IInflammatory bowel disease (IBD) is a chronic inflammatory disease of the intestines with an unknown cause, including ulcerative colitis (UC) and Crohn's disease (CD). The pathogenesis of IBD is not yet fully understood, and the influencing factors mainly include genetics, environment, gut microbiota, and immune responses. Its main symptoms include chronic abdominal pain, diarrhea, bloody stools, weight loss, and more.
Once diagnosed with IBD, patients often require long-term medication to manage the condition, which is prone to relapse. Crohn's disease, in particular, is difficult to treat, expensive, and can lead to complications. Chronic intestinal inflammation, such as IBD, involves more complex mechanisms and poses long-term health risks, requiring continuous management and treatment for patients.
Our project focuses on developing intelligent engineered probiotics for the precise detection and treatment of Inflammatory Bowel Disease (IBD). Through three core systems—the sensing system, the therapeutic system, and the suicide system—we achieve an integrated solution from detection to treatment. The sensing system detects inflammatory markers in the gut, such as thiosulfate, and indicates inflammation through color changes; the therapeutic system secretes Epidermal Growth Factor (EGF) to promote intestinal mucosal repair; and the suicide system ensures that the engineered bacteria automatically die after completing their task, preventing long-term survival in the body or the environment, ensuring biosafety. Our initial product is designed in the form of a capsule.
Our project not only provides a convenient at-home method for monitoring intestinal inflammation but also offers the advantages of low cost, in-situ treatment, and high safety. This innovative therapeutic system allows patients to reduce their reliance on invasive examinations, improve their quality of life, and lower treatment costs, with significant potential for promotion, particularly in areas with limited medical resources.
Our primary target customers are IBD patients. During the project, we conducted interviews and surveys with IBD patients to better understand their needs. We also engaged with patients' families, pharmacists, and other relevant parties to gather various perspectives and feedback, helping us gain a comprehensive understanding of our target customers. These efforts will aid in developing a product that better meets their needs.
During our conversation, a patient shared that when she initially experienced abdominal pain, she didn't take it seriously, thinking it was just a minor issue, possibly due to catching a cold or poor diet. As the discomfort persisted, she eventually decided to get checked. After researching online, she learned that a colonoscopy was required, which caused psychological resistance, as she believed the procedure would be too painful and thus was reluctant to go to the hospital. This attitude led to the worsening of her condition. Her experience reflects that many people often don’t take the symptoms of Inflammatory Bowel Disease (IBD) seriously, and the inconvenience and psychological pressure of traditional testing methods make patients more likely to delay seeking medical help, worsening their health problems.
We interviewed the families of Inflammatory Bowel Disease (IBD) patients to gain insight into the challenges of early diagnosis and routine monitoring. Many patients avoid necessary health check-ups, not because of busy schedules, but due to the fear of undergoing invasive procedures like colonoscopies. This fear leads them to delay or forgo regular screenings, making it difficult to manage their condition effectively. Despite encouragement from their families, this hesitation results in missed opportunities for early diagnosis and proper health monitoring.
We consulted Dr. Yang online and learned that a colonoscopy, performed through the anus, costs between 800 and 1,000 yuan. Even with subsidies for certain groups, patients still need to pay 199 yuan. Beyond the high cost, the process also requires patients to visit a hospital for approximately half a day, making it inconvenient for self-diagnosis or for diagnosis in smaller clinics. This further limits access to timely and affordable medical care, contributing to delays in addressing symptoms of inflammatory bowel disease.
After the project concept was formed, we communicated with various biomedical experts. Not only did they affirm our project idea, but they also provided valuable suggestions for optimization. Under their guidance, our project was gradually improved, moving in a direction that better aligns with practical needs.
We communicated with doctors from the Department of Colorectal Surgery, who pointed out that during flare-ups of inflammatory bowel disease (IBD), the intestinal mucosal barrier is damaged, exposing the inner lining of the intestine to harmful environments. Therefore, rapidly restoring the integrity of the intestinal epithelium becomes key to treatment. After discussion, the doctors recommended epidermal growth factor (EGF), which can promote cell migration and effectively repair mucosal wounds in a short time. This suggestion provided a new direction for our project, and we optimized our project based on the doctors' recommendations.
We interviewed a lawyer from Guangdong Songjie Law Firm to gain a detailed understanding of the safety regulations that must be followed during the project development process. These include the "Regulations on the Safety Management of Agricultural Genetically Modified Organisms," the "Environmental Protection Law of the People's Republic of China," the "Biosafety Law of the People's Republic of China," and the "Consumer Rights Protection Law of the People's Republic of China," among others. These laws and regulations provide important guidance for ensuring the compliance and safety of our project.
To address issues such as high costs, complex procedures, and psychological resistance that patients face in current inflammatory bowel disease (IBD) testing, we have developed a home monitoring method for IBD. This method is not only low-cost but also easy to operate, meeting the actual needs of users. This will provide patients with a more feasible option, enabling them to conduct monitoring in a comfortable environment, thereby enhancing their attention to and management of their own health.
Based on the stakeholder interviews we conducted, we have categorized our customers:
1.Our target group consists of people who suspect they have IBD but have not been tested due to the invasiveness and high cost of existing colonoscopy technology. Their pain point is the inability to accept these factors. Therefore, our product uses intelligent engineered probiotics; patients only need to take capsules orally with warm water and can determine whether they have IBD by observing the color of their excreta.
2.We found that some people believe that the detection and treatment processes for IBD are complicated, and doctors must follow prescribed procedures, reflecting the potential needs of customers. To address this, we have integrated the detection and treatment production lines into one, making our product a combination of detection and treatment to simplify the patient experience.
In the initial stage, our product mainly targets four markets, including two high-risk groups and two potential groups.
1. Young people with poor dietary habits: According to the survey results on the age distribution of people seeking consultations for intestinal health by Zhongjian Lianxing, young people aged 0-40 make up the majority of these consultations. Due to irregular and unhealthy eating habits, this group has become a key market we are focusing on. We hope that through our product, we can help them pay more attention to intestinal health, thereby improving their lifestyle.
2.Cities in Southern China with Humid Climates: The figure below shows the top 10 cities in sales of Changyanning (an anti-enteritis medicine) and their market shares within their provinces. Among these, six cities are located in the south, and Guangdong, which ranks first, is also a southern city. Due to the high humidity in these cities, their dietary habits tend to favor spicy food to dispel dampness, making them an important market for us.
1.Family Members of Patients with Inflammatory Bowel Disease (IBD): We believe that the onset of IBD may be closely related to poor dietary habits within the family, so the family members of patients also face the risk of developing the disease. For this group, our product can help them prevent the occurrence of enteritis and improve the overall health of the family.
2.People Who Have Previously Had IBD and Are at Risk of Recurrence: Through interviews with pharmacy staff, we learned that IBD is very prone to recurrence. Even after successful treatment, if exposed to pathogens again, it may still lead to repeated episodes of IBD. Therefore, this group is also a potential customer base we focus on. Our product can not only help them monitor their own health but also serve as an effective tool to prevent relapse.
The routine fecal occult blood test diagnoses diseases by analyzing whether there are blood cells, pus cells, and pathogens (such as bacteria and parasitic eggs) in the excreta. This method can provide a preliminary assessment of intestinal health.
Disadvantages: Unhygienic operation; inconvenient sample collection and handling.
Colonoscopy is currently the most common, direct, and effective method for detecting intestinal diseases, encompassing both colonoscopy and enteroscopy, with colonoscopy being more commonly used. Doctors insert the colonoscope through the anus to observe and diagnose intestinal lesions from multiple angles, and can even perform treatments.
Disadvantages: Invasive, expensive, and the examination process causes significant discomfort to patients.
Histopathological examination is a medical diagnostic method that involves removing tissue samples from the human body, which are then fixed, sectioned, and stained. Microscopic observation of microstructures and pathological changes is used, commonly to determine the nature of lesions.
Disadvantages: The method involves certain pain, is costly, and sample collection may cause discomfort to patients.
Includes antibiotics, steroids, and other medications, usually used to alleviate intestinal inflammation.
Disadvantages: These drugs may cause side effects, such as antibiotic resistance and damage to other organs due to long-term use of steroids. Moreover, drug therapy can only relieve symptoms and is difficult to provide a long-term cure.
For severe intestinal inflammation, surgical removal of the affected intestinal segments is a common treatment method.
Disadvantages: Surgery carries high risks, long recovery periods, and potential complications. Surgery cannot completely cure the underlying cause, and some patients have a high recurrence rate after surgery.
When conducting industry analysis, we used the macro-environmental analysis tool—PEST analysis. By evaluating from four key dimensions: Political, Economic, Social, and Technological, we can comprehensively understand the impact of the external environment on the industry.
The Chinese government actively supports and promotes the research and development of new drugs, with new drugs approved for market almost every one to two months. Additionally, China implements tax incentives for companies launching new drugs, providing more opportunities for the growth and marketing of our product.
(1) Level of Economic Development
In recent years, China's economic development has been robust. The table below shows the growth trend of China's per capita GDP in recent years. The continuously rising income levels have given people more financial capacity to pay attention to and invest in their own health. This provides strong support for the market demand for our product.
(2) Market Size
| Sub-categories | Same period last year | Sales share | Year-on-year change |
| Gastrointestinal medication | 68.7% | 70.1% | 1.3% |
| Hepatobiliary medication | 22.5% | 21.9% | -0.6% |
| Anorectal medication | 7.6% | 6.9% | -0.6% |
| Antiparasitic drugs | 0.7% | 0.7% | 0.0% |
| Other digestive medicines | 0.4% | 0.4% | 0.0% |
The figure shows the changes in the sales proportion of digestive system medications in 2023. It can be seen that gastrointestinal medications account for the highest proportion and are showing a year-on-year growth trend. It is expected that this growth trend will continue in the coming years, which means our product will have a broad market space.
(3) Growth Rate
According to the report "Global and China Gastrointestinal Therapeutic Drugs Market 2023-2029: Growth Trends, Competitive Landscape, and Outlook" by APO Research, the global demand for gastrointestinal therapeutic drugs is expected to increase to $80.3 billion by 2029, with a compound annual growth rate (CAGR) of 6.3% from 2023 to 2029. Against the backdrop of the increasing severity of gastrointestinal diseases, our product has enormous development potential.
1.Rising Health Awareness: With the continuous progress of society, people's attention to health has significantly increased, especially among the younger generation. They are paying more and more attention to monitoring and managing their own health status. Therefore, the detection method we have developed precisely fits this trend, meeting the growing health management needs of young people. It is expected that the market demand from this group will continue to grow.
2.Aging Population in China: China is facing the increasingly severe problem of population aging. The incidence rate among the elderly population is generally higher than that of younger people, and they are more inclined to choose convenient medications for timely disease detection and treatment. As the elderly population increases, the demand for medications is expected to continue rising, bringing huge development potential for our product in the elderly market.
In the context of rapid technological development, traditional colonoscopy brings many inconveniences to patients due to its invasiveness and high cost. In contrast, our product design is much simpler, can effectively reduce patient discomfort, and has greater market acceptance and application prospects.
1.Strong scientific research resources and R&D technology
2.Professional R&D team
3.No better alternatives in the market at present
Existing intestinal monitoring methods rely on large medical equipment, are highly invasive, and before undergoing colonoscopy, patients need to consume a large amount of bowel-cleansing solutions, making the whole process both painful and arduous. In contrast, our product only requires taking capsules with warm water, which is simple to operate and non-invasive. Patients or high-risk groups for enteritis can achieve intestinal monitoring at home, making it more convenient than colonoscopy and routine blood tests in hospitals. Moreover, our product integrates detection and treatment, providing patients with a more comprehensive health management solution.
4.Relatively low market price
According to reports from Peking University People's Hospital, the cost of a colonoscopy usually ranges between 500 to 1,000 yuan, with preoperative testing fees about 200 to 400 yuan, and medication costs ranging from 20 to 200 yuan. In first-tier cities, colonoscopy fees generally reach as high as 800 to 1,000 yuan. Our product has good cost control. Although production and marketing costs may be slightly higher during the initial market launch, the price will gradually decrease later through cooperation with medical insurance, further improving the product's cost-effectiveness. The expected pricing will be more competitive.
1.Lengthy and complex approval process by the Drug Administration
2.Potential risks in the initial use of new products
3.Insufficient bargaining power
1.More comfortable and convenient compared to traditional detection methods, attracting potential users
2.Large space for product promotion
3.Long market lifespan of the product
4.Wide audience
5.No better alternatives at present
1.Market distrust of new drugs
2.Social pressure and influence of public opinion
3.Technological changes and future competition
Our R&D team is composed of experienced professors and students, led by Professor Wu Chengcheng. Team members possess professional knowledge in multiple fields such as bioengineering, pharmacy, and bioinformatics, providing solid technical support for the project and ensuring high-quality product development and technological innovation.
1.Production Cost of Freeze-Dried StrainsEach capsule contains 10 billion CFU (colony-forming units) of strains. The specific production cost needs to be further determined through experiments and supplier quotations.
2.X-gal Procurement CostThe wholesale price is 1,070 RMB/kg, and each capsule contains 1–2 grams of X-gal.3.X-gal Cost Calculation:Cost per 1g of X-gal = 1,070 RMB / 1,000g = 1.07 RMBThe X-gal cost per capsule is 1.07–2.14 RMB.
4.Capsule Packaging CostThe capsule packaging cost is tentatively set at 0.5 RMB per capsule.
5.Processing Cost by OEM FactoryProcessing fees account for 40% of the production cost. Assuming the total production cost is A, the processing cost is 0.4A.
The total production cost A consists of the freeze-drying cost of strains, X-gal cost, and capsule packaging cost:
A = Freeze-Drying Cost of Strains + X-gal Cost + Capsule Packaging Cost
Assuming the freeze-drying cost of strains is B, the total production cost is:
A = B + (1.07–2.14) + 0.5
Processing cost is:
0.4A = 0.4(B + 1.57)
The total cost per capsule is:
Total Cost = A + 0.4A = 1.4A
After conducting more comprehensive market research in the future, we will price our product based on competitor prices to ensure market competitiveness.
Medical insurance pricing is usually 50% of the product's set price.
Medical Insurance Pricing = Product Pricing × 50%
Initial Funding Requirements:
1.R&D Expenses: Includes the purchase of laboratory equipment, reagents, and strains.
2.Production Costs: Initial production of a certain quantity of products for market promotion.
3.Marketing Expenses: Costs for market research and promotional activities.
Funding Sources: Self-financing, government research grants, venture capital, angel investments, etc.
Break-Even Point = Fixed Costs / (Unit Selling Price - Unit Variable Cost)
1.Sales Revenue ForecastAnalyze sales revenue under optimistic, neutral, and pessimistic scenarios to predict different market demand developments.
2.Cost and Expense ForecastWith the expansion of production scale, R&D, production, and marketing costs decrease year by year.
3.Profit ForecastPredict annual net profit and its growth trend to assess financial health.
The financial plan provides a detailed analysis of the product's cost structure, pricing strategy, and future funding needs, offering clear financial support for the project's sustainable development. Through scientific and rational financial planning and management, we believe the product can be successfully promoted, and its market share will steadily increase.
Currently, in the market for inflammatory bowel disease (IBD) medications, there are almost no competitors whose product philosophy aligns exactly with ours. Therefore, our main competitors are traditional conservative treatments and diagnostic methods—colonoscopy. In light of this, our product design will focus on combining the advantages of colonoscopy while addressing its drawbacks, providing a more convenient and non-invasive solution for IBD detection and treatment. Our goal is to integrate treatment and detection, meeting patients' needs for early diagnosis while also providing effective therapy. This allows patients to manage their health more easily, replacing the cumbersome and expensive traditional colonoscopy examinations.
By merging the two production lines of detection and treatment into one, our product offers IBD patients an integrated solution that combines diagnosis and therapy. This product not only enables non-invasive early detection but also simultaneously provides effective treatment options, simplifying the traditional diagnostic and therapeutic processes for intestinal diseases and enhancing user convenience and experience.
We will combine various online and offline methods to ensure the product can widely reach the target audience and increase market awareness.
1.Prescription Sales: Conducted in hospitals or clinics to ensure patients use the medication correctly under doctors' supervision.
2.Terminal Sales: Direct sales to end-users through hospitals, pharmacies, clinics, etc. This type of channel can quickly cover the target population and enhance product credibility through professional venues.
3.Distribution Sales: The medication flows from the manufacturer through wholesalers to pharmacies, hospitals, and other terminal sales points. Distribution sales can expand the market coverage of the medication.
4.Other Channels: Includes online sales and mail-order methods. With the development of e-commerce, online sales provide a new sales model for the product, allowing easy access to a broad consumer group through online platforms.
Our business objective is to achieve a 10% increase in market share over the next three years through continuous innovation and development of our product, gradually attaining industry leadership. According to market research, capturing about 25%–30% of the market share is sufficient to become a leader in this field. At the same time, we will strive to optimize operational processes, improve production efficiency, and promote continuous growth in net profit margin. Through sustained R&D investment, we will maintain the competitiveness of our product, enhance customer satisfaction and loyalty, and achieve significant growth in sales revenue.
Our target market covers multiple sectors of the medical market, including hospitals, pharmacies, online healthcare, and self-testing. Below is a detailed analysis of these markets:
Hospitals are the main sales channels for inflammatory bowel disease (IBD) detection and treatment drugs. Since most patients choose to go to the hospital first when they feel unwell and purchase medications upon doctors' recommendations, hospitals become the core market for our product. In recent years, the number of hospitals has been continuously increasing with widespread coverage. Government subsidies for the medical industry and significant investments in hospital construction also provide greater promotional opportunities for our product.
Pharmacies are the primary places where consumers purchase medications. Through interviews with pharmacy staff, we learned that the current market for IBD detection equipment and oral medications is limited in variety and has side effects. Our product has made innovations in this field, offering a more convenient option with fewer side effects. However, market challenges still exist; many consumers are accustomed to purchasing established medications like "Changyanning" and have low acceptance of new drugs. To address this issue, we will increase promotional efforts in the next three years, enhancing product awareness through advertising, social media, and expert recommendations.
With technological advancements and the development of the internet, online healthcare is gradually becoming an important way for people to obtain health information and purchase medications. Patients often search for their conditions online and find corresponding detection methods and drugs. Our product will actively expand into this market.
Our self-testing product (product name) offers great convenience. Compared to traditional colonoscopy, patients do not need to go to the hospital to use complex equipment; they only need to purchase our product to achieve self-testing for IBD. To promote the development of this market, we will intensify our promotional efforts in the next three years.
Through market expansion and promotional strategies across the above channels, we expect to achieve a 10% market share by 2027.
1.Improving Patient Quality of Life: Through a non-invasive, low-cost capsule product, patients can monitor their intestinal health at home, reducing reliance on invasive examinations and enhancing daily convenience.
2.Reducing Medical Expenses: Compared to expensive detection and treatment methods like traditional colonoscopy, our product can significantly reduce patients' treatment costs.
3.Promoting Medical Technology Innovation: The application of intelligent engineered probiotics will advance precision medicine, providing more efficient and safer diagnostic and therapeutic solutions for intestinal inflammation, contributing to overall technological progress in the industry.
4.Enhancing Health Awareness: Convenient monitoring methods can increase patients' attention to their own health, promoting early detection and treatment of diseases, and reducing the risk of condition deterioration.
1.Increased Dependency: Long-term use of intelligent probiotic products may cause patients to become dependent on the technology, reducing emphasis on other healthy lifestyle choices such as dietary adjustments and daily care.
2.Market Competition and Misuse Risks: As the product gains popularity, it may face competition and misuse of similar technologies in the market, leading to challenges in safety and quality control, which could affect user trust.
1.Education and Promotion: Emphasize health lifestyle education during promotion, guiding patients to maintain good diet and routines while using the product to avoid over-reliance.
2.Strengthening Regulation and Cooperation: Collaborate with regulatory agencies to ensure that the production and use of the product comply with biosafety standards, establishing effective market supervision mechanisms to prevent misuse or improper use.
We participated in the Conference of China iGEMer Community (CCiC), where we promoted our project idea. We hope to attract more people with the same goals to join our project and jointly advance the development of enteritis detection and treatment.
We visited a medical device exhibition to explore the equipment currently used for colonoscopy examinations, gaining a comprehensive understanding of the strengths and limitations of traditional colonoscopy technology. This knowledge has provided us with valuable references for refining our project. Additionally, we had discussions with several manufacturers who expressed interest in our product’s potential. They recognized it as a promising development direction, and if we decide to pursue commercialization, they may consider offering financial or technical support to collaborate in further research and development.
Although our product has not yet been officially launched, we have already prepared the product user manual in advance. This helps future users understand how to use the product and lays the foundation for subsequent market promotion.
Through interviews with pharmacists, we learned that the current medications used for treating intestinal inflammation have numerous problems. For example, the misuse of antibiotics can easily lead to antibiotic resistance, and long-term use of steroids may cause damage to other organs in the body. Moreover, existing drug treatments mostly can only alleviate symptoms and cannot provide a long-term cure. These issues made us realize that the market needs a safer and more effective solution, which also strengthened our confidence in developing our project.
We visited Sun Yat-sen University to gain a comprehensive understanding of the freeze-dried powder production process. This experience provided crucial technical support, helping us optimize our product’s manufacturing process while ensuring stability and efficacy. Additionally, we learned about the essential equipment and instruments required for drug research and small-scale trial production in a university setting. This visit has laid a solid foundation for our subsequent product development, enabling us to effectively transition from research to initial production stages.
We participated in a series of business courses with the goal of improving our business acumen and laying a stronger foundation for the future growth and success of our project. These courses equipped us with essential skills in business strategy, market analysis, and entrepreneurship, helping us better understand the competitive landscape. By enhancing our ability to navigate market challenges, we are more prepared to drive the commercialization of our product and ensure a smoother transition from research to market-ready development. This knowledge will play a key role in our long-term success.
We participated in the Guangzhou Synthetic Biology Industry-Academia-Research Exchange Conference, where we gained a comprehensive understanding of the entire process of taking synthetic biology research from the lab to industrial-scale implementation. The conference highlighted key stages such as research innovation, scaling up production, navigating regulatory requirements, and market introduction. By interacting with experts from academia and industry, we learned about the challenges and opportunities involved in translating synthetic biology breakthroughs into commercially viable products. This experience has provided us with valuable insights for our own project development.
We attended the Pharmaceutical Practice Capability Training Course, which significantly deepened our knowledge of drug research, development, and manufacturing processes. The course covered various stages, including drug discovery, clinical trials, regulatory compliance, and large-scale production. Through hands-on learning and expert guidance, we gained valuable insights into quality control, formulation, and the intricate steps required to bring a pharmaceutical product from concept to market. This training has laid a strong professional foundation for the advancement of our project, equipping us with the skills necessary to ensure its success in the biotech industry.
We participated in a lecture on Functional Probiotics Development and the Industrial Production of Microorganisms, where we gained in-depth knowledge about the specific methods used to produce probiotic-based products on an industrial scale. The lecture covered key topics such as fermentation processes, strain selection, large-scale cultivation, and quality control in commercial settings. This knowledge provided essential technical guidance for the industrialization of our project, helping us understand how to scale up our research and effectively transition from laboratory development to commercial production.
We attended an event hosted by Jiuxian.com. Alcohol consumption is one of the main causes of inflammatory bowel disease (IBD). However, drinking is also a lifestyle habit for many people worldwide. As China's top omnichannel and all-category liquor retailer, Jiuxian.com provided us with the opportunity to communicate with many professionals in the liquor industry. We discussed a new business model, planning to have liquor companies purchase our product and offer it as a gift with their alcoholic products. This not only helps more high-risk individuals receive timely detection and treatment but also allows liquor merchants to demonstrate their sense of social responsibility in this way.
The founder's speech brought us many insights for our future business development. He mentioned that in business, one must courageously face various problems, and as long as the project is excellent enough, it will definitely be recognized by the market. These encouraging words have injected confidence and motivation into our future development.
In the future, we will continue to conduct market research and further optimize our project, striving to provide our target users with a cost-effective and easy-to-operate solution that truly meets their actual needs. This will help us better serve the market and enhance the practicality and user experience of our product.