To highlight our efforts, we've mapped our work to iGEM's entrepreneurship criteria. For a more complete perspective, we recommend reviewing our full deliverables.

Breast milk is the gold standard for infant nutrition, yet many families find it difficult to maintain exclusive breastfeeding due to work and health pressures. Current formula still faces three major shortcomings: the absence of key human milk oligosaccharides (2′-FL), poor digestibility of casein, and lactose intolerance.

To address these challenges, our team, ProBabyotics, introduces 2-FLuxe, a synthetic biology–driven upgrade that integrates:

• Biosynthesis of 2′-FL to enhance immunity,
• Pre-digestion of casein using trypsin,
• Supplementation with β-galactosidase to improve lactose digestion.

Compared with traditional approaches, 2-FLuxe strikes a balance between safety, nutrition, and accessibility, offering infants a scientifically designed alternative closer to breast milk, while also creating sustainable business opportunities for the industry.

Figure: Mission, vision and goal.

Through market research and stakeholder communication, we identified three main categories of potential customer groups. Each has different needs and expectations, which provide clear direction for the positioning and design of ProBabyotics.

1 Primary Caregivers

They are the most direct consumers and the most sensitive to needs. Issues such as lactose intolerance, indigestion, or immune concerns during infant feeding make them eager for safer and more nutritionally balanced options.

We identified them as our core customer group. Our team conducted surveys and interviews to capture real pain points, ensuring the product directly addresses families’ feeding challenges.

2 Infant Formula Enterprises

These companies control production and distribution channels and pay close attention to the introduction of premium formulas and functional ingredients. Beyond meeting consumer demand, they are also seeking differentiated competitive advantages.

We regard them as potential B2B partners, collaborating on formula optimization, process integration, and regulatory pathways to accelerate the translation of lab results into industrial applications.

3 Hospitals & Maternity Care Facilities, Pediatricians & Nutritionists

Healthcare and nutrition professionals have a significant influence on infant feeding decisions. They value scientific evidence and clinical safety, and they are a critical source of trust for parents.

We consider them key opinion leader (KOL) customers. By engaging with them, we can obtain professional feedback and leverage their endorsements in future promotion to enhance the medical and scientific credibility of our products.

Figure: Potential customers analysis.

In recent years, consumer willingness to pay for premium infant formula has increased significantly, especially for products containing special nutrients such as OPO, lactoferrin, and DHA. According to data from iiMedia Research, more than 60% of consumers are willing to pay a premium for mid-to-high-end formula, reflecting strong recognition and demand for high-quality products.

However, a key gap remains in the market: Food for Special Medical Purposes (FSMP). Although its current market size is relatively small, it is growing rapidly and is expected to exceed RMB 10 billion by 2025. The main demand comes from infants with special nutritional needs, such as preterm babies, infants with allergies, and those with digestive issues.

As parents place increasing emphasis on infant health and nutrition, their demand for safe, comprehensive, and personalized nutrition solutions continues to grow. The current unmet need lies in providing formula products that not only meet basic nutritional requirements but also offer precise interventions tailored to individual differences.

ProBabyotics adopts an integrated approach combining synthetic biology and nutritional science, focusing on the key challenges of infant feeding. We provide a safer and more nutritious alternative for babies who cannot be exclusively breastfed, while always upholding the principle that breast milk is the best choice for infants.

Our design achieves three major functional upgrades:

• 2′-FL supplementation to support immunity and gut health;
• Trypsin pre-digestion of casein to reduce digestive burden and improve protein absorption;
• β-galactosidase supplementation to help lactose-intolerant infants safely digest lactose.

Currently, our product is at the proof-of-concept stage. We have validated the biosynthesis of 2′-FL and functional enzymes under controlled laboratory conditions and ensured that the final purified products contain no residual engineered bacteria or genetic material. The end products are functional ingredients that can be directly incorporated into formula design to provide targeted nutritional support.

Looking ahead, we plan to expand along two application paths:

• Functional formula milk (B2C) for ordinary families, improving daily nutrition and addressing common feeding challenges;
• FSMP (Food for Special Medical Purposes, B2B) for preterm infants or those with special nutritional needs, meeting clinical standards and regulatory requirements.

At the same time, we will explore collaborations with formula enterprises to accelerate industrialization and regulatory approval, achieving scalable and cost-effective production.

By incorporating feedback from caregivers, formula companies, and medical nutrition experts, we continuously refine our product pathway, ensuring scientific rigor and compliance while addressing real-world needs. This foundation positions ProBabyotics as a solution with feasibility, scalability, and innovation, which are the keys to its success.

Figure: Interview with Mr. Yu, who works in the microelectronics and semiconductor field

During our interview with Mr. Yu, who works in the microelectronics and semiconductor field, he explained why he chose entrepreneurship. For him, entrepreneurship begins with identifying unmet market demand: when he saw opportunities in a field with novelty and growth potential, he decided to start a business. He emphasized that products should serve real needs, and once the demand becomes clear, entrepreneurship naturally follows.

Figure: Interview with entrepreneurs. Mr. Cao

In advancing the ProBabyotics project, we also learned from entrepreneurs. Mr. Cao emphasized three key points: (i) deeply identify niche pain points, (ii) build a complementary team, and (iii) keep the business model flexible. He recognized the value of our innovation, but reminded us to focus on market education and suggested starting with small-scale pilot collaborations. These insights sharpened our approach to market research, user analysis, and team collaboration, strengthening the link between science and commercialization.

Project and Comprehensive Considerations

Our ProBabyotics project is dedicated to providing families who cannot or are unable to breastfeed with a safer, more scientific, and affordable infant nutrition alternative. To clarify our value proposition and validate market feasibility, we conducted a Golden Circle analysis.

Through Human Practices research, we identified three major pain points for parents during feeding:

• High cost of premium formula,
• Limited options for infants with special nutritional needs,
• Food safety and trust crisis.

These pain points reveal real gaps in the industry and point to opportunities for innovative breakthroughs. The Golden Circle framework helped us systematically answer Why we do it, How we do it, and What we have achieved, forming a clear strategic logic and value blueprint.

Figure: Golden circle analysis

Why

Breast milk is the ideal source of infant nutrition, but due to work pressure, health issues, and social factors, not all mothers can breastfeed. Key active components in breast milk (such as 2′-FL, HMOs, and lactoferrin) cannot be fully replicated in current formulas, creating nutritional gaps. At the same time, high costs, limited options for infants with special needs, and a food safety trust crisis drive demand for a safer, more scientific, and affordable alternative.

How

ProBabyotics leverages synthetic biology to overcome traditional bottlenecks, achieving low-cost production of 2′-FL and other HMOs in the lab, while integrating lactase and hydrolyzed proteins to design solutions for both regular infants and those with lactose intolerance or allergies. Throughout development, we uphold “safety as the first red line” by ensuring strict raw material screening, transparent labeling, and compliance pathways, making every step safe and traceable.

What

We have developed a prototype and roadmap centered on functional infant formula, combined with education and social responsibility, to drive industry innovation and public awareness. ProBabyotics not only provides families with nutrition closer to breast milk in the short term but also holds the potential for global expansion. With scientific feasibility, scalability, and creativity, ProBabyotics is positioned to become a trusted innovation in infant nutrition.

Legal Considerations

To ensure the feasibility, scalability, and innovation of ProBabyotics, we conducted a systematic review of regulations related to infant nutrition and biotechnology in both China and international markets. Our compliance strategy focuses on three key areas: ingredient approval, labeling & advertising regulations, and GMO biosafety.

1. Ingredient Approval

• 2′-Fucosyllactose (2′-FL) has been approved by China’s National Health Commission as a new food nutrition enhancer (Approval Nos. (2024) 0002/0005/0009).
• Usage limits must comply with National Food Safety Standard for Food Additive Use (GB 2760-2025): 0.7–2.4 g/L (calculated for ready-to-eat products, powdered products adjusted for dilution).
• Internationally, FDA (USA), EFSA (EU), and FSANZ (Australia/New Zealand) have all approved 2′-FL for use in infant formula.
• Feasibility: With established approval pathways and international precedents, 2′-FL has clear regulatory support for commercialization.

2. Labeling & Advertising

• Mandatory labeling: Ingredient lists must explicitly state “2′-Fucosyllactose”; vague or misleading terms such as “human milk-type oligosaccharide” are prohibited.
• Prohibited claims: Terms such as “humanized,” “mother’s milk equivalent,” or “breast milk substitute” are banned, according to the Advertising Law, Infant Formula Registration Regulations, and Breast-Milk Substitute Sales Regulations.
• Mandatory reminders: Packaging must state “Breastfeeding is superior.”
• Legal consequences: Violations may result in fines ranging from 200,000 to 1,000,000 RMB, or even business license revocation in severe cases.
• Innovation: Instead of exaggerating claims, we will emphasize scientific evidence and public health education to build trust through compliance.

3. GMO Biosafety

• Since 2′-FL is produced via fermentation using engineered E. coli, compliance with the Regulations on Biosafety of Agricultural GMOs and the GMO Labeling Regulations is required.
• Labeling requirement: If no GMO components remain in the final product, labels must state “This product is processed using genetically modified ××, but no GMO components remain in the final product.”
• Testing standards: NY/T 672-2023 requires GMO PCR detection sensitivity of 0.1%.
• Legal consequences: Failure to comply may result in fines up to 10× product value and possible license revocation.
• Scalability: By combining strain documentation, third-party testing, and clear labeling strategies, we ensure scalable production with strong international compliance potential.

Safety Considerations

In advancing the ProBabyotics project, we have always regarded safety as the top priority and a non-negotiable red line. Whether in R&D design, industrial translation, or future promotion, every innovation and expansion must be grounded in safety.

1. Ingredient Safety

• Our core functional ingredients—2′-FL, trypsin, and β-galactosidase—are obtained as high-purity molecules through synthetic biology, not as live bacteria or genetic fragments.
• Before incorporation into infant formula, all products undergo strict purification, testing, and quality control to ensure no GMO components or engineered bacterial residues remain.

2. Regulatory Compliance

• We strictly follow NHC regulations on 2′-FL usage limits (0.7–2.4 g/L) and labeling requirements, avoiding misleading terms such as “human milk-type.”
• All publicity complies with the Advertising Law and Infant Formula Registration Regulations, emphasizing that “breastfeeding is the best option” and avoiding exaggerated claims.
• For future FSMP (Foods for Special Medical Purposes) pathways, we plan proactive clinical validation to meet higher approval standards.

3. Production Safety

• We use controlled engineered strains (e.g., E. coli Nissle 1917) and maintain strict strain documentation and biosafety protocols to prevent leakage or spread.
• All processes comply with the GMO Biosafety Regulations and labeling standards, ensuring production is traceable, testable, and regulatable.

4. Social Responsibility & Transparency

• In communication and promotion, we emphasize that breast milk remains the best source of infant nutrition, and our product is only a scientific alternative when breastfeeding is insufficient or not possible.
• We ensure transparent information and scientific dialogue with doctors, nutritionists, regulators, and families to prevent misunderstandings caused by one-sided messaging.

5. Research Stage & Boundaries

• We recognize our current research capacity is limited, and the product remains at the laboratory proof-of-concept stage.
• To date, no animal or human trials have been conducted; all studies are limited to molecular and cellular validation in the lab.

Market Considerations

China’s infant formula market shows strong growth momentum, especially in the high-end segment enriched with OPO, lactoferrin, DHA, and other special nutrients. According to iiMedia Research, more than 60% of consumers are willing to pay a premium for mid- to high-end formulas, showing strong recognition and demand for high-quality products.

Within this space, the FSMP (Food for Special Medical Purposes) segment, although currently small, is expanding rapidly. Research projects its market size to exceed 10 billion RMB by 2025, mainly driven by preterm infants, allergic infants, and those with digestive problems.

This growth trajectory highlights ProBabyotics’ unique advantage in tapping emerging markets. By addressing both daily nutritional upgrades (functional formulas) and clinically directed needs (FSMPs), our solution aligns with consumer expectations and industry trends, ensuring scalability and long-term market potential.

Investor Engagement

Figure: Interview with investor

We received interest from Mr. Zhou, an early-stage investor familiar with the consumer health sector. Following a review of our plan, he encouraged us to (i) sharpen our business model (pricing logic, channel mix, and unit economics) and (ii) deepen our market and cost analysis (COGS breakdown, CAPEX/OPEX assumptions, and sensitivity tests). His feedback has been incorporated into our next iteration, informing our channel strategy, margin targets, and milestone-linked budget.

Market Analysis

To plan the success path of ProBabyotics, it is essential to conduct an in-depth study of market size and growth opportunities. Therefore, we analyzed Serviceable Obtainable Market (SOM), Serviceable Available Market (SAM), and Total Addressable Market (TAM) to illustrate the core concepts of market evaluation.

As revealed by our human practices research, parents have an urgent demand for a safer, more scientific, and breast milk–like nutrition solution. Our main objective is to validate the existence of the premium and functional formula market from a macro perspective, thereby confirming the potential profitability of ProBabyotics. To this end, we conducted the following systematic market segmentation analysis to clearly outline our market outlook.

SOM：China’s Premium Functional Infant Formula Market

SOM represents the market share we can realistically capture in the short term, focusing on families with infants suffering from lactose intolerance, allergies, or gut health issues.

According to the China Dairy Industry Association, the domestic infant formula market reached RMB 136.67 billion in 2024, with a strong premiumization trend. If the top three brands occupy about 60% of the premium segment, our obtainable share in this niche market is estimated at USD 5.3–10.6 million (RMB 530 million–1.06 billion), depending on market penetration and promotion speed.

SAM：Global Premium Infant Formula Market

In the mid-term, our strategy targets the global premium formula segment. According to WiseGuy Reports, the global premium infant formula market was USD 1.758 billion in 2023, and is expected to grow from USD 1.824 billion in 2024 to USD 2.44 billion by 2032, with a CAGR of about 3.6%. This trend indicates that parents worldwide increasingly prefer premium products enriched with HMOs, probiotics, and bioactive proteins.

TAM：Global Infant Formula Market

At the macro level, TAM covers the entire global infant formula industry, including basic, mid-range, and premium segments. According to Chamc Media data, the global market is projected to reach USD 12.36 billion by 2025. Even by capturing only a small fraction of TAM, 2′-FLuxe has the potential to become a breakthrough product with both commercial value and social impact, addressing the global nutrition gap for infants.

Figure: The graph summarizes the SOM, SAM, and TAM.

Competitiveness

ProBabyotics aims to address unmet needs in infant nutrition with a safer, more scientific, and affordable solution. Through integrated Human Practices research, we identified parents’ demand for products that are closer to breast milk in composition, while remaining affordable and transparently safe. In fact, the core strengths of ProBabyotics—precision nutrition design, strong safety assurance, and cost control—directly match the most urgent needs of our target users.

At the same time, we continuously track industry dynamics across traditional dairy-based formula, imported high-end functional formulas, and FSMPs (Food for Special Medical Purposes). Based on collected market and regulatory insights, we conducted a SWOT analysis. It is clear that ProBabyotics, with its synthetic biology–driven innovation, cost advantages, and commitment to child health, demonstrates a unique competitiveness in the infant nutrition market.

Figure: SWOT analysis

In addition, by benchmarking against existing products, we systematically evaluated market competitiveness. The core advantages of ProBabyotics are:

• Nutritional Innovation — Biosynthesis of 2′-FL and other HMOs to achieve functions closer to breast milk.
• Cost Advantage — Leveraging synthetic biology to lower production costs, making premium nutrition more affordable.
• Safety Foundation — Treating safety as a red line, ensuring compliance and transparency in production, and rebuilding parental trust.

Figure: Market competitiveness

PESTEL

In developing the ProBabyotics project, we not only focused on market demand and user pain points but also systematically examined the macro environment. Through a PESTEL analysis (Political, Economic, Social, Technological, Environmental, Legal), we found that: strict regulations and public health policies provide support for science-based innovation; the rapidly growing functional formula segment creates economic opportunities; rising parental awareness strengthens the social foundation; synthetic biology and digital communication technologies drive differentiation; sustainability and environmental concerns raise industry standards; and compliance requirements and advertising transparency define clear boundaries for market entry. Together, these external factors shape the feasibility, scalability, and long-term competitiveness of ProBabyotics.

Figure: PESTEL analysis

Scalability

Compared with conventional formula milk relying on traditional dairy processes, ProBabyotics demonstrates significant advantages in large-scale production. By producing 2′-FL and other HMOs through synthetic biology fermentation pathways, we can substantially reduce production costs while ensuring stable yields, laying the foundation for meeting the rapid growth of the high-end and functional formula markets.

Currently, our product prototype already covers functional formula milk, suitable for lactose-intolerant infants, allergic infants, and basic HMO-enhanced formulas. In the future, as our R&D pipeline expands into Foods for Special Medical Purposes (FSMPs), ProBabyotics will be widely applicable across hospitals, maternity care facilities, and retail consumer channels. With these advantages, we are confident in rapidly expanding market coverage.

Figure: Infant formula enterprises we visit（Top 10 Infant formula enterprises in china)

Thanks to China’s mature biomanufacturing foundation, and with guidance from local industrial plants, we have already confirmed the feasibility of scaled-up production. As mass production is achieved and market size grows, economies of scale will further lower unit costs, strengthen competitive advantages, and unlock new market potential.

Figure: The cost of products decreases as mass production is achieved

The figure below illustrates the gradual decline in unit costs of ProBabyotics across different development stages.

Lab R&D (Laboratory Research & Development Stage)

• Core tasks: Validate synthetic biology processes and achieve stable lab-scale output.
• Cost features: High raw material and small-scale fermentation costs, with unit costs at a high level (~140–150 RMB/unit).

Pilot Production (Pilot Trial Stage)

• Core tasks: Scale up to small fermenters and pilot lines, optimize purification and formulation processes, and test stability and initial safety.
• Cost features: Increased capacity and shared R&D costs reduce unit costs to ~120–130 RMB.

Regulatory & Clinical Validation Stage

• Core tasks: Submit new food ingredient or nutritional enhancer applications (e.g., 2′-FL), complete animal studies and necessary clinical nutrition validations.
• Cost features: Additional compliance and testing expenses slow cost reduction (~115–120 RMB), but this lays the foundation for market entry.

Pre-Mass Production Stage

• Core tasks: Scale up production in GMP-compliant formula factories, gradually integrating the entire process from raw material → fermentation → formulation → filling → packaging.
• Cost features: Early economies of scale lower unit costs to ~110 RMB.

Mass Production & Market Launch Stage

• Core tasks: Full-scale production and commercialization, establishing supply chain systems and partnerships with dairy companies or distributors.
• Cost features: Economies of scale and mature supply chains further reduce unit costs to ~95–105 RMB.

Inventiveness

The uniqueness of ProBabyotics in the infant nutrition field lies in our pioneering integration of synthetic biology into functional formula design. Through engineered microbial fermentation, we can produce human milk oligosaccharides (HMOs, e.g., 2′-FL) at low cost and high efficiency—an achievement that traditional chemical synthesis or extraction cannot easily realize. Our research shows that parents urgently need products that are closer to breast milk nutrition, safer and more transparent, and affordable, a market gap that current high-end formulas have yet to fully address.

Moreover, we go beyond the single function of 2′-FL by introducing an innovative dual-track product line:

• Functional infant formula: For general families, enriched with HMOs, lactoferrin, and other bioactive components.
• FSMP (Foods for Special Medical Purposes): For infants with lactose intolerance, allergies, or preterm birth, meeting specific nutritional needs.

This combination of scientific nutrition + personalized solutions makes our approach highly original in the formula milk market.

Looking ahead, we plan to expand our library of biosynthesized functional factors, such as more types of HMOs, prebiotics, and immune-regulating proteins, to further enhance product differentiation. At the same time, we commit to keeping safety as a red line, engaging proactively with regulators and medical experts, ensuring our innovations not only overcome current technical bottlenecks but also establish higher scientific standards for infant nutrition.

Business model canvas

Building a business model canvas is essential for ProBabyotics, as it provides a strategic blueprint to help us analyze, plan, and optimize our path into the infant formula market. The canvas presents a comprehensive view of our value propositions in infant nutrition, covering customer segments, channels, customer relationships, revenue streams, key resources, key activities, partnerships, and cost structure. It serves as a crucial tool for achieving both commercialization and social impact.

Figure: Business Model Canvas displaying the overall structure and activities of ProBabyotics.

Our team upholds the core principle of providing families with nutrition closer to breast milk in a scientific, safe, and affordable way. Based on this principle, we designed a business model canvas and outlined our development pathway.

Development Timeline

Figure: Milestones for probabyotics

2025 – Project Launch & Concept Validation

• Officially launched the project, focusing on the biosynthesis pathway and process feasibility of 2′-FL.
• Completed basic experimental design and small-scale lab validation to confirm stable production of target compounds.
• Identified key pain points (lactose intolerance, allergies, breastfeeding alternatives) through literature research and social surveys.

2026 – Prototype Development & Early Partnerships

• Created the first prototype formulas (basic version + low-lactose version).
• Initiated preliminary discussions with mother & baby channels, research institutions, and OEM factories to define pilot production conditions.
• Began preparing basic procedures for ingredient testing and quality evaluation.

2027 – Functional Validation & Pilot Preparation

• Completed nutritional composition testing to ensure the safety and stability of 2′-FL and related components.
• Conducted small-scale functional validation (e.g., digestive tolerance, solubility testing).
• Advanced pilot production plans in partner factories to verify scale-up feasibility.

2028 – Product Optimization & Regulatory Consultation

• Optimized formulas based on testing results (hypoallergenic and low-lactose iterations).
• Consulted with food safety regulators and industry experts to clarify certification pathways for FSMP and functional formula.
• Prepared regulatory submission materials, entering the pre-approval stage.

2029 – Market Preparation & Pilot Applications

• Launched small-scale market trials (e.g., trial packs via maternal & infant channels and e-commerce).
• Collected feedback from consumers and professionals to refine formulas and product positioning.
• Partnered with hospitals and pediatric clinics to explore pre-clinical application scenarios.

2030 – Market Launch & Scale-up

• Achieved regulatory certification and officially entered the premium maternal & infant market.
• Expanded distribution through e-commerce, specialty stores, and medical channels.
• Leveraged large-scale production to reduce costs, strengthen brand reputation, and support international expansion.

Phased Summary

• 2025–2026: Foundation & Prototype
• 2027: Functional Validation
• 2028–2029: Optimization & Regulatory Preparation
• 2030: Market Launch
• 2031–2033: Expansion & Internationalization
• 2034–2035: Globalization & Sustainability

Sales Strategy

Differentiation Model

To meet parents’ demand for premium and functional formulas, we adopt a differentiation model. ProBabyotics focuses on functional infant formula as its core product line, offering multiple variants such as basic, low-lactose, and hypoallergenic to cover both ordinary families and those with special needs. Compared with traditional formula, our strength lies in the low-cost biosynthesis enabled by synthetic biology, which allows the production of key breast milk active ingredients like 2′-FL. This approach ensures scientific transparency, cost efficiency, and accessibility.

Through a “series + differentiation” product layout, we build a comprehensive product matrix, enhancing both market competitiveness and customer loyalty.

Direct-to-Consumer Channels

To reduce channel markups and build direct relationships with users, we will adopt a direct sales and omni-channel model:

• Online channels: E-commerce platforms (Tmall, JD.com, Pinduoduo), mother & baby content platforms (Xiaohongshu, Douyin, Bilibili), and our own mini-program store.
• Offline channels: High-end mother & baby specialty stores, community hospitals, maternity centers, and parent–child activity spaces in kindergartens.
• Science-driven outreach: Build trust and drive conversion through WeChat public accounts, community education, expert lectures, and offline events.

Community & Education-Driven Sales

Instead of relying solely on advertising, we focus on science communication and community engagement:

• Stage 1: Build WeChat groups with early adopters and surveyed parents, offering lectures and Q&A sessions—creating an “education-first” sales model.
• Stage 2: Leverage word-of-mouth to attract more parents into the community, enabling organic viral growth.
• Stage 3: Collaborate with mother & baby e-commerce platforms, parenting experts, and hospitals, using professional endorsements to boost conversion and brand credibility.

Financial analysis

We have developed a detailed financial forecast for ProBabyotics, covering multiple dimensions including R&D, raw materials, production, quality testing, marketing, and channel development. In the early start-up phase (the first two years), funding will be primarily allocated to process R&D, small-scale production validation of core ingredients (such as 2′-FL and other HMOs), as well as product functionality testing and market education. This stage offers limited profit margins but lays the foundation for future scale-up and brand building.

From 2027 onwards, we plan to complete nutritional composition testing and small-scale functional validation, obtain regulatory certification, and begin pilot-scale production. Once scaled manufacturing begins, fermentation system expansion and supply chain optimization will gradually reduce unit costs and significantly improve gross margins. By combining direct sales with mother & baby distribution channels, we expect to achieve initial profitability in 2028–2029, providing financial support for international market expansion.

In addition, we have prepared a five-year business asset projection to evaluate the financial impact of expanding production capacity and entering new channels (such as cross-border e-commerce and premium maternal & infant retail chains). This strategic financial plan will provide ProBabyotics with a solid capital foundation and risk buffer for sustainable growth and expansion.

Figure: Estimated revenue stream

Expert Financial Feedback

Figure: Interview with Nestlé financial specialist

In reviewing our financial model, a Nestlé financial specialist advised that our channel allocation was imbalanced, with too little weight on online sales and excessive reliance on mother & baby stores and supermarkets. Additionally, he noted a mismatch in feeding frequency assumptions—real-world data shows infants are typically fed 6+ times daily in smaller volumes, rather than 3–4 times. This correction significantly refined our revenue forecasts and adjusted our unit economics.

Resources

Key Partners

• Mother & baby channel partners
• Pediatric and nutrition experts
• Universities and research laboratories
• External testing and certification agencies
• Investors and incubators
• Industry associations and mother & baby education platforms
• Potential overseas brand and channel partners

Key Resources

• Scientific R&D capabilities: strain engineering, 2′-FL biosynthesis pathway development, formula optimization
• Human Practices (HP) network: feedback from parents, baby stores, hospitals, and researchers
• Early technical achievements: validated 2′-FL production process, low-lactose/hypoallergenic formula design
• Market research data: quantitative & qualitative insights into consumer needs, price sensitivity, and pain points
• Brand & communication assets: science outreach influence built via Xiaohongshu, Douyin, and WeChat
• Regulatory & patent reserves: compliance consulting, regulatory pathway preparation, patent applications
• Funding & financial support: initial capital from early investors, incubators, or social funds

Key Activities

• Proof-of-concept and small-scale lab production
• HP research and integration into product iteration
• Education and promotional campaigns
• Establish pilot collaborations
• Ingredient testing and regulatory preparation
• Prototype design and formula optimization
• Branding and market communication
• Supply chain and industry partnership expansion
• Fundraising and patent applications

Risk Analysis

To ensure the smooth progress of ProBabyotics in R&D, certification, and commercialization, we have systematically identified potential key risks and proposed corresponding solutions.

Exit Strategy

To adapt to different market outcomes and regulatory environments, ProBabyotics has designed a diversified exit strategy:

1. Merger & Acquisition (M&A)

One feasible pathway is to sell ProBabyotics to a larger dairy or infant nutrition company with established production lines, regulatory expertise, and global distribution networks. An acquisition would accelerate the market rollout of our HMOs (such as 2′-FL) and functional formulas. This model provides flexibility: we may retain an advisory role to influence quality and pricing, or opt for a complete exit.

2. Strategic Partnership + Partial Exit

Another option is to form strategic partnerships with leading infant formula or FSMP enterprises. Through technology licensing (e.g., 2′-FL biosynthesis pathway, low-lactose and hypoallergenic formulas) combined with revenue sharing, we can gradually divest equity. This pathway ensures continuous returns while maintaining ProBabyotics’ brand independence and shifting part of the operational risk to the partner.

3. Initial Public Offering (IPO)

If the brand achieves steady growth and broad consumer recognition, an IPO serves as a long-term exit option. Going public would not only deliver significant returns to the founding team and early investors but also enhance ProBabyotics’ international visibility and credibility, supporting global expansion. However, this route is challenging and requires strong financial transparency and regulatory compliance.

4. Liquidation

If M&A, strategic partnerships, or IPO cannot be achieved, liquidation remains an option. This would involve selling patents (such as 2′-FL biosynthesis technology and special formula designs) and research outcomes to existing nutrition companies, enabling a complete exit. Although it means leaving the market entirely, it would still allow our innovations to benefit the industry and families.

Skills and Capabilities

ProBabyotics is driven by a team of high school students with both scientific passion and social responsibility. Team members come from diverse schools and academic backgrounds—some excel in experimental design and data analysis, while others specialize in communication and business planning. This diversity creates complementarity and synergy across scientific validation, social research, science outreach, and business modeling.

Throughout the project, members not only designed and executed synthetic biology experiments but also engaged in social research, channel exploration, and regulatory studies, cultivating cross-disciplinary skills. We have already completed preliminary lab validation of 2′-FL, while Human Practices enabled us to deeply understand the real needs of parents and infants—bridging science with society.

In addition, the team has maintained close connections with mother & baby channel partners, pediatric nutrition experts, and academic laboratories, gaining access to lab facilities, professional guidance, and market insights. This combination of resources and capabilities lays a solid foundation for turning ProBabyotics from a laboratory concept into real-world applications.

Through targeted business skills training, our team members improved their capabilities in financial modeling, market analysis, and entrepreneurial strategy, further enhancing our ability to translate scientific results into feasible business pathways.

Figure: Attending business skills training

By learning from entrepreneurs Mr. Cao and Mr. Yu, our team gained practical insights into startup challenges and resilience. This experience enhanced our entrepreneurial mindset and strengthened our capability to translate synthetic biology into real-world applications.

Stakeholders

In advancing the project, we conducted a systematic stakeholder analysis to map different groups’ influence and concerns. Rather than merely showing a “power-interest” matrix, we emphasized their actual roles, focus areas, and modes of collaboration in project development—helping us identify communication priorities and cooperation strategies. (See HP for details)

Figure: Stakeholder map

Recognizing the nutritional challenges faced by infants who cannot receive breast milk or struggle to fully digest it—and the limitations of existing infant formula—the ProBabyotics team is committed to developing a safe, functional, and affordable product through synthetic biology. Our analysis suggests that ProBabyotics will generate significant long-term impacts across health, society, and the environment:

1. Health & Nutrition

• Positive Impact: ProBabyotics provides key nutritional factors (e.g., 2′-FL) to close the gap between formula and breast milk, helping improve infant immunity and gut health, thereby reducing the risk of early infections and allergies.
• Potential Concern: Long-term reliance on formula may raise public concerns that substitutes could weaken natural breastfeeding rates.
• Solution: Position the product as a supplement to insufficient breast milk rather than a replacement, reinforced through physician and nutritionist education programs to ensure proper use.

2. Economic Accessibility

• Positive Impact: Large-scale fermentation reduces costs, making functional formulas accessible beyond the premium segment and ensuring more families can afford balanced nutrition.
• Potential Concern: High upfront R&D and certification expenses may push initial prices higher, undermining inclusivity.
• Solution: Collaborate with government nutrition subsidy programs and maternal-infant foundations to launch tiered pricing and public-benefit packs, ensuring access for low-income families.

3. Safety & Trust

• Positive Impact: Using a GRAS chassis strain (E. coli Nissle 1917) combined with rigorous quality testing enhances food safety and builds parental trust.
• Potential Concern: Public misunderstanding or fear about the use of “synthetic biology” in food.
• Solution: Promote open science communication and third-party testing endorsements, supported by a transparent traceability system giving parents real-time access to test reports and certifications.

4. Environmental Impact

• Positive Impact: Fermentation-based production reduces dependence on animal whey, lowering the dairy industry’s carbon footprint and advancing green manufacturing.
• Potential Concern: Poorly managed fermentation could lead to increased energy use or waste disposal issues.
• Solution: Implement circular production processes and renewable energy sourcing, while partnering with environmental organizations to enforce strict recycling and emissions standards.

5. Social & Ethical Implications

• Positive Impact: ProBabyotics can help relieve anxiety in families with insufficient breast milk, improve early-life nutrition security, and contribute to the UN Sustainable Development Goals (SDG 3: Good Health and Well-being).
• Potential Concern: Excessive commercialization may trigger concerns that profit is prioritized over infant welfare.
• Solution: Establish an independent ethics oversight committee, regularly disclosing R&D directions and sales strategies to balance commercial interests with public health.

Considering its potential impact, ProBabyotics is expected not only to improve infant nutrition and health but also to enhance economic accessibility, strengthen food safety, and foster environmental sustainability. By proactively addressing risks, ensuring transparent communication, and embedding ethical governance, ProBabyotics aims to become a trusted solution that supports global sustainable development efforts.

1. https://www.fortunebusinessinsights.com/industry-reports/infant-formula-market-101498
2. UNICEF. (2023). Global Breastfeeding Scorecard, 2023: Tracking Progress for Breastfeeding Policies and Programmes. UNICEF.
3. Andreas, N. J., Kampmann, B., & Mehring Le-Doare, K. (2015). Human breast milk: A review on its composition and bioactivity. Early Human Development, 91(11), 629--635.
4. Weichert, S., Jennewein, S., Hüfner, E., Weiss, C., Borkowski, J., Putze, J., & Schroten, H. (2013). Bioengineered 2′-fucosyllactose and 3-fucosyllactose inhibit the adhesion of Pseudomonas aeruginosa and enteric pathogens to human intestinal and respiratory cell lines. Nutrition Research, 33(10), 831-838.