New Delhi: Anti-diabetic drugs are a major driver for Indian companies and it continues to propel in the metabolic disorder space. The need for anti-diabetic drugs is now surging following cardiac drugs, which reflects the rise in the number of diabetic patients in the country, and the increasing focus of pharmaceutical companies on therapy areas. The Indian pharma companies opine that they are continuing to bring in novelties, and innovative approaches and trying to meet unmet needs while launching new anti-diabetic drugs.
Pharma experts speaking to ETHealthworld cited that most of them have pioneered newer approaches in the management of diabetes, particularly type 2 diabetes (T2D) and they are working continuously to bring in new and effective treatment options for diabetic patients, supported by research focussed on the Indian population. The burden of diabetes is high in India and is mainly fuelled by the increasing prevalence of overweight/obesity and unhealthy lifestyles. According to the World Health Organisation (WHO), in 2019, non-communicable diseases (NCDs) India ranks second after China in the global diabetes epidemic with 77 million people suffering from the condition.
IQVIA MAT Sept 2022 data suggests, diabetes is the fourth largest therapeutic segment in the Indian pharmaceutical industry and has been growing consistently at a CAGR of 10 per cent over the last five years. The data indicates that the market for anti-diabetic drugs in India is around Rs 15,700 crore. The market for oral anti-diabetic drugs in India is estimated to be Rs 11,796 crore, with an annual growth of 7 per cent against the corresponding period last year (MAT Sept 2021).
As per Global Data’s Pharma Intelligence Centre, nine Indian companies are currently involved in the development of T2D drugs. Moreover, Indian companies are mainly focusing on new combinations of existing drugs. No Indian pharma companies are involved in the development of type 1 diabetes (T1D) drugs. The data further states that the T2D market in India generated sales of $4.8 billion and is expected to reach $5.8 billion in 2028 at a CAGR of 3.11 per cent. The number of diagnosed prevalent cases of T2D market in India is estimated to grow at a CAGR of 3.97 per cent, from 76.2 million in 2021 to 91.7 million in 2028. The number of diagnosed prevalent cases of T1D in India is estimated to grow at a CAGR of 5.49 per cent, from 42.2 million in 2021 to 59.8 million in 2028.
Elaborating on the same, Prashant Khadayate, Pharma Analyst, Global Data said, “T2D is one of the most common NCDs in the world and the leading metabolic disorder. According to International Diabetes Federation (IDF) estimates, around 425 million people globally had T2D in 2017 and this number is expected to rise to 629 million by 2045. Around 75 per cent of people with T2D live in low- and middle-income countries. There are an estimated 76.2 million people with T2D in India, second only to China. The recent epidemiological surveys suggest that the prevalence of T2D in India ranges from five per cent to 17 per cent. The burden is expected to increase further as a result of rapid demographic and lifestyle changes that include an ageing population, increasing urbanisation, dietary changes, reduced physical activity and unhealthy behaviours.”
Even though the Indian diabetes drug market is highly crowded, there is still a huge opportunity for new entrants due to the need for more treatments that help manage T2D, and thereby reduce the cost burden of diabetic complications, along with the need for more affordable T2D drugs in general. Adding to it the Government of India taking steps to make diabetes therapies accessible for all. The Union Health Ministry launched the new National List of Essential Medicines (NLEM), expanding the list to include newer therapies for diabetes. There is a stark rise in the anti-diabetic drug space.
Developing anti-diabetic drugs is intricate and complex
The drug development of anti-diabetic drugs is complex compared to other metabolic disorder drugs, elucidating on it, Alok Malik, EVP and Business Head, India Formulations, Glenmark Pharmaceuticals Ltd, said, “Development of anti-diabetic drugs is very critical compared to the other metabolic diseases because of the epidemic proportions of the growth of the disease across the globe and especially in India. Being a chronic, lifetime illness it is a syndrome comprising insulin resistance with possible ramifications to end-stage renal disease, microvascular complications, organ damage and nonalcoholic steatohepatitis (NASH). Therefore significant research and development efforts are globally directed to find newer therapies for the treatment of diabetes.”
Further adding to it Dr Dhananjay Bakhle, EVP, Medical Research, Lupin, said, “Diabetes is a silent disorder affecting many other organs resulting in complications. Hence, it is one of the most important diseases for India to keep under check by developing new drugs, increasing awareness, and improving patient’s adherence to treatment.”
Terming that diabetes is a metabolic syndrome which is a result of eight pathways of disease, Dr Anil Kukreja, Vice-President, Medical Affairs and Regulatory, AstraZeneca India, said,” It is a disease known to reduce life expectancy and also increase the rate of deaths, cardiovascular diseases, renal disease and cancer by 1.3-3.0 times. It is also one of the leading causes of blindness, especially in people of working age. The co-occurrence of these morbidities severely impairs quality of life, reduces productivity, and causes major suffering. Hence, while addressing solutions to this disease, all the pathways have to be considered to have an overall positive impact on patients’ lives. The drug-development process has now moved beyond glucose control to cardio-renal safety and benefits thus increasing the overall drug development research cost.”
Giving insights on the precautions that need to be taken during the development of anti-diabetic drugs, Malik said, “There are multiple critical quality attributes (CQA’s) that are to be considered during development of an anti-diabetic formulation to ensure safety and efficacy. Some of the critical CQA include– physio-chemical properties of drugs like – solubility, particle size, hygroscopic, drug-drug interaction, drug–excipient interaction, degradation pathway etc. These are the factors which we have to take care of along with strict compliance to good manufacturing practices (GMP), FDA guidance so as to develop a stable and robust product having equally robust manufacturing process that gives flawless commercial supply.”
Citing that diabetes is associated with numerous comorbidities that could lead to the development of various complications, Bakhle said,” It demands in-depth studies and an elevated understanding of the comorbidities and complications while developing a drug. By and large, T2D management has focused on managing blood glucose levels. Much recently, this approach is being supplemented with a patient-centric complication-prevention approach. While developing new approaches and drugs, instead of solely relying on glucose control mechanisms, different routes are being evaluated, such as supporting renal and cardiac actions and preventing complications.”
Pointing out that cardio-renal burden is the most common complication of diabetes, Kukreja said, “In fact, these diseases start to manifest sub-clinically in the body before the diagnosis of diabetes. Hence, any drug coming into this space must be at least safe for the heart and kidney.”
Referring to the US FDA 2020 guidelines, which recommends the enrolment of a broader range of patients with comorbidities and diabetes-associated conditions, including patients with underlying cardiovascular and kidney disease and older patients, as part of the clinical trials, Khadayate said, “Pharma companies need to ensure that a broader range of patients are included as part of the clinical trials on diabetes drugs in development to show renal and cardiovascular benefits. Lately, multiple drugs in diabetes are reporting how their drugs improve cardiovascular and renal outcomes.”
Progressing towards effective diabetes treatment
In the Indian market, it is always the patient-doctor relationship and the process of standardisation that determine the course of medication. Hence, it is very crucial for the pharma brands of diabetes medications to maintain their quality to influence the doctor/physician. Pharma companies inform that they are using new and innovative approaches to capture their target audiences.
Talking about research, development and launch of drugs by Glenmark, Malik said, “We launched globally researched innovator molecule, Remogliflozin in 2019, which had been the subject of extensive global studies to treat T2D in adults. Apart from it, we introduced the FDC Vildagliptin (50 mg), and Metformin (500/1000 mg) in 2021 in India. In 2022, Sitagliptin was launched and its FDC, followed by Lobeglitazone, Lobeglitazone and Metformin FDC and FDC of Teneligliptin + Dapagliflozin in India for adult patients with T2D. We also have an ongoing large post-marketing surveillance (PMS) study on Remogliflozin + Metformin FDC in India which involves more than 5000 patients with type 2 diabetes. This is one of the largest studies with any SGLT2 inhibitors in Indian diabetic patients.”
Kukreja spoke about AstraZeneca’s newer approaches in the management of T2D, he said, “We have gone beyond glucose control with the innovations in SGLT-2i and GLP-1 RA classes of medications. Not only in the anti-diabetes segment but also it is first to prove the benefit of its research product Dapagliflozin beyond diabetes in heart failure (HF) and chronic kidney disease (CKD) irrespective of diabetes.”
Noting that Lupin ranks third in India in terms of diabetes market share, Bakhle informed that their right insulin injection technique programme, Anya, a first-of-its-kind chatbot for disease awareness. Dietitian & Nutrition Assistance Programme (DNA) and Humrahi programme offer services like diet and counselling, pen education, insulin storage tips and exercise tips.
Diabetes is a disease which can be kept under control only through medication and stringent lifestyle management. As pharma firms chase the holy grail of new drugs, pharma analysts believe that the secret ingredient for anti-diabetic drugs success would be to address the high unmet needs in the market, a faster regulatory approval process with a well-established standard of care.