Phosphodiesterase-3/4 (PDE3/4) Inhibitors - Target Population, Competitive Landscape, and Market Forecast - 2034

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.
• 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 American Depository Share (ADS), each of which represents eight Verona Pharma ordinary shares, for a total transaction value of approximately USD 10 billion. The transaction is expected to close in the fourth quarter of 2025.
• 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 - 2034" 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 2020 to 2034. 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: 2020-2034

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 2020 to 2034.

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.

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 2025-2034.

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

• Ten-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 2034? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2034?
• 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.