2021年10月にEuropean Journal of Medical Researchに発表された研究記事「特発性肺線維症におけるピルフェニドンの効果と安全性：メタアナリシスと系統的レビュー」によると、薬剤ピルフェニドンは特発性肺線維症（IPF）患者の無増悪生存期間（PFS）を延長し、肺機能を改善することが証明されています。しかし、IPFの治療に対する信頼できる証拠を提供するためには、より質の高いランダム化比較試験（RCT）が必要です。

北米が世界の特発性肺線維症市場を支配しています

• 1 イントロダクション

  • 1.1 調査の前提条件と市場の定義

  • 1.2 本調査の範囲

• 2 調査手法

• 3 エグゼクティブサマリー

• 4 市場力学

  • 4.1 市場概要

  • 4.2 市場の促進要因

    • 4.2.1 増加する特発性肺線維症の患者数

    • 4.2.2 線維性疾患における研究開発活動の活発化

  • 4.3 市場の抑制要因

  • 4.4 ポーターのファイブフォース分析

    • 4.4.1 新規参入の脅威

    • 4.4.2 買い手・消費者の交渉力

    • 4.4.3 サプライヤーの交渉力

    • 4.4.4 代替品の脅威

    • 4.4.5 競合・競争状況の激しさ

• 5 市場セグメンテーション

  • 5.1 薬品タイプ別

    • 5.1.1 ニンテダニブ

    • 5.1.2 ピルフェニドン

    • 5.1.3 その他薬品タイプ

  • 5.2 作用機序別

    • 5.2.1 抗線維化剤

    • 5.2.2 チロシンキナーゼ阻害剤

    • 5.2.3 その他の作用機序

  • 5.3 エンドユーザー別

    • 5.3.1 病院・クリニック

    • 5.3.2 その他のエンドユーザー

  • 5.4 地域別

    • 5.4.1 北米

      • 5.4.1.1 米国
      • 5.4.1.2 カナダ
      • 5.4.1.3 メキシコ

    • 5.4.2 ヨーロッパ

      • 5.4.2.1 ドイツ
      • 5.4.2.2 英国
      • 5.4.2.3 フランス
      • 5.4.2.4 イタリア
      • 5.4.2.5 スペイン
      • 5.4.2.6 その他ヨーロッパ

    • 5.4.3 アジア太平洋

      • 5.4.3.1 中国
      • 5.4.3.2 日本
      • 5.4.3.3 インド
      • 5.4.3.4 オーストラリア
      • 5.4.3.5 韓国
      • 5.4.3.6 その他アジア太平洋

    • 5.4.4 中東・アフリカ

      • 5.4.4.1 GCC地域
      • 5.4.4.2 南アフリカ
      • 5.4.4.3 その他中東・アフリカ

    • 5.4.5 南米

      • 5.4.5.1 ブラジル
      • 5.4.5.2 アルゼンチン
      • 5.4.5.3 その他南米

• 6 競合情勢

  • 6.1 企業プロファイル

    • 6.1.1 United Therapeutics Corporation

    • 6.1.2 Boehringer Ingelheim International GmbH

    • 6.1.3 Bristol-Myers Squibb Company

    • 6.1.4 Cipla Inc

    • 6.1.5 F. Hoffmann-La Roche Ltd

    • 6.1.6 FibroGen, Inc

    • 6.1.7 MediciNova, Inc

    • 6.1.8 Jubliant Pharma Limited (Jubliant Cadista Limited)

    • 6.1.9 Merck & Co. Inc

    • 6.1.10 Horizon Therapeutics, Inc

• 7 市場機会と今後の動向

The idiopathic pulmonary fibrosis market is estimated to be USD 3,669.25 million in 2021 and it is expected to reach USD 5,723.69 million by 2027, registering a CAGR of 7.55% over the forecast period of 2022-2027.

Severe coronavirus disease 2019 (COVID-19) affects the respiratory system and develops into respiratory failure. Patients with pre-existing chronic lung disorders, such as idiopathic pulmonary fibrosis (IPF), are thought to be at high risk of death. Patients with IPF often suffer from acute exacerbation (AE), a significant part of which is assumed to be triggered by respiratory viral infection. The study “COVID-19-Triggered Acute Exacerbation of IPF, an Underdiagnosed Clinical Entity With Two-Peaked Respiratory Failure: A Case Report and Literature Review” published in February 2022 stated that COVID-19 patients with pre-existing interstitial lung diseases (ILDs), especially fibrotic ILDs, are at very high risk of death. The study also assessed that decreased lung function and a diagnosis of IPF have been reported as risk factors for developing acute exacerbation of pre-existing ILDs leading to increased mortality of COVID-19 patients. Therefore, this study indicated that COVID-19 patients faced comorbidities with IPF thereby increasing the demand for its therapeutics, thus impacting the market growth.

With the increase in prevalence and incidence rate of idiopathic pulmonary fibrosis (IPF) disease, there is a continuous demand for innovative and affordable treatments due to which public authorities, government organizations, and key market players are focusing more on the development of effective treatment solutions. Thus, there are increasing research and development activities in the market which is expected to propel the market growth during the study period. In April 2022, Curebase initiated the pilot phase of COMPANION, the first clinical investigation of a new digital therapeutic (DTx) for patients with IPF, a rare lung disease. The COMPANION study is a randomized, controlled, parallel-group clinical investigation evaluating the impact of Vicore's digital cognitive behavioral therapy on psychological symptom burden, specifically anxiety and depressive symptoms, in adults diagnosed with idiopathic pulmonary fibrosis (dCBT IPF). Thus, rising technological advancements to minimize the burden on IPF patients will bolster the market growth.

Additionally, as elderly people are more prone to getting affected by IPF, the rise in the geriatric population will also boost the market. For instance, according to the October 2021 update of the World Health Organization, the population of people of age 60 years and more is expected to increase from 1 billion in 2020 to 2.1 billion by 2050 and as older people are more prone to idiopathic pulmonary fibrosis (IPF), the burden of IPF is further expected to increase over the forecast period, thereby propelling the market towards growth. Therefore, owing to the above-mentioned factors, the idiopathic pulmonary fibrosis market is expected to grow over the forecast period. However, lack of awareness and unavailability of proper treatment for IPF are expected to restrain the growth of the idiopathic pulmonary fibrosis market during the forecast period.

Key Market Trends

Pirfenidone is Expected to Hold a Significant Share in the Global Idiopathic Pulmonary Fibrosis Market Over the Forecast Period

Pirfenidone is an orally administered drug with antifibrotic, anti-inflammatory, and antioxidant effects. This drug is used to slow down the disease progression in patients with idiopathic pulmonary fibrosis (IPF). The rising research and development activities and rising adoption of strategic initiatives such as mergers, acquisitions, partnerships, and investments by key market players associated with the drug pirfenidone are expected to contribute to the studied market growth over the study period.

For instance, in May 2022, the company Sandoz announced the United States launch of generic pirfenidone which is an AB-rated (fully substitutable) equivalent to Genentech's Esbriet for the treatment of patients with idiopathic pulmonary fibrosis (IPF). Moreover, in June 2021, the company Genentech, a member of the Roche Group announced the United States Food and Drug Administration (FDA) supplemental New Drug Application (sNDA) and granted Priority Review for Esbriet (pirfenidone).) In June 2022, another company Accord Healthcare, Inc also announced the addition of Pirfenidone to its oral solid products portfolio. This new drug is therapeutically equivalent to Genentech's Esbriet and is approved to treat idiopathic pulmonary fibrosis (IPF)

As per the study article ‘The effects and safety of pirfenidone in the treatment of idiopathic pulmonary fibrosis: a meta-analysis and systematic review’ published in the European Journal of Medical Research in October 2021, the drug Pirfenidone is proved to be beneficial to prolong the progression-free survival (PFS) of idiopathic pulmonary fibrosis (IPF) patients and improve lung function. However, more high-quality randomized controlled trials (RCTs) are still needed to provide reliable evidence for the treatment of IPF.

Furthermore, as per the study article Efficacy and safety of pirfenidone in the treatment of idiopathic pulmonary fibrosis patients published in the National Institute of Health 2021, the drug Pirfenidone can provide survival benefits for patients with idiopathic pulmonary fibrosis (IPF). Moreover, the other company Alembic Pharma gets United States Food and Drug Administration (USFDA) approval to market Pirfenidone tablets. Hence, the rising product launches and acquisitions by key market players are likely to contribute significantly to segment growth.

North America Dominates the Global Idiopathic Pulmonary Fibrosis Market

The market for idiopathic pulmonary fibrosis in North America is expected to experience lucrative growth during the study period due to the rising burden of idiopathic pulmonary fibrosis, and technological advancements in treatment in the studied market. In addition, the product launches and strategic initiatives by key market players will also contribute to the market growth.

In January 2022, a research study published titled "Idiopathic Pulmonary Fibrosis: An Update on Pathogenesis" stated that idiopathic pulmonary fibrosis (IPF) is a progressive, lethal fibrotic lung disease that occurs primarily in middle-aged and elderly adults. It is a major cause of morbidity and mortality. With an increase in life expectancy, the economic burden of IPF is expected to continuously rise in the near future. IPF primarily occurs in middle-aged and elderly adults. In the United States, the median age of newly diagnosed patients is 62 years, and 54% are male. According to the Administration of Community Living’s 2020 Profile of Older Americans, published in May 2021, reports that in 2019, in the United States there is about 54.1 million population aged 65 years or above and the count will become 94.7 million by 2060. Hence, increasing the prevalence of the disease is one of the critical factors for market growth.

The product launches, partnerships, and mergers and acquisitions will help the companies in expanding their product offering and geographical footprints, thereby contributing to the lucrative growth of the market. In February 2020, Bristol-Myers Squibb Company and its partner BioMotiv launched a new company called Anteros Pharmaceuticals that will focus on investigating drugs with a specific focus on idiopathic pulmonary fibrosis. The intellectual property behind Anteros was first developed by Yale University and in-licensed by Bristol-Myers Squibb and subsequently assigned to Anteros. Similarly, in September 2020, Bristol-Myers Squibb Company acquired Forbius for its TGF-beta program, including its lead investigational asset AVID200, currently in Phase 1 for oncology and fibrosis.

In May 2022, Sandoz launched its generic pirfenidone, the first AB-rated (fully substitutable) equivalent to Genentech’s Esbriet, to treat patients with idiopathic pulmonary fibrosis (IPF). This prescription oral medicine is immediately available to patients via specialty pharmacies, with a USD 0 co-pay program for eligible patients. The availability of generic medicine would increase the demand for treatment thus increasing the market growth. Thus, due to the abovementioned factors, the studied market is expected to witness significant growth.

Competitive Landscape

The market is fairly competitive and consists of a few major players along with other small players in the market. Companies, like Afferent Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Cipla Inc., F. Hoffmann-La Roche Ltd, FibroGen, Genentech USA Inc., Jubilant Cadista, Merck & Co. Inc., Prometic Life Sciences, among others, hold the substantial market share in the market.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

• 1 INTRODUCTION

  • 1.1 Study Assumptions and Market Definition

  • 1.2 Scope of the Study

• 2 RESEARCH METHODOLOGY

• 3 EXECUTIVE SUMMARY

• 4 MARKET DYNAMICS

  • 4.1 Market Overview

  • 4.2 Market Drivers

    • 4.2.1 Increasing Prevalence of Idiopathic Pulmonary Fibrosis

    • 4.2.2 Rising Research and Development Activities in Fibrotic Diseases

  • 4.3 Market Restraints

    • 4.3.1 Unavailability of Proper Treatment and Lack of Awareness in Developing Countries

  • 4.4 Porter's Five Forces Analysis

    • 4.4.1 Threat of New Entrants

    • 4.4.2 Bargaining Power of Buyers/Consumers

    • 4.4.3 Bargaining Power of Suppliers

    • 4.4.4 Threat of Substitute Products

    • 4.4.5 Intensity of Competitive Rivalry

• 5 MARKET SEGMENTATION

  • 5.1 By Drug Type

    • 5.1.1 Nintedanib

    • 5.1.2 Pirfenidone

    • 5.1.3 Other Drug Types

  • 5.2 By Mode of Action

    • 5.2.1 Antifibrotic Agents

    • 5.2.2 Tyrosine Kinase Inhibitors

    • 5.2.3 Other Modes of Action

  • 5.3 By End User

    • 5.3.1 Hospitals and Clinics

    • 5.3.2 Other End Users

  • 5.4 Geography

    • 5.4.1 North America

      • 5.4.1.1 United States
      • 5.4.1.2 Canada
      • 5.4.1.3 Mexico

    • 5.4.2 Europe

      • 5.4.2.1 Germany
      • 5.4.2.2 United Kingdom
      • 5.4.2.3 France
      • 5.4.2.4 Italy
      • 5.4.2.5 Spain
      • 5.4.2.6 Rest of Europe

    • 5.4.3 Asia-Pacific

      • 5.4.3.1 China
      • 5.4.3.2 Japan
      • 5.4.3.3 India
      • 5.4.3.4 Australia
      • 5.4.3.5 South Korea
      • 5.4.3.6 Rest of Asia-Pacific

    • 5.4.4 Middle East and Africa

      • 5.4.4.1 GCC
      • 5.4.4.2 South Africa
      • 5.4.4.3 Rest of Middle East and Africa

    • 5.4.5 South America

      • 5.4.5.1 Brazil
      • 5.4.5.2 Argentina
      • 5.4.5.3 Rest of South America

• 6 COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles

    • 6.1.1 United Therapeutics Corporation

    • 6.1.2 Boehringer Ingelheim International GmbH

    • 6.1.3 Bristol-Myers Squibb Company

    • 6.1.4 Cipla Inc

    • 6.1.5 F. Hoffmann-La Roche Ltd

    • 6.1.6 FibroGen, Inc

    • 6.1.7 MediciNova, Inc

    • 6.1.8 Jubliant Pharma Limited (Jubliant Cadista Limited)

    • 6.1.9 Merck & Co. Inc

    • 6.1.10 Horizon Therapeutics, Inc

• 7 MARKET OPPORTUNITIES AND FUTURE TRENDS