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米国のジェネリック医薬品市場規模は、2022年に869億米ドルに達しました。今後、IMARC Groupは、2023年から2028年にかけて4%の成長率（CAGR）を示し、2028年までに1107億米ドルに達すると予測しています。

ジェネリック医薬品とは、用量、強度、品質、形状、効果、使用目的、副作用、投与経路などの点で先発医薬品と生物学的に同等な特許切れの医薬品を指します。米国では、ジェネリック医薬品はブランド医薬品よりも安価で、大規模な研究やテストを必要としないため、生産量が大幅に増加しています。さらに、ジェネリック医薬品の導入は、患者のアクセスを改善し、納税者、雇用者、保険業者にとって節約となるため、同国の医療制度の維持に役立っています。さらに、心血管疾患、糖尿病、アルツハイマー病、パーキンソン病などの慢性疾患の有病率が地域全体で上昇しているため、現在、市場は大きな成長を遂げています。

市場の推進力
近年、ジェネリック医薬品メーカーが直面する障壁の解消を目指すFDAの医薬品競争アクションプランの実施に支えられ、米国全体でジェネリック医薬品の承認件数が増加しています。さらに、ジェネリック医薬品の開発・承認プロセスを強化するために、米国食品医薬品局（USFDA）は2017年にジェネリック医薬品ユーザーフィー改正を再承認した。GDUFA IIは、FDAにジェネリック医薬品審査のための追加リソースを提供するために、ジェネリック医薬品メーカーからユーザーフィーを徴収することを認めています。これ以外にも、政府は医師や薬剤師にインセンティブを提供し、国内でのジェネリック代替を促進するためのプログラムを複数導入しています。さらに、多くの先発医薬品が近い将来、特許保護を失い、国内のジェネリック医薬品市場に好影響を与えることが予想されています。

主要な市場セグメンテーション
IMARC Groupは、米国ジェネリック医薬品市場レポートの各サブセグメントにおける主要動向の分析と、世界レベルおよび米国における2023年から2028年の予測結果を提供しています。当レポートでは、セグメント、治療分野、ドラッグデリバリー、流通チャネルに基づいて市場を分類しています。

セグメント別構成比：

無印良品
ブランデッド

市場はノーブランドとブランドジェネリックに区分される。現在、ノンブランドジェネリック医薬品は、市場シェアの大半を占め、明確な優位性を示しています。

治療領域別の内訳：

中枢神経系
心血管系
皮膚科学
泌尿器・ホルモン
呼吸器
リウマチ科
糖尿病
オンコロジー
その他

市場は、主に中枢神経系、心血管、皮膚科、泌尿生殖器/ホルモン、呼吸器、リウマチ、糖尿病、腫瘍などの治療分野別に分類されています。

ドラッグデリバリーによるブレークアップ：

オーラル
インジェクタブル
経皮・外用
吸入器

薬物送達方法別では、患者にとって便利であり、最小限の医療補助しか必要としない経口薬が最大のセグメントを占めています。

流通チャネル別構成比：

病院内薬局
小売薬局

販売チャネル別では、この地域のジェネリック医薬品販売の大半を占める病院薬局が市場を支配しています。

競争環境：
市場の特徴は、品質と価格で競争するメーカーが存在することである。市場で活動している主要なプレーヤーは以下の通りです：

テバ
マイラン
アクタビス（テバ）
サンド（ノバルティス）
サンファーマ
パー・ファーマシューティカルズ（エンド・ファーマシューティカルズ）
ルパンファーマシューティカルズ
ドクターレディーズ
ホスピーラ（ファイザー）

本レポートで回答した主な質問

1.2022年、米国のジェネリック医薬品の規模はどうなったか？
2.2023年～2028年の米国ジェネリック医薬品の成長率はどのくらいと予想されますか？
3.米国のジェネリック医薬品市場を牽引する主要因は何か？
4.COVID-19が米国のジェネリック医薬品市場に与えた影響について教えてください。
5.米国のジェネリック医薬品市場のセグメント別構成比は？
6.米国のジェネリック医薬品市場の治療分野別の内訳は？
7.米国のジェネリック医薬品市場の薬物送達に基づく内訳はどうなっているか？
8.米国のジェネリック医薬品市場の流通チャネル別の内訳は？
9.米国のジェネリック医薬品市場における主要企業/プレーヤーは？

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目次

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)

List of Figures

Figure 1: Structure of the Pharmaceutical Industry
Figure 2: Classification of Generic Drugs
Figure 3: US: Patent Expiry Exposure (in Billion US$), 2010-2019
Figure 4: US: Savings from Generic Drugs (in Billion US$), 2007-2019E
Figure 5: Global: Generic Drug Market: Sales Value (in Billion US$), 2017-2022
Figure 6: Global: Generic Drug Market: Sales Volume (in Billion Standards Units), 2017-2022
Figure 7: Global: Generic Drug Market: Sales Value Breakup by Country (in %), 2022
Figure 8: Global: Generic Drug Market: Sales Volume Breakup by Country (in %), 2022
Figure 9: Global: Generic Drug Market Forecast: Sales Value (in Billion US$), 2023-2028
Figure 10: Global: Generic Drug Market Forecast: Sales Volume (in Billion Standards Units), 2023-2028
Figure 11: US: Pharmaceutical Market: Sales Volume (in Million Prescriptions), 2017-2022
Figure 12: US: Pharmaceutical Market: Sales Value (in Billion US$), 2017-2022
Figure 13: US: Pharmaceutical Market: Sales Volume Breakup of Branded and Generic Drugs (in %), 2017 & 2022
Figure 14: US: Pharmaceutical Market: Sales Value Breakup of Branded and Generic Drugs (in %), 2017 & 2022
Figure 15: US: Pharmaceutical Market Forecast: Sales Volume (in Million Prescriptions), 2023-2028
Figure 16: US: Pharmaceutical Market Forecast: Sales Value (in Billion US$), 2023-2028
Figure 17: US: Generic Drug Market: Sales Volume (in Million Prescriptions), 2017-2022
Figure 18: US: Generic Drug Market: Sales Value (in Billion US$), 2017-2022
Figure 19: US: Generic Drug Market: Breakup by Segment (in %), 2022
Figure 20: US: Generic Drug Market: Breakup by Therapy Area (in %), 2022
Figure 21: US: Generic Drug Market: Breakup by Drug Delivery (in %), 2022
Figure 22: US: Generic Drug Market: Breakup by Distribution Channel (in %), 2022
Figure 23: US: Generic Drug Market Forecast: Sales Volume (in Million Prescriptions), 2023-2028
Figure 24: US: Generic Drug Market Forecast: Sales Value (in Billion US$), 2023-2028
Figure 25: Generic Drug Market: Price Structure
Figure 26: US: Generic Drug Industry: SWOT Analysis
Figure 27: US: Generic Drug Industry: Value Chain Analysis
Figure 28: US: Generic Drug Industry: Pricing Mechanism and Profit Margins at the Various Levels of the Supply Chain
Figure 29: US: Generic Drug Industry: Porter's Five Forces Analysis
Figure 30: US: Generic Drug Market: Unbranded Generics (in Million Prescriptions), 2017 & 2022
Figure 31: US: Generic Drug Market Forecast: Unbranded Generics (in Million Prescriptions), 2023-2028
Figure 32: US: Generic Drug Market: Branded Generics (in Million Prescriptions), 2017 & 2022
Figure 33: US: Generic Drug Market Forecast: Branded Generics (in Million Prescriptions), 2023-2028
Figure 34: US: Generic Drug Market: CNS (in Million US$), 2017 & 2022
Figure 35: US: Generic Drug Market Forecast: CNS (in Million US$), 2023-2028
Figure 36: US: Generic Drug Market: Cardiovascular (in Million US$), 2017 & 2022
Figure 37: US: Generic Drug Market Forecast: Cardiovascular (in Million US$), 2023-2028
Figure 38: US: Generic Drug Market: Dermatology (in Million US$), 2017 & 2022
Figure 39: US: Generic Drug Market Forecast: Dermatology (in Million US$), 2023-2028
Figure 40: US: Generic Drug Market: Genitourinary/Hormonal (in Million US$), 2017 & 2022
Figure 41: US: Generic Drug Market Forecast: Genitourinary/Hormonal (in Million US$), 2023-2028
Figure 42: US: Generic Drug Market: Respiratory (in Million US$), 2017 & 2022
Figure 43: US: Generic Drug Market Forecast: Respiratory (in Million US$), 2023-2028
Figure 44: US: Generic Drug Market: Rheumatology (in Million US$), 2017 & 2022
Figure 45: US: Generic Drug Market Forecast: Rheumatology (in Million US$), 2023-2028
Figure 46: US: Generic Drug Market: Diabetes (in Million US$), 2017 & 2022
Figure 47: US: Generic Drug Market Forecast: Diabetes (in Million US$), 2023-2028
Figure 48: US: Generic Drug Market: Oncology (in Million US$), 2017 & 2022
Figure 49: US: Generic Drug Market Forecast: Oncology (in Million US$), 2023-2028
Figure 50: US: Generic Drug Market: Others (in Million US$), 2017 & 2022
Figure 51: US: Generic Drug Market Forecast: Others (in Million US$), 2023-2028
Figure 52: US: Generic Drug Market: Oral (in Million US$), 2017 & 2022
Figure 53: US: Generic Drug Market Forecast: Oral (in Million US$), 2023-2028
Figure 54: US: Generic Drug Market: Injectables (in Million US$), 2017 & 2022
Figure 55: US: Generic Drug Market Forecast: Injectables (in Million US$), 2023-2028
Figure 56: US: Generic Drug Market: Dermal/Topical (in Million US$), 2017 & 2022
Figure 57: US: Generic Drug Market Forecast: Dermal/Topical (in Million US$), 2023-2028
Figure 58: US: Generic Drug Market: Inhalers (in Million US$), 2017 & 2022
Figure 59: US: Generic Drug Market Forecast: Inhalers (in Million US$), 2023-2028
Figure 60: US: Generic Drug Market: Retail Pharmacies (in Million US$), 2017 & 2022
Figure 61: US: Generic Drug Market Forecast: Retail Pharmacies (in Million US$), 2023-2028
Figure 62: US: Generic Drug Market: Hospital Pharmacies (in Million US$), 2017 & 2022
Figure 63: US: Generic Drug Market Forecast: Hospital Pharmacies (in Million US$), 2023-2028
Figure 64: US: Generic Drug Market: Sales Breakup of Top Players (in %)
Figure 65: US: Generic Drug Market: Volume Share of Top Players (in %)
Figure 66: US: Generic Drug Market: Volume Share by Distribution (in %)
Figure 67: US: Generic Drug Prices as a Percentage of Branded Drug Prices – Based on Number of Competitors
Figure 68: US: Generic Drug Market: Detailed Process Flow
Figure 69: US: Generic Drug Market: Raw Material Requirements
Figure 70: US: Generic Drug Market: Plant Layout
Figure 71: US: Generic Drug Market: Packaging Requirements

List of Tables

Table 1: US: Sales and Patent Expiry of Major Drugs Expected to Lose Patent Protection (in Billion US$)
Table 2: US: Expenses of Generic and Branded Drug Manufacturers (in %)
Table 3: Global: Generic Drug Market: Volume Performance of Top Generic Drugs (in Million Prescriptions)
Table 4: Global: Branded Drug Market: Volume Performance of Top Branded Drugs (in Million Prescriptions)
Table 5: US: Generic Drug Market: Sales Performance of Top Players (in Billion US$), 2022
Table 6: US: Generic Drug Market: Volume Performance of Top Players (in Billion Units), 2022
Table 7: US: Generics Market: Volume Performance of Top Generic Drugs (in Million Prescriptions), 2022
Table 8: US: Overview of Pharmaceutical Regulations
Table 9: US: Generic Drug Market: Land and Construction Requirements
Table 10: US: Generic Drug Market: Machinery and Infrastructure Requirements
Table 11: US: Generic Drug Market: Utility Requirements
Table 12: US: Generic Drug Market: Manpower Requirements