포스포디에스테라제-3/4(PDE3/4) 저해제 : 대상 환자층, 경쟁 구도 및 시장 예측(2036년)

Key Highlights:

• The recent approval of the dual PDE3/4 inhibitor OHTUVAYRE for chronic obstructive pulmonary disease (COPD) sparked new hope for developing more such inhibitors, anticipating that effective inhaled dual PDE3/4 inhibitors have the potential to replace or reduce inhaled corticosteroids and its side effects.
• Although several companies initiated studies on PDE3/4 (dual) inhibitors, many were eventually terminated due to safety issues, highlighting both the industry's interest in the mechanism and the challenges posed by the favorable therapeutic ratio associated with dual inhibition.
• OHTUVAYRE has had a strong market introduction since its launch in August 2024, recording sales of USD 71 million in Q1 2025, a significant increase from USD 37 million in the previous quarter (Q4 2024).

DelveInsight's "Phosphodiesterase-3/4 (PDE3/4) Inhibitors - Target Population, Competitive Landscape, and Market Forecast - 2036" report delivers an in-depth understanding of the PDE3/4 inhibitors, historical and competitive landscape as well as the PDE3/4 inhibitors market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The PDE3/4 inhibitors market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM PDE3/4 inhibitors market size from 2022 to 2036. The report also covers current PDE3/4 inhibitors treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

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

Study Period: 2022-2036

Phosphodiesterase-3/4 (PDE3/4) Inhibitors Understanding and Treatment Algorithm

Phosphodiesterase-3/4 (PDE3/4) Inhibitors Overview

PDE3/4 dual inhibitors represent a promising therapeutic approach by simultaneously targeting both cardiovascular and inflammatory pathways. PDE3 inhibition primarily enhances cardiac function and smooth muscle relaxation, while PDE4 inhibition reduces inflammation by modulating immune cell activity. By combining these mechanisms, dual inhibitors have the potential to offer synergistic effects in conditions where both vascular tone and inflammation play a role. This includes diseases such as asthma, chronic inflammatory disorders, and certain neurological conditions. Dual inhibition may also improve therapeutic efficacy while reducing the need for multiple medications. However, careful development is needed to manage safety concerns, particularly related to cardiovascular and gastrointestinal effects, which are commonly associated with each class individually. Ongoing research into dual PDE3/4 inhibitors aims to optimize the balance between efficacy and tolerability, offering new possibilities for complex, multifactorial diseases.

Phosphodiesterase-3/4 (PDE3/4) Inhibitors Epidemiology

The PDE3/4 inhibitors epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total cases of selected indications for PDE3/4 Inhibitors, total eligible cases of selected indications for PDE3/4 Inhibitors, total treated cases of selected indications for PDE3/4 Inhibitors in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2022 to 2036.

• According to Kumar R et al. (2024), COPD affects an estimated 11.7% of the global population, with the highest prevalence reported in the Americas (22.93%). Prevalence increased from 10.43% during 2016-2019 to 15.17% in 2020-2022, and COPD remains a leading global cause of mortality and healthcare burden.
• Total prevalent cases across all listed indications in 2025 (US) are approximately 28.2 million. In percentage terms, COPD accounts for ~59.9%, plaque psoriasis ~23.0%, IBD ~10.6%, Fragile X syndrome ~4.3%, psoriatic arthritis ~2.1%, and Jordan's syndrome ~0.0005% of the total burden.

Phosphodiesterase-3/4 (PDE3/4) Inhibitors Drug Chapters

The drug chapter segment of the PDE3/4 inhibitors report encloses a detailed analysis of PDE3/4 inhibitors in different stages of development. It also helps understand the PDE3/4 inhibitors' 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

OHTUVAYRE (ensifentrine): VERONA PHARMA

OHTUVAYRE is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Verona has evaluated nebulized OHTUVAYRE in its Phase III clinical program ENHANCE for COPD maintenance treatment. It showed a low discontinuation rate due to adverse events. OHTUVAYRE experienced strong uptake following its launch, generating USD 114 million in net sales within the first eight months.

OHTUVAYRE can be used in all symptomatic COPD patients regardless of background therapy.

With >80% of dispensed patients paying <USD 10 per prescription, the product appears to have successfully navigated the reimbursement landscape, primarily via Medicare Part B and Advantage plans, ensuring broad and affordable access-a critical factor in chronic diseases like COPD.

• In June 2024, Verona Pharma announced that the US Food and Drug Administration (FDA) approved OHTUVAYRE for the maintenance treatment of COPD in adult patients. OHTUVAYRE is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.
• In July 2025, Merck announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Verona Pharma for USD 107 per ADS, each of which represents eight Verona Pharma ordinary shares, for a total transaction value of approximately USD 10 billion.

Emerging Drugs

Zatolmilast: Shionogi

Shionogi is developing Zatolmilast (BPN14770), an investigational oral selective PDE4D inhibitor primarily for Fragile X syndrome. The drug works by enhancing cAMP signaling in the brain to improve cognition, language, and synaptic function. Zatolmilast received FDA Fast Track, Rare Pediatric Disease, and Orphan Drug designations, along with EU orphan status.

Early clinical studies showed encouraging improvements in cognitive and language-related outcomes with a favorable safety profile; however, later Phase IIb/III EXPERIENCE studies did not meet primary endpoints, although some exploratory benefits were observed in adult subgroups. Shionogi is continuing to evaluate the program and is also exploring the drug's potential in other rare neurodevelopmental disorders such as Jordan's Syndrome.

PALI-2108: Palisade Bio

Palisade Bio is developing PALI-2108, an investigational orally administered PDE4 inhibitor designed for the treatment of inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn's disease. The drug utilizes a targeted prodrug formulation intended to release the active compound locally in the gastrointestinal tract, aiming to maximize anti-inflammatory activity while minimizing systemic side effects commonly associated with PDE4 inhibition. Preclinical studies demonstrated reductions in intestinal inflammation, improved mucosal healing, and favorable tolerability, supporting advancement into clinical development.

Recent Developments in the PDE3/4 Inhibitors Market

• In May 2026, Shionogi is reassessing the future of zatolmilast for Fragile X syndrome after the drug failed to meet primary endpoints in the Phase IIb/III EXPERIENCE-204 and EXPERIENCE-301 studies. Although secondary analyses in adults showed improvements in language, communication, and daily functioning, the company stated these findings were not conclusive and are unlikely to support regulatory approval on their own.
• In May 2026, Palisade Bio reported first-quarter 2026 financial results and highlighted continued clinical advancements of its lead program, PALI-2108, including recent data readouts and anticipated Phase II trial initiations.
• In March 2026, Palisade Bio reported positive topline Phase 1b data for PALI-2108, a first-in-class once-daily oral PDE4 inhibitor prodrug designed for targeted activation in the ileum and colon, in patients with fibrostenotic Crohn's disease (FSCD). The study supported the drug's safety, tolerability, and targeted delivery approach, reinforcing its potential as a novel treatment for inflammatory bowel disease.
• In October 2025, Arcutis Biotherapeutics received US FDA approval for the supplemental NDA of ZORYVE cream 0.05% for treating mild-to-moderate atopic dermatitis in children aged 2-5 years. The once-daily topical therapy offers rapid disease clearance and provides a steroid-free treatment option suitable for long-term use.

Phosphodiesterase-3/4 (PDE3/4) Inhibitors Market Outlook

PDE3/4 dual inhibitors represent a novel therapeutic class that targets both inflammation and smooth muscle dysfunction by elevating intracellular cAMP and cGMP levels. The first-in-class agent, OHTUVAYRE was approved by the FDA in June 2024 for maintenance treatment of COPD. In the first half of 2025, OHTUVAYRE achieved strong market uptake with approximately 25,000 prescriptions filled, driven by its dual bronchodilator and anti-inflammatory action. OHTUVAYRE'S novel mechanism has drawn interest, evidenced by Merck's recent USD 10 billion acquisition of Verona Pharma to strengthen its cardiorespiratory portfolio.

On the development front, OHTUVAYRE remains the primary clinical-stage dual PDE3/4 inhibitor, with more ongoing studies evaluating inhaled formats (nebulizer, pMDI, DPI) for COPD, asthma, cystic fibrosis, and bronchiectasis.

For OHTUVAYRE challenge ahead will be maintaining momentum against entrenched bronchodilators, biologics in overlapping indications (e.g., eosinophilic COPD), and managing long-term safety and tolerability in real-world use. However, its positioning as an inhaled, non-steroidal, dual-mechanism therapy may allow it to carve out a niche in moderate-to-severe COPD patients who remain symptomatic on standard therapies.

Early-phase trials have shown significant improvements in lung function, symptom control, and mucociliary clearance, with a favorable safety profile. These data highlight the therapeutic potential of dual PDE3/4 inhibition: combining bronchoprotection and anti-inflammatory effects in a single molecule, with promising efficacy and tolerability. Continued research and growing market momentum suggest that dual PDE3/4 inhibitors could become key players in respiratory disease management.

Phosphodiesterase-3/4 (PDE3/4) Inhibitor Drugs Uptake

This section focuses on the uptake rate of potential approved and emerging PDE3/4 inhibitors expected to be launched in the market during 2026-2036.

Phosphodiesterase-3/4 (PDE3/4) Inhibitors Pipeline Development Activities

The report provides insights into different therapeutic candidates in early stage. It also analyzes key players involved in developing targeted therapeutics.

The presence of numerous drugs at different stages is expected to generate immense opportunities for the PDE3/4 inhibitors market growth over the forecasted period.

Pipeline development activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for PDE3/4 inhibitors emerging therapies.

The increasing strategic collaborations among major market players to enhance the growth of their pipeline products are anticipated to drive market expansion.

KOL Views

To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on PDE3/4's evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight's analysts connected with 25+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Penn Medicine's Hematologic Malignancies Translational Center of Excellence, UC Davis Comprehensive Cancer Center, University of Texas MD Anderson Cancer Center, etc. were contacted.

Their opinion helps understand and validate current and emerging therapy treatment patterns or PDE3/4 inhibitors 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 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.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health Technology Assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug.

In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.

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, and a descriptive overview of the PDE3/4 Inhibitor, explaining its mechanism, and emerging PDE3/4 inhibitors.
• Comprehensive insight into the competitive landscape, and forecasts, the future growth potential of treatment rate, drug uptake, and drug information have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current landscape.
• A detailed review of the PDE3/4 Inhibitor market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis, expert insights/KOL views, and treatment preferences that help shape and drive the 7MM PDE3/4 Inhibitor market.

Phosphodiesterase-3/4 (PDE3/4) Inhibitors Report Insights

• PDE3/4 Inhibitors Targeted Patient Pool
• Therapeutic Approaches
• PDE3/4 Inhibitors Pipeline Analysis
• PDE3/4 Inhibitors Market Size and Trends
• Existing and Future Market Opportunity

Phosphodiesterase-3/4 (PDE3/4) Inhibitors Report Key Strengths

• 11-Year Forecast
• The 7MM Coverage
• Key Cross Competition
• Drug Uptake and Key Market Forecast Assumptions

Phosphodiesterase-3/4 (PDE3/4) Inhibitors Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT)
• Analyst Views
• Conjoint Analysis

Key Questions:

• What was the PDE3/4 inhibitor total market size, the market size by therapies, market share (%) distribution, and what would it look like in 2036? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2036?
• Which is the most lucrative market for PDE3/4 Inhibitors?
• What are the pricing variations among different geographies?
• What are the risks, burdens, and unmet needs of treatment for PDE3/4 inhibitors? What will be the growth opportunities across the 7MM for the patient population of PDE3/4 inhibitors?
• What are the key factors hampering the growth of the PDE3/4 inhibitors market?
• What key designations have been granted to PDE3/4 inhibitors?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?

Reasons to buy:

• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the PDE3/4 inhibitors market.
• Understand the existing market opportunities 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, and Japan.
• Detailed analysis and ranking of indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs 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. Executive Summary of PDE3/4 Inhibitors

4. Key Events

5. Epidemiology and Market Forecast Methodology for PDE3/4 Inhibitors

6. PDE3/4 Inhibitors Market Overview at a Glance in the 7MM

• 6.1. Market Share (%) Distribution by Therapies in 2025
• 6.2. Market Share (%) Distribution by Therapies in 2036

7. PDE3/4 Inhibitors: Background and Overview

• 7.1. Introduction
• 7.2. Treatment

8. Target Patient Pool

• 8.1. Key Findings
• 8.2. Assumptions and Rationale: 7MM
• 8.3. Epidemiology Scenario in the 7MM
• 8.4. Total Cases of Selected Indications for PDE3/4 Inhibitors in the 7MM
• 8.5. The United States
  • 8.5.1. Total Cases of Selected Indications for PDE3/4 Inhibitors in the US
  • 8.5.2. Total Eligible Cases of Selected Indications for PDE3/4 Inhibitors in the US
  • 8.5.3. Total Treated cases of Selected Indications for PDE3/4 Inhibitors in the US
• 8.6. EU4 and the UK
  • 8.6.1. Total Cases of Selected Indications for PDE3/4 Inhibitors in EU4 and the UK
  • 8.6.2. Total Eligible Cases of Selected Indications for PDE3/4 Inhibitors in EU4 and the UK
  • 8.6.3. Total Treated cases of Selected Indications for PDE3/4 Inhibitors in EU4 and the UK
• 8.7. Japan
  • 8.7.1. Total Cases of Selected Indications for PDE3/4 Inhibitors in Japan
  • 8.7.2. Total Eligible Cases of Selected Indications for PDE3/4 Inhibitors in Japan
  • 8.7.3. Total Treated cases of Selected Indications for PDE3/4 Inhibitors in Japan

9. Marketed Therapies for PDE3/4 Inhibitors

• 9.1. Key Competitors
• 9.2. OHTUVAYRE (ensifentrine): VERONA PHARMA
  • 9.2.1. Product Description
  • 9.2.2. Regulatory Milestone
  • 9.2.3. Other Developmental Activities
  • 9.2.4. Clinical Development
    • 9.2.4.1. Clinical Trials Information
  • 9.2.5. Safety and Efficacy
  • 9.2.6. Analyst Views

10. PDE3/4 Inhibitors: Seven Major Market Analysis

• 10.1. Key Findings
• 10.2. Market Outlook for PDE3/4 Inhibitors
• 10.3. Conjoint Analysis for PDE3/4 Inhibitors
• 10.4. Key Market Forecast Assumptions for PDE3/4 Inhibitors
  • 10.4.1. Cost Assumptions and Rebates
  • 10.4.2. Pricing Trends
  • 10.4.3. Analogue Assessment
  • 10.4.4. Launch Year and Therapy Uptakes
• 10.5. Total Market Size of PDE3/4 Inhibitors in the 7MM
• 10.6. Market Size of PDE3/4 Inhibitors by Indication in the 7MM
• 10.7. Market Size of PDE3/4 Inhibitors by Therapies in the 7MM
• 10.8. The United States Market Size
  • 10.8.1. Market Size of PDE3/4 Inhibitors by Indication in the United States
  • 10.8.2. Market Size of PDE3/4 Inhibitors by Therapies in the United States
• 10.9. EU4 and the UK Market Size
  • 10.9.1. Market Size of PDE3/4 Inhibitors by Indication in EU4 and the UK
  • 10.9.2. Market Size of PDE3/4 Inhibitors by Therapies in EU4 and the UK
• 10.1. Japan Market Size
  • 10.10.1. Market Size of PDE3/4 Inhibitors by Indication in Japan
  • 10.10.2. Market Size of PDE3/4 Inhibitors by Therapies in Japan

11. Market Access and Reimbursement for PDE3/4 Inhibitors

12. SWOT Analysis for PDE3/4 Inhibitors

13. KOL Views for PDE3/4 Inhibitors

14. Unmet Needs for PDE3/4 Inhibitors

15. Appendix

• 15.1. Bibliography
• 15.2. Report Methodology

16. DelveInsight Capabilities

17. Disclaimer

18. About DelveInsight