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International Clinical Trials

Beating Diabetes

Sylvia Miriyam Findlay at Frost and Sullivan looks at what the future holds for the global diabetes market

The prevalence of diabetes has been increasing at an annual rate of five per cent, and diabetes is considered to be the fifth leading cause of death in developed countries. The World Health Organization (WHO) estimates that the diabetic population is likely to reach 366 million in 2030. The US is expected to have an increase of 102 per cent in the diabetic epidemic in 2030 compared to 2000. Likewise, Europe is likely to face an increase of 43 per cent, Asia Pacific a 130 per cent increase and Africa and Middle East a huge 162 per cent increase.

An analysis of the cause of diabetes reveals that obesity is the primary factor. Obesity and diabetes are the two major problems currently faced by the medical community. An increase in obesity, especially among younger people, has led to the higher incidence of adult-onset or type-2 diabetes. Children are becoming obese due to their lifestyles, which is causing serious concern among healthcare authorities globally.

‘Diabesity’ is a term coined in the US to show the combined effects of obesity and diabetes. In Europe, the disease burden for type-2 diabetes alone is estimated to be $20 billion a year. Expenditure on diabetes constitutes around 10 per cent of the total healthcare spend.

Diabetes management is extremely challenging and it must be noted that two thirds of patients do not meet the treatment goal. The first line of treatment includes diet and exercise followed by a single oral drug. Twenty-seven per cent of diabetics are on a single diabetic drug, followed by dual oral and triple oral drugs with 19 per cent and seven per cent respectively. The percentage of the population on insulin is only seven, compared to 53 per cent on oral drugs.


The diabetes market is a key area in the pharmaceutical industry demonstrating incredible growth opportunities. The market’s landscape is dynamic and has changed significantly with a host of new participants. This transition has taken place because the diabetes market offers the potential for increasing revenues.

The market comprises oral antidiabetic drugs and insulins. The most prominent oral drugs currently in use are metformins, sulphonylureas and thiazolodinediones (TZD). Dipeptidyl peptidase 4 (DPP – 4) inhibitors are also prescribed.

The growth in the diabetes market is propelled by the sales of insulin and insulin analogues. The insulin market has witnessed bold changes with the introduction of insulin analogues – a trend which has in turn been enhanced with the introduction of advanced forms of insulin delivery pens. Although there were attempts to introduce inhaled formulations, the move was unsuccessful. Several companies pursuing research in that area terminated studies due to the poor performance of Exubera (Pfizer’s inhaled insulin). Apart from analogues, the insulin market has not seen any major novel introductions, unlike the oral antidiabetic drugs market.


Screening and primary intervention are still major areas for development. In the US, 40 per cent remain undiagnosed. Thirty per cent of adults suffer from a condition called pre-diabetes, with symptoms that include elevated blood sugar levels that do not fall under the diabetic range. In Europe, almost 50 per cent of the German population remain undiagnosed, and the UK is estimated to have around 500,000 people facing undiagnosed diabetes. Early diagnosis is the current priority, and addressing this factor is likely to reduce the disease burden.

Despite advances in type-2 diabetes treatment, effective disease management is still a challenge. The current drugs for type-2 diabetes treatment lack the desired efficacy and are unable to meet the various demands of a type-2 diabetic. Limited efficacy is coupled with undesired side effects, thereby increasing non-compliance to therapy.

With the negative side effects (heart risks) brought about by GlaxoSmithKline’s oral anti-diabetic drug Avandia, the FDA has tightened its approval on diabetic drugs, thus there are delays in the approval of anti-diabetic drugs. Such delays affect the revenue model of pharmaceutical companies, in addition to delaying the opportunity for the medical community to use novel drugs.


The last decade has witnessed various novel drugs being introduced in the diabetes market, thereby altering the market dynamics. The traditional diabetes medications such as metformins and suplhonylureas have been cannibalised by these novel drugs.

Incretin mimetics constitute glucagon-like peptide-1 (GLP-1) agonists and dipeptidyl peptidase (DPP-4) inhibitors. These medications mimic the action of incretin hormones and help to control diabetes. Researchers are now focusing on PPAR delta agonists. These drugs increase the serum high density lipoprotein (HDL) levels and also reduce blood glucose levels. In addition, research is ongoing in the areas of PPAR alpha/delta, PPAR gamma/delta and PPAR pan agonists targeting alpha, delta and gamma receptors. These compounds are in the very early stages of research and have yet to pass strict safety measures so as to succeed in this market. Long acting glucagon-like peptide-1 (GLP-1) analogues are likely to gain significant importance, almost equivalent to insulins in the near future. This trend is likely to be beneficial for type-2 diabetics who have not responded to other oral antidiabetic agents.

Sodium glucose co-transporter (SGLT) inhibitors are in the very early stages of development and their success in the market depends on the efficacy data. Analysis reveals that these drugs are likely to be second-line therapy drugs that can aid in reducing blood glucose levels for patients already on metformins or sulphonylureas.

Other novel drugs in development are protein tyrosine phosphatase 1B (PT1B) inhibitors, glycogen synthase kinase- 3 (GSK-3) inhibitors, 11-beta-hydroxysteroid dehydrogenase (11beta-HSD1) inhibitors and GPR119 agonists. These drugs are still at the research and preclinical development stages.


With the downfall of the world’s first inhaled insulin, major pharmaceutical companies have withdrawn their research in this area. Companies such as Novo Nordisk and Eli Lilly have withdrawn their research efforts to produce inhaled insulin. However, research is still ongoing in developing non-invasive forms of delivering insulin and such devices are likely to be available for the diabetic community in the near future. However, their success will depend on whether they score highly on efficacy, safety, cost and ease of use. Failure to satisfy every parameter will result in the likely rejection of the delivery method.

Mannkind Corporation has two drugs in the pipeline: AFRESA (which has been submitted for NDA) and MKC253. These are diabetic drugs to be delivered through the pulmonary route using the Technosphere platform technology. Once approved, AFRESA would be the only pulmonary insulin in the global diabetes market. However, the success of this novel form of insulin delivery will be determined by the safety, efficacy, ease of use and pricing. Since it is an ultra rapidacting insulin, it needs to be used in combination with other long-acting insulins. In addition, the downfall of Exubera is also likely to have an impact on the market acceptance of AFRESA. The penetration of AFRESA in the diabetes market would be slow during the launch. Its usage in combination with other insulins, and the benefit it offers against the cost of therapy will determine its market success.

Nasulin, for the nasal delivery of insulin, is currently being tested by Bentley Pharmaceuticals, Inc, based in India. It is in Phase II of clinical trials and is being tested for adjunct therapy with oral drugs. However, studies to demonstrate its safety are to be conducted, and only these results can determine its success in the market.

Oral delivery of insulin is also being researched and there are a handful of players participating in this area. Oralyn, from Generex Biotechnology Corp is currently available in Ecuador, and has been approved for sales in India. The insulin, delivered orally through a drug delivery device called RapidMist, is proven to be a safe mode of insulin delivery causing less pain. Emisphere is developing an oral insulin tablet using its proprietary technology Eligen. Biocon is also developing an oral insulin tablet IN-105, which successfully completed Phase IIa trials in India. It has shown promising results and the company is looking forward to moving the drug candidate to the next phase of the trial. Finally, Oramed has another oral insulin capsule in its Phase I stage of the pipeline.


With effective use of artificial intelligence, the diabetes market will witness the emergence of ‘bio-monitoring’. Efficient disease management will be made possible, especially in rapid screening of diabetes, and it will also help patients to selfmanage diabetes. Increasing knowledge on the pathology of diabetes can only lead to the introduction of improved drugs to treat the disease. By 2015, the global diabetes market is expected to witness improved therapies and novel drug delivery forms. The emergence of newer classes of drugs to treat diabetes and co-morbidities are likely to change the market dynamics, particularly with the introduction of combination drugs to treat lifestyle disorders covering diabetes, obesity, hypertension and so on. Hence companies offering advanced drugs addressing the co-morbidities in addition to diabetes are expected to perform well in this market.

However, the era of finding a cure for diabetes is yet to come. As healthcare moves towards preventive medicine, a few companies have set about researching diabetes vaccines. If they succeed, the entire market landscape is bound to undergo instant change.

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Sylvia Miriyam Findlay is a Programme Leader with the Pharmaceutical- Biotechnology team for the EIA healthcare practice. She is involved in market engineering research services and consulting in the pharmaceutical and biotechnology sectors. She has nine years of pharmaceutical industry expertise. As an analyst at Frost & Sullivan, Sylvia has worked on projects such as new technology, market and competitor analyses and M&A, and has been involved in various consulting projects. Prior to joining Frost & Sullivan, Sylvia was an Executive Territory Manager with Eli Lilly and Co, India, where she was responsible for the infectious diseases, endocrinology, cardiology and diabetology portfolio. Sylvia is a science graduate (BSc) from Madras University, India. She also holds a Masters in Life Sciences from Pondicherry University, India.
Sylvia Miriyam Findlay
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