Entrepreneurship

Starting a business is a miraculous dream for many teenagers. As the founders and managers of the Business Society in our school and as keen learners of molecular and synthetic biology, we decided to support our iGEM project to design a company. The company we describe here aims to use our team's scientific results.
Of course, we are aware of the fact that in today's world, it is not easy to build a business where the founders can manage to create a whole lab site at the correct scale, do enough R&D in the pharmaceutical sector, develop an environmentally friendly image, and still make enough profit to compete with the big companies. Despite all the difficulties, our team set out to write a business plan that would meet all the criteria and portray a modern-thinking company that would be able to stand its ground in the 21st century.



Business Plan


Executive Summary

Overview of the Business Concept

Our product lies in decreasing the pathological histamine concentration in human tissues mainly in the skin and in the gastrointestinal tract. Our solution is effective through histamine-degrading enzymes(HNMT and DAO) and histamine-binding ssDNA aptamers.
Histamine causes inconvenience and small inflammations that we all experience. We want to help companies in the cosmetic and pharmaceutical industry with working active ingredients that reduce these bad effects. Although this market is fairly competitive we believe that our solution can create a new line of innovation that is steroid-free and secure.

Our Business Concept evolved through many possibilities as we recognized the importance of expert advice.
With the interview and help of a local natural cream producer, we recognized that the Hungarian market for cream-based products is small and we concluded that the right decision is to sell our solution to other cream production companies. Our Business’s Products and Services:

Key Financial Projections

Our financial strategy is fully based on updated market research and on the Hungarian wage and production market. We had the opportunity to explore these fields with expert help locally who played a key part in our planning and work.

The key financial projections contain the initial search for investments which play a key role in establishing the first operational steps. The other key capital source will be a 5 year infrastructural loan that will be paid back in yearly installments and play a key role in the construction and equipment purchasing process.

The realistic projection of the break-even is in the third year of the company’s existence. This will be the first opportunity for major investors to experience the profiting results on their initial investments.

The third year will be a projection of the company’s health which gives us the opportunity to raise more capital for R&D purposes which include the new construction of a Development Department which will play a key role in the Tailored Aptamer Design and Production service of the company.
The fourth year of the company will focus on the expansion and scaling of the company to grow the investment returns on the initial and third year investments. We plan to focus a great proportion of the capital and profit on the development side which increases our opportunities in a larger and more developed market. The fifth year will be focused on the systematization of the company which serves the plan for a potential exit for investors and founders. As detailed in the Financial Strategy section we plan to finish the installments of our Infrastructural Loan which will increase the profit in the following years because the liability will no longer be a threat.

The different exit strategies include different advantages and disadvantages detailed in the Exit Strategies section.

Company Description

Mission Statement

Our objective is to create an innovative solution that effectively reduces histamine effects without using steroid-based active ingredients. Our sustainable approach, developed through synthetic biology experiments, ensures non-irritating and safe products. Our research and development efforts aim to use histamine-degrading enzymes such as HNMT (Histamine N-methyltransferase) and DAO (Diamine oxidase), delivering localized effects in the skin. Additionally, we plan to use ssDNA aptamers to inactivate histamines. Our final goal is to incorporate the tested formula into various products such as hydrogels.

Vision and Goals

Our vision is to introduce the developed formula as a premium active ingredient to companies in the cosmetic and pharmaceutical industry. This approach will enable us to showcase our innovative solution, reduce marketing costs, and maximize its market potential. In the first two years, our goal is to enter the cosmetics market, and afterward, we plan to enter the Pharma market by manufacturing aptamers designed to order, for which we plan to raise more capital.

Legal Structure and Ownership

The company will be registered as a Liability Company (LLC):
For emerging pharmaceutical startups or those operating with limited financial backing, opting for a business structure that provides personal liability protection and flexibility in decision-making can be particularly advantageous. This approach allows for greater security for the owners while enabling adaptability in managing the company's operations and strategic direction.

Advantages

Disadvantages

Transition to a Corporate Structure

As the company grows and aims to expand beyond the startup phase, we may need to change from an to a corporate structure (like a C-Corporation) to attract significant venture capital investment. This change makes it easier to fundraise. A corporate structure is generally more appealing to institutional investors, which is important for large-scale funding rounds in the pharmaceutical and biotechnology industries. If the company decides to go public in the future, transitioning to a corporate structure would be necessary to handle the complexities of public ownership and shareholding.

We plan to operate as an LLC in the early growth, but as we approach significant scaling milestones, particularly when entering the pharmaceutical market or seeking larger investment rounds (from Year 3 onward), we will consider restructuring the company into a corporation to better meet investor expectations and facilitate further growth.

Before transitioning to a corporate structure, we will implement strategies to address challenges associated with securing venture capital as an LLC. In the early stages, we can offer investors convertible notes, which provide a flexible investment mechanism that can convert into equity once the company transitions to a corporate structure. We will also clearly outline exit strategies for early-stage investors, assuring how their investment can yield returns, whether through acquisition, mergers, or transitioning into a corporate entity for later-stage growth.

Detailed Considered Ownership Structure

Summarized Ownership Structure

Facility Construction Plan and Timeline

Planning and Initial Setup

The first phase of the project involves company registration and securing the necessary capital. This process is expected to take 2-3 months. The company will be registered as an LLC, and initial capital will be acquired through a combination of investors, loans, and grants. Additionally, opportunities for Hungarian and European tenders will be explored to secure further funding.

Once capital is secured, the next step is land acquisition, which is anticipated to take 2-3 months. A suitable 500m² plot will be identified in an industrial area of Szeged, ensuring good access to utilities such as water, electricity, and internet, as well as transportation links. The land must be zoned for industrial or commercial use to permit pharmaceutical production. Legal procedures, including surveys and environmental assessments, will be completed during this phase.

In order to be able to design the Facility Construction Plan authentically, we talked to an expert who has been an architect and engineer for 20-25 years, and based on our plans, he wrote a possible budget, which, according to Hungarian prices, would cost approximately 354 000 USD + lab and production equipment in Szeged, but the more detailed cost plan see Construction and Investment Costs.

Design and Construction Phases

Once the land is acquired, the project will move into the design and construction phases.
Phase 1: Architectural Design and Permits
This phase is expected to take 3-4 months. It begins with hiring a professional architect with experience in pharmaceutical facility design to create the building’s blueprints. Regulatory compliance will be a key focus, working with consultants to ensure the design of building codes, Good Manufacturing Practice (GMP) standards, and environmental regulations. Detailed blueprints will be prepared, covering HVAC, plumbing, and electrical systems, as well as material flow. Finally, the necessary building permits will be secured from local authorities.

Phase 2: Construction
The construction phase is expected to last 12-18 months, starting with site preparation, which will take 1-2 months. This includes clearing and leveling the land and laying a foundation that meets industry standards for stability and sterility, particularly for the later construction of cleanrooms.
The structural construction, lasting 4-6 months, will involve erecting the steel or concrete framework of the building and installing walls, roofs, and floors. Special care will be taken to ensure that floors in the laboratory and production areas are easy to clean and free of contaminants.
Next, the installation of HVAC, plumbing, and electrical systems will take 3-4 months. The HVAC system will be designed to meet cleanroom and environmental control standards, and the building will be equipped with water filtration systems, fire suppression, and power backup solutions.
The interior work will follow over the next 2-4 months, setting up cleanroom areas and walls for the laboratory and production spaces. Materials that resist contamination and are easy to clean will be used. The communal office will also be built, with a focus on adequate communication infrastructure and IT networking.
Finally, the construction phase will conclude with inspections and certifications to ensure compliance with industry standards such as GMP and ISO (International Organization for Standardization). This process is expected to take 1-2 months.

Facility Layout

The facility layout will be divided into several key areas:

Communal Office Space (50m²)
This area will serve management, administrative work, and meetings. Space will be allocated for desks, meeting rooms, and storage, with a robust IT and internet infrastructure to support communication and research needs.

Laboratory (40m²)
The laboratory will focus on research and development (R&D), quality control, and testing. It will include cleanroom facilities with controlled air filtration and areas for handling various stages of product development. The lab will be equipped with benches, fume hoods, biosafety cabinets, and cold storage.

Production Area (70m²)
This area will be dedicated to manufacturing and packaging pharmaceutical products. The design will ensure a proper material flow, separating raw material entry from finished product exit to avoid contamination. Critical equipment such as mixers, reactors, fermentors, and packaging machines will be installed, along with HVAC systems to maintain cleanroom compliance and product sterility.

Warehouse (40m²)
The warehouse will store raw materials, intermediates, and finished products. It will include temperature-controlled areas for sensitive materials and comply with safety standards, including fire suppression and pest control measures.

Equipment Setup and Procurement

The equipment setup will be carried out in two phases.

Phase 1: Equipment Planning
Over 4-6 months, an equipment list will be developed based on production and laboratory needs. This will include lab instruments, production machines, and safety equipment. Space will be allocated for equipment installation, ensuring proper ventilation, power supply, and ease of maintenance.

Phase 2: Installation and Calibration
This phase, lasting 3-4 months, will involve coordinating equipment delivery with the completion of construction. Technicians will be hired to install and calibrate the equipment, ensuring all instruments meet regulatory standards. A maintenance schedule will be established to ensure smooth operation after the facility launch.

Regulatory and Compliance Setup

Throughout the process, regulatory and compliance considerations will be prioritized. The facility will be designed to meet Good Manufacturing Practice (GMP) standards, particularly in the production and laboratory areas. A quality control system will be implemented to test raw materials, intermediates, and finished products.
Efforts will also be made to ensure that the facility and processes meet the approval standards of the EMA (European Medicines Agency) for pharmaceutical manufacturing. Additionally, skilled personnel will be hired for R&D, production, and quality assurance, with training provided in GMP, cleanroom procedures, and safety protocols.

Development Plan

Year 1: Foundation and Market Entry (Cosmetics)

Company Registration & Initial Capital
The company will first complete its registration process, which includes legal structuring, securing intellectual property protection, and preparing for regulatory compliance. The initial capital will be secured through investors or grants, supplemented by applications for construction and equipment loans. The company will then purchase a 500m² plot of land to build a production and laboratory facility. Meanwhile, product development efforts will focus on creating active ingredients for topical skin use, specifically targeting the cosmetics industry. Regulatory preparations will be made to comply with relevant cosmetics regulations, such as REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) in Europe and FDA (Food and Drug Administration) guidelines for the U.S.

Facility Construction & Product Testing
We will start building the 200m² facility, focusing first on setting up production and lab spaces for cosmetics. At the same time, we’ll continue research and development on enzymes (DAO and HNMT) and ssDNA aptamers for use in cosmetic products. By the end of the year, we will conduct pre-market testing to confirm the effectiveness, safety, and stability of these active ingredients in skincare products.

Year 2: Launch into the Cosmetics Market

Complete Construction & Equipment Setup
The facility construction will be completed, and essential equipment for R&D and production will be set up. During this phase, the company will finalize product formulations, optimizing enzymes and aptamers for various cosmetic applications such as hydrogels. Outreach efforts will begin to secure early partnerships with cosmetics manufacturers, to establish supply contracts for active ingredients.

Product Launch and Scaling
The company will launch its first active ingredients containing enzymes (DAO and HNMT) and ssDNA aptamers for cosmetic companies. Regulatory approvals, such as securing the CE mark for the EU, will be obtained for the active ingredient of the cosmetic formulations. Simultaneously, marketing and distribution strategies will be implemented to build brand recognition, attend industry events, and establish distribution channels. As demand grows, production capacity will be scaled accordingly, with a focus on optimizing the supply chain and logistics.

Year 3: Expansion into Pharmaceuticals & Aptamer Development

Intellectual Property
Based on our experiments with HNMT enzymes and DNA aptamers, we foresee the potential to obtain patent rights as a result of our discoveries. Based on our research, in the case of patents filed by small and medium-sized enterprises based on innovative ideas in Hungary companies receive free advice from the Intellectual Property National Office. B2B Expansion & Aptamer Efficiency Testing Solutions
As part of a broader shift towards the pharmaceutical market, significant R&D efforts will be allocated to the development of ssDNA aptamers. The company will establish a manufacturing setup for these aptamers and begin offering custom-designed solutions to pharmaceutical companies and research institutions. At the same time, B2B outreach will intensify to engage with potential partners in the pharmaceutical industry. Preparations will also begin for regulatory submissions to the FDA or EMA for future pharmaceutical products.

Years 4-5: Market Expansion and Scale-up

Scale-up Pharmaceutical Offerings
We’ll expand our B2B model for testing aptamer efficiency, offering custom-designed aptamers to pharmaceutical companies. We will also seek research grants and partnerships to further grow aptamer research and production.

Patents and International Expansion
During this period, the company will secure patents for its enzyme-aptamer complexes, ensuring robust intellectual property protection. Efforts will also focus on expanding into international markets, with regulatory approval processes initiated for new geographic regions, particularly within the pharmaceutical sector.

Strategic Focus

In the early stages, the company’s focus will be on establishing credibility and generating revenue by launching high-quality cosmetics products that showcase the effectiveness of enzymes and aptamers. In the long term, the company aims to transition into the pharmaceutical market, leveraging its early R&D successes and scaling up its production of aptamer-based solutions. This balanced approach will position the company for sustainable growth and market expansion across both industries.

History and Background

The only Hungarian iGEM team, TERMOSZ-Selye-HUN started a project to tackle issues related to itching by histamine at Radnoti Miklos Experimental Grammar School. The team of 34 members was created in the TERMOSZ lab at our school, and most of the work took place there. The project's progress was guided by Sandor Ban, the team leader and mentor. We gained experience through the Business Society initiative launched at our school, during the construction of which we learned a lot about being an entrepreneur. In the past year, we were able to test ourselves in several competitions and gain practice in topics such as casting an innovative idea into a startup format, developing critical thinking and presentation skills. All these experiences contributed to our ability to write a successful business plan.

Industry Overview

Cosmetics and Pharmaceutical Industries and Key Drivers

The antihistamine market presents an appealing opportunity for both the Cosmetics and Pharmaceutical industries. This is driven by the increasing demand for allergy treatments, a growing aging population, and the rising use of antihistamines in skincare products.

Rising Global Prevalence of Allergies

The increasing number of allergies like hay fever, hives, and allergic rhinitis is causing a higher demand for antihistamines. This trend is expected to continue and strengthen as the global population ages and environmental factors, especially pollution, make people more susceptible to allergies. Future Market Insights predicts that the worldwide antihistamine market will grow by 8.6% each year from 2023 to 2031. This significant growth presents a great opportunity for the Cosmetics and Pharmaceutical industries to benefit from the increasing demand for antihistamines. Data Bridge Market Research forecasts that the antihistamine market could reach USD 568.16 million by 2031.

Innovative Skincare Applications

The cosmetics industry is witnessing a rising trend of integrating antihistamines into skincare products. Histamine is known to contribute to skin inflammation, redness, and itchiness, making antihistamines valuable for creating products that supply sensitive skin and relieve allergic reactions. Consequently, there is a growing demand for skincare solutions incorporating antihistamines.

High ROI in Pharmaceuticals

The Pharmaceutical industry sees significant returns from investing in antihistamines due to the increasing prescription and over-the-counter use of these drugs. As more people experience allergies, pharmaceutical companies are investing in research to produce more effective and longer-lasting antihistamine drugs.



Market Analysis

Target Markets

Hungarian Market

The use and production of antihistamine products in Hungary have been evolving and developing with awareness of allergies and skin-care products.

In our analysis of the Hungarian market, we found that the total sales of antihistamine products in the past 6 years were 15,5 million US$, which leads to the point that this market is small for our production and scaling purposes. In our research, we found that the market is growing and has high sales increases and in 2023 the market had 5 million US$ in total sales which is promising.

In conclusion, in the Hungarian market, we have a low potential for success, so we expanded our analysis for a broader view.

European Market

From our sources, we found that the European Market has two of the largest global antihistamine product producers based on the data from Mordor Intelligence, these two companies are Novartis(based in Switzerland) and Bayer AG(based in Germany). Other larger companies in Europe are Sanofi(France), AstraZeneca(UK), and Boehringer Ingelheim(Germany) based on AMA Analytics. The biggest producer country in Europe is the United Kingdom based on Credence Research.

The valuation of the European Market is not exact, but the global valuation of the antihistamine market in 2023 was 279.96 million US$ based on Data Bridge Research. Based on the market trends the market share of Europe is 20-25% meaning the European market is valued at 62 million US$.

Our possibilities in the European market are higher than in the Hungarian market, but based on further research, the global market has more potential for our business.

American Market

The North American market is the largest market based on Mordor Intelligence. The companies with the largest market share are Pfizer, Johnson & Johnson, and Merck & Co.
Based on Future Market Insights the North American market is 34.6% of the global market meaning the valuation is close to 97 million US$.

Global Market

The global market is valued at 279.96 million US$ based on Data Bridge Market Research’s Report. The leading countries in the market are China, India, United States, Canada, United Kingdom, Germany, and France based on Credence Research’s Report.

Our company has the opportunity to become partners in any of these countries, even though there might be more extensive restrictions in some of them.
The business opportunity comes from more product developers, as we sell our specific solution to them to increase their effectiveness. In the global market, there are enough potential partner companies we can approach.

Regulatory Environment

The global Regulatory Environment is fairly complicated and needs further research in the case of different future partners. In the Hungarian system, the producer has to comply with many legal implications, meaning extensive reports on production, laboratory environment and equipment, and other legalities like human rights and taxes.

For our laboratory, we will comply with GMP - Good Manufacturing Practice - regulations and will contact for help from professionals in the design and paperwork.

As one scalability problem, the difference in the global regulatory environments can be challenging. The European Policies are fairly the same on the continent, but there are minor changes between countries.

The market’s competitive side, North America and Asia Pacific has more regulations due to the nature of market competition and possibilities of production failures.

Customer Segmentation

Cosmetic Companies

Our Primary Customers will be cosmetics manufacturer companies. These companies can vary in size and business model because our product is not tailored for each product. The largest market share in the cosmetic industry is the East Asian territory, which accounts for 45% market share globally, based on Grand View Research’s Report. The more known products globally originate from the European market, which offers great opportunities for our business.

Needs: The cosmetic skin-care products have increasing, new science-backed ingredients, but there is a need for more well-researched substances that can be used in these products. The growing awareness of skin-care needs a more reliable environment, which we can provide.

Pharmaceutical Companies and Research Institutes

Our Primary Customers will be pharma companies developing treatments for histamine-related conditions and research institutions focused on drug discovery and aptamer technology.

The fastest-growing market of active ingredient production is the Asian Pacific territory, but that is not the largest market. The North American territory has the largest market share of 38.3% in 2023, which indicates that our business can thrive with partners in this area.

There is a growing market of production in Europe as well, which expands the count of opportunities in the local area of our business. These facts are based on Grand View Research’s Report.

Needs: Reliable testing platforms for ssDNA aptamer efficiency and access to new histamine-degrading enzymes to enhance therapeutic product development. These sectors can only thrive if there is compliance with the strict regulatory environment.

Competitive Landscape

Our global competitors in active ingredient production are the big pharmaceutical companies in America and Europe.

The fastest growing market in this sector is the Asian-Pacific area, where there is cheap labor and low production costs. This is their competitive advantage, but the quality of production varies.

Key Competitors

There are global competitors who compete to deliver active solutions to production companies. Our business has the opportunity to work with many types of companies which in case of partnership will not be our competitors.

The larger trend-leading companies like Pfizer, Johnson & Johnson, Bayer AG, and Novartis can be our partners, but mostly as big pharmaceutical companies, they have their own resources to produce these active ingredients.

Competitive Advantage

Our competitive advantage is our innovative use of aptamers in the antihistamine market. We have the opportunity to deliver our solution to many partners in the world with a specialized product and manufacturing practice.

Market Needs and Opportunities

Unmet Needs: The growing market of skin-care and active ingredient production, there is a boom in unregistered production, which leads to many cases of legal action. The larger production companies have really complicated systems for new production and innovation.

Opportunities: Our opportunity as a medium-sized company is that we can produce in high-grade quality while maintaining research and innovation. As the market’s non-disclosed members create low-grade products, we have the ability to rebuild the trust and growing research in the market.

Conclusion

The optimal market for our products is global, particularly focusing on major markets like the United States and Europe. These regions offer the highest growth potential due to their large consumer bases, advanced biotech sectors, and robust demand for innovative solutions in skincare and pharmaceuticals. By targeting these key markets, our business can capitalize on unmet needs, leverage partnerships, and scale effectively to establish a strong presence in both the cosmetics and cream production industries.



Products and Services

Active Ingredients for Cosmetics

Our plan is to create a steroid-free, complex active ingredient that contains our tested enzymes (DAO and HNMT) and ssDNA aptamers. We will supply these ingredients first to cosmetics and then to pharmaceutical companies that focus on developing products that reduce the local effects of histamine. With this complex formula, we want to provide more effective active ingredient to our potential partners.

ssDNA Aptamer Efficiency Testing Solutions

We plan on exploring aptamers and delivering more innovative solutions efficiently. In the early years, we'll concentrate on enzymes because there's a lot of research available, making breakthroughs easier. However, we believe that aptamers have great potential for the future. Once we achieve some early success, in the 3rd year we’ll gradually dive deeper into aptamer research to take advantage of their potential. Our strategy includes developing a manufacturing process to create custom DNA aptamers tailored to our clients’ needs and then distributing these products to specific companies and universities.

Aptamer Synthesis and Production Process

Our approach to aptamer synthesis utilizes cutting-edge ssDNA aptamer technology, where short strands of DNA are designed to specifically bind and neutralize specific molecules. The production process involves:

Design Phase: Custom aptamers are designed using bioinformatics tools to optimize their binding affinity and specificity for histamines.
Synthesis: We employ high-throughput DNA synthesizers and PCR to produce the aptamers in large quantities.
Validation and Testing: Aptamers undergo rigorous testing for binding efficiency and stability in a variety of conditions, ensuring their effectiveness in both cosmetic and pharmaceutical applications.

Unique Value Proposition

The enzymes and aptamers, carefully studied and used as key active ingredients, are expected to perform better than similar products without this special formula. In our opinion, this unique composition will be able to compete with competitors. In addition, due to the fact that our solution is steroid-free, they will much prefer to use our active ingredient than a steroid-based one.



Marketing and Sales Strategy

Marketing Plan

Our fundamental marketing strategy is to reach medium and large-sized cosmetic and semi-pharma companies with cream and skin-care product production.

In our marketing plan, we outline our goals and basic initial plan but we plan to outsource the marketing and event organizing procedures for a professional company.

Objectives

Reach more potential clients and break into the global market through tailored B2B marketing campaigns. We focus on ABM(account-based marketing) which helps us create more personalized marketing content and events.

Potential Clients

With a global market, we have many opportunities in the sector, so here we include a few potential clients who we can propose our products and services to.

Europe: L’Oréal Group; Bayer AG; Novartis AG; Henkel AG
America: Estee Lauder Companies, Inc. Procter & Gamble; Coty Inc.; Pfizer
China: Pechoin; Chando
Reaching these companies with a reasonable offer can be a major risk and difficulty. The risk lies in the delays and potential cancellations of orders which can cause a lot of inventories and capital going to waste. For this, in the early days, we want to concentrate on reaching closer and smaller potential partners whose orders could be filled.

Public Relations and Media Outreach:

Our plan is to build a website, which helps skin-care and biotech enthusiasts to further explore new resources and possibilities in the market. With this, we gain the reputation of a leading voice in this field which can be helpful in finding manufacturers and research facilities.

We would engage in the media as a politically indifferent production company.

Sales Channels

To effectively reach our target customers, we will utilize both direct and indirect sales approaches to reach our potential partners and customers.

These are the sales channels we would consider.

Direct Sales:

We will employ a dedicated sales team to engage directly with potential clients in the cosmetics industry.

Utilize a consultative sales approach, offering tailored solutions that meet the specific needs of our customers, such as customized ingredient formulations or testing protocols.

These employees would search for potential customers and organize business meetings or events where we can further improve the business relationships and create a more tailored offer.

Indirect Sales:

Our approach to indirect sales is to organize valuable conferences for industry leaders to meet and create an environment for more business opportunities and proposals. We will detail our plan in the next points with Promotional Activities.

Promotional Activities

Product Launch Events and Webinars:

Host launch events and webinars to introduce our products to the market, featuring live demonstrations and expert guest speakers.
Use these platforms to educate potential customers on the benefits of our technology and answer their questions in real-time.

Samples and Trial Programs:

Offer samples of our active ingredients to cosmetic formulators and manufacturers, allowing them to test our products in their formulations before committing to larger purchases.

Provide trial access to our testing platform for pharmaceutical companies and research institutes to demonstrate the ease and accuracy of our technology.

Trade Shows and Industry Conferences:

Our plan is to participate in as many conferences as possible, so we can improve our company’s awareness in the market. With participation, we can convert valuable relationships into business opportunities.

In the future, we plan to organize these Industry Conferences with expert speakers and industry-leading guests. These events will allow us to showcase the expertise and quality of our products and turn our company into a well-known manufacturer.

These conferences will be the cornerstone of our marketing strategy. From our start, we will participate in these assemblies and will organize from 2-3 years after breaking into the market.

Referral and Ambassador Programs:

Create a referral program that rewards existing clients and industry partners for recommending our products to new clients.
Develop an ambassador program with key opinion leaders (KOLs) in the skincare and biotech sectors to promote our products through their networks.

This comprehensive Marketing and Sales Plan will position our business for successful market entry, drive customer engagement, and build a solid foundation for sustained growth in the global market.

Pricing Strategy

Our pricing strategy is based on the market’s average which indicates our future income rates and potential exit strategies.

Value-Based Pricing for Active Ingredients:

In this table, we explain what our pricing strategy looks like.

Product or Service Pricing
Enzyme Production Average 50 USD/100 mg
Aptamer Production 1.4-1.7 US$/ base

Our first palette of products will increase in production and variety with the growth of the company. We plan to increase sales through Pharmaceutical Aptamer Design and Production from year 3 with the help of new capital investments.




Operations Plan


Service Providers

Service Duty Price/month Source (Hungarian)
Marketing team And Event management Organization of conferences 422-1547 USD Vantgard digital, DEBmarketing, 360marketing, maximumbusiness
Accountant Reviewing financial records to determine taxable income, expenses, profits and losses. 1693 USD ksh.hu
Guard service A security guard ensures a safe environment by maintaining visibility, identifying risks, managing access, conducting patrols, and responding to incidents while coordinating with public safety officials. 907 USD ksh.hu
Transportation Delivery of our active ingredients using refrigerated trucks 2,5-3 USD/km Source

Production Process

Histamine-Binding Aptamers & Enzymes (DAO and HNMT)
Sourcing Raw Materials:

We considered two options for the production of our raw materials which are DAO, HNMT, and ssDNA aptamers:

  1. We synthesize our materials, but this requires that we need to buy the equipment for it, which requires, but as we analyzed the long-term results of these investments, we concluded that it is better for us to invest in this equipment.
  2. We buy all of our raw materials from companies that specialized in synthesizing, which is cheaper at the start. Therefore, it requires less money than the first option, but in the long term, when we will need to synthesize more and more this will be more expensive

Conclusion:
After analyzing the costs, we found the first option to be more favorable. Making a larger initial investment yields a better return on investment compared to the second option.

R&D and Formulation:

All of our R&D will be focusing on the development of formulations for skin applications to reduce itching more effectively

At the beginning, we will be focusing on the development to offer the best products, and then we will produce it which will contain the two enzymes(DAO and HNMT) and the ssDNA aptamers. Approximately 3 years after the start we plan to bring new investments for more development.

After the third year, we will start to design aptamers to order, which will require additional staff and equipment investment.

Manufacturing Process:

Enzyme production: Production of DAO and HNMT in a Microbial Culture Bioreactor Fermentor cell
Aptamer production: Production of ssDNA aptamers using DNA synthesizing machine
The active ingredients (aptamers + enzymes) will be formulated into a final product:

Production Equipment Price(Including customs for Hungary) Source
Enzymes 2 pieces of Microbial Culture Bioreactor Fermentor cell for each enzyme 322 000 USD
- Two units: 308 000 USD
- One unit: 154 000 USD
- Installation fee for two units: 14 000 USD
- Installation fee per unit: 7.000 USD
Alibaba
Aptamers DNA synthesizing machine 84 000 USD Alibaba
Other machines
- centrifuges
- vortexes
- PCR
- qPCR
Approximately 147 000 USD bio-rad.com
Total: 553 000 USD

For other procedures:
After synthesizing our materials, we will need additional machines to carry out the subsequent steps. Specifically, we will require centrifuges, vortexes, PCR, and qPCR machines, which will cost approximately 105 000 USD.

Packaging and Labeling:

We will use sustainable packaging to reduce our ecological footprint using reusable stainless steel containers. Adherence to global standards for labeling, including active ingredient concentration, expiration dates, and usage instructions.

Quality Assurance (QA)

People – All of our employees will be expected to strictly meet the manufacturing processes and regulations. They will have to go through the current GMP training to fully understand their roles and responsibilities. After the results, it will be easier to boost their performance, productivity, efficiency, and competency.
Products – All of our products will undergo constant testing, comparison, and quality assurance before distributing to consumers. We will ensure that primary materials including raw products and other components have clear specifications at every phase of production. The standard method must be observed for packing, testing, and allocating sample products.
Processes – Our processes will be properly documented, clear, consistent, and distributed to all employees. Regular evaluation should be carried out to ensure all employees are corresponding with the current processes and are meeting the required standards of the company.
Procedures – A procedure is a set of guidelines for undertaking a critical process or part of a process to achieve a consistent result. It must be described to all employees and followed consistently. Any deviation from the standard procedure will be reported immediately and investigated.
Factory – Factories will promote cleanliness at all times to avoid cross-contamination, accidents, or even fatalities. All equipment will be placed or stored properly and calibrated regularly to make sure they are fit for the purpose of producing consistent results to prevent the risk of equipment failure.

Product Testing:

We will constantly test throughout the production process to verify:


Regulatory Compliance:

We are going to follow the requirements and guidelines from bodies like EMA and the FDA and comply with Good Manufacturing Practices’ rules.

Supply Chain Management

Raw Material Procurement:

We will establish long-term contracts with reliable suppliers for our bacterial cultures, which require a growth medium. Regarding our production size, we'll place monthly orders and store the medium properly. This approach ensures we always have fresh growth mediums in sufficient amounts.

Logistics:

As our product is an active ingredient, we will focus more on outgoing deliveries rather than incoming ones. We'll order growth mediums directly to our factory, so we're less concerned about incoming deliveries. Our main logistical focus will be on outgoing deliveries.

Inventory Management:

Our active ingredient requires refrigeration, therefore we will have refrigerators that will allow us to easily store it in the factory's inventory area. This enables faster shipping as we'll have the product available in stock. We'll carefully manage production to avoid overproducing the active ingredient, as it can lose its activity over time and become useless. During the first few months, we'll conduct surveys to determine the optimal production range, ensuring we always have just enough active ingredients.

Partnership and Collaborations

Research Institutes & Universities:

We plan to work with universities to test our products before they go to market. This will help us to create new patents together and as we conduct these projects together we could employ some of the students therefore it is more likely that they will come to work for us later on if they want to make a career in the research area. We also plan to partner with companies and research centers which will keep us up to date on the latest technologies in our field and give us an edge over our competitors because we can react to the changes that can happen in the biotech industry.

Cosmetics Companies:

We will agree on the terms and supply our active ingredient to cosmetic companies therefore they can use it in their product to reduce itching. We plan to make partnerships with them to create new products together which will focus on reducing the effect of histamine besides the cosmetic company’s product’s effect.



Management and Organization

Management and Organization Plan


First Year:



Fifth Year:



Hiring Plan



Management & Key Personnel

The Chief Executive Officer (CEO) and his/her assistant will be responsible for setting the company’s vision and strategy, making major decisions, and managing overall operations and resources. He/She oversees operations, makes key business decisions, and manages executive leadership. Moreover, they represent the company to stakeholders, including investors, employees, and the public.

R&D Team:

The R&D Team will be responsible for aptamer designs which we will do to order. They will collaborate with other departments to improve existing offerings and ensure alignment with market demands. Moreover, they will test and refine prototypes, ensuring that new developments meet quality, cost, and performance standards.

Production & QA Team:

The team will consist of biotechnologists specializing in enzyme and aptamer production, alongside a QA expert who ensures compliance with pharmaceutical-grade and cosmetic industry standards. The team will start with 4 people and as the volume of the production increases we will expand the team.

Support:

An administration person for any kind of administration duty but more importantly salespeople who will engage with businesses, and effectively promote our active ingredient to achieve our targets.

Maintenance:

The building maintenance person will be responsible for keeping the warehouse clean and it is important that this work will be done by one person because he/she will be taught how and what to clean. This way we ensure that nothing harmful will be done by a person who does not know how to clean our specific equipment.
The equipment maintenance person will be responsible for maintaining our equipment regularly.

Logistics:

The warehouse and logistics assistant will be responsible for the incoming deliveries and placing them into the correct area inside the inventory area.
The Procurement Manager will be responsible for the procurement of the materials that we need for production.



Financial Strategy

Starting Costs and Capitalization

There are many considerable costs in starting a new business. In this detailed starting cost analysis, we would like to show how much capital or investment is needed at the start of the project.

Construction and Investment Costs

We would like to build a well-designed laboratory and production facility in the rural area of Szeged, Hungary.
As we examined the potential land positions, we decided to search for land that is near to other research and production facilities. These places offer better access to main transportation routes and have more opportunities for partnerships and tenders.

Type Capital Source Capital amount Source
Land Initial Investment 28 000 US$ Link for Sale of Land
Facility Construction Costs Loan and Investment 354 000 US$ (265 000 Loan, 89 000 Investment) Local Construction Company, see details in Human Practices
Laboratory Equipment Initial Investment 147 000 US$ Based on Market Prices
Production Machinery Loan and Investment 406 000 US$ (304 500 Loan, 101 500 Investment) See details in Operations Plan

Capitalization Plan

Our business concept requires a 794 508 US$ initial capital, so we proposed our idea to many investors, who helped us professionally and said to invest in the concept if we proceeded.
Our other type of capital is a 5-year loan, which will be used in the initial construction and equipment purchases.

Capital Sources and Management Table

Source Amount Stake in Company Purpose of Investment
Venture Capital Investment 225 008 US$ 35-40% Initial Investments - Human Resource and Other Expenses
Loans 569 500 US$ No stake Equipment and Facility

Income and Cost Analysis - Financial Projection (5 years)

In our Business Plan, we tend to focus on real information that we use in the construction of this Financial Projection.

Yearly Summary

Year 1: Construction of site and equipment purchase. R&D and Product Launch.
Year 2: First initial sales and company growth.
Year 3: Achieve break-even; expand market reach.
Year 4: Scale operations; drive profitability.
Year 5: Consolidate market position and maximize profit.

Tables

In this table, we show how our incomes and costs vary throughout 5 years.

Revenue Year 1 (US$) Year 2 Year 3 Year 4 Year 5
Enzyme Sales 650 000 1 670 000 2 500 000 3 600 000 4 950 000
Aptamer Sales 167 000 385 000 650 000 1 120 000 2 340 000
Aptamer Design - - 175 000 360 000 720 000
Total Revenue 817 000 2 055 000 3 325 000 5 080 000 8 010 000

Operating Expenses Year 1 (US$) Year 2 Year 3 Year 4 Year 5
Salaries and Wages 317 532 392 904 548 184 634 464 634 464
Facility Maintenance 13 500 15 600 23 670 24 890 26 970
Office Expenses 64 600 73 260 83 460 87 260 92 760
Marketing 12 800 14 290 30 300 36 700 43 290
Guard service 8 600 9 800 10 570 11 290 12 300
Accounting service 20 316 23 840 25 780 26 600 26 850
Transportation 49 170 56 475 70 455 74 790 80 385
Equipment and Maintenance 17 980 18 970 19 450 19 980 22 830
Material Costs 611 000 634 000 817 000 890 000 953 000
Loan Installments 127 568 127 568 127 568 127 568 127 568
Additional Costs 103 210 67 760 82 201 95 780 107 312
Total Expenses 1 346 276 1 434 267 1 838 635 2 029 322 2 127 729

Expenses to Revenue


Overview Table

Overview Year 1 Year 2 Year 3 Year 4 Year 5
Income 817 000 2 055 000 3 325 000 5 080 000 8 010 000
Operating Costs 1 346 276 1 434 267 1 838 635 2 029 322 2 127 729
Variable Costs 23 000 11 000 45 000 75 400 103 670
Taxation (25%) 408 750 513 750 831 250 1 270 000 2 002 500
Net income -961 026 -247 043 563 072 1 705 278 3 776 101

Balance Sheets (End of Year Summary for 5 Years)

Assets Year 1 (US$) Year 2 Year 3 Year 4 Year 5
Cash and Equivalents 6 508 21 540 386 900 890 360 1 470 540
Equipment Investment 553 090 512 450 630 670 580 040 603 312
Facility and land Investment 382 000 402 000 381 000 368 000 396 700
Inventories 13 000 15 310 17 340 19 760 23 540
All Assets 954 598 951 300 1 415 910 1 858 160 2 494 092
Liabilities Year 1 (US$) Year 2 Year 3 Year 4 Year 5
Loans 510 272 382 704 255 136 127 568 0
Company Balance -490 764 -345 854 149 104 782 552 1 494 080

Break-Even Analysis

We plan to reach our break even in the third year, meaning the company’s profitability can be measured by this.



This model represents the real-life break-even of the company. The first investment returns are expected in the third and following years.

Assumptions and Risk Analysis

Assumptions

Market Growth: The CAGR(Compound Annual Growth Rate) of the antihistamine market is 9.25% in the 2024-2031 period, based on Data Bridge Research’s Report.
Sales Growth: Our sales growth is expected in the current market. This is backed by the innovative environment of the product and the efficient marketing strategy.
Pricing Strategy: Competitive pricing in this market is true, but our business concept is unique and has low competition which causes a customized pricing strategy.
R&D Efficiency: Our future company is an R&D based that helps other companies make their products better.

Risks

Regulatory Risks: Changes in regulatory requirements could delay or change product launches and product structures.
Market Risks: Shifts in consumer preferences or economic downturns could impact sales projections. This volatility of the market raises immense risks.
Operational Risks: Potential delays in product development or manufacturing could affect timelines and client appreciation. Bad management decisions can increase these risks.
Competition: Established players with larger resources could outcompete or replicate solutions quickly which can cause the failure or overcompetition of the company.
Financial Risks: Funding shortfalls or unexpected expenses could challenge sustainability and further growth.
Logistical Risks: As a scalability issue, we can experience future logistical issues like problems in procurement or in the intercontinental transportation of our products. These delays can cause scarcity of raw materials and customer dissatisfaction with delayed arrivals.

Mitigation Strategies:

Regulatory Compliance: Engage with regulatory experts early in the development process to make approvals faster and better. We plan to monitor all decisions in these sectors.
Diversified Revenue Streams: Target both the cosmetics and pharmaceutical sectors to reduce dependency on a single market.
Cost Management: Regularly review and optimize operational efficiencies to keep costs in check. Management will play a key role in these inner regulations.
Innovation Focus: Maintain a strong R&D focus to differentiate products and stay ahead of competitors and create more revenue streamlines.
Financial Stability: We plan to welcome long-term investors with long-term contracts to reduce the financial risks. We further plan to invest some proportion of the capital to hedge unexpected events.
Reduce Competition: To decrease the possibility of market competition, we plan to keep our methods within the company. To ensure this, all company employees will sign an NDA. We further plan to use IP patents to ensure our position in the market.
Solution for logistics: We will partner up with well-known and vetted production companies, which we can rely on on the procurement side. With intercontinental transportation, we will rely on trusted transport companies like DSV. In case of further problems, we will maintain a high-level inventory space, where we can store our raw materials and finished products.



SWOT Analysis

Our SWOT analysis contains the Strengths, Weaknesses, Opportunities, and Threats of this business concept. In our analysis, we used many tools to enhance the quality.

Detailed SWOT Analysis

Strengths
Weaknesses
Opportunities
Threats

Mitigation of Threats

Regulatory Challenges: The global market has numerous differences in perspective of Regulatory Compliance. In case of a new market entry, we will hire multiple experts in these fields to mitigate potential complications and prepare for smoother market entries. Further, we want to monitor the regulatory environments in these fields, therefore we can adapt quickly and efficiently in changing times.

Strong Competition: Established players with larger resources could outcompete or replicate solutions quickly which can cause the failure or overcompetition of the company. To decrease the possibility of market competition, we plan to keep our methods within the company. To ensure this, all company employees will sign an NDA. We further plan to use IP patents to ensure our position in the market.

Technological and Market Risks: The fast pace of technological improvements in biotechnology poses the possibility that our company cannot keep up and loses market potential. For this, we want to keep larger investments on the R&D side of the company, so we can further improve and develop our technologies.

Potential delays: Our solution for procurement delays would be partnering up with well-known and trusted production companies therefore we can rely on them, but delays can happen with every company therefore we will invest in high-level inventory space, where we can create an inventory of our raw materials which will contain the raw materials for a month of production, this way the procurement delay will not affect us.
Another delay can happen during production due to machinery issues. For this, we will hire a full-time equipment maintenance person to minimize the possible issues.
There can be a delay owing to increased demand in the market. To avoid this we invest in a larger capacity fermenter, therefore in the early stages we will not use 100% of its capacity but in case of an increase in demand, we can use its full capacity meaning we can satisfy the market demands.



Exit Strategy

Potential Exit Options

Strategic Merger or Partnership

A merger or partnership can enhance the inner structure of the company, and create a new profit streamline for the partner company. The strategic merger can help us get more capital for investments which can help develop new technological systems.

Pros:
The risks will be shared and we can access a bigger market through that company.

Cons:
The complicated legal issues in mergers are time and capital-consuming, which can lead to less production.
Management and control issues can arise in partnerships and mergers.

Company Changes: We would expect management changes, potential changes in goals and production purposes caused by the partner company’s operations and decision-making.

Private Equity Buyout

Selling the company to a private equity firm that specializes in growing promising startups. The private equity firm would provide resources and strategic advice to scale the business before selling it at a higher valuation.

Pros:
Strong financial background and expert advice.
Opportunity to scale faster and increase production efficiency.
Exact timelines for exit, often 3-5 years after acquisition.

Cons:
Changes in company management and vision.
Focus on profitability could shift priorities away from long-term innovation.

Company Changes: More reliance on partner company’s management and operations. Rigorous changes in reducing Operating Expenses and Maximizing Profits. Potential management laydown and structural changes.

Timeline and Milestones

Establish Market Presence and Validation (Year 1-2)

Facility construction, and achieve regulatory approvals for the company and products.
Launch products and break into the market in key regions (U.S., Europe, China).
Create key partnerships and enhance the company picture with potential clients.

Scale Operations and Drive Revenue Growth (Years 3-4)

Expand market reach through new partnerships and entry into additional geographic markets.
Achieve break-even by Year 3, showing financial stability and business viability.
Focus on product development with the help of new capital investments.
Break into the pharmaceutical market with tailored aptamer production.

Position for Exit (Year 5-6)

Achieve sustained profitability and show consistent revenue growth.
Discover different exit options with the help of experts and create strategic mergers or partnerships, or consider a company buyout or acquisition.

Return on Investment Projections

Year 1-2: The company operates at a loss as it invests heavily in R&D, product development, and market entry.
Year 3: Break-even is achieved, and ROI begins to turn positive as revenues catch up with operational costs. Breaking into the new market of tailored aptamer production for pharmaceutical companies requires new capital investments.
Year 4: Returns on Investments improve significantly with profitability driven by expanded market reach, new product launches, and efficient scaling of operations.
Year 5: Expected ROI ranges from 300-500% for early investors, driven by strong revenue growth and a profitable exit event.

Summary of Exit ROI Projections

Merger or Strategic Partnership: Returns vary but generally offer moderate Return on investments with the benefit of long-term stability.
Private Equity Buyout: Returns of 2-4x initial investment, with structured exit timelines providing clarity and exact returns on investments.
These exit strategies provide multiple pathways for investors to investment returns, each with its own risk-reward profile. The optimal strategy will depend on market conditions, company performance, and the change in the landscape of the cosmetics and pharmaceutical industries.