Exosome Therapeutics Market, 2022-2035

Exosome Therapeutics Market, 2022-2035

In recent years, therapies utilizing extracellular vesicles have garnered significant attention among the industry stakeholders for the treatment of diverse target indication, primarily owing to the various benefits offered by them, including target specificity, enhanced tissue regeneration, and reduced inflammation and chronic pain. Over time, various research studies have demonstrated the potential of exosomes (membrane bound extracellular vesicles) in disease diagnosis, drug delivery and therapeutic applications. Currently, both industry and non-industry players are attempting to develop exosome based therapeutics for disease management, some of which are already in clinical trials. Moreover, post the onset of the COVID-19 pandemic, there has been a steady increase in the investigational new drug (IND) applications filed for exosome therapies. In a recent review of more than 200 studies evaluating mesenchymal stem cell (MSC) derived exosomes for preclinical use, the exosomes demonstrated benefits in more than 70% of studies.

Q1. What is the current market landscape and recent trends in the exosome therapeutics domain?

The exosome therapeutics market is presently growing at a significant pace among the dynamic sectors of pharmaceutical industry. At present, the pipeline features close to 120 therapeutic candidates, and this number is anticipated to grow further in the foreseen future. More than 40% of the total number of drugs are in clinical stage of development. Further, around 30% of the exosome therapeutics are being developed against oncological indications. It is also worth highlighting that, in the last five years, capital investments worth around USD 500 million have been made by strategic investors for the research and development of exosome therapeutics. Additionally, over time, more than 60 pharmaceutical companies and academic / research institutes have undertaken various initiatives to develop effective exosome therapies against multiple target indications. Of the total candidates, seven exosome therapies, including EXOMSC-COV19 (Dermama Biotech Lab), Dex2 (Gustave Roussy Institute), SF-MSC-EX (Osmangazi University), are currently being evaluated in the advanced clinical stages of development. Moreover, multiple collaborations have been inked between both industry and non-industry players in order to advance the efforts in research and development of various pipeline candidates, over the past decade.

Q3. What are the key challenges faced in the exosome therapeutics domain?

Despite the numerous benefits offered by exosome therapies, developers often face concerns related to the weak therapy preparations, bacterial infections, and contamination with non-exosomal components. Additionally, the heterogeneous nature of such extracellular vesicles (EVs) is one of the major challenges faced during the quantification and characterization of the required EVs from a diverse population of cells. In order to mitigate the aforementioned challenges, novel technologies are being adopted by several stakeholders.

Q4. What are the key value drivers in the exosome therapeutics market?

The factors contributing to the growth of exosome therapeutics market include increasing disease burden, rise in research and development activities for exosome therapeutics, and government funding for the production of such therapeutics. Moreover, the growth potential in the emerging economies bolsters the exosome therapeutics market growth.

Q6. How is the revenue generation potential, associated with exosome therapeutics market likely to evolve in the coming years?

The exosome therapeutics market is projected to grow at a CAGR of more than 30%, with anticipated release of a number of therapies in the foreseen future. In terms of route of administration, the market is likely to be driven by exosome therapeutics designed for intravenous administration. Further, in terms of therapeutic area, majority share of the revenues is expected to be generated by infectious diseases. Specifically, in terms of geography, the exosome therapeutics market in North America is likely to grow at a significant pace, in the long term.

Q7. Who are the key players engaged in the exosome therapeutics market?

The key players engaged in this domain (which have also been capture in this report) include Cellular Biomedicine Group, Codiak BioSciences, Coya Therapeutics, Curexsys, EV Therapeutics, Evox Therapeutics, ExoCoBio, ILIAS Biologics, Rion and SHIFTBIO.

1.1. SCOPE OF THE REPORT

The “Exosome Therapeutics Market by Distribution by Target Indication (COVID-19 Disease, Degenerative Meniscal Injury and Retinitis Pigmentosa), Therapeutic Area (Infectious Diseases, Musculoskeletal Disorders and Ophthalmic Diseases), Type of Formulation (Liquid and Aerosol), Route of Administration (Inhalation, Intravenous, Intra-articular and Intra-ocular) and Geography (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, Industry Trends and Global Forecasts, 2022-2035” report features an extensive study on the current market landscape, offering an informed opinion on the likely evolution of the exosome therapies in the treatment of various diseases. The study presents an in-depth analysis, highlighting the diverse capabilities of players engaged in this domain, across different geographies. In addition to other elements, the report includes:

General introduction to exosomes, types of extracellular vesicles and their origin, secretion, and type of membrane. In addition, it provides information on the development process of exosomes and details on applications of exosomes, mechanism of different therapies, along with the advantages, risks associated with exosome therapeutics and the future perspectives.

A detailed assessment of the current market landscape of exosome therapeutics, based on several relevant parameters, such as phase of development (clinical and preclinical), technology platform (DeliverEXTM platform, iPSC Platform, engEx™ Platform, mTEV Platform, PEP Exosome Technology and others), type of payload (protein, biologics, RNA, vaccine, antisense oligonucleotide, DNA / protein and AAV capsids), target disease indication (s) (COVID-19, acute respiratory distress syndrome, skin regeneration, cancer and others), therapeutic area (oncological disorders, dermatological disorders, neurological disorders, infectious diseases, rare disorders, autoimmune disorders and respiratory disorders and others), biological target, route of administration (intravenous, oral, subcutaneous, intratumoral, nasal and others), type of therapy (monotherapy and combination therapy), combination drug, line of treatment and dosing frequency. In addition, it provides details on the companies engaged in the development of exosome therapeutics, along with information on their year of establishment, company size and location of headquarters.

Elaborate profiles of the key players engaged in the development of exosome therapeutics, with maximum number of therapeutic programs in their pipeline. Each profile features a brief overview of the company, its financial information (if available), details on its product portfolio and a section on recent developments and an informed future outlook.

Elaborate drug profiles of the key therapeutics in the highest phase of development. Each profile features a brief information on product portfolio and clinical trial information including study title, study detail, status of trial, phase of development, trial location, patient enrollment, study start and end date.

A detailed analysis of completed and ongoing clinical trials of various exosome therapeutics, based on different parameters, such as trial status, trial registration year, type of sponsor / collaborator, study design, and number of patients enrolled. In addition, the chapter highlights year-wise trend of completed and recruiting trials, age group of the patients enrolled, active industry and non-industry players and location of the trials.

An in-depth analysis of academic grants that have been awarded to various research institutes for projects related to exosome therapeutics, during the period, 2017-2022, based on several parameters, such as year of grant awarded, amount awarded, type of funding institute center, popular NIH departments, support period, emerging focus area, purpose of grants, grant activity code, local recipients, type of recipient organization study section and type of grant application. Further, the chapter also highlights the popular recipient organizations, (in terms of number of grants and amount awarded).

A detailed analysis of the global events attended by the exosome therapy developers, based on several relevant parameters, such as year of event, type of event platform, location of event, emerging focus areas, active organizers (in terms of number of events), active industry and non-industry participants, designation of participants, affiliated department of participants, and active speakers (in terms of number of events).

An analysis of the partnerships that have been established in this domain since 2017, covering instances of research agreement, licensing agreement, manufacturing agreement, product development and commercialization agreement, merger / acquisition, and other relevant deals.

A detailed analysis of the various investments made since 2017, including grant / award, seed financing, venture capital financing, IPOs, secondary offering, debt financing, other equity, in companies focused on the development of exosome therapeutics.

An analysis of start-ups / small companies engaged in the development of exosome therapeutics, based on parameters, such as pipeline strength, pipeline maturity, financial support, number of investors, partnership activity and start-up health indexing.

A case study highlighting the companies engaged in offering exosome development and manufacturing services along with the information on their year of establishment, company size, location of headquarters, types of service(s) offered (isolation, characterization, purification, chromatography, engineering, targeted delivery, diagnostic biomarker, and quality control), method of isolation, method of purification, method of characterization, method of exosome manufacturing (engineering and targeted delivery), scale of operation (discovery / research, pre-clinical, clinical or commercialized) and scalability (small, mid-sized or large).

An in-depth analysis of exosome therapeutics that failed to progress to later stages of clinical development, based on various relevant parameters, such as trial status of discontinuation, target disease indication(s), route of administration and type of sponsor.

One of the key objectives of the report was to identify the primary growth drivers and estimate the future growth opportunity associated with exosome therapies market in the mid to long term. Based on various parameters, such as historical sales, target patient population, likely adoption rates and expected pricing, we have provided informed estimates on the likely evolution of the market for the period 2027-2035. Our year wise projections of the current and forecasted opportunity within the exosome therapies market have further been segmented across target disease indication(s) (COVID-19, degenerative meniscal injury and retinitis pigmentosa), therapeutic area (infectious diseases, ophthalmic diseases and musculoskeletal disorders), route of administration (intravenous, intra-ocular, intra-articular and inhalation), type of formulation (liquid and aerosol), geography (North America, Europe and Asia-Pacific). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

The opinions and insights presented in the report were influenced by discussions held with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company / organization names):

Xavier Avat (Chief Business Officer, Capricor Therapeutics)

Patricia C. Freire (R&D and Innovation Manager, Exogenus Therapeutics)

Soonho Song (Chief Business Officer, ILIAS Biologics)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

1.2. MARKET SEGMENTATION

Exosome Therapeutics: Market Segmentation

Market Segments Details

Forecast Period 2027 – 2035

Target Disease Indication(s) COVID-19

Degenerative Meniscal Injury

Retinitis Pigmentosa

Therapeutic Area Infectious Diseases

Musculoskeletal Disorders

Ophthalmic Diseases

Type of Formulation Liquid

Aerosol

Route of Administration Inhalation

Intravenous

Intra-articular

Intra-ocular

Geographical Regions North America

Europe

Asia-Pacific and Rest of the World

Source: Roots Analysis

1.3. RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry and other associations) to solicit their opinions on emerging trends in the market. This information is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been validated from multiple sources of information.

The secondary sources of information include:

Annual reports

Investor presentations

SEC filings

Industry databases

News releases from company websites

Government policy documents

Industry analysts’ views

While the focus has been on forecasting the market till 2035, the report also provides our independent views on various non-commercial trends emerging in this industry. The opinions are solely based on our knowledge, research and understanding of the relevant market trends gathered from various secondary and primary sources of information.

1.4. KEY QUESTIONS ANSWERED

Who are the leading industry and non-industry players engaged in the development of exosome therapies?

Which are the key drugs being developed across early and late stages of development?

What are the key agenda items being discussed in various global events / conferences related to exosomes?

What kind of partnership models are commonly adopted by industry stakeholders?

Which are the leading funding institutes / centers supporting the research related to exosome therapies?

Which geographies are the most active in conducting clinical trials related to exosome therapies?

How is the current and future market opportunity, related to exosome therapies likely to be distributed across key market segments?

1.5. CHAPTER OUTLINES

Chapter 2 is an executive summary of the key insights captured during our research. It offers a high-level view on the current state of exosome therapeutics market and its likely evolution in the mid to long term.

Chapter 3 provides a general introduction to exosomes, types of extracellular vesicles and their origin, secretion, and type of membrane. In addition, the chapter provides information on the development process of exosomes. Further, the chapter presents details on applications of exosomes, mechanism of different therapies, along with the advantages, risks associated with exosome therapeutics and the future perspectives.

Chapter 4 provides an overview of the current market landscape of exosome therapeutics, based on several relevant parameters, such as phase of development (clinical and preclinical), technology platform (DeliverEXTM platform, iPSC Platform, engEx™ Platform, mTEV Platform, PEP Exosome Technology and others), type of payload (protein, biologics, RNA, vaccine, antisense oligonucleotide, DNA / protein and AAV capsids), target disease indication(s) (COVID-19, acute respiratory distress syndrome, skin regeneration, cancer and others), therapeutic area (oncological disorders, dermatological disorders, neurological disorders, infectious disorders, rare disorders, autoimmune disorders and respiratory disorders and others), biological target, route of administration (intravenous, oral, subcutaneous, intratumoral, nasal and others), type of therapy (monotherapy and combination therapy), combination drug, line of treatment and dosing frequency. In addition, the chapter provides details on the companies engaged in the development of exosome therapeutics, along with information on their year of establishment, company size and location of headquarters.

Chapter 5 includes detailed profiles of the key players engaged in the development of exosome therapeutics, with maximum number of therapeutic programs in their pipeline. Each profile features a brief overview of the company, its financial information (if available), details on its product portfolio and a section on recent developments and an informed future outlook.

Chapter 6 includes detailed drug profiles of the key therapeutics in the highest phase of development. Each profile features a brief information on product portfolio and clinical trial information including study title, study detail, status of trial, phase of development, trial location, patient enrollment, study start and end date.

Chapter 7 provides information on completed and ongoing clinical trials of various exosome therapeutics, based on different parameters, such as trial status, trial registration year, type of sponsor / collaborator, study design, number of patients enrolled. In addition, the chapter highlights year-wise trend of completed and recruiting trials, age category of the patients enrolled, active industry and non-industry players and location of the trials.

Chapter 8 provides an in-depth analysis of academic grants that have been awarded to various research institutes for projects related to exosome therapeutics, during the period, 2017-2022, based on several parameters, such as year of grant awarded, amount awarded, type of funding institute center, popular NIH departments, support period, emerging focus area, purpose of grants, grant activity code, local recipients, type of recipient organization study section and type of grant application. Further, the chapter also highlights the popular recipient organizations, (in terms of number of grants and amount awarded).

Chapter 9 features an analysis of the global events attended by the participants, based on several relevant parameters, such as year of event, type of event platform, location of event, emerging focus areas, active organizers (in terms of number of events), active industry and non-industry participants, designation of participants, affiliated department of participant, active speakers (in terms of number of events).

Chapter 10 features an analysis of the partnerships that have been established in this domain since 2017, covering instances of research agreement, licensing agreement, manufacturing agreement, product development and commercialization agreement, merger / acquisition, and other relevant type of deals.

Chapter 11 presents a review of the funding and investments in this domain since 2017, including grant / award, seed financing, venture capital financing, IPOs, secondary offering, debt financing, other equity, in the companies focused on the development of exosome therapeutics.

Chapter 12 presents an analysis of start-ups / small companies engaged in the development of exosome therapeutics, based on parameters, such as pipeline strength, pipeline maturity, financial support, number of investors, partnership activity and start-up health indexing.

Chapter 13 includes information on more than 45 exosome service providers that are currently offering services related to development and manufacturing exosomes, and a detailed analysis based on several parameters, such as types of service(s) offered, method of isolation, method of purification, method of characterization, method of exosome manufacturing, scale of operation and scalability. In addition, it provides details on the companies along with information on their year of establishment, company size and location of headquarters.

Chapter 14 provides a detailed analysis focused on exosome therapeutics that failed to progress to later stages of clinical development, based on various relevant parameters, such as trial status of discontinuation, target disease indication(s), route of administration and type of sponsor

Chapter 15 presents an insightful market forecast analysis, highlighting the likely growth of exosome therapeutics market, till 2035. In order to provide a detailed future outlook, our projections have been segmented across target disease indications (COVID-19 Disease, degenerative meniscal injury and retinitis pigmentosa), therapeutic areas (infectious diseases, musculoskeletal disorders and ophthalmic diseases), routes of administration (inhalation, intravenous, intra-articular and intra-ocular), types of formulations (liquid and aerosol), and geography (North America, Europe and Asia-Pacific and Rest of the World).

Chapter 16 is a collection of interview transcripts of the discussions held with key stakeholders in this industry. In this chapter, we have presented details of interviews held with (in alphabetical order of company / organization names) Xavier Avat (Chief Business Officer, Capricor Therapeutics), Patricia C. Freire (R&D and Innovation Manager, Exogenus Therapeutics) and Soonho Song (Chief Business Officer, ILIAS Biologics)

Chapter 17 is an appendix that contains tabulated data and numbers for all the figures in the report.

Chapter 18 is an appendix that provides the list of companies and organizations mentioned in the report.