Gestational Diabetes - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• Gestational diabetes is initially managed through non-pharmacologic methods such as dietary changes, exercise, and monitoring glucose levels. The American Diabetes Association (ADA) advises personalized nutritional counseling by a registered dietitian, tailored to the patient's BMI.
• Women with gestational diabetes have an increased 35 to 60% risk of developing diabetes mellitus over 10 to 20 years after pregnancy.
• The first line of treatment for gestational diabetes is insulin. The therapy with insulin has been considered the standard therapy for gestational diabetes management when adequate glucose levels are unachievable with diet and exercise.
• The oral hypoglycemic agents, metformin and glyburide, are increasingly being used among women with gestational diabetes, despite the lack of FDA approval.
• HUMALOG (lispro) and NOVOLOG (aspart) are approved treatments for diabetes mellitus and are also used during pregnancy, where they have been associated with a lower risk of hypoglycemia.
• Along with medicines to lower blood sugar, people with diabetes often need medications to lower their blood pressure and statins to reduce the risk of complications.

DelveInsight's "Gestational Diabetes - Market Insight, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of gestational diabetes, historical and forecasted epidemiology as well as the gestational diabetes market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The gestational diabetes market report provides current treatment practices, emerging drugs, gestational diabetes share of individual therapies, and current and forecasted gestational diabetes market size from 2020 to 2034, segmented by seven major markets. The report also covers current gestational diabetes treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Gestational Diabetes Disease Understanding and Treatment Algorithm

Gestational Diabetes Overview

Gestational diabetes mellitus (GDM) is a condition where women without a previous diagnosis of diabetes exhibit abnormal blood glucose levels during pregnancy. In normal pregnancy pancreatic B-cell hyperplasia occurs from the stimulation of human placental lactogen and prolactin, resulting in higher insulin levels. The International Association of Diabetes and Pregnancy Study Groups (IADPSG) classify hyperglycemia first detected during pregnancy as either overt diabetes or GDM. In 2013, the World Health Organization (WHO) recommended that hyperglycemia first detected during pregnancy be classified as either diabetes mellitus in pregnancy or GDM. Gestational diabetes often has no symptoms, or they may be mild, such as being thirstier than normal or having to urinate more often. Gestational diabetes is sometimes related to the hormonal changes of pregnancy that make your body less able to use insulin. Genes and extra weight may also play a role.

Gestational Diabetes Diagnosis

Several laboratory and aneuploid screening studies are performed during the second trimester to provide optimal time for potential interventions. During the second trimester, GDM screening is recommended for all pregnant individuals between 24 and 28 weeks, as per American College of Obstetricians and Gynecologists (ACOG), the United States Preventive Services Task Force (USPSTF), and other professional bodies. Two main screening approaches are used: the 1-step method, endorsed by IADPSG and ADA, involves a 2-hour 75-g oral glucose tolerance test (OGTT) after fasting and allows for diagnosis in a single visit. The 2-step method, preferred by ACOG, begins with a nonfasting 1-hour 50-g glucose challenge test, followed by a 3-hour 100-g OGTT if the initial result is abnormal. The cut-off thresholds for the 50-g test vary, and diagnosis of GDM is confirmed if at least two values in the 3-hour test exceed set limits. While the 1-step method uses stricter criteria and may diagnose more women with milder hyperglycemia, both methods are considered acceptable, as studies show no significant differences in perinatal outcomes.

Gestational Diabetes Treatment

GDM management begins with non-pharmacologic strategies, including dietary modifications, increased physical activity, and regular glucose monitoring. Patients are advised to engage in at least 30 minutes of moderate-intensity aerobic exercise five days a week (or 150 minutes per week), with post-meal activity encouraged to improve glycemic control for up to three hours after eating. Nutritional counseling by a registered dietitian is also essential and should be tailored to the patient's BMI to ensure adequate nutrition while preventing excessive weight gain.

If lifestyle interventions fail to achieve glycemic targets, pharmacologic treatment is initiated. Insulin is the preferred first-line therapy, as it does not cross the placenta and is effective in controlling both fasting and postprandial glucose levels. Insulin regimens typically include a combination of basal insulin for fasting hyperglycemia and short-acting insulin for postprandial spikes. Initial dosing is calculated based on the patient's weight and gestational age, with subsequent adjustments guided by glucose log trends. Although oral agents such as metformin and glyburide are used in clinical practice, their use is considered off-label, and they may cross the placenta, raising concerns about fetal exposure. Therefore, insulin remains the standard and most reliable option for managing GDM when non-pharmacologic measures are insufficient.

Gestational Diabetes Epidemiology

The gestational diabetes epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the total prevalent cases of gestational diabetes, type-specific cases of gestational diabetes, age-specific cases of gestational diabetes, and total treated cases of gestational diabetes, in the 7MM market covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• Gestational diabetes affects around 2 to 10% of pregnancies in the US.
• The prevalence of pregnant women with diabetes (pre-gestational diabetes and gestational diabetes) was 8.2% and gestational diabetes 6.5%.
• Increases in gestational diabetes were seen in each maternal age group, and rates rose steadily with maternal age; in 2021, the rate for mothers aged >=40 years (15.6%) was nearly six times as high as the rate for mothers aged <20 years (2.7%).
• In Europe, gestational diabetes yielded a prevalence estimate of 5.4% in 2023, reflecting a moderate burden of the condition across the region.

Gestational Diabetes Drug Chapters

The current key players for emerging drugs and their respective drug candidates include Mannkind [AFREZZA], and others. The drug chapter also helps understand the gestational diabetes clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details, and the latest news and press releases.

Emerging Drugs

AFREZZA (Inhaled Technosphere Insulin): Mannkind

AFREZZA is a man-made insulin that is breathed-in through your lungs (inhaled) and is used to control high blood sugar in adults with diabetes mellitus. It is currently being developed in the Phase II/III in women with gestational diabetes.

In its recent corporate presentation, the company mentioned that Investigator initiated trial launched in Q2 2025 for gestational diabetes.

Drug Class Insight

Insulin lowers blood glucose levels in adult patients with diabetes mellitus by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in adipocytes, inhibits proteolysis, and enhances protein synthesis.

Gestational Diabetes Market Outlook

The treatment landscape for GDM primarily revolves around non-pharmacologic interventions such as lifestyle modifications, dietary management, glucose monitoring, and pharmacologic therapies when glycemic control is inadequate. While insulin remains the gold-standard pharmacologic treatment due to its efficacy and safety profile during pregnancy, the development pipeline for novel GDM-specific drugs remains notably limited with AFREZZA being investigated in GDM. No new therapies have received FDA approval specifically for GDM in recent years, and most investigational efforts have focused more broadly on diabetes or maternal health rather than GDM exclusively.

In clinical practice, off-label use of oral antidiabetic agents such as metformin and glyburide remains common, despite their lack of formal approval for GDM. Metformin is often favored for its ease of use and favorable maternal weight outcomes, though it crosses the placenta and its long-term effects on offspring remain under study. Glyburide, though also widely used, has been associated with a higher risk of neonatal hypoglycemia and macrosomia compared to insulin. Nevertheless, many physicians continue to prescribe these agents in cases where insulin therapy is not feasible or is poorly tolerated by the patient.

Overall, the pharmaceutical pipeline for GDM remains scarce, with limited innovation beyond repurposing existing diabetes therapies. Most treatment advances have occurred in the realm of care delivery-such as digital glucose monitoring tools and individualized nutrition counseling-rather than novel pharmacologic agents. As GDM prevalence continues to rise globally, particularly in high-burden regions like the United States, there is a clear need for targeted research and drug development that addresses both maternal and fetal outcomes more effectively.

Gestational Diabetes Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034.

Gestational Diabetes Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I/II stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for gestational diabetes emerging therapies.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, Professor and Vice Chair of the Department of Rheumatology and Director, PhD, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or gestational diabetes market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Delveinsight's analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the Washington University School of Medicine, University Medical Center Hamburg-Eppendorf, and University Graduate School of Medicine etc. were contacted. Their opinion helps understand and validate gestational diabetes epidemiology and market trends.

Qualitative Analysis

We perform qualitative and market intelligence analysis using various approaches, such as SWOT and conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.

In efficacy, the trial's primary and secondary outcome measures are evaluated.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and a payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a descriptive overview of gestational diabetes, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into gestational diabetes epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for gestational diabetes is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the gestational diabetes market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM gestational diabetes market.

Gestational Diabetes Report Insights

Gestational Diabetes Report Insights

• Patient Population
• Therapeutic Approaches
• Gestational Diabetes Pipeline Analysis
• Gestational Diabetes Market Size and Trends
• Market Opportunities
• Impact of Upcoming Therapies

Gestational Diabetes Report Key Strengths

• Ten Years Forecast
• 7MM Coverage
• Gestational Diabetes Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake and Key Market Forecast Assumptions

Gestational Diabetes Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

• What was the gestational diabetes market share (%) distribution in 2024 and what it would look like in 2034?
• What would be the gestational diabetes total market size as well as market size by therapies across the 7MM during the study period (2020-2034)?
• What are the key findings about the market across the 7MM and which country will have the largest gestational diabetes market size during the study period (2020-2034)?
• At what CAGR, the gestational diabetes market is expected to grow at the 7MM level during the study period (2020-2034)?
• What are the disease risks, burdens, and unmet needs of gestational diabetes?
• What is the historical gestational diabetes patient pool in the United States, EU4 (Germany, France, Italy, and Spain), and the UK, and Japan?
• What would be the forecasted patient pool of gestational diabetes at the 7MM level?
• What will be the growth opportunities across the 7MM concerning the patient population of gestational diabetes?
• Amon the 7MM which country would have the most prevalent cases of gestational diabetes during the study period (2020-2034)?
• At what CAGR the population is expected to grow across the 7MM during the study period (2020-2034)?
• How many companies are developing therapies for the treatment of gestational diabetes?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of gestational diabetes?
• What are the key collaborations (industry-industry, industry-academia), Mergers and acquisitions, and licensing activities related to gestational diabetes therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What are the clinical studies going on for gestational diabetes and their status?
• What are the key designations that have been granted for the emerging therapies for gestational diabetes?
• What are the 7MM historical and forecasted market of gestational diabetes?

Reasons to buy:

• The report will help in developing business strategies by understanding trends shaping and driving the gestational diabetes market.
• To understand the future market competition in the gestational diabetes market and insightful review of the SWOT analysis of gestational diabetes.
• Organize sales and marketing efforts by identifying the best opportunities for gestational diabetes in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• To understand the future market competition in the gestational diabetes.