PUBLISHER: DelveInsight | PRODUCT CODE: 1074043
PUBLISHER: DelveInsight | PRODUCT CODE: 1074043
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.
Study Period: 2019-2032
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.
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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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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
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.
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…
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
This section provides the total Acute Respiratory Distress Syndrome market size and market size by therapies in the United States.
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.
The total Acute Respiratory Distress Syndrome market size and market size by therapies in Japan are provided.
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.
Key Questions
Market Insights:
Epidemiology Insights:
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies: