Type 1 Diabetes

Pharmacor -- August 2008

  Introduction:

Type 1 diabetes is a chronic disorder that requires intensive insulin replacement therapy to maintain glycemic control and prevent the development of long-term macrovascular complications (e.g., atherosclerosis) and microvascular complications (i.e., diabetic retinopathy, diabetic neuropathy, and diabetic nephropathy). The microvascular complications are the leading causes of, respectively, adult-onset blindness, nontraumatic amputations, and end-stage renal disease in the major pharmaceutical markets. Although the type 1 diabetes market is dominated by subcutaneous formulations of insulin analogues and constrained by clinicians’ conservative approach to therapy, high-growth opportunities lie in the development of disease-modifying agents and novel formulations of insulin delivery.

  Questions Answered in This Report:

By the latter half of our study period, several novel formulations that allow buccal, inhaled, oral, transdermal, or intranasal delivery of insulin will enter the market. How will these agents affect sales of subcutaneously injected insulins and insulin analogues? Which novel insulin formulations will have the greatest uptake and what clinical parameters are endocrinologists most excited about? What competitive challenges will these novel insulins face in the treatment of type 1 diabetes?

Treatment of type 1 diabetes is characterized by a high level of unmet need for disease-modifying therapies. Immunomodulators are the first agents to address this unmet need and are forecast to enter the market beginning in 2015. How do thought leaders view the immunomodulators in the late-stage pipeline? Which patient populations will be eligible for treatment? How does each therapy fare in terms of safety and efficacy?

Endocrinologists tell us they are increasingly prescribing premium-priced insulin analogues rather than less-expensive regular human insulin and neutral protamine Hagedorn (NPH) insulin. What is driving this shift in standard of care? What factors are preventing insulin analogues from completely penetrating the market?

  Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 63 country-specific interviews with endocrinologists and diabetologists.

Epidemiology: Diagnosed prevalence of type 1 diabetes.

Population segments in market forecast: Type 1 diabetes.

Emerging therapies: Phase II: 9 drugs; Phase III: 5.

Market forecast features: Using a patient-based model, we forecast population sizes and drug sales for type 1 diabetes through 2017.