AUSTIN, Texas and TOKYO, Nov. 14, 2025 /PRNewswire/ -- According to DataM Intelligence, the Cardiovascular Biologics Market Size was valued at approximately USD 2.20 billion in 2024 and is projected to grow to USD 4.23 billion by 2033, representing a CAGR of 7.5% over the forecast period 2025-2033.
This growth is driven by the increasing development of biologic and gene-based therapies targeting cardiovascular disease (CVD) pathways, including monoclonal antibodies (mAbs), siRNA-based therapeutics, recombinant proteins and other biologic platforms.
Growth Drivers: Innovation Meets Unmet Clinical Need
- Rising global burden: Cardiovascular diseases account for 18 million deaths annually, representing nearly 32% of all global fatalities (WHO, 2024).
- Therapy adoption rate: Biologic penetration in cardiovascular therapeutics increased from 3% in 2019 to 9% in 2024, projected to exceed 20% by 2030.
- R&D investment: Annual cardiovascular biologics R&D spending surpassed USD 2.5 billion in 2024, a 40% increase since 2020, led by mRNA and siRNA-based platforms.
- Regulatory momentum: Over 45 late-stage cardiovascular biologics are currently in clinical development worldwide, including monoclonal antibodies targeting PCSK9, ANGPTL3, and IL-6 pathways.
- Cost-effectiveness: Biologics can reduce LDL-C levels by up to 60%, translating to 27% lower cardiac event rates in high-risk populations.
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Market Segmentation Analysis
By Biologic Type
The market is categorized into Monoclonal Antibodies (mAbs), siRNA-Based Therapeutics, Recombinant Proteins, and Others.
- Monoclonal Antibodies (mAbs) dominate the market with 52% share (USD 1.14 billion in 2024), driven by successful launches such as Repatha (Amgen) and Praluent (Regeneron/Sanofi). The segment is expected to reach USD 2.2 billion by 2033, growing at 7.7% CAGR.
- siRNA-Based Therapeutics represent 25% share (USD 550 million) and are the fastest-growing category, with 10% CAGR, led by Alnylam Pharmaceuticals' inclisiran, showing sustained LDL-C reduction for up to six months.
- Recombinant Proteins hold 15% share (USD 330 million), used in ischemic and heart failure indications, while Others (gene therapies and peptide biologics) account for 8% (USD 180 million), with significant pipeline potential beyond 2030.
By Indication
- Coronary Artery Disease (CAD) is the largest indication, capturing 38% share (USD 836 million in 2024) and expected to grow at 7.8% CAGR, owing to the widespread use of PCSK9 inhibitors and siRNA-based lipid therapies.
- Heart Failure (HF) accounts for 25% (USD 550 million), bolstered by biologics targeting myocardial regeneration and neurohormonal pathways.
- Arrhythmias and Valvular Heart Diseases collectively contribute 20% (USD 440 million), with novel biologics improving structural and electrical cardiac function.
- Hypertension represents 10% (USD 220 million), primarily driven by siRNA-based approaches targeting angiotensinogen.
- Other conditions (e.g., pulmonary hypertension, vascular inflammation) account for 7% (USD 154 million) with early-stage biologic trials progressing steadily.
By Distribution Channel
- Hospital Pharmacies dominate with 60% market share (USD 1.32 billion in 2024), given the requirement for specialist prescription and in-patient administration.
- Retail Pharmacies represent 40% (USD 880 million), projected to exceed USD 1.7 billion by 2033, supported by wider access to self-administered biologics.
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Regional Insights
United States
The U.S. market held 45% global share (USD 990 million in 2024) and is projected to reach USD 1.95 billion by 2033, expanding at 7.8% CAGR.
- The country accounts for over 35% of global cardiovascular biologics prescriptions.
- FDA-approved biologics like Leqvio (inclisiran) and Repatha dominate lipid-lowering therapy, supported by Medicare's recent inclusion of siRNA drugs in reimbursement programs.
- U.S. federal R&D grants for biologic drug development exceeded USD 1.1 billion in 2024, emphasizing RNA-based innovation and atherosclerosis immunotherapy.
Japan
Japan's market reached USD 210 million in 2024 and is expected to grow to USD 420 million by 2033, registering a 7.9% CAGR.
- The Ministry of Health, Labour and Welfare (MHLW) approved its first siRNA-based cardiovascular drug in 2024.
- Japan's cardiovascular biologics R&D funding rose 25% YoY, targeting localized production under the Pharma Innovation Japan 2030 initiative.
- Rising geriatric population (29% aged 65+) continues to drive biologic demand for chronic heart diseases.
Competitive Landscape
Key players in this market include Regeneron Pharmaceuticals, Inc.; Amgen Inc.; Novartis Pharmaceuticals Corporation; Alnylam Pharmaceuticals, Inc.; Genentech USA, Inc.; Reliance Life Sciences; Biocon Biologics Limited; and Shanghai Junshi Biosciences Co.
Highlights (FY2024):
- Amgen Inc. generated USD 28.2 billion in total revenue, with Repatha contributing USD 1.9 billion (+12% YoY).
- Regeneron Pharmaceuticals reported USD 13.3 billion revenue, with Praluent achieving USD 730 million sales globally.
- Novartis recorded USD 52 billion in total revenue; its siRNA therapy Leqvio reached USD 500 million sales within 18 months of launch.
- Alnylam Pharmaceuticals earned USD 1.7 billion, with inclisiran licensing revenue driving 60% YoY growth.
- Biocon Biologics expanded its cardiovascular biosimilars segment by 35% YoY, targeting emerging markets across Asia and LATAM.
Market Outlook and Strategic Implications
The forecast to USD 4.23 billion by 2033 at a 7.5% CAGR suggests a steady but relatively moderate growth path compared to some other biologics segments. Key strategic implications include:
- The dominance of mAbs (45% share) means newer modalities (siRNA, recombinant proteins) must broaden their pipeline and approval success to capture incremental share.
- Indications beyond CAD - such as heart failure, valvular disease and hypertension - represent potential for expansion as biologic therapies prove their efficacy.
- Emerging markets (Asia-Pacific) with higher CVD incidence and improving biologic access are key growth frontiers.
- Distribution strategy will remain important: hospital pharmacy channels are critical because of infusion/injection workflows, but as subcutaneous and outpatient biologics expand, retail pharmacy access may rise.
Recent Industry Developments
- Regeneron and Sanofi initiated Phase III trials for an anti-ANGPTL3 monoclonal antibody to reduce triglycerides (April 2025).
- Amgen launched an oral biologic delivery partnership with Rani Therapeutics for peptide-based cardiac therapeutics (February 2025).
- Novartis received EMA approval for Leqvio (inclisiran) expansion across multiple cardiovascular risk categories (March 2025).
- Alnylam began a next-generation siRNA program targeting multiple lipid biomarkers (January 2025).
- Reliance Life Sciences announced entry into the Indian cardiovascular biologics market with recombinant protein-based therapies (December 2024).
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Conclusion
The cardiovascular biologics market is entering a phase of sustained growth, anchored by biologic innovations targeting cardiovascular disease pathways. With the market expected to increase from USD 2.20 billion in 2024 to USD 4.23 billion by 2033, the 7.5% CAGR underlines the long-term potential of biologics in cardiovascular care. According to DataM Intelligence, companies that invest in next-generation biologic platforms (such as siRNA, gene therapies, recombinant proteins) and expand indications beyond traditional lipid-lowering will be best positioned to capture growth.
Related Report:
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