Diagnostic Exosome Biomarkers Market Outlook (2023 to 2033)

The global diagnostic exosome biomarkers market is anticipated to reach USD 196.8 million by 2023. Diagnostic exosome biomarkers sales are anticipated to expand at a significant CAGR of 16.3% between 2023 to 2033. By 2033, the diagnostic exosome biomarkers market is expected to be worth USD 888.5 million.

The market growth can be attributed to the increasing prevalence of cancer, ongoing research on exosomes, and the rising number of clinical studies and trials in exosome-based research expected to spur the diagnostic exosome biomarkers market during the forecast period. Even though there is no FDA-approved clinical exosome product, the number of clinical trials using exosome-based medicines and diagnostics continues to rise.

  • As of June 2021, ClinicalTrials.gov lists about 63 research trials using exosomes to treat disorders, a significant number associated with cancer development.
  • As per the International Agency for Research on Cancer’s GLOBOCAN 2020, there were about 19.3 million new cases of cancer and about 10 million cancer deaths in 2020.
  • It is anticipated that more than 1.8 million new cancer cases can be diagnosed in the United States in 2020, and over 0.6 million people to die due to the disease.

There has been a rise in studies focusing on comprehending the functionality of exosomes in diseases, especially cancer. Exosomes are associated with several cancer hallmarks that affect tumor spread, immunological regulation, and therapeutic hallmarks.

Attributes Diagnostic Exosome Biomarkers Industry (From 2018 to 2022)
CAGR 14.5%
Market Size - 2018 USD 100.07 million
Market Size - 2022 USD 172.1 million
Attributes Diagnostic Exosome Biomarkers Industry (From 2023 to 2033)
CAGR 16.3%
Market Size - 2023 USD 196.8 million
Market Size - 2033 USD 888.5 million

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Beyond Growth: Assessing Diagnostic Exosome Biomarkers Markets from 2018 to 2022 to the Booming Era of From 2023 to 2033

From 2018 to 2022, the diagnostic exosome biomarkers business experienced substantial growth as research and development in exosome-based diagnostics surged.

Advances in technology and an increased understanding of exosomes' role in disease pathology led to identifying potential biomarkers for various conditions, including cancer, neurodegenerative disorders, and infectious diseases. As a result, the diagnostic exosome biomarkers industry witnessed rising investments, product launches, and collaborations between biotech companies and research institutions.

The diagnostic exosome biomarkers market is expected to enter a booming era from 2023 to 2033. With the validation of exosome biomarkers and their adoption in clinical settings, exosome-based tests are likely to become routine diagnostic tools.

The shift toward personalized and non-invasive diagnostics may boost market growth for diagnostic exosome biomarkers, as these tests offer early detection and monitoring capabilities. The expanding applications of exosome-based therapeutics are anticipated to fuel market expansion for diagnostic exosome biomarkers.

Challenges such as standardization, regulatory hurdles, and cost considerations must be addressed to ensure the sustainable growth of the diagnostic exosome biomarkers market in the coming decade.

What Factors Contribute to The Growth of the Global Diagnostic Exosome Biomarkers Market?

Growing Investments in the Pharmaceutical Sector to Augment the Market Size

Most biopharmaceutical, pharmaceutical, and medical equipment manufacturers invest hugely in developing novel drugs and devices. Pharmaceutical companies make heavy research and development investments to produce high-quality and innovative products.

  • As per the EvaluatePharma report, pharmaceutical research and development expenditure was valued at USD 136 billion in 2012, which increased to USD 186 billion in 2019.

The introduction of new technologies is likely to benefit the diagnostic exosome biomarkers industry notably. Exotic devices, a new exosome isolation technology, were introduced recently and expanded significantly over time due to their various benefits, such as purity, high yield, and efficiency. The market is expected to flourish in the forecast period due to such factors.

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Sabyasachi Ghosh

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What are the Factors Hindering the Global Diagnostic Exosome Biomarkers Market?

Lack of Awareness and Strict Rules for Product Approval Hamper the Market

Lack of awareness and stringent rules for product approval are expected to hamper the market growth during the forecast period despite various developments in the market. Other factors hampering the market include a lack of unique biomarkers, inefficient separation techniques, and a need for high-resolution visualization equipment limiting understanding of exosomes.

The growing collaboration among diagnostic exosome biomarkers manufacturers is likely to counter the hampering factors and propel growth.

  • In August 2020, Aethlon Medical, a healthcare company, announced its collaboration with the University of Pittsburgh on a National Institute of Health Grant for treating head and neck cancer.

What are the Prevailing Opportunities in the Global Diagnostic Exosome Biomarkers Market?

Increasing Demand for Specialized Testing Services to Expand Market Size

The diagnostic exosome biomarkers manufacturers are outsourcing specialized testing services like Liquid Chromatography-Mass Spectrometry, RNA sequencing, wet chemistry, gene expressions, and others earlier in the API process development cycle. These services are mainly used for structural elucidation of key impurities, removing class I and II solvents, removing column chromatography, and efforts toward overall cost reduction and process efficiency.

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Category- Wise Outlook

Category Product
Leading Segment  Reagents & Kits
Market Share 58.8%
Category End User
Leading Segment  Diagnostic Centers
Market Share 37.3%

From Convenience to Standardization: Why Reagents & Kits Dominate Exosome Biomarker Diagnostics

Reagents and kits lead the demand in the diagnostic exosome biomarkers market. The reagents are essential components used in various diagnostic procedures and research involving exosome biomarkers, making them a fundamental requirement for most applications.

The commercially available kits' convenience and time-saving aspects, including reagents and necessary protocols, attract researchers and clinicians, streamlining the experimental process. Moreover, the increasing adoption of exosome-based diagnostics in various fields, such as oncology and neurology has fueled the demand for efficient and standardized testing solutions, contributing to the popularity of reagents & kits in the market.

A Winning Strategy: Why Diagnostic Centers Lead in Exosome Biomarker Sales

Diagnostic centers lead the diagnostic exosome biomarkers sales. The diagnostic centers are dedicated facilities specializing in various diagnostic tests, including advanced biomarker assessments. Their focus on accurate and timely diagnoses attracts many patients seeking cutting-edge diagnostic services.

The diagnostic centers often collaborate with research institutions and pharmaceutical companies, surging demand for exosome biomarker testing in clinical trials and drug development studies. These centers have a broader reach, serving patients from different medical backgrounds, making them a central hub for biomarker-based testing. Also, their expertise, accessibility, and collaborative efforts contribute to their leading position in the diagnostic exosome biomarkers market.

Is Diagnostics Exosome Biomarkers Deployment Likely to be Maximum across Cancer Institutes?

Extensive Research to Develop Key Breakthroughs for Cancer Treatment Fueling Growth Prospects

According to Future Market Insights, the application of exosomes in cancer diagnosis and the development of translational precision medicine is expected to be maximum across cancer institutes. A market share worth 38.4% is anticipated for this segment in 2023.

Exosomes have proven to be highly effective in detecting multiple cancers in their early stages, with a reasonably high degree of sensitivity and specificity. Their intrinsic characteristics provide a unique ability to bypass biological impediments, notably the blood-brain barrier, or BBB. Since exosomes can target particular cell types, the transmission of therapeutic agents by exosomes could be more efficient than other vectors.

Regional Outlook

Countries Value Share in the Global Market
North America 52.6%
Europe 30.6%

How is Rising Product Launch in North America Favoring the Global Diagnostic Exosome Biomarkers Market?

North America is expected to dominate the global diagnostic exosome biomarkers industry during the forecast period. As of 2023, the region is expected to secure about 52.6% of global revenue. Domination of the region can be attributed to established players and the growing launch of products.

  • In April 2020, Exosome Diagnostics, a biotechnology company, launched an ExoDx Prostate test kit at home. ExoDx Prostate (EPI) test is a urine-based, genomic test that assists in detecting prostate cancer.

Such factors are expected to benefit the regional market in the forecast period.

How is the Growing Prevalence of Cancer Supporting the Market Growth of the Diagnostic Exosome Biomarkers Market?

As per the analysis, Europe is expected to be the second-leading diagnostic exosome biomarkers industry during the forecast period. In 2023, the region is likely to claim 30.6% of revenue. The development of the regional diagnostic exosome biomarkers market can be attributed to the increasing incidences of cancer across the region.

  • Cancer.org revealed an estimated 3.9 million new cancer cases and 1.9 million cancer deaths in Europe in 2018, which has propelled the demand for diagnostic exosome biomarkers.

Another factor contributing to the development of the regional market is the government's increasing expenditure on healthcare infrastructure.

Countries Market CAGR (From 2023 to 2033)
China 19.8%
India 16.2%
Australia 9.5%

What are the Growth Prospects for Diagnostic Exosome Biomarkers in the Asia Pacific?

Asia Pacific is projected to witness maximum growth opportunities, the study reveals. The region's expansion can be attributed to the increasing demand from developing economies like India, China, and Japan. In addition, the rising healthcare expenditures by developing countries are likely to offer remunerative opportunities for market development in the coming time.

Other factors contributing to the market growth for diagnostic exosome biomarkers include the growing prevalence of chronic disorders, increasing healthcare expenditures, and an increasing number of exosome diagnostics. Due to such factors, the diagnostic exosome biomarkers business in the Asia Pacific is likely to expand in the forecast period.

Countries Value Share in Global Market
The United States 48.3%
Germany 8.7%
Japan 4.2%

Which Marketing Tactics Can Manufacturers Utilize To Promote Diagnostic Exosome Biomarkers Market?

  • Collaborate with research institutions for credibility and exposure.
  • Host webinars and workshops to educate healthcare professionals.
  • Utilize social media platforms for targeted outreach and engagement.
  • Offer free trials and samples to encourage adoption.
  • Publish research papers and case studies for thought leadership.
  • Attend medical conferences and exhibitions to showcase products.

How are Startups Contributing to the Growth of the Diagnostic Exosome Biomarkers Industry?

Codiak Biosciences (USA), Exosome Diagnostics (USA), Evox Therapeutics (USA), ExoCoBio (South Korea), ILIAS Biologics (South Korea), Anjarium Biosciences (Switzerland), Xollent (USA), Craif (Japan), and Carmine Therapeutics (USA), are some of the emerging names in the global diagnostic exosome biomarkers market.

Update from the Industry:

  • In July 2017, Exosome Diagnostics Inc. announced the conclusion of its USD 30 million Series C financing, led by insiders Tiger Partners and Forbion Capital Partners. Blue Ridge Capital, NGN Capital, Arcus Ventures, b-to-v Partners, CD Ventures, and others participated in the round, which was oversubscribed.
  • ExoCoBio, a South Korea-based exosome startup, raised around USD 27 million in series B funding. The round was supported by CSQUARED Global Asset Management, Seven Tree Equity Partners, TS Investment Partners, Intervest, K2 Investment, KDB Capital, GU Equity Partners, Atinum Investment, Quantum Ventures Korea, and Platinum Technology Investment.

Competitive Landscape

Key diagnostic exosome biomarker manufacturers include AMS Biotechnology Limited, 101Bio, BioRegenerative Sciences, Inc., Cell Guidance Systems LLC, Codiak BioSciences, Evomic Science LLC, ExoCyte Therapeutics Pte Ltd, Exovita biosciences, Immune Therapy Holdings AB, Lonza Group, Norgen Biotek Corp., ReNeuron Group plc and Therapeutic Solutions International, Inc.

Novel Developments

Company Exo Therapeutics
Strategy Exo Therapeutics Secures USD 78 million in Series B Financing
Details In October 2021, Exo Therapeutics raised USD 78 million in series B financing to develop a new strategy for drugging enzymes. Exo has developed an indirect approach to inhibit enzymes by blocking their exosites.
Company Bio-Techne inked
Strategy Bio-Techne and Thermo Fisher Unite for ExoTRU Kidney Transplant Rejection Test
Details In February 2022, Bio-Techne inked an exclusive agreement with Thermo Fisher Scientific for developing and commercializing the ExoTRU kidney transplant rejection test designed by Bio-Techne. This liquid biopsy test provides allograft health information suitable for clinical and research applications.

Key Segmentation

By Product Type:

  • Reagents
  • Kits
  • Serum/Plasma Kits
  • Urine Kits
  • Software

By Application:

  • Neurodegenerative Disorders
  • Oncology
  • Metabolic Disorders
  • Others

By End User:

  • Cancer Institute
  • Hospital
  • Diagnostic Center
  • Others

By Region:

  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • The Middle East and Africa

Frequently Asked Questions

What is the Projected Size of the Diagnostic Exosome Biomakers Market by 2033?

The global market size to reach USD 888.5 million by 2033.

Top Key Players in the Diagnostic Exosome Biomakers Market?

AMS Biotechnology Limited and Lonza Group are the top key players.

What is the Growth Potential of the Diagnostic Exosome Biomakers Market?

The global market is estimated to secure a CAGR 16.3% through 2033.

What Limits the Growth Potential of the Diagnostic Exosome Biomakers Market?

The rising costs are likely to limit market growth.

Which Product Category is Highly Preferred?

The reagents & kits segment is highly preferred in the global market.

Table of Content
	1. Executive Summary
	2. Market Overview
	3. Market Background
	4. Global Market Analysis 2018 to 2022 and Forecast, 2023 to 2033
	5. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Product Type
		5.1. Reagents
		5.2. Kits
		5.3. Serum/Plasma Kits
		5.4. Urine Kits
		5.5. Software
	6. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Application
		6.1. Neurodegenerative Disorders
		6.2. Oncology
		6.3. Metabolic Disorders
		6.4. Others
	7. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Region
		7.1. North America
		7.2. Latin America
		7.3. Western Europe
		7.4. Eastern Europe
		7.5. South Asia and Pacific
		7.6. East Asia
		7.7. Middle East and Africa
	8. North America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
	9. Latin America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
	10. Western Europe Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
	11. Eastern Europe Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
	12. South Asia and Pacific Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
	13. East Asia Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
	14. Middle East and Africa Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
	15. Key Countries Market Analysis
	16. Market Structure Analysis
	17. Competition Analysis
		17.1. AMS Biotechnology Limited
		17.2. 101Bio
		17.3. BioRegenerative Sciences
		17.4. Cell Guidance Systems LLC
		17.5. Codiak BioSciences
		17.6. Evomic Science LLC
		17.7. Exovita Biosciences
		17.8. Immune Therapy Holdings AB
		17.9. Lonza Group
		17.10. Norgen Biotek Corp.
		17.11. ReNeuron Group plc
		17.12. Therapeutic Solutions International, Inc.
	18. Assumptions & Acronyms Used
	19. Research Methodology
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