PUBLISHER: DelveInsight | PRODUCT CODE: 1605436
PUBLISHER: DelveInsight | PRODUCT CODE: 1605436
DelveInsight's "Acute Respiratory Distress Syndrome (ARDS)- Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of Acute Respiratory Distress Syndrome (ARDS), historical and forecasted epidemiology as well as the Acute Respiratory Distress Syndrome (ARDS) market trends in the United States, EU4, and the UK (Germany, France, Italy, Spain) and the United Kingdom, and Japan.
The Acute Respiratory Distress Syndrome (ARDS) market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Acute Respiratory Distress Syndrome (ARDS) market size from 2020 to 2034. The Report also covers current Acute Respiratory Distress Syndrome (ARDS) treatment practices, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.
Study Period: 2020-2034
Acute Respiratory Distress Syndrome (ARDS) Overview
Acute Lung Injury (ALI) is a common condition characterized by acute severe hypoxia that is not due to left atrial hypertension. The term ALI encompasses a continuum of clinical and radiographic changes that affect the lungs, with the ARDS representing the more severe end of this continuum. Despite advances in the understanding of the pathophysiology and management of ALI, it is still associated with high mortality
ARDS is categorized into three severity levels based on the PaO2/FiO2 ratio, which helps guide treatment decisions: mild (200-300 mmHg), moderate (100-200 mmHg), and severe (<100 mmHg). ARDS may develop over a few days, or it can get worse very quickly. Usually, the first symptom of ARDS is shortness of breath. Besides, other signs and symptoms of ARDS are low blood oxygen, rapid breathing, and clicking, bubbling, or rattling sounds in the lungs when breathing.
Acute Respiratory Distress Syndrome (ARDS) Diagnosis
The diagnosis of Acute Respiratory Distress Syndrome (ARDS) is primarily based on clinical criteria and imaging studies. It begins with identifying symptoms such as severe shortness of breath, rapid breathing, and hypoxia (low blood oxygen levels), often following a known trigger like pneumonia, trauma, or sepsis. Chest X-rays or CT scans reveal bilateral infiltrates, which help exclude other conditions, such as heart failure.
The Berlin Definition (2012) is commonly used, categorizing ARDS based on the severity of hypoxemia-mild, moderate, or severe-assessed through the PaO2/FiO2 ratio. Additionally, arterial blood gas analysis is critical in confirming hypoxemia and ruling out other causes. Exclusion of cardiac causes of pulmonary edema is necessary to confirm ARDS, often achieved by evaluating left atrial pressure or conducting an echocardiogram. Early and accurate diagnosis is essential for timely intervention and improving patient outcomes.
Acute Respiratory Distress Syndrome (ARDS) Treatment
The treatment of Acute Respiratory Distress Syndrome (ARDS) focuses on supporting respiratory function and addressing the underlying cause. The primary management strategy involves mechanical ventilation with lung-protective strategies, such as low tidal volume ventilation (6 mL/kg of predicted body weight) and the use of positive end-expiratory pressure (PEEP) to prevent alveolar collapse. Prone positioning may also be utilized to improve oxygenation in severe cases. In some instances, extracorporeal membrane oxygenation (ECMO) is considered for patients who fail to respond to conventional ventilation.
Pharmacologically, corticosteroids are sometimes used to reduce inflammation, though their use remains controversial. Antibiotics and antivirals may be administered if infection is the underlying cause. Supportive care includes fluid management to avoid both under- and over-resuscitation, as well as careful monitoring of organ function. The treatment approach is tailored to the severity of ARDS and the patient's overall condition, with multidisciplinary care often required for optimal outcomes.
As the market is derived using a patient-based model, the Acute Respiratory Distress Syndrome (ARDS) epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Incident Cases of Acute Respiratory Distress Syndrome (ARDS), Severity-specific Incident Cases of Acute Respiratory Distress Syndrome (ARDS), and Incident Cases of Acute Respiratory Distress Syndrome (ARDS) by Risk Factors, in the 7MM covering, the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034.
The drug chapter segment of the Acute Respiratory Distress Syndrome (ARDS) report encloses a detailed analysis of Acute Respiratory Distress Syndrome (ARDS) off-label drugs and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Acute Respiratory Distress Syndrome (ARDS) clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
Emerging Drugs
Sabizabulin (Veru-111): Veru
Sabizabulin (VERU-111) is an orally bioavailable bis-indole that binds to the colchicine binding site of alpha and beta tubulin and inhibits tubulin polymerization at low nanomolar concentrations. The drug disrupts the microtubules, the central mechanism that contributes to both their antiviral and anti-inflammatory activities, by disrupting the intracellular transport of viruses, such as SARS CoV-2, along microtubules. Microtubule trafficking is critical for viruses to cause infection.
The company is currently investigating a Phase III study of VERU-111 for the treatment of SARS-CoV-2 in patients at high risk for ARDS. However, a planned interim analysis was conducted in the first 150 patients randomized into the study.
In January 2022, the US FDA granted Fast Track Designation (FTD) for Sabizabulin for the treatment of hospitalized COVID-19 patients at high risk for ARDS.
In September 2023, Veru Inc. reported an agreement with the FDA on the design of a new Phase III clinical trial for sabizabulin in combination with standard care for patients with virus-induced ARDS. The randomized, placebo-controlled study will assess the efficacy and safety of a 9 mg oral daily dose of sabizabulin in hospitalized adult patients. This trial may serve as the sole study required for NDA submission.
Additionally The Phase III (904) study involving hospitalized patients with viral ARDS is currently paused, according to the company's latest pipeline update. The continuation of this study is contingent upon securing funding from government grants, partnerships with pharmaceutical companies, or similar third-party external sources. This indicates a dependency on external financial support to advance the study's progress.
Further detail in the report...
ExoFlo (DB-001): Direct Biologics
ExoFlo (DB-001) by Direct Biologics is an extracellular signal product isolated from human Bone Marrow Mesenchymal Stem or Stromal Cells (BM-MSCs) that contains growth factors and extracellular vesicles, including exosomes.
ExoFlo provides natural bioactive signals that downregulate inflammation, direct cellular communication, and upregulate tissue repair in humans. These vesicles are 30-150 nm in size and are purified using proprietary cGMP processing.
Recently, in July 2022, the company initiated the evaluation of the drug in Phase III for COVID-19 moderate-to-severe ARDS. In April 2022, the US FDA awarded ExoFlo a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of ARDS associated with COVID-19.
ARDS, a life-threatening condition, was described as a form of respiratory failure that closely resembled respiratory distress syndrome in infants. This can be caused by a variety of pulmonary (such as pneumonia and aspiration) or non-pulmonary (like sepsis, pancreatitis, and trauma) abuses, leading to the development of non-hydrostatic pulmonary edema.
ARDS is characterized by an acute, diffuse, inflammatory lung injury, leading to increased alveolar-capillary permeability, increased lung weight, and loss of aerated lung tissue. Clinically, this establishes hypoxemia, with bilateral opacities on chest radiography, associated with reduced lung compliance and increased venous admixture and physiological dead space. Morphologically, diffuse alveolar damage is observed in the acute phase of ARDS.
Despite decades of research, treatment options for ARDS are restricted. Supportive care with mechanical ventilation remains the mainstay of management. There are relatively few treatments available for ARDS.
Other treatment options to which the patients with ARDS are generally subjected include supplemental oxygen, prone positioning, use of paralytics, fluid management, and a technique called Positive End-expiratory Pressure (PEEP) to help push the fluid out of air sacs. These are combined with continuing treatment of the original illness or injury. Because people with ARDS are less able to fight lung infections, they may develop bacterial pneumonia during the illness. Antibiotics are given to fight infection. Also, supportive treatment, such as intravenous fluid or food, may be needed.
Alveolar flooding and pulmonary edema formation are important pathophysiological derangements in patients with ARDS. Experimental data have shown that B2 agonists can increase sodium transport by activating B2 receptors on alveolar type I and type II cells, accelerating the resolution of pulmonary edema.
Because injury to the alveolar epithelium is a significant cause of ARDS, the acceleration of alveolar epithelial repair may assist in the resolution of pulmonary edema and lung injury. Keratinocyte Growth Factor (KGF) is important in alveolar epithelial repair, and experimental and human studies support the concept that KGF may be beneficial in patients with ARDS.
Inflammation is an additional pathological hallmark of ARDS and may contribute to both pulmonary and non-pulmonary organ failure. Statins can decrease inflammation and the development of lung injury in experimental models. Statins are a class of drugs that doctors often prescribe to help decrease cholesterol levels in the blood. By lowering the levels, heart attacks and stroke can be prevented. Several studies show that, in certain people, statins reduce the risk of heart attack, stroke, and even death from heart disease. However, some studies contradict STATINS use in the management of ARDS because statins neither provide benefits for lowering the morbidity of ARDS in high-risk patients nor improve the clinical outcomes of ALI/ARDS patients. Hence, it may not be appropriate to advocate statin use for the prevention and treatment of ALI/ARDS.
Statins are expected to reduce inflammation in the lungs of patients with ARDS due to their anti-inflammatory effects. Many clinical investigations have revealed contradictory results regarding the role of statin therapy in ARDS.
Despite promising pathophysiological rationale and encouraging preclinical data, treatments like B2 agonists, Keratinocyte Growth Factor (KGF), and statins are not currently recommended for the routine management of ARDS. While preclinical studies and some clinical trials suggest that B2 agonists may help reduce pulmonary edema in acute lung injury and ARDS, their potential benefits have not yet been confirmed on a larger scale.
Given the lack of proven effectiveness for these treatments, management of ARDS typically involves alternative therapies such as neuromuscular blocking agents, inhaled vasodilators, and corticosteroids. These options have shown more established benefits, including improved oxygenation and reduced inflammation, making them part of the standard care for ARDS patients.
Mechanical ventilation is the foundation of ARDS management. The use of protective ventilation is a priority in this acute phase of lung inflammation. According to various studies, Neuromuscular Blocking Agents (NMBAs) play an important role in the management of a large number of hospital patients. NMBAs induce reversible muscle paralysis. Their use in patients with ARDS remains controversial but occurs frequently. In addition to their routine use in surgical anesthesia, NMBAs may be valuable in many new and evolving critical care situations. NMBAs exert their pharmacologic effects by modulating signal transmission in skeletal muscle. Action potentials reaching skeletal muscle activate the release of acetylcholine into the motor endplates.
One of the primary clinical concerns for patients who develop ARDS is to reduce pressure and stress on the lungs, thereby reducing additional inflammation beyond the initial damage or insult. Because of their effects on diaphragmatic tone, NMBAs have been suggested as a method for decreasing ventilator asynchrony and pulmonary pressures. Three primary studies have been published that evaluated the use of NMBAs in the early phase of ARDS. Based on the findings of these studies, it is reasonable to consider NMBAs for the treatment of acute ARDS in patients presenting to the ICU.
Few new agents are being developed and tested as potential treatments for Acute Respiratory Distress Syndrome (ARDS); the emerging drugs include Sabizabulin by Veru Inc., ExoFlo by Direct Biologics, MultiStem by Athersys/Healios, Ibudilast by MediciNova, and others.
This section focuses on the uptake rate of potential drugs expected to launch in the market during 2020-2034. For example, Sabizabulin in the US is expected to be launched by 2028 with a peak share of 12%. Sabizabulin is anticipated to take 7 years to peak with a medium uptake.
Acute Respiratory Distress Syndrome (ARDS) Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Acute Respiratory Distress Syndrome (ARDS) emerging therapies.
KOL Views
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate the secondary research. Industry Experts were contacted for insights on Acute Respiratory Distress Syndrome (ARDS) evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake' along with challenges related to accessibility, including KOL from Cardiovascular Research Institute, University of California San Francisco; University of Utah, Salt Lake City, US; Respiratory Institute, Cleveland, Ohio, US; Stanford University School of Medicine, US; ARDS and ECMO Centre, Witten/Herdecke University Hospital, Germany; Hopital Raymond Poincare (APHP), Garches, France; University of Angers, Angers, Italy; Hospital Universitario Rio Hortega, Valladolid, Spain; Hirosaki University Graduate School of Medicine, Japan; and others.
Delveinsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or Acute Respiratory Distress Syndrome (ARDS) market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Access and Reimbursement
The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Market Insights
Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies
The Acute Respiratory Distress Syndrome (ARDS) Epidemiology and Market Insight report for the 7MM covers the forecast period from 2024 to 2034, providing a projection of market dynamics and trends during this timeframe.
The Acute Respiratory Distress Syndrome (ARDS) market is quite robust. The major layers are Veru Inc., Direct Biologics, Athersys, Healios, MediciNova, and others which are currently developing drugs for the treatment of Acute Respiratory Distress Syndrome (ARDS).
The market size is estimated through data analysis, statistical modeling, and expert opinions. It may consider factors such as Incident cases, treatment costs, revenue generated, and market trends.
The increase in diagnosed Incident cases of Acute Respiratory Distress Syndrome (ARDS) and the launch of emerging therapies are attributed to be the key drivers for increasing the Acute Respiratory Distress Syndrome (ARDS) market.
Introducing new therapies, advancements in diagnostic techniques, and innovations in treatment approaches can significantly impact the Acute Respiratory Distress Syndrome (ARDS) treatment market. Market forecast reports may provide analysis and predictions regarding the potential impact of these developments.
The market forecast report may include information on the competitive landscape, profiling key market players, their product offerings, partnerships, and strategies, and helping stakeholders understand the competitive dynamics of the Acute Respiratory Distress Syndrome (ARDS) market.