Team:WHU-China/Entrepreneurship
Enterpreneurship
In this part, we think about how to take our project into a commercially feasible product, which consists of four parts below.
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Background  |
Development and market analysis  |
Business model and market strategy  |
Competitive risks and countermeasures  |
According to 2001 The Food and Agriculture Organization (FAO)and the World Health Organization (WHO), probiotics are defined as living bacteria that have an effective effect on the health of the consumer by ingesting the appropriate amount.
At present, probiotics are widely used in food and health care.
(1)In the food industry, the common probiotics are mainly used in fermented food, such as yogurt, lactobacillus drinks, kimchi, etc.
(2)In the field of health care products, it can be found in probiotics, that is, health care products made with probiotics as the main functional ingredients and other substances, including traditional dosage tablets, capsules, granules and new forms such as oral liquid, chewing gum, toothpaste and so on.
(3)However, due to the limited research on the mechanism of action of probiotics, probiotics are rarely used as drugs.
In terms of market conditions, Japan is the most developed country in the world in the probiotic industry, followed by Europe and the United States. In China, the start of probiotics is much later, but with the improvement of people's health awareness and business, media publicity, foreign probiotic products continue to pour into China. Now the international research on probiotics such as lactic acid bacteria is very active, the product consumption achievement is amazing, the growth index is increasing year by year, showing an upward trend of development.
Figure 1.1.1 Global Probiotic Market Structure Ratio
At present, the probiotics industry in the world has reached 40 billion US dollars, with an annual growth rate of 15%-20%.
Figure 1.1.2 Market size and forecast of Probiotics products in China from 2015 to 2020
At present, as for the use of drugs, the famous foreign brands include BIO THREE and Miya from Japan, Medilac-Vita from South Korea, Lacteol Fort and BIOFLOR from France, etc.
Take Seres Therapeutics as an example, it is an American company that uses probiotics to treat clostridium difficile infections (CDI). On June 12, 2015, ser-109, a phase II clinical microbe blend developed by the company, received the "Breakthrough Treatment" designation from FDA. On August 21 of the same year, SER-109 was again rated by FDA as an "orphan drug" for the treatment of adult CDI.
Based on the widespread application of probiotics, synthetic biologists put forward the concept and assumption of engineering probiotics. They can achieve the purpose of treatment by changing metabolism of the host, regulating the immune system and resisting to pathogenic microorganisms. They are important applications of synthetic biology in the field of health care.
At present, a variety of probiotics base organisms like E. coli Nissle 1917, Lactobacillus and Bifidobacterium have been developed. In addition, there has been a relatively perfect process and method for the industrial transformation of probiotics, which has greatly expanded the application scope of engineering probiotics and promoted the commercialization process of related industries. Due to the high modularization of engineered probiotics, engineered probiotics has been involved in many commercial fields.
At the present, a variety of probiotics base organisms like E. coli, Lactobacillus and bifidobacterium have been developed. In addition, there has been a relatively perfect process and method for the industrial transformation of probiotics, which has greatly expanded the application scope of engineering probiotics and promoted the commercialization process of related industries. Due to the high modularization of engineering probiotics, engineering probiotics has been involved in many commercial fields.
The development of engineering probiotics is mainly dominated by the United States, where ZBiotics, a U.S. gene engineering company that focuses on consumers’ health, recently launched the first genetic engineering probiotic – Zbiotics. Zbiotics is a functional beverage whose central function is to break down acetaldehyde, an unwanted by-product of alcohol. Meanwhile, the industry benchmark for synthetic biologic, Synlogic, has started a phase of clinical trials and is gaining momentum.
China's engineering probiotic field is in its infancy, with large-scale probiotic enterprises represented by Scitop Bio, abundant reserves of fine strains, complete technical system and a solid foundation for the development of engineering probiotics, a good development momentum of engineering probiotics can be foreseen.
1.more and more invasive operations in the medical process, such as tracheotomy, trachea intubation, inhalation device, monitoring instrument probe and so on. These operations can import outside microorganism and damage the body's defense barrier.
2.the use of antibiotics and other drugs, drug-resistant strains are continuously increasing.
All of these factors may significantly increase the risk of infection in the hospital. According to we our interview, the secondary infection in first-line is indeed widespread, and has a significant negative impact on the lasting treatment. For example, during this COVID-19 outbreak, a large number of patients flocked to hospitals, making medical devices full used or overused, of which particularly short in ventilators – one ventilator may serve many different patients in a short time. Frequent use coupled with incomplete disinfection is likely to cause residual of Pseudomonas aeruginosa and other gram-negative bacteria in the ventilators, causing secondary infection in the hospital during the tracheal intination process.
For infectious diseases such as in-hospital infections, antibiotics are still used in mainstream treatment options. According to recent surveys, the rate of carbapenem resistance in Pseudomonas aeruginosa has reached 26.4%. Drugs target carbapenem- resistant Enterobacteriaceae (CRE), Baumann's Bacillus (CRAB) and pseudomonas aeruginosa (CRPA) have been identified by the World Health Organization as key requirements for research and development. At the same time, patients in the ICU are now often treated with empirical broad-spectrum antibiotics to prevent Gram-negative bacteria infections. Although this means that to a certain extent to solve the current house of the Gram-negative bacteria infections, but also will inevitably cause the resistance of related bacteria to further improve and Gram-negative bacteria infection drug-free crisis is approaching.
Due to the limitations of treatment, the market for new therapies for bacterial infection caused by the widely drug-resistant Gloran-negative pathogen has not been met, and effective new therapies need to be developed.
There is no uniform definition of the concept of synthetic biology, but it can simply be described as the fine design of biological systems and the "engineering" of living organisms, a study that obtains new biological functions by assembling structural and functional biological components into more complex biological systems. Designing, constructing and manipulating new biological systems at the molecular level is the main research content.
Synthetic biology represents a new trend in the development of biotechnology, using synthetic biology technology to overcome biological barriers, has made significant progress in the production of low-cost bio-petroleum hydrocarbons, efficient and low-cost preparation of hydrogen, integrated biological treatment of cellulose substances into ethanol, synthetic antimalarial drugs, synthetic enterobacterials and other aspects of researches. Many scholars believe that synthetic biology will develop rapidly in a few years, and will be widely used in the energy, environment, chemicals, materials, medicine and other fields, which will produce huge social and economic benefits.
In a research released in May 2020 called The Bio Revolution: Innovations Transforming Economies, Societies and Our Lives by McKinsey Global Institute [5], they describe a prospective future for biological applications. They estimate that over the next ten to 20 years, biological applications could have direct annual economic impact of between about $2 trillion and $4 trillion globally.
Additionally, in the field of medicine, synthetic biology research has the advantages of rich and diverse technology, strong operability and large space for independent design, which can not only provide new ways for new drug research and development, but also provide new ideas for drug preparation, and have obvious advantages in realizing the autonomy and innovation of drug research and development. In the international community, synthetic biology research as an innovative technology has become a commercial hot spot, especially because of its broad prospects in drug research and development and huge profit returns, has attracted the world's top pharmaceutical companies and investment institutions of special attention and a large amount of money. It can be foreseen that in China's pharmaceutical industry, synthetic biology research will be expected to promote source innovation, promote overall development, achieve breakthrough in drug research and development, to solve the drug problem of more than one billion people in China to provide long-term support.
China's biopharmaceutical industry is developing rapidly. A foreign analyst said that over the past two or three decades, the traditional pharmaceutical industry has been dominated by the United States, Western Europe and Japan, but the current situation is changing very quickly because China has made significant progress. The analyst said that emerging markets represented by China would continue to grow at a high rate and would attract more foreign products to China as China's policy regulations become more transparent and global. Because China is a promising biopharmaceutical market and ongoing reforms are becoming more and more open.
Figure 1.5.1 Market Size and Forecast of Biosimilars in China
However, China's innovative drug research and development capacity and investment still have a large gap comparing with foreign countries. China's innovative drug clinical applications concentrated in the field of anti-tumor, the new virus drug research and development investment is insufficient, which is directly related to the poor short-term investment returns of pharmaceutical research. With the spread of the COVID-19 epidemic, the biopharmaceutical industry has become a pioneer in the fight against the virus, pushing all parties to re-examine its strategic value, this outbreak is also expected to encourage the government to pay more attention to and support the research and development of new drugs. The prospects for biomedicine are promising, and Bill Gates even predicted that the next world's richest man to surpass him would have to come from the genetic field. According to the 2019-2025 Market Monitoring and Future Prospects Forecast Report of China's Biomedical Industry released by Zhiyan Consulting Network, the market size of China's biopharmaceutical industry will reach a growth rate of 10%-15% in 2020-2025, and the market size of China's biopharmaceutical industry is expected to exceed 500 billion yuan by 2025.
Figure 1.5.2 Proportion and Target Field of Biological Drugs in China in 2018
The ten key fields mentioned in the strategy document -"Made in China 2025"- issued in May, 2015, which aims at deploying comprehensive promotion and implementation of a strong manufacture, includes biomedicine and high-performance medical devices. The document proposes the development of new products of chemical drugs, traditional Chinese medicines and biotechnology drugs for major diseases, with emphasis on new mechanisms and new targets of chemical drugs, antibody drugs, antibody conjugates, new structural proteins and polypeptides, new vaccines, innovative traditional Chinese medicines with prominent clinical advantages and personalized medicine. The government's attention will greatly accelerate the development of high-performance, high-tech biomedicine and medical devices in China.
In collaboration with Tongji-China and UCAS-China, we, China Synthetic Biotic Delta, together analyze the business prospects of novel probiotic therapies implemented in first-tier and second-tier cities in China which include Wuhan, Beijing and Shanghai.
WHU-China (Wuhan)
With the strong support of the national policy, Biolake in Wuhan started constructing in November, 2008. This bioindustry base focuses on biomedicine, biomedical engineering, bio-agriculture, precision diagnosis and treatment, intelligent medical treatment, bio-services and other fields and creating a new bio-industry city integrating research and development, incubation, production, logistics and life. In the base, the biopharmaceutical park, which covers an area of 6 square kilometers, focuses on the development of genetic engineering drugs, chemical preparations, diagnostic reagents and other fields and collocates the largest professional logistics center in central China, gathered more than 200 enterprises such as Human Fu Pharmaceuticals, Fessenyus, National Drug Flow, Hikang Bio, etc. It is an important new drug creation center, national innovative drug incubator, national new pharmaceutical creation integrated platform, national genetic engineering drug public service platform in China. In the field of chemical preparations, Biolake has become China’s largest production base of antiviral prescription drugs and has constructed the first cGMP standard soft capsule export production base in China. It can be said that in the field of biomedicine, with the support of national policies, Wuhan has a unique advantage in the conditions for the development of biomedicine great prospects.
UCAS-China (Beijing)
ZhongguanCun DaXing Bio-Medicine Industry Park has the advantages of "Zhongguancun", enjoys dual preferential policies for national high-tech industrial parks and national economic and technological development zones, backed by the rich resources of major authoritative institutions, universities and hospitals. The high-end industries in the park continue to gather, forming a development model centered on drug license approval and medical research and development, with biopharmaceuticals, modern Chinese medicines, and medical devices as the main body, and health products, cosmetics and veterinary medicine vaccines as the expansion. Authoritative institutions such as China Food and Drug Control Research Institute, National Veterinary Microbiology Center, China Animal Disease Prevention and Control Center and mature incubator companies settle in the park. All process from research and development to final industrialization of a product can be realized in the park. There are nearly 100 high-tech enterprises in the park, including the world's top 500 Fresenius Kabi, China's time-honored Tongrentang, and Centennial Concord. In the context of the coordinated development of Beijing-Tianjin-Hebei and the globalization of the health industry, the pharmaceutical base relies on the capital city's industrial and strategic position and leverages the advantages of Beijing Daxing International Airport in international exchanges. It has good development prospects.
Tongji-China (Shanghai)
With the national policies’ supporting, Shanghai’s Zhangjiang high tech Park was established in July 1992. Located in the central part of Pudong New Area, Zhangjiang high tech Park has planned to cover an area of 25 square kilometers. In August 1999, Shanghai Municipal Party Committee and Shanghai Municipal Government issued the strategic decision of "Focusing on Zhangjiang", which made it clear that the park would take integrated circuits, software and biomedicine as the leading industries, and concentrate on the main functions of innovation and entrepreneurship. Since then, Zhangjiang Park has stepped into a stage of rapid development. Zhangjiang Biomedical Base, known as "Zhangjiang Medicine Valley". It is the national Shanghai Biomedical Science and Technology Industrial Base jointly built by Shanghai Municipal government, the Ministry of Technology, the Ministry of Health, the Chinese Academy of Sciences and the State Food and Drug Administration in Zhangjiang in 1996, to gather and develop innovative enterprises in the field of biotechnology and modern medicine. At present, there are nearly 400 biomedical projects covering the four fields of biotechnology, modern Traditional Chinese medicine, chemical drugs and medical devices. The world's top 20 pharmaceutical sales enterprises, nearly half have settled in Zhangjiang, such as PfizerNOVARTIS, AstraZeneca, GE, ROCHE, LILYSANKYO, KIRIN. In addition to the multinational corporation r&d center, the park also brought together a large number of national and municipal key research institutes. They support the enterprise to build the perfect technical service public platform, improve the utilization rate of resources, and effectively reduce the enterprise's development into operation. In the field of biomedicine, relying on the national policies and a mature park composed of several enterprises, Shanghai has unique advantages and great prospects for the development of biomedicine.
In addition, in a research called The Bio Revolution: Innovations Transforming Economies Societies and Our Lives by McKinsey Global Institute [5], which have been mentioned above, they refer to the fact that the leader of China’s Basic Research Department said the country was seeking to position itself as a global leader in synthetic biology, motivated by a need to address the country’s public health, nutrition, and resource needs.
In recent years, the state has increased its investment in the field of biopharmaceuticals. "Made in China 2025"- issued in May, 2015, which aims at deploying comprehensive promotion and implementation of a strong manufacture, includes biomedicine and high-performance medical devices. The document proposes the development of new products of chemical drugs, traditional Chinese medicines and biotechnology drugs for major diseases, with emphasis on new mechanisms and new targets of chemical drugs, antibody drugs, antibody conjugates, new structural proteins and polypeptides, new vaccines, innovative traditional Chinese medicines with prominent clinical advantages and personalized medicine, which clearly take biomedicine and high-performance medical devices as one of the ten key areas of development and gives strategic support and protection and put forward development goals.
In 2025, we will basically achieve drug quality standards and systems in line with international standards, develop new products for chemical, traditional Chinese and biotechnology drugs for 10 major diseases, realize the industrialization of 20-30 innovative drugs, and 5 product -10 new drugs with independent property rights in China will enter the international market through FDA or EU certification. We will build a national drug innovation system that improves and supports external services, form a high-level innovation team with an international perspective, and promote the international development strategy of Chinese medicine.
And, for the implementation of the The 13th Five-Year Plan for Economic and Social Development of the People’s Republic of China and A Guideline on Emerging Sectors of Strategic Importance During the 13th Five-Year Plan Period, further strengthen the biological industry innovation base, promote the modern biological technology more benefits to the people's livelihood, focus on creating new biological and economic momentum. The proposals for technological innovation in the next five years were also put forward, and the direction of investment development in the field of medicine and health was also pointed out. According to the Plan, the innovation platform's resource sharing and open services have basically established a national drug innovation system with the world's advanced level. The comprehensive capacity and overall level of new drug research and development have entered the international advanced ranks, accelerating China's transformation from a large pharmaceutical country to a major medical country. According to the plan, the compound growth rate of China's biological industry has reached more than 15 percent since the 12th Five-Year Plan period, and the size of the industry exceeded 3.5 trillion yuan in 2015. By 2020, the scale of the biological industry will reach 8-10 trillion yuan, and the added value of the biological industry will account for more than 4% of GDP, becoming the leading industry of the national economy. According to the relevant analysis organizations, under the strategic background of independent innovation, the demand for testing safety and effectiveness in the early stage of drug development has greatly increased, directly driving the sustained growth of China's preclinical CRO industry in recent years.
Of course, relevant national institutions have also issued a number of other policies to strongly support the development of the biopharmaceutical industry, including representative of the major policy support as follows:
The government's attention will greatly accelerate the development of high-performance, high-tech biomedicine and medical devices in China. This project has a good prospect and huge development space under the environment of rapid development of biomedicine industry.
1. Market demand
In recent years, with the emergence of drug-resistant bacteria, the types and dosing of antibiotics needed to treat bacterial infections have been increasing. And the real situation is:
(1) Since the 1970s, it has been difficult to obtain antibiotics with development value from microbial metabolites through the method of pure culture of microorganisms under laboratory conditions. At present, the research and development of antibacterial drugs mainly focuses on the modification or optimization of known compounds.
Figure 2.1.1 Models of antibiotic drug discovery and development [9]
(2) Meanwhile, the market for new therapies for bacterial infections caused by extensively resistant Gram-negative pathogens has not been met, with carbapene-resistant enterobacteriaceae (CRE), acinetobacter baumannii (CRAB) and pseudomonas aeruginosa (CRPA) identified by the World Health Organization as key needs for research and development.
Figure 2.1.2 Percentage of CRO infection of three bacteria in Chinese hospitals in 2017.
It can be seen that the increase in demand for antibiotics and the restriction of antibiotic use and research and development bottlenecks have formed a huge conflict, the market demand for antibiotic substitutes is very urgent.
2. Industrial supply.
There are about ten alternatives to antibiotics (e.g. antimicrobial peptides, thymus peptides, phages, etc.), but there may be only four or five commonly used on the market. Although there are many alternatives, each product is defective in some way and can only be used as an adjuvant therapy, not a complete substitute for antibiotics. As a result, the available supply of industry is very limited.
From the above, the huge market and limited supply conditions, effective antibiotic substitutes such as engineering probiotics have broad economic prospects.
In recent years, the problem of drug-resistant bacterial infection has become more and more serious. It is predicted that by 2050, the number of human deaths due to multiple drug resistance will increase to 10 million, surpassing cancer deaths as one of the world's major causes of human death. The production of drug-resistant bacteria is closely related to the use of antibiotics. With the increasing use of antibiotics, bacterial resistance is also increasing in the round of screening. The misuse of antibiotics adds to the problem. As a result, there are growing calls to limit the use of antibiotics. In this context, there is an urgent need for a treatment of bacterial infections that does not require antibiotics.
Figure 2.1.3 Global antibiotic consumption by country: 2000–2015 [10]
Figure 2.1.4 Projected total global antibiotic consumption (billions of DDDs): 2000–2030 [10]
Quorum sensing (QS) refers to the change of physiological and bio-chemical characteristics of microbial groups in their growth process. The reason for this change is that when the density of microbial population in the environment reaches a threshold and the concentration of signaling molecules reaches a certain level, the signal transmission of related proteins, including the subject protein, induces or inhibits the signal to be eventually transmitted to the cell, affects the expression of specific genes, and regulates the physiological characteristics of the microbiome, such as bioluminescent, antibiotics synthesis, biofilm formation, etc. Through QS mechanism, microorganisms are able to coordinate in complex environments to "team combat capability" to better survive the entire population.
This mechanism allows bacteria to form high-density biofilms when Gram-negative bacteria invade the human body, causing great harm to human health.
Figure 2.1.5 Proposed model of the effects of 3O-C12-HSL on the host during P. aeruginosa infections [11]
Quorum quenching (QQ) means to inhibit the QS system, the discovery of this therapy can greatly inhibit the occurrence of biofilms, thereby slowing the bacterial infection process in the human body. Because it interferes with the internal communication path of bacteria itself, it can effectively cope with the current situation of increasing bacterial resistance, so as to achieve a better auxiliary treatment effect.
Figure 2.2.1 3C's Strategic Triangle Model.
Through the analysis of our product technology, we can conclude that our target customers should mainly be medical or immunology research institutions, major hospitals and their relevant cooperative institutions or enterprises, which are summarized as follows:
1. In the treatment of infections, hospitals will become our most important customer base at present.
2. In the area of research or teaching, research institutions in related fields such as immunology, microbiology and medicine, as well as laboratories in universities, will form an additional group of clients.
Product Sales: For hospitals, new treatment ideas can be provided, as well as cheaper and more efficient treatment methods, and for research institutes, new research materials can be provided to reduce research and development costs and improve research efficiency.
Technical services: We will provide technical services for some biopharmaceutical companies, assist in more efficient and professional R & D of products, and improve research efficiency and product quality.
Patent licensing: We will cooperate with biomedical companies to promote the industrialization of products and create a win-win industrial chain.
The relationship between customers and us is an interactive relationship.
The service platform provides a communication platform for target customers: for researchers, the platform can provide product related statistical data and research results of other researchers, which helps to better understand the product and lead further research. For drug sales companies, product feedback and communication can be carried out on the platform, and personalized customized scheme can be designed, that is, engineering probiotics products for specific Gram-negative bacteria. For consumers, the raw materials provided by the platform are traceable, which helps to gain the trust of customers and establish a good reputation for the products.
After our platform provides customers with high-quality services, customers will become our free advertising, which helps to improve the company's visibility, increase our influence in target customers, increase market share, attract more funds, further promote the development and improvement of products and platforms, so as to better serve customers Households. As a result, a virtuous development cycle has been formed, so that our projects and products can have more sustainable development.
Our business model is divided into three parts: product sales, patent licensing and technical services: .
①Product sales: we hope to promote the products we have developed (which can be carried out through the intermediary of pharmaceutical representatives) and sell them to patients infected with gram-negative bacteria, and make profits by selling the products.
② Patent authorization:in the early stage of R & D, in order to support us, we can also sell a certain technology or patent in the whole technology system to relevant R & D units, help them develop related similar products more quickly and effectively, and promote the development of the whole market environment.
③ Technical services: our team has a relatively complete technical system for the construction of Engineering probiotics, which can provide R & D services for relevant pharmaceutical companies and help them build engineering probiotics.
We are now using laboratories provided by the college of life sciences of Wuhan University for independent research, but we are looking for cooperation with companies or institutions engaged in anti-biofilm research or engineering probiotics.
In terms of research, we are trying to apply the latest research results in related fields to expand the application of our product technology, hoping to enable the product to have a wider spectrum of therapeutic effect. In this regard, we will improve our product technology and strengthen the cooperation with research teams in related fields.
In the early stage of development, our products will be produced by OEM companies with production qualification around Wuhan. As an emerging business team, we lack production management experience, so it is necessary to find a suitable contract manufacturer for mass production to reduce production costs and improve efficiency, so as to enhance our market competitiveness and enable our business team to focus more on product research. Later in the development of the "negotiator" project, we plan to invest in our own factory to produce products. The preliminary production plan arrangement is as follows: the company's production department formulates the production plan according to the monthly sales plan and the order status, and arranges the production according to the plan. And each production link is standardized and recorded to realize the traceability of product quality. The quality department monitors the production process, checks the strains, finished products and important operation links to ensure the biological safety and product quality in the production process. At the same time, the company strictly implements the inventory management system to ensure that the product inventory can meet the reasonable market demand and improve the inventory turnover rate.
At this stage, our main target market is patients with pulmonary infection caused by Pseudomonas aeruginosa. Pseudomonas aeruginosa is a common pathogen of nosocomial infection, but also a "super bacteria" in Gram-negative bacteria. Its treatment is difficult, and the market demand for new treatment is large. In addition, we use engineering probiotics for treatment, which theoretically can effectively treat infections caused by a variety of Gram-negative bacteria, and has great development potential.
Our products have core competitiveness in principle. In order to show our product strategy to the market, we have made the following analysis on our products.
| product hierarchy | description |
|---|---|
| core product | The core product of our project is the biological preparation for the treatment of gram-negative bacterial infection. The advantage is that the use of Gram-negative bacteria group induction effect, immunotherapy, avoid the use of antibiotics, can better solve the problem of bacterial drug resistance. |
| formal product | Our expected product is to produce inhaled spray containing engineered bacteria to treat gram negative bacteria in the lungs. |
| future product | We hope that we can use our principle to make biological agents that can be used to treat Gram-negative bacteria infection in all parts of the body, and improve the applicability of the products to various infections. |
| potential product | Promote new technologies and patents in the process of product development, promote the development of the industry, accelerate drug research and development, and improve the treatment level for Gram-negative bacteria. |
In the early stage of the company's development, we will mainly focus on the core business of early capital accumulation, actively cooperate with drug companies and research institutions dedicated to the treatment of Gram-negative bacteria infection, and sell our products. For this part of the business, considering the traditional antibacterial market and the positioning of our innovative products, we decided to adopt a satisfactory pricing strategy. Through cost and market analysis, we selected the optimal price which is relatively favorable to consumers, producers and middlemen. The initial price was 4000 yuan / L. With the expansion of business scale and the increase of sales volume, the company will achieve the purpose of profit maximization by properly adjusting the price and influencing the change of sales at anytime
Channels are crucial to the chemical, agricultural, food and pharmaceutical industries. According to the market characteristics of bacteriostatic therapy, we developed a channel strategy combining point-to-point sales in the early stage and agent distribution in the later stage to meet the needs of improving market coverage, channel flexibility and channel control. At the same time, we will also strictly control products and services, prices, promotion activities, distribution processes, etc., to ensure the normal operation of the channel network.
| Competitive risks and countermeasures | |
|---|---|
| Descriptions of the risk | Countermeasures |
| 1. Competitors The main competitors of our product are antibiotics, including antibiotics and synthetic drugs. However, China is a big country in the production and use of antibacterial drugs. The annual production of antibacterial raw materials is about 210000 tons, and the export is about 30000 tons. According to the "survey report on the current situation of public safe drug use" issued by the State Food and Drug Administration on September 1, 2012, about 25% of China's households have antibacterial drugs on hand, and 23.9% of people use antibacterial drugs after catching a cold. Among the top 100 drugs sold in China's medical institutions, 29 belong to antibacterial drugs, and the annual sales of the third generation cephalosporins alone exceed 1 billion yuan. It can be seen that antibacterial drugs occupy a large market share, so the first problem to be solved is to occupy a certain market. |
Although the market for antimicrobials is more important, but in recent years, the problem of drug-resistant bacteria is becoming more serious, and the abuse of antibiotics is exacerbating the problem, and this product can be a good target for specific bacteria, the killing of drug-resistant bacteria can play a very good effect, from the quality and effect of strong competitiveness. |
| 2. Public acceptance. Public confidence in GM technology is low, and the GM technology used in the production of this product may be questioned, while oral microorganisms may also create a psychological burden on customers. |
The safety of the product needs to be fully controlled, and within the permitted scope in the product description to explain the production process for the control of GM safety technology, the use of probiotic chassis, a brief introduction to the biological characteristics of the probiotic chassis used to reduce the psychological burden of the public on oral microorganisms. And apply for relevant permits to improve public acceptance. |
| 3. Promotion and application. The role of this product at this stage is more in favor of auxiliary treatment, the scope of application is narrower. |
In view of the current bacterial resistance problem is becoming more and more serious, and this product can solve this problem well, so at this stage with some companies producing antimicrobial drugs to cooperate, mutual benefit and win-win situation. In the long run, we will continue to make technological innovations to enhance the therapeutic effect of our products, moving from complementary therapy to therapeutic direction. |
To summarize, China Synthetic Biotic Delta made individualized business plans based on ‘A collaborative manuscript for engineered probiotics’, click here for downloading the complete version!
Special thanks to Prof. Liu Tiangang, Prof. Yang Daichang and Dr. Ma Zhaotang! Prof. Liu Tiangang recommended us to search for information about Synlogic and Seres Therapeutics, which determined our minds to develop our own business plan. Prof. Yang Daichang’s stories of Oryzogen deeply impressed us, and Prof. Yang’s suggestions are critical for us freshmen to produce a meaningful business plan. Dr. Ma Zhaotang explained the policies of novel drug development and registration to us, which broadened our horizons accordingly.
During the 7th Conference of China iGEMer Community, we listened to several profound lectures delivered by experienced industrial practitioners in China, including Mr. Liu Bingqian from Oriza Holdings, Dr. Zhang Haoqian and Dr. Li Teng, the co-founders of Bluepha, which improved our understanding of entrepreneurship.
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