Prediabetes - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• Prediabetes is a significant but silent incubator of future morbidity. It affects over one-third of US adults and over one-fifth of adults in Europe, making it a widespread condition.
• There is a huge unmet need in the prediabetes market for approved therapies since its effective treatment and management can lead to prevention of diabetes. There are no US FDA approved drugs available for the treatment of prediabetes.
• At present there is no concrete evidence to formulate clinical guidelines for treatment of prediabetes. Lifestyle interventions remain an essential part of management of prediabetes. The use of pharmacotherapy should be on an individual case based approach. Drugs approved for the treatment of type 2 diabetes are used as off-label therapies for prediabetes.
• Companies like Novo Nordisk (semaglutide) and Aphaia Pharma (APH-012) are engaged in developing therapies for the treatment of prediabetes.
• Apart from the pharmacological therapy, nutraceutical approaches are also used for the treatment of prediabetes.
• The market is anticipated to be driven by the growing incidence of prediabetes in Europe, which is being caused by factors including the ageing population and rising obesity rates. The need for efficient prevention and treatment strategies is fuelled by the rising number of prediabetes diagnoses.
• The market for prediabetes is being revolutionized by the rapid expansion of technology, including wearables and digital health platforms.
• A multimodal approach should be used to manage prediabetes, involving dietary changes, physical activity, lifestyle modifications, psychological support, and, where necessary, medication.

DelveInsight's "Prediabetes - Market Insight, Epidemiology and Market Forecast - 2034" report delivers an in-depth analysis of Prediabetes epidemiology, market, and clinical development in Prediabetes. In addition to this, the report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the Prediabetes market trends in the United States, EU4 (Germany, France, Italy, and Spain ) and the United Kingdom, and Japan.

Prediabetes market report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted Prediabetes market size from 2020 to 2034 in 7MM. The report also covers current Prediabetes treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's underlying potential.

Geography Covered:

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

Prediabetes Understanding and Treatment Algorithm

Prediabetes Overview

Prediabetes is a widespread and often silent metabolic condition in which blood sugar levels are elevated above the normal range but not yet high enough for a type 2 diabetes diagnosis. Some lifestyle and genetic factor including obesity, family history of type 2 diabetes sedentary lifestyles, obesity, a family history of the disease, and other genetic and lifestyle variables. Since there are frequently no obvious symptoms, many people are unaware that they have it. Among the symptoms that could be present are increased hunger, weariness, impaired vision, and thirst. By leading a healthy lifestyle, you can avoid prediabetes and the development of type 2 diabetes.

Prediabetes Diagnosis

Most adults start having their diabetes screened at age 35, but if a patient is overweight or has other risk factors, doctors typically advise getting examined earlier. There are three types of testing: haemoglobin A1c, which has values between 5.7% and 6.4%; oral glucose tolerance test, which is less common than other tests, with the exception of pregnancy; and fasting plasma glucose (FPG), whose levels between 100 and 125 mg/dL indicate prediabetes. Since prediabetes frequently has no symptoms, early detection is essential. The diagnosis is typically confirmed by repeat testing on a different day.

Prediabetes Treatment

Changes to one's lifestyle can help prevent or postpone the development of type 2 diabetes. Eating a balanced diet low in added sugars and refined carbs, exercising, decreasing 5-7% of body weight, and consuming nutritious, high-fiber foods. By making these adjustments, the chance of getting diabetes can be decreased by over 50%. Although they have shown promise in clinical trials, newer drugs including as GLP-1 receptor agonists (e.g., tirzepatide, semaglutide) are not yet FDA-approved specifically for prediabetes.

Prediabetes Epidemiology

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

• Among the 7MM, the United States has captured the highest market share of Prediabetes in 2024.
• As per the secondary search, the adjusted prevalence of prediabetes is higher in males than females and in people with obesity.
• Around 98 million adults aged 18 years or older have prediabetes.
• Prediabetes progresses to T2D in approximately 30% of subjects within 3-5 years, and as many as 70% of individuals with prediabetes will develop overt diabetes within their lifetime.
• Prediabetes has a prevalence of 11% in England, 21% in Germany, 30% in France, according to the American Diabetes Association criteria. France has a prediabetes prevalence of around 10%, according to WHO criteria.
• Prediabetes can raise the risk of developing type 2 diabetes, therefore adopting lifestyle modifications can reduce the risk of developing type 2 diabetes by up to 50%.

Prediabetes Drug Chapters

The drug chapter segment of the Prediabetes report encloses a detailed analysis of Prediabetes emerging pipeline drugs. It also deep dives into Prediabetes's pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Emerging Drugs

Semaglutide: Novo Nordisk

Novo Nordisk is investigating semaglutide 2.4 mg subcutaneous injection in subjects with obesity and prediabetes. It is essentially a GLP-1 receptor agonist. Currently the drug is in Phase III trial.

• In May 2024, Novo Nordisk published results of Phase III trial (STEP 10) of semaglutide in subjects with obesity and prediabetes in which semaglutide 2.4 mg provided superior reduction in body weight and reversion to normoglycaemia vs. placebo, and improvements in cardiometabolic risk factors.

APH-012: Aphaia Pharma

APH-012 is being evaluated by Aphaia Pharma in a Phase II trial to evaluate its ability to improve glucose tolerance in participants with prediabetes with a pathological Oral Glucose Tolerance Test (OGTT) after 6 weeks of APH-012 administration.

• The ongoing Phase II trial of APH-012 for obesity is currently being conducted in the US and Germany. Based on the outcomes of these studies, the company will plan to expand clinical trials to evaluate the drug's effectiveness in patients with prediabetes type 2 diabetes across the seven major markets (7MM). At present, a trial involving prediabetes type 2 diabetes patients is already underway in Slovakia.
• In June 2024, Aphaia Pharma announced that the Phase II trial of APHD-012 for prediabetes achieved its primary endpoint, significantly improving glucose tolerance in 6 weeks with a positive safety profile.

The prevalence of prediabetes and unknown diabetes increases steadily with male sex, age, and body mass index.

Drug Class Insights

GLP-1 receptor agonist

GLP-1 receptor agonists are a class of medications that mimic the action of glucagon-like peptide-1 (GLP-1), an incretin hormone released from the gut in response to food. They enhance insulin secretion, suppress glucagon release, slow gastric emptying, and promote satiety, thereby improving blood glucose control and supporting weight loss. These drugs are widely used in type 2 diabetes and obesity treatment. Common GLP-1 receptor agonists include semaglutide (OZEMPIC, WEGOVY). They are typically administered via subcutaneous injection (weekly or daily), although oral semaglutide is also available. According to clinical research, GLP-1 agonists can dramatically reduce fasting glucose and HbA1c in prediabetic people, which may postpone or even stop the onset of Type 2 diabetes. But the common side effects associated with the GLP-1 receptor agonists include nausea, vomiting, diarrhea, and sometimes pancreatitis or gallbladder issues.

Prediabetes Market Outlook

Apart from proper lifestyle management, prediabetic patients need to opt for several pharmacological interventions, i.e., an alternative approach, enhancing insulin impact, and limiting Impaired Glucose Tolerance (IGT) that will eventually obstruct the progression toward T2D.

Metformin is an antihyperglycemic agent, which improves glucose tolerance in patients who are having prediabetes or T2D by lowering both basal and postprandial plasma glucose. It can be prescribed off-label. Metformin decreases hepatic glucose production, intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Another class of drugs used for the treatment includes GLP-1 analogues that are consumed orally and provide two- to three-fold greater plasma insulin response compared to the same level of hyperglycemia enhanced by intravenous glucose.

The next class of medication includes DPP-IV inhibitors, i.e., vildagliptin that works by binding covalently to the catalytic site of DPP-4, eliciting prolonged enzyme inhibition. Lastly, alpha-glucosidase inhibitors, sometimes referred to as starch blockers, are antidiabetic medicines that help to reduce postmeal blood-glucose levels.

The pipeline of prediabetes is not so robust and lacks essential key players. Some of the emerging therapies include semaglutide (Novo Nordisk), APH-012 (Aphaia Pharma), and others.

Prediabetes drug uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034, which depends on the competitive landscape, safety, and efficacy data, along with the order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Prediabetes Pipeline Development Activities

The report provides insights into different therapeutic candidates in the emerging stages. It also analyses key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Prediabetes therapies.

KOL Views

To keep up with the real-world scenario in emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Professors, and Others.

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as University of Bari, Virginia Mason Medical Center, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or prediabetes market trends.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

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. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

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 segment of key events, an executive summary, a descriptive overview of prediabetes, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the prediabetes market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM Prediabetes market.

Prediabetes Report Insights

• Patient Population
• Therapeutic Approaches
• Prediabetes Pipeline Analysis
• Prediabetes Market Size and Trends
• Existing and Future Market Opportunity

Prediabetes Report Key Strengths

• Ten-Year Forecast
• 7MM Coverage
• Prediabetes Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Prediabetes Report Assessment

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

FAQs:

• What was the prediabetes total market size, the market size by therapies, market share (%) distribution in 2024, and what would it look like in 2034? What are the contributing factors for this growth?
• At what CAGR, the prediabetes market is expected to grow at the 7MM level during the study period (2020-2034)?
• What will be the impact of the GLP-1 receptor agonist market in 2034?
• How will upcoming emerging therapies be going to impact current market share?
• What are the disease risks, burdens, and unmet needs of prediabetes?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to prediabetes?
• What is the historical and forecasted prediabetes patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• How emerging therapies are performing on parameters like efficacy, safety, route of administration (RoA), prediabetes treatment duration, and frequencies on the basis of their clinical trial results?
• Which key designations have been granted for the emerging therapies for prediabetes?
• What is the 7MM historical and forecasted market of prediabetes?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reason to Buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics and driving factors for the prediabetes market.
• Insights on patient share/disease burden, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying upcoming players in the market will help devise strategies to help get ahead of competitors.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand KOLs' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.