Cardiovascular Biologics Market to Reach USD 4.23 Billion by 2033 | CAGR 7.5% | Key Drivers: RNA & Biologics Innovation | Major Players: Novartis, Alnylam, Genentech, Reliance Life Sciences, Biocon, Shanghai Junshi

The global cardiovascular biologics market was valued at US$ 2.20 billion in 2024 and is projected to reach US$ 4.23 billion by 2033, growing at a CAGR of 7.5% during the forecast period 2025-2033. The market is experiencing rapid growth driven by advancements in RNA and biologic technologies. Biologics, including recombinant proteins and monoclonal antibodies, enable precise targeting of biological pathways involved in inflammation, thrombosis, and lipid metabolism, improving treatment specificity and outcomes. Additionally, RNA-based therapies such as siRNA and mRNA offer innovative approaches to inhibit or modify gene expression associated with cardiovascular disorders, providing long-lasting therapeutic benefits with fewer side effects. Expanding research on pathways such as PCSK9, IL-6, and TTR has led to the approval of groundbreaking biologics and broadened clinical applications, further driving market adoption across cardiovascular patient populations.

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Recent Developments:

✅ April 2025: Regeneron and Sanofi initiated Phase III clinical trials for an anti‐ANGPTL3 monoclonal antibody aimed at reducing triglycerides in patients with cardiovascular risk, marking progress toward potential new lipid‐lowering biologics.

✅ March 2025: Novartis received expanded regulatory approval for its siRNA‐based therapy, Leqvio (inclisiran), to include additional cardiovascular risk categories, broadening its clinical use and market reach.

✅ February 2025: Amgen launched a strategic oral biologic delivery partnership with Rani Therapeutics to develop peptide‐based cardiac therapeutics, reflecting innovation in delivery methods beyond traditional injections.

✅ January 2025: Alnylam Pharmaceuticals advanced a next‐generation siRNA program targeting multiple lipid biomarkers, aiming to improve outcomes for high‐risk cardiovascular patients.

✅ December 2024: Reliance Life Sciences announced its entry into the Indian cardiovascular biologics market with recombinant protein‐based therapies, expanding regional participation in biologic treatments.

Mergers & Acquisitions:

✅ September 2025: Novartis announced a US$ 1.4 billion acquisition of Tourmaline Bio, bringing the clinical‐stage biopharmaceutical company focused on the anti‐IL‐6 monoclonal antibody pacibekitug into its cardiovascular portfolio to address inflammation in atherosclerotic cardiovascular disease.

✅ April 2025: Novartis completed its up to US$ 3.1 billion acquisition of Anthos Therapeutics, regaining full ownership of abelacimab, a late‐stage Factor XI inhibitor for stroke and thrombosis prevention, strengthening its cardiovascular biologics pipeline.

✅ June 2025: Eli Lilly agreed to acquire Verve Therapeutics for up to US$ 1.3 billion, gaining access to the in vivo gene editing platform for lifelong LDL reduction and expanding its presence in next‐generation cardiovascular therapies.

✅ March 2024: Novo Nordisk completed the acquisition of Cardior Pharmaceuticals for approximately US$ 1.1 billion, reinforcing its cardiovascular drug development capabilities with RNA‐targeted therapeutics such as CDR132L for heart failure.

✅ May 2024: Johnson & Johnson acquired Shockwave Medical for about US$ 13.1 billion to expand its cardiovascular intervention portfolio, including technologies for treating calcified plaque and structural heart conditions.

Key Players:
Regeneron Pharmaceuticals, Inc. | Amgen Inc. | Novartis Pharmaceuticals Corporation | Alnylam Pharmaceuticals, Inc. | Genentech USA, Inc. | Reliance Life Sciences | Biocon Biologics Limited | Shanghai Junshi Biosciences Co.

Key Highlights:

• Regeneron Pharmaceuticals, Inc. - Specializes in monoclonal antibodies and RNA-based therapeutics targeting inflammation and lipid metabolism in cardiovascular disorders.

• Amgen Inc. - Offers biologics targeting PCSK9 and other pathways, expanding its cardiovascular portfolio with innovative lipid-lowering and anti-thrombotic therapies.

• Novartis Pharmaceuticals Corporation - Focuses on siRNA therapeutics and monoclonal antibodies, including Leqvio (inclisiran), for LDL-cholesterol reduction and cardiovascular risk management.

• Alnylam Pharmaceuticals, Inc. - Develops RNAi-based therapies for cardiovascular disorders, including programs targeting TTR and other high-risk pathways.

• Genentech USA, Inc. - Provides recombinant proteins and monoclonal antibody therapies for cardiovascular and metabolic diseases, leveraging advanced biologic platforms.

• Reliance Life Sciences - Newly entered the cardiovascular biologics space in India, offering recombinant protein-based therapies for regional patient populations.

• Biocon Biologics Limited - Expanding biologics development in India, focusing on recombinant proteins and novel RNA-based therapeutics for cardiovascular diseases.

• Shanghai Junshi Biosciences Co. - Focused on cardiovascular and metabolic biologics in China, including monoclonal antibodies and gene-targeted therapies for high-risk patients.

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Market Segmentation:

➥By biologic type, monoclonal antibodies dominate with an estimated 40% share, driven by their targeted mechanism of action against PCSK9, IL-6, and other cardiovascular pathways. siRNA-based therapeutics hold approximately 25%, fueled by growing adoption of therapies such as inclisiran for LDL-cholesterol reduction and gene-silencing approaches targeting cardiovascular risk factors. Recombinant proteins account for 20%, widely used in thrombolytic and enzyme replacement therapies, while other biologics, including peptides and fusion proteins, contribute 15% to the market.

➥By indication, coronary artery disease leads with a 30% share, supported by the high prevalence of atherosclerosis and lipid-related disorders. Heart failure accounts for 20%, driven by RNA and monoclonal antibody therapies addressing myocardial stress and remodeling. Arrhythmias represent 15%, while valvular heart diseases and hypertension each hold 10%, reflecting niche but growing adoption of biologics. Other cardiovascular indications, including stroke prevention and peripheral artery disease, contribute 15% to the market.

➥By distribution channel, hospital pharmacies dominate with a 45% share, as most biologics are administered under physician supervision. Retail pharmacies account for 25%, primarily for outpatient chronic therapies such as lipid-lowering RNA-based drugs. Online pharmacies and specialty distributors collectively hold 20%, while other channels, including clinic-based dispensaries and government programs, represent 10%, supporting accessibility in emerging markets.

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Market Dynamics:

Drivers: The cardiovascular biologics market is being strongly driven by a robust research and development (R&D) pipeline and rapid biologics innovation. The approval of new treatments, such as PCSK9 inhibitors and RNAi therapeutics, has been facilitated by ongoing advancements in gene therapies, RNA-based medications, and monoclonal antibodies. Biotech and pharmaceutical companies are investing heavily to discover new molecular targets for conditions like cardiomyopathies, hyperlipidemia, and heart failure, accelerating market growth. For instance, in August 2025, Roche and Alnylam advanced zilebesiran into a global Phase III cardiovascular outcomes trial to evaluate its potential in reducing major adverse cardiovascular events in patients with uncontrolled hypertension, marking a major milestone in RNAi-based cardiovascular therapy.

Restraints: The market's growth is limited by the small number of approved cardiovascular biologics. Only a few biologics have received commercial approval, restricting the variety of available treatments and keeping accessibility low while maintaining high pricing. Healthcare professionals continue to rely heavily on conventional small-molecule medications due to this limited repertoire. Additionally, regulatory uncertainties have delayed new approvals for gene- and cell-based cardiovascular therapies, hindering pharmaceutical companies' investment and innovation in late-stage pipeline candidates.

Regional Insights:

North America leads the market with an estimated 35% share, supported by high adoption of monoclonal antibodies and RNA-based therapeutics, strong clinical trial activity, and the presence of major players like Amgen, Regeneron, and Novartis.

Europe holds around 25%, driven by cardiovascular research hubs in Germany, Switzerland, and the UK, coupled with favorable regulatory frameworks for biologics approvals. Asia-Pacific accounts for approximately 30%, fueled by increasing prevalence of cardiovascular diseases, growing biopharmaceutical manufacturing capabilities in India, China, and Japan, and rising healthcare spending.

Latin America and the Middle East & Africa collectively contribute about 8%, supported by emerging healthcare infrastructure and adoption of innovative therapies. Oceania represents roughly 2%, with moderate uptake due to smaller populations but strong access to advanced therapeutics.

Key Developments:

In September 2025, Novartis announced its acquisition of Tourmaline Bio, a New York-based clinical-stage biopharmaceutical company, to strengthen its cardiovascular pipeline with pacibekitug, an anti‐IL‐6 monoclonal antibody targeting atherosclerotic cardiovascular disease. This acquisition addresses systemic inflammation and complements Novartis' strategy by adding a Phase 3-ready biologic asset for cardiovascular disease treatment. Earlier, in July 2025, Novartis received FDA approval for a label update of Leqvio (inclisiran), allowing its use as a monotherapy alongside diet and exercise to reduce LDL cholesterol in adults with hypercholesterolemia. This approval marks the expansion of Leqvio as a first-line PCSK9-targeting cardiovascular biologic therapy, increasing patient accessibility and adoption in clinical practice.

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