Unmet Needs
Unmet Needs 2016: Type 2 Diabetes
November 15, 2016

Type 2 Diabetes Market Expected to Double by 2025


 The global type 2 diabetes market is set to almost double from $31.2 billion in 2015 to $58.7 billion by 2025, representing a compound annual growth rate of 6.5%, according to research and consulting firm GlobalData.

The company’s latest report states that this growth, which will occur across the nine major markets of the US, France, Germany, Italy, Spain, the UK, Japan, China, and India, will primarily be attributable to a dramatic increase in the diagnosis and prevalence of the disease, and the fact that the rise in type 2 diabetes-related comorbidities has fueled a more aggressive approach in treatment and the use of multiple-drug therapies.

Jesus Cuaron, Ph.D., PPM, GlobalData’s Analyst covering Cardiovascular and Metabolic Disorders, explains: “Increases in disease incidences will result from increased life expectancy and lifestyle changes, such as dietary changes and a reduction in exercise.

“Indeed, the US will be impacted the most by such changes, increasing its global market share from 58% to 66% during the forecast period.”

Due to the increasing prevalence and progressive nature of type 2 diabetes, there are considerably high unmet needs within the indication. Overall, these unmet needs are interrelated and include improved durability of treatment, a better balance of efficacy of glycemic control with cardiovascular safety, hypoglycemia avoidance, and tolerability and ease of compliance.

Cuaron continues: “Currently, all available treatments for type 2 diabetes are initially effective and reduce complication rates. The need for drugs which are able to maintain glycemic control in the long term, however, represents a significant growth opportunity for new patent-protected products.

“Molecules in the earlier stages of development – Phase II or earlier – employ various novel mechanisms of action. Early-stage novel drug classes include those such as 11-beta-hydroxysteroid dehydrogenase type 1 inhibitors and glucokinase activators”

GlobalData believes that to address the biggest unmet need in type 2 diabetes, new drugs must address the problem of insulin resistance, as this is the root of the disease.

“New products must address insulin resistance while offering a strong safety profile and not causing weight gain,” the analyst concludes.

Type 2 Diabetes | Unmet Need | Detailed, Expanded Analysis 


Type 2 diabetes (T2D) is a complex metabolic disorder characterized by a declining ability to produce or utilize insulin. The chronic and progressive nature of the disease, as well as its complications and comorbidities, often results in patients requiring multiple medications. The T2D therapy market is a crowded one, but despite the number and variety of T2D therapies available, patients typically follow a well-defined treatment progression, beginning with oral therapies and then adding injectable agents as the disease progresses. The lack of any disease-modifying agents and the inability of current agents to maintain patients’ target HbA 1c levels over the long term remain areas of substantial unmet need. The cardiovascular (CV) safety of T2D agents has long been a concern because CV-related deaths account for about 50% of diabetes-related mortality. Fortunately, there have been advances in CV safety; the T2D therapies Jardiance and Victoza now offer CV benefits compared with the standard of care. Over the next few years, several fixed-dose combinations comprising a range of drug classes, including SGLT-2 inhibitors, GLP-1 receptor agonists, and insulins, will launch; drug developers are increasingly focusing on these combinations in hopes they will offer greater efficacy and reduce the medication burden for T2D patients, many of whom are elderly and are being treated for comorbidities. As these new agents compete for positioning and uptake, physicians must consider how best to incorporate them into their treatment while keeping the cost to the patient in mind. Even with a broad range of treatments available and recent advances in CV safety, the unmet need in T2D treatment is considerable, and, as the prevalence of the disease grows, there is significant market opportunity.

Improving Management of Type 2 Diabetes Mellitus


The MD Magazine Peer Exchange “Improving Management of Type 2 Diabetes Mellitus” features a panel of physician experts discussing current best practices to treating and managing patients with T2DM that generally includes lifestyle modifications as well as medication. The mechanisms of action, patient selection criteria, and side effects for various oral medication classes are included in the discussion.

One of the huge needs are new drugs that really improve insulin sensitivity. Pioglitazone is a great insulin-sensitizing drug. Metformin, we showed many years ago, doesn’t improve insulin sensitivity in muscles. It works on the liver and it’s not, in my opinion, a true insulin sensitizer, it inhibits gluconeogenesis. So, there’s a huge deficiency here, and there are lots of leads but nothing that I would say looks like a slam dunk.

IDMPS is identifying unmet needs for diabetes in the developing world


Practical Strategies for Advancing Insulin Therapy:

From Timely Initiation and Appropriate Titration of Basal Insulin to Addressing Postprandial Glucose Control


The Med-IQ/Taking Control Of Your Diabetes New and Emerging Insulin Continuing Medical Education evening series will be offered in ten different cities during the 2016 year.

The importance of postprandial glucose control has long been overlooked. In type 2 diabetes, there is an unmet need for ultra fast-acting insulins to more effectively and efficiently control post-meal glucose values while simultaneously limiting delayed hypoglycemia and weight gain. In addition to controlling postprandial glucose values, there is a need to treat incidental hyperglycemia between meals when appropriate, which points to the demand for a rapid-on, rapid-off insulin. Identification of postprandial elevation is an important first step, followed by the design of an individualized insulin regimen to address basal and prandial insulin needs, which is crucial for overall safe and effective glucose control.

There is a marked behavioral resistance to advancing insulin therapy in type 2 diabetes for not only patients, but also HCPs. In particular, HCPs avoid intensifying mealtime insulin for a host of reasons: time constraints, or the perception of time constraints, lack of comfort and confidence regarding how to intensify and titrate mealtime therapy, fear of complications due to advancing therapy, and deficient knowledge and training regarding how to address these concerns. As mentioned above, patients are often resistant to advancing insulin therapy primarily due to common misconceptions, including: fear and concern about additional injections, the belief that more insulin and/or more injections means that their health is worsening, concern that additional insulin will contribute to poorer health outcomes, feelings of being overwhelmed by the complexity that mealtime therapy will presumably introduce, the possibility of social stigma, and worries about weight gain and hypoglycemia.

Improving Type 2 Diabetes Therapy Adherence and Persistence in the United States


EASD 2016: Renal benefit seen with Victoza in LEADER 3 unlikely to lead to label expansion


 Additional data from Victoza’s (liraglutide; Novo Nordisk) LEADER 3 cardiovascular outcomes trial in type 2 diabetes were presented on 15 September 2016 at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD 2016). The results suggest that Victoza may have a potential renal benefit, as investigators reported reduced incidence of renal microvascular events. However, the reduction in composite outcome renal microvascular events was driven primarily by decreased new onset of persistent macroalbuminuria. This endpoint is generally considered not to have a strong association with renal outcomes, and is unlikely to generate growth or provide compelling evidence for a label addition for Victoza on its own.

Victoza’s failure to show a reduction in measures associated with renal outcomes represents a missed opportunity to meet a huge unmet need in type 2 diabetes. Approximately 20­–30% of patients with type 2 diabetes develop moderate to severe renal impairment (Inzucchi et al., 2012). This accounts for 11% of deaths within the type 2 diabetes population (Morrish et al., 2001), and also limits the type of antidiabetic treatments available to patients.

Management of Diabetes: Beyond the Insulin and Incretin Pathways