Entrepreneurship

Executive Summary

It has been estimated that the chronic wound market will grow to $19.52 billion by 2029. The industry has been guided by three interlinked medical trends: growing rates of diabetes, obesity and ageing population. The increasing need for efficient treatments would plausibly allow novel products, like our product QBlock, to enter the market.

Yet, it remains challenging to find efficient treatment for chronic wounds. QBlock would stop wounds from chronifying for long periods of time, as it would prevent the formation of biofilm, one of the key components in extended infection and one of the main barriers to healing. Our product has to be used as part of a combinatorial therapy, because in itself it does not contribute to the healing - it only slows the further infection and chronification of the wound by inhibiting biofilm from building up. This is not a disadvantage in our product, but rather an advantage, because it strengthens the effect of other products and therapeutics, making a wider choice of therapies available and accessible.

Our diverse DARPin library and ribosomal display protocol can be applied to different signalling molecules and bacteria, which allows us to scale up our production and broaden our range of treatments. Currently, there are no DARPin treatments in the market.

With medical treatments, it will be a long process to get a product into the market, especially having to go through many regulatory reviews. We are however optimistic that our connections across biotechnology, business and medicine, as well as possible help from our home universities, would assist us to continue developing QBlock and take it to market, so that it would eventually have a positive effect on millions of people's lives.

Industry Analysis

Industry size, growth rate, sales projections

Across the globe chronic wounds are becoming an increasing issue. In 2016, the chronic wound care market had a value of approximately $18 billion according to the “Global Wound Care Market” (2016) report (K. Las Heras, et al., 2020). Furthermore, the market of wound care products exceeded US$15 billion (Han and Ceilley, 2016). In 2021 the wound care market was estimated at $11.61billion and projected to grow to $19.52 billion by 2029 according to the latest published market research report (Fortune Business Insights, 2022)

Industry structure

The chronic wound care market can be categorised according either to the type of treatment, type of wound or the delivery/application method. An overview can be found in Table 1.

Chronic wound treatments include traditional wound dressings, medicated or advanced wound dressings, wound therapy devices and others (R. Laurano, M. Boffito, G. Ciardelli et al., 2022). The vast majority has comprised traditional wound treatments, though medicated wound dressings and advanced wound dressings have been gaining popularity.

The key industry players in recent years have been Smith & Nephew, ConvaTec Inc., and 3M, which benefit from a strong product portfolio and a wide distribution network (Fortune Business Insights). All of these companies focus mostly on advanced wound dressings. Other major players in this market include Mölnlycke Health Care AB (Sweden), Tissue Regenix, B. Braun Melsungen AG, Integra LifeSciences Corporation, Coloplast Corp, Cardinal Health, and Triad Life Sciences, Inc. .

Key success factors

• Strong product portfolio (Fortune Business Insights, 2022)
• Wide distribution network (Fortune Business Insights, 2022)
• Price, quality, brand recognition (market presence)
• Scientific validation

Industry trends

Trends that favour the industry:

• Diabetes, obesity and the ageing population are all linked to heightened prevalence of chronic wounds. With a globally increasing number of patients in one or more of these categories, the number of chronic wound patients is in turn steadily rising and, thus, more wound care treatments are required to cover their demand (Mahmoudi and Gould, 2020).
• Emerging new technologies and research allow for novel treatment products.

Trends that work against the industry:

• High cost of treatments and complexity in insurance and reimbursement procedures (Mahmoudi and Gould, 2020).
• Difficulties of new technologies to be accepted and recognised by health plans and payers due to limited clinical history (Fetterolf, 2019)

Long-term prospects

The current growth of the chronic wound care market is likely to persist due to the increasing age of society, obesity and diabetes that are connected to the prevalence of chronic wounds. With ever-faster technological advancement it is likely that more wound care devices will enter the market, even triggering a shift towards more personalised treatment based on different disease etiologies behind a chronic wound.

Competitor analysis

Direct competitors are the key industry players mentioned above in the wound care market. Smith & Nephew, ConvaTec Inc, and 3M hold the biggest share in the market and mostly focus on advanced wound dressing. Advanced wound dressings are popular due to their low cost and high efficiency (Fortune Business Insights, 2022). Examples for direct competitors in wound dressing treatments can be found in Table 2.

A clinical-stage biotechnology company, Molecular Partners AG could be considered as an indirect competitor, since they are using similar methodology as our company would. They research and develop DARPins to be possible therapeutics. In our analysis we did not find information that they would directly target chronic wound patients. They have a general pipeline but mostly focus on oncology, infectious diseases and ophthalmology. Based on Molecular Partners H1 2022 Corporate Highlights and Financials-report their revenue was reported as CHF 184.5 million (approx. 190 million euros) which was primarily due to a payment from Novartis. This was for exercise of option to in-licence global rights to Tris-specific anti-viral in COVID-19, ensovibep.

Market Analysis

Target market selection

Chronic wounds are a prevalent problem all around the world. However, starting off as a company we would focus on entering first the Finnish chronic wound market and then the European market. Specifically, QBlock as a product would be targeted towards hospitals and wound care centres, which chiefly take care of chronic wound patients. We also consider the Defence forces to be a possible customer due to the need to prevent infections in wounds acquired in battle. After establishing our presence in this trade area it would be feasible to also target the American and global market.

Target market size

Following UCopenhagen team example, we took the following steps to analyse our target market size.

Step 1: What is QBlock's trade area?
We seek to launch QBlock on the Finnish as well as on the European market. After talking to Finnish doctors and nurses, we could conclude that hospitals and healthcare providers are open to testing new strategies to combat chronic wounds. At later stages growing and expanding to markets outside Europe, such as North American markets, will also be an option since treating chronic wounds is a global problem especially in high-income countries. We are aware that regulations may differ substantially in their stringency and requirements, and would thus seek extensive legal counsel to ensure compliance.

Step 2: What is the number of wound care patients, more specifically chronic wound care patients in this area?
In Europe alone 4 million patients suffer from chronic wounds every year (R. Laurano, M. Boffito, G. Ciardelli et al., 2022) and 1-3 % of total healthcare costs go towards chronic wound management (Järbrink et al., 2017). Within the EU, up to 50% of the hospital beds are occupied by patients with wounds (Posnett et al., 2009).

Step 3: What is the global size of QBlock target market in dollars or Euro for 2022?
To determine the size of the chronic wound market, we look at the current costs of treating a chronic wound. Unfortunately, it is difficult to specifically determine the exact value of the chronic wound care market for Finland or the EU in 2022. However, a report from 2019 has estimated that in the Helsinki metropolitan area, the treatment of wounds costs approximately 7 to 14 million euros per year (Ahmajärvi et al., 2019). Furthermore, wound care costs in Germany accumulate to 8 billion euros per year (https://healthcare-in-europe.com/en/news/chronic-wound-care-today.html). Taking a look at the United States, in 2016 wound care products were estimated at US$15 billion (Han and Ceilley, 2016).

Step 4: What is the global size of QBlock target market in dollars for the near future?
According to the latest published market research report the global wound care market is predicted to grow to $19.52 billion by 2029. Since our project is in such an early stage, it is difficult to estimate QBlock's annual sales thus we do not have an estimate of our market share.

Marketing Plan

Overall marketing strategy

QBlock belongs to topical treatments, which would be used as a combinatorial therapy with other therapeutic molecules and antibodies to improve the healing process of the wound.

We would need to make a survey and further analysis of the pricing of the product. Price would need to be affordable enough so that it would be available for the clinics and hospitals and hence for all the patients. We are hoping to partner with a company that would have developed hydrogel where our DARPin could be included in a similar way we had with our partners TU Dresden. Outsourcing the production of hydrogels would ensure efficient and low-cost production.

Within our network we have a lot of experts who we could contact and ask for further guidance on marketing our product. This includes Jouni Lounasmaa, former leader of the Finnish Startup Foundation, who has previously advised us on the management side of our project (see: Human Practices) and who has already offered to connect us to other regenerative biotechnology startups. In addition, we could reach out to our contacts at Slush, a global start-up conference held annually in Helsinki, to receive guidance about building our marketing and sales plan.

Sales process

At first, we would be concentrating on public relationships like we have done until now. By presenting our project in three European iGEM conferences, public presentations at the ScienceBasement and university courses, and recording our own podcast, we have been trying to create a good image of our team and project that would eventually turn into our company. Since our customers would be clinics and hospitals, we would not use public advertisement but promotion presentations to present our product. In addition, conferences for biotechnology, wound care and overall healthcare would be optimal places to form new contacts and present our business to new customers.

As our plan to treat wounds with DARPins is a novel approach, we are hoping that the media's interest would grow as we would continue developing a novel way to treat chronic wounds.

Product Design and Development

Development status

According to Lääketeollisuus (Pharma Industry Finland) the process including discovery of the active substance and clinical trials can take 10 to 12 years before our medicine would be available in the market. We are currently in the stage where we have found our DARPin that has an affinity to our target molecule. The next stage would be the further testing of the properties of the selected peptides.

Throughout the year we have been in contact with experts in startup communities and our team has identified the key components of the company we would establish (see Figure 1.). Both University of Helsinki and Aalto University have active entrepreneurship societies, which organise multiple different accelerators for developing start-ups. After looking into them, we realised that either Helseed or Terkko Health X or both would be beneficial for our team to develop our product and business plan. In addition, both universities have broad expertise on innovation services where we are planning to contact.

Challenges and risks

Establishing a company and trying to develop a medical treatment will always include risks. Risks related to establishing a company include lack of funding, not obtaining a patent for our product and not being able to compete in the market.

We would need to move onto additional safety checks to verify the pharmacological viability of our product. Our team is in its early stages of product design. Currently we have a proof of concept hence we know which amino acids have the greatest affinity to our target molecule, AIP. Next we would like to proceed studying our peptide in silico to ensure that the DARPin does not have other targets in the human body. Then continue to test with organoids and possibly even artificial skin - an innovative collagen scaffold that induces regeneration (Yoon et al, 2016; Garfein et al., 2009). After receiving promising results, we would continue towards the clinical trials. More extensive descriptions of our implementation including safety measurements and clinical trials are found on our Implementation page

Finally, we would seek further advice from the clinicians we previously spoke to at the HUS Wound and Burn Centre, particularly researchers like Dr. Esko Kankuri who are in strong contact with the pharmaceutical and medical devices industry. This would further help us to understand how to best position our product when pitching it to both target clients and end-users (hospitals and physicians/nurses) and manufacturing partners.

Intellectual property

Since we are first going to target Finnish market, we would be contacting the Finnish patent and registration office (PRH) to advise us on filling out the patent application. In Finland, the patent can be kept in force for 20 years from the filling date of the application. However, according to PRH if the patent projects the active ingredients used in medicinal products, the patent protection can be extended by applying Supplementary Protection Certificate, SPC. Even though our product would fulfil that criteria, we do not hope to extend our patent. We would get the patent to ensure our competitiveness in the market to begin with and to bring more attention to it. We would do so with the knowledge that the patent would expire anyway and by the time the medication is more well-known, it would be an open access formula for other manufacturers to refine even further.

Since the patent protection is only 20 years, and 10-12 years would be taken to the development process, we would have around 10 years of patent time left for which our product would be on the market.

In addition to our product patent, we would need to trademark our company name, logo, product name and domain.

Financial Projections

In order to make reliable estimations on biotechnology start-up expenses, we would like to consult other regenerative biotechnology startups. Estimation for the payroll expenses for the one year would already be 240 000 € for the whole team. For laboratory spaces we would need to negotiate with the local universities or rent them in the private sector. During the first year we would be applying for the patent in Finland. The application of the patent from the Finnish patent and registration office would be electronically 900 €.

The production of DARPins can be easily achieved and is cost-efficient. Expression of the DARPin can be easily done in E. coli as we have shown. Then extraction needs to be scaled-up and improved, but in general it is low in cost, because very little materials are required. The addition of the DARPin to a hydrogel can be easily achieved due to our close partnership with TU Dresden and we would therefore have a low cost product. In further stages where we are scaling up our production, we would apply investments from investors and government organisations such as Business Finland. Business Finland provides funding, loans, information and connections for companies and start-ups. One of them being research and development funding for companies that are expanding to international markets. We could also approach pharmaceutical companies with existing manufacturing facilities to outsource our scaled-up production of our DARPin task to them.

Conclusion

We are hopeful that our product, QBlock, would be taken into the market in the next 10 years. Evaluation of the next steps lead us to a conclusion that we need further consultation from innovation services and reach out to our contacts from the start-up field as well as the future customers and investors. The reason why we started this project was to solve local and global problems and to make a maximum positive impact in our medical niche of choice. We have decided to apply for a patent to ensure our competitiveness in the market but after its expiration, we hope that other companies would also continue developing our product further. As the environment for start-ups is especially good in the capital area of Finland, we are optimistic that we will certainly obtain guidance for further development of our business plan and product development.

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