ジェネリック医薬品の米国市場の評価：用途別、タイプ別、ブランド別、投与経路別、流通チャネル別、地域別、機会、予測（2017年～2031年）

米国のジェネリック医薬品の市場規模は、2023年の1,173億2,000万米ドルから2031年に1,967億9,000万米ドルに達すると予測され、2024年～2031年の予測期間にCAGRで6.68％の成長が見込まれます。市場の成長は、市場参入企業によるバイオシミラーやジェネリック医薬品の上市の増加、慢性疾患の有病率の上昇、主要市場参入企業間の戦略的提携やパートナーシップによって促進されています。また、ジェネリック医薬品製造施設に対するさまざまな企業による投資の増加も、米国のジェネリック医薬品市場の拡大を後押ししています。2024年3月、Mark Cuban Cost Plus Drug Company, PBCは、無菌注射薬を手始めにジェネリック医薬品の製造を開始すると発表しました。同社は3月、集中治療室（ICU）入院患者用のノルエピネフリンとエピネフリンの商業ロットの製造を開始しました。Cost Plus Drug Companyは、医薬品不足に対処するため、ダラスに1,100万米ドル、2万2,000平方フィートの充填・仕上げ施設を建設しました。

さらに、国内で慢性疾患の脅威が高まっていることも、市場の需要を増大させています。ほとんどの疾患では、患者が効果的に病状を管理するために、長期間にわたって頻回投薬する必要があるためです。ジェネリック医薬品はコスト効率の高い方法で患者に効果的なソリューションを提供するため、このことがジェネリック医薬品への要求を後押ししています。

主要市場企業の新規上市が市場拡大を支える

拡大するさまざまな疾病の脅威に対抗し、患者の利便性を確保するため、米国ではさまざまなジェネリック医薬品の導入を強化する主要市場企業の取り組みが活発化しており、米国のジェネリック医薬品の市場規模を押し上げています。2024年4月、Zydus Groupは米国食品医薬品局（USFDA）の承認を得て、25mgのミラボグロンを発売しました。このジェネリック医薬品は過活動膀胱の治療に使用されます。同社はジェネリック医薬品を発売した最初の企業の1つであり、50mgの錠剤の発売も準備中です。米国におけるジェネリック医薬品の発売の増加は、特許切れの増加や、治療費削減のために患者の間でジェネリック医薬品への選好が高まりにも起因していると考えられます。

慢性疾患の有病率の増加が市場の需要を押し上げる

国内におけるさまざまな慢性疾患の有病率の増加は、市場に有利な成長機会をもたらしています。National Cancer Instituteの推計によると、2024年に米国で約61万1,720人がこの疾患で死亡し、200万1,140人が新たにがんと診断されます。同様に、糖尿病の患者数も増加しています。American Diabetes Associationの推計によると、米国では3,800万人以上の成人と子供が糖尿病を患っています。ジェネリック医薬品は、患者が慢性疾患を効果的に管理し、経済効率を確保するのに役立つため、このような疾患の有病率の増加が、米国のジェネリック医薬品市場の需要を促進しています。ジェネリック医薬品は、先発医薬品と同じ作用機序を持ち、同じ有効成分を含んでいるため、患者に質の高い治療を提供することができます。

小売薬局が大きな市場シェアを占める

米国で小売薬局が選好されているのは、患者の利便性を向上させ、顧客体験を向上させるために個別化されたソリューションを提供する、このセグメントの技術主導の変革によるものと考えられます。2022年3月に発表された米国の薬局と薬局給付管理者に関する2022年経済レポートの推計によると、米国では年間約13万8,000件の処方箋が小売チェーンによって調剤されています。

一方、オンライン薬局セグメントは予測期間に大きく成長すると見込まれます。この成長は、オンライン薬局の経済的効率性と利便性によるものと考えられます。慢性疾患や障害のある患者は特に、物理的に薬を購入する必要がなく、患者の負担が軽減される一方、1日配達や夜間配送などの利点があるため、これらの薬局を好みます。さらに、さまざまな市場企業がオンライン薬局での呼吸器系薬剤の販売にも注力しています。例えば2023年9月、Lupin Ltd.はCost Plus Drugsというオンライン薬局で呼吸器系ジェネリック医薬品を販売すると発表しました。

当レポートでは、米国のジェネリック医薬品市場について調査分析し、市場規模と予測、市場力学、主要企業の情勢と見通しなどを提供しています。

目次

第1章 プロジェクトの範囲と定義

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 米国のジェネリック医薬品市場の見通し（2017年～2031年）

• 市場規模の分析と予測
  • 金額
  • 数量
• 市場シェア分析と予測
  • 用途別
  • タイプ別
  • ブランド別
  • 投与経路別
  • 流通チャネル別
  • 地域別
  • 市場シェア分析：企業別（金額）（上位5社とその他 - 2023年）
• 市場マップ分析（2023年）
  • 用途別
  • タイプ別
  • ブランド別
  • 投与経路別
  • 流通チャネル別
  • 地域別

第5章 需給分析

第6章 輸入と輸出の分析

第7章 バリューチェーン分析

第8章 ポーターのファイブフォース分析

第9章 PESTLE分析

第10章 価格分析

第11章 市場力学

• 市場促進要因
• 市場の課題

第12章 市場の動向と発展

第13章 規制枠組みとイノベーション

• バイオアベイラビリティ/生物学的同等性試験
• 規制当局の承認

第14章 特許の有効期限

第15章 ケーススタディ

第16章 競合情勢

• マーケットリーダー上位5社の競合マトリクス
• 上位5社のSWOT分析
• 主要企業上位10社の情勢
  • Hikma Pharmaceuticals plc
  • Sandoz Group AG
  • Viatris Inc.
  • Aurobindo Pharma US Ltd.
  • Lupin Ltd.
  • Sun Pharmaceutical Industries Ltd.
  • Teva Pharmaceuticals Industries Ltd.
  • Dr. Reddy's Laboratories
  • Glenmark Pharmaceuticals Inc.
  • Zydus Group

第17章 戦略的推奨

第18章 当社について、免責事項

List of Tables

• Table 1. Pricing Analysis of Products from Key Players
• Table 2. Competition Matrix of Top 5 Market Leaders
• Table 3. Mergers & Acquisitions/ Joint Ventures (If Applicable)
• Table 4. About Us - Regions and Countries Where We Have Executed Client Projects

List of Figures

• Figure 1. United States Generic Drugs Market, By Value, In USD Billion, 2017-2031F
• Figure 2. United States Generic Drugs Market, By Volume, In Number of Prescriptions, 2017-2031F
• Figure 3. United States Generic Drugs Market Share (%), By Application, 2017-2031F
• Figure 4. United States Generic Drugs Market Share (%), By Type, 2017-2031F
• Figure 5. United States Generic Drugs Market Share (%), By Brand, 2017-2031F
• Figure 6. United States Generic Drugs Market Share (%), By Route of Administration, 2017-2031F
• Figure 7. United States Generic Drugs Market Share (%), By Distribution Channel, 2017-2031F
• Figure 8. United States Generic Drugs Market Share (%), By Region, 2017-2031F
• Figure 9. By Application Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 10. By Type Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 11. By Brand Size Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 12. By Route of Administration Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 13. By Distribution Channel Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 14. By Region Map-Market Size (USD Billion) & Growth Rate (%), 2023

United States generic drugs market is projected to witness a CAGR of 6.68% during the forecast period 2024-2031, growing from USD 117.32 billion in 2023 to USD 196.79 billion in 2031. The market's growth is boosted by the increasing launch of biosimilars and generics by the market players, the rising prevalence of chronic diseases, and strategic collaborations and partnerships among the key market players. The increasing investments by various companies towards generic drug manufacturing facilities are also supporting the expansion of the United States generic drugs market. In March 2024, Mark Cuban Cost Plus Drug Company, PBC announced that they would start manufacturing generic drugs, beginning with sterile injectables. The company began manufacturing commercial batches of norepinephrine and epinephrine for patients admitted to the intensive care unit (ICU) in March. Cost Plus Drug Company constructed the USD 11 million, 22,000-square-foot fill and finish facility in Dallas to address the drug shortage.

Furthermore, the growing threat of chronic diseases in the country is also augmenting the market's demand, as in most conditions, patients require frequent dosages over a long period of time to manage the condition effectively. This, in turn, is propelling the requirement for generic drugs as they provide effective solutions to patients in a cost-efficient manner.

New Launches by Key Market Players Support Market Expansion

The growing efforts of key market players to bolster the introduction of different generics in the country to combat the growing threat of different diseases and ensure patient accessibility are boosting the United States generic drugs market size. In April 2024, Zydus Group launched Mirabegron with the strength of 25 mg after receiving approval from the United States Food and Drug Administration (USFDA). The generic drug is used for treating overactive bladder. The company is one of the first to launch generic medication and is preparing to launch tablets for the same with 50 mg strength. The rising launch of generics in the United States can also be attributed to the growing number of patent expiration and increasing preference for generics among patients to reduce treatment expenses.

Growing Prevalence of Chronic Diseases Boosts Market Demand

The increasing prevalence of various chronic diseases in the country is providing lucrative growth opportunities to the market. As per the estimates of the National Cancer Institute, in 2024, approximately 611,720 individuals will die from the disease, and 2,001,140 new cancer cases will be diagnosed in the United States. Similarly, the cases of diabetes are also increasing in the country. The American Diabetes Association estimates that over 38 million adults and children in the United States are living with diabetes. The increasing prevalence of such diseases is propelling the United States generic drugs market demand as generic drugs aid patients in effectively managing chronic diseases while ensuring economic efficiency. Generic drugs have the same mechanism of action and contain the same active ingredient as brand-name drugs, thus providing quality treatments to patients.

Retail Pharmacies Account for Significant Market Share

The preference for retail pharmacies in the United States can be attributed to the technology-driven transformation of the segment that is increasing patients' convenience and providing them with personalized solutions to improve the customer experience. As per the 2022 economic report estimates on U.S. pharmacies and pharmacy benefit managers, published in March 2022, approximately 138,000 prescriptions are dispensed annually by retail chains in the United States.

Meanwhile, the online pharmacy segment is expected to grow significantly over the forecast period. This growth can be attributed to the economically efficient and convenient nature of online pharmacies. Patients with chronic diseases and disorders especially prefer these pharmacies as they eliminate the requirement of physically purchasing drugs, reducing the strain on the patients while offering advantages such as one-day delivery and overnight shipping. Additionally, various market players are also focusing on selling their respiratory drugs across online pharmacies. For instance, in September 2023, Lupin Ltd. announced that they would be selling their generic respiratory drugs across the online pharmacy called Cost Plus Drugs.

Biosimilars Hold Major Market Share

The rising approvals by the USFDA for the launch of different biosimilars in the United States support the growth of the segment. In February 2024, the FDA provided approval to Alvotech for AVT02; Simlandi, their adalimumab biosimilar, making it the tenth US approval for the biosimilar referencing Humira (adalimumab) and the first for the company. The medication also received approval as an interchangeable biosimilar. The marketing and commercialization of the drug will be done as part of an exclusive partnership by Teva Pharmaceuticals Industries Ltd., supporting the introduction of additional treatment options for patients and ensuring cost efficiency across the country's healthcare system. Such approvals are expected to bolster the availability of different biosimilars across the country and boost the United States generic drugs market growth. They also mark partnership milestones for Teva, one of the key players in the market, and Alvotech to ensure the uptake and availability of biosimilars across the United States by collaborating on seven biosimilars.

Future Market Scenario (2024-2031F)

As per the United States generic drugs market analysis, the market is estimated to witness significant growth over the forecast period. The rising prevalence of chronic diseases such as diabetes and cancer in the country supports this growth. The market is also expected to witness the introduction of complex biosimilars and generics. A wide range of patents are expiring in the coming years, providing opportunities for the creation of their generics. Meanwhile, the increasing costs of healthcare are bolstering the demand for generics. With increasing the affordability of healthcare being one of the primary focus areas of the government, the market is expected to witness lucrative growth opportunities in the coming years.

Key Players Landscape and Outlook

The rising efforts by key market players in the market to boost the introduction of different generics in the United States are expected to provide lucrative growth opportunities to the market. In August 2024, Glenmark Pharmaceuticals, Inc. introduced a generic eye treatment medication, Olopatadine Hydrochloride Ophthalmic Solution, in the United States. Such introductions showcase the commitment of the key players of the market to provide high-quality solutions to the patients and meet the diverse requirements of the market. Even though the Office of Generic Drugs published 98 drug-specific guidelines last year, the growth potential for generics in the United States is significant, and market penetration can lead to significant profits.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. United States Generic Drugs Market Outlook, 2017-2031F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
  • 4.1.2. By Volume
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Application
    • 4.2.1.1. Neurovascular
    • 4.2.1.2. Cardiovascular
    • 4.2.1.3. Dermatology
    • 4.2.1.4. Oncology
    • 4.2.1.5. Diabetology
    • 4.2.1.6. Respiratory
    • 4.2.1.7. Others
  • 4.2.2. By Type
    • 4.2.2.1. Biosimilar Generics
    • 4.2.2.2. Small Molecule Generics
  • 4.2.3. By Brand
    • 4.2.3.1. Branded Generic
    • 4.2.3.2. Pure Generic
  • 4.2.4. By Route of Administration
    • 4.2.4.1. Oral
    • 4.2.4.2. Injectable
    • 4.2.4.3. Topical
    • 4.2.4.4. Others
  • 4.2.5. By Distribution Channel
    • 4.2.5.1. Hospital Pharmacy
    • 4.2.5.2. Retail Pharmacy
    • 4.2.5.3. Online Pharmacy
  • 4.2.6. By Region
    • 4.2.6.1. Northeast
    • 4.2.6.2. Midwest
    • 4.2.6.3. West
    • 4.2.6.4. South
  • 4.2.7. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2023)
• 4.3. Market Map Analysis, 2023
  • 4.3.1. By Application
  • 4.3.2. By Type
  • 4.3.3. By Brand
  • 4.3.4. By Route of Administration
  • 4.3.5. By Distribution Channel
  • 4.3.6. By Region

5. Demand Supply Analysis

6. Import and Export Analysis

7. Value Chain Analysis

8. Porter's Five Forces Analysis

9. PESTLE Analysis

10. Pricing Analysis

11. Market Dynamics

• 11.1. Market Drivers
• 11.2. Market Challenges

12. Market Trends and Developments

13. Regulatory Framework and Innovation

• 13.1. Bioavailability/Bioequivalence Studies
• 13.2. Regulatory Approvals

14. Patent Expiration

15. Case Studies

16. Competitive Landscape

• 16.1. Competition Matrix of Top 5 Market Leaders
• 16.2. SWOT Analysis for Top 5 Players
• 16.3. Key Players Landscape for Top 10 Market Players
  • 16.3.1. Hikma Pharmaceuticals plc
    • 16.3.1.1. Company Details
    • 16.3.1.2. Key Management Personnel
    • 16.3.1.3. Products and Services
    • 16.3.1.4. Financials (As Reported)
    • 16.3.1.5. Key Market Focus and Geographical Presence
    • 16.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisitions
  • 16.3.2. Sandoz Group AG
  • 16.3.3. Viatris Inc.
  • 16.3.4. Aurobindo Pharma US Ltd.
  • 16.3.5. Lupin Ltd.
  • 16.3.6. Sun Pharmaceutical Industries Ltd.
  • 16.3.7. Teva Pharmaceuticals Industries Ltd.
  • 16.3.8. Dr. Reddy's Laboratories
  • 16.3.9. Glenmark Pharmaceuticals Inc.
  • 16.3.10. Zydus Group

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

17. Strategic Recommendations

18. About Us and Disclaimer