment options provides an opportunity for the development of improved and new CHS therapies.

Growing awareness: The rising expense of healthcare in the US, along with a growing awareness of CHS and its implications for quality of life, may result in increased insurance coverage for CHS therapies. This improved access to medical care encourages patients to seek diagnosis and treatment, resulting in market growth.

Market Restraints

High costs of treatment: Many CHS treatments are expensive, limiting their affordability, which restricts market penetration and patient adherence to prescribed drugs. The lack of an FDA-approved medicine, results in limited patient access and hinders market growth.

High development costs: Developing new medications for specialized populations such as those with CHS can be both costly and time-intensive, given the smaller trial sizes and distinct requirements involved. This dissuades pharmaceutical companies from making substantial investments in this market. Negotiating rigorous regulatory standards and protracted approval procedures further compounds the challenges, hindering the prompt accessibility of innovative therapies for patients.

Limited understanding of CHS: The diagnosis of CHS presents difficulties as its symptoms overlap with those of other respiratory conditions. The absence of well-defined diagnostic criteria and biomarkers increases the risk of misdiagnosis and underdiagnosis, acting as a hindrance to market growth. The evolving understanding of the distinct pathophysiology of CHS subtypes adds complexity, impeding the development of precisely targeted therapies.

Notable Updates

December 2023, The FDA denied Merck's request for approval of a novel tablet medicine for chronic cough. The FDA ruled that Merck's application for Gefapixant lacked sufficient evidence of efficacy in treating refractory chronic cough and unexplained chronic cough.

Healthcare Policies and Regulatory Landscape

In the US, the primary regulatory body overseeing drugs, pharmaceuticals, and other medical products is the Food and Drug Administration (FDA). The FDA is a federal agency within the Department of Health and Human Services and is responsible for ensuring the safety and efficacy of a wide range of products. The FDA plays a crucial role in the approval and ongoing regulation of these products, conducting rigorous evaluations of their safety and effectiveness before they can be marketed and distributed to the public.

The process of obtaining licensure for drugs and pharmaceuticals in the U.S. typically involves several stages. The pharmaceutical company submits a New Drug Application (NDA) to the FDA, which reviews the data to determine if the product meets the necessary standards for approval. If approved, the drug can be marketed and sold to the public, with ongoing post-marketing surveillance to monitor for any unforeseen issues.

The regulatory environment for new entrants involves adherence to these stringent processes and compliance with FDA guidelines to ensure the safety and effectiveness of pharmaceutical products entering the market. This regulatory framework is designed to protect public health and maintain high standards in the pharmaceutical industry.

Competitive Landscape

Key Players

• Pfizer
• GlaxoSmithKline
• Boehringer Ingelheim
• AstraZeneca
• F. Hoffman-La Roche Ltd
• Teva Pharmaceuticals
• Novartis
• Merck
• Vertex Pharmaceuticals
• Johnson & Johnson