Exosome Diagnostics and Therapeutics Market

The report "Exosome Diagnostics and Therapeutics Market by Type (Diagnostics, Therapeutics), Product & Service (Instruments, Kits, Reagents), Source (Stem Cells, Blood, Blood Plasma, Urine), Application (Cancer, Musculoskeletal, CVD) - Global Forecast to 2032", is projected to grow from USD 59 million in 2024 to USD 6,848 million by 2032 at a CAGR of 108.9%.

Browse 335 market data Tables and 45 Figures spread through 250 Pages and in-depth TOC on "Exosome Diagnostics and Therapeutics Market by Type (Diagnostics, Therapeutics), Product & Service (Instruments, Kits, Reagents), Source (Stem Cells, Blood, Blood Plasma, Urine), Application (Cancer, Musculoskeletal, CVD) - Global Forecast to 2032"
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Emerging potential of exosome-based liquid biopsy is one of the key driving factors of the market growth. Exosomes have gained traction in clinical research, primarily attributed to their stability & ability to carry genetic material such as cellular DNA, mRNA, and miRNA. Exosomes serve as a novel source of biomarkers suitable for diagnostic applications. Recently, exosomes have emerged as a promising liquid biopsy tool offering non-invasive options for disease diagnosis, prognosis, and treatment response monitoring in both communicable and non-communicable diseases.

With significant technological advancements, biopsy techniques have evolved from open surgical biopsies to minimally invasive needle biopsies and non-invasive biopsies. Tissue biopsy does not provide entire tumor heterogeneity due to its size and can act as a barrier to diagnosing cancer. A liquid biopsy offers several benefits over traditional incisional biopsy, such as non-invasiveness, reduced procedural costs, easy disease monitoring, early-stage cancer diagnosis, as well as determining the risk of relapse. These benefits have driven the adoption of liquid biopsies among end users.

The exosome diagnostics segment accounted for the largest share of the market in 2023.

The market is segmented based on type into exosome diagnostics and exosome therapeutics. The ExoDx prostate cancer test offered by Exosome Diagnostics (a wholly owned subsidiary of Bio-Techne) is the key contributor to the market revenue through the study period (2022−2032). As of 2024, this is the only FDA-approved exosome-based diagnostic test, with few in the pipeline. All candidates for exosome therapeutics are in clinical trials, with no candidates in Phase 3 or Phase 4. Based on the clinical landscape, the commercialization of exosome therapeutics is anticipated to begin post-2028.

The kits & reagents segment is expected to dominate the exosome diagnostics market through the forecast period.

Based on product & service, the market is segmented into instruments & services and kits & reagents. The market growth for the exosome diagnostics kits & reagents segment is attributed to the growing demand for noninvasive commercial diagnostic kits. With only one exosome-based test (the ExoDx, an at-home sample collection test kit) approved in the market, the kits & reagents segment is monopolized by one key player, Bio-Techne, until 2029. However, the instruments & services segment is expected to gain traction in the coming years.

The blood & blood plasma segment is expected to grow at an exponential growth rate from 2024-2029.

Based on source, the market is segmented into stem cells, blood & blood plasma, urine, and other samples (saliva and endothelial cells). Exosomes derived from blood plasma play critical roles in intercellular communication, immune regulation, coagulation, and tissue homeostasis. These exosomes can shuttle bioactive molecules, such as microRNAs, growth factors, cytokines, and lipids, between cells and tissues, influencing cellular processes and diagnosing diseases. High demand for non-invasive and minimally invasive liquid biopsies is anticipated to support the segment growth.

Cancer is expected to emerge as the dominant application segment in the exosome therapeutics market.

Based on application, the exosome therapeutics market is segmented into cancer, dermatological diseases, musculoskeletal disorders, cardiovascular diseases, and other applications (rare genetic disorders and infectious diseases). Exosomes also play a critical role in cancer therapy as carriers of therapeutic cargo, delivering drugs, RNA interference molecules, or immunomodulatory agents to target cancer cells. In cancer diagnosis, exosomes detect tumor-specific molecules in bodily fluids. These exosomes act as a stable source of tumor-derived antigens, miRNAs, circRNAs, cDNAs, and proteins that can be used for early diagnosis & prognosis of cancer.

North America dominates the global exosome diagnostics and therapeutics market throughout the forecast period.

In 2023, North America (US and Canada) dominated the market in 2023, acting as the sole revenue contributor to the market revenue. The large share of North America is attributed to the product approval of the only commercial exosome-based test for prostate cancer offered by Bio-Techne (US). Other factors that support the growth of the market include significant investments in R&D for the development of exosome diagnostics and therapeutics, a favourable environment for market players, and a strong regulatory framework.

The prominent players in the exosome diagnostics and therapeutics market include Bio-Techne (US), NanoFCM Inc. (UK), System Biosciences, LLC. (US), Capital Biosciences, Inc. (US), AMSBIO (UK), INOVIQ (Australia), Direct Biologics LLC (US), Regeneus Ltd (Australia), CUREXSYS (Germany), Aegle Therapeutics (US), Mercy Bioanalytics (US), multimmune GmbH (Germany), RION (US), Exogenus Therapeutics (Portugal), Everzom (France), Kimera Labs (US) NanoSomiX, Inc. (US), Exonox Biosciences, Inc. (Taiwan), Capricor Therapeutics, Inc. (US), Evox Therapeutics (US), and ILIAS Biologics Inc. (Korea).

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