Breakthrough Clinical Results
Non-profit pharmaceutical company Civica is set to launch a long-acting insulin, insulin glargine-yfgn, in pre-filled pens at the lowest list price in the US market, starting January 2026. The insulin will be available for $45 per box of five pens, with a recommended maximum price of $55 for consumers. This initiative aims to provide a more affordable and transparent pricing option for patients with diabetes, contrasting with existing copay assistance programs. The product, interchangeable with Lantus, will be manufactured by Biocon Biologics under its existing U.S. marketing approval.
Key Highlights
- Civica to launch affordable insulin glargine-yfgn at $45 per box of five pens.
- The launch aims to provide a low-cost option for diabetes patients, addressing issues of affordability.
- Civica's insulin glargine is interchangeable with Lantus.
- Biocon Biologics will manufacture the insulin under existing U.S. marketing approval.
Incidence and Prevalence
Latest Global Estimates of Diabetes Incidence and Prevalence
The prevalence of diabetes continues to increase worldwide, becoming a major health care problem with significant macrovascular morbidity and mortality. According to current data, Diabetes Mellitus ranks among the top ten leading causes of mortality globally and is projected to rank seventh by 2030.
Regional Prevalence Variations
In the United States, as of 2021, 38.4 million Americans have diabetes. Earlier data from 2014 estimated that 26 million persons aged ≥20 years (11.3% of the U.S. population) had diabetes. The prevalence of diabetes is over 50% higher in Latinos than in the general population, with this group suffering higher rates of complications and diabetes-related mortality than non-Hispanic whites. The Northern Manhattan Study (1993-2014) found that being non-Hispanic black (HR 1.69) or Hispanic (HR 2.25) versus non-Hispanic white was associated with greater diabetes risk.
In Florida, the overall prevalence was 11.5% in 2020, while pre-diabetes was 8.2%.
In Australia (2024), the overall diabetes prevalence was 6.3% among adults 20 years and above, with significant variations across ethnic groups. East Asian populations showed prevalence ranging from 4.2% (Japanese) to 12.6% (Filipino). South/Central Asian populations ranged from 7.3% (Armenian) to 18.4% (Bangladeshi). In Oceania, several populations exceeded the Australian average: Australian Aboriginal (17.5%), Fijian (12.3%), Maori (10.0%), Samoan (16.3%), and Tongan (17.4%).
In Europe, Norway saw the incidence of type 2 diabetes decrease significantly from 609 cases per 100,000 person-years in 2009 to 398 cases per 100,000 in 2014, an annual reduction of 10.1%. Despite this, prevalence increased from 4.9% to 6.1% during the study period. In Malmö, Sweden, the prevalence of type 2 diabetes in 2018 doubled from 2011, increasing from 2.46% to 4.26%, with the highest increase in younger age groups. In Italy, the prevalence of known diabetes was 6.0-8.1% in 2014, with variations by age.
In England, diabetes prevalence increased in men from 3.74% in 1994 to 7.25% in 2006, and in women from 2.28% to 4.88%.
Developing Regions
Sub-Saharan Africa is predicted to have the steepest increase in diabetes prevalence in the next 25 years. In Mozambique, the prevalence was 7.4% in 2014/2015, more than twofold higher than in 2005 (2.9%). Notably, prevalence was almost double in participants with overweight/obesity (10.6%) compared to leaner counterparts (6.3%), and 50% more people with diabetes lived in urban areas than rural areas. Only 10% of people with diabetes were aware of their disease.
In the Republic of Srpska (Bosnia and Herzegovina), the average incidence of type 1 diabetes in children under 15 years was 19/100,000 in 2017-2022, with the highest incidence of 28.7/100,000 occurring in 2020 during the first year of the COVID-19 pandemic.
In China, the standardized prevalence of diabetes in Guizhou (2016) was 6.01% in urban residents and 3.47% in rural residents. In Japan, a systematic review indicated the pooled incidence rate was 8.8 per 1000 person-years.
These statistics highlight the global burden of diabetes with significant regional variations and concerning trends in many populations worldwide.
Emerging Unmet Needs
Key Unmet Needs and Target Populations for Diabetes
Socioeconomic and Demographic Disparities
Recent publications highlight persistent socioeconomic disparities in diabetes management, with lower SES patients facing a higher risk of diabetes. Mexican Americans and males with low SES represent particularly vulnerable populations requiring targeted interventions. The COVID-19 pandemic exacerbated these challenges, with patients having both diabetes and COVID-19 more likely to experience worse glycemic control.
Type 1 Diabetes Unmet Needs
For Type 1 diabetes, there is an urgent need for therapies that can delay disease progression and protect pancreatic β-cells since no curative treatment exists. Research indicates a need for adjunctive glycemic therapies beyond insulin to address insulin resistance and reduce complications. The field requires a paradigm shift toward smaller mechanistic trials to define immune mechanisms and identify treatment responders. Limited study exists on the application of SGLT2 inhibitors, particularly empagliflozin, despite their use in Type 2 diabetes.
Type 2 Diabetes Management Gaps
A paradigm shift in disease management of Type 2 diabetes is urgently needed as a "glucocentric" approach is no longer viable. Despite evidence suggesting T2D reversal is achievable through bariatric surgery, low-calorie diets, or carbohydrate restriction, only treatment, not reversal, is discussed in major guidelines, representing a significant treatment gap. Only one-third of individuals with T2D receive care as recommended by clinical practice guidelines.
Specific Target Populations
Recent literature identifies several specific populations being targeted: - Type 1 diabetes patients at risk for cardiovascular disease - Adults with Type 2 diabetes requiring support for medication adherence and self-management - Patients using insulin pens with poor injection technique - Youth with diabetes, particularly those transitioning from pediatric to adult care - Patients at risk of insulin pump withdrawal - Patients with diabetic ketoacidosis (DKA) - Individuals with diabetes and severe mental illness (SMI) who face higher risk of complications
Psychological and Behavioral Factors
Psychological factors significantly impact diabetes self-management, with 70% of patients experiencing diabetes distress and 37.50% having clinically significant distress requiring physician attention. Barriers to management include financial concerns, social stigma, medication side effects, and cognitive impairment due to hyperglycaemia.
COVID-19 Related Challenges
COVID-19 vaccination uptake among people with diabetes remains suboptimal at only 57%, despite WHO recommendations for 100% vaccination in this high-risk group. Factors improving vaccination rates include healthcare provider advice and strong perceived benefit of vaccination.