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PUBLISHER: DelveInsight | PRODUCT CODE: 1605436

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PUBLISHER: DelveInsight | PRODUCT CODE: 1605436

Acute Respiratory Distress Syndrome Market Insight, Epidemiology And Market Forecast - 2034

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Key Highlights:

  • Acute Respiratory Distress Syndrome (ARDS) is a critical condition characterized by the rapid onset of respiratory failure due to extensive inflammation in the lungs. This syndrome can arise from various acute injuries, leading to significant morbidity and mortality rates among affected individuals.
  • In 2023, the market size of Acute Respiratory Distress Syndrome (ARDS) was highest in the US among the 7MM accounting for approximately USD 1,643 million that is further expected to increase at a CAGR of 3.6%.
  • The current treatment strategies mainly rely upon the use of Neuromuscular Blockades, Inhaled vasodilators, Corticosteroids, and others. Inhaled vasodilators accounted for highest market share of ~ 1,063 million in 2023, for treatment of Acute Respiratory Distress Syndrome (ARDS) in the 7MM.
  • In August 2024, MediciNova received a Notice of Allowance from the US Patent and Trademark Office for a pending patent application related to MN-166 (ibudilast) for post-COVID conditions.
  • The total market size of the Acute Respiratory Distress Syndrome (ARDS) is anticipated to experience growth during the forecast period due to expected entry of emerging therapies that includes Sabizabulin (VERU-111), ExoFlo, Invimestrocel, and Ibudilast.
  • The market for Acute Respiratory Distress Syndrome (ARDS) is experiencing significant growth, driven by rising incidences of respiratory diseases, advancements in therapeutic options, and increased healthcare investments. The development of targeted treatments, including novel biologics and mechanical ventilation technologies, is further boosting the market demand.

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.

Geography Covered:

  • The United States
  • EU4 (Germany, France, Italy, and Spain) and the United Kingdom
  • Japan

Study Period: 2020-2034

Disease Understanding and Treatment Algorithm

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.

Acute Respiratory Distress Syndrome (ARDS) Epidemiology

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 total Incident cases of Acute Respiratory Distress Syndrome (ARDS) in the United States were around 591 thousand cases in 2023.
  • The United States contributed to the largest incident population of Acute Respiratory Distress Syndrome (ARDS), acquiring ~62% of the 7MM in 2023. Whereas, EU4 and the UK, and Japan accounted for around 34% and 4% of the total population share, respectively, in 2023.
  • Among the EU4 countries, Germany accounted for the largest number of Incident Acute Respiratory Distress Syndrome (ARDS) (181 thousand Cases) cases followed by France (47 thousand Cases), whereas Spain accounted for the lowest number of cases (25 thousand Cases) in 2023.
  • In 2023, it was estimated that there were around 177 thousand Incident cases were of Mild severity, 276 thousand cases of Moderate severity, and 138 thousand cases of Severe severity in the US.
  • According to DelveInsight estimates, in 2023, among the risk factor-associated cases of ARDS in the US, there are approximately 210,560 incident cases of pneumonia, 175,076 cases of sepsis, 18,169 cases of trauma, 61,157 cases of aspiration, 8,974 cases of pancreatitis, 4,757 cases of COVID-19, 63,242 cases of other types, and about 49,340 cases of unknown types.

Acute Respiratory Distress Syndrome (ARDS) Drug Chapters

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.

Acute Respiratory Distress Syndrome (ARDS) Market Outlook

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.

  • The therapeutic market size of Acute Respiratory Distress Syndrome (ARDS) in the 7MM was approximately USD 1,643 million in 2023.
  • The market size in the 7MM will increase at a CAGR of 3.6% due to increasing awareness of the disease, better diagnosis, and the launch of the emerging therapy.
  • The United States accounted for the highest market size of Acute Respiratory Distress Syndrome (ARDS) approximately 74% of the total market size in 7MM in 2023, in comparison to the other major markets i.e., EU4 countries (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.
  • Among the European countries, Germany had the highest market size with nearly USD 206 million in 2023, while Spain had the lowest market size of Acute Respiratory Distress Syndrome (ARDS) with ~USD 29 million in 2023.
  • The market size for Acute Respiratory Distress Syndrome (ARDS) in Japan was estimated to be ~USD 46 million in 2023, which accounts for 3% of the total 7MM market.
  • With the expected launch of upcoming therapies, such as Sabizabulin the total market size of Acute Respiratory Distress Syndrome (ARDS) is expected to show change in the upcoming years.

Acute Respiratory Distress Syndrome (ARDS) Drugs Uptake

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.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, and a descriptive overview of Acute Respiratory Distress Syndrome (ARDS), explaining its causes, signs and symptoms, and currently available therapies.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
  • Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
  • A detailed review of the Acute Respiratory Distress Syndrome (ARDS) market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the approach is included in the report covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Acute Respiratory Distress Syndrome (ARDS) market.

Acute Respiratory Distress Syndrome (ARDS) Report Insights

  • Patient Population
  • Therapeutic Approaches
  • Acute Respiratory Distress Syndrome (ARDS) Pipeline Analysis
  • Acute Respiratory Distress Syndrome (ARDS) Market Size and Trends
  • Existing and Future Market Opportunities

Acute Respiratory Distress Syndrome (ARDS) Report Key Strengths

  • 11 years Forecast
  • The 7MM Coverage
  • Acute Respiratory Distress Syndrome (ARDS) Epidemiology Segmentation
  • Key Cross Competition
  • Conjoint Analysis
  • Drugs Uptake and Key Market Forecast Assumptions

Acute Respiratory Distress Syndrome (ARDS) Report Assessment

  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness
  • Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions:

Market Insights

  • What was the Acute Respiratory Distress Syndrome (ARDS) market share (%) distribution in 2020 and what it would look like in 2034?
  • What would be the Acute Respiratory Distress Syndrome (ARDS) total market size as well as market size by therapies across the 7MM during the forecast period (2024-2034)?
  • What are the key findings pertaining to the market across the 7MM and which country will have the largest Acute Respiratory Distress Syndrome (ARDS) market size during the forecast period (2024-2034)?
  • At what CAGR, the Acute Respiratory Distress Syndrome (ARDS) market is expected to grow at the 7MM level during the forecast period (2024-2034)?
  • What would be the Acute Respiratory Distress Syndrome (ARDS) market outlook across the 7MM during the forecast period (2024-2034)?
  • What would be the Acute Respiratory Distress Syndrome (ARDS) market growth till 2034 and what will be the resultant market size in the year 2034?
  • 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, burden, and unmet needs of Acute Respiratory Distress Syndrome (ARDS)?
  • What is the historical Acute Respiratory Distress Syndrome (ARDS) patient population in the United States, EU4 (Germany, France, Italy, Spain) and the UK, and Japan?
  • What would be the forecasted patient population of Acute Respiratory Distress Syndrome (ARDS) at the 7MM level?
  • What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Acute Respiratory Distress Syndrome (ARDS)?
  • Out of the above-mentioned countries, which country would have the highest Incident population of Acute Respiratory Distress Syndrome (ARDS) during the forecast period (2024-2034)?
  • At what CAGR the population is expected to grow across the 7MM during the forecast period (2024-2034)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

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

Reasons to Buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Acute Respiratory Distress Syndrome (ARDS) Market.
  • Insights on patient burden/disease Incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
  • Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), 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.
  • Detailed analysis and potential of current and emerging therapies under the conjoint analysis section to provide visibility around leading emerging drugs.
  • Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
  • To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions:

1. What is the forecast period covered in the report?

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.

2. Who are the key players in the Acute Respiratory Distress Syndrome (ARDS) market?

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).

3. How is the market size estimated in the forecast report?

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.

4. What is the key driver of the Acute Respiratory Distress Syndrome (ARDS) market?

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.

5. What is the expected impact of emerging therapies or advancements in Acute Respiratory Distress Syndrome (ARDS) treatment on the 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.

6. Does the report provide insights into the competitive landscape of the market?

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.

Product Code: DIMI0011

Table of Contents

1. Key Insights

2. Report Introduction

3. Acute Respiratory Distress Syndrome (ARDS) Market Overview at a Glance

  • 3.1. Market Share (%) Distribution of ARDS in 2020
  • 3.2. Market Share (%) Distribution of ARDS in 2034

4. Methodology of ARDS Epidemiology and Market

5. Executive Summary

6. Key Events

7. Disease Background and Overview

  • 7.1. Introduction of ARDS
  • 7.2. Consensus Definitions of Acute Lung Injury and ARDS
    • 7.2.1. Development of Berlin Definition of ARDS
    • 7.2.2. Problems with the AECC Definition and Subsequent Berlin Definition of ARDS
  • 7.3. Causes and Risk Factors
    • 7.3.1. Risk Factors of ARDS
      • 7.3.1.1. ARDS associated with COVID-19
  • 7.4. Pathophysiology of ARDS
  • 7.5. Stages of ARDS
  • 7.6. Ventilator-Induced Lung Injury (VILI)
  • 7.7. Diagnosis of ARDS
    • 7.7.1. Diagnosis Guidelines
      • 7.7.1.1. ARDS: Diagnosis and Management: American Family of Physician
    • 7.7.2. Differential Diagnosis
    • 7.7.3. Diagnosis Algorithm
  • 7.8. Treatment and Management of ARDS
    • 7.8.1. Treatment of ALI/ARDS associated with COVID-19
    • 7.8.2. Treatment Guidelines
      • 7.8.2.1. American Thoracic Society/European Society of Intensive Care Medicine/Society of Critical Care Medicine Clinical Practice Guideline: Mechanical Ventilation in Adult Patients with ARDS
      • 7.8.2.2. Clinical Practice Guideline by the Japanese Society of Respiratory Care Medicine and the Japanese Society of Intensive Care Medicine for the Management of ARDS in Japan
      • 7.8.2.3. Infectious Diseases Society of America (IDSA) Guidelines on the Treatment and Management of Patients With COVID-19
      • 7.8.2.4. WHO Guidance for the Treatment of ARDS Associated With COVID-19
    • 7.8.3. Treatment Algorithm

8. Patient Journey

9. Epidemiology and Patient Population

  • 9.1. Key Findings
  • 9.2. Assumptions and Rationale: The 7MM
    • 9.2.1. Total Incident Cases of ARDS
    • 9.2.2. Severity-specific Incident Cases of ARDS
    • 9.2.3. Incident Cases of ARDS by Risk Factors
  • 9.3. Total Incident Population of ARDS in the 7MM
  • 9.4. The United States
    • 9.4.1. Total Incident Cases of ARDS in the United States
    • 9.4.2. Severity-specific Incident Cases of ARDS in the United States
    • 9.4.3. Incident Cases of ARDS by Risk Factors in the United States
  • 9.5. EU4 and the UK
    • 9.5.1. Germany
      • 9.5.1.1. Total Incident Cases of ARDS in Germany
      • 9.5.1.2. Severity-specific Incident Cases of ARDS in Germany
      • 9.5.1.3. Incident Cases of ARDS by Risk Factors in Germany
    • 9.5.2. France
      • 9.5.2.1. Total Incident Cases of ARDS in France
      • 9.5.2.2. Severity-specific Incident Cases of ARDS in France
      • 9.5.2.3. Incident Cases of ARDS by Risk Factors in France
    • 9.5.3. Italy
      • 9.5.3.1. Total Incident Cases of ARDS in Italy
      • 9.5.3.2. Severity-specific Incident Cases of ARDS in Italy
      • 9.5.3.3. Incident Cases of ARDS by Risk Factors in Italy
    • 9.5.4. Spain
      • 9.5.4.1. Total Incident Cases of ARDS in Spain
      • 9.5.4.2. Severity-specific Incident Cases of ARDS in Spain
      • 9.5.4.3. Incident Cases of ARDS by Risk Factors in Spain
    • 9.5.5. The UK
      • 9.5.5.1. Total Incident Cases of ARDS in the UK
      • 9.5.5.2. Severity-specific Incident Cases of ARDS in the UK
      • 9.5.5.3. Incident Cases of ARDS by Risk Factors in the UK
  • 9.6. Japan
    • 9.6.1. Total Incident Cases of ARDS in Japan
    • 9.6.2. Severity-specific Incident Cases of ARDS in Japan
    • 9.6.3. Incident Cases of ARDS by Risk Factors in Japan

10. Emerging Drug Profiles

  • 10.1. Key Cross Competition
  • 10.2. Sabizabulin (Veru-111): Veru
    • 10.2.1. Product Description
    • 10.2.2. Other Developmental Activities
    • 10.2.3. Clinical Trials Information
    • 10.2.4. Safety and Efficacy
    • 10.2.5. Analyst Views
  • 10.3. ExoFlo (DB-001): Direct Biologics
    • 10.3.1. Product Description
    • 10.3.2. Other Developmental Activities
    • 10.3.3. Clinical Trials Information
    • 10.3.4. Safety and Efficacy
    • 10.3.5. Analyst Views
  • 10.4. MultiStem (HLCM051): Athersys/Healios
    • 10.4.1. Product Description
    • 10.4.2. Other Developmental Activities
    • 10.4.3. Clinical Trials Information
    • 10.4.4. Safety and Efficacy
    • 10.4.5. Analyst Views
  • 10.5. Ibudilast (MN-166): MediciNova
    • 10.5.1. Product Description
    • 10.5.2. Other Developmental Activities
    • 10.5.3. Clinical Trials Information
    • 10.5.4. Safety and Efficacy
    • 10.5.5. Analyst Views

11. ARDS: Market Analysis

  • 11.1. Key Findings
  • 11.2. Key Market Forecast Assumptions
  • 11.3. Market Outlook
  • 11.4. Conjoint Analysis
  • 11.7. Market Size of ARDS in the US
    • 11.7.1. Total Market Size of ARDS in the US
    • 11.7.2. The Market Size of ARDS by Therapies in the US
  • 11.8. Market Size of ARDS in EU4 and the UK
    • 11.8.1. Germany
      • 11.8.1.1. Total Market Size of ARDS in Germany
      • 11.8.1.2. Market Size of ARDS by therapies in Germany
    • 11.8.2. France
      • 11.6.2.1. Total Market Size of ARDS in France
      • 11.8.2.2. Market Size of ARDS by therapies in France
    • 11.8.3. Italy
      • 11.8.3.1. Total Market Size of ARDS in Italy
      • 11.8.3.2. Market Size of ARDS by therapies in Italy
    • 11.8.4. Spain
      • 11.8.4.1. Total Market Size of ARDS in Spain
      • 11.8.4.2. Market Size of ARDS by therapies in Spain
    • 11.8.5. The United Kingdom
      • 11.8.5.1. Total Market Size of ARDS in the United Kingdom
      • 11.8.5.2. Market Size of ARDS by therapies in the United Kingdom
  • 11.9. Market Size of ARDS in Japan
    • 11.9.1. Total Market Size of ARDS in Japan
    • 11.9.2. The Market Size of ARDS by Therapies in Japan

12. Key Opinion Leaders' Views

13. SWOT Analysis

14. Unmet Needs

15. Market Access and Reimbursement

  • 15.1. The United States
    • 15.1.1. Center for Medicare and Medicaid Services (CMS)
  • 15.2. In EU4 and the UK
    • 15.2.1. Germany
    • 15.2.2. France
    • 15.2.3. Italy
    • 15.2.4. Spain
    • 15.2.5. The United Kingdom
  • 15.3. Japan
    • 15.3.1. MHLW

16. Appendix

  • 16.1. Bibliography
  • 16.2. Acronyms and Abbreviations
  • 16.3. Report Methodology

17. DelveInsight Capabilities

18. Disclaimer

19. About DelveInsight

Product Code: DIMI0011

List of Tables

  • Table 1: Summary of ARDS Epidemiology and Market (2020-2034)
  • Table 2: Key Events
  • Table 3: Definition of ARDS
  • Table 4: American European Consensus Conference Criteria for ALI and the ARDS
  • Table 5: Berlin Definition of Mild, Moderate, and Severe ARDS
  • Table 6: Factors That Distinguish ARDS, CHF, and Pneumonia
  • Table 7: Management of ARDS
  • Table 8: Spontaneous Breathing Trial
  • Table 9: Therapeutic Options for Severe ARDS-related to COVID-19
  • Table 10: Recommendations for Specific Treatment Questions for the Management of ARDS
  • Table 11: The Clinical Practice Guideline for the Management of ARDS in Japan (1/4)
  • Table 12: The Clinical Practice Guideline for the Management of ARDS in Japan (2/4)
  • Table 13: The Clinical Practice Guideline for the Management of ARDS in Japan (3/4)
  • Table 14: The Clinical Practice Guideline for the Management of ARDS in Japan (4/4)
  • Table 15: Recommendations by the Infectious Diseases Society of America (1/2)
  • Table 16: Recommendations by the Infectious Diseases Society of America (2/2)
  • Table 17: Total Incident Population of ARDS in the 7MM (2020-2034)
  • Table 18: Total Incident Cases of ARDS in the US (2020-2034)
  • Table 19: Severity-specific Incident Cases of ARDS in the US (2020-2034)
  • Table 20: Incident Cases of ARDS by Risk Factors in the US (2020-2034)
  • Table 21: Total Incident Cases of ARDS in EU4 and the UK (2020-2034)
  • Table 22: Severity-specific Incident Cases of ARDS in EU4 and the UK (2020-2034)
  • Table 23: Incident Cases of ARDS by Risk Factors in EU4 and the UK (2020-2034)
  • Table 24: Total Incident Cases of ARDS in Germany (2020-2034)
  • Table 25: Severity-specific Incident Cases of ARDS in Germany (2020-2034)
  • Table 26: Incident Cases of ARDS by Risk Factors in Germany (2020-2034)
  • Table 27: Total Incident Cases of ARDS in France (2020-2034)
  • Table 28: Severity-specific Incident Cases of ARDS in France (2020-2034)
  • Table 29: Incident Cases of ARDS by Risk Factors in France (2020-2034)
  • Table 30: Total Incident Cases of ARDS in Italy (2020-2034)
  • Table 31: Severity-specific Incident Cases of ARDS in Italy (2020-2034)
  • Table 32: Incident Cases of ARDS by Risk Factors in Italy (2020-2034)
  • Table 33: Total Incident Cases of ARDS in Spain (2020-2034)
  • Table 34: Severity-specific Incident Cases of ARDS in Spain (2020-2034)
  • Table 35: Incident Cases of ARDS by Risk Factors in Spain (2020-2034)
  • Table 36: Total Incident Cases of ARDS in the UK (2020-2034)
  • Table 37: Severity-specific Incident Cases of ARDS in the UK (2020-2034)
  • Table 38: Incident Cases of ARDS by Risk Factors in the UK (2020-2034)
  • Table 39: Total Incident Cases of ARDS in Japan (2020-2034)
  • Table 40: Severity-specific Incident Cases of ARDS in Japan (2020-2034)
  • Table 41: Incident Cases of ARDS by Risk Factors in Japan (2020-2034)
  • Table 42: Comparison of Emerging Drugs
  • Table 43: Sabizabulin (VERU-111), Clinical Trial Description, 2024
  • Table 44: ExoFlo (DB-001), Clinical Trial Description, 2024
  • Table 45: MultiStem (HLCM051), Clinical Trial Description, 2024
  • Table 46: Ibudilast (MN-166), Clinical Trial Description, 2024
  • Table 47: Key Market Forecast Assumptions for Sabizabulin
  • Table 48: Key Market Forecast Assumptions for MultiStem
  • Table 49: Key Market Forecast Assumptions for DB-001
  • Table 50: Key Market Forecast Assumptions for MN-166 (ibudilast)
  • Table 51: Total Market Size of ARDS in the 7MM, in USD million (2020-2034)
  • Table 52: Market Size of ARDS by Therapies in the 7MM, USD million (2020-2034)
  • Table 53: Total Market Size of ARDS in the US, in USD million (2020-2034)
  • Table 54: Market Size of ARDS by Therapies in the US, USD million (2020-2034)
  • Table 55: Total Market Size of ARDS in EU4 and the UK, in USD million (2020-2034)
  • Table 56: Market Size of ARDS by Therapies in Germany, USD million (2020-2034)
  • Table 57: Market Size of ARDS by Therapies in France, USD million (2020-2034)
  • Table 58: Market Size of ARDS by Therapies in Italy, USD million (2020-2034)
  • Table 59: Market Size of ARDS by Therapies in Spain, USD million (2020-2034)
  • Table 60: Market Size of ARDS by Therapies in the UK, USD million (2020-2034)
  • Table 61: Market Size of ARDS by Therapies in EU4 and the UK, USD million (2020-2034)
  • Table 62: Total Market Size of ARDS in Japan, in USD million (2020-2034)
  • Table 63: Market Size of ARDS by Therapies in Japan, USD million (2020-2034)

List of Figures

  • Figure 1: Risk factors of ARDS
  • Figure 2: A Simplified Model of the Pathogenesis of ARDS
  • Figure 3: Effects of Mast Cell Activation
  • Figure 4: Diagnosis Algorithm
  • Figure 5: Treatment Flowchart for ARDS
  • Figure 6: Treatment Algorithm
  • Figure 7: Patient Journey
  • Figure 8: Total Incident Population of ARDS in the 7MM (2020-2034)
  • Figure 9: Total Incident Cases of ARDS in the US (2020-2034)
  • Figure 10: Severity-specific Incident Cases of ARDS in the US (2020-2034)
  • Figure 11: Incident Cases of ARDS by Risk Factors in the US (2020-2034)
  • Figure 12: Total Incident Cases of ARDS in EU4 and the UK (2020-2034)
  • Figure 13: Severity-specific Incident Cases of ARDS in EU4 and the UK (2020-2034)
  • Figure 14: Incident Cases of ARDS by Risk Factors in EU4 and the UK (2020-2034)
  • Figure 15: Total Incident Cases of ARDS in Germany (2020-2034)
  • Figure 16: Severity-specific Incident Cases of ARDS in Germany (2020-2034)
  • Figure 17: Incident Cases of ARDS by Risk Factors in Germany (2020-2034)
  • Figure 18: Total Incident Cases of ARDS in France (2020-2034)
  • Figure 19: Severity-specific Incident Cases of ARDS in France (2020-2034)
  • Figure 20: Incident Cases of ARDS by Risk Factors in France (2020-2034)
  • Figure 21: Total Incident Cases of ARDS in Italy (2020-2034)
  • Figure 22: Severity-specific Incident Cases of ARDS in Italy (2020-2034)
  • Figure 23: Incident Cases of ARDS by Risk Factors in Italy (2020-2034)
  • Figure 24: Total Incident Cases of ARDS in Spain (2020-2034)
  • Figure 25: Severity-specific Incident Cases of ARDS in Spain (2020-2034)
  • Figure 26: Incident Cases of ARDS by Risk Factors in Spain (2020-2034)
  • Figure 27: Total Incident Cases of ARDS in the UK (2020-2034)
  • Figure 28: Severity-specific Incident Cases of ARDS in the UK (2020-2034)
  • Figure 29: Incident Cases of ARDS by Risk Factors in the UK (2020-2034)
  • Figure 30: Total Incident Cases of ARDS in Japan (2020-2034)
  • Figure 31: Severity-specific Incident Cases of ARDS in Japan (2020-2034)
  • Figure 32: Incident Cases of ARDS by Risk Factors in Japan (2020-2034)
  • Figure 33: Total Market Size of ARDS in the 7MM (2020-2034)
  • Figure 34: Market Size of ARDS by Therapies in the 7MM (2020-2034)
  • Figure 35: Total Market Size of ARDS in the US (2020-2034)
  • Figure 36: Market Size of ARDS by Therapies in the US (2020-2034)
  • Figure 37: Total Market Size of ARDS in EU4 and the UK (2020-2034)
  • Figure 38: Market Size of ARDS by Therapies in EU4 and the UK (2020-2034)
  • Figure 39: Total Market Size of ARDS in Japan (2020-2034)
  • Figure 40: Market Size of ARDS by Therapies in Japan (2020-2034)
  • Figure 41: SWOT Analysis
  • Figure 42: Unmet Needs
  • Figure 43: Health Technology Assessment
  • Figure 44: Reimbursement Process in Germany
  • Figure 45: Reimbursement Process in France
  • Figure 46: Reimbursement Process in Italy
  • Figure 47: Reimbursement Process in Spain
  • Figure 48: Reimbursement Process in the United Kingdom
  • Figure 49: Reimbursement Process in Japan
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