Acute Respiratory Distress Syndrome (ARDS) - Market Insight, Epidemiology And Market Forecast - 2032

DelveInsight's, 'Acute Respiratory Distress Syndrome-Market Insights, Epidemiology, and Market Forecast-2032' report delivers an in-depth understanding of the Acute Respiratory Distress Syndrome, historical and forecasted epidemiology as well as the Acute Respiratory Distress Syndrome market trends in the United States, the EU-5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

The Acute Respiratory Distress Syndrome market report provides current treatment practices, emerging drugs, market share of the individual therapies, and the current and forecasted 7MM Acute Respiratory Distress Syndrome market size from 2019 to 2032. The Report also covers current Acute Respiratory Distress Syndrome 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

Acute Respiratory Distress Syndrome Disease Understanding and Treatment Algorithm

Acute Respiratory Distress Syndrome Overview

ARDS is a rapidly progressive disease occurring in critically ill patients. The major complication in ARDS is marked by leakage of fluid into the lungs, making breathing difficult or impossible. It is a severe lung condition that causes low blood oxygen. People who develop ARDS are usually ill due to another disease or a major injury which leads to fluid build-up inside the tiny air sacs of the lungs, and surfactant breakdown.

The causes of ARDS are divided into two categories: direct or indirect injuries to the lung. Some of the direct injuries to the lung include pneumonia, aspiration, trauma, and others. Whereas the indirect injuries to the lung include inflammation of the pancreas, severe infection (also known as sepsis), blood transfusions, burns, and medication reactions.

Usually, the first symptom of ARDS is shortness of breath, cough, and fever. Other signs and symptoms of ARDS are low blood oxygen, rapid breathing, clicking, bubbling, or rattling sounds in the lungs when breathing.

ARDS is generally characterized by three stages such as exudative stage, fibroproliferative (or proliferative) stage, resolution, and recovery stage. The exudative stage is the accumulation of protein, excessive fluid and inflammatory cells in the alveoli occur in the exudative stage. This phase usually is seen within the first 2 to 4 days after the onset of lung injury. Fibroproliferative (or proliferative) stage is the proliferation of connective tissue and other structural elements in the lungs in response to the initial lung injury. The chances of a patient having pneumonia sepsis and rupture of the lungs are very high in this stage. Resolution and Recovery are in this stage, the lung reorganizes and recovers. During this stage, lung function may continue to improve in patients. The fourth phase of ARDS is also seen according to some experts in which when some patients due to acute illness have continued health problems while some may experience anxiety, depression, and flashback memories of their critical illness, which are very similar to post-traumatic stress disorder. This stage is still an area under research.

Acute Respiratory Distress Syndrome Diagnosis

Early recognition of ARDS is important for the timely initiation of lung-protective ventilation strategies. Even after attempts to improve the definition of the disease, ARDS remains under-recognized by clinicians. Oftentimes, when a diagnosis is made, it has been after a significant delay. The rate of under-diagnosis is reported to be as high as 40%, with higher rates of diagnosis with increasing disease severity. ARDS is a syndrome with several different clinical criteria that must be fulfilled; however, none of these data points is particularly precise. The current clinical criteria have low specificity, for example, 63% for the Berlin definition to identify DAD at autopsy. At present, no biomarker is present to aid in the diagnosis, and this is now an area of much active research.

Chest X-rays for the diagnosis of ARDS have relatively low sensitivity and specificity of approximately 70% when compared to CT scans. CXR performs better when the infiltrates are diffuse or patchy as opposed to focal. The use of CT scans and other imaging techniques in the diagnosis and management of ARDS has become increasingly important. Lung ultrasound is another modality that can be used as a bedside tool to facilitate the diagnosis of ARDS.

Continued in the report…..

Acute Respiratory Distress Syndrome Treatment

Treatment of ARDS is supportive, including mechanical ventilation, prevention of stress ulcers and venous thromboembolism, and nutritional support. Good supportive care, as for all ICU patients, should include nutritional support with an aim for early enteral feeding, good glycemic control, deep venous thrombosis, and stress ulceration prophylaxis. It is important to identify and treat any underlying infections with antibiotics targeted at culture sensitivities and if unavailable, toward common organisms specific to the infection site.

Other treatment options, 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.

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Acute Respiratory Distress Syndrome Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Incident Cases of Acute Respiratory Distress Syndrome, Severity-specific Cases of Acute Respiratory Distress Syndrome, and Incident Cases of Acute Respiratory Distress Syndrome by Risk Factors scenario of Acute Respiratory Distress Syndrome 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 total incident cases of ARDS were estimated to be 1,088,015 cases in the 7MM. These cases are expected to increase by 2032 at a CAGR of 1.5% during the study period (2019-2032).
• Among the 7MM, the United States has the highest number of incident cases of ARDS with approximately 630,584 cases in 2021.
• Assessments as per DelveInsight's, analysts show that in terms of severity-specific incidence, a similar trend is observed in all countries, with a majority of the cases pointing to moderate ARDS, except France, where severe cases of ARDS accounted for a maximum patient population.
• Generally, among the 7MM countries, the primary risk factor associated with the highest number of incident cases of ARDS was pneumonia, except for the United Kingdom, where sepsis was the primary risk factor for ARDS
• In the United States, there were a total of 189,175, 293,852, and 147,557 severity-specific cases of mild, moderate, and severe ARDS respectively, in 2021. Assessments as per DelveInsight's, analysts show that the majority of cases of ARDS are of moderate ARDS, followed by mild and severe and this is subject to change due to a rapid increase in the coming years.
• Among the EU-5, Germany had the highest total incident population of ARDS with 193,828 cases, followed by France (73,541 cases), and Italy with 55,522 cases in 2021. On the other hand, Spain (31,286 cases) had the lowest incident population for 2021.
• In 2021, Japan had approximately 69,628 total incident cases of ARDS which are expected to increase by 2032 at a CAGR of 0.5% during the study period (2019-2032).

Acute Respiratory Distress Syndrome Epidemiology

The epidemiology segment also provides the Acute Respiratory Distress Syndrome epidemiology data and findings across the United States, the EU-5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

Acute Respiratory Distress Syndrome Drug Chapters

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

Acute Respiratory Distress Syndrome Emerging Drugs

EB05: Edesa Biotech

EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive and dysfunctional immune response associated with ARDS. Specifically, the drug inhibits toll-like receptor 4 (TLR4) signaling which is an important mediator of inflammation responsible for acute lung injury that is activated by SARS-CoV2, SARS-CoV1, and Influenza viruses. EB05 has demonstrated safety in two clinical studies (>120 patients) and was able to block LPS-induced (TLR4 agonist) IL-6 release in humans. The company received approval from Health Canada to test EB05 as rescue therapy for critically ill patients in the Phase III part of Phase II/III clinical study. While in the US, the company is currently in discussions with the FDA on the design of the final Phase III protocol. As per the company pipeline company is also checking the potential of EB06 which is a monoclonal antibody candidate that binds specifically and selectively to chemokine ligand 10 (CXCL10) and inhibits the interaction of CXCL10 with its receptors.

Products detail in the report…

Alteplase (Actilyse): Boehringer Ingelheim/ Genentech

Alteplase is the only licensed blood clot-dissolving treatment (thrombolytic) for acute ischemic stroke therapy, which is used in many stroke centers. In addition, it can be used for the treatment of acute myocardial infarction, acute massive pulmonary embolism, and catheter clearance due to thrombotic occlusion (indications vary across countries). Alteplase is marketed as Actilyse by Boehringer Ingelheim in countries outside of the US and Canada. In the US and Canada, it is marketed by Genentech. The drug is presently being evaluated in Phase II/III (TRISTARDS) to treat Covid-19 ARDS.

Products detail in the report…

BIO-11006: BioMarck Pharmaceuticals

BioMarck Pharmaceuticals is developing its lead compound BIO-11006 for the treatment of ARDS. Biomarck's BIO-11006 is a novel, highly soluble, patented, 10 amino acid peptide. It acts as a MARCKS (Myristoylated alanine-rich C kinase substrate) protein inhibitor and is being developed to specifically target the MARCKS protein to inhibit cancer cell division and movement. Furthermore, it is a water-soluble, stable aerosolized anti-MARCKS peptide inhalation solution that involves aerosolized delivery of either the active drug or placebo by the "Aeroneb Pro nebulizer." In April 2020 the company announced positive phase II results. The drug is ready to enter Phase III for the treatment of ARDS.

Products detail in the report…

ExoFlo (DB-001): Direct Biologics

ExoFlo (DB-001) being developed 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. It provides natural bioactive signals that downregulate inflammation, direct cellular communication, and upregulate tissue repair in humans. In April 2022, the US FDA awarded ExoFlo a Regenerative Medicine Advanced Therapy (RMAT) designation. In July 2022, the company initiated the evaluation of the drug in Phase III for COVID-19 moderate-to-severe ARDS.

Products detail in the report…

List of products to be continued in the report…

Acute Respiratory Distress Syndrome Market Outlook

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.

The US FDA had issued an emergency use authorization (EUA) for the drug Actemra/RoActemra (tocilizumab for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The US FDA also approved the Pluristem Therapeutics Expanded Access Program (EAP) for the use of its PLX-PAD cells to treat ARDS caused by COVID-19 outside of the ongoing Phase II COVID-19 study in the US. The current therapies have only been useful in addressing ARDS-associated inflammation, but none treat impaired lung function.

To meet the high unmet need for the ARDS treatment regimen, companies across the globe have shifted their focus toward this therapeutic area. Emerging therapies are focused on the treatment of ARDS and hence are expected to create a significant impact on market size. These include EB05 (Edesa Biotech), BIO-11006 (BioMarck Pharmaceuticals), MultiStem (Athersys), Alteplase (Boehringer Ingelheim/Genentech), Lucinactant (Windtree Therapeutics), and DB-001 (Direct Biologics), which are expected to launch during the forecast period [2022-2032].

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

Key Findings

• The market size of Acute Respiratory Distress Syndrome in seven major markets was approximately USD 1,173.1 million in 2021, which is further expected to increase by 2032 at a Compound Annual Growth Rate (CAGR) of 10.31% for the study period (2019-2032)
• The expected launch of potential therapies may increase the market size in the coming years, assisted by an increase in the incident population of Acute Respiratory Distress Syndrome.
• Upcoming therapies such as MultiStem, Zyesami (Aviptadil), and others have the potential to create a significant positive shift in the Acute Respiratory Distress Syndrome market size.
• The United States accounts for the largest market size for Acute Respiratory Distress Syndrome, in comparison to EU5 (Germany, Italy, France, Spain, and the United Kingdom) and Japan.
• Among the EU5 countries, Germany had the highest market size with approximately USD 166.2 million followed by France in 2021.
• The market size for ARDS in Japan was valued at approximately USD 68.2 million in 2021. It is expected that the market will show growth, mainly attributed to the increasing incident cases and launch of upcoming therapy during the forecast period

The United States Market Outlook

This section provides the total Acute Respiratory Distress Syndrome market size and market size by therapies in the United States.

The EU-5 Market Outlook

The total Acute Respiratory Distress Syndrome 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 Acute Respiratory Distress Syndrome market size and market size by therapies in Japan are provided.

Acute Respiratory Distress Syndrome Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the Acute Respiratory Distress Syndrome market or expected to get launched in the market during the study period 2019-2032. The analysis covers the Acute Respiratory Distress Syndrome 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 allow, 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.

Acute Respiratory Distress Syndrome 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 Acute Respiratory Distress Syndrome emerging therapies.

Reimbursement Scenario in Acute Respiratory Distress Syndrome

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

We perform competitively and market Intelligence analysis of the Acute Respiratory Distress Syndrome 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 Acute Respiratory Distress Syndrome, explaining its etiology, signs and symptoms, pathophysiology, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the Acute Respiratory Distress Syndrome epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Acute Respiratory Distress Syndrome is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the Acute Respiratory Distress Syndrome 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 Acute Respiratory Distress Syndrome market.

Report Highlights:

• The robust pipeline with novel MOA and oral ROA and increasing incidence will positively drive the Acute Respiratory Distress Syndrome market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Acute Respiratory Distress Syndrome 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 Acute Respiratory Distress Syndrome. The launch of emerging therapies will significantly impact the Acute Respiratory Distress Syndrome 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.

Acute Respiratory Distress Syndrome Report Insights

• Patient Population
• Therapeutic Approaches
• Acute Respiratory Distress Syndrome Pipeline Analysis
• Acute Respiratory Distress Syndrome Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Acute Respiratory Distress Syndrome Report Key Strengths

• 11-Years Forecast
• The 7MM Coverage
• Acute Respiratory Distress Syndrome Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Acute Respiratory Distress Syndrome Report Assessment

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

Key Questions

Market Insights:

• What was the Acute Respiratory Distress Syndrome market share (%) distribution in 2019 and how it would look like in 2032?
• What would be the Acute Respiratory Distress Syndrome 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 Acute Respiratory Distress Syndrome market size during the forecast period (2022-2032)?
• At what CAGR, the Acute Respiratory Distress Syndrome market is expected to grow at the 7MM level during the forecast period (2022-2032)?
• What would be the Acute Respiratory Distress Syndrome market outlook across the 7MM during the forecast period (2022-2032)?
• What would be the Acute Respiratory Distress Syndrome 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 Acute Respiratory Distress Syndrome?
• What is the historical Acute Respiratory Distress Syndrome patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
• What would be the forecasted patient pool of Acute Respiratory Distress Syndrome 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?
• Out of the above-mentioned countries, which country would have the highest incidence population of Acute Respiratory Distress Syndrome 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 Acute Respiratory Distress Syndrome along with the approved therapy?
• What are the current treatment guidelines for the treatment of Acute Respiratory Distress Syndrome in the US and Europe?
• What are the Acute Respiratory Distress Syndrome 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 Acute Respiratory Distress Syndrome?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Acute Respiratory Distress Syndrome?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and licensing activities related to the Acute Respiratory Distress Syndrome 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 Acute Respiratory Distress Syndrome and their status?
• What are the key designations that have been granted for the emerging therapies for Acute Respiratory Distress Syndrome?
• What is the 7MM historical and forecasted market for Acute Respiratory Distress Syndrome?

Reasons to buy:

• The report will help in developing business strategies by understanding trends shaping and driving Acute Respiratory Distress Syndrome.
• To understand the future market competition in the Acute Respiratory Distress Syndrome market and an Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Acute Respiratory Distress Syndrome 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 Acute Respiratory Distress Syndrome market.
• To understand the future market competition in the Acute Respiratory Distress Syndrome market.