RoSynth Biotechnologies Business Plan

Value Proposition

Our optimized 3D bioprinter is a novel biomanufacturing technique that provides an efficient, cost-effective synthesis of plant-derived molecules for individuals, organizations, and companies who want a reliable production of complex chemicals regardless of climate and geographical agricultural restrictions.

Market Segmentation for Potential Customers and Unmet Needs

As a startup synthetic biomanufacturing company, RoSynth plans to market the parallel 3D printing device in Rochester, NY and utilize it as a testing ground to assess product demand, sensitivity to product pricing, marketing expenses, manufacturing costs, and the ability to scale up production before venturing into more extensive markets such as different places in United States, China, and India. We plan to extend the markets to the European Union and the broader Australasia region after future specific market demand analyses.

We are targeting potential customers in the cosmetic, nutraceutical industries, as well as academia.

Cosmetic Industry:

• Customizable skincare product ingredients and quantities with the exact formulation ingredients.
• Bioavailability for the skin delivery by traditional topical formulations is less than 2% of each dose applied [1]. The 3D biomanufacturing approach has several benefits when compared to conventional manufacturing methods, including the ability for one-step fabrication and customization [2]. In addition, the utilization of 3D printing has demonstrated promise in enhancing the effectiveness of skin delivery and encouraging adherence among users [3].
• Our system enables printing complex compound ingredients and allows for anti-aging and antioxidant creams [4] that could be customized for different people.
• Branding 3D printed skincare ingredient method through co-culture could stand us out among the competitors and differentiate ourselves from the market competition.

Nutraceutical/Pharmaceutical Industry:

• We could personalize the ingredients needed by different people.
• Research has shown rosmarinic acid can prevent tumorigenesis due to its antioxidative and anti-inflammatory properties [5]. Rosmarinic acid can inhibit the growth of tumor cells and therefore widely used in tumor therapies [5]. To increase the bioavailability of rosmarinic acid, several technologies was developed such as modifying the excipients and developing drug delivery systems etc. [5].

Research Labs/ Healthcare Research & Development Sector:

• From our interview with Dr. Alshakim Nelson, he was particularly interested in our customizable duo-channel 3D bioprinter and mentioned that such device has a great market potential used by different research groups for their projects.

I. Total Addressable Market by Our Parallel Culture System

The total addressable market (TAM) represents the largest market opportunity of a specific product or solution. To determine RoSynth’s total addressable market, we assumed that by proofing our method, we will expand our product lines to all other valuable botanical ingredients.

Following the introduction of our 3D bioprinting system to the industry and the launch of optimized chemical production in the North American market, our objective is to expand our offerings initially to the Asia-Pacific and European regions. These regions are prominent in the botanical ingredients market, particularly within the personal care and cosmetic industries, as highlighted by Frost & Sullivan’s Global Botanical Ingredients Growth Opportunities Report 2023 [4]. Our expansion will be conducted with a strong commitment to upholding human rights and a comprehensive consideration of bioethical, environmental, and socio-economic factors throughout our development process. According to Frost & Sullivan's revenue forecast by region for the period 2020-2030, it is projected that the botanical ingredient market in Asia-Pacific will attain an estimated revenue of $1,424.5 million, while the North American market is anticipated to reach $743.1 million, and the European market is expected to reach $461.5 million by the year 2030 with a CAGR of 6.7% [4].

II. Serviceable Available Market by Our 3D Bioprinter

In recent years, Additive Manufacturing (AM) has seen significant technological progress, advancing to a point where it is widely adopted by major sectors like manufacturing, automotive, aerospace, and healthcare for the large-scale 3D printing of components [6]. We are specifically targeting the Laboratory Chemical Reagents Market when first entering the market with small to medium sized customizable chemical productions by our synthetic biotechnologies. Biopharmaceutical research labs had the highest budget increase of 4% in 2022 compared to 2021 [7].

III. Serviceable Obtainable Market

The United States has one of the largest pharmaceutical, cosmetic and chemical markets in the world. Since RoSynth is still in its early stages, it would be advantageous to develop this biomanufacturing system where industry and academia work closely together.

The New York State Department of Development's Science, Technology and Innovation (NYSTAR) programs and centers emphasize the importance of partnering with industry to leverage New York State's technological advantages to produce new products [8], and the University of Rochester's venture capital can also help make our projects successful. The state also offers other innovation development support resources, including financial incentives, to promote university collaboration, research and innovation, providing an ideal entrepreneurial incubation environment for RoSynth’s development.

We can easily build distribution channels in-house from our short-term focus on the greater Rochester area for rosmarinic acid manufacturing markets as well as our 3D bioprinters. The University of Rochester has more than 3,000 researchers and more than 500 laboratories dedicated to scientific research, and Rochester's 2021 research spending was $409 million [9].

Nationally, preliminary federal budget authorizations for R&D facilities total $169.9 billion in 2022 which has increased 5% from 2021 [10]. Proposed federal budget authorization for R&D plants in fiscal 2023 was $191 billion which has increased extensively by 12.7% from 2022 [10].

Academia and government spend approximately 62% of their budgets on purchasing chemicals and reagents etc. [8]. This puts our SOM at $253 million annually in Rochester and $118 billion nationally, with numbers only growing year over year [11].

Exit Plan

We are planning on deploying a Merge and Acquisition Strategy (M&A) and merging with a similar yet larger biotechnology firm with similar operations after the proof-of-concept stage [12]. Another feasible plan could be licensing agreements with strategic partners with already well-established companies which can provide immediate funding and resources; however, careful negotiation is required to protect both parties’ products and rights. The firm is ideally having experiences on FDA clinical trials and is able to take its biotechnologies for upscaling production such as DuPont and Johnson & Johnson. Before the Merge and Acquisition step, we are planning to prioritize our research and development and upscaling strategic development to build a strong portfolio and increase our competitiveness and attract potential investors. By talking with Ms. Shalini Sitaraman Menezes, we also are planning to apply for intellectual property protection, if necessary, to further drive up our revenue and increase the company’s liquidity after entering the market.

After entering the market, we are anticipating to participate in the global nutraceutical botanical ingredients which had revenue of $1,211.0 million in 2022 and is anticipated to reach $2,040.5 million in 2030, and the demand is only increasing [4].

SWOT Analysis

Currently, commercial 3D bioprinters cost more ($10,000-150,000) and have low customization capabilities [13]. A few companies have developed dual-channel bioprinters such as FELIX BIOPrinter, which is more expensive at about $29,411.76 [14], proving that our solution is highly feasible and it’s more accessible for average users. Our customizable partner culture 3D bioprinter is actually a very promising product for sale.

To better illustrate our idea, SWOT analysis is used to better think about our strengths, weaknesses, opportunities and threats to better design and market our products.

Competitive Analysis Grid

Besides the accessibility consideration and enhancing user experiences, RoSynth also carefully evaluates our competitiveness with the current agricultural and extraction method.

Development Plans and Stakeholder Analysis

Furthermore, we also carefully assess, and iterate on their business model by using The Business Model Canvas. We will use this model to strategically plan out our customer segments, value propositions, channels, revenue streams, and cost structure providing a holistic view of our business and identifying potential gaps or inefficiencies, test hypotheses, and continue design or refine our sustainable and profitable business model that cater to customer needs, create value, and drive growth in a dynamic and competitive business environment for our product developments.

I. Business Model Canvas (BMC)

Finances

I. Cost Structure

Our primary area of investment will be directed towards research and development, representing the largest allocation of our capital. This allocation encompasses expenses related to completing proof of concept, conducting preclinical and clinical trials, and covering the costs associated with the registration process for scaling up production. As our company advances, we will need to procure materials in larger quantities, allowing us to negotiate more favorable unit prices in order to achieve economies of scale. In general, it's common for startups to experience an approximate 11% cost overrun for marketing purposes [15].

II. Pricing

If interested to learn more, check our hardware page for the cost breakdown of our 3D bioprinter.

III. Funding

The combined system of our products and methods is novel, completely new. Because of this, we can rely on additional support from other agencies throughout the development process. Most production costs are largely concentrated in the later stages, by which time we have implemented our exit strategy: mergers and acquisitions.

During our discovery phase, iGEM to proof-of-concept, the majority of our funding will come from parents, alumni, friends, crowdfunding, university support and grants. However, we understand that strategic large investors may play a key role for our later success. We will rely on grants, crowdfunding and business angel investors as our manufacturing methods. During the preclinical and clinical trial phase, we will seek support from venture capital, initial public offerings (IPOs), and private equity investment.

There are many funding opportunities which provides an ideal environment for incubating our project:

Local funding sources in the Upstate New York region, including Excell Technology Ventures [16], Simon School Venture Fund [17], Rochester Angel Network [18], Cayuga Venture Fund [19], and several others, provide critical financial support and resources for RoSynth. Also, Excell Technology Ventures in Rochester focuses on Seed and Early Stage investments that can also contribute to RoSynth’s regional economic development. Furthermore, we have the Simon School Venture Fund from University of Rochester's renowned business school which can offer extra funding opportunities and expertise. The Rochester Angel Network connects accredited investors with promising startups, while Cayuga Venture Fund supports startups in various industries. Additional resources like Launch NY [20], Chloe Capital [21], Armory Square Ventures [22], and RIT Venture Fund [23] further enrich the local ecosystem, fostering innovation and entrepreneurial growth of RoSynth in the Greater Rochester area.

Local incubators and accelerators in the Rochester, New York area, including Luminate [24], NextCorps [25], and Venture Creations [26], offer comprehensive support services to startups at various stages of development, as well as manufacturing businesses. They serve as invaluable resources for nurturing early-stage companies and promoting growth. Additionally, RoSynth is actively seeking additional support by participating in business competitions such as 43North [27], which provides $5 million annual investments for pre-seed and seed stage startups in Buffalo, NY, and the New York Business Plan Competition (NYBPC) [28], aimed at fostering entrepreneurship and innovation across New York's colleges and universities. These competitions offer opportunities for RoSynth to gain financial backing and valuable exposure, further enhancing RoSynth’s prospects for success.

Roadmap / Milestones

Future

I. Risk Assessment

RoSynth actively seeks to identify and address potential challenges and uncertainties at different phases of its project development. Through a systematic assessment of risks throughout the project's evolution, RoSynth gains the insights needed to make well-informed decisions regarding resource allocation, strategy adjustments, and proactive measures to mitigate setbacks. This proactive approach not only strengthens RoSynth's capacity to maintain course and achieve milestones but also enhances its overall resilience and adaptability in the ever-changing entrepreneurial environment, thereby augmenting its prospects for sustained success.

II. Upscaling Production

In order to produce products at the scale required by Big Chemicals, we have developed a detailed upscaling plan. You can read more about the this on our project implementation plan.

III. Stakeholders’ Opinions

Throughout the course of our project, we have established numerous valuable connections with stakeholders and experts. This includes individuals like Dr. Zaixin Chen from BioScene Pharma, Dr. Alshakim Nelson from University of Washington, Mr. Jack Johnson from Cayman Chemical, Dr. Elizabeth Onderko from Capra Biosciences, and Mr. Bill Saltzstein from Code Blue Consulting. Furthermore, we have taken into account the perspectives and impact of various stakeholders who will play a role in our company's operations. You can find additional information about our stakeholders and experts by visiting the provided link.

IV. Long-Term Impacts

We have given significant attention to impact analysis throughout our project. The direct consequences of our products will involve alleviating local shortages and enabling global access to our bioprinting systems, irrespective of climate or geographical constraints. We are highly positive to utilize our system to develop drugs and secure approvals from the Food and Drug Administration (FDA), our printing technology will drive a shift in demand away from traditional farming methods and lengthy shipping processes toward more straightforward and convenient procedures. In the long run, this transformation will contribute to substantial economic growth for both the Greater Rochester area and the broader U.S. economy. Furthermore, since individuals, organizations, and companies can customize the chemicals they produce and the quantities they require, there will be reduced waiting times and cost savings through minimized shipping.

Indirect impacts encompass factors such as greenhouse gas emissions stemming from product production and transportation, as well as concerns related to over-harvesting of wild populations and unregulated agricultural practices, particularly in the cultivation of herbs. Additionally, there are considerations regarding potential long-term effects resulting from exposure to microorganisms during various stages of production, transportation, or environmental release. The impact of yeast and bacteria escaping from laboratory settings on the health of individuals remains uncertain, although stringent safety and security measures make such occurrences unlikely. Nonetheless, our commitment lies in significantly mitigating the release of microorganisms into the environment through the development of comprehensive policies and regulations that discourage dual-use scenarios in the project, as previously emphasized.

V. Company Values

“Working with the right people” - Diverse Skill Sets and Backgrounds

Our team consists of individuals from a wide range of backgrounds who share a common passion for synthetic biology. Our team members come from diverse cultures and locations, such as the United States, Morocco, China, Poland, India and Malaysia, which enriches our problem-solving capabilities with a myriad of perspectives. Furthermore, we highly appreciate the valuable guidance and assistance we receive from tutors and teaching assistants who bring diverse experiences and backgrounds to the table as well. Many thanks to team supervisors, Dr. Anne S. Meyer, Dr. Alexis Stein, and Dr. Nancy Chen, who possesses extensive expertise, knowledge, and skills, and plays a pivotal role in helping us navigate and resolve complex challenges.

Additionally, the University of Rochester's established reputation and credibility give us a competitive advantage in the startup landscape. We also have the potential to receive support from the university such as the Ain Center for Entrepreneurship, as well as family friends of our team members. We identify potential partners and cultivating long-term relationships with these companies is invaluable. With the combined efforts of these individuals, we have a strong belief in our capacity to successfully develop RoSynth into a thriving startup.