Acute Myocardial Infarction - Market Insights, Epidemiology and Market Forecast - 2034

Key Highlights

• The market size of AMI in the 7MM is estimated to be around USD 1.60 billion in 2023 and is expected to increase with a significant CAGR during the forecast period.
• Among the 7MM countries, the United States is expected to account for the largest market size of AMI among the 7MM countries. Accounting for approximately 75% of the overall market in 2023.
• The increasing use of cardiac biomarkers for diagnosing AMI during the past two decades and the changing cutoff levels for the laboratory tests used to define myocardial injury or AMI are the most apparent complicating factors in many studies of AMI trends.
• The use of biomarkers has likely improved the ascertainment of myocardial infarction over time, which would have the dual effects of potentially masking actual reductions in disease incidence because of primary prevention efforts and leading to false improvements in myocardial infarction-related case fatality attributable to the inclusion of smaller infarctions that previously would have been clinically unrecognized.
• The total incident cases of AMI in the 7MM were ~1,468,400 in 2023 out of which the highest incident cases of this disease were in the United States.
• With the approval of AGEPHA Pharma's LODOCO, patients with residual inflammatory risk now have, for the first time, an FDA-approved treatment option specifically designed to reduce the risk of cardiovascular disease. LODOCO works by targeting inflammatory pathways that contribute to major cardiac events.
• Zalunfiban and selatogrel represent an exciting new generation of platelet antagonists that may be administered easily via subcutaneous injection at first medical contact in patients with STEMI.
• The dynamics of AMI market are anticipated to change in the coming years owing to the improvement in the diagnosis methodologies, raising awareness of the disease, incremental healthcare spending across the world. Key players such as Idorsia Pharmaceuticals and Viatris (Selatogrel), Recardio (dutogliptin), Amgen (Olpasiran), Faraday Pharmaceuticals (FDY-5301), Novo Nordisk (Ziltivekimab), Bristol Myers Squibb and Johnson & Johnson Innovative Medicine (Milvexian), CeleCor Therapeutics (Zalunfiban), Kancera (KAND567), CellProthera and BioCardia (ProtheraCytes), and others are evaluating their lead candidates in different stages of clinical development, respectively and will significantly impact the AMI market during the forecast period (2024-2034).
• Among the total AMI incident cases, NSTEMI type were estimated to be more than STEMI type, with NSTEMI accounting for approximately 607,300 cases in the United States in 2023.

Report Summary

• The detailed report provides significant knowledge about epidemiological segments, including the historical and forecasted patient pool data, thus providing a thorough picture of anticipated future development in incident pool and treatment guidelines. It gives deep insights into various areas, allowing for a complete examination of the subject.
• The report also includes an all-inclusive account of current management techniques and emerging therapies and elaborative profiles of late-stage (Phase III, Phase IIa, and Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift. The therapy profiles include a detailed assessment of the current and emerging therapies, information regarding the approval-based and ongoing trials, and a thorough drug description.
• The report also encompasses a comprehensive analysis of the AMI market, providing an in-depth examination of its historical and projected market size (2020-2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
• The report includes qualitative as well as quantitative insights that provide an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, which gives an overview of the patient landscape commencing from detection of the disease to treatment being administered to the patients, with the treatment preferences that help shape and drive the 7MM AMI market.

Market

Various key players are currently investigating their drugs for AMI, such as Idorsia Pharmaceuticals, Viatris, AstraZeneca, Boehringer Ingelheim and Eli Lilly and Company, Amgen and Arrowhead Pharmaceuticals, Idorsia Pharmaceuticals, Faraday Pharmaceuticals, Novo Nordisk, Bristol Myers Squibb and Johnson & Johnson Innovative Medicine, Recardio, CeleCor Therapeutics, Kancera, CellProthera and BioCardia, Mesoblast, Boehringer Ingelheim, and others. The details of the country and therapy-wise market size have been provided below.

• In the 7MM region, the United States captured the largest market size in 2023.
• Among the 7MM countries, Spain accounted for the smallest market size in 2023, ~USD 25 million.
• Among the emerging therapies that are estimated to be launched in our forecast period, Ziltivekimab is estimated to have the highest revenue by 2034.

AMI Drug Chapters

The AMI report’s drugs section includes an in-depth examination of marketed drugs and late-stage pipeline therapeutics (Phase III, Phase IIa, and Phase II) for AMI.

The drug chapters section contains useful information on various aspects of AMI clinical trials, including specific details such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. It also includes the most recent news updates and press releases on drugs that treat AMI.

Marketed Therapies

LODOCO (colchicine): AGEPHA Pharma

Colchicine - an anti-inflammatory alkaloid - has assumed an important role in the management of cardiovascular inflammation after its first medicinal use in ancient Egypt. Primarily used in high doses for the treatment of acute gout flares during the 20th century, research in the early 21st century demonstrated that low-dose colchicine effectively treats acute gout attacks, lowers the risk of recurrent pericarditis, and can add to secondary prevention of major adverse cardiovascular events. As the first FDA-approved targeted anti-inflammatory cardiovascular therapy, colchicine currently has a unique role in the management of atherosclerotic cardiovascular disease.

In June 2023, the US FDA approved LODOCO as the first anti-inflammatory atheroprotective cardiovascular treatment demonstrated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

TNKase (tenecteplase): Genentech

TNKase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using an established mammalian cell line. Tenecteplase is a variant of the native tissue-type plasminogen activator (tPA) molecule with 14-fold greater fibrin specificity than alteplase, a longer half-life, slower plasma clearance, and 80-fold greater resistance to inhibition by plasminogen activator inhibitor type 1. Its half-life of ~18 min allows single-bolus administration.

In June 2000, the US FDA approved TNKase to reduce mortality associated with AMI.

Emerging Therapies

Dutogliptin: Recardio

Dutogliptin (REC-01), developed by Recardio, is a potent and selective DPP4 inhibitor. Dutogliptin is administered via SC injection; the protein belongs to the class of enzyme inhibitors called gliptins or DPP-IV inhibitors. The combination of G-CSF with dutogliptin significantly enhanced survival and reduced infarct size in the preclinical model. Once the diagnosis of AMI is confirmed and percutaneous intervention and stent implantation are completed, the patient receives or can self-administer daily SC injection of dutogliptin for 2 weeks in co-administration with G-CSF for 5 days.

In March 2024, Recardio completed the first partnering agreements, closing with regional partners outside of its key territories US and Europe. The selected regional partners will be involved in the global pivotal Phase III study for Recardio’s lead therapeutic candidate, dutogliptin, which is being developed for the treatment of AMI.

Selatogrel: Idorsia Pharmaceuticals and Viatris

Selatogrel is a potent, highly selective, fast-acting, and reversible P2Y12 receptor antagonist being developed for treating AMI in patients at high risk of recurrent AMI. It is self-administered subcutaneously via a drug delivery device (autoinjector) upon the occurrence of symptoms suggestive of an AMI. In 2020, the FDA designated the investigation of Selatogrel for treating a suspected AMI in adult patients with a history of AMI as a fast-track development program.

In February 2024, Indorsia announced that the company has entered into agreements for a significant global research and development collaboration with Viatris for the global development and commercialization of two Phase III assets - selatogrel and cenerimod - for an upfront payment of USD 350 million, potential development and regulatory milestone payments, and certain contingent payments of additional sales milestone payments and tiered royalties from mid-single- to low double-digit percentage on annual net sales.

AMI Market Outlook

Acute Myocardial Infarction (AMI), commonly referred to as a heart attack, is a medical emergency that occurs when there is a sudden interruption in the blood supply to a portion of the heart muscle. This interruption is typically caused by a blockage in one of the coronary arteries, which are responsible for supplying oxygen and nutrients to the heart muscle

AMI carries a common manifestation of CVD in the elderly with an increased risk of mortality, morbidity, and excess costs. Currently, there are multiple effective management options following myocardial infarction, and guidelines recommend lifelong pharmaceutical prevention with beta-blockers, ACE inhibitors or angiotensin II receptor blockers, acetylsalicylic acid, and statins if not contraindicated.

The market size of AMI in the 7MM was estimated to be around USD 1.60 billion in 2023 and is expected to increase during the forecast period [2024-2034]. The United States is expected to account for the largest market size of AMI among the 7MM countries, during the study period [2020-2034]. Among the EU4 countries and the UK, Germany is expected to generate the largest revenue during the forecast period.

The current market has been segmented accordingly into different commonly used therapeutic classes based on the prevailing treatment pattern across the 7MM, which present itself with minor variations in the overall prescription pattern. Antiplatelet agents, Anticoagulants, Vasodilators, Beta Blockers, Lipid-lowering drugs, Angiotensin-converting Enzyme Inhibitors (ACE), Angiotensin-II receptor Blockers (ARBs), and Calcium channel blockers are the major classes that have been covered in the forecast model.

AMI Understanding and Treatment

AMI Overview

Acute myocardial infarction (AMI) is myocardial necrosis resulting from acute obstruction of a coronary artery. Symptoms include chest discomfort with or without dyspnea, nausea, and/or diaphoresis. Diagnosis is by electrocardiography (ECG) and the presence or absence of serologic markers. Treatment is antiplatelet drugs, anticoagulants, nitrates, beta-blockers, statins, and reperfusion therapy. For ST-segment-elevation myocardial infarction, emergency reperfusion is via fibrinolytic drugs, percutaneous intervention, or, occasionally, coronary artery bypass graft surgery. For non-ST-segment-elevation myocardial infarction, reperfusion is via percutaneous intervention or coronary artery bypass graft surgery.

AMI is one of the leading causes of death in the developed world. AMI can be divided into two categories, non-ST-segment elevation MI (NSTEMI) and ST-segment elevation MI (STEMI). Unstable angina is similar to NSTEMI. However, cardiac markers are not elevated.

AMI Diagnosis

The initial evaluation of a patient with a suspected AMI should include a focused clinical history, physical examination, electrocardiography, cardiac markers, and a chest radiograph. An ECG is especially useful for distinguishing between an NSTEMI and a STEMI. Serum biomarkers of myocardial necrosis include cardiac-specific troponins T and I, MB isoforms of creatine (CK-MB), creatine kinase (CK), and myoglobin. Myocardial injury is diagnosed as wall motion abnormalities on echocardiography. An echocardiogram, however, cannot distinguish between an acute STEMI from an old myocardial scar or severe acute ischemia, but ease and safety make it useful as a screening tool to aid management decisions. There are several other causes of chest pain that can masquerade as a myocardial infarction. Most notable include acute pericarditis, pulmonary embolism, acute aortic dissection, costochondritis, and gastroesophageal reflux disease.

AMI Treatment

The goals of initial treatment of an MI are relief of pain, immediate identification of ST changes via 12-lead EKG, initiation of reperfusion (if the patient is a candidate), and assessment and treatment of hemodynamic abnormalities. Pain relief is best achieved with oxygen, nitroglycerin, and morphine sulfate. Patients with ST-segment elevation or a new LBBB with symptoms for 12 h or less are candidates for reperfusion therapy. Further treatment of an MI may be separated into two pathways depending on whether or not the patient has a STEMI or an NSTEMI.

AMI Epidemiology

The AMI epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Incident Cases of AMI, Type-specific Incidence of AMI, and Gender-specific Incidence of AMI covering the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034

• The total incident cases of AMI in the United States is estimated to be ~822,800 in 2023. The cases are expected to increase by 2034.
• There were ~45,700 cases of STEMI and ~34,500 cases of NSTEMI in Japan in 2023.
• In EU4 and the UK, the incident cases of AMI were ~930,900 cases in males and ~537,500 cases in females in 2023.

KOL Views

In order to stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.

We have reached out to industry experts to gather insights on various aspects of AMI, including the evolving treatment landscape, patients’ reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.

Our team of analysts connected with more than 10 KOLs across the 7 Major Markets (7MM). We contacted institutions such as Stanford Medicine, University of Barcelona and others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the AMI market, which will assist our clients in analyzing the overall epidemiology and market scenario.

Qualitative Analysis

We conduct qualitative and market intelligence analysis employing various methods, including SWOT analysis and Conjoint Analysis. Strengths, weaknesses, opportunities, and threats in disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are described in the SWOT analysis. These recommendations are based on the Analyst’s evaluation of the patient burden, cost analysis, and the current and emerging therapy landscape. Conjoint Analysis compares the effectiveness and safety of numerous approved and emergent drugs depending on key criteria such as frequency of administration, designation, route of administration, and order of entry. To assess the success of therapy, several factors are evaluated.

Furthermore, the drug’s safety is analyzed, in which acceptability, tolerability, and adverse events are closely monitored, and it establishes a firm grasp of the side effects of the drugs used in the trials. Furthermore, for each therapy, the rating is based on the route of administration, sequence of entrance and designation, chance of success, and addressable patient pool. These characteristics determine the ultimate weightage score and ranking of developing therapeutics.

Market Access and Reimbursement

Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved 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.

AMI Insights

• Patient Population
• Therapeutic Approaches
• Market size of each therapy
• AMI Market Size and Trends
• Existing Market Opportunity

AMI Report Key Strengths

• Eleven-year Forecast
• The 7MM Coverage
• AMI Epidemiology Segmentation (Segmented by incident cases, type, and gender-specific Cases)
• Key Cross Competition evaluating the marketed as well as emerging therapies

AMI Report Assessment

• Current Treatment and Management Practices
• Unmet Needs
• Market Attractiveness
• Qualitative Analysis (SWOT, Conjoint Analysis)

Key Questions

• Would there be any changes observed in the current treatment approach?
• Will there be any improvements in AMI management recommendations?
• Would research and development advances pave the way for future tests and therapies for AMI?
• Would the innovations in diagnostic tests of AMI space experience a significant impact and lead to a positive shift in the treatment landscape of AMI?
• What kind of uptake will the new therapies witness in the coming years in AMI patients?