Barcelona_UB - iGEM 2022

ENTREPRENEURSHIP

Introduction

We have carefully considered the feasibility of our project in order to be implemented in the real world. With the aim of doing so, we have considered vital to analyze multiple factors both about our project and the market. Those include a global and regional analysis of the exosomes market, the growing scientific interest on the matter and the current ongoing clinical matters about exosomes, and aspects about our project, like its scalability, its potential customers, and a SWOT analysis, and with all of that research, we have proposed the possibility of creating a start-up. During productive discussions we agreed on goals, terms, deadlines, and several alternatives on how to achieve these particular milestones.

Economic matters: Market analysis (Collaboration)

The economic matters that must be taken into consideration include an analysis of the international market of nanovesicles in general and exosomes in particular, evaluating its size, expected growth, key players, and segmentation. This analysis is one of the results of a collaborative effort with another IGEM group, IISER Thiruvananthapuram from India: we have focused our analysis in the occidental market (America and Europe), whereas their effort has been centered in the oriental market (Asia Pacific).

When analyzing the international market for nanovesicles, according to reports by Grand View Research, Inc. and Allied Market Research, there has been significant growth in both market volume and R&D investment in this field for years, which is expected to continue to grow exponentially in the upcoming years. Specifically in relation to exosomes, in 2020 the market size was estimated to be US$224 million. Looking at growth forecasts, the prevision in 2018 was that by 2030 the market size would reach US$2.28 billion; however, these growth forecasts have been exceeded, as new reports this year anticipate a revaluation in 2030 that would reach US$2.9 billion, something that would represent an annual growth ratio of 29.4%.

This expected growth is related to the increasing government funding for exosome research due to all the aforementioned potential applications as carriers of functional content, both for diagnostic and therapeutic purposes, for multiple chronic diseases that have been growing in prevalence for years and for which there is an ever-increasing therapeutic demand. The diseases whose therapies are expected to be the most lucrative due to their high prevalence and cost to healthcare systems are heart failure, Parkinson's disease, Alzheimer's disease and, especially, neoplastic diseases. Moreover, this growth has increased thanks to the greater interest in molecular diagnostics and targeted therapies that the SARS-CoV-2 pandemic has sparked, leading to technological advances in exosomes isolation and analytical procedures in recent years.

The global exosomes market can be segmented by application (diagnostics, therapeutics, vaccines), product (instruments, kits and reagents, software), indication (cancer, neurodegenerative diseases, cardiovascular diseases, infectious diseases, others), end user (cancer institutes, hospitals, diagnostics centers, others), and region (North America, Europe, Asia Pacific, Latin America, Middle East and Africa). The therapeutic application segment, the kits and reagents product segment, and the cancer indication segment are the categories that are expected to hold the largest market share during the next few years. Centring on the geographical segmentation, North America has and is likely to hold the largest share of the market, due to the good healthcare infrastructure, effective government policies, large number of government-funded research studies, presence of the majority of the key participants of the market and their frequent collaboration with state universities, and high awareness among population about healthcare; Europe is projected to held second leading share of the market due to the increase in the prevalence of cancer and high per capita healthcare expenditure by the governments; Asia Pacific is though expected to have the most significant growth during the next years also due to the increase in the prevalence of cancer; and finally, Latin America and Middle East and Africa will show moderate growth, owing to rising disposable income, escalating number of tobacco consumers, and the notable rise in the number of healthcare and diagnostic centers.

The key participants operating in the occidental submarket of this sector that are expected to majorly contribute to the expected growth include companies like Aegle Therapeutics (USA), Aethlon Medical, Inc. (USA), AMS Biotechnology (UK), Beckman Coulter, Inc. (USA), Bio-Techne (USA), Capricor Therapeutics (USA), Codiak BioSciences, Inc. (USA), Diagenode, Inc. (USA), Exiqon A/S (Denmark), Exosome Diagnostics, Inc. (USA), Exosome Sciences (USA), Illumina, Inc. (USA), Lonza Group (Switzerland), Malvern Panalytical (UK), Miltenyi Biotec (Germany), NanoSomiX, Inc. (USA), NX Pharmagen (USA), Qiagen (Germany), System Biosciences, Inc. (USA), and Thermo Fisher Scientific, Inc. (USA). These key players in the exosome market utilize strategies involving management of their manufacturing operations through countries which offer lower manufacturing costs, and acquisition, development and monetization of mature clinical-stage breakthrough technologies. Therefore, the occidental exosome market depends highly but not exclusively on the United States of America, and it is not consolidated, but highly competitive, since it consists of a number of major players, without any of them dominating the market.

On the other hand, key players in the oriental submarket are companies like Fujifilm (Japan), Hitachi Chemical Co., Ltd. (Japan), Takara Bio, Inc. (Japan). Therefore, at the moment, the Asia Pacific exosomes market depends highly on Japan, and there are far less big companies compared to the occidental market, which explains why its market share is lower, but the growing expectancy is much higher.

Scientific interest and ongoing clinical trials

In addition to the economic growth, a parallel growth of scientific interest in exosomes is observable, especially with respect to their applications: as a reference, when analyzing the results of the Pubmed database with respect to the keyword "exosome", about 6900 articles appear, with an exponentially increasing distribution, such that, of these, about 2550 were published since January 2021, representing 37% of the total (see attached figure).

Specifically, with respect to clinical research on exosomes, according to the U.S. National Library of Medicine database, there have been 279 clinical studies related to exosomes. Of these, the vast majority correspond either to the use of exosomes derived from unmodified mesenchymal stem cells for the treatment of multiple pathologies, or to the detection of exosomes in plasma, as a form of liquid biopsy for early diagnosis or prognostic staging of neoplastic diseases, and others.

There are only 5 studies (out of these 279) that attempt to apply the same philosophy as our project, i.e. the therapeutic use of modified exosomes with a specific cargo for the treatment of specific diseases. These 5 studies are still ongoing and 3 of them attempt to treat infectious diseases (specifically, COVID-19) and 2 attempt to treat neoplastic diseases (specifically, hepatocellular carcinoma and pancreatic ductal adenocarcinoma).

Therefore, it is a very broad field of study with multiple potentially treatable diseases, but which is still very little exploited, being therefore a great opportunity for research and investment. This fact, together with a growing market and considering that our field of study corresponds to the segments of the exosomes market that are expected to hold the largest market share during the next years (the therapeutic application segment, the kits and reagents product segment, and the cancer indication segment), we consider our project to have a lot of both scientific and profit potential.

Scalability

All the potential benefits and applications of our product have led us to consider our project scalable. First of all, it can be applied for treating different diseases as discussed extensively in the implementation section of the wiki, which enlarges the potential consumers and uses of Vesiprod. Secondly, the kit format makes its usage efficient and easy. Furthermore, our product takes advantage of this new niche in the market of the biotechnological industry by exploiting the exosome technology as a delivery system of drugs.

We propose a new approach that has not been developed before, so the innovative character of our product is another trait that makes it scalable. To make scalability possible, one of our main purposes is to fully ensure and guarantee the standardization, safety and quality of Vesiprod.

Because of all that, and after proper research and consultation, we have concluded that we have the capability of commercializing Vesiprod also on a large scale. However, this procedure comes with its own challenges to overcome. For example, although escalation results in a reduction in material costs due to bulk consumption, many big one-time purchases must be made. Therefore, for clinical trials and escalation procedures sufficient funding must be acquired.

Potential customers

Our proposed end users would be the pharmaceutical and biotechnological industry, in particular the members of research groups of either the public or private sector centered on therapeutics development and, eventually, medical providers and patients all over the world, having the potential to change medicine as we know it today by giving symptomatic and even prognostic-changing possibilities to many diseases we still consider intractable.

Creation and funding of a Start-Up

Because of the cited scientific and profit potential, for the real-world application of our product, our proposal is the creation of a start-up company for the patenting of our designed products, both the kit to create engineered exosomes with a personalized cargo and targeting membrane proteins, as well as the engineered exosomes loaded with siRNA against MYC and overexpression of CD19-L for the treatment of Burkitt's lymphoma, in addition to possible future exosomes with other cargoes for the treatment of other pathologies that we could use our developed kit for.

For the financing of this start-up, it is necessary to take into account that according to the previous analysis of the current exosomes market, it is still an incipient market, which we could define as a Blue Ocean in the terms of Kim and Mauborgne, in which there are not yet fully established competitors. This prevents financing within the framework of companies in the sector (or an early acquisition of the start-up by them). Therefore, the most feasible option would be to receive funding from so-called "seed capital" to cover the initial costs and investments of the company in exchange for a variable share of the company.

Once the company is up and running, it would be necessary to seek additional funding from Venture Capital. Due to the type of company and the sector (considering the high uncertainty of these projects and the possibility of a lack of results) this type of financing is the most feasible to obtain, compared to more traditional sources (such as banks). Moreover, in many occasions they are the best option to, in the medium term, scale up operations to ensure the achievement of results and, consequently, the viability of the company. In addition, it is particularly useful that certain sectorial Venture Capital funds in the biotechnology field, usually get involved in a notorious way with their investees, contributing their "know-how" in companies of the referred field.

SWOT: Strength, Weakness, Opportunities and Threats

We have conducted a SWOT analysis to assess the competitive advantages of our project, its weaknesses and how to turn them into strengths, other opportunities and threats to our business growth. In this regard, we recognize our weaknesses and threats and understand that it is necessary to create strategies to address them in order to gain a foothold in the global market. We will overcome them by expanding our knowledge, increasing our competencies and maintaining close relationships with our target audience.

Among the most important skills that we consider essential to running a business are financial literacy, scientific knowledge and the ability to use it, effective marketing and communication skills, strong leadership and good time management. As our team consists mainly of undergraduate members with little entrepreneurial experience, we are certain that professional guidance is needed for the development of our business. For this we count on the fact that our team has many strong long-term connections with several scientific research teams and experts in entrepreneurship at both the University of Barcelona and the Josep Carreras Foundation. These connections give us the opportunity to gain specific expertise in fields where our team may lack specific experience or skills and lead to faster growth of the company.

Entrepreneurship