Japan Atherosclerosis Therapeutics Market Analysis

Japan Atherosclerosis Therapeutics Market Executive Summary

Japan Atherosclerosis Therapeutics Market was valued at $174 Mn in 2022 and is estimated to reach $282 Mn in 2030, exhibiting a CAGR of 6.2% during the forecast period.

Plaque, a sticky substance made of calcium, fat, cholesterol, and other ingredients, builds up inside the artery walls as a result of atherosclerosis. Because of this accumulation, there is a higher chance of developing severe conditions, including heart attacks and strokes, which constrict or clog blood vessels. Atherosclerosis can be caused by a variety of factors, such as high blood pressure, high cholesterol, diabetes, obesity, smoking, a family history of heart disease, inactivity, and an unhealthful diet. Several drugs, such as beta-blockers, aspirin, and statins, have shown potential for preventing or reducing the advancement of atherosclerosis.

In Japan, the estimated prevalence of high-risk atherosclerotic cardiovascular disease (ASCVD) is 1,869 per 100,000 people. This includes people who have had acute coronary syndrome, peripheral artery disease, cerebrovascular atherosclerotic disease, or coronary artery disease with diabetes in the past. Age-specific patterns are seen in atherosclerosis, with a U-shaped curve showing greater prevalence in both older and younger age groups. Traditional risk factors, like dyslipidemia and hypertension, are more common in those between the ages of 40 and 49 and 70 and 79. Gender differences show men have a higher prevalence, particularly at younger ages, but this gap narrows with age, and women may surpass men after menopause. Atherosclerosis risk is complex and has multiple contributing factors, including the Westernization of nutrition, physical inactivity, smoking, diabetes, and hereditary predisposition.

Recently, Daiichi Sankyo released positive results from the Phase 3 trials of Entresto (sacubitril/valsartan), proving the medication's effectiveness in lowering hospitalization and death rates for patients suffering from chronic heart failure with preserved ejection fraction (HFpEF). Due to the lack of effective treatment options, HFpEF, a disorder that is on the rise, has proven challenging to treat. Given the positive study results, Entresto's use may be expanded beyond its current prescription for heart failure with decreased ejection fraction (HFrEF).

Mitsubishi Tanabe Pharma has embarked on Phase 3 trials for MBP-8244, an investigational PCSK9 inhibitor. Its efficacy in lowering low-density lipoprotein (LDL) cholesterol levels in patients with familial hypercholesterolemia (FH) is the primary objective of these trials. Notably, this investigational drug targets individuals who do not adequately respond to statins or ezetimibe, addressing a crucial gap in treatment for this high-risk population.

Market Dynamics

Market Growth Drivers

Increased Prevalence of Risk Factors: Atherosclerosis is more likely to develop and progress in Japan due to the high prevalence of risk factors such as diabetes, smoking, sedentary lifestyles, and bad diets. The nation's smoking rate was 18% in 2022, with men making up 25.4% of the total and women making up 7.7%. This means that increased awareness and improved diagnosis of these risk factors will likely drive a rise in the demand for medications, which will drive the growth of the atherosclerosis drug treatment market. The demand for atherosclerosis drugs is expected to be driven by the high incidence of risk factors in Japan, as well as increased awareness and diagnosis. This indicates a strong growth trajectory for the market.

Aging Population: Japan is undergoing one of the fastest demographic changes in the world, with over 29% of its population over 65 in 2022; by 2060, that percentage is expected to reach 40%. The atherosclerosis drug treatment market in Japan is growing due to the increased susceptibility of this age group to atherosclerosis and its related conditions. As a result, there is a higher need for medications that address these disorders.

Advancements in Drug Development: Pharmaceutical companies' continued efforts to develop advanced and effective atherosclerosis drugs that target various pathways and offer customized treatment options may attract more patients and thus lead to market expansion in Japan's atherosclerosis drug treatment industry. This innovation-driven strategy will probably encourage market expansion by meeting a wider range of patient demands.

Market Restraints

Affordability: A large fraction of the population has barriers to accessibility because of the high cost of modern atherosclerosis treatment drugs, as well as expenses from imported medications due to import tariffs and exchange rate changes. Even with the growing availability of generic medications, there are still gaps in affordability that mostly affect people with low incomes and those living in remote regions. This affordability issue affects a significant portion of the population that has financial difficulties and impedes the wider acceptance and accessibility of atherosclerosis drug treatment in Japan.

Healthcare infrastructure limitations: Inequitable access to healthcare services, particularly in remote regions, may impede prompt identification and treatment of atherosclerosis. A lack of knowledge about risk factors and financial difficulties brought on by inadequate insurance coverage for chronic conditions like atherosclerosis might cause delays. These challenges in Japan's healthcare infrastructure impact patient awareness, accessibility, and financial support, posing obstacles to effective atherosclerosis management.

Compliance and Adherence Issues: The prolonged use of drugs in atherosclerosis treatment poses challenges such as adverse effects, forgetfulness, and low motivation for some patients. Managing numerous prescriptions for different medical conditions makes adherence problems worse, which could limit the commercial potential of atherosclerosis treatment options because of difficulties with patient compliance.

Healthcare Policies and Regulatory Landscape

The Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour, and Welfare (MHLW) are principally responsible for the administration of healthcare policies and regulatory monitoring of therapeutic pharmaceuticals in Japan. The PMDA works with the MHLW to develop and implement regulatory requirements while conducting a thorough assessment of the quality, safety, and efficacy of pharmaceuticals. Comprehensive clinical trials are a requirement of the drug approval process, and post-marketing surveillance guarantees continued safety monitoring. The national health insurance system's prescription price and reimbursement rules are significantly influenced by the MHLW. Japan prioritizes granting access to cutting-edge treatments and has put policies in place to hasten the approval of ground-breaking and regenerative medications.

Competitive Landscape

Key Players

• Novartis
• Eisai
• AstraZeneca
• Pfizer
• Mitsubishi Tanabe Pharma Corporation
• Merck Sharp & Dohme
• Sanofi
• Bayer
• Daiichi Sankyo
• Takeda Pharmaceutical Company