The global atherosclerosis drugs market is undergoing a transformative shift, driven by advancements in treatment modalities and the integration of personalized medicine. With a projected market size of USD 24.25 billion by 2034, growing at a CAGR of 3.63% from 2025, these innovations are poised to redefine therapeutic strategies and patient outcomes in cardiovascular care .

Innovative Treatment Modalities

1. RNA-Based Therapies Targeting Lipoprotein(a)

Emerging RNA-based therapies are addressing the unmet need for treating elevated lipoprotein(a) [Lp(a)] levels, a genetic risk factor for cardiovascular diseases that traditional statins cannot effectively manage. Notably, Eli Lilly's lepodisiran and Amgen's olpasiran have demonstrated significant reductions in Lp(a) levels, achieving up to 94% and 97% reductions, respectively, in Phase 2 trials . These therapies utilize small interfering RNA (siRNA) technology to silence the gene responsible for Lp(a) production, offering long-lasting effects with infrequent dosing schedules.

2. Gene Editing Therapies

Gene editing, particularly CRISPR-based approaches, is emerging as a potential one-time solution for managing atherosclerosis. Verve Therapeutics' VERVE-101, a CRISPR base-editing therapy targeting the PCSK9 gene, has shown promise in early trials by reducing LDL cholesterol levels by approximately 59% with a single infusion . This approach aims to provide a permanent solution for patients with genetically elevated LDL-C levels, potentially reducing the need for lifelong medication adherence.

Sonodynamic therapy is being explored as a non-invasive treatment for atherosclerosis. Studies have indicated that SDT can inhibit plaque development and reduce inflammation by targeting macrophages within atherosclerotic plaques . This modality offers a novel approach to managing plaque progression without the need for surgical intervention.

Personalized Medicine Approaches

1. Genetic and Pharmacogenomic Profiling

Advancements in genetic testing enable the identification of individual risk factors for atherosclerosis, such as specific gene variants associated with lipid metabolism and inflammation. Pharmacogenomic profiling further allows for the customization of drug therapies based on a patient's genetic makeup, optimizing efficacy and minimizing adverse effects .

2. Biomarker-Based Diagnostics

The utilization of biomarkers, including C-reactive protein and specific lipid profiles, facilitates early detection and risk stratification in atherosclerosis. These diagnostics support the development of targeted treatment plans, aligning with the principles of personalized medicine .

3. Integration of Digital Health Technologies

Digital health tools, such as wearable devices and telemedicine platforms, are enhancing patient monitoring and engagement. These technologies enable real-time tracking of cardiovascular parameters, support remote consultations, and promote adherence to personalized treatment regimens .

Key Drug Classes and Their Production

1. Statins (HMG-CoA Reductase Inhibitors): These are the most widely prescribed medications for lowering cholesterol levels. Major statins include atorvastatin, rosuvastatin, and simvastatin. Their production is dominated by large pharmaceutical companies, with manufacturing facilities located primarily in North America, Europe, and Asia.
2. Anti-platelet Agents: Medications like aspirin and clopidogrel prevent blood clots. Their production involves complex chemical synthesis processes and is subject to stringent regulatory standards.
3. Cholesterol Absorption Inhibitors: Ezetimibe is a key drug in this category. Its production requires specialized facilities capable of handling complex organic synthesis.
4. PCSK9 Inhibitors: Innovative therapies such as alirocumab and evolocumab are produced using advanced biotechnological methods. Their manufacturing is limited to a few specialized facilities due to the complexity and cost involved.

Manufacturing Trends

• Outsourcing and Contract Manufacturing: Many pharmaceutical companies are outsourcing production to contract manufacturing organizations (CMOs) to reduce costs and increase flexibility. Countries like India and China are significant players in this domain due to their established pharmaceutical manufacturing capabilities.
• Regulatory Compliance: Manufacturers must adhere to Good Manufacturing Practices (GMP) and other regulatory standards set by authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Compliance ensures product quality and safety, which is critical for maintaining market access.
• Supply Chain Challenges: The global supply chain for atherosclerosis drugs faces challenges such as raw material shortages, geopolitical tensions, and transportation issues. These factors can lead to production delays and affect the availability of medications. 

Combination Therapies and Novel Drug Delivery Systems

The adoption of combination therapies is gaining traction, offering synergistic effects in managing atherosclerosis. For instance, combining statins with PCSK9 inhibitors has shown enhanced efficacy in lowering LDL cholesterol levels .

Innovations in drug delivery systems, including nanoparticle-based and microneedle technologies, are improving the bioavailability and targeting of atherosclerosis drugs. These systems aim to reduce side effects and enhance patient compliance by facilitating minimally invasive administration .

Market Outlook

The convergence of advanced treatment modalities and personalized medicine is poised to drive significant growth in the atherosclerosis drugs market. As these innovations continue to evolve, they hold the potential to improve patient outcomes, reduce healthcare costs, and address the global burden of cardiovascular diseases.