Market Analysis
IBD, inflammatory bowel disease is a notorious intestinal problem all over the world. People are suffering from diarrhea and abdominal pain from this disease. Worst of all, IBD is very difficult to cure with the potential to become cancer. Patients usually repeatedly experience flare-ups and relapses. Flare-ups can be easily triggered by factors such as stress, infection, spicy diet, environment, etc. IBD is a chronic condition that needs to be managed. It often requires ongoing care and treatment to keep symptoms under control.
IBD is estimated to affect 0.3% population worldwide, and its prevalence rate has been steadily growing over the years. IBD prevalence was 321.2 per 100,000 population in 2021, compared to that of 200 per 100,000 population in 2006. This represents a 3% annual growth rate in patients' number. The increase in incidence is due to the rapid change in lifestyle, diet, environment, etc., with industrialized countries representing the highest incidence rate typically ranging from 1-2%. For example, it is reported that 2.5-3 million people in Europe are affected by IBD, with direct healthcare costs of 4.6-5.6 billion Euros per year. The worldwide IBD patients are estimated to be 24 million people with direct healthcare costs of 50 billion Euros per year. The IBD treatment market is expected to grow at 3% annually.
Our initial market is hospitals and clinics that treat IBD patients. We plan to roll out our product from China Hunan and Hubei province where our university is located. The two provinces are known for their spicy food and lightly polluted environment which causes a higher IBD prevalence rate. The two provinces have a population of 124 million. We estimate that IBD patients in the two provinces are 1 million, and the growth rate is 3% annually.
Product
IBD poses three challenges for healthcare. First, IBD repeatedly causes flare-ups with no obvious signs. It is hard to predict let alone to manage. Second, IBD symptoms are atypical and doctors frequently mix it up with other diagnoses. Third, due to the complexity of the intestine structure, it is hard for doctors to see inside and judge the severity of the situation. Last but not least, the IBD prevalence rate is expected to grow fast in the near future as modern lifestyles sweep around the world.
The latest research shows that the concentration of tetrathionate in the human gut can reflect the pathogenesis of IBD. Our product CHRISPReporter is a biosensor that is designed to test the tetrathionate concentration in the human gut thus ensuring timely care. The key component of CHRISPReporter is a specially designed capsule that dissolves only in the alkaline conditions of the human intestinal tract. The capsule contains engineered bacteria that do not harm the human body. After these engineered bacteria colonize the human intestine, the bacteria can sense the tetrathionate concentration. The colonization period takes about 3 weeks. Once there is IBD, the tetrathionate concentration will rise correspondingly, the threshold-optimized promoter will stimulate the recording module, a piece of DNA segment is knocked out and the next expressing cassette is brought to the proper site. If another wave of tetrathionate comes, the second cassette is deleted and the third is brought up, and so on. The patient collects his or her stool sample and hands over to the doctor. The stool sample contains the DNA segment mentioned above. By simply counting the amount of deleted cassettes, the doctor can get a readout representing the tetrathionate concentration variation and waving pattern. The doctor can give the patient a record-erasing reagent that activates a "suicide circuit" in the bacteria and effectively removes the bacteria.
Competitive Analysis
As we know, there is no testing product like ours in the market yet. IBD diagnosis currently relies on colonoscopy or enteroscopy, which requires patients to go through complicated procedures to prepare for the examination. Patients need to fast for 24 hours and to clean the colon. It takes at least a day to prepare for the examination. During the examination day, the actual exam normally takes 2 hours and the patients need at least half a day to rest afterwards. Compared to colonoscopy and enteroscopy, our product has the following obvious advantages. First, our product is comfortable and non-invasive for patients. Second, our product is easy for patients to use. Patients need to swallow a capsule and take stool samples to the clinic. Our product requires minimal training and is easy for lab technicians to execute as well. Third, our product is cheap compared to colonoscopy and enteroscopy. Anesthetic colonoscopy and enteroscopy range from RMB 800-1200 in China. Our product's initial price is targeted at RMB 600.
Our key disadvantage is that our technology is new and needs time to educate patients to accept it. We plan to leverage our university's brand name to first target hospitals and clinics. In central provinces in China, our university ranks number one, and so do our university-affiliated hospitals. We plan to start from our affiliated hospitals. We also plan to apply for a patent for our product. This will help the product's credibility.
Even though we don't know local companies that are developing products similar to ours, there are many international companies actively developing biosensor products for other industries. They can be interested in our field in the future and the biosensor technology is very adaptive among fields. We also may develop biosensor products for other industries as well. Possible industries include agriculture, consumer health, medical research, bioinformatics, ecology research, etc.
Business Model
Product Line
Our initial products are targeted at potential IBD patients. They are for doctors to use to diagnose IBD. Once we established our position in this field, we plan to use the same technology to develop products for other industries. The potential product line is as follows:
Diagnostic tools for IBD patients. Our product will be fine-tuned for easy use. It will require minimal training to execute effective diagnostic procedures for IBD patients.
Research Institutions. Our product will include detailed experimental protocols and tools for data analysis to help researchers delve deeper into the genetic and molecular biology aspects.
Agriculture. Our product can be adapted for monitoring soil health, pesticide, levels, or specific bacteria or viruses that are harmful to crops and environments.
Consumer Health. Our product can be adapted into diagnostic kits for broader health-monitoring solutions.
R&D
Wuhan University is the number one ranking university in central China. The university's affiliated hospital ranks number one in the region as well. In recent years, the Chinese government has been heavily investing in bio-science areas and even college students are on their funding radar. We plan to leverage our platform to apply for Chinese government funds to further our research. We have already talked to some government officials and lawyers. It is promising for us to get funds. We also plan to leverage our platform to find experts that we can work with. Their expertise can help speed up the project.
Production
We plan to outsource our production at the beginning. There are abundant production facilities in China, especially around the central China region. Many of these factories are low at capacity. We plan to select adjacent factories close to Wuhan. Besides price, selection criteria include previous experience, previous product quality, ability to deliver on time, ability to scale up, etc.
Sales & Marketing, Distribution
Our product will need CFDA approval. We are working on raising funds to allow us to work on CFDA approval. We have already talked to a lawyer about applying for a patent. The lawyer told us that China right now has an expedited process for patent approval for new technology and our solution qualifies for the expedited process. We probably can get a patent approval within six months.
While working on CFDA approval, we plan to start on educating patients and doctors on our products. We will utilize online platforms such as websites and social media to do this job. Our website will serve as an information hub, providing comprehensive insights into CRISPReporter's features, benefits technical specifications, etc. Social media will allow us to receive patients' and doctors' feedback and answer their concerns quickly. Via online platforms, we will actively disseminate the latest trends in genomics and molecular biology, showcasing CRISPReporter's applications in these domains. By consistently sharing valuable content, our objective is to not only attract a broader audience but also establish a robust social media presence, fostering meaningful interactions.
The actual sales happen at the hospitals and clinics. We work with doctors and have doctors to prescribe our tools to patients. Initially, we might partner with companies to sell our products to hospitals. Eventually, we want to build our own sales force to mainly work with doctors. Since our products are easy to use and require minimal training, we expect limited aftersales services.
Implementation Plan
The project from now to product launch takes about 17 months. The time to complete CFDA approval is unpredictable. However, we have talked to some industry experts and the best estimate for getting CFDA approval is about 1 year. When our model enhancement is completed, we will start patent approval, CFDA approval, and fundraising at the same time. To save time, we will start selecting manufacturers and building in-house sales as soon as we have better clarity on getting CFDA approval.
Gene Editing Optimization
The actual sales happen at the hospitals and clinics. We work with doctors and have doctors to prescribe our tools to patients. Initially, we might partner with companies to sell our products to hospitals. Eventually, we want to build our own sales force to mainly work with doctors. Since our products are easy to use and require minimal training, we expect limited aftersales services.
Model Enhancement
The CRISPReporter model consists of multiple components, including the reporter gene, the promoter, the terminator, and the regulatory elements. Each component plays a crucial role in ensuring a robust and reliable performance of the model. Based on experimental results and user feedback, we will regularly refine these components to improve their functionality. In addition to refining existing components, we are also open to exploring new features that could enhance our model. These features could include inducible expression, multiplexing capability, and compatibility with different platforms.
Risk Management
We anticipate two key challenges which are regulatory uncertainties and technical obstacles.
Regulatory uncertainties
Regulatory uncertainty is always a risk in China. New regulations come out frequently. We will work closely with the government to anticipate regulation change. We also will expedite the product launch process by multi-tasking when fit. For example, we will manage the CFDA approval process, build an in-house sales force, and establish an online site at the same time.
Technical obstacles
CRISPReporter still has technical obstacles in promoter evolution, gene editing, and visualization, etc. In terms of promoter evolution and gene editing, we use error-prone PCR and CRISPR-Cas9 techniques. For detection, we use qPCR, but this is not a convenient, multi-application visualization process. We are working with experts to overcome technical obstacles.