특수 제네릭 시장 - 세계 산업 규모, 점유율, 동향, 기회, 예측, 투여 경로별, 적응증별, 유통 채널별, 지역별, 경쟁 시장별(2020-2030년)
Specialty Generics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Route of Administration, By Indication, By Distribution Channel, By Region & Competition, 2020-2030F
상품코드:1692196
리서치사:TechSci Research
발행일:2025년 03월
페이지 정보:영문 180 Pages
라이선스 & 가격 (부가세 별도)
ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
한글목차
특수 제네릭 세계 시장 규모는 2024년 556억 달러로 평가되었고, 2030년까지 9.70%의 연평균 복합 성장률(CAGR)을 나타내며 예측 기간 동안 괄목할 만한 성장이 예상됩니다.
복합제네릭이라고도 불리는 특수 제네릭은 기존 제네릭 의약품과 몇 가지 측면에서 다른 제네릭 의약품 카테고리입니다. 이러한 차이점은 의약품 자체의 복잡성, 승인을 위한 규제 경로, 대상 치료 영역과 관련이 있습니다. 복잡한 저분자 특수 제네릭의 경우, 규제 당국은 기준 의약품과 비교하여 치료적 동등성 또는 생물학적 동등성을 입증하기 위해 추가적인 데이터와 시험을 요구할 수 있습니다. 여기에는 보다 광범위한 임상시험과 분석적 특성 평가가 포함될 수 있습니다. 특수 제네릭은 암, 자가면역질환, 류마티스 질환, 신경질환 등 만성질환이나 복잡한 질환의 치료제로 개발되는 경우가 많습니다.
시장 개요
예측 기간
2026-2030년
시장 규모(2024년)
556억 달러
시장 규모(2030년)
961억 4,000만 달러
CAGR(2025-2030년)
9.70%
급성장 부문
주사제
최대 시장
북미
이들 의약품은 특정 질병 경로나 메커니즘을 표적으로 삼고 있습니다. 특수 제네릭, 특히 바이오시밀러는 일반적으로 안전성과 유효성을 입증하기 위해 대규모 임상시험을 진행합니다. 이러한 임상시험에는 임상 평가 변수뿐만 아니라 약동학적 및 약력학적 평가도 포함됩니다. 의료비 상승으로 인해 의료 시스템과 지불자는 비용 효율적인 솔루션을 찾아야 하는 상황에 직면해 있습니다. 바이오시밀러와 복합제네릭을 포함한 특수 제네릭은 오리지널 의약품에 비해 상당한 비용 절감 가능성을 제공합니다. 예를 들어, Niti Aayog의 2021년 데이터에 따르면, 인도는 60개 치료 카테고리에 걸쳐 60,000개의 제네릭 의약품 브랜드를 보유하고 있으며, 세계 최대 제네릭 의약품 공급국으로서 전 세계 제네릭 의약품 수출량의 20%를 차지하고 있습니다.
시장 성장 촉진요인
기술 발전
주요 시장 이슈
지적재산권 및 특허소송
주요 시장 동향
전문치료에 집중
목차
제1장 개요
제2장 조사 방법
제3장 주요 요약
제4장 고객의 소리
제5장 세계의 특수 제네릭 시장 전망
시장 규모와 예측
금액별
시장 점유율과 예측
투여 경로별(주사, 경구, 기타)
적응증별(종양학, 자가면역질환, 감염증, 기타)
유통 채널별(소매 약국, 전문 약국, 병원 약국)
지역별
기업별(2024년)
시장 맵
제6장 아시아태평양의 특수 제네릭 시장 전망
시장 규모와 예측
시장 점유율과 예측
아시아태평양 : 국가별 분석
중국
인도
호주
일본
한국
제7장 유럽의 특수 제네릭 시장 전망
시장 규모와 예측
시장 점유율과 예측
유럽 : 국가별 분석
프랑스
독일
스페인
이탈리아
영국
제8장 북미의 특수 제네릭 시장 전망
시장 규모와 예측
시장 점유율과 예측
북미 : 국가별 분석
미국
멕시코
캐나다
제9장 남미의 특수 제네릭 시장 전망
시장 규모와 예측
시장 점유율과 예측
남미 : 국가별 분석
브라질
아르헨티나
콜롬비아
제10장 중동 및 아프리카의 특수 제네릭 시장 전망
시장 규모와 예측
시장 점유율과 예측
중동 및 아프리카 : 국가별 분석
남아프리카공화국
사우디아라비아
아랍에미리트
제11장 시장 역학
성장 촉진요인
과제
제12장 시장 동향과 발전
최근 동향
제품 출시
인수합병(M&A)
제13장 세계의 특수 제네릭 시장 : SWOT 분석
제14장 Porter의 Five Forces 분석
업계내 경쟁
신규 참여 가능성
공급업체의 힘
고객의 힘
대체품의 위협
제15장 PESTEL 분석
제16장 경쟁 구도
Teva Pharmaceuticals Industries Ltd
Viatris Inc.
Novartis AG
Hikma Pharmaceuticals PLC
Bausch Health Companies Inc.
Dr. Reddy's Laboratories Ltd.
Endo Pharmaceuticals Inc.
Apotex Corp.
Sun Pharmaceutical Industries Ltd
STADA Arzneimittel AG
제17장 전략적 제안
제18장 리서치사에 대해 & 면책사항
LSH
영문 목차
영문목차
Global Specialty Generics Market was valued at USD 55.60 billion in 2024 and is anticipated to witness an impressive growth in the forecast period with a CAGR of 9.70% through 2030. Specialty generics, also known as complex generics, are a category of generic drugs that differ from traditional generic drugs in several ways. These differences relate to the complexity of the drugs themselves, the regulatory pathway for approval, and the therapeutic areas they target. For complex small-molecule specialty generics, regulatory agencies may require additional data and studies to establish therapeutic equivalence and bioequivalence when compared to the reference drug. This can involve more extensive clinical testing and analytical characterization. Specialty generics are often developed for the treatment of chronic and complex diseases, including cancer, autoimmune disorders, rheumatologic conditions, and neurological disorders.
Market Overview
Forecast Period
2026-2030
Market Size 2024
USD 55.60 Billion
Market Size 2030
USD 96.14 Billion
CAGR 2025-2030
9.70%
Fastest Growing Segment
Injectables
Largest Market
North America
These drugs target specific disease pathways and mechanisms. Specialty generics, particularly biosimilars, typically undergo extensive clinical trials to demonstrate safety and efficacy. These trials involve pharmacokinetic and pharmacodynamic assessments, as well as clinical endpoints. Escalating healthcare costs have put pressure on healthcare systems and payers to find cost-effective solutions. Specialty generics, including biosimilars and complex generics, offer the potential for substantial cost savings compared to their branded counterparts. For instance, according to Niti Aayog's 2021 data, India has 60,000 generic brands across 60 therapeutic categories and is the world's largest generic medicine provider, contributing 20% of global generic drug exports by volume.
Key Market Drivers
Technological Advancements
Biotechnology has revolutionized the production of biologic drugs, including biosimilars. Improved cell culture techniques and bioreactors allow for the efficient growth of cells that produce therapeutic proteins, monoclonal antibodies, and other complex molecules. This has made it possible to create biosimilars that closely mimic the originator biologics. High-resolution analytical tools, such as mass spectrometry, nuclear magnetic resonance (NMR) spectroscopy, and high-performance liquid chromatography (HPLC), have advanced the characterization of complex generics and biosimilars. These tools help manufacturers ensure the quality, purity, and consistency of their products. Innovative process intensification technologies improve the yield and efficiency of pharmaceutical manufacturing. This is particularly important for specialty generics that involve complex and costly production processes. Single-use bioreactors are increasingly used in the production of biologics, including biosimilars.
They offer flexibility, reduce the risk of contamination, and accelerate manufacturing timelines. For instance, in April 2023, Endo International plc launched a generic version of Noxafil (posaconazole) oral suspension, expanding treatment options for oropharyngeal candidiasis and enhancing access to affordable antifungal medication. Continuous manufacturing processes, as opposed to batch processes, are being adopted in the production of certain specialty generics. Continuous manufacturing can increase productivity and reduce the time and resources required for production. Advances in gene editing techniques, such as CRISPR-Cas9, have improved the development of high-yield cell lines for biologic production. This results in higher efficiency and reduced production costs. Specialty generics may include novel drug delivery systems to enhance drug stability and patient compliance. Technologies like microneedles, nanoparticles, and liposomal formulations have been employed to improve drug delivery. 3D printing technology is being explored for the development of personalized dosage forms, including patient-specific formulations of specialty generics. This could lead to more precise dosing and improved patient outcomes.
AI and machine learning algorithms are used to analyze large datasets in drug discovery, development, and manufacturing. These technologies can accelerate research, predict manufacturing issues, and optimize production processes. Quality-by-Design (QbD) principles involve designing quality into pharmaceutical products from the start of the development process. This approach uses scientific understanding and risk assessment to ensure product quality and consistency.
Key Market Challenges
Intellectual Property and Patent Litigation
Innovator pharmaceutical companies secure patents for their new drugs, which grant them exclusive rights to manufacture, market, and sell these drugs for a specified period, typically 20 years from the date of filing. During this exclusivity period, other companies are prohibited from manufacturing and selling generic versions of the drug. When the patents on brand-name drugs expire, it creates opportunities for specialty generics, including biosimilars and complex generics, to enter the market. These products aim to offer more affordable alternatives to the originator drugs. Innovator companies often file patent infringement lawsuits against generic manufacturers that attempt to market specialty generics. These lawsuits can delay the entry of specialty generics into the market, as they can take years to resolve in court.
In the United States, the Hatch-Waxman Act provides a framework for the approval of generic drugs while respecting innovator patents. It includes provisions for patent litigation, known as Paragraph IV challenges, which can trigger patent disputes between innovators and generic manufacturers. Biosimilars, which are similar but not identical to biologic drugs, often face complex patent disputes. The biosimilar approval process may require exchanges of patent-related information between the biosimilar manufacturer and the innovator, potentially leading to litigation. Innovator pharmaceutical companies and generic manufacturers may reach settlement agreements that allow for the entry of generic or biosimilar drugs before the patent expires. Such agreements can have implications for market competition and pricing. Some innovator companies employ strategies to extend their drug exclusivity, such as obtaining additional patents for variations of the original drug or for specific formulations. This can delay generic market entry.
Key Market Trends
Focus on Specialty Therapies
The growing prevalence of chronic diseases, including cancer, autoimmune disorders, and rare diseases, has created a substantial need for specialty therapies. Specialty generics, including biosimilars and complex generics, are developed to provide more affordable options for patients with these conditions. Many specialty therapies are biologics or other complex drugs. As patents for these drugs expire, pharmaceutical companies are focusing on the development of specialty generics to capture a share of this lucrative market. Specialty generics typically offer significant cost savings compared to their branded counterparts. This is particularly appealing for patients, healthcare systems, and payers, who seek effective treatments while managing healthcare costs. Regulatory agencies, such as the U.S. FDA and the European Medicines Agency (EMA), have established clear pathways for the approval of biosimilars. This has accelerated the development and marketing of biosimilar specialty generics, especially for biologics used in oncology, rheumatology, and gastroenterology. Over time, healthcare providers, payers, and patients have become more accepting of biosimilars and other specialty generics.
Key Market Players
Teva Pharmaceuticals Industries Ltd
Viatris Inc.
Novartis AG
Hikma Pharmaceuticals PLC
Bausch Health Companies Inc.
Dr. Reddy's Laboratories Ltd.
Endo Pharmaceuticals Inc.
Apotex Corp.
Sun Pharmaceutical Industries Ltd
STADA Arzneimittel AG
Report Scope:
In this report, the Global Specialty Generics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Specialty Generics Market, By Route of Administration:
Injectable
Oral
Others
Specialty Generics Market, By Indication:
Oncology
Autoimmune Diseases
Infectious Diseases
Others
Specialty Generics Market, By Distribution channel:
Retail Pharmacies
Specialty Pharmacies
Hospital Pharmacies
Specialty Generics Market, By Region:
North America
United States
Canada
Mexico
Asia-Pacific
China
India
South Korea
Australia
Japan
Europe
Germany
France
United Kingdom
Spain
Italy
South America
Brazil
Argentina
Colombia
Middle East & Africa
South Africa
Saudi Arabia
UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the Global Specialty Generics Market.
Available Customizations:
Global Specialty Generics Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:
Company Information
Detailed analysis and profiling of additional market players (up to five).
Table of Contents
1. Product Overview
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2. Research Methodology
2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations
3. Executive Summary
3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends
4. Voice of Customer
5. Global Specialty Generics Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Route of Administration (Injectable, Oral, others)
5.2.2. By Indication (Oncology, Autoimmune Diseases, Infectious Diseases, others)
5.2.3. By Distribution Channel (Retail Pharmacies, Specialty Pharmacies, Hospital Pharmacies)
5.2.4. By Region
5.2.5. By Company (2024)
5.3. Market Map
6. Asia Pacific Specialty Generics Market Outlook
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Route of Administration
6.2.2. By Indication
6.2.3. By Distribution Channel
6.2.4. By Country
6.3. Asia Pacific: Country Analysis
6.3.1. China Specialty Generics Market Outlook
6.3.1.1. Market Size & Forecast
6.3.1.1.1. By Value
6.3.1.2. Market Share & Forecast
6.3.1.2.1. By Route of Administration
6.3.1.2.2. By Indication
6.3.1.2.3. By Distribution Channel
6.3.2. India Specialty Generics Market Outlook
6.3.2.1. Market Size & Forecast
6.3.2.1.1. By Value
6.3.2.2. Market Share & Forecast
6.3.2.2.1. By Route of Administration
6.3.2.2.2. By Indication
6.3.2.2.3. By Distribution Channel
6.3.3. Australia Specialty Generics Market Outlook
6.3.3.1. Market Size & Forecast
6.3.3.1.1. By Value
6.3.3.2. Market Share & Forecast
6.3.3.2.1. By Route of Administration
6.3.3.2.2. By Indication
6.3.3.2.3. By Distribution Channel
6.3.4. Japan Specialty Generics Market Outlook
6.3.4.1. Market Size & Forecast
6.3.4.1.1. By Value
6.3.4.2. Market Share & Forecast
6.3.4.2.1. By Route of Administration
6.3.4.2.2. By Indication
6.3.4.2.3. By Distribution Channel
6.3.5. South Korea Specialty Generics Market Outlook
6.3.5.1. Market Size & Forecast
6.3.5.1.1. By Value
6.3.5.2. Market Share & Forecast
6.3.5.2.1. By Route of Administration
6.3.5.2.2. By Indication
6.3.5.2.3. By Distribution Channel
7. Europe Specialty Generics Market Outlook
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Route of Administration
7.2.2. By Indication
7.2.3. By Distribution Channel
7.2.4. By Country
7.3. Europe: Country Analysis
7.3.1. France Specialty Generics Market Outlook
7.3.1.1. Market Size & Forecast
7.3.1.1.1. By Value
7.3.1.2. Market Share & Forecast
7.3.1.2.1. By Route of Administration
7.3.1.2.2. By Indication
7.3.1.2.3. By Distribution Channel
7.3.2. Germany Specialty Generics Market Outlook
7.3.2.1. Market Size & Forecast
7.3.2.1.1. By Value
7.3.2.2. Market Share & Forecast
7.3.2.2.1. By Route of Administration
7.3.2.2.2. By Indication
7.3.2.2.3. By Distribution Channel
7.3.3. Spain Specialty Generics Market Outlook
7.3.3.1. Market Size & Forecast
7.3.3.1.1. By Value
7.3.3.2. Market Share & Forecast
7.3.3.2.1. By Route of Administration
7.3.3.2.2. By Indication
7.3.3.2.3. By Distribution Channel
7.3.4. Italy Specialty Generics Market Outlook
7.3.4.1. Market Size & Forecast
7.3.4.1.1. By Value
7.3.4.2. Market Share & Forecast
7.3.4.2.1. By Route of Administration
7.3.4.2.2. By Indication
7.3.4.2.3. By Distribution Channel
7.3.5. United Kingdom Specialty Generics Market Outlook
7.3.5.1. Market Size & Forecast
7.3.5.1.1. By Value
7.3.5.2. Market Share & Forecast
7.3.5.2.1. By Route of Administration
7.3.5.2.2. By Indication
7.3.5.2.3. By Distribution Channel
8. North America Specialty Generics Market Outlook
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Route of Administration
8.2.2. By Indication
8.2.3. By Distribution Channel
8.2.4. By Country
8.3. North America: Country Analysis
8.3.1. United States Specialty Generics Market Outlook
8.3.1.1. Market Size & Forecast
8.3.1.1.1. By Value
8.3.1.2. Market Share & Forecast
8.3.1.2.1. By Route of Administration
8.3.1.2.2. By Indication
8.3.1.2.3. By Distribution Channel
8.3.2. Mexico Specialty Generics Market Outlook
8.3.2.1. Market Size & Forecast
8.3.2.1.1. By Value
8.3.2.2. Market Share & Forecast
8.3.2.2.1. By Route of Administration
8.3.2.2.2. By Indication
8.3.2.2.3. By Distribution Channel
8.3.3. Canada Specialty Generics Market Outlook
8.3.3.1. Market Size & Forecast
8.3.3.1.1. By Value
8.3.3.2. Market Share & Forecast
8.3.3.2.1. By Route of Administration
8.3.3.2.2. By Indication
8.3.3.2.3. By Distribution Channel
9. South America Specialty Generics Market Outlook
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Route of Administration
9.2.2. By Indication
9.2.3. By Distribution Channel
9.2.4. By Country
9.3. South America: Country Analysis
9.3.1. Brazil Specialty Generics Market Outlook
9.3.1.1. Market Size & Forecast
9.3.1.1.1. By Value
9.3.1.2. Market Share & Forecast
9.3.1.2.1. By Route of Administration
9.3.1.2.2. By Indication
9.3.1.2.3. By Distribution Channel
9.3.2. Argentina Specialty Generics Market Outlook
9.3.2.1. Market Size & Forecast
9.3.2.1.1. By Value
9.3.2.2. Market Share & Forecast
9.3.2.2.1. By Route of Administration
9.3.2.2.2. By Indication
9.3.2.2.3. By Distribution Channel
9.3.3. Colombia Specialty Generics Market Outlook
9.3.3.1. Market Size & Forecast
9.3.3.1.1. By Value
9.3.3.2. Market Share & Forecast
9.3.3.2.1. By Route of Administration
9.3.3.2.2. By Indication
9.3.3.2.3. By Distribution Channel
10. Middle East and Africa Specialty Generics Market Outlook
10.1. Market Size & Forecast
10.1.1. By Value
10.2. Market Share & Forecast
10.2.1. By Route of Administration
10.2.2. By Indication
10.2.3. By Distribution Channel
10.2.4. By Country
10.3. MEA: Country Analysis
10.3.1. South Africa Specialty Generics Market Outlook
10.3.1.1. Market Size & Forecast
10.3.1.1.1. By Value
10.3.1.2. Market Share & Forecast
10.3.1.2.1. By Route of Administration
10.3.1.2.2. By Indication
10.3.1.2.3. By Distribution Channel
10.3.2. Saudi Arabia Specialty Generics Market Outlook
10.3.2.1. Market Size & Forecast
10.3.2.1.1. By Value
10.3.2.2. Market Share & Forecast
10.3.2.2.1. By Route of Administration
10.3.2.2.2. By Indication
10.3.2.2.3. By Distribution Channel
10.3.3. UAE Specialty Generics Market Outlook
10.3.3.1. Market Size & Forecast
10.3.3.1.1. By Value
10.3.3.2. Market Share & Forecast
10.3.3.2.1. By Route of Administration
10.3.3.2.2. By Indication
10.3.3.2.3. By Distribution Channel
11. Market Dynamics
11.1. Drivers
11.2. Challenges
12. Market Trends & Developments
12.1. Recent Developments
12.2. Product Launches
12.3. Mergers & Acquisitions
13. Global Specialty Generics Market: SWOT Analysis
