Entrepreneurship
The goal of our team was to find a new therapeutic approach for IBD. While a big part involves the research necessary to demonstrate a valid in-vitro and in-vivo proof of concept, the only way to improve the life of patients is through building a final product. To be able to go from bench to market, multiple challenges need to be addressed and solved. To better understand the challenges ahead of a project like ours, we talked to various experts in Switzerland. They gave us insight into what it takes to get IBD NanoBiotics from its exploratory stage to a final product able to help patients suffering from Inflammatory Bowel Disease directly. As outlined in the partnership section, we also informed ourselves about regulations in other countries, such as the European Union, which would allow the product to be implemented internationally and increase its market presence giving us more resources to improve IBD NanoBiotics.
Financial analysis of the local costs of IBD on the Swiss healthcare system
Inflammatory bowel disease (IBD) is a chronic condition of unknown etiology. Data on the Swiss incidence and prevalence show an increasing trend. In the year 2014 for example, an estimated 0.41 % (33’540 out of 8.2 Mio people) were suffering from IBD. 1. Following this upward trend, adding to the fact that no significant change in disease management has occurred, this number must have increased drastically between 2014 and 2022.
IBD patients suffer from a myriad of symptoms including bloody stools, abdominal pain and diarrhea. A key characteristic of IBD is periodic episodes of inflammation in certain intestinal sections, which worsen the symptoms mentioned previously. Current treatment options include aminosalicylates, immunosuppressants, biologics and steroids that aim to mitigate symptoms but lack the ability to cure the condition. Therefore, patients rely on their long-term use for sustained remission. Data on health care costs shows that patients treated with biologics a higher cost than patients using a different therapy. 1 Furthermore, our analysis shows that biologics are the most used treatment option for our IBDN cohort participants.
In addition to increased costs, patients on biologics are a heavy burden on the healthcare system due to the medical care the treatment requires. For instance, patients need to consult an infectious disease specialist that will examine the presence of latent or active infections (like tuberculosis) before a biologics therapy can be started. The same scenario is true for Italy as discussions with an Italian infectious disease specialist revealed. Moreover, the delivery of the treatment requires additional healthcare resources as it needs to be administered intravenously by medical staff. Swiss data show that IBD patients have a significantly higher number of annual physician visits in 2014 when compared to the non-IBD population, with the median number being 15 and 4 respectively. 1 Moreover, almost 25% of IBD patients included in a Swiss observatory epidemiological study had to be hospitalized once a year 1. The costs for the clinical management of IBD could be even higher due to the occurrence of other comorbidities that patients suffer from, as demonstrated by our IBDNC study. These findings show that IBD is a relatively common condition among the Swiss population that requires a high proportion of healthcare resources for its clinical management. A treatment that reduces the economic burden and increases the well-being of patients is highly demanded.
Our novel solution: IBD NanoBiotics
By utilizing synthetic biology's tools, we came up with the pioneering idea to genetically engineer the probiotic E. coli Nissle 1917 strain to locally dampen inflammation in the gastrointestinal (GIT) tract of IBD patients. Taking into consideration the wishes by IBD patients, we plan to encapsulate our probiotic strain in a pill to be delivered orally in order to simplify administration. Current treatment options have a systemic mode of action leading to a long list of potential side effects. They also often fail at inducing complete remission in IBD patients or decline in efficacy as patients develop resistances. In contrast, IBD NanoBiotics would specifically and locally dampen the inflammation in the GIT without interfering with immune functions outside the inflamed areas. To address the issues described with biologics, we expect our chassis to:
- Decrease health care costs and resources related to its administration
- Decrease systemic side effects and reduce annual physician visits related to them
In figure 1, the corresponding SWOT analysis for IBD NanoBiotics is shown. It is integral to know where we stand as well as what our strengths and weaknesses are to successfully implement our product on the market.
Global Market Analysis
The global market for Inflammatory Bowel Disease treatment was valued at 23.9 billion US Dollars in 2021. 2 Projections predict a Compound Annual Growth Rate (CAGR) of 5.7%, leading to a market size of 37 billion US Dollars by 2029. 2 Therefore, we expect the demand for our product to increase as well, making it a promising investment option for future stakeholders.
Market strategy
Firstly, we need to establish an intellectual property strategy to protect our innovative solution. Ideally, we would need to patent our idea. Experts from the IPI (Swiss Federal Institute for Intellectual Property) advised us to implement a solid intellectual protection policy because it is an integral part of research and development. It increases the chances of securing funding for these initial stages, as relevant results can be protected. When considering entering the market, freedom to operate should be a top priority. Therefore, extensive research into current patents is required and identifying the marketing strengths of our project will be necessary. A strength of our project is its modular nature, as parts can be adapted to address different problems. An example of this would be the ability to change the nanobody target while retaining the ability to secrete. This is beneficial for us, as IBD research is still ongoing and novel research might reveal new and better suited targets. Translating our findings to later market application requires the consideration of several important questions. For instance, is the development of new nanobody sequences that target TNF economically beneficial over purchasing a license and continuing to use the current patented sequences? Can our developed nanobodies show the same or better properties as the patented versions?
Applying for a patent would mean that all the project components should be ready and functional. Therefore, further research and proof of concept will be required to apply for a patent. Experts have advised us to stay affiliated with an academic institution as long as possible in order to gather the data required to file a patent and think about founding a start-up. To conclude, collaboration with a more prominent pharmaceutical company will be absolutely necessary to move our research to the clinical phase. Experts that we have reached out to estimate the costs for clinical trials to appoint 70 Mio. Swiss francs, highlighting the need to collaborate to implement our project as described here .
Stakeholders
Our collaboration with Pharmabiome, an ETH spin-off, has been fundamental to understanding and dissecting the market of microbiome-based therapies. As they are also at an early market stage, they provided us with fundamental insight and expertise. We are thrilled to see what the future holds for IBD NanoBiotics!
References:
- Bähler, C., Vavricka, S. R., Schoepfer, A. M., Brüngger, B., & Reich, O. (2017). Trends in prevalence, mortality, health care utilization and health care costs of Swiss IBD patients: a claims data based study of the years 2010, 2012 and 2014. BMC gastroenterology, 17(1), 138.
- Fortune Business Insights, May 2022. "The global inflammatory bowel disease treatment market is projected to grow from $25.18 billion in 2022 to $37.00 billion by 2029, at a CAGR of 5.7%..."