North America Fibrotic Disease Treatment Market - Industry Trends and Forecast to 2032

North America Fibrotic Disease Treatment Market Analysis

The rising prevalence of fibrotic diseases, such as idiopathic pulmonary fibrosis, hepatic cirrhosis, and renal fibrosis, is a significant driver of the fibrotic diseases treatment Market. Factors such as aging populations, lifestyle changes, and increasing rates of chronic conditions like diabetes and hypertension are contributing to a higher incidence of these diseases. As the number of affected individuals grows, the demand for effective treatments intensifies, driving the need for advanced therapies, including antifibrotic drugs and biologics. Healthcare systems face growing pressure to manage chronic fibrotic conditions, driving demand for more effective treatments and fueling market growth.

North America Fibrotic Disease Treatment Market Size

The North America fibrotic disease treatment market is expected to reach USD 6.01 billion by 2032 from USD 3.29 billion in 2024, growing at a CAGR of 7.9% in the forecast period of 2025 to 2032.

North America Fibrotic Disease Treatment Market Trends

“Rising Adoption of Biomarker-Based Diagnostics”

The use of biomarker-based diagnostics in Testicular Germ Cell Tumors (TGCT) is becoming more prevalent, with biomarkers such as alpha-fetoprotein (AFP), beta-human chorionic gonadotropin (β-hCG), and lactate dehydrogenase (LDH) playing a crucial role in clinical practice. These biomarkers enable clinicians to achieve early detection, monitor disease progression, and tailor treatments to the individual characteristics of each patient. This trend reflects advancements in precision medicine and is leading to more accurate staging and risk stratification of TGCT. As research continues to identify additional biomarkers, the integration of these diagnostic tools is becoming a standard approach, enhancing treatment protocols and improving patient outcomes.

North America Fibrotic Disease Treatment Market Segmentation        

North America Fibrotic Disease Treatment Market Definition

Fibrotic disease is a condition where excessive fibrous connective tissue (fibrosis) forms, often as a result of chronic inflammation or tissue injury. This abnormal tissue build-up disrupts the normal function of organs, commonly affecting the lungs (pulmonary fibrosis), liver (liver fibrosis), heart, kidneys, and skin.

Treatment for fibrotic disease focuses on slowing or halting the progression of fibrosis, reducing inflammation, and managing symptoms. Approaches may include anti-fibrotic drugs, immunosuppressive agents, lifestyle modifications, and in advanced cases, surgical options like organ transplantation. Newer treatments explore targeted therapies that block specific pathways responsible for fibrosis development.

North America Fibrotic Disease Treatment Market Dynamics

Drivers  

• Rising Prevalence of Fibrotic Diseases

The rising prevalence of fibrotic diseases, such as idiopathic pulmonary fibrosis, hepatic cirrhosis, and renal fibrosis, is a significant driver of the Fibrotic Diseases Treatment Market. Factors such as aging populations, lifestyle changes, and increasing rates of chronic conditions like diabetes and hypertension are contributing to a higher incidence of these diseases. As the number of affected individuals grows, the demand for effective treatments intensifies, driving the need for advanced therapies, including antifibrotic drugs and biologics. Healthcare systems face growing pressure to manage chronic fibrotic conditions, driving demand for more effective treatments and fueling market growth.

For instance,

• In January 2023, according to an article published by PubMed Central, the incidence and prevalence of idiopathic pulmonary fibrosis (IPF) are rising globally, no longer fitting its rare disease classification. In North America, prevalence rates range from 2.4 to 2.98 per 10,000 people, with South Korea having the highest prevalence at 4.51 per 10,000

The rising prevalence of fibrotic diseases significantly fuels market expansion by highlighting the need for better, more accessible treatment solutions, while also encouraging increased research and development in the field.         

• Increase in the Number of People Smoking Cigarettes

Cigarette smoking is one of the most recognized risk factors for development of idiopathic pulmonary fibrosis (IPF). Furthermore, recent work suggests that smoking may have a detrimental effect on survival of patients with IPF. The mechanism by which smoking may contribute to the pathogenesis of IPF is largely unknown. However, accumulating evidence suggests that increased oxidative stress might promote disease progression in IPF patients who are current and former smokers.

For instance,

• In June 2023, according to an article published by NCBI, smoking is a key risk factor for interstitial lung diseases (ILDs) like idiopathic pulmonary fibrosis (IPF), with studies indicating that 41% to 83% of IPF patients have a smoking history and a 60% higher risk
• In May 2022, according to the article published in National Center for Biotechnology Information (NCBI), Smoking has been considered an important risk factor for idiopathic pulmonary fibrosis (IPF) incidence. According to the study conducted in the article the risk of IPF was significantly higher in current and former smokers than in never smokers, with an aHR of 1.66 (95% CI 1.61 to 1.72) and 1.42 (95% CI 1.37 to 1.48), respectively. Current smokers had a higher risk of IPF than former smokers (aHR 1.17, 95% CI 1.13 to 1.21). The risk of IPF development increased as the smoking intensity and duration increased

Opportunities

• Rising Research and Development Activities

The increasing prevalence of fibrotic diseases and the demand for more effective treatments are prompting pharmaceutical and biotech companies to boost their R&D investments. These efforts aim to develop innovative therapies, including new antifibrotic drugs, biologics, and gene therapies targeting the underlying causes of fibrosis. Additionally, advancements in personalized medicine and diagnostic technologies are expected to improve treatment outcomes and overall patient care. As R&D progresses, new therapeutic options will emerge, boosting market growth and improving the management of fibrotic diseases.

For instance,

• In May 2024, according to Boehringer Ingelheim International GmbH, Boehringer Ingelheim has secured a license agreement to develop a first-in-class treatment for fibro-inflammatory diseases, reinforcing its commitment to breakthrough therapies aimed at improving patient outcomes
• In July 2021, according to the article published by Moez Ghumman et.al, existing oral therapies, pirfenidone and nintedanib, may attempt to improve the patients’ quality of life by mitigating symptoms and slowing disease progression, however chronic doses and systemic deliveries of these drugs can lead to severe side effects. The lack of effective treatment options calls for further investigation of restorative as well as additional palliative therapies for IPF. Nanoparticle-based sustained drug delivery strategies can be utilized to ensure targeted delivery for site-specific treatment as well as long-acting therapy, improving overall patient compliance

The rise in R&D activities presents a major opportunity to accelerate market expansion by fostering innovation and enhancing treatment strategies.

• Advancements in Pipeline Drug Developments

A growing number of promising therapies, including new antifibrotic drugs, biologics, and gene therapies, are currently in various stages of development. These drugs aim to target the underlying causes of fibrotic diseases, offering the potential for more effective treatments and improved patient outcomes, particularly for conditions like idiopathic pulmonary fibrosis, hepatic cirrhosis, and renal fibrosis. The successful approval and commercialization of these drugs will expand the range of therapeutic options available, meet the increasing demand for better treatments, and foster market growth.

For instance,

• In September 2024, according to an article published by the Pulmonary Fibrosis Foundation, drugs like AP01, BBT-877, GKT137831, and others are currently in Phase 2 of development for fibrotic diseases
• In February 2022, according to NCBI, a Phase I/II clinical trial, started in February 2021, is testing Imatinib (200mg/day) for advanced liver fibrosis (grades 3-4) at Taleghani Hospital in Tehran. The trial compares Imatinib with standard treatment and a placebo over 24 weeks

This study underscores the advancement in pipeline drug development, potentially introducing a novel treatment for liver fibrosis, which could fuel growth in the global fibrotic diseases treatment market

The advancements in pipeline drug developments are poised to significantly drive market expansion by offering innovative solutions for the management of fibrotic diseases.

Restraints/Challenges

• High Cost of Medication and Treatments

Fibrotic disease treatments have become increasingly expensive due to the growing number of patients suffering from fibrosis and the risen prices of medical devices and medications. The modern technological devices used in fibrosis treatment is also playing significant role in high prices of treatments, and high accuracy, provide a definitive diagnosis for idiopathic pulmonary fibrosis (IPF). Therefore, the high cost of medications and treatment procedure for fibrotic disease is hampering the growth of the market.

For instance,

• In October 2022, according to an article published by PubMed Central, therapeutic options for IPF are limited, with only two approved antifibrotic drugs—pirfenidone and nintedanib—available for mild to moderate cases. These drugs are costly, ranging from USD2,000 to USD14,000 per person monthly, depending on the country
• In September 2022, according to the article published by Alan Katz et.al, cost per treatment of the hyperbaric oxygen therapy will generally range between USD 250-USD 600 per treatment depending on a few factors, including the number of sessions and location of services
• In January 2022, according to an article published in BMC Pulmonary Medicine reported that the annual list price of pirfenidone was approximately USD 36,070.80, whereas the annual cost for both pirfenidone and nintedanib in the U.S. exceeds USD 100,000, and in Belgium, the annual list price of nintedanib is around USD 28,910. This high cost of medications and treatments is expected to act as a restraint for the global fibrotic diseases treatment market, limiting access to these therapies and placing financial strain on patients and healthcare systems

The Complex and Multifactorial Nature of Fibrotic Diseases

Fibrosis is driven by a variety of factors, including genetic predispositions, environmental exposures, and underlying chronic conditions, making it difficult to pinpoint a single cause or develop a one-size-fits-all treatment. This complexity complicates the development of effective therapies that can address the diverse mechanisms involved in fibrosis. Additionally, the progressive and often asymptomatic nature of these diseases until advanced stages further complicates early diagnosis and treatment, leading to delayed interventions.

For instance,

• In January 2023, according to an article published by PubMed Central, in IPF, normal lung tissue is replaced by abnormal matrix build up, impairing alveolar function and leading to respiratory failure. Repeated micro-injuries and disrupted cell repair drive irreversible lung damage

The multifaceted nature of fibrotic diseases requires a highly tailored approach to treatment, posing a challenge for pharmaceutical companies to develop universally effective therapies and strategies to manage these conditions.

North America Fibrotic Disease Treatment Market Scope

The market is segmented on the basis of treatment, application, and end user. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

This research report categorizes the North America Fibrotic Disease Treatment market into the following segments:

By Treatment

• Medication
  • Nintedanib (OFEV)
  • Pirfenidone (ESBRIET)
• Organ Transplantation
• Oxygen Therapy
• Others

By Application

• Idiopathic Pulmonary Fibrosis
• Hepatic Cirrhosis
• Renal Fibrosis
• Cutaneous Fibrosis
• Others

By End User

• Hospitals
• Specialty Clinics
• Academic and Research Institutes
• Others

North America Fibrotic Disease Treatment Market Regional Analysis

The market is analyzed and market size insights and trends are provided, treatment, application, and end user.

The countries covered in the market are U.S, Canada, Mexico, Dominican Republic, Jamaica, and Panama.

U.S. is expected to dominate and fastest growing country due to its well-established healthcare infrastructure, high prevalence of fibrotic diseases such as idiopathic pulmonary fibrosis and liver fibrosis, and robust investment in research and development.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points like down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of North America brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

North America Fibrotic Disease Treatment Market Share

The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, North America presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.

North America Fibrotic Disease Treatment Market Leaders Operating in the Market Are:

• C.H. Boehringer Sohn AG & Co. KG. (Germany)
• F. Hoffmann-La Roche Ltd (Switzerland)
• Teva Pharmaceutical Industries Ltd. (Israel)
• Sandoz International GmbH (Germany)
• Accord Healthcare (U.K.)

Latest Developments in North America Fibrotic Disease Treatment Market

• In September 2024, Boehringer Ingelheim International GmbH announced that the FIBRONEER-IPF trial met its primary endpoint of FVC improvement at week 52, and it plans to submit a new drug application for nerandomilast for IPF treatment to the FDA and other global authorities. This successful trial and upcoming submission will strengthen Boehringer Ingelheim’s position in the competitive IPF market, potentially expanding its respiratory drug portfolio
• In July 2024, Teva and Sanofi announced an updated timeline for the anti-TL1A program, duvakitug, a monoclonal antibody targeting TL1A for moderate-to-severe IBD. Advancing this program strengthens both companies’ positions in the IBD treatment market, potentially expanding their offerings in immunology
• In November 2022, Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced a new collaboration with Rimidi, a leading clinical management platform designed to optimize clinical workflows, enhance patient experiences and achieve quality objectives. This has helped the company to expand globally
• In March 2022, Genentech, a member of the Roche Group announced that the Phase III SKYSCRAPER-02 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) and chemotherapy (carboplatin and etoposide) as an initial (first-line) treatment for people with extensive-stage small cell lung cancer (ES-SCLC), did not meet its co-primary endpoint of progression-free survival. This has helped the company to expand globally

SKU-69896