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Challenges and Opportunities of Cardiovascular Drugs in the Trillion-Dollar Market



May 18th is “National Vascular Health Day”. The significance of 5.18 originates from a metric: 5.18 mmol/L, which is the critical value for abnormal total cholesterol levels in the blood of a normal person.

Currently, cardiovascular disease (CVD) has become an important topic in the global public health. According to the “2022 Report on Cardiovascular Health and Diseases in China,” the number of cardiovascular disease patients in China is as high as 330 million, including 245 million hypertensive patients, 13 million stroke patients, 11.39 million coronary heart disease patients, and 8.9 million heart failure patients.

Figure 1: Prevalence of Cardiovascular Disease in China
Figure 1: Prevalence of Cardiovascular Disease in China

Meanwhile, a special report on the global burden of cardiovascular diseases published by the JACC journal pointed out that from 1990 to 2022, despite a relative decrease of 34.9% in age-standardized cardiovascular disease mortality rates, the number of deaths annually due to cardiovascular diseases rose from 12.4 million to 19.8 million.  This growth is mainly attributed to the continued impact of metabolic, behavioral, and environmental risk factors, resulting not only in a loss of up to 396 million years of life but also in 449 million years of life lost due to disability (YLD).  These data profoundly reveal the severe situation of cardiovascular diseases and strongly call for further strengthening efforts in prevention, treatment, and control of cardiovascular diseases. 

Figure 2 compares the age-standardized disability-adjusted life years (DALYs) per 100,000 people in 2022 for (A) cardiovascular diseases by region and (B) the burden caused by globally selected risk factors with the theoretically lowest risk exposure level
Figure 2 compares the age-standardized disability-adjusted life years (DALYs) per 100,000 people in 2022 for (A) cardiovascular diseases by region and (B) the burden caused by globally selected risk factors with the theoretically lowest risk exposure level

Cardiovascular Diseases: Overcoming Clinical Challenges and Exploring Unmet Treatment Needs

Cardiovascular diseases have a long course and severe onset, such as heart failure, heart disease, primary hypertension, etc., leading to a significant number of unmet clinical needs. According to statistics, the overall prevalence of dyslipidemia in Chinese adults is as high as 40.4%, but existing therapeutic drugs still have many shortcomings in terms of efficacy and safety. Therefore, developing safer and more effective cardiovascular drugs has become an urgent need. However, according to the Pharmacodia database, in recent years, the indications for Investigational New Drug (IND) applications for therapeutic drugs in China have mainly focused on oncology, anti-infectives, respiratory, and digestive systems. There are fewer pharmaceutical companies paying attention to the urgent clinical demand for cardiovascular diseases. Therefore, the annual approval rate for innovative drugs in this field is very low. Firstly, the complexity of cardiovascular diseases makes drug development extremely challenging.  Cardiovascular diseases involve multiple factors, such as genetics, environment, lifestyle, etc., which makes drug development require comprehensive consideration of various aspects. Secondly, the research and development costs for innovative drugs in the cardiovascular field are high, and the success rate is relatively low. According to statistics, the research and development costs for innovative drugs in the cardiovascular field can reach hundreds of millions of dollars, yet the success rate of Phase I clinical development is only 4%. Furthermore, the approval and registration requirements for cardiovascular drugs are strict, and their efficacy and safety need to be proven through rigorous clinical trials. These challenges slow down the development process of cardiovascular drugs, making it difficult to meet the needs of patients.

Cardiovascular drug market worth hundreds of billions: Rising imminently, with unlimited potential

Cardiovascular diseases have a long course and severe onset, such as heart failure, heart disease, primary hypertension, etc., leading to a significant number of unmet clinical needs. According to statistics, the overall prevalence of dyslipidemia in Chinese adults is as high as 40.4%, but existing therapeutic drugs still have many shortcomings in terms of efficacy and safety. Therefore, developing safer and more effective cardiovascular drugs has become an urgent need. However, according to the Pharmacodia database, in recent years, the indications for Investigational New Drug (IND) applications for therapeutic drugs in China have mainly focused on oncology, anti-infectives, respiratory, and digestive systems. There are fewer pharmaceutical companies paying attention to the urgent clinical demand for cardiovascular diseases. Therefore, the annual approval rate for innovative drugs in this field is very low. Firstly, the complexity of cardiovascular diseases makes drug development extremely challenging.  Cardiovascular diseases involve multiple factors, such as genetics, environment, lifestyle, etc., which makes drug development require comprehensive consideration of various aspects. Secondly, the research and development costs for innovative drugs in the cardiovascular field are high, and the success rate is relatively low. According to statistics, the research and development costs for innovative drugs in the cardiovascular field can reach hundreds of millions of dollars, yet the success rate of Phase I clinical development is only 4%. Furthermore, the approval and registration requirements for cardiovascular drugs are strict, and their efficacy and safety need to be proven through rigorous clinical trials. These challenges slow down the development process of cardiovascular drugs, making it difficult to meet the needs of patients.

 

Rodent Cerebrovascular Disease Drug Efficacy Evaluation System

Cardiovascular and cerebrovascular diseases generally refer to ischemic or hemorrhagic diseases of the heart, brain and systemic tissues caused by hyperlipidemia, blood viscosity, atherosclerosis, and hypertension.Model evaluation is a critical step in testing results. Medicilon strictly follows the STAIR preclinical drug development strategy for stroke and has significant experience in MCAO model establishment and a mature MCAO model system evaluation system.

Cardiovascular drug market worth hundreds of billions: Rising imminently, with unlimited potential

According to Pharbers’ data, among all pharmaceutical institutions, the market size of cardiovascular system medications reached RMB 125.98 billion in 2022, a year-on-year decrease of 7.4%, with a compound annual growth rate of -7.6% from 2019 to 2022. From the perspective of the overall channel structure, the scale of the core market and the broad market are proportionate. 

Figure 3: Market Size of Cardiovascular Drug Market from 2019 to 2022

Facing the severe challenges of cardiovascular diseases, the cardiovascular drug market is experiencing rapid growth. The overall scale of the cardiovascular drug category market ranks among the top in the category segmentation industry, second only to the markets of gastrointestinal and metabolic drugs, anti-tumor drugs, immunomodulators, and blood and hematopoietic organ drugs. With the gradual implementation of the “Healthy China” strategy, China has set a clear target to reduce the mortality rate of cardiovascular and cerebrovascular diseases to 190.7 per 100,000 or lower by 2030. The achievement of this goal relies heavily on the research and application of cardiovascular drugs.

In the cardiovascular system drug market, antihypertensive and lipid-lowering drugs are key areas where China has included a large number of varieties in bulk procurement.  As the aging of the population accelerates and the number of patients continues to expand, the market demand for cardiovascular drugs will continue to grow.  However, despite some progress in the R&D of cardiovascular drugs, many patients still fail to achieve satisfactory treatment outcomes.  Therefore, the development of innovative cardiovascular drugs with better efficacy and safety is an urgent problem that needs to be solved.

New generation of cardiovascular drugs: Innovation and challenges coexist from a comparative perspective

With the vigorous development of pharmaceutical technology, a new generation of cardiovascular disease treatment drugs are gradually emerging, bringing unprecedented treatment hope to patients.

PCSK9 Inhibitors: Significantly reduce the risk of cardiovascular events by lowering LDL-C levels, which is particularly suitable for high-risk patient groups and provides long-term and stable efficacy.  However, during application, factors such as the patient’s individual condition, potential side effects, and economic costs need to be comprehensively considered.

SGLT-2 Inhibitors: Originally used as therapeutic drugs for type 2 diabetes, their cardiovascular protective effects have also attracted much attention.  This class of drugs can reduce the risk of cardiovascular events, including cardiovascular death, cardiac events, and stroke, while improving cardiovascular function, reducing the burden on the heart, and reducing the risk of high blood pressure.  Although its specific mechanism of action is not yet fully understood, the development of individualized treatment plans has become the key to its clinical application.

Inflammation-Modulating Drugs: Shows great potential in the treatment of cardiovascular diseases.  They target the inflammatory process in atherosclerosis, slowing or preventing disease progression by inhibiting the inflammatory response.  A variety of drugs, including nonsteroidal anti-inflammatory drugs and IL-1β inhibitors, are being studied.  Although it is still in the clinical trial stage, it has shown positive therapeutic prospects.

RNA Interference Therapy: As an emerging treatment method, it shows great potential in the field of cardiovascular diseases.  It provides a new strategy for the treatment of cardiovascular diseases by silencing specific genes, regulating lipid metabolism, inhibiting inflammation, promoting angiogenesis, protecting myocardium and treating gene mutations.  However, the technology still needs to overcome challenges such as delivery, safety and dose optimization before clinical application, and further research and clinical trials will be key to its development.

To summarize, the new generation of cardiovascular disease treatment drugs is bringing new hopes and challenges to the treatment of cardiovascular diseases with the power of innovation and breakthrough.  We look forward to the early clinical application of these cutting-edge drugs to provide patients with safer, more effective and personalized treatment options.

Medicilon Drug Efficacy Evaluation Model: assisting in the research of cardiovascular drugs and promoting health undertakings

In the face of the severe challenge of cardiovascular disease, Medicilon Pharmacy Department has built a variety of cardiovascular disease animal models, such as hyperlipidemia model, atherosclerosis model, stroke model, thrombosis model, anticoagulation model and anemia model, used for drug efficacy evaluation research on common cardiovascular diseases.

Among them, the middle cerebral artery occlusion (MCAO) not only shows stable lesions, high success rate and high survival rate in rats and mice, but also can accurately evaluate the dose-response and time-response relationship and evaluate the efficacy of transient and permanent cerebral ischemia.  These models strictly follow the STAIR technical guidelines to ensure that core pharmacodynamic indicators are comprehensively and in-depth examined, thereby ensuring the accuracy and reliability of experimental results.

In addition, Medicilon can also conduct customized modeling for rodents with special diseases according to the individual needs of clients, complete corresponding activity evaluations, and provide clients with customized research and development services.

Looking forward to the future, Medicilon will continue to delve into the research and development of cardiovascular drugs and is committed to promoting the progress of global cardiovascular health.  Through continuous technological innovation and R&D efforts, Medicilon will help achieve more breakthrough results in the field of cardiovascular drugs.

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