Exosome Diagnostics and Therapeutics Market

Exosome Diagnostics and Therapeutics Market Size, Share & Trends

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.

Exosome Diagnostics and Therapeutics Market Trends

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Exosome Diagnostics And Therapeutics Market Dynamics

DRIVER: Increasing initiatives for product commercialization

Despite the robust product development initiatives by market players, commercialization of both exosome-based diagnostics and therapeutics is slow-paced. This has led to a spike in strategic collaborations to expedite commercial market opportunities. Companies operating in the exosome diagnostics market aim to capitalize on the growing opportunities in this dynamic industry and overcome the challenges associated with developing & commercializing exosome-based diagnostic technologies. In comparison, companies operating in therapeutics collaborate to leverage proprietary advanced exosome technologies, including exosome isolation, characterization, and analysis, to ensure the rapid launch of therapeutic candidates in the market. In March 2024, BIONET (China), a prominent player in Taiwan’s regenerative medicine sector, collaborated with UNIVERCELLS TECHNOLOGIES (Belgium) to integrate the latter’s scale-X fixed-bed bioreactor. By leveraging the scale-X hydro system, BIONET aims to optimize the production of extracellular vesicles (including exosomes) generated by MSCs for therapeutic applications. This development signifies a potential advancement in the large-scale manufacturing of standardized exosome-based therapies.

RESTRAINT: Technical complexities associated with exosome isolation

The complexities associated with isolating and characterizing exosomes, along with existing technological limitations, are significant impediments to the progress of exosome research. These challenges hinder the development of robust methodologies and impact the overall advancement of the field. The complications involved in working with exosomes, which are small extracellular vesicles, pose difficulties in their isolation and thorough characterization. Technological limitations further exacerbate these challenges, preventing achieving precise and consistent results.

OPPORTUNITY: Growing adoption of exosome biomarkers for personalized medicine

Over the years, the popularity of personalized medicine has increased due to limitations of standard diagnosis and treatment. Different fields of medicine, from cancer to psychiatry, are heading towards tailored treatments for each patient based on their biological & clinical characteristics. In 2022, the FDA approved 12 personalized medicines, representing approximately 34% of all newly approved therapeutic molecular entities. Also, five new gene or cell-based therapies were approved. Additionally, in 2022, the FDA expanded the indications for several personalized therapies, showing increased research in personalized medicines backed by increased investments, supporting the growth opportunities of the exosome research space.

CHALLENGE: Inadequate protocols for exosome development & production

The exosome field is still nascent, and no gold standards have been developed. The diversity of exosome isolation techniques, including ultracentrifugation, precipitation, and chromatography, lacks a universally agreed-upon methodology, resulting in variations in purity, yield, and contamination levels. Standardizing parameters for exosome characterization, such as size distribution, surface markers, and cargo content, is complicated by the inherent heterogeneity within exosome populations. The prevalent method, differential centrifugation, often relies on factors such as sample viscosity, resulting in inconsistent exosome capture. Alternative approaches, including size-exclusion chromatography and immunoaffinity capture, though presenting certain benefits, encounter limitations in accuracy and specificity.

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).

Ecosystem Analysis: Exosome Diagnostics and Therapeutics Market

Source: Annual Reports, SEC Filings, Investor Presentations, Expert Interviews, and MarketsandMarkets Analysis

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.

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.

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The global exosome diagnostics and therapeutics market is monopolized, with commercial products approved only in the diagnostics market space. This has created a monopoly in the market, with Bio-Techne (US) being the only player currently offering commercial exosome-based tests. The ExoDx prostate cancer test is a key product offered by Bio-Techne. Companies mapped in the report include 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).

Scope of the Healthcare IT Industry

This research report categorizes the exosome diagnostics and therapeutics market to forecast revenue and analyze trends in each of the following submarkets:

By Type

• Exosome Diagnostics
• Exosome Therapeutics

By Product & Service

• Instruments & Services
• Kits & Reagents

By Source

• Stem Cells
• Blood & Blood Plasma
• Urine
• Other Sources

By Application

• Cancer
• Dermatological Diseases
• Musculoskeletal Disorders
• Cardiovascular Diseases
• Other Application

By End User

• Hospitals
• Clinics and Physician Settings

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • RoE
• Asia Pacific
  • China
  • South Korea
  • Australia
  • India
  • Japan
  • RoAPAC
• Rest of the World

Recent Developments of the Exosome Diagnostics And Therapeutics Industry:

• In September 2023, INOVIQ entered into a license and supply agreement with ResearchDx for INOVIQ’s EXO-NET exosome capture technology. Through this agreement, ResearchDx incorporated EXO-NET technology in its portfolio of exosome diagnostic services.
• In April 2022, INOVIQ expanded its collaboration with the University of Queensland (UQ) for the co-development of exosome-based ovarian cancer screening tests. Through the development, INOVIQ has exclusive rights to license and commercialize this exosome-based early-detection test for ovarian cancer.
• In March 2021, Exosome Diagnostics revealed that its ExoDx Prostate test (EPI) kit completed clinical validation, enabling self-certification as CE-IVD.

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