Edema Clinical Trials Market Size and Outlook 2030

Report Description

Forecast Period	2026-2030
Market Size (2024)	USD 1.19 Billion
CAGR (2025-2030)	4.00%
Fastest Growing Segment	Phase II
Largest Market	North America
Market Size (2030)	USD 1.51 Billion

Market Overview

The Global Edema Clinical Trials Market, valued at USD 1.19 Billion in 2024, is projected to experience a CAGR of 4.00% to reach USD 1.51 Billion by 2030. The Global Edema Clinical Trials Market focuses on research studies evaluating the safety and efficacy of novel drugs, therapies, and medical devices developed to manage edema, which involves the abnormal accumulation of fluid in body tissues. Key drivers supporting this market’s expansion include the escalating global prevalence of underlying conditions such as heart failure, kidney disease, and various inflammatory disorders, alongside an aging demographic and continuous advancements in understanding edema's complex pathophysiology.

According to PhRMA, in 2023, the biopharmaceutical industry sponsored nearly 5,300 clinical trials of medicines in the U. S. , indicative of significant research and development activity that encompasses numerous edema-related investigations. Nevertheless, a substantial challenge hindering market growth is the considerable financial investment required for conducting comprehensive clinical trials, coupled with extended timelines for regulatory approvals.

Key Market Drivers

The rising global burden of edema-associated chronic diseases is a primary impetus for the clinical trials market. As the prevalence of conditions like heart failure, kidney disease, and liver cirrhosis escalates, the concurrent incidence of edema increases significantly. This expanding patient demographic urgently requires advanced therapeutic interventions. According to the World Health Organization (WHO), in a fact sheet updated May 2023, noncommunicable diseases (NCDs) accounted for 41 million deaths annually in 2021, representing 74% of all global deaths, with many NCDs directly contributing to edema. This substantial disease burden drives extensive research and development efforts, prompting pharmaceutical companies and academic institutions to launch comprehensive clinical trials aimed at developing effective and targeted treatments, thereby expanding market activity.

Increased pharmaceutical research and development investment in edema therapeutics critically drives market growth. Enhanced funding empowers biotechnology and pharmaceutical firms to explore novel therapeutic avenues, conduct preclinical studies, and progress promising drug candidates into rigorous human clinical trials. This financial commitment supports the specialized infrastructure and personnel needed for developing and validating new edema treatments. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA) in their "The Pharmaceutical Industry in Figures" 2023 report, R&D expenditure by EFPIA member companies reached €44,500 million in 2022. This substantial investment is indispensable for fostering scientific advancements and expanding treatment options. According to the U. S. Food and Drug Administration (FDA), in 2023, its Center for Drug Evaluation and Research (CDER) reported the approval of 55 novel drugs, highlighting dynamic innovation across domains relevant to edema management and contributing to the volume of global clinical trials.

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Key Market Challenges

The considerable financial investment required for conducting comprehensive clinical trials, coupled with extended timelines for regulatory approvals, presents a substantial impediment to the growth of the Global Edema Clinical Trials Market. The extensive capital outlay necessary for drug development, encompassing preclinical research through all phases of human trials, acts as a significant barrier for pharmaceutical companies. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), the estimated cost of researching and developing a new chemical or biological entity was €3,130 million ($3,296 million in 2022 dollars) in 2022. This substantial expenditure, often preceding any market return, restricts the number of novel edema therapies that can progress to clinical evaluation.

Furthermore, the prolonged duration of these trials, intensified by complex protocols and evolving regulatory requirements, delays market entry for successful treatments. The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) reported that the average time from clinical trial start to patient enrollment close increased by 26% from 2019 to 2023, further lengthening the overall development cycle. These combined factors diminish the appeal of investing in edema research, subsequently slowing the pace of innovation and the availability of new treatment options within the market.

Key Market Trends

The increased use of biomarkers for personalized treatment is a significant trend in edema clinical trials. This approach enhances drug development by identifying specific patient subpopulations likely to respond to a therapy, thereby improving trial efficiency and therapeutic outcomes. For example, in April 2025, research identified choroidal thickness (CCT) as a crucial biomarker for diabetic macular edema, where normal CCTs correlated with better treatment responses to aflibercept. This trend, promoting more targeted therapeutic development, is evidenced by the Personalized Medicine Coalition reporting that the U. S. Food and Drug Administration approved 26 new personalized medicines in 2023, a notable increase from the prior year.

A pivotal trend is the adoption of decentralized and virtual clinical trials, which are reshaping the operational aspects of edema research. These models utilize digital technologies for remote trial activities, broadening patient access and reducing logistical burdens. This patient-centricity fosters greater demographic diversity and accelerates trial timelines. According to IQVIA's "Global Trends in R&D 2024" report, digital and decentralized trial methodologies contributed to increased clinical development productivity in 2023. The August 2024 partnership between Walgreens and the Biomedical Advanced Research and Development Authority (BARDA) to innovate decentralized clinical trials underscores this commitment to expanding accessibility and efficiency in medical research.

Segmental Insights

The Phase II segment is currently the fastest-growing within the Global Edema Clinical Trials Market, driven by its critical role in advancing therapeutic development. This segment involves more extensive testing of experimental therapies in a larger group of patients, which is essential for thoroughly assessing both efficacy and safety profiles. Trials at this stage are crucial for refining optimal dosages, identifying potential adverse effects, and gathering preliminary evidence that justifies further investigation in later phases. Furthermore, the increasing prevalence of underlying conditions such as heart failure, kidney disorders, and liver cirrhosis, which frequently cause edema, necessitates robust research into novel treatments, thereby fueling the expansion of Phase II studies.

Regional Insights

North America leads the global edema clinical trials market due to its highly developed research infrastructure, encompassing numerous academic institutions and well-equipped research facilities. This dominance is further supported by substantial investment in research and development from leading pharmaceutical and biotechnology companies. Additionally, the region benefits from a robust and adaptive regulatory environment, with bodies like the U. S. Food and Drug Administration fostering a conducive atmosphere for clinical research and innovation. This combination of advanced capabilities, significant funding, and clear regulatory frameworks drives the substantial volume of edema clinical trials conducted within North America.

Recent Developments

In October 2025, SQ Innovation received U.S. FDA approval for Lasix ONYU (furosemide injection), a new drug-device combination designed for at-home treatment of edema in adult patients with chronic heart failure. This novel product, formulated with Captisol supplied by Ligand Pharmaceuticals, allows for subcutaneous administration outside of a healthcare setting. Lasix ONYU provides a high-concentration furosemide formulation delivered through a compact infusor, aiming to offer improved convenience and flexibility for patients managing fluid overload associated with chronic heart failure, as prescribed by their clinicians.

In March 2025, scPharmaceuticals, Inc. received expanded FDA approval for its furosemide injection (Furoscix) to treat edema in adult patients with chronic kidney disease (CKD), including nephrotic syndrome. This expanded indication followed the FDA's acceptance of a supplemental new drug application in July 2024. The subcutaneous loop diuretic became the first and only FDA-approved therapy offering intravenous-equivalent diuresis for CKD patients at home via the Furoscix On-Body Infusor, previously approved for heart failure. This development enhances treatment flexibility for managing fluid overload in a significant patient population.

In February 2025, Roche obtained FDA approval for ranibizumab injection (Susvimo) as a treatment for diabetic macular edema (DME). This therapy emerged as the first and only FDA-approved option to maintain vision in DME patients with fewer treatments compared to conventional injections. The approval was supported by one-year data from the Pagoda study, which demonstrated sustained vision improvements and a consistent safety profile. This new product launch represents a significant advancement in managing a leading cause of vision loss for individuals with diabetes.

In early 2025, Astria Therapeutics planned to initiate a Phase 3 clinical trial for navenibart, its preventive therapy for hereditary angioedema (HAE). This advanced clinical trial was set to evaluate different subcutaneous dosing schedules, specifically every three or six months, to provide flexible treatment options for patients. Navenibart, a kallikrein inhibitor, aims to reduce bradykinin production and prevent the characteristic swelling attacks of HAE. This progression into late-stage clinical development followed promising interim results from the Phase 1b/2 ALPHA-STAR trial, which indicated over a 90% reduction in swelling attacks.

Key Market Players

Otsuka Holdings Co. Ltd.
Novartis AG
Genentech, Inc.
Johnson & Johnson Services, Inc.
Merck & Co., Inc.
Sanofi S.A.
AstraZeneca plc
Bristol Myers Squibb India Pvt. Ltd.
GlaxoSmithKline plc
AbbVie Inc.

By Phase	By Participants	By Sponsor	By Type	By Region
Phase I Phase II Phase III Phase IV	Pediatrics Adults Geriatrics	Pharmaceutical Companies Academic Institutions Government Bodies	Systemic Edema Localized Edema	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Edema Clinical Trials Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Edema Clinical Trials Market, By Phase:

o Phase I

o Phase II

o Phase III

o Phase IV

Edema Clinical Trials Market, By Participants:

o Pediatrics

o Adults

o Geriatrics

Edema Clinical Trials Market, By Sponsor:

o Pharmaceutical Companies

o Academic Institutions

o Government Bodies

Edema Clinical Trials Market, By Type:

o Systemic Edema

o Localized Edema

Edema Clinical Trials Market, By Region:

o North America

§ United States

§ Canada

§ Mexico

o Europe

§ France

§ United Kingdom

§ Italy

§ Germany

§ Spain

o Asia Pacific

§ China

§ India

§ Japan

§ Australia

§ South Korea

o South America

§ Brazil

§ Argentina

§ Colombia

o Middle East & Africa

§ South Africa

§ Saudi Arabia

§ UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Edema Clinical Trials Market.

Available Customizations:

Global Edema Clinical Trials Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

Detailed analysis and profiling of additional market players (up to five).

Global Edema Clinical Trials Market is an upcoming report to be released soon. If you wish an early delivery of this report or want to confirm the date of release, please contact us at [email protected]

Table of content

1. Product Overview

1.1. Market Definition

1.2. Scope of the Market

1.2.1. Markets Covered

1.2.2. Years Considered for Study

1.2.3. Key Market Segmentations

2. Research Methodology

2.1. Objective of the Study

2.2. Baseline Methodology

2.3. Key Industry Partners

2.4. Major Association and Secondary Sources

2.5. Forecasting Methodology

2.6. Data Triangulation & Validation

2.7. Assumptions and Limitations

3. Executive Summary

3.1. Overview of the Market

3.2. Overview of Key Market Segmentations

3.3. Overview of Key Market Players

3.4. Overview of Key Regions/Countries

3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Edema Clinical Trials Market Outlook

5.1. Market Size & Forecast

5.1.1. By Value

5.2. Market Share & Forecast

5.2.1. By Phase (Phase I, Phase II, Phase III, Phase IV)

5.2.2. By Participants (Pediatrics, Adults, Geriatrics)

5.2.3. By Sponsor (Pharmaceutical Companies, Academic Institutions, Government Bodies)

5.2.4. By Type (Systemic Edema, Localized Edema)

5.2.5. By Region

5.2.6. By Company (2024)

5.3. Market Map

6. North America Edema Clinical Trials Market Outlook

6.1. Market Size & Forecast

6.1.1. By Value

6.2. Market Share & Forecast

6.2.1. By Phase

6.2.2. By Participants

6.2.3. By Sponsor

6.2.4. By Type

6.2.5. By Country

6.3. North America: Country Analysis

6.3.1. United States Edema Clinical Trials Market Outlook

6.3.1.1. Market Size & Forecast

6.3.1.1.1. By Value

6.3.1.2. Market Share & Forecast

6.3.1.2.1. By Phase

6.3.1.2.2. By Participants

6.3.1.2.3. By Sponsor

6.3.1.2.4. By Type

6.3.2. Canada Edema Clinical Trials Market Outlook

6.3.2.1. Market Size & Forecast

6.3.2.1.1. By Value

6.3.2.2. Market Share & Forecast

6.3.2.2.1. By Phase

6.3.2.2.2. By Participants

6.3.2.2.3. By Sponsor

6.3.2.2.4. By Type

6.3.3. Mexico Edema Clinical Trials Market Outlook

6.3.3.1. Market Size & Forecast

6.3.3.1.1. By Value

6.3.3.2. Market Share & Forecast

6.3.3.2.1. By Phase

6.3.3.2.2. By Participants

6.3.3.2.3. By Sponsor

6.3.3.2.4. By Type

7. Europe Edema Clinical Trials Market Outlook

7.1. Market Size & Forecast

7.1.1. By Value

7.2. Market Share & Forecast

7.2.1. By Phase

7.2.2. By Participants

7.2.3. By Sponsor

7.2.4. By Type

7.2.5. By Country

7.3. Europe: Country Analysis

7.3.1. Germany Edema Clinical Trials Market Outlook

7.3.1.1. Market Size & Forecast

7.3.1.1.1. By Value

7.3.1.2. Market Share & Forecast

7.3.1.2.1. By Phase

7.3.1.2.2. By Participants

7.3.1.2.3. By Sponsor

7.3.1.2.4. By Type

7.3.2. France Edema Clinical Trials Market Outlook

7.3.2.1. Market Size & Forecast

7.3.2.1.1. By Value

7.3.2.2. Market Share & Forecast

7.3.2.2.1. By Phase

7.3.2.2.2. By Participants

7.3.2.2.3. By Sponsor

7.3.2.2.4. By Type

7.3.3. United Kingdom Edema Clinical Trials Market Outlook

7.3.3.1. Market Size & Forecast

7.3.3.1.1. By Value

7.3.3.2. Market Share & Forecast

7.3.3.2.1. By Phase

7.3.3.2.2. By Participants

7.3.3.2.3. By Sponsor

7.3.3.2.4. By Type

7.3.4. Italy Edema Clinical Trials Market Outlook

7.3.4.1. Market Size & Forecast

7.3.4.1.1. By Value

7.3.4.2. Market Share & Forecast

7.3.4.2.1. By Phase

7.3.4.2.2. By Participants

7.3.4.2.3. By Sponsor

7.3.4.2.4. By Type

7.3.5. Spain Edema Clinical Trials Market Outlook

7.3.5.1. Market Size & Forecast

7.3.5.1.1. By Value

7.3.5.2. Market Share & Forecast

7.3.5.2.1. By Phase

7.3.5.2.2. By Participants

7.3.5.2.3. By Sponsor

7.3.5.2.4. By Type

8. Asia Pacific Edema Clinical Trials Market Outlook

8.1. Market Size & Forecast

8.1.1. By Value

8.2. Market Share & Forecast

8.2.1. By Phase

8.2.2. By Participants

8.2.3. By Sponsor

8.2.4. By Type

8.2.5. By Country

8.3. Asia Pacific: Country Analysis

8.3.1. China Edema Clinical Trials Market Outlook

8.3.1.1. Market Size & Forecast

8.3.1.1.1. By Value

8.3.1.2. Market Share & Forecast

8.3.1.2.1. By Phase

8.3.1.2.2. By Participants

8.3.1.2.3. By Sponsor

8.3.1.2.4. By Type

8.3.2. India Edema Clinical Trials Market Outlook

8.3.2.1. Market Size & Forecast

8.3.2.1.1. By Value

8.3.2.2. Market Share & Forecast

8.3.2.2.1. By Phase

8.3.2.2.2. By Participants

8.3.2.2.3. By Sponsor

8.3.2.2.4. By Type

8.3.3. Japan Edema Clinical Trials Market Outlook

8.3.3.1. Market Size & Forecast

8.3.3.1.1. By Value

8.3.3.2. Market Share & Forecast

8.3.3.2.1. By Phase

8.3.3.2.2. By Participants

8.3.3.2.3. By Sponsor

8.3.3.2.4. By Type

8.3.4. South Korea Edema Clinical Trials Market Outlook

8.3.4.1. Market Size & Forecast

8.3.4.1.1. By Value

8.3.4.2. Market Share & Forecast

8.3.4.2.1. By Phase

8.3.4.2.2. By Participants

8.3.4.2.3. By Sponsor

8.3.4.2.4. By Type

8.3.5. Australia Edema Clinical Trials Market Outlook

8.3.5.1. Market Size & Forecast

8.3.5.1.1. By Value

8.3.5.2. Market Share & Forecast

8.3.5.2.1. By Phase

8.3.5.2.2. By Participants

8.3.5.2.3. By Sponsor

8.3.5.2.4. By Type

9. Middle East & Africa Edema Clinical Trials Market Outlook

9.1. Market Size & Forecast

9.1.1. By Value

9.2. Market Share & Forecast

9.2.1. By Phase

9.2.2. By Participants

9.2.3. By Sponsor

9.2.4. By Type

9.2.5. By Country

9.3. Middle East & Africa: Country Analysis

9.3.1. Saudi Arabia Edema Clinical Trials Market Outlook

9.3.1.1. Market Size & Forecast

9.3.1.1.1. By Value

9.3.1.2. Market Share & Forecast

9.3.1.2.1. By Phase

9.3.1.2.2. By Participants

9.3.1.2.3. By Sponsor

9.3.1.2.4. By Type

9.3.2. UAE Edema Clinical Trials Market Outlook

9.3.2.1. Market Size & Forecast

9.3.2.1.1. By Value

9.3.2.2. Market Share & Forecast

9.3.2.2.1. By Phase

9.3.2.2.2. By Participants

9.3.2.2.3. By Sponsor

9.3.2.2.4. By Type

9.3.3. South Africa Edema Clinical Trials Market Outlook

9.3.3.1. Market Size & Forecast

9.3.3.1.1. By Value

9.3.3.2. Market Share & Forecast

9.3.3.2.1. By Phase

9.3.3.2.2. By Participants

9.3.3.2.3. By Sponsor

9.3.3.2.4. By Type

10. South America Edema Clinical Trials Market Outlook

10.1. Market Size & Forecast

10.1.1. By Value

10.2. Market Share & Forecast

10.2.1. By Phase

10.2.2. By Participants

10.2.3. By Sponsor

10.2.4. By Type

10.2.5. By Country

10.3. South America: Country Analysis

10.3.1. Brazil Edema Clinical Trials Market Outlook

10.3.1.1. Market Size & Forecast

10.3.1.1.1. By Value

10.3.1.2. Market Share & Forecast

10.3.1.2.1. By Phase

10.3.1.2.2. By Participants

10.3.1.2.3. By Sponsor

10.3.1.2.4. By Type

10.3.2. Colombia Edema Clinical Trials Market Outlook

10.3.2.1. Market Size & Forecast

10.3.2.1.1. By Value

10.3.2.2. Market Share & Forecast

10.3.2.2.1. By Phase

10.3.2.2.2. By Participants

10.3.2.2.3. By Sponsor

10.3.2.2.4. By Type

10.3.3. Argentina Edema Clinical Trials Market Outlook

10.3.3.1. Market Size & Forecast

10.3.3.1.1. By Value

10.3.3.2. Market Share & Forecast

10.3.3.2.1. By Phase

10.3.3.2.2. By Participants

10.3.3.2.3. By Sponsor

10.3.3.2.4. By Type

11. Market Dynamics

11.1. Drivers

11.2. Challenges

12. Market Trends & Developments

12.1. Merger & Acquisition (If Any)

12.2. Product Launches (If Any)

12.3. Recent Developments

13. Global Edema Clinical Trials Market: SWOT Analysis

14. Porter's Five Forces Analysis

14.1. Competition in the Industry

14.2. Potential of New Entrants

14.3. Power of Suppliers

14.4. Power of Customers

14.5. Threat of Substitute Products

15. Competitive Landscape

15.1. Otsuka Holdings Co. Ltd.

15.1.1. Business Overview

15.1.2. Products & Services

15.1.3. Recent Developments

15.1.4. Key Personnel

15.1.5. SWOT Analysis

15.2. Novartis AG

15.3. Genentech, Inc.

15.4. Johnson & Johnson Services, Inc.

15.5. Merck & Co., Inc.

15.6. Sanofi S.A.

15.7. AstraZeneca plc

15.8. Bristol Myers Squibb India Pvt. Ltd.

15.9. GlaxoSmithKline plc

15.10. AbbVie Inc.

16. Strategic Recommendations

17. About Us & Disclaimer

Report Description

Table of content

Figures and Tables

Frequently asked questions

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