PUBLISHER: DelveInsight | PRODUCT CODE: 1259778
PUBLISHER: DelveInsight | PRODUCT CODE: 1259778
Key Highlights
DelveInsight's"Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD) - Market Insights, Epidemiology and Market Forecast - 2032" report delivers an in-depth understanding of the Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD), historical and forecasted epidemiology and the Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD) market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, Japan, and China.
The Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD) market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM and China CTD-ILD market size from 2019 to 2032. The report also covers current CTD-ILD treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Study Period: 2019-2032
Connective Tissue Disease Associated with Interstitial Lung Disease (CTD-ILD) Overview
Connective Tissue Diseases (CTDs) are systemic autoimmune disorders caused by excessive immune-activated inflammation that targets the connective tissues of the body, as seen in rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), Sjogren's syndrome (SS), idiopathic inflammatory myopathies such as dermatomyositis (DM) and polymyositis (PM), systemic sclerosis (SSc), and mixed connective tissue disease (MCTD). CTDs can cause serious complications for the pulmonary system, including lung bleeding, inflammation, and scarring of the spaces between the lung's air sacs and the blood vessels. This kind of inflammation and scarring are typical of ILD, and when CTDs cause ILD (CTD-ILD), it can prevent oxygen from being absorbed in the lung and lead to shortness of breath, cough, and fatigue
Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD) Diagnosis
The diagnosis of CTD-ILDs is clinico-radiologic supported by the demonstration of autoantibodies. Plain chest radiographs are insensitive. The gold standard for ILD detection is high-resolution CT (HRCT).
A particular CTD must be diagnosed based on the classification criteria specific to that CTD. ILD is the primary cause of morbidity and mortality in 40-50% of individuals with CTDs. Various classification criteria affect the reported prevalence of ILDs in patients with CTDs (CTD-ILDs). Organizations like the British Thoracic Society, Japanese Respiratory Society, American Thoracic Society, and others have published criteria for diagnosing CTD-ILD.
Further details related to country-based variations are provided in the report
Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD) Treatment
Treatment choices in CTD-ILD are affected by the CTD diagnosis and time since diagnosis, the severity of the ILD, the course of the illness, extrapulmonary CTD manifestations, and patient-specific factors. Patients with CTD-ILD commonly receive immunotherapies and medications that slow the development of their illness. In CTD-ILD, immunosuppression is the cornerstone of pharmaceutical treatment to lower inflammation, prevent the development of established fibrosis, and prevent irreversible lung function loss.
Medicines taken alone or in combination for treating CTD-ILD include corticosteroids (like prednisolone), immunosuppressants (like cyclophosphamide, mycophenolate mofetil, methotrexate, and cyclosporin), antifibrotic medications like nintedanib and pirfenidone, and other medications like molecular-targeting biologics like tocilizumab and rituximab.
As the market is derived using the patient-based model, the Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD) epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Cases of Interstitial Lung Disease (ILD), Total Diagnosed Prevalent Cases of Interstitial Lung Disease (ILD), Total Diagnosed Prevalent Cases of CTD-ILD, and Type-specific diagnosed prevalent cases of CTD-ILD in the 7MM and China covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, Japan, and China from 2019 to 2032. The total diagnosed prevalent cases of Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD) in the 7MM and China comprised approximately 1 million cases in 2022 and are projected to increase during the forecast period.
The drug chapter segment of the Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD) report encloses a detailed analysis of CTD-ILD marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also understands the CTD-ILD 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.
Marketed Drugs
OFEV (Nintedanib): Boehringer Ingelheim Pharmaceuticals, Inc.
OFEV, an oral triple kinase inhibitor targeting pro-fibrotic pathways, has been used to treat idiopathic pulmonary fibrosis (IPF). Based on positive results from Phase III, a placebo-controlled, randomized comparative clinical trial conducted in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Nintedanib received marketing approval in the United States, EU, Japan, and China for treating SSc-ILD and other chronic fibrosing ILDs.
Note: Detailed current therapies assessment will be provided in the full report of CTD-ILD
Emerging Drugs
GSK1550188: GlaxoSmithKline
BENLYSTA is a fully human monoclonal antibody approved for treating Systemic lupus erythematosus and Lupus nephritis. It prevents B cells from differentiating into immunoglobulin-producing plasma cells and prevents the extended survival of B cells. The drug has recently been granted with Orphan Drug Designation (ODD) for SSc, after which the company plans to initiate a Phase II/III trial of belimumab for systemic sclerosis-associated interstitial lung disease (SSc-ILD) in the first half of 2023.
Pirfenidone (ETUARY): GNI-EPS Pharmaceuticals, Inc. (GNI Group)/Beijing Continent Pharmaceutical Co, Ltd./Shanghai Genomics, Inc.
GNI Group's ETUARY, originally designated as F647, is the commercial name for pirfenidone in China. Pirfenidone is a small molecule compound with antifibrotic, anti-inflammatory, and anti-oxidation effects. To treat SSc-ILD and DM-ILD, Beijing Continent obtained NMPA approval for the fourth ETUARY indication in September 2016. With the help of this IND approval, Continent was able to enter two clinical trials straight into Phase III for SSc-ILD and DM-ILD. The spread of a new coronavirus in China impacts the clinical trials for CTD-ILD and causes some delays in the enrollment of subjects.
Note: Detailed emerging therapies assessment will be provided in the final report of CTD-ILD.
Drug Class Insights
The most popular immunosuppressive medications used to treat Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD) include corticosteroids, cyclophosphamide, mycophenolate mofetil, and azathioprine, which have been shown to stabilize lung function in case studies and a few small randomized controlled trials in ILD linked to systemic sclerosis. Antifibrotic drugs (nintedanib and pirfenidone) and biological and non-biological disease-modifying anti-rheumatic medications have revolutionized the management of connective tissue diseases and idiopathic ILD, respectively.
There is currently no feasible treatment option or cure for any CTD-ILD type. Treatment choices in CTD-ILD are affected by the CTD diagnosis and time since diagnosis, the severity of the ILD, the course of the illness, extrapulmonary CTD manifestations, and patient-specific factors. Patients with CTD-ILD commonly receive immunotherapies and medications that slow the development of their illness.
Under the brand name OFEV (nintedanib) and ACTEMRA (Tocilizumab), the drugs were approved in 2019 and 2021, respectively, for SSc-ILD and are also used for treating other CTD-ILDs, help in slowing down the declining rate of lung function in adults.
The launch of emerging therapies, such as BENLYSTA (GlaxoSmithKline) and ETUARY (Beijing Continent Pharmaceutical Co), are expected to impact the market positively.
This section focuses on the uptake rate of potential drugs expected to launch in the market during 2019-2032. For example, for GSK1550188, in the US we expect the drug uptake to be medium with a probability-adjusted peak share of around 7%, and years to the peak is expected to be 7 years from the year of launch.
Further detailed analysis of emerging therapies drug uptake in the report…
Connective Tissue Disease Associated with Interstitial Lung Disease (CTD-ILD) Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. 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 CTD-ILD 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 Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD) evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from Massachusetts General Hospital, Hospices Civils de Lyon, University of Exeter, Jichi Medical University, First Hospital of Jilin University, 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 to understand and validate current and emerging therapies and treatment patterns or Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD) 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 cost of newly approved medications is usually high; patients can escape from proper treatment or opt for off-label and cheap medications. It affects access to newly launched medications in the market, and reimbursement is crucial. Often, the decision to reimburse comes down to the drug's price relative to the benefit it produces in treated patients. Market access and reimbursement options can differ depending on regulatory status, target population size, care setting, unmet need, the magnitude of incremental benefit claims, and costs.
Third-party financial assistance is available for patients seeking OFEV, who are enrolled in a government-healthcare prescription drug program, do not have insurance, or have private insurance that does not cover OFEV.
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.
Key Questions
Market Insights
Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies