The size of global exosome diagnostics and therapeutics market is projected to grow from USD 59 million in 2024 to USD 2,347 million by 2029 at a CAGR of 108.9%. However, the candidates for exosome-based therapeutics are expected to be launched in the market from 2029 onwards. Thus, Exosome Diagnostics and Therapeutics Market in terms of revenue was estimated to be worth $59 million in 2024 and is poised to reach $6,848 million by 2032, growing at a CAGR of 81.2% from 2024 to 2032. The comprehensive research encompasses an exhaustive examination of industry trends, meticulous pricing analysis, patent scrutiny, insights derived from conferences and webinars, identification of key stakeholders, and a nuanced understanding of market purchasing dynamics.

The growth of this market is driven by factors such as the increasing collaborations & commercialization initiatives, emerging potential of exosome-based liquid biopsy, and growing outsourcing of exosome manufacturing activities. However, inadequate protocols for exosome development & production may pose a challenge to the market growth.

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EXOSOME DIAGNOSTICS AND THERAPEUTICS: INDUSTRY ECOSYSTEM

Based on the current scenario of commercializing exosomes, concerning diagnostics and therapeutics, the exosome value chain includes four integral steps. These are research & development; raw material procurement & manufacturing; regulatory compliance and quality assurance (QA); and marketing, sales, and distribution. Within this value chain, cell souring, exosome generation/development, exosome engineering, exosome cargo loading, and exosome formulation are critical steps in commercializing exosomes. The supply chain for exosome therapies spans the entire process of sourcing materials to distribute the final product to healthcare providers (hospitals, clinics/physician settings) or patients. Based on the complexity of exosome manufacturing and the need for stringent quality control, establishing a robust supply chain is essential for ensuring the safety, efficacy, and scalability of exosome therapies.

The prominent players in the global exosome diagnostics and therapeutics market are 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).

The exosome therapeutics segment is expected to gain traction post of the exosome diagnostics and therapeutics industry 2029.

The market is segmented based on type into exosome diagnostics and exosome therapeutics. Exosome therapeutics have emerged as an attractive market space, with increasing candidates entering clinical trials. The current pipeline indicates that 30 candidates are under development, with a majority (~41%) in Phase 1/Early Phase 1. The Asia Pacific region is at the forefront of therapeutics, with over 40% of exosome therapeutic candidates in the clinical pipeline. Meanwhile, North America and Europe comprise 46% of the therapeutics pipeline. The Middle East represents the remaining 10-12% of the pipeline, with the applicants belonging to Israel.

The exosome kits & reagents segment is anticipated to dominate the exosome diagnostics and therapeutics industry through 2024-2032.

Based on product & service, the market is segmented into instruments & services and kits & reagents. Exosome kits and reagents simplify exosome isolation, identification, measurement, and characterization. The commercial kits in this segment include those for Exolution RNA, Exolution Plus, ExoEasy, and ExoDx (Bio-Techne); XCF Liquid Biopsy Ki and ExoELISA ULTRA (System Biosciences); SubX-Exo Kit (Capital Biosciences); and ExoGAG (AMSBIO). These kits aim to achieve the optimal extraction of exosomes from a wide range of biological samples while maintaining functionality and integrity efficiently.

The blood & blood plasma source segment of the exosome diagnostics and therapeutics industry is anticipated to grow at the fastest pace throughout the forecast period.

Based on source, the market is segmented into stem cells, blood & blood plasma, urine, and other samples (saliva and endothelial cells). Blood plasma-derived exosomes are being investigated as potential diagnostic biomarkers for several conditions, including cancer, cardiovascular diseases, neurodegenerative disorders, infectious diseases, and inflammatory conditions. The cargo of exosomes, particularly their nucleic acids and proteins, can reflect disease-specific changes in gene expression, signaling pathways, and cellular processes, offering valuable insights into disease diagnosis, prognosis, and treatment response.

Clinics and physician settings segment generated the highest revenue in 2024 in the exosome diagnostics and therapeutics industry.

Hospitals and clinics & physician settings are the key end users of exosome products. The distribution of exosome-based tests is expected to be influenced by establishing clinics and physician settings. The exosome diagnostics market heavily relies on clinics and physician settings to distribute products. Commercialized exosome separation, characterization, and at-home test kits are used or marketed through clinics and physician settings. The rising demand for liquid biopsy kits in this end-user segment is expected to drive the market growth. Clinical testing laboratories use data from exosome-based liquid biopsy kits to help expedite the development & approval of exosome-based diagnostic tests.

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The North America exosome diagnostics and therapeutics market is expected to dominate the exosome diagnostics and therapeutics industry.

The global exosome diagnostics and therapeutics market is segmented into four major regions, namely, North America, Europe, the Asia Pacific, and the Rest of the World. In 2023, North America (US and Canada) dominated the market being a sole a revenue contributor of revenue in 2023. 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 favorable environment for market players, and a strong regulatory framework.