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시장보고서
상품코드
2148809
심부전 치료제 시장 규모, 점유율, 성장률 및 업계 분석, 지역별 동향 및 예측(2026-2034년)Heart Failure Drugs Market Size, Share, Growth and Global Industry Analysis, Regional Insights and Forecast to 2026-2034 |
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2025년 전 세계 심부전 치료제 시장 규모는 117억 9,000만 달러로 평가되었습니다. 이 시장은 2026년 134억 3,000만 달러에서 2034년까지 384억 6,000만 달러로 성장하여, 2026년부터 2034년까지의 예측 기간 동안 연평균 성장률(CAGR) 14.06%를 나타낼 것으로 전망됩니다. 2025년, 북미는 전 세계 심부전 치료제 시장에서 43.34%의 시장 점유율을 차지하며 약 51억 1,000만 달러 규모에 도달해 시장을 주도했습니다.
전 세계 심부전 치료제 시장에는 다양한 적응증에 따른 만성 및 급성 심부전 관리에 사용되는 처방약이 포함됩니다. 시장 성장은 전 세계 심부전 유병률 증가, 인구 고령화, 당뇨병 및 고혈압과 같은 심대사성 질환 증가, 지침 기반 약물 요법(GDMT)의 보급 확대, 그리고 첨단 브랜드 치료제에 대한 수요 증가에 의해 주도되고 있습니다.
이 시장에는 SGLT2 억제제, ARNI, β-차단제, ACE 억제제 및 ARB, 미네랄코르티코이드 수용체 길항제, 이뇨제, 기타 심혈관 치료제 등 주요 약물군이 포함됩니다.
이 시장에서 사업을 전개하는 주요 기업으로는 Novartis AG, AstraZeneca, Boehringer Ingelheim International GmbH, Merck & Co., Inc., Amgen Inc., Pfizer Inc., Viatris Inc., Teva Pharmaceutical Industries Ltd. 및 Sandoz Inc. 등이 있습니다.
시장의 정의 및 범위
심부전 치료제란, 심부전을 앓고 있는 환자의 심장 기능을 개선하고, 입원 위험을 낮추며, 증상을 조절하고, 심혈관 사망을 줄이는 것을 목적으로 하는 의약품을 말합니다.
이러한 약물은 다음과 같은 다양한 심부전 분류에서 사용되고 있습니다.
본 시장은 병원 약국, 소매 약국, 온라인 약국 및 기타 헬스케어 채널을 통해 유통되는 브랜드 의약품 및 제네릭 의약품을 대상으로 합니다.
시장 역학
시장 동향
SGLT2 억제제의 급속한 보급이 심부전 치료를 혁신하고 있습니다.
SGLT2 억제제의 사용 확대는 심부전 치료제 시장을 형성하는 가장 중요한 동향 중 하나입니다. 당초 당뇨병 치료를 위해 개발된 이 약제들은 현재 HFrEF, HFpEF, HFmrEF 각 환자군에서 심부전 관리에 널리 채택되고 있습니다.
SGLT2 억제제의 용도 확대로 인해 치료 대상이 되는 환자층이 넓어지고, 매출에 대한 기여도도 높아지고 있습니다. 이러한 추세로 인해 β-차단제, ACE 억제제, ARB, 이뇨제와 같은 기존 치료법에 대한 의존도가 낮아지고 있습니다.
예를 들어, 2023년 5월, 아스트라제네카(AstraZeneca)는 좌심실 박출률 상태와 관계없이 심부전을 가진 성인의 심혈관 사망, 입원 및 심부전으로 인한 응급 내원을 감소시키기 위한 목적으로 ‘파르시가(Farxiga)’에 대해 미국 식품의약국(FDA)의 승인을 획득했습니다.
시장 성장 촉진요인
심부전 유병률 증가와 고령화가 약물 수요를 견인
전 세계적으로 증가하는 심부전의 부담이 시장 확대를 뒷받침하는 주요 요인이 되고 있습니다. 고령 인구 증가, 당뇨병, 고혈압, 비만 환자 수 증가, 그리고 심혈관 사건 발생 후 생존율 향상으로 인해 장기 치료가 필요한 환자 수가 증가하고 있습니다.
ARNI, SGLT2 억제제, MRA, ACE 억제제, ARB, β-차단제 등 가이드라인에 기반한 약물 요법의 도입이 확대됨에 따라, 브랜드 의약품과 제네릭 의약품 모두에서 처방량이 증가하고 있습니다.
헬스케어 관련 추정에 따르면, 미국에서는 20세 이상 성인 중 약 670만 명이 심부전을 앓고 있으며, 이 수치는 향후 몇 년 동안 크게 증가할 것으로 예상되어 치료 수요 증가가 두드러지게 나타나고 있습니다.
시장 성장 억제요인
고가의 심부전 치료제에 대한 보험 적용 범위 제한 및 접근성 제약
보험 급여 범위 제한 및 경제적 문제로 인해, 특히 저·중소득 국가에서 시장 성장이 제약을 받을 가능성이 있습니다.
ARNI나 SGLT2 억제제 등의 첨단 치료법은 큰 임상적 이점을 제공하지만, 높은 비용, 보험 적용 범위 제한, 전문의 부족 등의 이유로 인해 접근성에 어려움을 겪는 경우가 많습니다.
그 결과, 일부 신흥 시장에서는 여전히 저비용의 제네릭 심혈관 치료제에 대한 의존이 지속되고 있습니다.
시장 기회
HFpEF 및 HFmrEF 치료 대상 환자층의 확대
HFpEF 및 HFmrEF 환자 그룹에 대한 관심이 높아짐에 따라, 큰 성장 기회가 창출되고 있습니다.
기존에는 이러한 환자 집단의 치료 선택지가 제한적이었으나, 다양한 박출률 범위에서 SGLT2 억제제의 사용이 확대됨에 따라 치료 기회가 넓어지고 있습니다.
진단 기술의 발전, 지침의 보급, 임상 연구 증가로 인해 처방량이 늘어나며, 시장에 진입한 기업들에게 새로운 수익 기회가 창출될 것으로 예측됩니다.
시장의 과제
SGLT2 억제제와 관련된 안전성 및 내약성에 대한 우려
SGLT2 억제제와 관련된 안전성 우려는 특히 고령자, 신장 기능 장애가 있는 환자 및 고위험군 환자에서 더 광범위한 도입에 걸림돌이 될 수 있습니다.
당뇨병성 케톤산증, 체액량 감소, 중증 비뇨생식기 감염 등의 잠재적 위험이 있으므로 신중한 모니터링과 환자 선별이 필요합니다.
이러한 요인들로 인해 임상적 이점이 크더라도 도입 속도가 둔화될 가능성이 있습니다.
The global heart failure drugs market size was valued at USD 11.79 billion in 2025. The market is projected to grow from USD 13.43 billion in 2026 to USD 38.46 billion by 2034, exhibiting a CAGR of 14.06% during the forecast period from 2026 to 2034. North America dominated the global heart failure drugs market in 2025 with a market share of 43.34%, reaching a valuation of approximately USD 5.11 billion.
The global heart failure drugs market includes prescription therapies used for the management of chronic and acute heart failure conditions across different indications. Market growth is driven by the rising global prevalence of heart failure, aging population, increasing cardiometabolic diseases such as diabetes and hypertension, wider adoption of guideline-directed medical therapy (GDMT), and increasing demand for advanced branded therapies.
The market includes major drug classes such as SGLT2 inhibitors, ARNI, beta blockers, ACE inhibitors & ARBs, mineralocorticoid receptor antagonists, diuretics, and other cardiovascular therapies.
Key players operating in the market include Novartis AG, AstraZeneca, Boehringer Ingelheim International GmbH, Merck & Co., Inc., Amgen Inc., Pfizer Inc., Viatris Inc., Teva Pharmaceutical Industries Ltd., and Sandoz Inc.
Market Definition and Scope
Heart failure drugs are pharmaceutical products designed to improve heart function, reduce hospitalization risk, control symptoms, and decrease cardiovascular mortality among patients suffering from heart failure.
These medications are used across various heart failure categories, including:
The market covers branded and generic drugs distributed through hospital pharmacies, retail pharmacies, online pharmacies, and other healthcare channels.
Market Dynamics
Market Trends
Rapid Adoption of SGLT2 Inhibitors Transforming Heart Failure Treatment
The increasing use of SGLT2 inhibitors is one of the most important trends shaping the heart failure drugs market. These medicines, initially developed for diabetes treatment, are now widely adopted for heart failure management across HFrEF, HFpEF, and HFmrEF patient groups.
The broader application of SGLT2 inhibitors is expanding the treated patient population and increasing their revenue contribution. This trend is reducing dependence on traditional therapies such as beta blockers, ACE inhibitors, ARBs, and diuretics.
For instance, in May 2023, AstraZeneca received U.S. FDA approval for Farxiga to reduce cardiovascular death, hospitalization, and urgent heart failure visits among adults with heart failure regardless of left ventricular ejection fraction status.
Market Drivers
Rising Heart Failure Prevalence and Aging Population Driving Drug Demand
The increasing global burden of heart failure is the major factor supporting market expansion. Growing elderly populations, rising cases of diabetes, hypertension, obesity, and improved survival after cardiovascular events are increasing the number of patients requiring long-term treatment.
The rising adoption of guideline-directed medical therapies, including ARNI, SGLT2 inhibitors, MRAs, ACE inhibitors, ARBs, and beta blockers, is increasing prescription volumes for both branded and generic drugs.
According to healthcare estimates, around 6.7 million adults aged 20 years and above in the U.S. have heart failure, and the number is expected to increase significantly in the coming years, highlighting the growing treatment requirement.
Market Restraints
Limited Reimbursement and Access to Premium Heart Failure Therapies
Limited reimbursement coverage and affordability challenges may restrict market growth, especially in low- and middle-income countries.
Advanced therapies such as ARNI and SGLT2 inhibitors provide significant clinical benefits but often face accessibility issues due to high costs, limited insurance coverage, and insufficient specialist availability.
As a result, several emerging markets continue to depend on lower-cost generic cardiovascular medicines.
Market Opportunities
Expansion of HFpEF and HFmrEF Treatment Pool
Increasing focus on HFpEF and HFmrEF patient groups is creating significant growth opportunities.
Historically, these patient populations had limited treatment options; however, increasing adoption of SGLT2 inhibitors across different ejection fraction ranges is expanding treatment opportunities.
Improved diagnosis, wider guideline adoption, and increasing clinical research are expected to increase prescription volumes and create new revenue opportunities for market participants.
Market Challenges
Safety and Tolerability Concerns Associated with SGLT2 Inhibitors
Safety concerns related to SGLT2 inhibitors may challenge broader adoption, particularly among elderly, renal-impaired, and high-risk patients.
Potential risks such as diabetic ketoacidosis, volume depletion, and serious genitourinary infections require careful monitoring and patient selection.
These factors may slow adoption despite strong clinical benefits.
By Drug Class
ARNI Segment Dominates Due to Strong Treatment Value
Based on drug class, the market is segmented into:
The ARNI segment dominated the market in 2025 due to the strong commercial performance of Entresto in chronic heart failure treatment.
High treatment value, strong clinical adoption, guideline recommendations, and recurring prescriptions supported segment leadership.
The SGLT2 inhibitors segment is expected to grow at a CAGR of 23.92% during 2026-2034, making it the fastest-growing drug class.
By Indication
HFrEF Segment Leads Due to Established Treatment Pathways
The HFrEF segment accounted for the largest market share in 2025 due to established treatment guidelines and extensive use of combination therapies.
The segment is expected to maintain approximately 57.6% share in 2026.
The HFpEF segment is projected to witness strong growth due to increasing availability of effective treatment options.
By Type
Branded Segment Holds Leading Market Position
The branded segment dominated the market in 2025 due to strong demand for high-value therapies such as Entresto, Farxiga, Jardiance, and other innovative treatments.
The segment is expected to hold approximately 68.1% share in 2026.
The generic segment is projected to grow at a CAGR of 12.47% during the forecast period due to increasing affordability and access.
By Route of Administration
Oral Segment Dominates Due to Long-Term Treatment Usage
The oral segment captured the largest share in 2025 due to widespread use of tablets and capsules for chronic heart failure management.
The segment is expected to hold approximately 93.9% share in 2026.
By Age Group
Adults Segment Dominates Due to Higher Disease Burden
The adults segment accounted for the largest market share in 2025 due to higher prevalence of heart failure among adult and elderly populations.
The segment is expected to maintain approximately 98.2% share in 2026.
By Distribution Channel
Retail Pharmacies and Drug Stores Lead Market
Retail pharmacies and drug stores dominated the market in 2025 due to recurring prescriptions and long-term outpatient treatment requirements.
The segment is expected to hold approximately 59.8% share in 2026.
North America Heart Failure Drugs Market
North America dominated the global market in 2025 with a value of USD 5.11 billion.
Growth is supported by:
U.S. Heart Failure Drugs Market
The U.S. market is estimated to reach approximately USD 5.34 billion in 2026, representing around 39.8% of global market revenue.
Europe Heart Failure Drugs Market
Europe is projected to grow at a CAGR of 13.02% during 2026-2034.
Growth is supported by increasing adoption of guideline-based treatment, aging population, and rising use of SGLT2 inhibitors.
Germany Heart Failure Drugs Market
Germany is expected to reach approximately USD 0.76 billion in 2026.
U.K. Heart Failure Drugs Market
The U.K. market is expected to reach approximately USD 0.61 billion in 2026.
Asia Pacific Heart Failure Drugs Market
Asia Pacific is expected to be the fastest-growing region due to increasing cardiovascular disease burden, rising healthcare expenditure, and improving access to advanced therapies.
The regional market is projected to reach USD 2.75 billion in 2026.
China Heart Failure Drugs Market
China is expected to reach approximately USD 0.91 billion in 2026.
Japan Heart Failure Drugs Market
Japan is expected to reach approximately USD 0.61 billion in 2026.
India Heart Failure Drugs Market
India is expected to reach approximately USD 0.33 billion in 2026.
Latin America and Middle East & Africa
Latin America is projected to reach USD 0.74 billion in 2026, supported by increasing cardiovascular disease burden and improving access to medications.
The GCC market is expected to reach approximately USD 0.25 billion in 2026 due to healthcare modernization and chronic disease management initiatives.
Competitive Landscape
Key Industry Players
The global heart failure drugs market is moderately consolidated, with leading companies focusing on innovative therapies, clinical research, geographic expansion, and strategic collaborations.
Major companies include:
Companies are strengthening their market positions through branded drug development, generic launches, lifecycle expansion, and clinical evidence generation.
Key Industry Developments
Report Coverage
The global heart failure drugs market report provides detailed analysis of market size, forecast, segmentation, regional performance, competitive landscape, product developments, regulatory environment, and emerging treatment trends.
The report evaluates key market drivers, restraints, opportunities, and challenges influencing market growth during the forecast period of 2026-2034.
Conclusion
The global heart failure drugs market is projected to grow from USD 11.79 billion in 2025 to USD 38.46 billion by 2034, driven by rising heart failure prevalence, aging populations, increasing adoption of guideline-directed medical therapies, and rapid expansion of SGLT2 inhibitors.
North America will continue to maintain market leadership due to advanced healthcare infrastructure, strong reimbursement systems, and high adoption of innovative therapies. Meanwhile, Asia Pacific is expected to witness significant growth due to increasing cardiovascular disease burden, improving healthcare access, and rising demand for advanced heart failure treatments.
Future market expansion will depend on continued innovation in cardiovascular therapies, improved affordability of premium drugs, wider adoption of personalized treatment approaches, and increased availability of advanced heart failure medicines across emerging economies.
Segmentation By Drug Class, Indication, Type, Route of Administration, Age Group, Distribution Channel, and Region
By Drug Class
By Indication
By Type
By Route of Administration
By Age Group
By Distribution Channel
By Region