급성 폐색전증 시장 : 인사이트, 역학, 시장 예측(-2034년)

Key Highlights:

• The Acute Pulmonary Embolism (APE) market is projected to maintain a stable Compound Annual Growth Rate (CAGR) from 2025 to 2034, driven by the launch of innovative therapies, continual improvements in diagnostic methods, increasing disease awareness, and a rising incidence of reported cases globally.
• The rising cases of APE may be attributed to multiple factors, including improved awareness and detection, along with possible real shifts in epidemiology. Contributing factors under investigation include aging populations, higher incidence of risk factors like cancer and obesity, surgical interventions, and genetic predispositions that increase the likelihood of clot formation leading to APE.
• Daiichi Sankyo's SAVAYSA (edoxaban) is one of the key FDA-approved therapies for APE, meeting a critical need for effective anticoagulation. Its established role supports ongoing research into next-generation oral anticoagulants and innovative clot-targeted treatments, indicating a dynamic APE market with strong potential for future growth and improved patient care.
• Despite advances in anticoagulation, there remains a clear unmet need for emerging drugs in APE treatment that can offer faster clot resolution, reduce recurrence risk, and minimize long-term complications. Innovative therapies that go beyond standard anticoagulants are needed to address these gaps, improve patient outcomes, and strengthen the overall treatment landscape in the coming years.
• Another key unmet need in APE treatment is the lack of highly targeted therapies that can safely treat high-risk or complex cases, such as patients with contraindications to anticoagulation or those with recurrent clots despite standard care. Addressing this gap could significantly lower mortality and enhance long-term management for vulnerable patient groups.

DelveInsight's comprehensive report titled "Acute Pulmonary Embolism (APE) - Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of APE. The report presents historical and projected epidemiological data covering total incidence cases of APE, gender-specific incidence cases of APE, type-specific incidence cases of APE and treated cases of APE. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The report analyzes the existing treatment practices and unmet medical requirements in APE. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.

Acute Pulmonary Embolism (APE) Overview

Acute Pulmonary Embolism (APE) is a sudden blockage of an artery in the lungs, most often caused by a blood clot that has traveled from the deep veins of the legs or pelvis. It is not caused by infection or inflammation directly but is strongly linked to risk factors such as prolonged immobility, recent surgery, malignancy, or clotting disorders. APE can occur at any age but is more common in older adults and individuals with underlying cardiovascular risks.

The primary symptoms of APE include sudden shortness of breath, chest pain that may worsen with deep breathing, rapid heartbeat, and coughing, which may produce blood-streaked sputum. Some people feel lightheaded, faint, or experience anxiety. In severe cases, pulmonary embolism can cause low blood pressure, shock, or sudden death if not treated promptly.

Acute Pulmonary Embolism (APE) Diagnosis and Treatment Algorithm

Diagnosing APE is often complex due to symptom overlap with other conditions. Clinicians rely on a combination of factors, including sudden onset of unexplained shortness of breath, chest pain that worsens with breathing, rapid heart rate, and known risk factors such as recent surgery, prolonged immobility, or a history of blood clots. Imaging studies and blood tests are then used to confirm the diagnosis and guide treatment.

A normal D-dimer can help rule out the condition in low to moderate-risk patients, while elevated troponin and BNP levels point to right heart strain but lack diagnostic specificity. CTPA remains the gold standard for confirming APE, with V/Q scans or leg ultrasounds serving as useful alternatives when CTPA is unsuitable. Using clinical tools like the Wells criteria and Geneva score helps target testing, ensuring faster, more accurate diagnosis and appropriate treatment decisions.

Treatment of APE focuses on rapid anticoagulation to prevent clot propagation and recurrence. Initial therapy typically involves low molecular weight heparin or direct oral anticoagulants, with thrombolytic therapy reserved for high-risk or massive APE causing hemodynamic instability. Duration of anticoagulation depends on risk factors and recurrence risk, ranging from three months to lifelong therapy in some cases. Ongoing monitoring, patient education, and clear follow-up plans are essential to manage bleeding risks, monitor right heart function, and ensure adherence to therapy.

Acute Pulmonary Embolism (APE) Epidemiology

The epidemiology section of the APE market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the data with relevant tables and graphs, offering a clear and concise view of the prevalence of APE. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

Key Findings

Based on secondary analysis, the incidence of pulmonary embolism in the US was found to be 115 cases per 100,000 population.

Approximately 162 per 100,000 people in the US develop Deep Vein Thrombosis (DVT) each year, highlighting a crucial connection most APE cases happen when a DVT clot breaks loose and travels to the lungs, transforming a treatable vein clot into a serious, life-threatening condition.

In Germany, the incidence of APE is estimated at 115 cases per 100,000, with a slightly higher rate in men 130 per 100,000 compared to women 110 per 100,000, highlighting a modest gender difference in occurrence.

In the UK, the incidence of APE is estimated at 7-8 cases per 10,000 people, with risk increasing sharply with age approximately 1 in 10,000 among those under 40 and as high as 1 in 100 in individuals over 80, highlighting how advancing age significantly raises susceptibility.

The total incidence of APE in Japan is estimated to be approximately 6.7 cases per 100,000 population.

The epidemiology of APE is expected to change during the forecast period (2025-2034).

Acute Pulmonary Embolism (APE) Market Outlook

The APE therapeutics market is further expected to increase by the major drivers, such as the rising prevalent population, technological advancements, and upcoming therapies in the forecast period (2025-2034).

In January 2015, the US FDA approved SAVAYSA (edoxaban) for the treatment of acute pulmonary embolism following initial parenteral anticoagulation, offering a convenient once-daily oral option in this high-risk setting. With its differentiated safety profile and streamlined dosing, SAVAYSA is well-positioned to capture a share of the evolving anticoagulation market for acute pulmonary embolism.

With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the APE market in the 7MM is expected to change significantly during the study period 2020-2034.

Acute Pulmonary Embolism (APE) Drug Chapters

APE Marketed Drugs

SAVAYSA (edoxaban): Daiichi Sankyo

SAVAYSA (edoxaban), developed by Daiichi Sankyo, is an oral, once-daily selective factor Xa inhibitor approved in the US for the treatment of DVT and APE following 5-10 days of initial parenteral anticoagulation. It also reduces the risk of stroke and systemic embolism in patients with NVAF who have a creatinine clearance of 95 mL/min or less, offering an alternative to warfarin with a favorable risk profile in this subgroup.

ELIQUIS (apixaban): Pfizer/ Bristol Myers Squibb

ELIQUIS (apixaban) is an oral Factor Xa inhibitor that blocks clotting at a key step to reduce thrombin generation and clot formation. It is FDA-approved in the US for preventing and treating DVT, APE, and stroke in non-valvular atrial fibrillation, with proven safety and efficacy from seven Phase III trials. ELIQUIS comes as 2.5 mg and 5 mg tablets, with standard inactive ingredients and a film coating. Its convenient dosing and lower bleeding risk make it a widely used anticoagulant.

Acute Pulmonary Embolism (APE) Market Segmentation

DelveInsight's 'Acute Pulmonary Embolism (APE) - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a detailed outlook of the current and future APE market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.

Acute Pulmonary Embolism (APE) Market Size by Countries

The APE market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) APE market, primarily attributed to the country's higher prevalence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.

Acute Pulmonary Embolism (APE) Market Size by Therapies

APE Market Size by Therapies is categorized into current and emerging markets for the study period 2020-2034.

Acute Pulmonary Embolism (APE) Drugs Uptake

This section focuses on the sales uptake of potential APE drugs that have recently been launched or are anticipated to be launched in the APE market between 2020 and 2034. It estimates the market penetration of APE drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the APE market.

The emerging APE therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the APE market.

Acute Pulmonary Embolism (APE) Market Access and Reimbursement

DelveInsight's 'Acute Pulmonary Embolism (APE) - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of APE.

This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.

KOL Views

To keep up with current APE market trends and fill gaps in secondary findings, we interview KOLs and SMEs' working in the APE domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or APE market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the APE unmet needs.

Acute Pulmonary Embolism (APE): KOL Insights

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as Mercer University, US; University Hospital Tubingen, Germany; University of Barcelona, Barcelona, Spain; Bellvitge-Idibell University Hospital, Barcelona, Spain; University of Leeds, Leeds, UK; and University of Occupational and Environmental Health, Japan, among others.

"Diagnosing APE remains a significant clinical challenge," experts emphasize, "as it depends on combining validated risk scores, supportive blood markers like D-dimer, and confirmatory imaging such as CTPA or V/Q scans. While cardiac markers like troponin or B-type natriuretic peptide (BNP) can help assess severity, they are not diagnostic alone. The absence of a single definitive test for all patients underscores the importance of timely clinical judgment and structured diagnostic pathways to accurately identify or exclude APE."

"Initial management of APE focuses on prompt anticoagulation, using agents like low-molecular-weight heparin or direct oral anticoagulants to rapidly prevent clot progression. For patients with high-risk or massive APE, thrombolysis or catheter-directed therapies may be required to quickly restore blood flow. Because long-term anticoagulation carries a risk of bleeding, careful patient selection and ongoing monitoring are essential. Emerging options, including newer oral anticoagulants and advanced interventional techniques, aim to reduce complications and improve long-term outcomes."

"A key unmet need in the management of APE is the development of more precise therapies that can safely prevent recurrence while reducing the risks associated with long-term anticoagulation. Despite advances in direct oral anticoagulants and catheter-based interventions, gaps remain in preventing high-risk or recurrent APE, underscoring the need for novel targeted agents and better risk-adapted treatment strategies."

Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the APE Market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

Acute Pulmonary Embolism (APE) Pipeline Development Activities

The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for APE. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Pipeline Development Activities

The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging APE therapies.

Acute Pulmonary Embolism (APE) Report Insights

• APE Patient Population
• Therapeutic Approaches
• APE Pipeline Analysis
• APE Market Size and Trends
• APE Market Opportunities
• Impact of Upcoming Therapies

Acute Pulmonary Embolism (APE) Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage
• APE Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed APE Market
• APE Drugs Uptake

Acute Pulmonary Embolism (APE) Report Assessment

• APE Current Treatment Practices
• Unmet Needs
• APE Pipeline Product Profiles
• APE Market Attractiveness

Key Questions:

• How common is Acute APE?
• What are the key findings of APE epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020-2034)?
• What are the currently available treatments for APE?
• What are the disease risk, burden, and unmet needs of APE?
• At what CAGR is the APE market and its epidemiology is expected to grow in the 7MM during the forecast period (2025-2034)?
• How would the unmet needs impact the APE market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of APE in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2025-2034)?
• How many companies are currently developing therapies for the treatment of APE?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the APE Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity 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 current treatment in the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders 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.

Frequently Asked Questions:

1. What are the treatment goals for APE?

The main treatment goals for APE are to rapidly restore and maintain blood flow in the pulmonary arteries, prevent clot extension or new clot formation, and reduce the risk of life-threatening complications such as right heart failure. Management also aims to stabilize hemodynamics in high-risk patients and minimize long-term risks associated with anticoagulation, such as bleeding. Preventing recurrence through appropriate duration of anticoagulant therapy and patient-specific follow-up is crucial for sustained protection against future events.

2. What are the challenges in managing APE?

The main challenges in managing APE include its often vague and nonspecific symptoms, which can delay diagnosis and timely treatment. Balancing the benefits of anticoagulation with the risk of major bleeding requires careful patient selection and monitoring. In high-risk or unstable cases, decisions about thrombolysis or invasive interventions add complexity and potential complications. Long-term management must address recurrence prevention while minimizing side effects, highlighting the need for individualized care plans and adherence to follow-up.

3. What are the key factors driving the growth of the APE market?

The APE market is driven by rising incidence rates, advances in diagnostics and interventions, growing awareness, and the development of next-generation anticoagulants by leading pharmaceutical companies. Together, these factors boost demand for safer, more effective treatment options and support sustained market growth.

4. How will the APE Market and Epidemiology Forecast Report benefit the clients?

The APE Market and Epidemiology Forecast Report provides clients with in-depth insights into disease trends, patient populations, treatment patterns, and competitive landscapes. This helps stakeholders identify growth opportunities, make informed strategic decisions, and optimize market positioning for future advancements and investments.

Table of Contents

1. Key Insights

2. Report Introduction

3. Market Overview at a Glance

• 3.1. Market Share (%) Distribution of APE in 2020
• 3.2. Market Share (%) Distribution of APE in 2034

4. Epidemiology and Market Methodology

5. Executive Summary

6. Key Events

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Types
• 7.3. Causes
• 7.4. Pathophysiology
• 7.5. Symptoms
• 7.6. Risk Factor
• 7.7. Diagnosis
  • 7.7.1. Diagnostic Algorithm
  • 7.7.2. Diagnostic Guidelines
• 7.8. Treatment and Management
  • 7.8.1. Treatment Algorithm
  • 7.8.2. Treatment Guidelines

8. Epidemiology and Patient Population

• 8.1. Key Findings
• 8.2. Assumptions and Rationale: The 7MM
• 8.3. Total Incident Cases of APE in the 7MM
• 8.4. The US
  • 8.4.1. Total Incidence Cases of APE
  • 8.4.2. Gender-specific Incidence Cases of APE
  • 8.4.3. Type-specific Incidence Cases of APE
  • 8.4.4. Treated Cases of APE
• 8.5. EU4 and the UK
  • 8.5.1. Total Incidence Cases of APE
  • 8.5.2. Gender-specific Incidence Cases of APE
  • 8.5.3. Type-specific Incidence Cases of APE
  • 8.5.4. Treated Cases of APE
• 8.6. Japan
  • 8.6.1. Total Incidence Cases of APE
  • 8.6.2. Gender-specific Incidence Cases of APE
  • 8.6.3. Type-specific Incidence Cases of APE
  • 8.6.4. Treated Cases of APE

9. Patient Journey

10. Marketed Therapies

• 10.1. Key Cross Competition
• 10.2. ELIQUIS (apixaban): Pfizer/Bristol Myers Squibb
  • 10.2.1. Product Description
  • 10.2.2. Regulatory Milestone
  • 10.2.3. Other Development Activities
  • 10.2.4. Clinical Trials Information
  • 10.2.5. Safety and Efficacy
• 10.3. SAVAYSA (edoxaban): Daiichi Sankyo
  • 10.3.1. Product Description
  • 10.3.2. Regulatory Milestone
  • 10.3.3. Other Development Activities
  • 10.3.4. Clinical Trials Information
  • 10.3.5. Safety and Efficacy

11. APE: Seven Major Market Analysis

• 11.1. Key Findings
• 11.2. Key Market Forecast Assumptions
  • 11.2.1. Cost Assumptions and Rebates
  • 11.2.2. Pricing Trends
  • 11.2.3. Analogue Assessment
  • 11.2.4. Launch Year and Therapy Uptake
• 11.3. Market Outlook
• 11.4. Attribute Analysis
• 11.5. Total Market Size of APE in the 7MM
• 11.6. Market Size of APE by Therapies in the 7MM
• 11.7. The US Market Size
  • 11.7.1. Total Market Size of APE
  • 11.7.2. Market Size of APE by Therapies
• 11.8. EU4 and the UK Market Size
  • 11.8.1. Total Market Size of APE
  • 11.8.2. Market Size of APE by Therapies
• 11.9. Japan Market Size
  • 11.9.1. Total Market Size of APE
  • 11.9.2. Market Size of APE by Therapies

12. Key Opinion Leaders' Views

13. Unmet Needs

14. SWOT Analysis

15. APE Market Access and Reimbursement

16. Appendix

• 16.1. Bibliography
• 16.2. Abbreviations and Acronyms
• 16.3. Report Methodology

17. DelveInsight Capabilities

18. Disclaimer

19. About DelveInsight