발사르탄 시장 : 제품 유형, 적응증, 제제, 용량, 유통 채널, 지역별 분석 - 규모, 업계 역학, 기회 분석 및 예측(2026-2035년)

The global valsartan market is on a strong upward growth trajectory, reflecting both the rising global burden of cardiovascular diseases and the increasing reliance on cost-effective generic therapies. In 2025, the market was valued at approximately USD 1,545.78 million, and it is projected to reach around USD 3,184.29 million by 2035. This represents a compound annual growth rate (CAGR) of about 7.50% over the forecast period from 2026 to 2035, indicating sustained and structurally supported expansion rather than short-term cyclical growth.

This growth is primarily driven by the escalating prevalence of hypertension and heart failure worldwide, which continues to expand the patient pool requiring long-term antihypertensive treatment. As valsartan is widely used as a first-line angiotensin II receptor blocker (ARB), its demand remains closely linked to the rising incidence of lifestyle-related risk factors such as obesity, diabetes, sedentary behavior, and aging populations.

Noteworthy Market Developments

The global valsartan market is increasingly characterized by an oligopolistic structure dominated by a small group of large, vertically integrated pharmaceutical companies that control significant portions of both active pharmaceutical ingredient (API) production and finished dosage form (FDF) manufacturing. This concentration of market power allows these firms to exert strong influence over pricing, supply chains, and global distribution networks, while smaller players struggle to compete on scale, regulatory capacity, and cost efficiency.

Novartis, as the original innovator of valsartan through its branded product Diovan and the sacubitril/valsartan combination Entresto, continues to retain a presence in the high-value branded segment. Teva Pharmaceutical Industries remains one of the most influential players in the global valsartan supply chain, supported by its extensive international distribution network and diversified generics portfolio.

Lupin Limited has emerged as a strong challenger within the valsartan market, leveraging its aggressive expansion strategy in regulated and semi-regulated markets. Aurobindo Pharma stands out as one of the largest volume-driven suppliers in the valsartan market. The company is widely recognized for its aggressive pricing strategies and extensive backward integration capabilities, which enable it to control raw material sourcing and reduce production costs significantly.

Core Growth Drivers

Hypertension remains the primary structural driver of long-term demand in the valsartan market, supported by its extremely high global prevalence and chronic nature. According to the World Health Organization (WHO), approximately 1.4 billion adults aged 30-79 years were living with hypertension as of 2024, accounting for nearly one-third of the global population within that age group. This widespread disease burden creates a large and continuously expanding patient pool requiring lifelong antihypertensive therapy, of which valsartan remains one of the widely prescribed angiotensin II receptor blockers (ARBs).

Emerging Opportunity Trends

The Entresto pivot represents one of the most significant demand catalysts for the valsartan market, primarily due to the expected shift in market dynamics following the July 2025 patent expiry of Novartis's blockbuster heart failure therapy, Entresto. As a combination drug containing sacubitril and valsartan, Entresto has been a major driver of high-value ARB-related pharmaceutical revenues globally. Its loss of exclusivity is expected to fundamentally reshape both the competitive landscape and the underlying demand structure for valsartan-based products.

Barriers to Optimization

The risk assessment mandate has introduced a significant regulatory layer that is expected to moderately constrain the growth of the valsartan market, particularly within the generic drug segment. Under current regulatory expectations, every Abbreviated New Drug Application (ANDA) filer is required to submit a detailed and comprehensive risk assessment addressing the potential formation of nitrosamine impurities at each stage of the manufacturing process. This requirement reflects heightened global regulatory scrutiny following past contamination concerns in the angiotensin II receptor blocker (ARB) class, including valsartan.

Detailed Market Segmentation

By formulation, monotherapy products accounted for the largest share of the valsartan market in 2025, representing approximately 51% of total demand. This indicates that single-agent valsartan formulations continued to maintain a strong presence in clinical practice, despite the increasing shift toward combination therapies in modern hypertension management. Monotherapy formulations remain widely used due to their simplicity, ease of titration, and suitability for patients with mild to moderate hypertension or those newly diagnosed who require gradual treatment escalation.

By dosage strength, the 81-160 mg segment accounted for the highest share of the global valsartan market in 2025, contributing approximately 45% of total demand. This dominance reflects established clinical prescribing practices, where mid-range doses are most frequently used for long-term hypertension management. The concentration of demand within this dosage band highlights its role as the standard therapeutic range for maintaining stable blood pressure control in the majority of patients.

By indication, the hypertension segment accounted for the largest share of the global valsartan market in 2025, contributing approximately 52% of total market revenue. The segment's dominance is primarily attributed to the widespread prevalence of hypertension worldwide and the long-term nature of its treatment. As hypertension is one of the most common chronic cardiovascular disorders globally, the demand for antihypertensive medications such as valsartan continues to remain consistently high across both developed and emerging healthcare markets.

• Based on product type, Finished Dosage Forms (FDFs) accounted for the largest share of the global valsartan market in 2025, contributing approximately 62% of total market revenue. This significant share highlights the growing importance of downstream pharmaceutical manufacturing activities, where companies derive greater value from producing and commercializing the final consumable drug product rather than solely supplying the active pharmaceutical ingredient (API). FDFs, which include tablets, capsules, and combination drug formulations, represent the stage at which pharmaceutical companies can establish stronger pricing power, brand recognition, and market presence.

Segment Breakdown

By Product Type

• Valsartan API
• Finished Dosage Forms (FDFs)
• Tablets
• Fixed-dose combinations

By Formulation

• Monotherapy Formulations
• Combination Formulations

By Dosage Strength

• <= 80 mg
• 81-160 mg
• > 160 mg

By Indication

• Hypertension
• Heart Failure
• Post-Myocardial Infarction
• Other Cardiovascular Conditions

By Distribution Channel

• Retail Pharmacies
• Hospital Pharmacies
• Online Pharmacies
• Other Channels

By Region

• North America
• The U.S.
• Canada
• Mexico
• Europe
• Western Europe
• The UK
• Germany
• France
• Italy
• Spain
• Rest of Western Europe
• Eastern Europe
• Poland
• Russia
• Rest of Eastern Europe
• Asia Pacific
• China
• India
• Japan
• Australia & New Zealand
• South Korea
• ASEAN
• Rest of Asia Pacific
• Middle East & Africa (MEA)
• Saudi Arabia
• South Africa
• UAE
• Rest of MEA
• South America
• Argentina
• Brazil
• Rest of South America

Geography Breakdown

• North America accounted for the largest share of the global valsartan market in 2025, contributing approximately 38% of total market revenue. This leadership position was driven less by higher consumption volumes and more by the region's premium pharmaceutical pricing environment, particularly in the United States. Compared with many other regions where drug prices are regulated or subject to stricter reimbursement controls, the US market allows significantly higher pricing for branded cardiovascular therapies. As a result, revenue generation in North America remained disproportionately high relative to actual patient volume and prescription distribution.
• A major factor behind this dominance was the continued commercial strength of Sacubitril/Valsartan, marketed as Entresto, which remained one of the most valuable cardiovascular drugs in the region during 2025. The product's strong adoption in the treatment of heart failure, combined with favorable reimbursement coverage and widespread physician acceptance in the US healthcare system, substantially elevated the overall valuation of the valsartan-related market segment. Consequently, North America's market share reflected not only the demand for standard valsartan formulations but also the exceptionally high revenue contribution from this premium combination therapy.

Leading Market Participants

• Alembic Pharmaceuticals Limited
• AstraZeneca plc
• Aurobindo Pharma Limited
• Dr Reddy's Laboratories Ltd.
• Glenmark Pharmaceuticals Inc.
• Hetero Labs Limited
• Lupin Pharmaceuticals Ltd.
• Mylan N.V.
• Novartis AG
• Others
• Sandoz International GmbH
• Sun Pharmaceutical Industries
• Teva Pharmaceutical Industries Ltd
• Torrent Pharmaceuticals Limited
• Zydus Cadila
• Other Prominent Players

Table of Content

Chapter 1. Executive Summary: Global Valsartan Market

Chapter 2. Research Methodology & Research Framework

• 2.1. Research Objective
• 2.2. Product Overview
• 2.3. Market Segmentation
• 2.4. Qualitative Research
  • 2.4.1. Primary & Secondary Sources
• 2.5. Quantitative Research
  • 2.5.1. Primary & Secondary Sources
• 2.6. Breakdown of Primary Research Respondents, By Region
• 2.7. Assumption for Study
• 2.8. Market Size Estimation
• 2.9. Data Triangulation

Chapter 3. Global Valsartan Market Overview

• 3.1. Industry Value Chain Analysis
  • 3.1.1. Key Starting Material (KSM) Suppliers (OTBN, Sodium Azide)
  • 3.1.2. Active Pharmaceutical Ingredient (API) Manufacturers
  • 3.1.3. Excipient & Formulation Ingredient Providers
  • 3.1.4. Finished Dosage Form (FDF) & Generic Formulators
  • 3.1.5. Contract Manufacturing & Packaging Organizations (CMOs/CDMOs)
  • 3.1.6. Distributors, Wholesalers & Pharmacy Benefit Managers (PBMs)
  • 3.1.7. End Users (Hospitals, Retail Pharmacies, Online Pharmacies, Patients)
• 3.2. Industry Outlook
  • 3.2.1. Global Hypertension & Cardiovascular Disease Burden Outlook
  • 3.2.2. Regulatory Landscape (FDA, EMA, USP/EP Nitrosamine Limits, Entresto Patent Cliff)
• 3.3. PESTLE Analysis
• 3.4. Porter's Five Forces Analysis
  • 3.4.1. Bargaining Power of Suppliers
  • 3.4.2. Bargaining Power of Buyers
  • 3.4.3. Threat of Substitutes
  • 3.4.4. Threat of New Entrants
  • 3.4.5. Degree of Competition
• 3.5. Market Growth and Outlook
  • 3.5.1. Market Revenue Estimates and Forecast (US$ Mn), 2020-2035
  • 3.5.2. Price Trend Analysis, By Product Type

Chapter 4. Global Valsartan Market Analysis

• 4.1. Competition Dashboard
  • 4.1.1. Market Concentration Rate
  • 4.1.2. Company Market Share Analysis (Value %), 2025
  • 4.1.3. Competitor Mapping & Benchmarking

Chapter 5. Global Valsartan Market Analysis

• 5.1. Market Dynamics and Trends
  • 5.1.1. Growth Drivers
  • 5.1.2. Restraints
  • 5.1.3. Opportunity
  • 5.1.4. Key Trends
• 5.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 5.2.1. By Product Type
    • 5.2.1.1. Key Insights
      • 5.2.1.1.1. Valsartan API
      • 5.2.1.1.2. Finished Dosage Forms (FDFs)
        • 5.2.1.1.2.1. Tablets
        • 5.2.1.1.2.2. Fixed-dose Combinations
  • 5.2.2. By Formulation
    • 5.2.2.1. Key Insights
      • 5.2.2.1.1. Monotherapy Formulations
      • 5.2.2.1.2. Combination Formulations
  • 5.2.3. By Dosage Strength
    • 5.2.3.1. Key Insights
      • 5.2.3.1.1. <= 80 mg
      • 5.2.3.1.2. 81-160 mg
      • 5.2.3.1.3. > 160 mg
  • 5.2.4. By Indication
    • 5.2.4.1. Key Insights
      • 5.2.4.1.1. Hypertension
      • 5.2.4.1.2. Heart Failure
      • 5.2.4.1.3. Post-Myocardial Infarction
      • 5.2.4.1.4. Other Cardiovascular Conditions
  • 5.2.5. By Distribution Channel
    • 5.2.5.1. Key Insights
      • 5.2.5.1.1. Retail Pharmacies
      • 5.2.5.1.2. Hospital Pharmacies
      • 5.2.5.1.3. Online Pharmacies
      • 5.2.5.1.4. Other Channels
  • 5.2.6. By Region
    • 5.2.6.1. Key Insights
      • 5.2.6.1.1. North America
        • 5.2.6.1.1.1. The U.S.
        • 5.2.6.1.1.2. Canada
        • 5.2.6.1.1.3. Mexico
      • 5.2.6.1.2. Europe
        • 5.2.6.1.2.1. Western Europe
          • 5.2.6.1.2.1.1. The UK
          • 5.2.6.1.2.1.2. Germany
          • 5.2.6.1.2.1.3. France
          • 5.2.6.1.2.1.4. Italy
          • 5.2.6.1.2.1.5. Spain
          • 5.2.6.1.2.1.6. Rest of Western Europe
        • 5.2.6.1.2.2. Eastern Europe
          • 5.2.6.1.2.2.1. Poland
          • 5.2.6.1.2.2.2. Russia
          • 5.2.6.1.2.2.3. Rest of Eastern Europe
      • 5.2.6.1.3. Asia Pacific
        • 5.2.6.1.3.1. China
        • 5.2.6.1.3.2. India
        • 5.2.6.1.3.3. Japan
        • 5.2.6.1.3.4. South Korea
        • 5.2.6.1.3.5. Australia & New Zealand
        • 5.2.6.1.3.6. ASEAN
          • 5.2.6.1.3.6.1. Cambodia
          • 5.2.6.1.3.6.2. Indonesia
          • 5.2.6.1.3.6.3. Malaysia
          • 5.2.6.1.3.6.4. Philippines
          • 5.2.6.1.3.6.5. Singapore
          • 5.2.6.1.3.6.6. Thailand
          • 5.2.6.1.3.6.7. Vietnam
          • 5.2.6.1.3.6.8. Rest of ASEAN
        • 5.2.6.1.3.7. Rest of Asia Pacific
      • 5.2.6.1.4. Middle East & Africa
        • 5.2.6.1.4.1. UAE
        • 5.2.6.1.4.2. Saudi Arabia
        • 5.2.6.1.4.3. South Africa
        • 5.2.6.1.4.4. Rest of MEA
      • 5.2.6.1.5. South America
        • 5.2.6.1.5.1. Argentina
        • 5.2.6.1.5.2. Brazil
        • 5.2.6.1.5.3. Rest of South America

Chapter 6. North America Market Analysis

• 6.1. Market Dynamics and Trends
  • 6.1.1. Growth Drivers
  • 6.1.2. Restraints
  • 6.1.3. Opportunity
  • 6.1.4. Key Trends
• 6.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 6.2.1. Key Insights
    • 6.2.1.1. By Product Type
    • 6.2.1.2. By Formulation
    • 6.2.1.3. By Dosage Strength
    • 6.2.1.4. By Indication
    • 6.2.1.5. By Distribution Channel
    • 6.2.1.6. By Country

Chapter 7. Europe Market Analysis

• 7.1. Market Dynamics and Trends
  • 7.1.1. Growth Drivers
  • 7.1.2. Restraints
  • 7.1.3. Opportunity
  • 7.1.4. Key Trends
• 7.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 7.2.1. Key Insights
    • 7.2.1.1. By Product Type
    • 7.2.1.2. By Formulation
    • 7.2.1.3. By Dosage Strength
    • 7.2.1.4. By Indication
    • 7.2.1.5. By Distribution Channel
    • 7.2.1.6. By Country

Chapter 8. Asia Pacific Market Analysis

• 8.1. Market Dynamics and Trends
  • 8.1.1. Growth Drivers
  • 8.1.2. Restraints
  • 8.1.3. Opportunity
  • 8.1.4. Key Trends
• 8.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 8.2.1. Key Insights
    • 8.2.1.1. By Product Type
    • 8.2.1.2. By Formulation
    • 8.2.1.3. By Dosage Strength
    • 8.2.1.4. By Indication
    • 8.2.1.5. By Distribution Channel
    • 8.2.1.6. By Country

Chapter 9. Middle East & Africa Market Analysis

• 9.1. Market Dynamics and Trends
  • 9.1.1. Growth Drivers
  • 9.1.2. Restraints
  • 9.1.3. Opportunity
  • 9.1.4. Key Trends
• 9.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 9.2.1. Key Insights
    • 9.2.1.1. By Product Type
    • 9.2.1.2. By Formulation
    • 9.2.1.3. By Dosage Strength
    • 9.2.1.4. By Indication
    • 9.2.1.5. By Distribution Channel
    • 9.2.1.6. By Country

Chapter 10. South America Market Analysis

• 10.1. Market Dynamics and Trends
  • 10.1.1. Growth Drivers
  • 10.1.2. Restraints
  • 10.1.3. Opportunity
  • 10.1.4. Key Trends
• 10.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 10.2.1. Key Insights
    • 10.2.1.1. By Product Type
    • 10.2.1.2. By Formulation
    • 10.2.1.3. By Dosage Strength
    • 10.2.1.4. By Indication
    • 10.2.1.5. By Distribution Channel
    • 10.2.1.6. By Country

Chapter 11. Company Profile (Company Overview, Financial Matrix, Key Product landscape, Key Personnel, Key Competitors, Contact Address, and Business Strategy Outlook)

• 11.1. Alembic Pharmaceuticals Limited
• 11.2. AstraZeneca plc
• 11.3. Aurobindo Pharma Limited
• 11.4. Dr. Reddy's Laboratories Ltd.
• 11.5. Glenmark Pharmaceuticals Inc.
• 11.6. Hetero Labs Limited
• 11.7. Lupin Pharmaceuticals Ltd.
• 11.8. Mylan N.V.
• 11.9. Novartis AG
• 11.10. Sandoz International GmbH
• 11.11. Sun Pharmaceutical Industries
• 11.12. Teva Pharmaceutical Industries Ltd.
• 11.13. Torrent Pharmaceuticals Limited
• 11.14. Zydus Cadila
• 11.15. Other Prominent Players

Chapter 12. Annexure

• 12.1. List of Secondary Sources
• 12.2. Key Country Markets- Macro Economic Outlook/Indicators