브랜드 제네릭 시장 : 의약품 유형별, 제형별, 적응증별, 유통 채널별, 지역별 시장 규모, 점유율, 전망, 기회 분석(2023-2030년)

Branded Generics Market, By Drug Class By Formulation, By Indication, Distribution Channel and By Region - Size, Share, Outlook, and Opportunity Analysis, 2023 - 2030

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한글목차

브랜드 제네릭은 오리지널 의약품의 특허가 만료된 후 오리지널 의약품 제조업체가 제조하는 제네릭 의약품 또는 후발 의약품 제조업체가 제조하는 제네릭 의약품을 말합니다. 브랜드 제네릭은 판매되기 전에 신약 허가 신청(ANDA) 절차를 거쳐야 합니다. 브랜드 제네릭은 브랜드 제품보다 저렴하지만, 제네릭 의약품보다 더 비쌀 수 있습니다. 브랜드 제네릭은 특허가 만료된 브랜드 의약품의 새로운 제형으로, 오리지널과 다른 제조업체에서 제조한 제품 또는 특허가 만료된 제품에 상품명을 붙인 분자 복사본으로 정의됩니다. 브랜드 제네릭은 FDA가 승인한 브랜드 의약품의 다른 salts일 수도 있습니다.

브랜드 제네릭과 허가 받은 제네릭은 종종 혼동되기 쉽지만, 둘은 동일하지 않습니다. 브랜드 제네릭은 오리지널 의약품의 특허가 만료된 후 다른 제네릭과 동일한 FDA 승인 절차를 거칩니다. 반면, 허가 받은 제네릭은 오리지널 의약품과 동일한 NDA(신약승인)의 승인 하에 오리지널 의약품 제조업체에서 생산되며, 의약품의 특허가 만료되기 전에 판매될 수 있습니다.

시장 역학

ANDA 승인 증가는 시장 성장을 뒷받침하는 주요 요인입니다. 델리 약학대학(Delhi Pharmaceutical Sciences &Research University)이 2023년 3월 7일 발표한 기사에 따르면, 2022년 한 해 동안 승인된 ANDA(Abbreviated New Drug Application)는 742건으로 전년 대비 17% 증가했습니다. 가승인은 136건으로 이 역시 최종 승인(117건)과 마찬가지로 2021년 대비 증가세를 보였습니다. 올해 승인 건수는 작년보다 88건 더 많은데, 인도 시장의 기여가 컸습니다. 또한 브랜드 제네릭 의약품의 가격이 저렴해지면서 제네릭 의약품에 대한 수요가 급증하고 있습니다.

본 조사의 주요 특징

• 이 보고서는 세계 브랜드 제네릭 의약품 시장을 상세하게 분석하고, 2022년을 기준연도로 하여 예측 기간(2023-2030년) 동안 시장 규모와 연평균 성장률(CAGR) 7.30%를 제시합니다.
• 다양한 부문에서 잠재적인 수익 기회를 파악하고, 이 시장에 대한 매력적인 투자 제안 매트릭스를 설명합니다.
• 또한 시장 성장 촉진요인, 억제요인, 기회, 신제품 출시 및 승인, 시장 동향, 지역별 전망, 주요 기업이 채택한 경쟁 전략 등에 대한 중요한 고려 사항도 제공합니다.
• 세계 브랜드 제네릭 시장의 주요 기업을 기업 하이라이트, 제품 포트폴리오, 주요 하이라이트, 재무 성과, 전략 등의 매개 변수를 기반으로 프로파일링합니다.
• 본 조사 대상 주요 기업으로는 Mylan N.V, Novartis AG, Teva Pharmaceutical Industries Ltd., Pfizer Inc., Sun Pharmaceutical Industries Ltd., Aspen Pharmacare Holding Ltd., Abbott Laboratories, Valeant Pharmaceuticals International, Inc.가 있습니다.
• 이 보고서에서 얻은 통찰력을 통해 마케팅 담당자와 기업 경영진은 향후 제품 출시, 유형화, 시장 확대 및 마케팅 전략에 대한 정보에 입각한 의사결정을 내릴 수 있습니다.
• 세계의 브랜드 제네릭 시장 보고서는 투자자, 공급업체, 제품 제조업체, 유통업체, 신규 시장 진출기업, 재무 분석가 등 이 업계의 다양한 이해관계자를 대상으로 합니다.
• 이해관계자는 세계 브랜드 제네릭 시장 분석에 사용되는 다양한 전략 매트릭스를 통해 의사결정을 용이하게 할 수 있습니다.

목차

제1장 조사 목적과 전제

• 조사 목적
• 전제조건
• 약어

제2장 시장 전망

• 보고서 설명
  • 시장 정의와 범위
• 주요 요약
• Coherent Opportunity Map(COM)

제3장 시장 역학, 규제, 동향 분석

• 시장 역학
• 성장 촉진요인
• 성장 억제요인
• 시장 기회
• 영향 분석
• 최근 제품 발매
• 역학
• 합병, 인수 및 협업
• 규제 시나리오
• 주요 발전
• PEST 분석

제4장 세계의 브랜드 제네릭 시장 : COVID-19의 영향 분석

• 경제적 영향
• 신형 코로나바이러스(COVID-19) 역학
• 수요 및 공급에 대한 영향

제5장 세계의 브랜드 제네릭 시장 : 의약품 클래스별, 2018-2030년

• 알킬화제
• 대사 길항 물질
• 호르몬
• 강압제
• 지질 저하제
• 항우울제
• 항정신병제
• 항간질제
• 기타

제6장 세계의 브랜드 제네릭 시장 : 제제별, 2018-2030년

• Oral
• Parenteral
• Topical
• 기타

제7장 세계의 브랜드 제네릭 시장 : 적응증별, 2018-2030년

• 종양학
• 심혈관질환
• 당뇨병
• 신경내과
• 소화기 질환
• 피부과 질병
• 진통제 및 항염증제
• 기타

제8장 세계의 브랜드 제네릭 시장 : 유통 채널별, 2018-2030년

• 병원 약국
• 소매 약국
• 온라인 약국
• 드럭스토어

제9장 세계의 브랜드 제네릭 시장 : 지역별, 2018-2030년

• 북미
• 미국
• 캐나다
• 라틴아메리카
• 브라질
• 멕시코
• 아르헨티나
• 기타 라틴아메리카
• 유럽
• 영국
• 독일
• 이탈리아
• 프랑스
• 스페인
• 러시아
• 기타 유럽
• 아시아태평양
• 중국
• 인도
• 일본
• ASEAN
• 호주
• 한국
• 기타 아시아태평양
• 중동
• GCC
• 이스라엘
• 기타 중동
• 아프리카
• 북아프리카
• 중앙아프리카
• 남아프리카

제10장 경쟁 구도

• Mylan N.V
  • Novartis AG
• Teva Pharmaceutical Industries Ltd
• Pfizer Inc.
• Sun Pharmaceutical Industries Ltd.
• Aspen Pharmacare Holding Ltd.
• Abbott Laboratories
• Valeant Pharmaceuticals International, Inc.

제11장 섹션

• 조사 방법
• 출판사에 대해

LSH

영문 목차

영문목차

Branded generic is a generic drug, which is manufactured by either original manufacturer after patent expiry of the brand, or is manufactured by a generic manufacturer. Branded generic has to go through abbreviated new drug application (ANDA) process before it can be marketed. Branded generic are cheaper than their branded counterparts but can be costlier than generic versions of the drug. Branded generic is defined as a product that is a novel dosage form of a branded off-patent medicine, and is manufactured by a different manufacturer than originator, or a molecule copy of an off-patent product with a trade name. Branded generics can also be different salts of an FDA-approved brand name drug.

It is easy to confuse branded generics with authorized generics, but they are not the same. Branded generics go through the same FDA approval process as other generics after branded drug patents expire. Authorized generics, however, are created by makers of branded drugs, under the same NDA (New Drug Approval) authorization as the original branded drug, and they may be sold before drug patents expire.

Market Dynamics

Rising ANDA approvals is a major factor which is supporting the market growth. According to an article published by Delhi Pharmaceutical Sciences & Research University on March 7 2023, a total of 742 Abbreviated New Drug Application (ANDA) approvals were granted during the calendar year 2022, registering a growth of 17% over last year. Additionally, 136 Tentative Approvals were also granted, again a similar growth over 2021 numbers (117) as seen for final ANDA approvals. Indian players contributed a large proportion of the incremental number of approvals this year with 88 more approvals than last year. Additionally, demand for generic medications is in surge owing to the affordable prices of branded generics.

Key features of the study:

• This report provides an in-depth analysis of the global branded generics market and provides market size (US$ Million) and compound annual growth rate (CAGR) of 7.30% for the forecast period (2023-2030), considering 2022 as the base year.
• It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market.
• This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players.
• It profiles key players in the global branded generics market based on the following parameters-Company highlights, products portfolio, key highlights, financial performance, and strategies.
• Key companies covered as a part of this study include Mylan N.V, Novartis AG, Teva Pharmaceutical Industries Ltd., Pfizer Inc., Sun Pharmaceutical Industries Ltd., Aspen Pharmacare Holding Ltd., Abbott Laboratories, and Valeant Pharmaceuticals International, Inc.
• Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics.
• Global branded generics market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts.
• Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global branded generics market.

Detailed Segmentation:

• Global Branded Generics Market, By Drug Class:
  • Alkylating Agents
  • Antimetabolites
  • Hormones
  • Anti-Hypertensive
  • Lipid Lowering Drugs
  • Anti-Depressants
  • Anti-Psychotics
  • Anti-Epileptics
  • Others
• Global Branded Generics Market, By Formulation:
  • Oral
  • Parenteral
  • Topical
  • Others
• Global Branded Generics Market, By Indication:
  • Oncology
  • Cardiovascular Diseases
  • Diabetes
  • Neurology
  • Gastrointestinal Diseases
  • Dermatology Diseases
  • Analgesics and Anti-inflammatory
  • Others
• Global Branded Generics Market, By Distribution Channel:
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
• Drug Stores Global Branded generics Market, By Region:
  • North America
    • By Country:
  • U.S.
  • Canada
  • Latin America
    • By Country:
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
  • Europe
    • By Country:
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe
  • Asia Pacific
    • By Country
  • China
  • India
  • Japan
  • Australia
  • South Korea
  • ASEAN
  • Rest of Asia Pacific
  • Middle East
    • By Country:
  • GCC
  • Israel
  • Rest of Middle East
  • Africa
    • By Country/Region:
  • South Africa
  • Central Africa
  • North Africa
• Company Profiles
  • Mylan N.V*
    • Company Highlights
    • Products Portfolio
    • Key Highlights
    • Financial Performance
    • Strategies
  • Novartis AG
  • Teva Pharmaceutical Industries Ltd.
  • Pfizer Inc.
  • Sun Pharmaceutical Industries Ltd.
  • Aspen Pharmacare Holding Ltd.
  • Abbott Laboratories
  • Valeant Pharmaceuticals International, Inc

"*" marked represents similar segmentation in other categories in the respective section.

Table of Contents

1. Research Objectives and Assumptions

• Research Objectives
• Assumptions
• Abbreviations

2. Market Purview

• Report Description
  • Market Definition and Scope
• Executive Summary
  • Market Snapshot, By Drug Class
  • Market Snapshot, By Formulation
  • Market Snapshot, By Indication
  • Market Snapshot, By Distribution Channel
  • Market Snapshot, By Region
• Coherent Opportunity Map (COM)

3. Market Dynamics, Regulations, and Trends Analysis

• Market Dynamics
• Drivers
• Restraints
• Market Opportunities
• Impact Analysis
• Recent Product Launches
• Epidemiology
• Merger, Acquisition, and Collaborations
• Regulatory Scenario
• Key Developments
• PEST Analysis

4. Global Branded Generics Market- COVID-19 Impact Analysis

• Economic Impact
• COVID-19 Epidemiology
• Impact on Supply and Demand

5. Global Branded Generics Market, By Drug Class, 2018 - 2030, (US$ Million)

• Introduction
  • Market Share Analysis, 2023 and 2030 (%)
  • Y-o-Y Growth Analysis, 2018-2030
  • Segment Trends
• Alkylating Agents
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Antimetabolites
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Hormones
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Anti-Hypertensive
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Lipid Lowering Drugs
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Anti-Depressants
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Anti-Psychotics
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Anti-Epileptics
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Others
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)

6. Global Branded Generics Market, By Formulation, 2018 - 2030, (US$ Million)

• Introduction
  • Market Share Analysis, 2023 and 2030 (%)
  • Y-o-Y Growth Analysis, 2018-2030
  • Segment Trends
• Oral
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Parenteral
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Topical
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Others
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)

7. Global Branded Generics Market, By Indication, 2018 - 2030, (US$ Million)

• Introduction
  • Market Share Analysis, 2023 and 2030 (%)
  • Y-o-Y Growth Analysis, 2018-2030
  • Segment Trends
• Oncology
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Cardiovascular Diseases
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Diabetes
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Neurology
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Gastrointestinal Diseases
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Dermatology Diseases
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Analgesics and Anti-inflammatory
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Others
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)

8. Global Branded Generics Market, By Distribution Channel, 2018 - 2030, (US$ Million)

• Introduction
  • Market Share Analysis, 2023 and 2030 (%)
  • Y-o-Y Growth Analysis, 2018-2030
  • Segment Trends
• Hospital Pharmacies
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Retail Pharmacies
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Online Pharmacies
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)
• Drug Stores
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2018 - 2030, (US$ Mn)

9. Global Branded Generics Market, By Region, 2018 - 2030, (US$ Million)

• Introduction
  • Market Share Analysis, By Region, 2023 and 2030 (%)
  • Y-o-Y Growth Analysis, For Regions, 2018-2030
  • Regional Trends
• North America
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Drug Class, 2018 - 2030, (US$ Million)
  • Market Size and Forecast, and Y-o-Y Growth, By Formulation: , 2018 - 2030, (US$ Million)
  • Market Size and Forecast, and Y-o-Y Growth, By Country, 2018 - 2030, (US$ Million)
• U.S.
• Canada
• Latin America
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Drug Class, 2018- 2030, (US$ Million)
  • Market Size and Forecast, and Y-o-Y Growth, By Formulation: , 2018- 2030, (US$ Million)
  • Market Size and Forecast, and Y-o-Y Growth, By Country, 2018- 2030, (US$ Million)
• Brazil
• Mexico
• Argentina
• Rest of Latin America
• Europe
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Drug Class, 2018- 2030, (US$ Million)
  • Market Size and Forecast, and Y-o-Y Growth, By Formulation: , 2018- 2030, (US$ Million)
  • Market Size and Forecast, and Y-o-Y Growth, By Country, 2018- 2030, (US$ Million)
• U.K.
• Germany
• Italy
• France
• Spain
• Russia
• Rest of Europe
• Asia Pacific
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Drug Class, 2018- 2030, (US$ Million)
  • Market Size and Forecast, and Y-o-Y Growth, By Formulation: , 2018- 2030, (US$ Million)
  • Market Size and Forecast, and Y-o-Y Growth, By Country, 2018- 2030, (US$ Million)
• China
• India
• Japan
• ASEAN
• Australia
• South Korea
• Rest of Asia Pacific
• Middle East
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Drug Class, 2018- 2030, (US$ Million)
  • Market Size and Forecast, and Y-o-Y Growth, By Formulation: , 2018- 2030, (US$ Million)
  • Market Size and Forecast, and Y-o-Y Growth, By Country, 2018- 2030, (US$ Million)
• GCC
• Israel
• Rest of Middle East
• Africa
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Drug Class, 2018- 2030, (US$ Million)
  • Market Size and Forecast, and Y-o-Y Growth, By Formulation: , 2018- 2030, (US$ Million)
  • Market Size and Forecast, and Y-o-Y Growth, By Country, 2018- 2030, (US$ Million)
• North Africa
• Central Africa
• South Africa

10. Competitive Landscape

• Mylan N.V
  • Company Highlights
  • Product Portfolio
  • Key Highlights
  • Financial Performance
  • Market Strategies
  • Novartis AG
• Company Highlights
  • Product Portfolio
  • Key Highlights
  • Financial Performance
  • Market Strategies
• Teva Pharmaceutical Industries Ltd
  • Company Highlights
  • Product Portfolio
  • Key Highlights
  • Financial Performance
  • Market Strategies
• Pfizer Inc.
  • Company Highlights
  • Product Portfolio
  • Key Highlights
  • Financial Performance
  • Market Strategies
• Sun Pharmaceutical Industries Ltd.
  • Company Highlights
  • Product Portfolio
  • Key Highlights
  • Financial Performance
  • Market Strategies
• Aspen Pharmacare Holding Ltd.
  • Company Highlights
  • Product Portfolio
  • Key Highlights
  • Financial Performance
  • Market Strategies
• Abbott Laboratories
  • Company Highlights
  • Product Portfolio
  • Key Highlights
  • Financial Performance
  • Market Strategies
• Valeant Pharmaceuticals International, Inc.
  • Company Highlights
  • Product Portfolio
  • Key Highlights
  • Financial Performance
  • Market Strategies

11. Section

• Research Methodology
• About Us

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