US Generic Drug Market
Description
The US generic drug market size was valued at USD 96.78 Billion in 2025 and is projected to reach USD 129.2 Billion by 2034, growing at a compound annual growth rate of 3.3% from 2026-2034.
The market is driven by the increasing prevalence of chronic diseases, rising healthcare costs prompting demand for affordable medication alternatives, and supportive government policies encouraging generic drug adoption. Patent expirations of major brand-name pharmaceuticals continue to create substantial opportunities for generic manufacturers. Additionally, growing consumer awareness about therapeutic equivalence and cost savings is accelerating acceptance across healthcare systems, contributing to the expanding US generic drug market share.
Key Takeaways and Insights:
US Generic Drug Market Trends:
Biosimilars Emergence and Market Penetration
The generic pharmaceutical landscape is witnessing significant transformation through the emergence of biosimilars as a major growth category. According to sources, in 2025, Samsung Bioepis launched Ustekinumab biosimilars in the US following Stelara's exclusivity loss, offering over 80% WAC discounts and benefiting from FDA and EMA regulatory streamlining. These approvals aim to accelerate biosimilar adoption and intensify competition in the US market. Furthermore, healthcare systems are increasingly adopting biosimilar alternatives for complex biological therapies, creating new opportunities for manufacturers with advanced bioprocessing capabilities. Regulatory frameworks have evolved to facilitate biosimilar approvals while maintaining rigorous quality and efficacy standards. This trend is reshaping competitive dynamics as established generic manufacturers invest in biotechnology capabilities to capture emerging opportunities in high-value therapeutic segments.
Digital Health Integration and Supply Chain Modernization
Generic drug manufacturers are increasingly leveraging digital technologies to enhance operational efficiency and supply chain resilience. Furthermore, advanced analytics and artificial intelligence (AI) applications are optimizing inventory management, demand forecasting, and distribution logistics. Blockchain technology implementation is improving traceability and authentication across pharmaceutical supply networks. These technological investments are enabling manufacturers to respond more effectively to market demand fluctuations while ensuring product integrity and regulatory compliance throughout the distribution chain.
Specialty Generic Drug Development Focus
The market is experiencing a strategic shift toward specialty generic drug development as manufacturers seek higher-margin opportunities. As per sources, ANI Pharmaceuticals received FDA approval and launched Prucalopride Tablets, the first generic Motegrity®, with 180-day Competitive Generic Therapy exclusivity, strengthening its U.S. generics market position. Moreover, complex generics requiring specialized formulation technologies, including extended-release systems and combination products, are receiving increased investment attention. Manufacturers are developing capabilities in difficult-to-replicate dosage forms to establish competitive differentiation. This trend reflects the evolving market dynamics where traditional commodity generic margins face continued pressure, driving innovation toward technically challenging product categories.
Market Outlook 2026-2034:
The US generic drug market is positioned for sustained revenue growth through the forecast period, supported by ongoing patent expirations of branded pharmaceuticals and continued healthcare cost optimization efforts. Market revenue expansion will be driven by increasing generic penetration rates, biosimilar adoption acceleration, and demographic factors including population aging. Strategic consolidation among manufacturers and vertical integration initiatives are expected to reshape competitive dynamics while enhancing operational efficiencies across the value chain. The market generated a revenue of USD 96.78 Billion in 2025 and is projected to reach a revenue of USD 129.2 Billion by 2034, growing at a compound annual growth rate of 3.3% from 2026-2034.
Breakup by Segment:
Unbranded represent the dominant segment within the US generic drug market, characterized by their commodity-like market positioning and extensive therapeutic coverage across multiple treatment categories. These products compete primarily on price, with manufacturers focusing on operational efficiency and high-volume production capabilities to maintain profitability in increasingly competitive market environments. As per sources, Civica Rx’s Virginia facility began producing over 200 Million units of essential unbranded generic and biosimilar medications annually, enhancing availability, affordability, and FDA-compliant supply chain integrity. Moreover, the segment benefits from established regulatory pathways, widespread acceptance across healthcare delivery settings, and strong demand from cost-conscious healthcare systems seeking affordable medication treatment alternatives.
The leadership position for unbranded reflects the fundamental economics of generic drug markets, where therapeutic equivalence enables price-based competition among multiple manufacturers vying for market share. Pharmacy chains and healthcare institutions preferentially stock unbranded generics to maximize cost savings while maintaining treatment efficacy for patients across diverse conditions. Manufacturing scale advantages, streamlined distribution networks, and efficient supply chain operations continue to reinforce segment dominance across therapeutic categories, ensuring sustained market leadership throughout the forecast period.
Therapy Area Insights:
CNS commands the therapy area segmentation, reflecting the substantial burden of neurological and psychiatric conditions across the American population requiring ongoing medical intervention. Generic CNS medications effectively address prevalent conditions including depression, anxiety disorders, epilepsy, and various neurodegenerative disorders requiring chronic treatment regimens over extended periods. According to reports, in July 2025, Zenara Pharma received FDA approval for the first generic Sertraline Hydrochloride Capsules with 180-day CGT exclusivity, enhancing affordable treatment options for depression and OCD in the U.S. Furthermore, the segment benefits significantly from numerous patent expirations of major brand-name CNS pharmaceuticals, creating substantial opportunities for generic manufacturers to offer cost-effective therapeutic alternatives to patients.
CNS prominence is sustained by increasing mental health awareness and expanding diagnostic capabilities leading to higher treatment rates across diverse demographic groups. Healthcare providers routinely rely on established generic CNS medications with well-documented safety profiles for long-term patient management and ongoing therapeutic interventions. Formulary inclusion and insurance coverage policies consistently favor generic utilization in this therapeutic category, supporting continued segment leadership while ensuring accessible treatment options for patients requiring neurological and psychiatric care.
Drug Delivery Insights:
Oral maintains commanding market share due to patient convenience, self-administration capability, and well-established manufacturing infrastructure supporting large-scale production operations. Solid oral dosage forms including tablets and capsules dominate production volumes, supported by mature formulation technologies and cost-effective manufacturing processes developed over decades of pharmaceutical industry experience. As per sources, in November 2025, Ingenus Pharmaceuticals received FDA approval and launched the first generic Premarin® tablets in the U.S., enhancing access to essential oral hormone therapy nationwide. Further, the segment encompasses diverse therapeutic applications spanning chronic disease management, acute treatment needs, and preventive care interventions, making it essential for comprehensive patient treatment across healthcare settings.
The leadership for oral reflects healthcare delivery preferences favoring outpatient treatment models where patient compliance is optimized through convenient dosing regimens administered at home settings. Generic manufacturers benefit significantly from extensive experience in oral formulation development and streamlined regulatory approval processes established over years of operation. Distribution efficiency and storage stability characteristics further reinforce oral delivery dominance across pharmacy channels, ensuring reliable product availability and supporting sustained segment growth throughout the broader market landscape.
Distribution Channel Insights:
Retail pharmacies constitute the primary distribution channel for generic pharmaceuticals, serving as the principal interface between manufacturers and patients seeking prescription medications across the country. This channel encompasses independent pharmacies, chain drugstores, and mass merchandiser pharmacy operations serving diverse community populations nationwide. Retail pharmacies benefit from established prescription capture relationships with healthcare providers and convenient patient access locations throughout urban, suburban, and rural areas, ensuring comprehensive geographic coverage for medication dispensing and pharmaceutical care services.
Retail pharmacies dominance is reinforced by integrated pharmacy benefit management systems that direct prescription fulfillment toward retail networks with negotiated pricing arrangements and preferred provider agreements. Consumer preference for accessible local pharmacy services and the expanding role of pharmacists in medication therapy management significantly strengthen retail channel positioning. According to sources, in October 2025, CVS Health reported that nearly 8 in 10 U.S. adults visited a community pharmacy in the past year, with 77% trusting their local pharmacist for healthcare guidance. Moreover, generic drug manufacturers prioritize establishing retail distribution relationships to ensure broad market access, optimal inventory availability, and efficient product flow to patients requiring affordable prescription medication treatment options.
Market Dynamics:
Growth Drivers:
Why is the US Generic Drug Market Growing?
Patent Cliff and Branded Drug Exclusivity Expirations
The continuous expiration of patents and market exclusivities for branded pharmaceuticals creates substantial growth opportunities for generic manufacturers seeking market expansion. Major therapeutic categories are experiencing significant patent cliff events, enabling generic competition for previously protected blockbuster medications across diverse treatment areas. As per sources, in March 2025, the FDA approved the first generic Xarelto (rivaroxaban) 2.5 mg tablets, expanding affordable anticoagulant options for U.S. patients with coronary artery and peripheral artery disease. Furthermore, this dynamic generates recurring market entry opportunities as pharmaceutical portfolios mature and exclusivity periods conclude over time. Generic manufacturers strategically position product development pipelines to capitalize on upcoming patent expirations across high-value therapeutic segments, ensuring sustained market expansion and revenue growth opportunities.
Healthcare Cost Containment Imperatives
Escalating healthcare expenditures are driving stakeholders across the healthcare ecosystem to embrace generic pharmaceuticals as essential cost management tools. Insurance companies, pharmacy benefit managers, and healthcare delivery organizations implement policies favoring generic substitution to effectively control medication spending across patient populations. Government healthcare programs mandate generic utilization where therapeutically appropriate, creating structural demand drivers supporting market growth. As per sources, CMS announced that the Inflation Reduction Act will lower Medicare Part D out-of-pocket prescription drug costs by 30%, saving beneficiaries approximately $7.4 Billion nationwide. Further, employers seeking to manage employee health benefits increasingly adopt plan designs promoting generic medication adherence, amplifying market growth dynamics and reinforcing demand for affordable pharmaceutical alternatives.
Regulatory Environment Supporting Generic Approval Efficiency
Regulatory agencies have implemented streamlined approval pathways that accelerate generic drug market entry while maintaining rigorous quality and bioequivalence standards throughout the evaluation process. Further, policy initiatives addressing application backlogs have significantly improved approval timelines for generic pharmaceuticals awaiting market authorization. Guidance documents clarifying complex generic development requirements reduce regulatory uncertainty and facilitate informed investment decisions by manufacturers. These regulatory improvements enhance overall market attractiveness by providing manufacturers with clearer pathways to market authorization and successful commercial launch across therapeutic categories.
Market Restraints:
What Challenges the US Generic Drug Market is Facing?
Pricing Pressure and Margin Compression
Intense price competition among generic manufacturers combined with aggressive purchasing strategies by large pharmacy chains creates sustained margin pressure across the industry. Consolidated buying power enables purchasers to extract significant price concessions from manufacturers competing for contract awards. These dynamic challenges profitability sustainability for manufacturers lacking scale advantages or differentiated product portfolios.
Regulatory Compliance and Quality Assurance Burdens
Stringent manufacturing quality requirements necessitate the substantial ongoing investments in facilities, equipment, and personnel to maintain compliance standards. Regulatory inspections and enforcement actions can disrupt production operations and market supply continuity. Compliance costs represent significant operational burdens particularly impacting smaller manufacturers with limited resources to address evolving regulatory expectations effectively.
Supply Chain Vulnerabilities and Raw Material Dependencies
Geographic concentration of active pharmaceutical ingredient production creates supply chain fragility affecting generic manufacturers reliant on external sourcing. Quality issues or production disruptions at key manufacturing sites can trigger medication shortages with significant market implications. Raw material price volatility and availability constraints introduce operational uncertainties challenging manufacturing planning and cost management.
Competitive Landscape:
The US generic drug market features a competitive landscape characterized by participation from large multinational pharmaceutical companies alongside specialized generic manufacturers and emerging market entrants across therapeutic segments. Market participants pursue diverse strategic approaches including portfolio breadth expansion, vertical integration, and specialty generic focus to establish competitive positioning within the industry. Manufacturing excellence, regulatory compliance track records, and robust distribution capabilities serve as key competitive differentiators among market players. Strategic partnerships and acquisition activities continue reshaping competitive dynamics as participants actively seek scale advantages and portfolio enhancement opportunities to strengthen market presence.
Some of the key players include:
1.How big is the US generic drug market?
2.What is the projected growth rate of the US generic drug market?
3.Which segment held the largest US generic drug market share?
4.What are the key factors driving market growth?
5.What are the major challenges facing the US generic drug market?
The market is driven by the increasing prevalence of chronic diseases, rising healthcare costs prompting demand for affordable medication alternatives, and supportive government policies encouraging generic drug adoption. Patent expirations of major brand-name pharmaceuticals continue to create substantial opportunities for generic manufacturers. Additionally, growing consumer awareness about therapeutic equivalence and cost savings is accelerating acceptance across healthcare systems, contributing to the expanding US generic drug market share.
Key Takeaways and Insights:
- By Segment: Unbranded dominates the market with a share of 83% in 2025, driven by their significantly lower production costs and widespread acceptance by healthcare providers and insurance companies seeking cost-effective treatment options.
- By Therapy Area: CNS leads the market with a share of 16% in 2025, owing to the high prevalence of neurological disorders and mental health conditions requiring long-term medication regimens.
- By Drug Delivery: Oral represents the largest segment with a market share of 72% in 2025, driven by patient preference for convenient administration, ease of self-medication, and established manufacturing infrastructure.
- By Distribution Channel: Retail pharmacies dominate the market with a share of 78% in 2025, owing to widespread accessibility, established dispensing networks, and consumer preference for convenient prescription fulfillment.
- Key Players: The US generic drug market exhibits a moderately consolidated competitive landscape, with established pharmaceutical manufacturers competing alongside emerging players across diverse therapeutic segments. Market participants differentiate through product portfolio breadth, manufacturing capabilities, regulatory compliance excellence, and strategic distribution partnerships. Some of the key players operating in the market include Teva, Mylan, Actavis (Teva), Sandoz (Novartis), Sun Pharma, Par Pharmaceuticals (Endo Pharmaceuticals), Lupin Pharmaceuticals, and Dr Reddy’s and Hospira (Pfizer).
US Generic Drug Market Trends:
Biosimilars Emergence and Market Penetration
The generic pharmaceutical landscape is witnessing significant transformation through the emergence of biosimilars as a major growth category. According to sources, in 2025, Samsung Bioepis launched Ustekinumab biosimilars in the US following Stelara's exclusivity loss, offering over 80% WAC discounts and benefiting from FDA and EMA regulatory streamlining. These approvals aim to accelerate biosimilar adoption and intensify competition in the US market. Furthermore, healthcare systems are increasingly adopting biosimilar alternatives for complex biological therapies, creating new opportunities for manufacturers with advanced bioprocessing capabilities. Regulatory frameworks have evolved to facilitate biosimilar approvals while maintaining rigorous quality and efficacy standards. This trend is reshaping competitive dynamics as established generic manufacturers invest in biotechnology capabilities to capture emerging opportunities in high-value therapeutic segments.
Digital Health Integration and Supply Chain Modernization
Generic drug manufacturers are increasingly leveraging digital technologies to enhance operational efficiency and supply chain resilience. Furthermore, advanced analytics and artificial intelligence (AI) applications are optimizing inventory management, demand forecasting, and distribution logistics. Blockchain technology implementation is improving traceability and authentication across pharmaceutical supply networks. These technological investments are enabling manufacturers to respond more effectively to market demand fluctuations while ensuring product integrity and regulatory compliance throughout the distribution chain.
Specialty Generic Drug Development Focus
The market is experiencing a strategic shift toward specialty generic drug development as manufacturers seek higher-margin opportunities. As per sources, ANI Pharmaceuticals received FDA approval and launched Prucalopride Tablets, the first generic Motegrity®, with 180-day Competitive Generic Therapy exclusivity, strengthening its U.S. generics market position. Moreover, complex generics requiring specialized formulation technologies, including extended-release systems and combination products, are receiving increased investment attention. Manufacturers are developing capabilities in difficult-to-replicate dosage forms to establish competitive differentiation. This trend reflects the evolving market dynamics where traditional commodity generic margins face continued pressure, driving innovation toward technically challenging product categories.
Market Outlook 2026-2034:
The US generic drug market is positioned for sustained revenue growth through the forecast period, supported by ongoing patent expirations of branded pharmaceuticals and continued healthcare cost optimization efforts. Market revenue expansion will be driven by increasing generic penetration rates, biosimilar adoption acceleration, and demographic factors including population aging. Strategic consolidation among manufacturers and vertical integration initiatives are expected to reshape competitive dynamics while enhancing operational efficiencies across the value chain. The market generated a revenue of USD 96.78 Billion in 2025 and is projected to reach a revenue of USD 129.2 Billion by 2034, growing at a compound annual growth rate of 3.3% from 2026-2034.
Breakup by Segment:
- Unbranded
- Branded
Unbranded represent the dominant segment within the US generic drug market, characterized by their commodity-like market positioning and extensive therapeutic coverage across multiple treatment categories. These products compete primarily on price, with manufacturers focusing on operational efficiency and high-volume production capabilities to maintain profitability in increasingly competitive market environments. As per sources, Civica Rx’s Virginia facility began producing over 200 Million units of essential unbranded generic and biosimilar medications annually, enhancing availability, affordability, and FDA-compliant supply chain integrity. Moreover, the segment benefits from established regulatory pathways, widespread acceptance across healthcare delivery settings, and strong demand from cost-conscious healthcare systems seeking affordable medication treatment alternatives.
The leadership position for unbranded reflects the fundamental economics of generic drug markets, where therapeutic equivalence enables price-based competition among multiple manufacturers vying for market share. Pharmacy chains and healthcare institutions preferentially stock unbranded generics to maximize cost savings while maintaining treatment efficacy for patients across diverse conditions. Manufacturing scale advantages, streamlined distribution networks, and efficient supply chain operations continue to reinforce segment dominance across therapeutic categories, ensuring sustained market leadership throughout the forecast period.
Therapy Area Insights:
- CNS
- Cardiovascular
- Dermatology
- Genitourinary/Hormonal
- Respiratory
- Rheumatology
- Diabetes
- Oncology
- Others
CNS commands the therapy area segmentation, reflecting the substantial burden of neurological and psychiatric conditions across the American population requiring ongoing medical intervention. Generic CNS medications effectively address prevalent conditions including depression, anxiety disorders, epilepsy, and various neurodegenerative disorders requiring chronic treatment regimens over extended periods. According to reports, in July 2025, Zenara Pharma received FDA approval for the first generic Sertraline Hydrochloride Capsules with 180-day CGT exclusivity, enhancing affordable treatment options for depression and OCD in the U.S. Furthermore, the segment benefits significantly from numerous patent expirations of major brand-name CNS pharmaceuticals, creating substantial opportunities for generic manufacturers to offer cost-effective therapeutic alternatives to patients.
CNS prominence is sustained by increasing mental health awareness and expanding diagnostic capabilities leading to higher treatment rates across diverse demographic groups. Healthcare providers routinely rely on established generic CNS medications with well-documented safety profiles for long-term patient management and ongoing therapeutic interventions. Formulary inclusion and insurance coverage policies consistently favor generic utilization in this therapeutic category, supporting continued segment leadership while ensuring accessible treatment options for patients requiring neurological and psychiatric care.
Drug Delivery Insights:
- Oral
- Injectables
- Dermal/Topical
- Inhalers
Oral maintains commanding market share due to patient convenience, self-administration capability, and well-established manufacturing infrastructure supporting large-scale production operations. Solid oral dosage forms including tablets and capsules dominate production volumes, supported by mature formulation technologies and cost-effective manufacturing processes developed over decades of pharmaceutical industry experience. As per sources, in November 2025, Ingenus Pharmaceuticals received FDA approval and launched the first generic Premarin® tablets in the U.S., enhancing access to essential oral hormone therapy nationwide. Further, the segment encompasses diverse therapeutic applications spanning chronic disease management, acute treatment needs, and preventive care interventions, making it essential for comprehensive patient treatment across healthcare settings.
The leadership for oral reflects healthcare delivery preferences favoring outpatient treatment models where patient compliance is optimized through convenient dosing regimens administered at home settings. Generic manufacturers benefit significantly from extensive experience in oral formulation development and streamlined regulatory approval processes established over years of operation. Distribution efficiency and storage stability characteristics further reinforce oral delivery dominance across pharmacy channels, ensuring reliable product availability and supporting sustained segment growth throughout the broader market landscape.
Distribution Channel Insights:
- Retail Pharmacies
- Hospital Pharmacies
Retail pharmacies constitute the primary distribution channel for generic pharmaceuticals, serving as the principal interface between manufacturers and patients seeking prescription medications across the country. This channel encompasses independent pharmacies, chain drugstores, and mass merchandiser pharmacy operations serving diverse community populations nationwide. Retail pharmacies benefit from established prescription capture relationships with healthcare providers and convenient patient access locations throughout urban, suburban, and rural areas, ensuring comprehensive geographic coverage for medication dispensing and pharmaceutical care services.
Retail pharmacies dominance is reinforced by integrated pharmacy benefit management systems that direct prescription fulfillment toward retail networks with negotiated pricing arrangements and preferred provider agreements. Consumer preference for accessible local pharmacy services and the expanding role of pharmacists in medication therapy management significantly strengthen retail channel positioning. According to sources, in October 2025, CVS Health reported that nearly 8 in 10 U.S. adults visited a community pharmacy in the past year, with 77% trusting their local pharmacist for healthcare guidance. Moreover, generic drug manufacturers prioritize establishing retail distribution relationships to ensure broad market access, optimal inventory availability, and efficient product flow to patients requiring affordable prescription medication treatment options.
Market Dynamics:
Growth Drivers:
Why is the US Generic Drug Market Growing?
Patent Cliff and Branded Drug Exclusivity Expirations
The continuous expiration of patents and market exclusivities for branded pharmaceuticals creates substantial growth opportunities for generic manufacturers seeking market expansion. Major therapeutic categories are experiencing significant patent cliff events, enabling generic competition for previously protected blockbuster medications across diverse treatment areas. As per sources, in March 2025, the FDA approved the first generic Xarelto (rivaroxaban) 2.5 mg tablets, expanding affordable anticoagulant options for U.S. patients with coronary artery and peripheral artery disease. Furthermore, this dynamic generates recurring market entry opportunities as pharmaceutical portfolios mature and exclusivity periods conclude over time. Generic manufacturers strategically position product development pipelines to capitalize on upcoming patent expirations across high-value therapeutic segments, ensuring sustained market expansion and revenue growth opportunities.
Healthcare Cost Containment Imperatives
Escalating healthcare expenditures are driving stakeholders across the healthcare ecosystem to embrace generic pharmaceuticals as essential cost management tools. Insurance companies, pharmacy benefit managers, and healthcare delivery organizations implement policies favoring generic substitution to effectively control medication spending across patient populations. Government healthcare programs mandate generic utilization where therapeutically appropriate, creating structural demand drivers supporting market growth. As per sources, CMS announced that the Inflation Reduction Act will lower Medicare Part D out-of-pocket prescription drug costs by 30%, saving beneficiaries approximately $7.4 Billion nationwide. Further, employers seeking to manage employee health benefits increasingly adopt plan designs promoting generic medication adherence, amplifying market growth dynamics and reinforcing demand for affordable pharmaceutical alternatives.
Regulatory Environment Supporting Generic Approval Efficiency
Regulatory agencies have implemented streamlined approval pathways that accelerate generic drug market entry while maintaining rigorous quality and bioequivalence standards throughout the evaluation process. Further, policy initiatives addressing application backlogs have significantly improved approval timelines for generic pharmaceuticals awaiting market authorization. Guidance documents clarifying complex generic development requirements reduce regulatory uncertainty and facilitate informed investment decisions by manufacturers. These regulatory improvements enhance overall market attractiveness by providing manufacturers with clearer pathways to market authorization and successful commercial launch across therapeutic categories.
Market Restraints:
What Challenges the US Generic Drug Market is Facing?
Pricing Pressure and Margin Compression
Intense price competition among generic manufacturers combined with aggressive purchasing strategies by large pharmacy chains creates sustained margin pressure across the industry. Consolidated buying power enables purchasers to extract significant price concessions from manufacturers competing for contract awards. These dynamic challenges profitability sustainability for manufacturers lacking scale advantages or differentiated product portfolios.
Regulatory Compliance and Quality Assurance Burdens
Stringent manufacturing quality requirements necessitate the substantial ongoing investments in facilities, equipment, and personnel to maintain compliance standards. Regulatory inspections and enforcement actions can disrupt production operations and market supply continuity. Compliance costs represent significant operational burdens particularly impacting smaller manufacturers with limited resources to address evolving regulatory expectations effectively.
Supply Chain Vulnerabilities and Raw Material Dependencies
Geographic concentration of active pharmaceutical ingredient production creates supply chain fragility affecting generic manufacturers reliant on external sourcing. Quality issues or production disruptions at key manufacturing sites can trigger medication shortages with significant market implications. Raw material price volatility and availability constraints introduce operational uncertainties challenging manufacturing planning and cost management.
Competitive Landscape:
The US generic drug market features a competitive landscape characterized by participation from large multinational pharmaceutical companies alongside specialized generic manufacturers and emerging market entrants across therapeutic segments. Market participants pursue diverse strategic approaches including portfolio breadth expansion, vertical integration, and specialty generic focus to establish competitive positioning within the industry. Manufacturing excellence, regulatory compliance track records, and robust distribution capabilities serve as key competitive differentiators among market players. Strategic partnerships and acquisition activities continue reshaping competitive dynamics as participants actively seek scale advantages and portfolio enhancement opportunities to strengthen market presence.
Some of the key players include:
- Teva
- Mylan
- Actavis (Teva)
- Sandoz (Novartis)
- Sun Pharma
- Par Pharmaceuticals (Endo Pharmaceuticals)
- Lupin Pharmaceuticals
- Dr Reddy’s
- Hospira (Pfizer)
1.How big is the US generic drug market?
2.What is the projected growth rate of the US generic drug market?
3.Which segment held the largest US generic drug market share?
4.What are the key factors driving market growth?
5.What are the major challenges facing the US generic drug market?
Table of Contents
135 Pages
- 1 Preface
- 2 Scope and Methodology
- 2.1 Objectives of the Study
- 2.2 Stakeholders
- 2.3 Data Sources
- 2.3.1 Primary Sources
- 2.3.2 Secondary Sources
- 2.4 Market Estimation
- 2.4.1 Bottom-Up Approach
- 2.4.2 Top-Down Approach
- 2.5 Forecasting Methodology
- 3 Executive Summary
- 4 US Generic Drug Market - Introduction
- 4.1 What are Generic Drugs
- 4.2 Unbranded and Branded Generics
- 4.3 Authorized Generics
- 4.4 Commoditized and Specialty Generics
- 5 Why is the US Generic Drug Market So Lucrative
- 5.1 Patent Expiry of Blockbuster Drugs
- 5.2 Significant Price Differential between Generics and Innovator Drugs
- 5.3 Savings for the Government and Third-Party Payers
- 5.4 Incentives for Dispensing and Prescribing Generic Drugs
- 5.5 Reimbursement and Lower Co-payments
- 5.6 Biosimilars
- 6 Global Generic Drug Market
- 6.1 Market Performance
- 6.1.1 Volume Trends
- 6.1.2 Value Trends
- 6.2 Market Breakup by Country
- 6.3 Market Forecast
- 6.4 Most Prescribed Generic and Branded Drugs
- 7 US Generic Drug Market
- 7.1 US Pharmaceutical Market Performance
- 7.1.1 Volume Trends
- 7.1.2 Value Trends
- 7.1.3 Market Breakup by Type
- 7.1.4 Market Forecast
- 7.2 US Generic Drug Market Performance
- 7.2.1 Volume Trends
- 7.2.2 Value Trends
- 7.2.3 Impact of COVID-19
- 7.2.4 Market Breakup by Segment
- 7.2.5 Market Breakup by Therapy Area
- 7.2.6 Market Breakup by Drug Delivery
- 7.2.7 Market Breakup by Distribution Channel
- 7.2.8 Market Forecast
- 8 Market Breakup by Segment
- 8.1 Unbranded Generics
- 8.1.1 Market Trends
- 8.1.2 Market Forecast
- 8.2 Branded Generics
- 8.2.1 Market Trends
- 8.2.2 Market Forecast
- 9 Market Breakup by Therapy Area
- 9.1 CNS
- 9.1.1 Market Trends
- 9.1.2 Market Forecast
- 9.2 Cardiovascular
- 9.2.1 Market Trends
- 9.2.2 Market Forecast
- 9.3 Dermatology
- 9.3.1 Market Trends
- 9.3.2 Market Forecast
- 9.4 Genitourinary/Hormonal
- 9.4.1 Market Trends
- 9.4.2 Market Forecast
- 9.5 Respiratory
- 9.5.1 Market Trends
- 9.5.2 Market Forecast
- 9.6 Rheumatology
- 9.6.1 Market Trends
- 9.6.2 Market Forecast
- 9.7 Diabetes
- 9.7.1 Market Trends
- 9.7.2 Market Forecast
- 9.8 Oncology
- 9.8.1 Market Trends
- 9.8.2 Market Forecast
- 9.9 Others
- 9.9.1 Market Trends
- 9.9.2 Market Forecast
- 10 Market Breakup by Drug Delivery
- 10.1 Oral
- 10.1.1 Market Trends
- 10.1.2 Market Forecast
- 10.2 Injectables
- 10.2.1 Market Trends
- 10.2.2 Market Forecast
- 10.3 Dermal/Topical
- 10.3.1 Market Trends
- 10.3.2 Market Forecast
- 10.4 Inhalers
- 10.4.1 Market Trends
- 10.4.2 Market Forecast
- 11 Market Breakup by Distribution Channel
- 11.1 Retail Pharmacies
- 11.1.1 Market Trends
- 11.1.2 Market Forecast
- 11.2 Hospital Pharmacies
- 11.2.1 Market Trends
- 11.2.2 Market Forecast
- 12 US Generic Drug Market - SWOT Analysis
- 12.1 Overview
- 12.2 Strengths
- 12.3 Weaknesses
- 12.4 Opportunities
- 12.5 Threats
- 13 US Generic Drug Market - Value Chain Analysis
- 13.1 Research and Development
- 13.2 Raw Material Procurement
- 13.3 Manufacturing
- 13.4 Marketing
- 13.5 Distribution
- 13.6 End-Consumer
- 14 Pricing Mechanism and Profit Margins at Various Levels of the Supply Chain
- 15 Porter’s Five Forces Analysis
- 15.1 Overview
- 15.2 Bargaining Power of Buyers
- 15.3 Bargaining Power of Suppliers
- 15.4 Degree of Rivalry
- 15.5 Threat of New Entrants
- 15.6 Threat of Substitutes
- 16 US Generic Drug Market- Competitive Landscape
- 16.1 US Generic Drug Market - Competitive Structure
- 16.2 US Generic Drug Market - Breakup of Key Players
- 16.3 US Generic Drug Market - Most Prescribed Generic Drugs
- 16.4 US Generic Drug Market - Market Breakup by Distribution
- 16.5 US Generic Drug Market - Pricing Dynamics
- 17 Regulations in the US Generic Drug Industry
- 17.1 Overview of Pharmaceutical Regulations
- 17.2 Drug Applications
- 17.3 Patents and Market Exclusivity
- 17.4 Regulatory Requirements for Generic Drugs
- 17.5 The Hatch-Waxman Act
- 17.6 Certifications
- 17.7 Other Important Considerations
- 18 US Generic Drug Market: Key Success Factors
- 19 US Generic Drug Market: Road Blocks
- 20 Requirements for Setting Up a Generic Drug Manufacturing Plant
- 20.1 Manufacturing Process
- 20.2 Raw Material Requirements
- 20.3 Raw Materials Pictures
- 20.4 Land and Construction Requirements
- 20.5 Machinery and Infrastructure Requirements
- 20.6 Machinery Pictures
- 20.7 Plant Layout
- 20.8 Packaging Requirements
- 20.9 Utility Requirements
- 20.10 Manpower Requirements
- 21 US Generic Drug Market - Key Company Profiles
- 21.1 Teva
- 21.2 Mylan
- 21.3 Actavis (Teva)
- 21.4 Sandoz (Novartis)
- 21.5 Sun Pharma
- 21.6 Par Pharmaceuticals (Endo Pharmaceuticals)
- 21.7 Lupin Pharmaceuticals
- 21.8 Dr Reddy’s
- 21.9 Hospira (Pfizer)
Pricing
Currency Rates
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