United States Cardiometabolic Fixed-dose Combinations Market Size
| Study Period | 2019 - 2029 |
| Base Year For Estimation | 2023 |
| Market Size (2024) | USD 4.64 Billion |
| Market Size (2029) | USD 5.83 Billion |
| CAGR (2024 - 2029) | 3.74 % |
| Market Concentration | High |
Major Players
*Disclaimer: Major Players sorted in no particular order |
United States Cardiometabolic Fixed-dose Combinations Market Analysis
The United States Cardiometabolic Fixed-dose Combinations Market size is estimated at USD 4.64 billion in 2024, and is expected to reach USD 5.83 billion by 2029, at a CAGR of 3.74% during the forecast period (2024-2029).
Cardiometabolic diseases, encompassing conditions such as hypertension, dyslipidemia, and diabetes, have become a major public health concern in the United States. As the prevalence of these conditions rises, there is an increasing demand for effective and convenient treatment solutions, such as FDCs, which combine multiple medications into a single pill. The growing incidence of these diseases is a significant driver for the United States cardiometabolic fixed-dose combinations (FDC) market.
For instance, according to a study published in the American Journal of Preventive Medicine in August 2024, a study conducted in 2023 highlighted that between a decade period till 2022, age-standardized diabetes prevalence in the United States increased from 10.2% to 12.1%. Similarly, according to a study published in the American Heart Association Journals in June 2024, projections indicate that the prevalence of hypertension and diabetes, major risk factors for cardiovascular disease, will continue to rise dramatically in the United States in the coming decades. By 2050, the prevalence of hypertension is forecasted to increase from 51.2% to 61.0% within a period of 30 years, while the prevalence of diabetes is projected to surge from 16.3% to 26.8% in the same period. Therefore, this rapid rise in cardiometabolic diseases is likely to drive the growth of demand for cardiometabolic fixed-dose combinations, which addresses multiple risk factors in the country.
In addition, a significant innovation is the development of the polypill. This fixed-dose combination (FDC) pill contains several active pharmaceutical ingredients, addressing key risk factors of cardiovascular disease (CVD) like hypertension, dyslipidemia, and diabetes. Therefore, such innovations are likely to propel the growth of the market in the country. For instance, according to a study published in Frontiers in Pharmacology in September 2023, polypills, as a part of innovative drug delivery systems, have been widely researched for both primary and secondary prevention of CVD and its risk factors. A typical polypill can include components like aspirin, statins (such as atorvastatin or simvastatin), and a combination of blood pressure-lowering drugs, including beta-blockers, angiotensin receptor blockers, calcium channel blockers, and diuretics. Therefore, innovations in drug formulation and delivery, such as the polypill, are likely to drive the rapid expansion of the United States cardiometabolic fixed-dose combinations market.
Moreover, the studied market is advancing due to ongoing approvals in drug formulation and delivery methods. For instance, in September 2022, Prinston Pharmaceutical Inc. launched Vyduo (Nebivolol and Valsartan) Tablets, a combination of two potent antihypertensive agents, nebivolol, a beta-blocker, and valsartan, an angiotensin II receptor blocker (ARB). Vyduo is designed to improve blood pressure control by targeting multiple mechanisms involved in hypertension, thereby offering enhanced efficacy over monotherapy treatments. The innovative formulation allows for improved patient outcomes because it helps reduce the need for multiple medications and simplifies daily regimens.
Thus, owing to the increasing prevalence of cardiometabolic diseases, continuous advancements and the development of novel combinations coupled with regulatory approvals, the studied market is posied witness growth over the forecast period. However, lack of investment in the promotion of cardiometabolic fixed-dose combinations (FDCs) coupled with regulatory and approval hurdles may hamper the market growth in the forecast period.
United States Cardiometabolic Fixed-dose Combinations Market Trends
Hypertension is Expected to Hold a Significant Market Share Over the Forecast Period
Hypertension is high blood pressure and a major risk factor for cardiovascular diseases, prompting healthcare providers to seek effective management strategies. Factors such as the growing burden of hypertension, increased efforts to develop promising fixed-dose combinations for hypertension, and increasing government initiatives to support research related to anti-hypertensive fixed-dose combination drugs are driving the segment's expansion over the forecast period. Moreover, several promising effects shown by fixed-dose combination (FDC) therapies for hypertension are further anticipated to propel the segment's growth in the coming years.
An increasing burden of hypertension and various risk factors contributing to a further surge in the disease burden is expected to facilitate the development of novel fixed-dose combination therapies, and this, in turn, is expected to facilitate market growth. For instance, according to an article published in the American Journal of Managed Care in March 2024, around 1 in 3 adults in the United States had hypertension in 2022, and an estimated 60% of diagnosed adults were using medication for their hypertension. Thus, such a high burden of hypertension in the United States is projected to fuel the demand for promising anti-hypertensive medicines, and this is expected to propel the development of new generation FDCs for managing hypertension.
Moreover, the promising effects shown by FDCs in lowering blood pressure and their significant efficacy in managing blood pressure have opened new business avenues for market players to formulate anti-hypertensive agents as fixed-dose combinations. For instance, according to an article published in Frontiers in Pharmacology in February 2024, the fixed-dose combination of perindopril and amlodipine had significant efficacy in reducing blood pressure as compared to monotherapy and placebo. In addition, the article also highlighted the safety profiles of perindopril and amlodipine FDC as compared to various pill therapies and the safety was significant in polypill form as compared to individual therapies. Therefore, it is likely that the promising nature of the FDCs in the treatment of hypertension projects the adoption rates of FDCs in the country. This is expected to fuel the growth of the segment.
Furthermore, good tolerability with triple pill fixed-dose combination as compared to individual therapies is further expected to bolster segment expansion over coming years. For instance, according to an article published in the Journal of the American College of Cardiology, a novel low-dose triple single-pill combination showed good tolerability and clinically relevant BP reductions compared with placebo. Therefore, it is quite likely that the adoption of the FDCs would rise due to the optimal tolerability associated with fixed-dose combinations for hypertension. This is anticipated to augment the growth of the segment in the coming years.
Therefore, owing to the above-mentioned factors, such as the growing burden of hypertension, increasing demand for innovative treatment options for hypertension, and growing interest in developing fixed-dose combinations (FDC) products, the growth of this segment is expected to propel over the forecast period.
Oral Tablets and Capsules Segment is Likely to Dominate Throughout the Forecast Period
The Oral Tablets and Capsules segment of the cardiometabolic fixed-dose combination (FDC) market is experiencing robust growth due to several key factors, including the convenience and ease of administration associated with oral formulations. These formulations also enhance patient adherence to treatment regimens, which is critical for managing chronic conditions such as hypertension and diabetes. In addition, the promising effects of fixed-dose combination tablets are further expected to drive segment uptake over the coming years. Moreover, a supportive regulatory framework and growing product approvals are further projected to spur segment uptake over the coming years.
Tablets and capsules are highly preferred formulation types owing to several benefits associated with them, such as ease of self-medication and high patient compliance. In addition, the clinical benefits linked with the fixed‐dose combination of tablets in the management of various cardiometabolic conditions are likely to expand their adoption rates in the country, thereby supporting segment expansion. For instance, according to an article published in the Journal of American Heart Association in April 2024, treatment with a fixed-dose combination tablet of atorvastatin and amlodipine lowered the risk of hypercholesterolemia and hypertension as compared to free combination or alone treatment with atorvastatin. Therefore, the improved clinical outcomes from fixed-dose combination tablets are projected to bolster segment uptake over the coming years.
In addition, increasing research efforts that demonstrate the potential of polypill in the treatment of cardiometabolic conditions are projected to foster segment uptake over the coming years. For instance, in March 2024, scientists from the Washington University School of Medicine found that fixed-dose combination polypills are beneficial in preventing risk factors associated with cardiometabolic conditions. Hence, such benefits associated with polypills are projected to bolster their adoption rates, thereby supporting segment growth.
Furthermore, a growing number of regulatory approvals are anticipated to offer new growth opportunities for the market. For instance, in November 2023, the United States Food and Drug Administration (FDA) granted approval for Zydus Lifesciences' new drug application for Zituvimet tablets, comprising sitagliptin and metformin hydrochloride in dosages of 50 mg/500 mg and 50 mg/1,000 mg, aimed at treating type 2 diabetes mellitus in adults. Therefore, such regulatory approvals are poised to drive segment growth over the forecast period.
Thus, the above-mentioned factors, such as growing preference for tablet-form fixed-dose combinations, promising results from tablet-based fixed-dose combinations, and a surge in regulatory approvals, are anticipated to accelerate the segment growth, thereby supporting market growth.
United States Cardiometabolic Fixed-dose Combinations Industry Overview
The United States cardiometabolic fixed-dose combinations market is consolidated due to the presence of some established market players operating globally and regionally. The competitive landscape includes an analysis of a few international players who hold significant market share and are well known, including Merck & Co., Inc., AstraZeneca, Pfizer Inc., Sanofi, and Novo Nordisk A/S., among others.
United States Cardiometabolic Fixed-dose Combinations Market Leaders
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Merck & Co., Inc.
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AstraZeneca
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Pfizer Inc.
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Novo Nordisk A/S
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Sanofi
*Disclaimer: Major Players sorted in no particular order
United States Cardiometabolic Fixed-dose Combinations Market News
- September 2024: Eli Lilly and Company published positive topline results from the QWINT-1 and QWINT-3, phase 3 clinical trials, which evaluated once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes who were either insulin-naïve or had switched from daily basal insulin injections.
- August 2024: NewAmsterdam Pharma initiated a phase III randomized trial in the United States to evaluate the efficacy, safety, and tolerability of the fixed-dose combination of obicetrapib 10 mg and ezetimibe 10 mg as an adjunct to diet and maximally tolerated lipid-lowering therapy. The study started in August 2024, and the results are expected by October 2024.
- March 2024: Empros Pharma initiated the dosing of the first subjects in its obesity fixed-dose combination therapy during a Phase III trial b in the United States.
United States Cardiometabolic Fixed-dose Combinations Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing Prevalence of Cardiometabolic Diseases Across the Country
4.2.2 Continuous Innovations in Drug Formulation and Delivery
4.3 Market Restraints
4.3.1 Regulatory and Approval Hurdles
4.3.2 Lack of Investment in the Promotion of Cardiometabolic Fixed-dose Combinations
4.4 Porter's Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD)
5.1 By Disease Type
5.1.1 Hypertension
5.1.2 Diabetes
5.1.3 Dyslipidemia
5.1.4 Others
5.2 By Formulation Type
5.2.1 Oral Tablets and Capsules
5.2.2 Injectable Combinations
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Pfizer Inc.
6.1.2 Sandoz AG
6.1.3 Sanofi
6.1.4 Merck & Co., Inc.
6.1.5 Novo Nordisk A/S
6.1.6 Boehringer Ingelheim International GmbH
6.1.7 Azurity Pharmaceuticals, Inc.
6.1.8 Rehab-Robotics Company Limited
6.1.9 AstraZeneca
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
United States Cardiometabolic Fixed-dose Combinations Industry Segmentation
As per the report’s scope, cardiometabolic fixed-dose combinations (FDCs) are pharmaceutical formulations that combine two or more active ingredients into a single dosage form.
The United States cardiometabolic fixed-dose combinations market is segmented into disease type and formulation type. By disease type, the market is segmented into hypertension, diabetes, dyslipidemia, and others. The other segments include conditions such as obesity and others. By formulation type, the market is segmented into oral tablets and capsules, and injectable combinations. For each segment, the market sizing and forecasts have been done on the basis of value (in USD).
| By Disease Type | |
| Hypertension | |
| Diabetes | |
| Dyslipidemia | |
| Others |
| By Formulation Type | |
| Oral Tablets and Capsules | |
| Injectable Combinations |
United States Cardiometabolic Fixed-dose Combinations Market Research FAQs
How big is the United States Cardiometabolic Fixed-Dose Combinations Market?
The United States Cardiometabolic Fixed-Dose Combinations Market size is expected to reach USD 4.64 billion in 2024 and grow at a CAGR of 3.74% to reach USD 5.83 billion by 2029.
What is the current United States Cardiometabolic Fixed-Dose Combinations Market size?
In 2024, the United States Cardiometabolic Fixed-Dose Combinations Market size is expected to reach USD 4.64 billion.
Who are the key players in United States Cardiometabolic Fixed-Dose Combinations Market?
Merck & Co., Inc., AstraZeneca, Pfizer Inc., Novo Nordisk A/S and Sanofi are the major companies operating in the United States Cardiometabolic Fixed-Dose Combinations Market.
What years does this United States Cardiometabolic Fixed-Dose Combinations Market cover, and what was the market size in 2023?
In 2023, the United States Cardiometabolic Fixed-Dose Combinations Market size was estimated at USD 4.47 billion. The report covers the United States Cardiometabolic Fixed-Dose Combinations Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the United States Cardiometabolic Fixed-Dose Combinations Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
United States Cardiometabolic Fixed-dose Combinations Industry Report
Statistics for the 2024 United States Cardiometabolic Fixed-Dose Combinations market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. United States Cardiometabolic Fixed-Dose Combinations analysis includes a market forecast outlook for 2024 to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.
