Regulatory Support and Fast-Track Approvals Accelerate Diabetes Market Growth

Published: Oct 2025

Diabetes market was valued at $88.3 billion in 2024 and is projected to reach $354.9 billion by 2035, growing at a CAGR of 13.6% during the forecast period (2025–2035). The rapid approval of biosimilars and generics by the FDA increases industry competitiveness, expands next-generation therapy availability, and enhances investor confidence, propelling market growth. For instance, in February 2025, the FDA granted approval of subcutaneous Merilog for diabetes glycemic control, as the first quick-acting biosimilar insulin to enhance blood glucose control in patients with diabetes. Merilog, given as a shot, reduces blood sugar spikes at mealtime.

Browse the full report description of “Diabetes Market Size, Share & Trends Analysis Report by Type (Type 1 Diabetes, Type 2 Diabetes, and Gestational), by Drug Class (Alpha-Glucosidase Inhibitors, Amylin Analogs, Antidiabetic Combinations, Dipeptidyl Peptidase 4 Inhibitors, Incretin Mimetics, Insulin, Meglitinides, Non-Sulfonylureas, Sglt-2 Inhibitors, Sulfonylureas, and Thiazolidinedione), and by Devices (Blood Glucose Meters, Blood Glucose Strips, Insulin Injection Pens, Insulin Syringes, Continuous Glucose Monitoring Systems, Insulin Pumps, and Lancets), Forecast Period (2025-2035)” at https://www.omrglobal.com/industry-reports/diabetes-market

Key FDA Approvals Driving Diabetes Market Growth

  • In March 2025, the FDA approved Merilog, a fast-acting insulin biosimilar, as adjunct therapy for the treatment of diabetes in adults and pediatrics. Subcutaneous Merilog given five to 10 minutes before eating enhances glycemic control. It is available in a prefilled pen and multiple-dose vial. Side effects include hypoglycemia, allergic reaction, and cutaneous irritation.
  • In February 2025, the FDA approved Merilog, a fast-acting insulin biosimilar, for the treatment of diabetes in adults and pediatrics. Merilog reduces mealtime blood sugar surges and enhances glycemic control. The approval is for both a 3mL single-patient-use pen and a 10mL multiple-dose vial. This is the third insulin biosimilar product the FDA has approved.
  • In December 2024, the FDA approved the first generic of Victoza, a daily GLP-1 injection, to improve glycemic control in type 2 diabetes patients. The FDA prioritizes assessing generic drug applications to enhance patient access.
  • In September 2024, the FDA approved the Insulet SmartAdjust, the first automated insulin device for type 2 diabetes, which works with an automated pump and glucose sensor previously authorized for type 1 diabetes.
  • In June 2023, the FDA approved Lantidra, the first allogeneic pancreatic islet cellular therapy for treating type 1 diabetes in adults. Lantidra uses infused islet beta cells to secrete insulin, administered as a single infusion into the liver portal vein. Two studies were carried out to assess the safety and effectiveness.

Market Coverage

  • The market number available for – 2024-2035
  • Base year- 2024
  • Forecast period- 2025-2035
  • Segment Covered-
    • By Type
    • By Drug Class
    • By Devices

Regions Covered-

  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World
  • Competitive Landscape - Abbott Laboratories, Dexcom, Inc., Eli Lilly and Co., Medtronic MiniMed, Inc., Novo Nordisk A/S, and others.

Key questions addressed by the report.

  • What is the market growth rate?
  • Which segment and region dominate the market in the base year?
  • Which segment and region will project the fastest growth in the market?
  • Who is the leader in the market?
  • How are players addressing challenges to sustain growth?
  • Where is the investment opportunity?

Global Diabetes Market Report Segment

By Type

  • Type 1 Diabetes
  • Type 2 Diabetes
  • Gestational

By Drug Class

  • Alpha-Glucosidase Inhibitors
  • Amylin Analogs
  • Antidiabetic Combinations
  • Dipeptidyl Peptidase 4 Inhibitors
  • Incretin Mimetics
  • Insulin
  • Meglitinides
  • Non-Sulfonylureas
  • Sglt-2 Inhibitors
  • Sulfonylureas
  • Thiazolidinedione

By Devices

  • Blood Glucose Meters
  • Blood Glucose Strips
  • Insulin Injection Pens
  • Insulin Syringes
  • Continuous Glucose Monitoring Systems
  • Insulin Pumps
  • Lancets

Global Diabetes Market Report Segment by Region

North America

  • United States
  • Canada

Europe

  • UK
  • Germany
  • Italy
  • Spain
  • France
  • Russia
  • Rest of Europe

Asia-Pacific

  • China
  • India
  • Japan
  • South Korea
  • Australia and New Zealand
  • ASEAN Economies
  • Rest of Asia-Pacific

Rest of the World

  • Latin America
  • Middle East & Africa

 

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