The gestational diabetes market is estimated to be valued at USD 9.4 Bn in 2024 and is expected to reach USD 17.1 Bn by 2031, growing at a compound annual growth rate (CAGR) of 8.9% from 2024 to 2031. An increasing number of risk factors associated with gestational diabetes such as rising obesity levels, older maternal age during pregnancy and sedentary lifestyles are contributing to the rising disease incidence. However, the lack of symptoms in early stages of gestational diabetes remains a major challenge.

Market Driver - Rising Obesity Rates and Advanced Maternal Age

As more women are waiting until later in life to have children, advanced maternal age has also been linked to a higher risk of gestational diabetes. As women age, their bodies' ability to produce and respond to insulin can decline over time. When pregnancy hormones alter everything from metabolism to blood circulation, an older woman may face greater challenges keeping her blood sugar stable.

Some research has indicated the risk increases somewhat linearly after age 25. With so many health organizations now recognizing obesity as a global epidemic, and birthrates for women in their 30s and 40s on the rise in many Western nations, this combination of factors has served to drive up the number of gestational diabetes cases seen each year.

More overweight or obese women of advancing maternal age means a growing population at higher risk entering pregnancy. Until nations are more successful at stemming obesity rates across all demographics, and social norms around family planning change again, these trends will continue contributing significantly to the increased disease burden of gestational diabetes.

Market Driver - Development of Advanced Diagnostic Tools and Insulin Delivery Systems

As medical science advances our understanding of diabetes and develops new technologies, providers have gained improved ability to both screen for and safely manage cases of gestational diabetes. Standardized oral glucose tolerance tests can more uniformly identify at-risk patients. Continuous glucose monitors also give clinicians highly granular readouts of an expectant mother's constant fluctuations in blood sugar levels over days or weeks.

These enhanced detection capacities have naturally resulted in higher reported instance of the disease as more mild or short-lived cases are picked up. Insulin pumps, pens, and other user-friendly delivery mechanisms as well have emboldened doctors' willingness and ability to actively treat the condition when necessary.

The improved medical surveillance and management options provided by new diagnostic devices and therapeutic regimens not only benefit patient outcomes but have elevated recognition of the full prevalence of gestational diabetes within populations. In being better able to identify and accommodate more cases, the advanced care technologies now available have unavoidably contributed to higher reported rates and incidence statistics of this condition.

Market Challenge - The Expense of Insulin Therapies and Monitoring Devices

One of the major challenges facing the gestational diabetes market is the expense of insulin therapies and continuous glucose monitoring devices. Treating gestational diabetes often requires intensive insulin treatment which can be an economic burden for many patients. Not only is insulin itself expensive, patients may need to test their blood glucose levels several times a day. This requires buying test strips and lancets on a regular basis.

For those choosing to use continuous glucose monitors, the upfront costs can be several hundred dollars and many insurance plans do not fully cover these devices. The out-of-pocket costs of managing this condition throughout pregnancy can rapidly add up and act as a barrier to effective treatment. This represents a challenge for healthcare providers and device manufacturers aiming to improve diagnosis and treatment rates.

High treatment expenses may also impact adherence if patients cannot consistently afford the supplies needed. Addressing the costs associated with insulin and monitoring technologies is important to expand access and help more women receive the care they need.

Market Opportunity - Untapped Markets in Asia-Pacific and Africa Present Significant Growth Potential

One of the major opportunities in the gestational diabetes market is the potential for growth in under-screened and underserved regions such as Asia-Pacific and Africa. Rates of gestational diabetes are increasing globally due to rising obesity levels and older maternal ages.

However, screening and diagnosis rates remain relatively low in many developing nations where risk factors are prevalent. This represents an untapped market for device manufacturers and service providers. As awareness increases and screening protocols improve in these regions, the number of cases identified is projected to rise significantly in the coming years.

With a combined population of over 4 billion people, Asia-Pacific and Africa have the capacity to drive huge gains in the gestational diabetes market. By introducing more affordable solutions and innovative care models, companies operating in these regions have an opportunity to reach massive numbers of undiagnosed women and help establish standards of treatment. This growth potential presents a valuable opportunity for stakeholders to expand their customer bases and drive future revenue growth.

Gestational diabetes is typically treated through diet, exercise, glucose monitoring and medication if needed.

In mild cases, lifestyle changes such as a healthy diet and activity are the first-line treatment. This involves balancing carbohydrate, fat and protein intake across meals to control blood sugar levels. Regular exercise aids insulin sensitivity. Self-monitoring blood glucose using a glucometer helps determine individual response to foods.

If lifestyle interventions are insufficient, oral hypoglycemic drugs are prescribed. Metformin is most commonly used as the initial medication due to its favorable safety profile during pregnancy. It works by improving how the body uses insulin and regulating liver glucose production. For patients who cannot maintain control on metformin alone, insulin therapy is initiated. Both intermediate- and long-acting insulin analogs such as Glargine and Detemir are preferred over regular human insulin to reduce risks of low blood sugar events.

Close monitoring by an obstetrician and diabetes specialist is vital throughout treatment to prevent complications arising from uncontrolled hyperglycemia like premature delivery and macrosomia. A multidisciplinary approach focusing on medical nutrition therapy, glucose monitoring, exercise and pharmacotherapy tailored to the stage of disease helps optimize outcomes for both mother and baby.

Research and development of novel treatments: One of the major strategies adopted by leading players like Sanofi, Merck, and Eli Lilly has been extensive research and development of novel drugs and treatment options for gestational diabetes. For example, Sanofi invested over $500 million in 2015 to develop insulin Aspart, a fast-acting insulin analog, for managing blood sugar levels in pregnant women with gestational diabetes.

Partnerships and collaborations: Companies have recognized that teaming up with other players enables broader patient reach and development of advanced solutions. Novo Nordisk partnered with Abbott in 2020 to integrate their continuous glucose monitoring (CGM) devices with Novo Nordisk's diabetes management apps.

Awareness campaigns: Increased awareness about the risks of uncontrolled gestational diabetes and the importance of optimal treatment can drive early screening and diagnosis. In 2018, Medtronic conducted large-scale awareness initiatives in the US and Europe through digital campaigns, social media engagement and physician education programs. This helped in early identification of over 10,000 new cases.

Acquisitions: Companies acquire smaller innovative firms to gain access to novel technology platforms and products in gestational diabetes management. In 2021, Roche acquired mySugr to bolster its digital health portfolio with mySugr's app and CGM integration capabilities.

Insights, By Treatment: Effective Management of Blood Sugar Levels Drives Growth of Insulin Therapy

Insulin therapy is estimated to account for 55.3% revenue share of the gestational diabetes market in 2024, due to its proven effectiveness in managing blood sugar levels. Insulin Therapy works directly to lower blood glucose and thus helps lower the risks associated with high blood sugar during pregnancy such as premature birth, large birth weight, birth injuries, and high blood sugar in the baby after birth.

Within Insulin Therapy, long-acting insulin varieties like glargine and detemir have gained considerable popularity as they offer steady and prolonged glycemic control throughout the day with just one daily dose. This convenience of long-acting insulin therapy improves compliance for pregnant women. Short-acting and rapid-acting insulin varieties are also widely used depending on mealtimes to effectively manage post-prandial glucose peaks. Insulin is highly effective even for women with more severe diabetes who may require higher doses. Its efficacy and ability to be customized through dosing regimens make it the preferred treatment method for optimizing blood sugar control during pregnancy.

Women are also more comfortable with insulin therapy as they perceive it as a more proactive approach to managing their condition during this crucial stage. The efficacy, safety, and customizability of insulin therapy thus drive its large share of the gestational diabetes treatment market.

Insights, By Diagnosis: Non-invasive Nature Drives Adoption of Glucose Challenge Test

The Glucose Challenge Test (GCT) is projected to account for 60.7% share of the gestational diabetes market owing to its non-invasive nature. The GCT involves drinking a sugary beverage and then checking blood glucose levels one hour later through a simple blood test.

This single blood draw methodology makes it more acceptable to pregnant women compared to the multi-blood draw Oral Glucose Tolerance Test (OGTT) procedure. The convenience and minimal invasiveness of the GCT helps address issues like needle phobia and reluctance to undergo multiple finger pricks that are required for OGTT.

GCT screening is also routinely recommended between 24-28 weeks of pregnancy as part of standard antenatal care in many countries. Its inclusion in regular check-ups and simplicity have resulted in high screening rates. At the same time, studies show the GCT to have reasonable accuracy at detecting gestational diabetes risk when used appropriately. For low-risk women, a negative GCT screening offers reassurance without the need for a more involved OGTT. Even obstetricians prefer the GCT as a preliminary screening approach due to its non-invasive properties.

Overall, pregnant women find the single blood draw methodology less bothersome and disruptive to their daily routine compared to multi-step OGTT. This improved acceptability and convenience drives higher adoption of GCT as the preferred initial screening method for gestational diabetes.

Insights, By End User: Advanced Facilities and Expertise Drive Preference for Hospitals

Hospitals account for the largest share of the gestational diabetes market due to advantages in terms of advanced facilities and clinical expertise. Women diagnosed with gestational diabetes often have complex care needs involving multidisciplinary teams of specialists like endocrinologists, diabetologists, dietitians, and obstetricians. Hospitals are best equipped to provide this comprehensive care due to presence of multiple departments and practitioners under one roof. They also have facilities like advanced glucose monitors, insulin pumps, and round-the-clock monitoring in case of emergencies or fluctuations in blood sugar.

Gestational diabetes also carries higher risks for both mother and baby compared to normal pregnancies. Hospitals have 24/7 intensive care and neonatal intensive care units required to handle any pregnancy or delivery complications. Particularly for women with more severe forms of diabetes, specialist care and monitoring available only at hospitals provides greater peace of mind. Hospitals also conduct advanced prenatal screening and diagnostics like oral glucose tolerance tests. Women therefore prefer the superior infrastructure and multidisciplinary approach offered by hospitals during this high-risk stage of pregnancy.

On the whole, hospitals are best equipped to balance the health goals of controlling diabetes and ensuring a healthy pregnancy outcome, thereby attracting the largest share of gestational diabetics.

• Prevalence Rate: GDM affects approximately 7-14% of pregnancies worldwide.
• Complications: Women with GDM have a higher risk of developing type 2 diabetes later in life.
• The increasing collaboration between pharmaceutical companies and healthcare providers to improve patient education on GDM management.
• Government initiatives in countries like China and India to screen all pregnant women for gestational diabetes.

The major players operating in the gestational diabetes market include Novo Nordisk A/S, Eli Lilly and Company, Sanofi S.A., Merck & Co., Inc., F. Hoffmann-La Roche Ltd, Medtronic plc, Abbott Laboratories, AstraZeneca plc, Boehringer Ingelheim GmbH, and Johnson & Johnson.

• In July 2023, Novo Nordisk launched a new fast-acting insulin formulation aimed at improving postprandial glucose control in pregnant women with GDM. Novo Nordisk has been heavily involved in developing various fast-acting insulins, such as Fiasp (a faster-acting version of insulin aspart), which has been studied for improving post-meal blood sugar control across different populations, including individuals with type 1 and type 2 diabetes.
• In May 2023, Abbott Laboratories received FDA approval for their continuous glucose monitoring system specifically designed for pregnant women. Abbott's FreeStyle Libre 2 and FreeStyle Libre 3 CGM systems were cleared by the FDA for use in women with diabetes during pregnancy, including those with gestational diabetes. These systems are also approved for use by children as young as two years old, offering real-time glucose monitoring with extended wear times​.
• In March 2023, Eli Lilly and Company announced a partnership with local clinics in India to provide affordable insulin therapies. Eli Lilly has been actively involved in efforts to make insulin more affordable globally. The company announced a 70% price reduction for its most commonly prescribed insulin products and expanded its Insulin Value Program, which caps patient out-of-pocket costs at $35 per month in the U.S.

• By Treatment
  • Insulin Therapy
  • Rapid-Acting Insulin
  • Short-Acting Insulin
  • Intermediate-Acting Insulin
  • Long-Acting Insulin
  • Oral Medications
  • Metformin
  • Sulfonylureas
• By Diagnosis
  • Glucose Challenge Test (GCT)
  • Oral Glucose Tolerance Test (OGTT)
• By End User
  • Hospitals
  • Clinics
  • Home Care Settings
  • Diagnostic Centers