India, the diabetes capital of the world, is home to a whopping 77 million diabetics. Diabetes can be treated either by oral hypoglycemics or by using insulin injections with 4 in 10 diabetics in India and the Gulf using the latter. Oral medications may lead to unexpected hypoglycaemia if the dose is not titrated while insulin injections have the added disadvantage of pain, scarring and rashes. With success stories on oral insulin far away from the horizon, newer approaches are imperative. We present an out-of-the-box approach to tackle diabetes - “iβeta”.
iβeta is an affordable bio-therapeutic in capsule form that will reprogram the duodenal crypt cells by transdifferentiation into glucose-responsive β-islet-like cells. iβeta will facilitate the normal production of insulin by the body, in a glucose-responsive manner, overcoming unexpected hypoglycemia associated with conventional therapies. It will help diabetic patients lead a normal life, without diet restrictions & is not likely to have adverse effects on long-term usage as seen in the current therapy.
In order to understand the patient and market needs, we decided to conduct a survey and to perform a comparative analysis of the patients' experiences with their current diabetes therapy and understand their preference for the various dosage forms.
Out of the 119 responses received, 105 respondents said that they prefer tablets/capsules along with other dosage forms (respondents were allowed to select multiple options). Hence, we decided that our product will be made available as a capsule.
As evident from the graph above, a majority of the respondents (~85%) are not completely satisfied with the current treatment methods. Hence, it is imperative to develop a novel, user friendly solution to address challenges posed by currently available treatment methods.
Dr Anish Behl
Dr Behl suggested that we focus on Type 1 and Type 2 Diabetes patients with 8 to 10 years of diabetes history. He informed us that insulin injections release the insulin into the subcutaneous tissue and the insulin gets diffused. On the contrary, there is insulin movement across the portal vein in healthy patients. He remarked that our system, which closely mimics the function of the pancreas, will possibly be superior to injections as it would produce insulin in the gut which directly enters the bloodstream.
Mr Sonu Kapoor
In Mr Kapoor’s opinion, a patient is willing to spend a little extra for the convenience of a pill instead of insulin injections, but, the only way to establish the credibility of such a product is if an expert is able to share his faith in the product among his peers. He also suggested that we promote our product to a more niche market. He was confident of our product’s intent to replace insulin injection, however, was uncertain due to its GMO status.
Our product is an out-of-the-box approach to tackle a global problem - diabetes. To enter the market, protecting our product iβeta is of utmost importance. In this regard, we have worked out the costs for filing a patent in India as shown below.
We have also created a comprehensive Patent Guide for future Indian iGEM teams (part of our contribution) to give them an overview of the patent scenario in India.
Consumer Needs and Demographics
The Consumer is always King! In order to understand every expectation, belief, struggle and need of our end-user to develop a product that can incorporate their requirements, we mapped the demography of the diabetic population in India.
iβeta is proposed as a capsule, requiring no special manufacturing facilities. The pricing being affordable, it can cater to a large population and result in insulin substitution leading to enhanced quality of life over a period of time. iβeta will bring about a disruptive change in diabetes treatment using the inestimable potential of synthetic biology. Irrespective of market growth, it will shift the market of insulin users towards a safe and more easy-to-use alternative. Significantly, the poorer population of India will get an affordable alternative with most of them not adept at injecting themselves with insulin.
Decreased dosage frequency
The current Indian diabetes market is valued at INR 145 billion and is growing at a CAGR of 16.7%. iβeta will enter the market in about 12 years when the estimated market size is likely to be INR 925 billion. In the first year of launch, we plan to achieve sales of INR 200 million followed by exponential growth.
The short term goal of Diaβiologics LLP would be to establish the proof of concept and complete pre-clinical and clinical trials to enter into the market within the next 10 – 12 years. The company also plans on introducing a cloud-based, customisable and encrypted patient data storage platform to keep doctors up-to-date with patient data. Diaβiologics LLP aims to become a million-dollar company within the first three years of market entry followed by crossing the 100-million dollar mark within 20 years. The end-goal of Diaβiologics LLP is to become a leading provider of diabetes and solutions worldwide.
Please find below the Business Document outlining the project plan and its long-term and short-term goals. We have also taken into consideration all the stakeholders and human resources required for successfully setting up a start-up and the risks that we might face in the process.
Our team has already taken the first step towards converting iβeta into reality. We participated in CurveBall 2020 - an Institute Level Competition to support student ideas and facilitate startups, which was organised by the Innovation & Incubation Centre for Entrepreneurship (IICE).
We’re happy to announce that we were awarded a special prize and are eligible to access incubation space and support from IICE!