Exosome Diagnostics and Therapeutics Market Size, Share, Industry, Forecast and outlook (2024-2031)

Market Overview

Exosome Diagnostics and Therapeutics Market is estimated to grow at a CAGR of 20.0% during the forecast period (2024-2031).

Exosomes are nano-vesicles that constitute proteins, DNA, and RNA. Exosomes are vital in cancer diagnosis because they aid cell-to-cell communication. It aids in the regulation of complicated intracellular and extracellular vesicles and hepatocellular carcinoma pathways, which are increasingly relevant in the treatment of neurological diseases and cancer.

Market Scope

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Market Dynamics

Advancements in exosome isolation techniques are expected to drive market growth.

With the fast advances in science and technology, many techniques have been developed to isolate exosomes in appreciable quantity and purity. Each technique exploits a particular trait of exosomes, such as their density, shape, size, and surface proteins to aid their isolation. For instance, Ultracentrifugation-based isolation techniques are considered the gold standard and are among the most commonly used and reported techniques in exosome isolation.  It is estimated that ultracentrifugation accounts for 56% of all exosome isolation techniques employed by users in exosome research. Many often perceive this approach as easy to use, requiring very little technical expertise, affordability over time (i.e., one ultracentrifuge machine for long-term use), and moderately time-consuming with little or no sample pretreatments.

Moreover, there are two types of ultracentrifugation - analytical and preparative ultracentrifugation. As for exosome isolation, preparative ultracentrifugation plays an integral part since it is meant to fractionate small bioparticles such as viruses, bacteria, subcellular organelles, and extracellular vesicles. Therefore, ultracentrifugation-based techniques have become a rather popular option among researchers in exosome research.

Restraint:

Lack of awareness, high diagnostic costs and a high incidence of cancer in low-income groups, Exosome-based research products are approved under strict regulations are some of the factors the market is expected to hamper in the forecast period.

COVID-19 Impact Analysis

The COVID-19 pandemic has affected the healthcare systems and has a notable impact on the market. There are presently no FDA-approved antiviral medicines for COVID-19, and therapy options to decrease SARS-CoV-2 infection are urgently needed successfully. The COVID-19 pandemic caused significant interruptions to clinical trial execution in the U.S., affecting essential stakeholders across the industry. Moreover, the stakeholders experienced financial losses, driven by staff leaves and concerns about workers' safety. So far, a variety of techniques have been investigated, one of which is the new exosome-based therapy. Exosomes have been exploited for therapeutic benefits in patients afflicted with various diseases, including COVID-19. In particular, exosomes derived from mesenchymal stem cells (MSCs) are used as cell-free therapeutic agents. Mesenchymal stem cell-derived exosomes reduce the cytokine storm, reverse the inhibition of host antiviral defences associated with COVID-19 and enhance mitochondrial function repair lung injuries. Thus, the market will undergo impetus growth during the forecast period.

Market Segment Analysis

The diagnostic segment is expected to hold the largest market share in the exosome diagnostics and therapeutics market.

The diagnostic segment accounted for the largest market share in 2020. Early screening and accurate diagnosis are undoubtedly the primary issues for patients with tumors or precancerous lesions, reducing mortality and increasing the recovery rate. Exosomes play critical roles in various physiological and pathological processes, including cancer, pregnancy disorders, cardiovascular diseases, and immune responses. It is crucial to introduce liquid biopsy to clinical practice to reduce invasive operations and promote more precise medical intervention. Noninvasive liquid biopsy shows significant advantages for individualized and accurate diagnosis and treatment. Tumor-derived exosomes (TDEs) are critically related to tumor progression, metastatic niche formation, and immune evasion, which indicates that TDEs may hold great promise for cancer diagnosis, prognosis and treatment response assessment. For instance, In pancreatic cancer, a high probability of KRAS mutation in circulating exoDNA is found early. Given that the elevated level of GPC1+-circulating exosomes occurred in patients with pancreatic ductal carcinoma (PDAC) and colorectal cancer (CRC)compared to healthy controls, this could serve as an early detection tool for tumors in the digestive system. Therefore, from the above statements, the market is expected to hold the largest market share in the forecast period.

Market Geographical Share

North America region holds the largest market share in the global market

In 2020, North America accounted for the highest revenue share. The increasing prevalence of cancer-related deaths, significant rise with a rising focus on life science research, increased diagnostic procedures for cancer, and innovative and advanced applications of isolation kits in the region are some factors that the market is expected to boost in the forecast period. For instance, according to the American Cancer Society, In 2020, an estimated 1.8 million new cancer cases were diagnosed and 606,520 cancer deaths in the United States. In contrast, in 2021, there will be an estimated 1.9 million new cancer cases diagnosed and 608,570 cancer deaths in the United States. Moreover, AEGLE Therapeutics has spent decades researching clinical applications of mesenchymal stem cells (MSCs) in severe dermatological disorders, including conducting clinical trials in burns and wounds under multiple INDs. Thus, from the above statements, the North American region is expected to hold the largest market share in the forecast period.

Market Major Players

Major key players in the exosome diagnostics and therapeutics market are Norgen Biotek Corp, Evomic Science LLC, Cell Guidance Systems LLC, ExoDx, Aegle Therapeutics, Capricor Therapeutics, Creative Medical Technologies Holdings and EXOCEL BIO.          

Norgen Biotek Corp:

Overview:

Norgen Biotek was founded in 1998 by Dr Yousef Haj-Ahmad. The company is located in a 24,000 square foot state-of-the-art facility in Thorold, Ontario, Canada, a few blocks from Brock University. Norgen is an ISO 9001, ISO 13485 and Illumina Propel certified fully-integrated Canadian biotechnology company focusing on developing products for sample collection, sample preparation and sample detection and providing comprehensive research services to the scientific community. The Illumina Propel certification emphasizes proficiency with Illumina Next-Generation Sequencing (NGS) to support genetic and genomic research and provide high-quality services to our customers.

Product Portfolio:

Norgen’s Exosome Purification and RNA Isolation Kits: It enables fast, flexible, robust, and convenient all-in-one systems for intact exosome purification from a wide range of cell-free liquid biopsies in addition to the subsequent RNA isolation from both the purified intact exosomes and the circulating cell-free RNA.