Executive Summary
The iGEM Stockholm 2021 team consists of 17 young entrepreneurs with a background in biotechnology, biomedicine, nanotechnology, chemical engineering and other technical sciences. Together, we are developing MIKROSKIN, a rapid test for discerning imbalances in skin microbiota. For this, the test uses a set of DNA aptamers to diagnose dysbiosis in the form of imbalances in the amount of S. aureus and C. acnes on the skin.
We believe that MIKROSKIN can be valuable to many people, which led to the formation of the business model. Our stakeholders include researchers with a focus on skin microbiota and skincare companies including, but not limited to, pro- and prebiotics, national and international regulatory organs (WHO, EU), as well as people experiencing skin problems. To survey the necessity of our product, we conducted an extensive market and competitor analysis. Ethical concerns, discussed under the safety tab, as well as patent applications within Sweden via the Swedish Patent and Registration office (PRV) and intellectual property rights (IPR), will be discussed. All of these factors have to be taken into account to ensure a successful market launch of MIKROSKIN.
Stakeholder Analysis
To identify the impact our project might have on the organisations involved in our project, a stakeholder analysis was conducted. As can be seen in Figure 1 below, there is a diverse range of stakeholders involved in MIKROSKIN. The FDA, EMA, EU and WHO would be mildly interested due to the potential for research and the implications this research might have on world health and safety. All the previously mentioned organizations have substantial power and the possibility to modify and transform our project, by e.g. by changing our ethics and safety guidelines. The EU is additionally involved owing to its laws concerning promotion, advertising and the safety and ease of use of the rapid test. Furthermore, the EU and WHO would be interested due to the implications a rapid test might have on the environment.
Cosmetic brands, including both skincare and makeup brands, are stakeholders with moderate power, but more shares. MIKROSKIN might affect the development, production and advertising of makeup and skincare in the future. Cosmetic brands specialized in pre- or probiotic treatment have even higher interest in MIKROSKIN. Dermatology clinics can use the rapid test to help personalize diagnosis and treat patients with severe skin problems. Universities and research institutes, as well as the research departments of cosmetic companies, will be interested due to its impact on general health, development of medication in the form of topical skin creams and the development of cosmetics.
The society as a whole will be affected because of the decreased stigma surrounding skin problems and possible lowered use of antibiotics. It would add to global health, by contributing to the understanding of the skin microbiota and a variety of skin disorders. In order to reduce the waste produced by the use of rapid tests, reusable and recyclable material would be used.
A special category in our stakeholder analysis includes 'social media influencers'. Instagram and TikTok are common social networking platforms among teenagers all over the world. Influencers, people with a huge online audience on the aforementioned platforms, are often involved in endorsements and product placements. A specific branch of influencers is concerned with normalizing skin problems. These influencers are crucial stakeholders due to both their personal interest and their impact over the target audience.
In the future, individual customers will form the last stakeholder, one with relatively high interest and financial power.
Figure 1: Stakeholder power interest matrix
Market analysis and competitor analysis
Market analysis
The key to a successful product launch is to know your customer, and to know them well. Analysing the market gave us a clear overview of the advantages of our product and how it would appeal to our clients. Our business model was adapted accordingly.
Market segmentation
Our market can be divided based on a few different premises. These include demography, location and behaviour. Geographically speaking, the focus would be on Europe for now. This is because of the size of the population and the ease of distribution within Europe. Additionally, the use of relatively few different currencies makes pricing easier. Our target audience consists mainly of research groups with a focus on the skin microbiome.
Our market, in addition to research groups, might in the future contain dermatologists and individual customers. However, this will only be after adaptation of our product to suit individual purposes. A separate business plan will be made once there is enough ground and opportunity to adapt MIKROSKIN for individual purposes.
Market size
Our market size is dependent on a variety of factors, including location, funding of research groups, population size, the number of universities and research institutes and their focus. Depending on the location, the shipping time will also vary. . Some research groups might decide against using MIKROSKIN as the kit takes too long to arrive. Also, the funding a research group receives can decide whether they would like to invest in MIKROSKIN. If the cost is too high, researchers might decide to try an alternate way or try to set up their own assay.
The bigger the research institutes and universities, the bigger the chance there will be groups that can use MIKROSKIN. Additionally, a higher density means more chances of collaborations, with which the word about MIKROSKIN can be spread.
With the focus of the research group, we refer to the area of skin microbiology. MIKROSKIN is a lot cheaper than cultivating and sequencing skin samples, but for some purposes, groups might prefer sequencing whole genomes. In that case, MIKROSKIN does not fulfil the exact criteria. Data on the number of researchers is hard to obtain, which is why we haven't included specific numbers.
Competitor analysis
It appears there is not a single company that offers the rapid skin test for human microbiota, like MIKROSKIN does. However, some companies offer an online quiz, solely based on the look and feel of the skin to find optimal treatment for problematic skin. These companies focus on skin microbiota and the improvement thereof for the treatment of problems associated with the skin, such as acne or atopic dermatitis. Hereunder, we list some of the companies using either creams or supplements that target, support or add to skin microbiota. Due to their specific targets, we feel like most of the companies listed in Table 1 can be seen as potential collaborators in addition to being competitors. Collaborating with one of these companies, or others not mentioned in the table, can enable personalized skin care recommendations and monitoring of skin condition, based on the treatment used.
| Company | Product | Skin or gut | Test, quiz, or treatment | App/No app | Certified where |
|---|---|---|---|---|---|
| Dermala | #FOBO kit: Prebiotic + cleanser | Both | Quiz and treatment | App | FDA |
| Gallinee | Duo inside out: Cream & supplements | Both | Treatment | No app | France |
| ROELMI HPC | AECTIVE: molecule for topical application | Skin | Treatment | No app | Italy |
| Aurelia | Probiotic concentrate | Skin | Treatment | No app | Unknown |
| Zelens | Microbiota P3:Balancing mist | Skin | Treatment | No app | UK |
| Biossance | Squalane probiotic gel moisturizer | Skin | Treatment | No app | US |
| Symbiome | The One | Skin | Treatment | No app | US |
| Osea | Vitamin C Probiotic Polish | Skin | Quiz and treatment | No app | US |
| ZitSticka | Skin Discipline supplement | Gut | Treatment | No app | UK |
We predict our biggest competitors, and thus most important potential collaborators, will be:
- Dermala: Dermala is a US based company that makes use of a digital quiz to personalize a Dermala kit. This kit generally consists of acne treatment, cleanser and a probiotic mix. An app will then be used to track the progress obtained using the Dermala products. Dermala thus uses probiotics for the gut: improving the skin through the gut microbiota. Additionally, it does not test the skin microbiota as such, but bases treatment on looks and feel of the skin by the audience themself.
- Gallinee: Gallinee is a French company that mainly sells within Europe. While they don't have a test, they target the skin both through creams and supplements. Our test, meanwhile, gives an accurate view of the current balance of bacterial species on the skin. The products Gallinee offers might make the test seem redundant, but our test can help decide on the best personalised treatment.
- Osea is a company based in the US that ships their products to multiple countries. They offer a probiotic face polish that maintains the skin's natural barrier. Moreover they offer users a quiz on their website that will guide customers to products that could help them with their specific skin problems. Although their quiz does not work the same way as MIKROSKIN does, it does help the customers to customize their treatment methods. This does, however, only focus on treatment methods specifically developed by Osea.
Intellectual property analysis (IPR)
In order to remain in the market, companies apply for patents to protect their products nationally, regionally or internationally from competitive variations during a limited timespan. The patents themselves are divided into various categories, some being: utility, pattern and plant patents. Utility patents protect inventions or improvements of established inventions concerning processes, machines, manufacture or a composition of matter; pattern patents protect the decorative feature of a product; plant patents protect invented or discovered asexually reproductive plants (1).
Because our project revolves around detecting macromolecules on pathogenic microorganisms using DNA aptamers, the utility type would suit our purposes. However, many patents concerning aptamers already exist.
In 2020 a Korean team patented a kit containing DNA aptamers for Propionibacterium acnes (today better known as Cutibacterium acnes). The kit comprises compositions and methods for detecting, diagnosing and treating skin diseases.
Another patent was published in 2012, describing two RNA aptamers binding to teichoic acid on Staphylococcus aureus. The patent claims aptamers acting like biosensors for both S. aureus and food additives, as well as a pharmaceutical composition for prophylaxis or treatment.
Another utility patent claiming a sensor chip and a way of producing it was claimed in 2008. The invention utilizes vesicle-bound polydiacetylene, aptamers and the chip in order to rapidly identify proteins either on microorganisms or as solutes.
Fortunately, the DNA patent and the sensor chip patent was only granted in Korea, allowing us to circumvent the similarities of probe type, target organism and means of detection. Additionally, this enables us to potentially enter the European or American market. The RNA patent, however, was granted worldwide, which could pose a problem if a transition into RNA aptamers is needed. Furthermore, our method also distinguishes itself by including both a control test and a diagnostic test, i.e. to detect more than one species of microbe.
Business Model
Customer segments and key propositions
To bridge the existing knowledge gap between our skin and its inhabitants, a faster tool than traditional cultivation of bacteria is needed. This became clear during our interview with the MTA-SZTE Dermatological Research Group. By producing a customizable, high throughput test, MIKROSKIN will satisfy this need and enable rapid skin sample analysis and identification of microorganisms. This will benefit researchers performing semi-quantitative analysis on healthy skin microbiota and will allow for monitoring the effects of topical skin pharmaceuticals.
As mentioned above, our main customers will be researchers with a focus on skin microbiota, but skincare companies including, but not limited to, pro- and prebiotics may also benefit from using MIKROSKIN as a tool to provide personalized skin solutions to their customers.
Key partners and activities
Currently the field is lacking research data; this motivates our initiative to collaborate with both research groups and skincare companies such as SZTE Dermatology group and Dermala to create the MIKROSKIN database. When using MIKROSKIN the customer may contribute to the mapping of the healthy and unhealthy abundances of skin bacteria by submitting anonymized data yielded from their sample. For more information about this, visit our ethics workplan (hyperlink).
Another key activity for us is prototyping our potential product. Find more info about it here.
Customer relationships and channels
We hope to build a community dedicated to stopping the stigma around skin conditions, and investing in research about the skin microbiome. In our 'Skin microbiota survey' 98% of the respondents were open to using our product. We plan to continue contacting the public via regular surveys marketed on social media. We have been in contact with a Swedish acne influencer Sofia Grahn about raising awareness on the relationship between our skin microbiota and skin conditions. We hope to initiate this and similar projects in the future. Through the usage of the MIKROSKIN database we plan on keeping in contact with researchers, as we imagine the database having a feedback section in addition to a section where data is submitted.
Key resources
To launch MIKROSKIN we need to produce the components of our test on a large scale. Key resources include producers of PCDA, producers of aptamers and single use supplies such as well-plates of different sizes and cotton swabs. Furthermore we need people with competence in SELEX and bacterial cultivation. The results from our MIKROSKIN database is our most important key resource, as it will allow us to interpret the readout from our test correctly.
Cost structure
Developing a product is costly, especially in the biotechnology industry. Our general overview of costs, includes the following major expenditures: rent for an equipped laboratory, operational costs, in general, packaging and labelling. Additionally, there will be labour costs, as well as costs for different marketing efforts. Furthermore, costs for patent application and distribution also need to be considered.
Revenue streams
When it comes to revenues, it is advisable to have several streams to have various cash flow sources that are coming in. For MIKROSKIN, we have considered two different revenue streams. One is revenue generated through sales of our rapid test. This includes sales to researchers, research organizations, and skin companies (B2B). Eventually, we also aim to target individual, private customers in cooperation with major skin companies (B2B2C). In addition to sales, we are also thinking about licensing our skin microbiota specific aptamers, which can be used for further research in the field.
Regulatory affairs
As a starting point of the regulatory strategy, we have decided to focus solely on the EU market. The process for obtaining a CE mark is considerably shorter than the American equivalent and is usually available in just 4 weeks. Based on the delineations within the EMA's rules regarding the risk of medical devices, our product would be a Class I item under rule 4 (1). The reasons for this are that the rapid test is non-invasive, and thus it presents a very low risk to patients. As rule 4 states, the device is Class I if it is non-invasive but in contact with injured skin. Since the product is a semi-quantitative device, an independent organization that assesses the device (notified body) is necessary (1).
For Class I devices, there is no need for robust clinical evidence to be shown and as such, the vast majority of the responsibility for safety lies with the manufacturer, as according to paragraph 60 of the EU directive (1). Article 52 goes on to say that in order for the manufacturers to prove that the Class I product is in alignment with the EU standards, they need to issue a declaration of conformity, as set out in article 19, alongside the technical documentation. The company would work with the EU manufacturer of our choosing to make sure that all documentation is in place and ready as soon as possible, allowing us to certify early. Once the CE mark has been received, the product is ready to be sold on the EU market.
Time plan
We have made a five year forecast of steps that we need to do in order for our project to succeed (Figure 2). All of the timeframes are rough estimations and can change greatly. If a correlation is established by researchers between bacteria present on the skin and a specific skin condition, a new phase is entered where a new product needs to be developed that is suitable for individuals to use at home, see business model.
Figure 2: 5-year Timeplan
Future Outlook
After rolling out MIKROSKIN in Europe, many possibilities remain. First of all, the US market could be targeted. The US market is a big market, where self-testing is common and gain popularity in the coming years as per the articles Global Home Diagnostics Market is Expected To Reach USD and Molecular Diagnostics Market Size & Share Report, 2021-2028]. We predict our rapid test would find a welcoming market in the US, due to its size and culture of self-testing and treatment, especially with an increasing consciousness of health and point of care treatment.
Secondly, the test has the potential to be used by individual customers, at home. For this, a specific 3- to 6-well plate would be designed that can be used for the aptamer binding to take place. This enables rapid at home testing, with quick results. This would make information on your current state of health easily available for customers at any location and outside of research purposes.
Thirdly, personalized recommendations for skin care can be given based on the output of the test. This can possibly be done in collaboration with other skin care brands, and would enable the inclusion of an app to include personal recommendations. This would be the first step towards completely personalized skin care: personal information derived from the test can be coupled to the development of personalized pre- or probiotics. These would be made specifically for the client, based on the current microbial population on the skin. Again collaborations with other companies would be possible. This would allow diagnosing and treating the client, from start to finish, however, it also poses quite some ethical questions. A slightly less personalized route can also be taken to ensure that less data is gathered, thus making it easier to store the data and preventing data leakage. However, a collaboration with skin care companies remains our second future plan, with or without an app!
Moreover, there is the possibility to equip the current test with a more complex set of aptamers, to allow for testing of a broader range of bacterial species commonly seen to be imbalanced in skin disorders. Additionally, there is the ability to add aptamers specific for antibiotic resistance to the test. This would only necessitate one test to research imbalances common in a range of skin diseases, thus keeping it simple for researchers and individual customers.
References
U.S. PATENT AND TRADEMARK OFFICE. Electronic Information Products Division, Patent Technology Monitoring Team [Internet]. U.S. Patent and Trademark Office, 2016. Available from: https://www.uspto.gov/web/offices/ac/ido/oeip/taf/data/patdesc.htm [Accessed 14 Sept 2021].
Commission E, Others. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices, Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and Repealing Council Directives 90/385/EEC and 93/42/EEC [Internet]. European Commission. 2017. p. 175. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN [Accessed 14 Sept 2021].