Identifying our Stakeholders

Our project, centered on addressing H. pylori infections through innovative synthetic biology, brings together a diverse group of stakeholders who play pivotal roles in our venture's success. At the forefront are pharmaceutical companies, who are integral stakeholders due to their potential to fast-track our treatment through clinical trials and into production. Their expertise in drug development, regulatory compliance, and market access is invaluable. Investors and funding bodies represent another critical stakeholder group, as their financial support allows us to overcome initial financial hurdles and navigate complex regulatory requirements. Research institutions are key stakeholders due to their potential for collaboration, knowledge exchange, and joint research projects. Furthermore, healthcare providers and patients are essential stakeholders as their endorsement and acceptance of our experimental treatment are pivotal for its widespread adoption. Finally, our interdisciplinary team, comprising protein engineers, business students, and synthetic biologists, forms the core stakeholder group, bringing together diverse expertise to drive the project's success. Together, these stakeholders are the driving force behind our mission to revolutionize the treatment landscape for H. pylori infections.

Competitor Analysis

Aspect	Resistance Development	Impact on Gut Microbiota	Safety and Side Effects	Future Concerns
Probiotic Therapy	Low risk of resistance due to can search and destroy bad things.	Restores balance and diversity by promoting beneficial microorganisms and inhibiting harmful ones.	Generally considered safe, with minimal side effects.	Considered a potential alternative to antibiotics in the face of increasing antibiotic resistance.
Antibiotics	High risk of resistance due to extreme selection pressure of microbial communities under antibiotic treatment	Disrupts the population structure, leading to dysbiosis, deficiency of beneficial microorganisms, and enrichment of potentially harmful microorganisms.	Can cause various side effects, including disruption of gut microbiota, gastrointestinal issues, and antibiotic resistance.	Rising concerns about the effectiveness of antibiotics due to antimicrobial resistance, posing a threat to global health.

SWOT Analysis

Strength innovative and Effective Treatment: genetically modified probiotic therapy offers a unique and promising solution to H. pylori infections, which is a significant strength in a market seeking more effective treatments. Safe and Sustainable Solution: The use of an FDA-approved and GRAS probiotic strain enhances safety and sustainability, making it an attractive option for healthcare institutions and patients Adaptability: The adaptability of our engineered probiotic strains for targeting multiple pathogens in the gastrointestinal tract demonstrates versatility and future potential is a strength.

Opportunity Growing H. pylori problem: The growing intractability of H. pylori infections, even in regions where it is not currently prevalent creates a substantial market opportunity for effective treatments. Research Collaborations: Collaboration with research institutions and pharmaceutical companies can lead to joint research projects and grant funding. Market Expansion: Potential expansion into other gastrointestinal infections or related therapeutic areas offers growth possibilities. Public Awareness: Increasing awareness about synthetic biology and engineered probiotics can foster public support and interest in our project.

Weakness High Initial Costs: The resources required to scale this startup to a point that it can be bought out by a larger pharmaceutical. Complex Regulatory Environment: Navigating FDA regulations and compliance requirements can be time-consuming and expensive. Clinical Trial Costs: Conducting extensive clinical trials to validate safety and effectiveness can be a significant financial burden.

Threats Regulatory Hurdles: Stringent regulatory requirements could delay product development and increase costs. Market Acceptance: Convincing healthcare providers and patients to adopt a new and experimental treatment may face resistance. Funding Uncertainty: Dependence on research partnerships and grants could lead to financial instability if funding sources are limited.

PEST Analysis

Political Factors Regulatory Framework: The project faces political factors related to the regulatory environment for biotechnology and healthcare. Navigating FDA regulations and compliance requirements is a critical challenge. Government Funding: Depending on government policies and funding priorities in the regions where the project operates, there may be opportunities for government grants and support for biotechnological research.

Social Factors Public Awareness: Raising awareness about synthetic biology, engineered probiotics, and their potential impact on healthcare is important. Public perception and acceptance of genetically modified treatments may influence the project's success. Healthcare Practices: Cultural and social factors can affect healthcare practices and the willingness of patients to try new treatments. Understanding cultural attitudes toward health and medicine is crucial.

Economic Factors Funding Availability: The availability of funding for research and development is a key economic factor. Access to funding can determine the pace of research and product development. Market Demand: The economic feasibility of our project depends on the market demand for effective treatments for H. pylori infections, especially in regions where the infection is prevalent. The current demand for our product is unfounded as we have such a niche product.

Technological Factors Advancements in Synthetic Biology: Staying updated with the latest advancements in synthetic biology is essential for the project's success. Rapid technological developments can both benefit and challenge the project. Protecting our IP: In this industry our Intellectual Property(IP) can be quickly picked up by a larger company so protecting our IP via provisional patents, NDA’s and regular IP audits will safeguard our project.

Overall, the PEST analysis highlights the importance of not only the scientific and medical aspects of the project but also the regulatory, economic, social, and technological factors that can influence its success. Navigating these factors effectively will be crucial for the project's viability and impact in the field of synthetic biology and healthcare.

Market Gaps

Niche therapeutic for H. Pylori

“Although 7-d triple therapies (PPI, clarithromycin plus amoxicillin or metronidazole) have been the most used treatment in the management of H. pylori infection, their efficacy has decreased gradually worldwide during the last decade. This has been largely related to a worldwide increase of bacterial resistance, particularly against clarithromycin, the key antibiotic in the H. pylori treatment.”¹

“A prospective, multicenter placebo-controlled study performed in eight tertiary hospitals in Greece was done by Viazis et al. regarding a four-probiotics regimen combined with a standard H. pylori-eradication treatment reduces side effects and increases eradication rates. Data analysis was done for 329 patients in probiotic arm A and 335 patients in standard arm B. Now 56 (17%) patients in the probiotic cohort and 170 (50.7%) patients in the standard cohort reported with an incidence of H. pylori and severity of gastrointestinal problems. (p = 0.00001). Complete eradication of H. pylori is reported in 303 patients in probiotic arm (92.0%) and 291 patients in standard arm (86.8%), (p = 0.028).Results have shown that twice-daily probiotic supplementation reduced new-onset symptoms and severity associated with standard therapy. There was also an increase in eradication rates²

“Studies have reported several probiotic uses in the management of H. pylori, either when used alone or in conjunction with the standard treatment therapy. Clinical trials have demonstrated its association with a higher H. pylori eradication rate, less common self-reported side effects, and higher treatment compliance. Nevertheless, probiotics, when used alone demonstrated to help restore the gastric dysbiosis caused by eradication therapy partially, but it has not shown any significant improvement in H. pylori eradication.”²

Exit Strategy

• We recognize the tremendous potential of our project given its innovative approach to addressing H. pylori and other antibiotic-resistant infections. With multiple revenue streams in our arsenal, we understand that there are some challenges ahead. We're aware of the initial financial hurdles and the complexity of navigating regulatory requirements. We also acknowledge the presence of competition and the need to convince healthcare providers and patients to embrace our experimental treatment. Our success depends on how effectively we secure funding through research partnerships and grants while strategically addressing these challenges. Together, we're committed to overcoming these obstacles and making a meaningful impact on the healthcare landscape.
• As passionate members of this pioneering project, we are not only dedicated to addressing H. pylori infections but also to ensuring that our venture flourishes and makes a significant impact in the healthcare landscape. Strategic Acquisition: Our first avenue for exit involves positioning ourselves for acquisition by a pharmaceutical company or biotech firm that specializes in gastrointestinal health or therapeutic biologics. This exit strategy leverages our project's unique position within the market, offering a valuable and non-antibiotic solution to H. pylori infections. We would actively seek acquisition by a reputable company that can take our technology to a broader audience, leveraging their existing resources, regulatory expertise, and market presence. This approach would enable us to secure substantial returns for our investors while ensuring that our groundbreaking treatment reaches those who need it most.
• Continued Growth: While our exit strategy is strategically designed to maximize returns and impact, we also recognize the possibility of choosing not to exit. Instead, we may opt for continued growth and expansion as an independent entity, leveraging our multiple revenue streams, strategic partnerships, and accumulated expertise. This approach would allow us to further penetrate the market, pursue additional research projects, and develop complementary products and treatments to address a broader spectrum of gastrointestinal infections.
• In conclusion, our exit strategy is dynamic, designed to adapt to the evolving landscape of the therapeutic biologics and synthetic biology industries. We understand the initial financial challenges, regulatory complexities, and competitive nature of our venture. Nevertheless, we are committed to strategically addressing these challenges, securing funding through research partnerships and grants, and ultimately realizing our vision of transforming the healthcare landscape by providing a safe, sustainable, and effective treatment for H. pylori infections.

Business Collaborations

In our pursuit of entrepreneurial opportunities for our groundbreaking project, we proactively engaged with various departments within the University of Oregon. Notably, we established a crucial partnership with the Lundquist School of Business, a collaboration that would prove pivotal in propelling our vision forward. This partnership was solidified through our participation in the Oregon Innovation Challenge, an incubator competition co-organized by the Oregon Entrepreneurship Group and the University of Oregon Lundquist Center for Entrepreneurship.

Our Entrepreneurship team, consisting of members Adam McNichols, Walker Cullins, and Vaughn Mestman. This dynamic fusion allowed us to glean invaluable insights into the intricacies of transforming our groundbreaking scientific research into a market-ready solution. The Lundquist School of Business became our beacon of guidance, offering a diverse range of resources to nurture our entrepreneurial mindset.

Throughout this journey, our team undertook a multi-faceted approach. We established a strong presence across the university's academic landscape, connecting with the Knight Campus, the Knight Library, and the Lundquist School of Business. Our aim was to extend our project's reach beyond the laboratory and into the broader academic community. Through various outreach initiatives, we illuminated the tangible impacts of synthetic biology, demonstrating that involvement extended far beyond traditional lab work.

Our commitment to dissemination reached new heights as we took to the university's campus television displays, where we presented an engaging infographic designed to attract aspiring scientists and anyone intrigued by the potential of iGEM. Simultaneously, we conducted an extensive outreach campaign, reaching out to over 150 different companies. Our objective was to forge vital connections, seek sponsorship, and garner invaluable guidance.

As our project gained momentum, we recognized the power of a strong online presence. We established an active and informative social media presence to showcase our continuous progress and educate our growing online following. You can find us on Instagram with the handle @igem_uoregon and on LinkedIn as UOregon IGEM.

Through this collaborative journey with the Lundquist School of Business and our extensive outreach efforts, we have successfully melded cutting-edge science with entrepreneurial prowess. The inception of our project at the Knight Campus, University of Oregon's bioengineering school, marked the genesis of our mission to combat H. pylori infections. With each step forward, we've solidified our commitment to pioneering solutions in the field of synthetic biology. Our project stands as a testament to the remarkable outcomes that can be achieved when interdisciplinary collaboration and entrepreneurial spirit intersect, guiding us towards a brighter, healthier future.

Finance Analysis

Our project was funded through the Knight Campus & Department of Bioengineering, Crowdfunding through DuckFunder and from CURE on the UO campus.

Here is a breakdown of the financial statement for the duration of experimentation.

Experimentation will cost $10 000; need to buy DNA, bacteria, reagents, and consumables to make an initial design

Market Opportunity

Our venture operates at the intersection of the therapeutic biologics and synthetic biology industries, offering a unique and promising solution to tackle H. pylori infections. As we delve into this exciting market, we recognize that it is deeply segmented, and we have strategically chosen our initial target market. Our primary focus lies on pharmaceutical companies, entities capable of expediting our product through clinical trials and fast-tracking it for production. We possess unwavering confidence in our ability to deliver a functional product substantiated by robust evidence and data.

Segmented Market

• In our market segmentation analysis, we've identified specific sectors within the broader industry, each representing substantial market value and offering immense potential for growth.
• These segments include: Pharmaceutical Industry: Our primary target market, the pharmaceutical industry, is expected to experience significant growth, projected at 8.9% by 2030. The industry's market size is valued at USD 391.5 billion in 2023, with revenue forecasted to reach USD 682.9 billion by 2030.
• Probiotic Industry: The probiotic industry, where our product finds its place, is projected to grow by 8.1% by 2027. The market size was valued at USD 57.8 billion in 2022, with revenue expected to reach USD 85.4 billion by 2027.
• Therapeutic Biologics Industry: The therapeutic biologics market has experienced a surge in demand, driven by the increasing frequency and diagnosis of diseases. Our product, positioned uniquely within this sector, has the potential to tap into one of the fastest-growing industries. The recent COVID-19 epidemic has underscored the need for advanced diagnostics and treatment medications. As H. pylori infections continue to pose a challenge and antibiotic resistance escalates, there is a high demand for innovative treatment solutions. With the effectiveness of antibiotics diminishing, our non-invasive and highly effective treatment option is poised to fill a crucial gap in the market. The global biologics market was estimated at US$ 348.03 billion in 2022 and it is expected to hit over US$ 620.31 billion by 2032 with a noteworthy CAGR of 6% from 2023 to 2032.

The pharmaceutical industry is expected to grow by 8.9% by 2030³

Market size value in 2023	Revenue forecast in 2030
USD 391.5 billion	USD 682.9 billion

The probiotic industry is expected to grow by 8.1% by 2027⁴

Market size value in 2023	Revenue forecast in 2030
USD 57.8 billion	USD 85.4 billion

Therapeutics biologics industry⁵

Identified Market Gap

As we look at the current landscape, one glaring gap is evident - the impending obsolescence of antibiotics as the primary treatment option. The rise of antibiotic resistance poses a genuine global threat. Our product stands as a beacon of hope in this scenario, offering an alternative solution that is potentially both non-invasive and more effective. We operate in a niche within the therapeutic biologics market, distinctly separate from the conventional antibiotic pharmaceutical companies. Our unique positioning and potential to meet the burgeoning demand for innovative H. pylori infection treatments, fueled by increasing antibiotic usage and declining effectiveness, place us at the forefront of a pivotal shift in the industry. As H. pylori infections persist and antibiotics lose their edge, our solution emerges as the answer to a pressing healthcare challenge, with the potential to revolutionize the landscape.

References

1. Francesco, V. D.; Ierardi, E.; Hassan, C.; Zullo, A. Helicobacter PyloriTherapy: Present and Future. World Journal of Gastrointestinal Pharmacology and Therapeutics 2012, 3 (4), 68. DOI:10.4292/wjgpt.v3.i4.68. .
2. Mestre, A.; Sathiya Narayanan, R.; Rivas, D.; John, J.; Abdulqader, M. A.; Khanna, T.; Chakinala, R. C.; Gupta, S. Role of Probiotics in the Management of Helicobacter Pylori. Cureus 2022. DOI:10.7759/cureus.26463.
3. Generic Pharmaceuticals Market Size & Share Report, 2030, Grand View Research, 2023, www.grandviewresearch.com/industry-analysis/generic-pharmaceuticals-market-report. .
4. Markets and Markets. “Global Probiotics Market Size & Forecast [Latest].” Markets and Markets, Oct. 2022, www.marketsandmarkets.com/Market-Reports/probiotics-market-69.html.
5. Precedence Research. “Biologics Market (by Source: Microbial, Mammalian, Others; by Product: Mabs, Vaccines, Antisense, Rnai & Molecular Therapy, Recombinant Proteins, Others; by Indication: Oncology, Immunological Disorders, Cardiovascular Disorders, Hematological Disorders, Others; by Manufacturing: Outsourced, in-House; by Distribution Channel) - Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2023 – 2032.” Precedence Research, 2023, www.precedenceresearch.com/biologics-market.