ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
ㅁ 보고서에 따라 최신 정보로 업데이트하여 보내드립니다. 배송기일은 문의해 주시기 바랍니다.
한글목차
주요 하이라이트
최근 만성 폐색성 폐질환(COPD)에 대한 이 중 PDE3/4 억제제 OHTUVAYRE의 승인은 효과적인 흡입 이중 PDE3/4 억제제가 흡입 코르티코스테로이드와 그 부작용을 대체하거나 완화시킬 수 있을 것으로 예측하고, 이러한 억제제의 추가 개발에 새로운 희망을 안겨주었습니다.
2025년 7월, 머크는 자회사를 통해 베로나 파마를 아메리칸 디포지토리 공유(ADS) 1주당 107달러(1주가 베로나 파마의 보통주 8주를 대표), 총 거래액 약 100억 달러로 인수하는 최종계약을 체결했다고 발표했습니다. 이 거래는 2025년 4분기에 완료될 예정입니다.
여러 기업이 PDE3/4(이중) 억제제에 대한 연구를 시작했지만, 대부분은 안전 문제로 인해 궁극적으로 중단되었습니다. 이것은 이 메커니즘에 대한 업계의 관심과 이중 억제와 관련된 양호한 치료 가능 비율이 초래하는 과제를 모두 부각시키고 있습니다.
OHTUVAYRE는 2024년 8월 출시 이후 호조 시장 도입을 하고 있으며, 2025년 1분기 매출은 7,100만 달러를 기록했으며, 전 분기(2024년 4분기)의 3,700만 달러에서 크게 증가했습니다.
포스포디에스테라제-3/4(PDE3/4) 억제제 시장 전망
PDE3/4 이중 억제제는 세포 내 cAMP와 cGMP 수준을 증가시켜 염증과 평활근 기능 장애를 모두 목표로 하는 새로운 치료제 클래스입니다. 퍼스트 인 클래스의 약물 인 OHTUVAYRE는 COPD의 유지 요법으로 2024년 6월 FDA에서 승인되었습니다. OHTUVAYRE는 기관지 확장작용과 항염증작용을 겸비한 것으로 2025년 상반기에는 약 2만 5,000건 처방되어 시장에서 높은 평가를 얻었습니다. OHTUVAYRE의 참신한 작용 메커니즘은 Merck가 최근 100억 달러를 들여 Verona Pharma를 인수하고 회사의 심폐 포트폴리오를 강화했기 때문에 분명히 관심을 모으고 있습니다.
개발 측면에서 OHTUVAYRE는 임상 단계에 있는 주요 이중 PDE3/4 억제제이며, COPD, 천식, 낭포성 섬유증, 기관지 확장증에 대한 흡입제(네뷸라이저, pMDI, DPI)를 평가하는 많은 시험이 진행 중입니다.
OHTUVAYRE의 향후 과제는 기존 기관지 확장제, 중복 적응증(예를 들어, 호산구성 COPD)에서 생물학적 제형에 대한 기세를 유지하고, 실제 사용에서 장기적인 안전성과 내약성을 관리하는 것입니다. 그러나 흡입, 비 스테로이드, 이중 메커니즘 치료제의 위치에 따라 표준 치료에서 증상이 남아있는 중등도에서 심한 COPD 환자에게 틈새를 열 수 있습니다.
초기 단계의 임상시험은 좋은 안전 프로파일과 함께 폐 기능, 증상 조절, 점막 클리어런스의 상당한 향상을 보여줍니다. 이 데이터는 기관지 보호 작용과 항 염증 작용을 하나의 분자로 결합하고 효능과 내약성을 기대할 수 있다는 이중 PDE3/4 억제의 잠재적 치료 능력을 명시하고 있습니다. 지속적인 연구와 시장에서의 기세 증가는 이중 PDE3/4 억제제가 호흡기 질환 관리에 중요한 존재가 될 가능성을 시사합니다.
본 보고서에서는 포스포디에스테라제-3/4(PDE3/4) 억제제의 주요 7개 시장(미국, 독일, 프랑스, 이탈리아, 스페인, 영국, 일본)에 대한 조사 분석하여 각 지역 시장 규모와 예측, 현재의 치료법, 신약, 미충족 수요(Unmet Needs) 등의 정보를 제공합니다.
목차
제1장 주요 인사이트
제2장 보고서 서문
제3장 PDE3/4 억제제 주요 요약
제4장 주요 사건
제5장 PDE3/4 억제제의 역학과 시장 예측 수법
제6장 주요 7개 시장 포스포디에스테라제-3/4(PDE3/4) 억제제 시장 개요
시장 점유율 분포 : 치료법별(2024년)
시장 점유율 분포 : 치료법별(2034년)
제7장 PDE3/4 억제제 : 배경과 개요
서론
치료
제8장 표적 환자 집단
주요 조사 결과
전제조건 및 근거 : 주요 7개 시장
주요 7개 시장 역학 시나리오
주요 7개 시장 PDE3/4 억제제의 특정 적응증 총 환자 수
미국
미국의 PDE3/4 억제제의 특정 적응증 총 환자 수
미국의 PDE3/4 억제제의 특정 적응증 총 적격 환자 수
미국의 PDE3/4 억제제의 특정 적응증 총 치료 환자 수
유럽 4개국 및 영국
유럽 4개국 및 영국의 PDE3/4 억제제의 특정 적응증 총 환자 수
유럽 4개국 및 영국의 PDE3/4 억제제의 특정 적응증 총 적격 환자 수
유럽 4개국 및 영국의 PDE3/4 억제제의 특정 적응증 총 치료 환자 수
일본
일본의 PDE3/4 억제제의 특정 적응증 총 환자 수
일본의 PDE3/4 억제제의 특정 적응증 총 적격 환자 수
일본의 PDE3/4 억제제의 특정 적응증 총 치료 환자 수
제9장 PDE3/4 억제제의 출시된 치료법
주요 경쟁
OHTUVAYRE(ensifentrine) : VERONA PHARMA
제10장 PDE3/4 억제제 : 주요 7개 시장 분석
주요 조사 결과
포스포디에스테라제-3/4(PDE3/4) 억제제 시장 전망
PDE3/4 억제제 공동 분석
PDE3/4 억제제 주요 시장 예측의 전제조건
비용 가정 및 리베이트
가격 동향
유사 제품 평가
출시 연도 및 치료제 보급률
주요 7개 시장 PDE3/4 억제제 전체 시장 규모
주요 7개 시장 포스포디에스테라제-3/4(PDE3/4) 억제제 시장 규모 : 적응증별
주요 7개 시장 포스포디에스테라제-3/4(PDE3/4) 억제제 시장 규모 : 치료법별
미국 시장 규모
미국의 포스포디에스테라제-3/4(PDE3/4) 억제제 시장 규모 : 적응증별
미국의 포스포디에스테라제-3/4(PDE3/4) 억제제 시장 규모 : 치료법별
유럽 4개국 및 영국 시장 규모
유럽 4개국 및 영국의 포스포디에스테라제-3/4(PDE3/4) 억제제 시장 규모 : 적응증별
유럽 4개국 및 영국의 포스포디에스테라제-3/4(PDE3/4) 억제제 시장 규모 : 치료법별
일본 시장 규모
일본의 포스포디에스테라제-3/4(PDE3/4) 억제제 시장 규모 : 적응증별
일본의 포스포디에스테라제-3/4(PDE3/4) 억제제 시장 규모 : 치료법별
제11장 포스포디에스테라제-3/4(PDE3/4) 억제제 시장 접근성 및 보험 적용
제12장 PDE3/4 억제제 SWOT 분석
제13장 PDE3/4 억제제의 KOL의 견해
제14장 PDE3/4 억제제 미충족 수요(Unmet Needs)
제15장 부록
제16장 DelveInsight 역량
제17장 면책사항
제18장 DelveInsight 정보
KTH
영문 목차
영문목차
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
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.
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.
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.
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.
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 2024
6.2. Market Share (%) Distribution by Therapies in 2034
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
