Exosome Diagnostic & Therapeutic Market Size, Share and Trends Analysis, By Product Type (Instruments, Kits & Reagents, Software, and Services), By Workflow (Isolation, Characterization, and Downstream Analysis), By Therapeutic Area, By End-Use, and By Region, Forecast 2025-2032

Exosome Diagnostic & Therapeutic Market Overview and Key Insights:

The exosome diagnostic & therapeutic market size reached USD 82.6 Million in 2024 and is expected to register a revenue CAGR of 46.7% during the forecast period. Exosomes are a type of extracellular vesicle produced by all cells and are found in a variety of bodily fluids. Exosomes serve critical roles in tumour initiation and development, immunological suppression, immune surveillance, metabolic reprogramming, angiogenesis, and macrophage polarization.

Market Drivers:

Rising prevalence of chronic diseases is a key driver of revenue growth in the exosome diagnostic & therapeutic market. According to the American Cancer Society, breast cancer is the most frequent cancer in women in the United States, except for skin cancers. It accounts for around 30% (or one in every three) of all new female malignancies each year. Estimates for breast cancer in the United States in 2025 are: There will be around 316,950 new instances of invasive breast cancer in women, 59,080 new cases of ductal carcinoma in situ (DCIS), and 42,170 deaths from breast cancer. In recent years, incidence rates have risen by 1% annually. Women under the age of 50 are experiencing a slightly greater increase in incidence rates (1.4%).

Exosomes have been shown to be essential regulators in health and illness, particularly tumour biology. Tumor-derived exosomes containing tumor-specific antigens and nucleic acids can be evaluated non-invasively as a diagnostic and predictive biomarker. Furthermore, exosomes could be utilized to identify people who are at risk of developing metastatic disease, and the process of producing exosomes could reveal new targets for cancer treatment.

On June 2025, a research team led by the Superintendent of China Medical University Hospital (Taiwan), in partnership with Shine-On Biomedical Co., has developed the world’s first targeted exosome medication delivery platform for HLA-G, marking a significant milestone in precision oncology. The innovative platform, known as SOB100, has completed preclinical trials and shown remarkable efficacy in treating aggressive tumors such as breast cancer and glioblastoma. With FDA approval, growing international reputation, and advanced clinical studies, SOB100 is set to play a crucial role in the future of precision medicine, providing new hope to cancer patients all over the world.

Market Opportunity:

Integration of artificial intelligence and big data analytics act as an opportunity for exosome diagnostic & therapeutic market. Exosomes’ versatility has caused them to be studied in the biomedical arena for diagnostic, prognostic, and therapeutic purposes. Concurrently, AI has transformed several industries, including medicine, due to its capacity to analyze vast information and detect complicated patterns. The combination of exosome analysis and AI processing has demonstrated a novel diagnostic technique for cancer and other disorders.

A machine learning strategy for non-invasive cancer diagnosis employing exosome protein markers has made a significant contribution to early cancer detection techniques, achieving excellent accuracy in identifying cancer types with an advanced biomarker signature and sophisticated data models. A paradigm change in cancer diagnosis has been brought about by the combination of liquid biopsies, nanotechnology, machine learning, and bioinformatics. This convergence makes it simpler to apply exosome analysis for dynamic disease monitoring and non-invasive, accurate early cancer detection.

On June 2025, Mursla Bio, a pioneer in Extracellular Vesicle (EV) science, has announced the commercial launch of their AI Precision Medicine Platform, as well as a pre-print describing the first validated method for separating hepatocyte EVs from plasma for organ-specific proteome and miRNA profiling. Mursla Bio is in discussions with possible partners about expanding its Platform to include more disease categories, biomarker discovery, and IVD translation programs. Mursla Bio’s Platform is based on its capacity to identify and analyze EVs released by specific organs into the circulation. The Platform decreases non-target background by up to five orders of magnitude when compared to typical bulk EV isolation, while also greatly improving data structure and prediction model generalization.

Recent Trends:

Emerging trends include advancements in exosome isolation technologies, use of siRNA-loaded exosomes in precision medicine, integration of AI in exosome-based diagnostics and therapies, and exosomes in vaccine development.

Exosome isolation technology advancements are critical to the transformation of personalized medicine and clinical diagnostics. While classic isolation techniques like as ultracentrifugation and polymer-based precipitation remain important, recent technology breakthroughs have provided more precise technologies such as microfluidics and immunoaffinity capture. These modern approaches enable high-throughput and precise exosome isolation by targeting surface markers, resulting in higher purity.

Nanotechnology-based techniques provide unique solutions by utilizing nanoscale materials to improve the specificity and efficiency of exosome capture, whereas automated and high-throughput systems speed the isolation process, providing consistency and scalability. These advanced technologies eliminate human error, enhance consistency, and can handle enormous sample volumes, making them very useful in clinical diagnostics and large-scale research.

On June 2025, Applied StemCell, a leading provider of advanced stem cell and gene editing technologies, has announced the launch of hiEX Research iPSC Exosomes, a new research-only product designed to allow scientists to investigate the therapeutic potential of iPSC-derived exosomes in areas such as wound healing, aging, and nerve regeneration. hiEX Research iPSC Exosomes are produced from a well-characterized induced pluripotent stem cell (iPSC) line, providing a consistent and scalable alternative to donor-derived exosomes.

Restraints & Challenges:

Isolating exosomes from diverse bodily fluids involves several obstacles that have a substantial impact on the purity, yield, and overall quality of the samples collected, all of which are critical for both research and therapeutic applications. One of the most difficult aspects of exosome isolation is balancing high purity with a sufficient yield. Exosomes have similar size ranges and physicochemical qualities to other forms of extracellular vesicles, including as microvesicles and apoptotic bodies, which complicates the situation. This closeness makes selective extraction of exosomes difficult in the absence of specialized markers that can reliably distinguish between various vesicle types.

Some of the more accurate separation approaches require large investments in equipment, such as modern ultracentrifugation setups and microfluidic devices, which are not widely available in all research settings. This disparity in equipment availability can cause inconsistency in the quality and reproducibility of exosome isolations performed in different settings or facilities.

Product Type Segment Insights and Analysis:

Based on the product type, the exosome diagnostic & therapeutic market is segmented into instruments, kits & reagents, software, and services.

Instruments segment contributed the largest market share in 2024. EVs, particularly exosomes, are emerging as viable platforms for cancer treatment and beyond, owing to their natural capacity to encapsulate and distribute bioactive cargo with high specificity and minimal immunogenicity. Recent advances in exosome engineering and therapeutic applications have highlighted their potential to transform precision medicine by overcoming obstacles in drug delivery, immunotherapy, and regenerative medicine. Recent advances in genetic engineering and surface modification have improved the precision of medication delivery systems. Targeted distribution of medicinal drugs or imaging moieties can be achieved through techniques like ligand display on exosome surfaces and chemical alterations like click chemistry.

On August 2025, Bio-Techne Corporation stated that Mdxhealth SA will buy its Exosome Diagnostics Inc. business, which includes the ExoDx Prostate (EPI) test, a CLIA-certified clinical laboratory, and other assets. Bio-Techne will maintain access to the unique exosome-based technology for future kit development in its precision diagnostics growth pillar.

Workflow Segment Insights and Analysis:

Based on the workflow, the exosome diagnostic & therapeutic market is segmented into isolation, characterization, and downstream analysis.

Isolation segment contributed the highest market share in 2024. It is further sub segmented into ultracentrifugation, size exclusion chromatography, and microfluidics-based isolation. Innovative approaches to EVs and exosome isolation are addressing long-standing difficulties to clinical translation. Exosome research continues to rely heavily on traditional isolation techniques such as ultracentrifugation, size-exclusion chromatography (SEC), and immunoaffinity capture. New technologies, such as microfluidic platforms and acoustic-based isolation approaches, are revolutionizing the sector. Microfluidic systems, for example, combine size-based filtration, density separation, and immunoaffinity methods on a single chip, allowing for quick, high-throughput isolation from small sample quantities.

Efforts are being made to develop automated, high-throughput technologies that will reduce unpredictability and streamline procedures. Advances in bioreactor systems and artificial exosome manufacturing show promise in meeting the demand for clinical-grade exosomes while solving the scalability difficulty. Exosome separation is poised to become a dependable cornerstone of precision oncology by combining technological improvements with globally accepted methodologies, allowing for dramatic advances in cancer diagnostics and therapies.

On September 2025, RION, a commercial and clinical-stage regenerative medicine company that pioneered platelet-derived exosomes for both human and animal health applications, has announced a collaboration with Lonza to provide cGMP manufacturing and technical support for commercial scale production of its Purified Exosome Product (PEP) drug substance for late phase clinical supply and beyond. This platform enables RION to progress its pipeline of exosome-based medicines across many indications.

Therapeutic Area Segment Insights and Analysis:

Based on the therapeutic area, the exosome diagnostic & therapeutic market is segmented into oncology, neurological disorders, cardiovascular disorders, infectious diseases, and others.

Oncology segment contributed the largest market share in 2024. Oncology is further sub segmented into lung cancer, breast cancer, colorectal cancer, prostate cancer, and ovarian cancer. Exosome-mediated drug delivery is important for cancer treatment because it has various advantages over previous approaches. One of the most notable advantages is the excellent biocompatibility and minimal immunogenicity of exosomes, which come from the body’s own cells. Exosomes also have the natural potential to target certain tissues, particularly cancers, via receptor-ligand interactions, which improves drug targeting precision. Targeted delivery reduces the amount of hazardous medications that reach healthy tissues, lowering side effects and improving the therapeutic index of cancer treatments.

Furthermore, exosomes can be modified to contain several medicinal payloads such as chemotherapeutic medicines, small interfering RNA (siRNA), and microRNA (miRNA), allowing for a wide range of cancer treatment applications. Their capacity to shield these payloads from degradation in the bloodstream improves the stability and bioavailability of the given medications, hence boosting the efficacy of cancer treatments. These unique properties of exosomes position them as a transformative technology in the field of oncology, with the potential to improve patient outcomes in various cancers, including those that are traditionally difficult to treat, such as brain and pancreatic cancer

On April 2023, Erasmus MC, ExoVectory, and biotech business Applikon-Getinge have received funding from the Dutch TKI (Topconsortia voor Kennis en Innovatie), Health Holland fund, to further develop ExoVectory’s exosome technology for the treatment of very aggressive metastasized prostate cancer. With this three-year project, ExoVectory deepens its research affiliations with Erasmus MC in order to develop its exosome technology as a tool for treating extremely aggressive malignancies such as (metastasized) prostate cancer and brain cancer.

Geographical Outlook:

Exosome diagnostic & therapeutic market is strategically segmented by geography to provide a comprehensive understanding of regional market dynamic. Discover demand analysis, emerging trends, and growth opportunities shaping market performance across different region and countries.

North America Exosome Diagnostic & Therapeutic Market:

North America is registered to have highest market share in exosome diagnostic & therapeutic market in 2024. This is mainly driven by rising prevalence of chronic diseases, rising demand for non-invasive diagnostics, and expanding role in targeted drug delivery and precision medicine. Companies are investing in scalable manufacturing technologies and AI-driven bioinformatics to support high-throughput analysis, enabling wider clinical adoption. The region’s strong intellectual property protection and regulatory incentives for advanced biologics encourage start-ups and established firms to accelerate product pipelines. Furthermore, dominance in precision medicine initiatives and early adopters in academic medical centers position it as the global hub for exosome-based translation research.

On January 2024, Aruna Bio, Inc., a pioneer in the development of brain exosome-based medicines for the treatment of neurodegenerative illnesses, stated that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for the main program, AB126. AB126 is an unaltered neural-derived exosome that can cross the blood-brain barrier and exhibits anti-inflammatory and neuroprotective activities.

Asia Pacific Exosome Diagnostic & Therapeutic Market:

Asia Pacific is expected to register the fastest growth rate during the forecasted period, driven by the rising need for next-generation diagnostic tools, personalized treatment options, and sophisticated drug delivery platforms. Major countries across the region including Japan, China, South Korea, and India are experiencing heightened adoption of breakthrough medical technologies, with exosome-based solutions gaining significant traction. Asia-Pacific also hosts a growing network of top-tier universities and research institutions actively advancing exosome science, further accelerating innovation and commercialization in both diagnostics and therapeutics.

On May 2024, FUJIFILM Wako Pure Chemical Corporation has announced the release of the MassivEV EV Purification Column PS and MassivEV Purification Buffer Set, which are designed for high-purity and high-efficiency mass purification of extracellular vesicles (EVs) to aid exosome research. The MassivEV EV Purification Column PS and the MassivEV Purification Buffer Set can purify EVs from liter-scale cell culture supernatants while maintaining safety and pharmacological testing. MassivEV products can provide efficient single-step purification of EVs in higher purity than those produced using the standard mass EV purification method4, which needs multiple purification processes.

Europe Exosome Diagnostic & Therapeutic Market:

Europe is expected to register a considerable market share during the forecasted period. The European Union (EU) primarily classifies EV-based therapies as biological medicinal products, subject to severe regulatory scrutiny comparable to that applied to advanced therapy medicinal products (ATMPs), when their contents have a direct impact on physiological processes. Furthermore, the EMA actively publishes scientific advice and guidelines to facilitate the safe clinical translation and commercialization of EV-based medicines.

On August 2023, Evox Therapeutics Ltd, a leading exosome therapeutics business, has established a research partnership and option agreement with the Icahn School of Medicine at Mount Sinai in New York. The cooperation will focus on creating exosome-encapsulated AAV (exoAAV) vectors as a novel gene delivery technique to improve heart disease treatments. Evox and Icahn Mount Sinai are collaborating to address a long-standing barrier in cardiovascular medicine: the safe and effective delivery of genetic medications to cardiomyocytes.

Competition Analysis:

The exosome diagnostic & therapeutic market is characterized by a fragmented structure, with several players competing across various segments and regions. List of major players included in the exosome diagnostic & therapeutic market report are:

• Capricor Therapeutics, Inc.
• Evox Therapeutics Limited
• AEGLE Therapeutics
• Aruna Bio, Inc.
• Exogenus Therapeutics, S.A.
• Exosome Diagnostics, Inc.
• Bio-Techne Corp.
• Coya Therapeutics, Inc.
• AGS Therapeutics
• System Biosciences, LLC
• Brexogen
• Creative Biostructure
• BioIVT
• Kimera Labs
• Mercy BioAnalytics

Strategic Developments in Exosome Diagnostic & Therapeutic Market:

• In September 2025, ION, a clinical-stage regenerative medicine business and global pioneer in exosome-based medicines, has announced the establishment of INTENT Biologics, a new independent biotechnology company dedicated only to creating first-in-class exosome therapies for Inflammation and Immunology (I&I). INTENT Biologics acquires exclusive, everlasting worldwide rights to RION’s Purified Exosome Product (PEP) biologic platform in I&I and plans to take PEP Biologic into Phase 3 clinical development for enhanced tissue regeneration and immune-mediated dermatologic applications.
• In February 2025, Brexogen, a prominent biotechnology company that specializes in exosome-based medicines, has announced a technology transfer and licensing deal with BMI Korea for BxC-I17e, a novel exosome-based injectable treatment. This arrangement is the first large licensing transaction for an exosome treatment in Korea, and it represents a significant milestone in the commercialization of exosome-based medications.

Key Advantages for Stakeholders:

Navistrat Analytics’ industry report provides an in-depth quantitative analysis of various market segments, historical and current trends, market forecasts, and dynamics within the global market. The historical years covered in this report are 2022 to 2023, with 2024 serving as the base year for market size calculations. The forecast period extends from 2025 to 2032.

The report includes an executive summary and a comprehensive overview of market drivers, restraints, opportunities, and challenges (DROC), along with insights into regulatory standards. It features detailed analyses such as PORTER’s Five Forces, SWOT, and PESTLE, as well as assessments of technological trends and the competitive landscape.

PORTER’s Five Forces analysis helps stakeholders evaluate the impact of new entrants, competitive rivalry, supplier power, buyer power, and substitution threats, enabling them to assess the level of competition and the attractiveness of the global market. The competitive landscape provides stakeholders with a clear understanding of the current market positions of key players, offering valuable insights into their competitive environment.

Scope And Key Highlights Of The Exosome Diagnostic & Therapeutic Market Report:

The Exosome Diagnostic & Therapeutic market report offers a detailed analysis of market size, including historical revenue (in USD Million) data for 2022-2023 and revenue forecasts for 2025-2032 across the following segments:

• Product Type Outlook (Revenue, USD Million; 2022-2032)
  • Instruments
  • Kits & Reagents
  • Software
  • Services

• Workflow Outlook (Revenue, USD Million; 2022-2032)
  • Isolation
    • Ultracentrifugation
    • Size exclusion chromatography
    • Microfluidics-based isolation
    • Others
  • Characterization
    • Nanoparticle tracking analysis (NTA)
    • Western blotting
    • Flow cytometry
    • Mass spectrometry
  • Downstream Analysis
    • RNA sequencing
    • Proteomic profiling

• Therapeutic Area Outlook (Revenue, USD Million; 2022-2032)
  • Oncology
    • Lung cancer
    • Breast cancer
    • Colorectal cancer
    • Prostate cancer
    • Ovarian cancer
  • Neurological Disorders
    • Alzheimer’s disease
    • Parkinson’s disease
    • Multiple sclerosis
  • Cardiovascular Disorders
  • Infectious Diseases
  • Others

• End-Use Outlook (Revenue, USD Million; 2022-2032)
  • Hospitals and Clinical Laboratories
  • Pharmaceutical and Biotechnology Companies
  • Academic and Research Institutes
  • Contract Research Organizations (CROs)
  • Diagnostic Centers

• Regional Outlook (Revenue, USD Million; 2022-2032)
  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • U.K.
    • Italy
    • Spain
    • Benelux
    • Nordic Countries
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Oceania
    • ASEAN Countries
    • Rest of APAC
  • Latin America
    • Brazil
    • Rest of LATAM
  • Middle East & Africa
    • GCC Countries
    • South Africa
    • Israel
    • Turkey
    • Rest of MEA

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