間質性肺疾患に伴う結合組織病（CTD-ILD）市場 - 市場の洞察、疫学、市場予測：2032年

2022年の間質性肺疾患に伴う結合組織病（CTD-ILD）の市場規模は、主要7ヶ国と中国の中で米国が最も大きく、約9億5,000万米ドルを占めており、スペインは約3,500万米ドルとなっています。今後、新興治療薬の参入が見込まれることから、予測期間中に同市場は急拡大すると予測されています。

当レポートでは、主要7ヶ国と中国における間質性肺疾患に伴う結合組織病（CTD-ILD）市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2032年までの市場規模予測、および医療のアンメットニーズなどを提供しています。

目次

第1章 主な洞察

第2章 レポートのイントロダクション

第3章 間質性肺疾患に伴う結合組織病（CTD-ILD）市場の概要

• 市場シェア（%）間質性肺疾患に伴う結合組織病（CTD-ILD）の分布、2019年
• 市場シェア（%）間質性肺疾患に伴う結合組織病（CTD-ILD）の分布、2032年

第4章 CTD-ILDの疫学と市場の調査手法

第5章 CTD-ILDのエグゼクティブサマリー

第6章 主な事象

第7章 疾患背景と間質性肺疾患に伴う結合組織病（CTD-ILD）

• 間質性肺疾患に伴う結合組織病（CTD-ILD）のイントロダクション
• 間質性肺疾患に伴う最も一般的な結合組織病
• 兆候と症状
• 病態生理学
• 危険因子
• 診断
• 治療

第8章 疫学と患者数

• 主な調査結果
• 仮定と理論的根拠：主要7ヶ国
• 主要7ヶ国と中国における間質性肺疾患の罹患総数
• 主要7ヶ国と中国における診断済み間質性肺疾患の罹患総数
• 主要7ヶ国と中国における間質性肺疾患に伴う結合組織病の診断済み罹患総数
• 米国
• 欧州4ヶ国と英国
• 日本
• 中国

第9章 患者動向

第10章 上市済み治療法

第11章 新たな治療法

第12章 間質性肺疾患に伴う結合組織病（CTD-ILD）：市場分析

• 主な調査結果
• 主要な市場予測の前提条件
• 市場の見通し
• 主要7ヶ国および中国におけるCTD-ILD市場全体の規模
• 主要7ヶ国および中国におけるCTD-ILD市場全体の規模、治療法別
• 米国におけるCTD-ILDの市場規模
• 欧州4ヶ国と英国におけるCTD-ILDの市場規模
• 日本におけるCTD-ILDの市場規模
• 中国におけるCTD-ILDの市場規模

第13章 キーオピニオンリーダーの見解

第14章 SWOT分析

第15章 アンメットニーズ

第16章 市場アクセスと償還

• 米国
• 欧州4ヶ国と英国
• 日本
• 中国

第17章 付録

第18章 DelveInsightのサービス内容

第19章 免責事項

List of Tables

• Table 1: Summary of CTD-ILD Market and Epidemiology (2019-2032)
• Table 2: Characteristic Histopathologic Patterns and Radiologic Findings in the Interstitium of IPF and CTD-ILD
• Table 3: Clinical Approach to Evaluating Patients With ILD for CTDs
• Table 4: Differential Diagnosis of CTD-ILD
• Table 5: Clinical Pearls for Diagnosis of CTD-ILD
• Table 6: Recommendations of the European Panel
• Table 7: Standard Immunosuppressants used in Different CTD-ILD
• Table 8: Proposed Therapies for CTD-ILD
• Table 9: Clinical Pearls for the Management of CTD-ILD
• Table 10: Summary of Key Recommendations of the European Consensus Statements
• Table 11: Recommendations of the European Panel
• Table 12: Total Prevalent Cases of ILD in the 7MM and China (2019-2032)
• Table 13: Total Diagnosed Prevalent Cases of ILD in the 7MM and China (2019-2032)
• Table 14: Total Diagnosed Prevalent Cases of CTD-ILD in the 7MM and China (2019-2032)
• Table 15: Total Prevalent Cases of ILD in the US (2019-2032)
• Table 16: Total Diagnosed Prevalent Cases of ILD in the US (2019-2032)
• Table 17: Total Diagnosed Prevalent Cases of CTD-ILD in the US (2019-2032)
• Table 18: Type-specific Diagnosed Prevalent Cases of CTD-ILD in the US (2019-2032)
• Table 19: Total Prevalent Cases of ILD in Germany (2019-2032)
• Table 20: Total Prevalent Cases of ILD in France (2019-2032)
• Table 21: Total Prevalent Cases of ILD in Italy (2019-2032)
• Table 22: Total Prevalent Cases of ILD in Spain (2019-2032)
• Table 23: Total Prevalent Cases of ILD in the UK (2019-2032)
• Table 24: Total Prevalent Cases of ILD in EU4 and the UK (2019-2032)
• Table 25: Total Diagnosed Prevalent Cases of ILD in Germany (2019-2032)
• Table 26: Total Diagnosed Prevalent Cases of ILD in France (2019-2032)
• Table 27: Total Diagnosed Prevalent Cases of ILD in Italy (2019-2032)
• Table 28: Total Diagnosed Prevalent Cases of ILD in Spain (2019-2032)
• Table 29: Total Diagnosed Prevalent Cases of ILD in the UK (2019-2032)
• Table 30: Total Diagnosed Prevalent Cases of ILD in EU4 and the UK (2019-2032)
• Table 31: Total Diagnosed Prevalent Cases of CTD-ILD in Germany (2019-2032)
• Table 32: Total Diagnosed Prevalent Cases of CTD-ILD in France (2019-2032)
• Table 33: Total Diagnosed Prevalent Cases of CTD-ILD in Italy (2019-2032)
• Table 34: Total Diagnosed Prevalent Cases of CTD-ILD in Spain (2019-2032)
• Table 35: Total Diagnosed Prevalent Cases of CTD-ILD in the UK (2019-2032)
• Table 36: Total Diagnosed Prevalent Cases of CTD-ILD in EU4 and the UK (2019-2032)
• Table 37: Type-specific Diagnosed Prevalent Cases of CTD-ILD in Germany (2019-2032)
• Table 38: Type-specific Diagnosed Prevalent Cases of CTD-ILD in France (2019-2032)
• Table 39: Type-specific Diagnosed Prevalent Cases of CTD-ILD in Italy (2019-2032)
• Table 40: Type-specific Diagnosed Prevalent Cases of CTD-ILD in Spain (2019-2032)
• Table 41: Type-specific Diagnosed Prevalent Cases of CTD-ILD in the UK (2019-2032)
• Table 42: Type-specific Diagnosed Prevalent Cases of CTD-ILD in EU4 and the UK (2019-2032)
• Table 43: Total Prevalent Cases of ILD in Japan (2019-2032)
• Table 44: Total Diagnosed Prevalent Cases of ILD in Japan (2019-2032)
• Table 45: Total Diagnosed Prevalent Cases of CTD-ILD in Japan (2019-2032)
• Table 46: Type-specific Diagnosed Prevalent Cases of CTD-ILD in Japan (2019-2032)
• Table 47: Total Prevalent Cases of ILD in China (2019-2032)
• Table 48: Total Diagnosed Prevalent Cases of ILD in China (2019-2032)
• Table 49: Total Diagnosed Prevalent Cases of CTD-ILD in China (2019-2032)
• Table 50: Type-specific Diagnosed Prevalent Cases of CTD-ILD in China (2019-2032)
• Table 51: Comparison of Approved Drugs
• Table 52: OFEV (nintedanib), Clinical Trial Description, 2023
• Table 53: Comparison of Emerging Drugs Under Development
• Table 54: PRA023 IV, Clinical Trial Description, 2023
• Table 55: Belimumab, Clinical Trial Description, 2023
• Table 56: ETUARY (pirfenidone), Clinical Trial Description, 2023
• Table 57: Vixarelimab, Clinical Trial Description, 2023
• Table 58: MK-2225 (ACE-1334), Clinical Trial Description, 2023
• Table 59: Key Market Forecast Assumptions for GSK1550188 (belimumab)
• Table 60: Key Market Forecast Assumptions for ETUARY (pirfenidone)
• Table 61: Total Market Size of CTD-ILD in the 7MM and China, in USD million (2019-2032)
• Table 62: Market Size of CTD-ILD by Therapies in 7MM and China, in USD million (2019-2032)
• Table 63: Market Size of CTD-ILD in the US, in USD million (2019-2032)
• Table 64: Market Size of CTD-ILD by Therapies in the US, in USD million (2019-2032)
• Table 65: Market Size of CTD-ILD in Germany, in USD million (2019-2032)
• Table 66: Market Size of CTD-ILD in France, in USD million (2019-2032)
• Table 67: Market Size of CTD-ILD in Italy, in USD million (2019-2032)
• Table 68: Market Size of CTD-ILD in Spain, in USD million (2019-2032)
• Table 69: Market Size of CTD-ILD in the UK, in USD million (2019-2032)
• Table 70: Market Size of CTD-ILD in EU4 and the UK, in USD million (2019-2032)
• Table 71: Market Size of CTD-ILD by Therapies in Germany, in USD million (2019-2032)
• Table 72: Market Size of CTD-ILD by Therapies in France, in USD million (2019-2032)
• Table 73: Market Size of CTD-ILD by Therapies in Italy, in USD million (2019-2032)
• Table 74: Market Size of CTD-ILD by Therapies in Spain, in USD million (2019-2032)
• Table 75: Market Size of CTD-ILD by Therapies in the UK, in USD million (2019-2032)
• Table 76: Market Size of CTD-ILD by Therapies in EU4 and the UK, in USD million (2019-2032)
• Table 77: Market Size of CTD-ILD in Japan, in USD million (2019-2032)
• Table 78: Market Size of CTD-ILD by Therapies in Japan, in USD million (2019-2032)
• Table 79: Market Size of CTD-ILD in China, in USD million (2019-2032)
• Table 80: Market Size of CTD-ILD by Therapies in China, in USD million (2019-2032)

List of Figures

• Figure 1: ILD in CTD
• Figure 2: Symptoms of CTD-ILD
• Figure 3: Mechanisms Perpetuating Pulmonary Fibrosis
• Figure 4: Diagnosis of CTD-ILD
• Figure 5: Diagnostic Algorithm for SSc-ILD
• Figure 6: Diagnosis of RA-ILD
• Figure 7: Clinical Management Algorithm for CTD-ILD
• Figure 8: Clinical Management Algorithm for SSc-ILD
• Figure 9: Algorithm for Remission in Systemic Sclerosis-Interstitial Lung Disease (SSc-ILD)
• Figure 10: Total Prevalent Cases of ILD in the 7MM and China (2019-2032)
• Figure 11: Total Diagnosed Prevalent Cases of ILD in the 7MM and China (2019-2032)
• Figure 12: Total Diagnosed Prevalent Cases of CTD-ILD in the 7MM and China (2019-2032)
• Figure 13: Total Prevalent Cases of ILD in the US (2019-2032)
• Figure 14: Total Diagnosed Prevalent Cases of ILD in the US (2019-2032)
• Figure 15: Total Diagnosed Prevalent Cases of CTD-ILD in the US (2019-2032)
• Figure 16: Type-specific Diagnosed Prevalent Cases of CTD-ILD in the US (2019-2032)
• Figure 17: Total Prevalent Cases of ILD in Germany (2019-2032)
• Figure 18: Total Prevalent Cases of ILD in France (2019-2032)
• Figure 19: Total Prevalent Cases of ILD in Italy (2019-2032)
• Figure 20: Total Prevalent Cases of ILD in Spain (2019-2032)
• Figure 21: Total Prevalent Cases of ILD in the UK (2019-2032)
• Figure 22: Total Prevalent Cases of ILD in EU4 and the UK (2019-2032)
• Figure 23: Total Diagnosed Prevalent Cases of ILD in Germany (2019-2032)
• Figure 24: Total Diagnosed Prevalent Cases of ILD in France (2019-2032)
• Figure 25: Total Diagnosed Prevalent Cases of ILD in Italy (2019-2032)
• Figure 26: Total Diagnosed Prevalent Cases of ILD in Spain (2019-2032)
• Figure 27: Total Diagnosed Prevalent Cases of ILD in the UK (2019-2032)
• Figure 28: Total Diagnosed Prevalent Cases of ILD in EU4 and the UK (2019-2032)
• Figure 29: Total Diagnosed Prevalent Cases of CTD-ILD in Germany (2019-2032)
• Figure 30: Total Diagnosed Prevalent Cases of CTD-ILD in France (2019-2032)
• Figure 31: Total Diagnosed Prevalent Cases of CTD-ILD in Italy (2019-2032)
• Figure 32: Total Diagnosed Prevalent Cases of CTD-ILD in Spain (2019-2032)
• Figure 33: Total Diagnosed Prevalent Cases of CTD-ILD in the UK (2019-2032)
• Figure 34: Total Diagnosed Prevalent Cases of CTD-ILD in EU4 and the UK (2019-2032)
• Figure 35: Type-specific Diagnosed Prevalent Cases of CTD-ILD in Germany (2019-2032)
• Figure 36: Type-specific Diagnosed Prevalent Cases of CTD-ILD in France (2019-2032)
• Figure 37: Type-specific Diagnosed Prevalent Cases of CTD-ILD in Italy (2019-2032)
• Figure 38: Type-specific Diagnosed Prevalent Cases of CTD-ILD in Spain (2019-2032)
• Figure 39: Type-specific Diagnosed Prevalent Cases of CTD-ILD in the UK (2019-2032)
• Figure 40: Type-specific Diagnosed Prevalent Cases of CTD-ILD in EU4 and the UK (2019-2032)
• Figure 41: Total Prevalent Cases of ILD in Japan (2019-2032)
• Figure 42: Total Diagnosed Prevalent Cases of ILD in Japan (2019-2032)
• Figure 43: Total Diagnosed Prevalent Cases of CTD-ILD in Japan (2019-2032)
• Figure 44: Type-specific Diagnosed Prevalent Cases of CTD-ILD in Japan (2019-2032)
• Figure 45: Total Prevalent Cases of ILD in China (2019-2032)
• Figure 46: Total Diagnosed Prevalent Cases of ILD in China (2019-2032)
• Figure 47: Total Diagnosed Prevalent Cases of CTD-ILD in China (2019-2032)
• Figure 48: Type-specific Diagnosed Prevalent Cases of CTD-ILD in China (2019-2032)
• Figure 49: Patient Journey of CTD-ILD
• Figure 50: Market Size of CTD-ILD in the 7MM and China, in USD million (2019-2032)
• Figure 51: Market Size of CTD-ILD in the 7MM and China by Therapies, in USD million (2019-2032)
• Figure 52: Market Size of CTD-ILD in the US, in USD million (2019-2032)
• Figure 53: Total Market Size of CTD-ILD by Therapies in the US, in USD million (2019-2032)
• Figure 54: Market Size of CTD-ILD in Germany, in USD million (2019-2032)
• Figure 55: Market Size of CTD-ILD in France, in USD million (2019-2032)
• Figure 56: Market Size of CTD-ILD in Italy, in USD million (2019-2032)
• Figure 57: Market Size of CTD-ILD in Spain, in USD million (2019-2032)
• Figure 58: Market Size of CTD-ILD in the UK, in USD million (2019-2032)
• Figure 59: Market Size of CTD-ILD in EU4 and the UK, in USD million (2019-2032)
• Figure 60: Market Size of CTD-ILD by Therapies in Germany, in USD million (2019-2032)
• Figure 61: Market Size of CTD-ILD by Therapies in France, in USD million (2019-2032)
• Figure 62: Market Size of CTD-ILD by Therapies in Italy, in USD million (2019-2032)
• Figure 63: Market Size of CTD-ILD by Therapies in Spain, in USD million (2019-2032)
• Figure 64: Market Size of CTD-ILD by Therapies in the UK, in USD million (2019-2032)
• Figure 65: Market Size of CTD-ILD by Therapies in EU4 and the UK, in USD million (2019-2032)
• Figure 66: Market Size of CTD-ILD in Japan, in USD million (2019-2032)
• Figure 67: Market Size of CTD-ILD by Therapies in Japan, in USD million (2019-2032)
• Figure 68: Market Size of CTD-ILD in China, in USD million (2019-2032)
• Figure 69: Market Size of CTD-ILD by Therapies in China, in USD million (2019-2032)
• Figure 70: Unmet Needs
• Figure 71: Health Technology Assessment
• Figure 72: Reimbursement Process in Germany
• Figure 73: Reimbursement Process in France
• Figure 74: Reimbursement Process in Spain
• Figure 75: Reimbursement Process in the United Kingdom
• Figure 76: Reimbursement Process in Japan

Key Highlights

• Total prevalent cases of ILD were estimated at nearly 5.5 million in 2022 in the 7MM and China, of which nearly 3.8 million patients receive a formal diagnosis.
• Among these diagnosed ILD patients, more than 1 million cases were estimated to have a diagnosis of CTD-ILD in the 7MM and China in 2022.
• Most CTD-ILD patients were estimated in China, followed by the US, EU4, and the UK, and Japan in 2022.
• The US consistently captured the highest market among the 7MM and China, whereas Spain captured the lowest market. The market size of CTD-ILD was estimated to be nearly USD 950 million in the US in 2022 and nearly USD 35 million in Spain.
• The current treatment market for CTD-ILD includes Corticosteroids, Immunosuppressants, Biologics, DMARDs, antifibrotic Drugs (OFEV), and others. Biologics have consistently taken the maximum share in the market.
• The total market size of the CTD-ILD is anticipated to upsurge during the forecast period due to the expected entry of emerging therapies that includes BENLYSTA and ETUARY (only China).
• The distribution of CTD-ILD by various types showed that pSS-ILD has the highest burden in the 7MM and China.

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.

Geography Covered:

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

Study Period: 2019-2032

Disease Understanding and Treatment Algorithm

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.

Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD) Epidemiology

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 total prevalent cases of Interstitial Lung Disease (ILD) in the 7MM and China was nearly 5.5 million, of which diagnosed ILD cases were around 4 million.
• China showed the highest diagnosed prevalent population of CTD-ILD compared to other 7MM countries, with nearly 7.7 million cases in 2022. As per DelveInsight'sestimates, the country alone accounts for nearly 73% of total diagnosed prevalent cases, for CTD-ILD, in the 7MM and China, followed by the US, contributing 12% of all the CTD-ILD cases.
• The type-specific distribution of diagnosed prevalent cases of CTD-ILD showed SSc-ILD, RA-ILD, pSS-ILD, SLE-ILD, PM/DM-ILD, and other CTD-ILDs comprised 7%, 22%, 39%, 4%, 4%, and 23% cases, respectively.
• EU4 and the UK accounted for around 91,000 diagnosed prevalent cases of CTD-ILD in 2022. Of these cases, the UK accounted for the highest number of diagnosed prevalent cases of CTD-ILD among EU4 and the UK.
• Japan accounted for 6% of the total diagnosed prevalent cases of CTD-ILD in the 7MM and China in 2022.

Connective Tissue Disease Associated with Interstitial Lung Disease (CTD-ILD) Drug Chapters

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.

Connective Tissue Disease Associated with Interstitial Lung Disease (CTD-ILD) Market Outlook

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.

• The total market size of Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD) in the 7MM and China was around USD 1700 million in 2022. This is estimated to increase by 2032 at a significant CAGR.
• Among the 7MM and China, the US captured the highest market in 2022, covering a total of 55% market, followed by China which is anticipated to grow during the forecast period (2023-2032).
• In 2022, EU4 and the UK captured nearly 18% of the total market in the 7MM and China.
• In 2022, China held second and Japan third in the market.
• Among the forecasted emerging therapies, BENLYSTA (belimumab/GSK1550188) is expected to capture the highest market in the 7MM and China by 2032.

Connective Tissue Disease Associated with Interstitial Lung Disease (CTD-ILD) Drugs Uptake

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.

Scope of the Report:

• The report covers a segment of key events, an executive summary, descriptive overview of Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD), explaining its causes, signs and symptoms, pathogenesis, 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, along with the elaborative profiles of late-stage and prominent therapies, will impact the current treatment landscape.
• A detailed review of the Connective Tissue Disease associated with the Interstitial Lung Disease (CTD-ILD) 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 and China 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 preference that help shape and drive the 7MM and China Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD) market.

Connective Tissue Disease Associated with Interstitial Lung Disease (CTD-ILD) Report Insights

• Patient Population
• Therapeutic Approaches
• CTD-ILD Pipeline Analysis
• CTD-ILD Market Size and Trends
• Existing and Future Market Opportunity

Connective Tissue Disease Associated with Interstitial Lung Disease (CTD-ILD) Report Key Strengths

• Ten Years Forecast
• The 7MM and China Coverage
• CTD-ILD Epidemiology Segmentation
• Key Cross Competition
• Attribute Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Connective Tissue Disease Associated with Interstitial Lung Disease (CTD-ILD) 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 Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD) total market size, the market size by therapies, and market share (%) distribution in 2019, and how would it all look in 2032? What are the contributing factors for this growth?
• What unmet needs are associated with the current treatment market of Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD)?
• What will be the impact of the OFEV patent expiry in the market?
• How will Belimumab (GSK1550188) compete with the existing therapies for CTD-ILD after approval?
• Which drug is going to be the largest contributor in 2032?
• What are the pricing variations among different geographies for approved and off-label therapies?
• 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 Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD)? What will be the growth opportunities across the 7MM and China concerning the patient population of Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD)?
• What is the historical and forecasted Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD) patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, Japan and, China?
• Why do only limited patients appear for diagnosis?
• Which type of CTD-ILD is more prevalent and why?
• What factors are affecting the diagnosis of the indication?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for treating Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD)? What are the current guidelines for treating Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD) in the US and Europe?
• How many companies are developing therapies for treating Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD)?
• How many emerging therapies are in the mid-stage and late stage of development for treating Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD)?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the key designations that have been granted for the emerging therapies for Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD)?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
• What are the 7MM and China historical and forecasted markets of Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD)?

Reasons to Buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Connective Tissue Disease associated with Interstitial Lung Disease (CTD-ILD) Market.
• Insights on patient burden/disease prevalence, 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, Japan, and China.
• Identifying strong upcoming players in the market will help devise strategies that will help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• 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 need of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. CTD-ILD Market Overview at a Glance

• 3.1. Market Share (%) Distribution of CTD-ILD in 2019
• 3.2. Market Share (%) Distribution of CTD-ILD in 2032

4. Methodology of CTD-ILD Epidemiology and Market

5. Executive Summary of CTD-ILD

6. Key Events

7. Disease Background and CTD-ILD

• 7.1. Introduction to CTD-ILD
• 7.2. Most Common CTDs Associated with ILD
• 7.3. Signs and Symptoms
• 7.4. Pathophysiology
• 7.5. Risk Factors
• 7.6. Diagnosis
  • 7.6.1. Diagnostic algorithm
  • 7.6.2. Diagnosis guidelines
    • 7.6.2.1. BTS guidelines for the diagnosis of ILD
    • 7.6.2.2. Evidence-based European consensus recommendations for the Diagnosis of SSc-ILD
    • 7.6.2.3. Recommendations of ATS/ERS/JRS/ALAT
• 7.7. Treatment
  • 7.7.1. Treatment algorithm
  • 7.7.2. Treatment guidelines
    • 7.7.2.1. BTS guidelines for the management of CTD-ILD
    • 7.7.2.2. Recommendations of the European Consensus Statements on CTD-ILD
    • 7.7.2.3. EULAR recommendations for the treatment of SSc-ILD

8. Epidemiology and Patient Population

• 8.1. Key Findings
• 8.2. Assumptions and Rationale: The 7MM
  • 8.2.1. Diagnosed prevalence rate of ILD
  • 8.2.2. Diagnosed prevalence of connective tissue diseases
    • 8.2.2.1. Systemic sclerosis
    • 8.2.2.2. Primary sjogren's syndrome
    • 8.2.2.3. Rheumatoid arthritis
    • 8.2.2.4. Systemic lupus erythematosus
    • 8.2.2.5. Dermatomyositis
    • 8.2.2.6. Polymyositis
  • 8.2.3. Interstitial lung disease associated with connective tissue diseases
    • 8.2.3.1. ILD (%) in systemic sclerosis
    • 8.2.3.2. ILD (%) in primary sjogren's syndrome
    • 8.2.3.3. ILD (%) in rheumatoid arthritis
    • 8.2.3.4. ILD (%) in systemic lupus erythematosus
    • 8.2.3.5. ILD (%) in dermatomyositis/polymyositis
• 8.3. Total Prevalent Cases of ILD in the 7MM and China
• 8.4. Total Diagnosed Prevalent Cases of ILD in the 7MM and China
• 8.5. Total Diagnosed Prevalent Cases of CTD-ILD in the 7MM and China
• 8.6. The United States
  • 8.6.1. Total prevalent cases of ILD in the US
  • 8.6.2. Total diagnosed prevalent cases of ILD in the US
  • 8.6.3. Total diagnosed prevalent cases of CTD-ILD in the US
  • 8.6.4. Type-specific diagnosed prevalent cases of CTD-ILD in the US
• 8.7. EU4 and the UK
  • 8.7.1. Germany
    • 8.7.1.1. Total prevalent cases of ILD
    • 8.7.1.2. Total diagnosed prevalent cases of ILD
    • 8.7.1.3. Total diagnosed prevalent cases of CTD-ILD
    • 8.7.1.4. Type-specific diagnosed prevalent cases of CTD-ILD
  • 8.7.2. France
    • 8.7.2.1. Total prevalent cases of ILD
    • 8.7.2.2. Total diagnosed prevalent cases of ILD
    • 8.7.2.3. Total diagnosed prevalent cases of CTD-ILD
    • 8.7.2.4. Type-specific diagnosed prevalent cases of CTD-ILD
  • 8.7.3. Italy
    • 8.7.3.1. Total prevalent cases of ILD
    • 8.7.3.2. Total diagnosed prevalent cases of ILD
    • 8.7.3.3. Total diagnosed prevalent cases of CTD-ILD
    • 8.7.3.4. Type-specific diagnosed prevalent cases of CTD-ILD
  • 8.7.4. Spain
    • 8.7.4.1. Total prevalent cases of ILD
    • 8.7.4.2. Total diagnosed prevalent cases of ILD
    • 8.7.4.3. Total diagnosed prevalent cases of CTD-ILD
    • 8.7.4.4. Type-specific diagnosed prevalent cases of CTD-ILD
  • 8.7.5. The UK
    • 8.7.5.1. Total prevalent cases of ILD
    • 8.7.5.2. Total diagnosed prevalent cases of ILD
    • 8.7.5.3. Total diagnosed prevalent cases of CTD-ILD
    • 8.7.5.4. Type-specific diagnosed prevalent cases of CTD-ILD
• 8.8. Japan
  • 8.8.1. Total prevalent cases of ILD in Japan
  • 8.8.2. Total diagnosed prevalent cases of ILD in Japan
  • 8.8.3. Total diagnosed prevalent cases of CTD-ILD in Japan
  • 8.8.4. Type-specific diagnosed prevalent cases of CTD-ILD in Japan
• 8.9. China
  • 8.9.1. Total prevalent cases of ILD in China
  • 8.9.2. Total diagnosed prevalent cases of ILD in China
  • 8.9.3. Total diagnosed prevalent cases of CTD-ILD in China
  • 8.9.4. Type-specific diagnosed prevalent cases of CTD-ILD in China

9. Patient Journey

10. Marketed Therapies

• 10.1. Key Cross Competition
• 10.2. OFEV (nintedanib): Boehringer Ingelheim Pharmaceuticals, Inc.
  • 10.2.1. Product description
  • 10.2.2. Regulatory milestones
  • 10.2.3. Other development activities
  • 10.2.4. Clinical development
  • 10.2.5. Clinical trial information
  • 10.2.6. Safety and efficacy
  • 10.2.7. Product profile

11. Emerging Therapies

• 11.1. Key Cross Competition
• 11.2. PRA023: Prometheus Biosciences, Inc.
  • 11.2.1. Product description
  • 11.2.2. Other development activities
  • 11.2.3. Clinical development
  • 11.2.4. Clinical trials information
  • 11.2.5. Safety and efficacy
  • 11.2.6. Product profile
• 11.3. GSK1550188: GlaxoSmithKline
  • 11.3.1. Product description
  • 11.3.2. Other development activities
  • 11.3.3. Clinical development
  • 11.3.4. Clinical trials information
  • 11.3.5. Safety and efficacy
  • 11.3.6. Product profile
• 11.4. Pirfenidone (ETUARY): GNI-EPS Pharmaceuticals, Inc. (GNI Group)/Beijing Continent Pharmaceutical Co, Ltd./Shanghai Genomics, Inc.
  • 11.4.1. Product description
  • 11.4.2. Other development activities
  • 11.4.3. Clinical development
  • 11.4.4. Clinical trial information
  • 11.4.5. Product profile
• 11.5. Vixarelimab (KPL-716): Genentech, Inc.
  • 11.5.1. Product description
  • 11.5.2. Other development activities
  • 11.5.3. Clinical development
  • 11.5.4. Clinical trials information
  • 11.5.5. Product profile
• 11.6. MK-2225 (ACE-1334): Merck & Co., Inc.
  • 11.6.1. Product description
  • 11.6.2. Other development activities
  • 11.6.3. Clinical development
  • 11.6.4. Clinical trial information
  • 11.6.5. Product profile

12. CTD-ILD: Market Analysis

• 12.1. Key Findings
• 12.2. Key Market Forecast Assumptions
• 12.3. Market Outlook
• 12.4. Total Market Size of CTD-ILD in the 7MM and China
• 12.5. Total Market Size of CTD-ILD by Therapies in the 7MM and China
• 12.6. Market Size of CTD-ILD in the US
  • 12.6.1. Total market size of CTD-ILD
  • 12.6.2. The market size of CTD-ILD by therapies
• 12.7. Market Size of CTD-ILD in EU4 and the UK
  • 12.7.1. Germany
    • 12.7.1.1. Total market size of CTD-ILD
    • 12.7.1.2. The market size of CTD-ILD by therapies
  • 12.7.2. France
    • 12.7.2.1. Total market size of CTD-ILD
    • 12.7.2.2. The market size of CTD-ILD by therapies
  • 12.7.3. Italy
    • 12.7.3.1. Total market size of CTD-ILD
    • 12.7.3.2. The market size of CTD-ILD by therapies
  • 12.7.4. Spain
    • 12.7.4.1. Total market size of CTD-ILD
    • 12.7.4.2. The market size of CTD-ILD by therapies
  • 12.7.5. The UK
    • 12.7.5.1. Total market size of CTD-ILD
    • 12.7.5.2. The market size of CTD-ILD by therapies
• 12.8. Market Size of CTD-ILD in Japan
  • 12.8.1. Total market size of CTD-ILD
  • 12.8.2. The market size of CTD-ILD by therapies
• 12.9. Market Size of CTD-ILD in China
  • 12.9.1. Total market size of CTD-ILD
  • 12.9.2. The market size of CTD-ILD by therapies

13. Key Opinion Leaders' Views

14. SWOT Analysis

15. Unmet Needs

16. Market Access and Reimbursement

• 16.1. The United States
  • 16.1.1. Centre for Medicare and Medicaid Services (CMS)
• 16.2. In EU4 and the UK
  • 16.2.1. Germany
  • 16.2.2. France
  • 16.2.3. Italy
  • 16.2.4. Spain
  • 16.2.5. The United Kingdom
• 16.3. Japan
  • 16.3.1. MHLW
• 16.4. China

17. Appendix

• 17.1. Bibliography
• 17.2. Acronyms and Abbreviations
• 17.3. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer