The burn treatment market is expanding with a steady growth, as the increased incidence of burn injuries and burn-related deaths highlights the demand for a cutting-edge solution. The AFCM iGEM team developed SONG-H to address the unmet needs of deep burn treatment, particularly the limited solutions available to improve long-term recovery. This has driven us to create a solution that addresses the immediate medical needs of burn patients and their long-term quality of life.
To bring SONG-H to the market we have conducted a strong business plan that covers the product form different manners, identifying the opportunities to penetrate the market. This plan is represented through 4 main parts on the page: Customer, Product, Company, and Business plan.
Starting with the customer page, the AFCM iGEM team identified the unmet needs of deep burn patients and the magnitude of the problem. The team came through the available opportunities to penetrate the market. The team also conducted a strong market analysis to identify the potential of the product in the current market conditions. We have identified our primary customers to be pharmaceutical and biotechnology companies, as they have the needed resources, facilities, and knowledge to develop innovative therapy. Moreover, we engaged with healthcare facilities, burn care hospitals, plastic surgeons, insurance companies, and burn survivors, gathering insights from the major stakeholders who will influence the success of SONG-H. More details about the meetings and visits will be discussed in human practice. At the end of the page, there is a detailed description of the deep burn patients’ journey, expressing their problems from day one to the end.
Through the product page, the team introduced a full project description and detailed presentation of the product possibility. We represented the evidence of research, technical feasibility, and regulatory pathway. The team also demonstrated the inventiveness of the product by highlighting the product's unique selling points and identifying the key competitors in the market. We also revealed determined steps toward protecting our intellectual property. The Page illustrates the potential of SONG-H for future applications and its scalability. It reveals the manufacturing process, upscaling plan, and market expansion strategies.
On the company page, the AFCM iGEM team showed the product mission and vision with a displayed SWOT analysis that stresses the strengths, weaknesses, opportunities, and threats. We have outlined detailed developmental plans with realistic milestones, timelines, resources, and risks. Our commitment extends beyond the commercial aspect, as we have also evaluated the positive impact our product can have on the community by enhancing the quality of burn care and improving patient outcomes. Furthermore, we have conducted a financial analysis, and business model with key activities timeline to ensure the financial viability of SONG-H and identify the opportunities and challenges In the business plan page, a full detailed business plan is showed with uploaded pitch deck.
On this page, the AFCM iGEM team identified the unmet needs of other existing
solutions, the magnitude of the existing problem, and the opportunity to enter the
market. We also discovered potential customers and relevant stakeholders affecting our
project directly and indirectly.
Problem
Around the world, anyone is susceptible to face burn injuries, but unfortunately, not all people get the same treatment.
Burns are a leading cause of hospitalization and the most common injury among children. It is the fourth most common type of trauma worldwide, following traffic accidents, falls, and interpersonal violence. It continues to present a significant public health problem, resulting in high scores of preventable deaths and disabilities every year.
First-degree and superficial second-degree burns affect the top layer of the skin and can be treated conservatively without leaving scars. On the other hand, deep second-degree and third-degree burns have more severe effects on the skin as they penetrate deeper layers, taking longer time to heal and increasing the risk of scarring and skin contractures. The issue arises from the time it takes for the wound to heal; faster healing can help prevent complications such as scars and contractures.
Fig (1): Epidemiology of burn injuries
Globally, 11 million burn injuries require medical attention yearly (1). In the United States, around 50,000 of these cases necessitate hospitalization with approximately 20,000 patients having significant burns of at least 25 percent of their total body (2).
Sadly, more than 180,000 people die from fire-related burn injuries each year, and millions more experience burn-related disabilities and disfigurements, which have profound psychological, social, and economic effects on both the survivors and their families (3). It's important to note that the burden of burn injury falls heavily on low- and middle-income countries, where 95% of fire-related burn deaths occur (4).
Treatment can be complex, expensive, and time-consuming, depending on the severity of the burns and the extent of the affected area. Treating burns often requires extensive wound care from nursing staff, multiple surgical procedures, and costly hospital care. In some places, limited resources lead to poorer outcomes, increased complications, higher mortality rates, and significant economic impact (5).
Opportunity
Burn traumas impose a significant social and economic burden on countries worldwide. The lifelong impact of this massive injury reflects the urgent need for innovative burn treatment products. SONG-H is designed to fill the gap of unmet needs of the customers with maximum benefits and minimal side effects compared to other market competitors. Burn care market size was valued at USD 2.73 Billion in 2023 and is poised to grow to USD 4.41 Billion by 2033, demonstrating a compound annual growth rate of 5.2% for the forecast period (2024-2033) (6) as shown in Fig (2).
Fig (2): Market size in 2023 and its compound annual growth rate of 5.2% for the forecast period (2024-2033).
This market growth is driven by the rising incidence of burn injuries, burn-related death, and the increasing demand for effective treatment.
Current treatment options, such as skin grafting and flaps, do not fully address the needs of burn victims in reducing functional disability and scarring associated with the injury. Existing treatments also carry several risks such as surgical complications, donor site discomfort, limited availability of donor skin , and the potential for graft failure. Skin grafting is also considered an invasive procedure which isn’t favorable by most patients and, on the long run, may cause skin contractures, hypertrophic scars, pain and cosmetic disfigurement (7).
Newly developing drugs like nanotherapeutics and biologics are emerging as potential competitors. They are vital in improving tissue regeneration and reducing wound scarring. In addition, they are considered the future of wound healing because they rely on regeneration rather than surgical procedures. However, they are still undergoing testing and have not yet approached the market (8).
Thus, we created SONG-H, a groundbreaking treatment using novel technology to reduce wound healing time and improve tissue regeneration. SONG-H's unique value proposition comes from its undebatable feature of minimizing the scars and contractures caused by sequelae of burn injuries. For more information on the whole product description, click here.
Market Analysis
Generally, with major deep burns, $44,000 is the median expense for management in the highly developed countries annually (9). That will vary from one condition to another, as burn management costs a wide range around the world. It depends on burn grade, degree, total body surface area affected, length of hospitalization, inhalational injury, and human development index.
The AFCM iGEM team identifies the USA as a key target market according to their certified statistics and regulations. The USA found an average of 400,000 deep burn injuries receiving medical treatment annually (10). That indicates the total addressable market (TAM) to be USD 17.6 billion.
SONG-H is specifically designed to address deep burn injuries that often result in stigmatizing scars, contractures, and muscle wasting. These injuries constitute 45,000 to of the total burn injuries in the USA, representing a serviceable addressable market (SAM) of approximately USD 1.98 billion (11).
Fig (3): Illustration of the predicted market analysis and the estimated TAM, SAM and SOM.
The primary competitors in the burn market are synthetic grafts and advanced dressing. Although these products are crucial for lifesaving procedures, they leave behind stigmatizing scars, contracture, and muscle wasting leading to loss of self-esteem and psychological impact. That affects the patient's ability to re-engage with the community (12).
On the other hand, SONG-H offers a unique advantage by promoting minimal scar wound healing and improvement of tissue regeneration leading to enhancement of the treatment outcomes and a more successful rehabilitation journey. This distinctive feature of SONG-H introduces our innovative technology as a promising solution for deep burn injury patients.
The estimated price for SONG-H is found to be 10000$. According to its superior benefits, our product is expected to achieve a market share of 5% within the next 5 years. This reflects the serviceable obtainable market (SOM) to be USD 0.099 Billion.
The AFCM iGEM team considers key actionable steps to effectively position SONG-H as the leading solution for deep burn injuries and achieve its market share. Verification of the data and the accuracy of the statistics used for burn injury incidence and market size are the beginning steps toward the goal. Moreover, the team planned to conduct a more in-depth analysis of direct and indirect competitors, focusing on their unique features, pricing, and market share. Additionally, the team considered the distribution strategy including partnerships with hospitals, clinics, and pharmacies. Also, conducting a strong marketing and sales plan to effectively reach the target market.
Primary Customer
We are targeting large pharmaceutical companies such as Smith & Nephew and BAYER as our primary customers, providing their financial resources and knowledge necessary to sell our medicine and make it accessible to those who need it (13,14). Moreover, working with such large firms will give us access to their extensive network of researchers, doctors, and regulatory experts, which will allow us to accelerate the development and commercialization of our medicine.
Additionally, they should have all necessary licenses for conducting clinical trials, and their facilities should be compliant with all GMO (Genetically Modified Organism) regulations and laws.
We contacted BAYER’s representatives in the African Health ExCON to seek partnership opportunities, to which they responded that such collaboration would accelerate the production of SONG-H and make it accessible to people worldwide.
Moreover, BAYER shares similar interests as our team; regarding the future of regenerative medicine as the ideal option for wound healing and an effective alternative to invasive surgeries.
More details can be found in the integrated human practices.
Fig (4): Logos of Smith & Nephew and BAYER, the primary customers for SONG-H.
Relevant Stakeholders
Next, after targeting large pharmaceutical companies for scale production of our drug, relevant stakeholders should be identified. The power interest grid is illustrated to show the influence of each stakeholder on our project's development as shown in Figure (5).
Health insurance companies are thought to be our next station following large pharmaceutical companies, as coverage by insurance is an essential step to ensure the selling of our drug and its prescription to burn patients. Therefore, we met with Mrs. Minar from the Sales Department in Allianz Insurance to inquire about the requirements needed for the drug to be adopted in insurance. More details are discussed in the integrated human practices stage 5.
Plastic surgeons are thought to be one of the most important stakeholders having the power to convince and prescribe the drug to burn victims as an alternative to reconstructive surgeries. Thus, it’s important to catch their interest in order to increase the credibility and distribution of our drug. More details are discussed in the integrated human practices stage 5.
Our team is considered a major stakeholder as bringing drugs to market can take many years so having a cohesive team will ensure the integrity of our company in the upcoming years. Thus, our drug could pass through the several phases following the current phase of proof of concept, like the post-approval phase and marketing monitoring.
Furthermore, burn associations organize conferences and events with the participation of plastic surgeons, patients, and decision-makers in the field. Approaching those associations will have a direct influence on the distribution and commercialization of our drug.
Finally, burn victims are the last station of our drug journey. Their interest and trust in our drug are essential as they are the end users of our product . As a result, we distributed patient surveys in several burn care centers to know the real needs of patients and what they are expecting to gain from a new drug that promotes wound healing. More details are discussed in our second visit to Helmia Hospital in the integrated human practices stage 3.
Fig (5): This Matrix represents the main stakeholders relevant to SONG-H.
Product Users
Patients suffering from deep 2nd and 3rd-degree burns will be the primary product users for SONG-H; as it promotes the healing process and enhances tissue regeneration. SONG-H will be applied as a topical scaffold hydrogel, replacing graft administration, to minimize scar formation and provide a better cosmetic appearance.
In General, a burn patient's journey is painful, expensive, lengthy, and leaves permanent physical and psychological impacts on the patient and his caregivers.
SONG-H will meet patients’ needs as it induces the healing process, minimizes contractures and muscle wasting, and limits the gained physical inabilities. Furthermore, it limits hypertrophic scars and leads to a better cosmetic appearance that has a direct impact on the everyday social activities of the patients. We had a clear identification of patients' needs and recovery journey through our human practices journey throughout the year.
Fig (6): Patient's journey along the course of the burn injury.
The chief complaint of burning injury patients depends on several factors ranging from the degree of the burn, the affected site, and the total body surface area affected.
The patient suffers only from redness and pain with first-degree burns, which affects only the outer layer of the skin. Starting from the deep 2nd degree and the third degree, the patient will suffer from severe pain, swelling, edema, blisters, red/white or charred skin, breathing problems, and bloodstream infection ( sepsis ) that will appear in form of elevated body temperature, increased heart rate, increased respiratory rate, and feeding problems (15).
Patient management will be divided according to its severity:
- If the patient suffers from a mild (1st and upper part of the 2nd degree), he will need only to cool the burn, remove rings and tight items, apply a lotion, and bandage it (16). He also may take an over-the-counter pain reliever and consider a tetanus shot.
- With severe burns (deep 2nd and 3rd degree), the care system has to use an ultrasound mist therapy to clean and stimulate the wound tissue, immediate fluids, pain, and anxiety medication (such as morphine, and ketamine), burn creams like sulfadiazine, broad-spectrum antibiotics, tetanus, and dressing. The patient may require physical and occupational therapy if the injury affects a large area including joints to preserve skin flexibility (17).
- With more severe conditions, he may require assistive surgical procedures such as Breathing assistance, feeding tubes, skin grafts, and plastic surgeries.
The recovery journey from mild burn injuries takes from one to two weeks. On the other hand, with more severe injuries, it takes 6-9 months to heal (18).
After injury and recovery, the patient may suffer from some physical, psychological, and social consequences. On the physical aspect, it always leaves a stigmatizing scar, depilating and deforming contracture that may lead to disability and muscle wasting. Regarding the psychological and social manners, the patient may have post-traumatic stress disorder, depression, anxiety, sleep disturbance, feelings of guilt and shame, and some personality changes that will affect his everyday activities and his interactions with the community.
Finally, the patient is going through a rehabilitation journey. It is a process that starts from day one of injury and continues for months and even years. It is done in a team approach manner with the patient and their family. The main aim is to restore the patient’s normal condition as much as possible through different rehabilitation strategies, trying to minimize post-injury contracture and maintain range of movement, minimize scar, restore psychological well being, and maximize social integration.
[1]Jeschke, M. G., van Baar, M. E., Choudhry, M. A., Chung, K. K., Gibran, N. S., & Logsetty, S. (2020). Burn injury. Nature reviews Disease primers, 6(1), 11.
[2]Pruitt, B. A., Wolf, S. E., & Mason, A. D. (2012). Epidemiological, demographic, and outcome characteristics of burn injury. Total burn care, 4, 15-45.
[3]Peck, M. D. (2012). Epidemiology and prevention of burns throughout the world. In Handbook of Burns: Acute Burn Care Volume 1 (pp. 19-60). Vienna: Springer Vienna.
[4]Peck, M., Molnar, J., & Swart, D. (2009). A global plan for burn prevention and care. Bulletin of the World Health Organization, 87, 802-803.
[5]Kaiser, M., Yafi, A., Cinat, M., Choi, B., & Durkin, A. J. (2011). Noninvasive assessment of burn wound severity using optical technology: a review of current and future modalities. burns, 37(3), 377-386.
[6]Sakti, A. Y. N., Babel, S., & Laohhasurayotin, K. (2023). Environmental impact assessment of a domestic wastewater treatment plant in Bangkok, Thailand (Doctoral dissertation, Thammasat University).
[7]Gacto-Sanchez, P. (2017). Surgical treatment and management of the severely burn patient: Review and update. Medicina Intensiva (English Edition), 41(6), 356-364.
[8]Das, S., & Baker, A. B. (2016). Biomaterials and nanotherapeutics for enhancing skin wound healing. Frontiers in bioengineering and biotechnology, 4, 82.
[9]Kotlikoff, L. J., & Burns, S. (2012). The clash of generations: Saving ourselves, our kids, and our economy. MIT press.
[10]Ye, C., Wang, X., Zhang, Y., Ni, L., Jiang, R., Liu, L., & Han, C. (2016). Ten-year epidemiology of chemical burns in western Zhejiang Province, China. Burns, 42(3), 668-674
[11]Solomon, H. (2021). CAUSES, PSYCHOSOCIAL PROBLEMS OF BURN AND SUPPORT SERVICES FOR HOSPITALIZED BURN INFLICTED PATIENTS AT YEKATIT 12 HOSPITA (Doctoral dissertation, Addis Ababa University Addis Ababa Ethiopia).
[12]Wurzer, P., Keil, H., Branski, L. K., Parvizi, D., Clayton, R. P., Finnerty, C. C., ... & Kamolz, L. P. (2016). The use of skin substitutes and burn care—A survey. Journal of Surgical Research, 201(2), 293-298.
[13]Foreman-Peck, J. (1995). Smith and Nephew in the health care industry. Books.
[14]www.bayer.com
[15]Summer, G. J., Puntillo, K. A., Miaskowski, C., Green, P. G., & Levine, J. D. (2007). Burn injury pain: the continuing challenge. The journal of pain, 8(7), 533-548.
[16]Parrish, K. R., & Barrett, N. (2020). Wound Classification and Management. Rehabilitation of the Hand and Upper Extremity; E-Book; Elsevier–Mosby: Maryland Heights, MO, USA, 196.
[17]Kotronis, G., & Vas, P. R. (2020). Ultrasound devices to treat chronic wounds: the current level of evidence. The International Journal of Lower Extremity Wounds, 19(4), 341-349.
[18]Dauber, A., Osgood, P. F., Breslau, A. J., Vernon, H. L., & Carr, D. B. (2002). Chronic persistent pain after severe burns: a survey of 358 burn survivors. Pain Medicine, 3(1), 6-17.
