Exosome Diagnostics Market

Exosome Diagnostics Market by Product Type (Instruments and Reagents & Kits), Indication (Prostate Cancer and Other), End-User (Hospitals and Clinics, Diagnostic Laboratories, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the increasing prevalence of cancer, expanding exosome diagnostic applications beyond oncology, and growing product development activities across the globe.

The exosome diagnostics market was valued at USD 119.28 million in 2024, growing at a CAGR of 47.13% during the forecast period from 2025 to 2032 to reach USD 2,557.97 million by 2032. The increasing prevalence of cancer is driving the demand for advanced diagnostic tools like exosome-based diagnostics, which offer non-invasive and precise detection methods. Beyond oncology, the expanding applications of exosome diagnostics in areas such as neurology and cardiology are broadening their market scope. Additionally, growing product development activities, including innovations in isolation and analysis techniques, are enhancing the efficiency and accessibility of these diagnostics, collectively fueling the growth of the exosome diagnostics market globally during the forecast period from 2025 to 2032.

Exosome Diagnostics Market Dynamics:

As per data provided by the International Agency of Research on Cancer (2024), in 2022, the estimated new cases of cancer were 20 million and the projections were indicated to increase to 32.6 million by 2045. Additionally, the types of cancers majorly boosting the market for exosome diagnostics are prostate cancer, lung cancer, pancreatic cancer, breast cancer, ovarian cancer, brain cancer (glioblastoma), and melanoma, among others.

Additionally, according to recent data provided by the International Agency of Research on Cancer (2024), in 2022, the estimated new cases of prostate cancer were 1.47 million and the projection were indicated to increase to 2.63 million by 2045. Exosome diagnostics offer a highly specific and sensitive method for detecting prostate cancer by isolating tumor-derived exosomes from bodily fluids like urine and blood. For instance, urine-based exosome tests can help differentiate between aggressive prostate cancers that require immediate treatment and indolent forms that may benefit from active surveillance, thereby reducing overtreatment and associated side effects.

Furthermore, the expanding applications of exosome diagnostics beyond oncology are gaining significant attention due to their potential in various medical fields such as neurodegenerative disorders, cardiology, immunology, infectious diseases, and others. Exosomes play a crucial role in the early detection of neurodegenerative diseases by serving as biomarkers that reflect the physiological and pathological states of cells. These small extracellular vesicles are released from various cell types, including neurons, and can carry proteins, lipids, and nucleic acids that provide insights into disease mechanisms. Exosomes can encapsulate disease-specific proteins and RNA, making them valuable for identifying biomarkers associated with neurodegenerative diseases such as Alzheimer’s and Parkinson’s. For example, proteins like tau and alpha-synuclein, which are implicated in these diseases, can be detected in exosomes derived from cerebrospinal fluid (CSF) and blood.

For instance in September 2023, INOVIQ and ResearchDx signed a license and supply agreement for INOVIQ’s EXO-NET® panexosome capture product to provide EXO-NET services in the US. ResearchDx Inc. is a US-based specialty contract diagnostics organisation, providing a full-suit of concept-to-market diagnostic biomarker discovery, assay development, clinical validation and IVD registration services, including companion diagnostics. Agreement enabled ResearchDx to provide EXO-NET enabled high-throughput exosome isolation, biomarker discovery and diagnostics development services to US customers.

Thus, the factors mentioned above are expected to boost the overall market of exosome diagnostics across the globe during the forecast period from 2025 to 2032.

However, challenges and limitations associated with exosome-based diagnostics and stringent regulatory concerns for product approval may hinder the future market of exosome diagnostics during the forecast period.

Exosome Diagnostics Market Segment Analysis:

Exosome Diagnostics Market by Product Type (Instruments and Reagents & Kits), Indication (Prostate Cancer and Other), End-User (Hospitals and Clinics, Diagnostic Laboratories, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

The reagents and kits category share in the exosome diagnostics market was valued at USD 61.21 million in 2024. It will grow at a CAGR of 46.97% during the forecast period from 2025 to 2032 to reach USD 1,858.58 million by 2032. Reagents and kits play a pivotal role in boosting the overall market of exosome diagnostics by simplifying and standardizing the complex processes involved in exosome isolation, purification, and analysis. These products enable researchers and clinicians to efficiently extract high-quality exosomes from diverse biological samples such as blood, urine, or saliva, making the diagnostic process more accessible and reliable. Reagents specifically tailored for labeling, staining, and detecting exosomal markers are crucial in enhancing the sensitivity and specificity of diagnostic assays. Similarly, ready-to-use kits reduce the time and effort required for exosome characterization, allowing for faster results in both clinical and research settings. The availability of such user-friendly solutions has significantly lowered the technical barriers for laboratories and healthcare providers to adopt exosome diagnostics. Additionally, the development of innovative kits compatible with advanced technologies like flow cytometry, nanoparticle tracking analysis, and next-generation sequencing is further driving the market by expanding the utility of exosome diagnostics across various fields, including oncology, neurology, and infectious diseases. 

Some examples of the reagents and kits by key market players include the ExoDx Prostate Test by Bio-Techne (the only approved exosome diagnostic test), Invitrogen by Thermofisher Scientific, TransExo® by TransGen Biotech, among others. The growing demand for reagents and kits tailored to specific diagnostic needs also encourages companies to invest in R&D, leading to the introduction of cost-effective and high-performance products. By streamlining workflows and enabling broader adoption, reagents and kits are instrumental in accelerating the growth of the exosome diagnostics market.

Thus, the factors mentioned above are expected to boost the segment thereby boosting the overall market of exosome diagnostics across the globe.

North America is expected to dominate the overall exosome diagnostics market:

The North America exosome diagnostics market was valued at USD 58.28 million in 2024 and will grow at a CAGR of 46.85% during the forecast period from 2025 to 2032 in order to reach USD 1,231.13 million by 2032. The growth of the exosome diagnostics market can be attributed to several factors including the rising cases of cancers in the US, increasing demand for non-invasive diagnosis, increasing awareness towards early diagnosis, and the increasing R&D activities.

According to the American Cancer Society 2024, nearly 2 million new cancer cases were expected to be diagnosed in the United States in 2024, up from 1.9 million in 2023. 

As per the Centers for Disease Control and Prevention (2024), the U.S. cancer statistics recorded 1,777,566 new cases of invasive cancer occurring in 2021; comprising of 272,454 breast cancers, 141,902 colorectal cancers, 209,500 lung cancers reported in the US in 2021.

As per data from the Lung Cancer Research Foundation (2024), 238,340 people were diagnosed with lung cancer in 2023 in the US, with one in 16 people expected to be diagnosed with lung cancer in their lifetime. Exosome-based diagnostics address this need by enabling liquid biopsies that use blood, urine, or other body fluids for real-time cancer monitoring without the need for invasive tissue biopsies. This approach not only enhances patient comfort but also facilitates early detection, which is crucial for improving survival rates. Furthermore, the rising cancer burden has intensified research and development activities focused on leveraging exosomes for personalized medicine, including targeted therapies and monitoring treatment efficacy. These advancements, along with the increasing adoption of precision medicine, are driving the demand for exosome diagnostics, thus propelling the market forward.

Additionally, the key players in the region are increasingly focusing on strategic partnerships to develop innovative exosome-based diagnostic tests. For instance, in April 2024, NeuroSense collaborated with Lonza to identify exosome-based biomarkers to advance neurodegenerative disease treatments and diagnostics. NeuroSense applied its expertise in biomarker utilization to enhance early diagnosis and treatment in neurodegeneration. Lonza developed, optimized, and qualified a method using Neuron-Derived Exosomes (NDEs), which was integrated into NeuroSense's clinical development program for PrimeC. Lonza's Dev-on-Demand solution facilitated rapid initiation, execution, and delivery of the project.

Thus, the above mentioned factors are expected to escalate the market of exosome diagnostics in the region.

Exosome Diagnostics Market Key Players:

Some of the key market players operating in the exosome diagnostics market include Bio-Techne, Biological Dynamics, TransGen Biotech Co., Ltd., BioFluidica, Lonza, Thermo Fisher Scientific Inc., Creative Biolabs, EXODUS BIO, Norgen Biotek Corp., System Biosciences, LLC, Capital Biosciences, Inc., AMSBIO, INOVIQ, FUJIFILM Holdings Corporation, GeneCopoeia, Inc., and others.

Recent Developmental Activities in the Exosome Diagnostics Market:

• In April 2022, INOVIQ and The University of Queensland (UQ) expanded their collaboration to develop the world’s-first exosome-based ovarian cancer screening test. Under a USD 2.7 million Medical Research Future Fund (MRFF) grant, UQ developed an exosome-based blood test for early ovarian cancer detection. INOVIQ provided its EXO-NET® technology for fast, accurate, and scalable exosome isolation from thousands of blood samples. INOVIQ also gained the exclusive option to license the rights to develop and commercialize UQ's exosome-based early detection test for ovarian cancer, aiming to improve women's health outcomes and save lives.
• In Feb 2022, Bio-Techne announced an agreement with Thermo Fisher Scientific to exclusively complete the development and commercialization of the ExoTRU kidney transplant rejection test. ExoTRU is an exosome-based, non-invasive multigene urine liquid biopsy assay that provides critical allograft health information, helping clinicians make informed decisions in managing kidney transplant patients and optimizing patient care. 

Key Takeaways from the Exosome Diagnostics Market Report Study

• Market size analysis for current exosome diagnostics size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened for the last 3 years
• Key companies dominating the exosome diagnostics market.
• Various opportunities available for the other competitors in the exosome diagnostics market space.
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing regions and countries in the current exosome diagnostics market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for exosome diagnostics market growth in the coming future?

Target Audience who can be benefited from this Exosome Diagnostics Market Report Study

• Exosome diagnostics product providers
• Research organizations and consulting companies 
• Exosome diagnostics -related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in exosome diagnostics 
• Various end-users who want to know more about the exosome diagnostics market and the latest technological developments in the exosome diagnostics market.