Press release
Cardiovascular Biologics Market to Reach US$ 4.23 Billion by 2033 | Key Players: Amgen, Regeneron, Novartis, Alnylam, AstraZeneca, Pfizer, Bristol Myers Squibb
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 witnessing rapid expansion driven by advancements in RNA-based therapies and biologic innovations that enable precise targeting of cardiovascular disease mechanisms. Biologics, including recombinant proteins, monoclonal antibodies, and gene-modulating RNA therapeutics (such as siRNA and mRNA), offer new and more effective approaches to modulating inflammatory, thrombotic, and lipid pathways. These biologics deliver long-lasting therapeutic outcomes, reduced side effects, and improved efficacy compared to conventional cardiovascular drugs.Get a Free Sample PDF Of This Report (Get Higher Priority for Corporate Email ID):-https://www.datamintelligence.com/download-sample/cardiovascular-biologics-market?Juli
Key breakthroughs in PCSK9, IL-6, and TTR pathways are transforming cardiovascular disease management, enabling the development of next-generation biologics that address hypercholesterolemia, atherosclerosis, heart failure, and amyloidosis. The success of therapies targeting these mechanisms such as PCSK9 inhibitors and TTR stabilizers has paved the way for expanded clinical applications and multiple late-stage pipeline candidates.
Recent Key Developments:
✅ January 2026 (Clinical Advancement - U.S.): Amgen Inc. announced positive Phase III clinical results for its next-generation PCSK9 inhibitor, demonstrating significant LDL cholesterol reduction and improved cardiovascular outcomes in high-risk patients compared to existing monoclonal antibody therapies.
✅ December 2025 (Strategic Collaboration - Europe): AstraZeneca entered a strategic research partnership with Silence Therapeutics to co-develop siRNA-based therapeutics targeting novel genetic pathways implicated in atherosclerosis and heart failure, expanding its RNA-based cardiovascular drug portfolio.
✅ October 2025 (FDA Approval - U.S.): Ionis Pharmaceuticals, in collaboration with Novartis, received FDA approval for pelacarsen, an antisense oligonucleotide therapy designed to lower lipoprotein(a) [Lp(a)] levels, marking a major milestone in addressing genetically driven cardiovascular risk factors.
✅ August 2025 (Product Launch - Japan): Pfizer Inc. launched its first RNA-based biologic for transthyretin amyloidosis (ATTR-CM) in Japan following regulatory approval, expanding patient access to gene-silencing therapies for rare cardiovascular diseases.
✅ June 2025 (Acquisition - Global Expansion): Bristol Myers Squibb (BMS) acquired Cardio Therapeutics, a biotech company specializing in IL-6-targeted biologics for inflammatory cardiovascular conditions, strengthening BMS's immuno-cardiology portfolio.
✅ In July 2025, Novartis announced that the U.S. FDA had approved a label update for Leqvio (inclisiran), allowing its use as a monotherapy alongside diet and exercise to reduce LDL cholesterol in adults with hypercholesterolemia, marking its expansion as a first-line PCSK9-targeting cardiovascular biologic therapy.
Key Players:
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.
Market Dynamics:
The Global Cardiovascular Biologics Market is witnessing robust growth driven by a strong research and development (R&D) pipeline and rapid innovation in biologic therapeutics. Continuous advancements in gene therapies, RNA-based treatments, and monoclonal antibodies have accelerated the approval of novel cardiovascular drugs such as PCSK9 inhibitors and RNA interference (RNAi) therapies.
Leading biotechnology and pharmaceutical companies are making substantial investments to discover and validate new molecular targets for cardiomyopathies, hyperlipidemia, heart failure, and atherosclerosis. The expansion of precision medicine approaches is further fueling innovation, allowing for more targeted and long-lasting therapeutic outcomes.
For example, in August 2025, Roche and Alnylam Pharmaceuticals advanced zilebesiran an investigational RNAi therapeutic into a global Phase III cardiovascular outcomes trial to evaluate its potential in reducing major adverse cardiovascular events in patients with uncontrolled hypertension. This milestone underscores the growing clinical momentum in RNA-based cardiovascular drug development and highlights the sector's shift toward next-generation biologic modalities.
Restraints:
Despite strong research momentum, the growth of the cardiovascular biologics market remains constrained by the limited number of approved biologics for cardiovascular indications. Compared to other therapeutic areas such as oncology and immunology, the cardiovascular segment has fewer commercially available biologics, restricting treatment options for both clinicians and patients.
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Regional Insights:
North America: 40.5% (Largest share, driven by strong R&D infrastructure, rapid adoption of RNA-based therapies, and presence of leading biopharma players such as Amgen, Regeneron, and Alnylam in the U.S.).
Europe: 30% (Significant share, supported by robust clinical trial activity, advanced biologics manufacturing, and favorable regulatory pathways through the EMA in countries like Germany, France, and the U.K.).
Asia Pacific: 20% (Fastest-growing region, fueled by expanding biotech sectors in China, India, and Japan, rising healthcare investments, and growing adoption of biosimilars and recombinant biologics).
Rest of the World (Latin America, Middle East & Africa): 9.5% (Emerging opportunities driven by improving healthcare infrastructure and rising cardiovascular disease prevalence, though limited by high biologic therapy costs).
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Market Segmentation:
By Biologic Type:
Monoclonal Antibodies - 45% (Largest segment, driven by wide clinical adoption of PCSK9 inhibitors and ongoing R&D in IL-6 and TTR-targeted antibodies for cardiovascular and inflammatory diseases).
siRNA-Based Therapeutics - 30% (Fastest-growing segment, supported by increasing approval of RNAi drugs such as inclisiran and expanding clinical trials targeting hypertension and lipid disorders).
Recombinant Proteins - 25% (Established segment, fueled by applications in thrombosis, heart failure, and cardiomyopathy, with growing advancements in long-acting protein therapeutics).
By Indication:
Coronary Artery Disease - 30% (Dominant indication, owing to high global prevalence and strong demand for biologics addressing cholesterol metabolism and plaque stabilization).
Heart Failure - 25% (Growing adoption of biologics improving cardiac remodeling and gene expression, with rising clinical research activity in protein- and RNA-based therapeutics).
Hypertension - 20% (Expanding rapidly with the development of novel RNA-based biologics targeting renin-angiotensin and nitric oxide pathways).
Arrhythmias - 10% (Steady growth driven by gene-modifying therapies and biologics targeting ion channel dysfunction).
Valvular Heart Diseases - 8% (Increasing use of biologic tissue products and regenerative approaches for valve repair and replacement).
Others - 7% (Includes cardiomyopathies and amyloidosis, with emerging potential from next-generation biologics and precision gene therapies).
By Distribution Channel:
Hospital Pharmacies - 70% (Dominant channel, driven by hospital-based biologic administrations, specialized cardiovascular care, and the requirement for controlled handling and monitoring).
Retail Pharmacies - 30% (Growing channel, supported by improved patient accessibility, chronic disease management programs, and expanding outpatient biologic prescriptions).
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