特殊仿製药市场 - 全球产业规模、份额、趋势、机会和预测，按给药途径、按适应症、按配销通路、按地区和竞争进行细分，2020-2030 年预测

2024 年全球特种仿製药市场价值为 556 亿美元，预计在预测期内将实现令人印象深刻的成长，到 2030 年的复合年增长率为 9.70%。特种仿製药，也称为复杂仿製药，是一类仿製药，与传统仿製药在几个方面有所不同。这些差异与药物本身的复杂性、审批的监管途径以及其针对的治疗领域有关。对于复杂的小分子特种仿製药，监管机构可能需要额外的资料和研究来确定与参考药物的治疗等效性和生物等效性。这可能涉及更广泛的临床测试和分析表征。专科仿製药通常用于治疗慢性和复杂疾病，包括癌症、自体免疫疾病、风湿病和神经系统疾病。

这些药物针对特定的疾病途径和机制。特殊仿製药，尤其是生物相似药，通常经过广泛的临床试验来证明其安全性和有效性。这些试验涉及药物动力学和药效学评估以及临床终点。不断上涨的医疗成本给医疗保健系统和付款人带来了压力，迫使他们寻找具有成本效益的解决方案。特殊仿製药（包括生物相似药和复杂仿製药）与品牌药相比具有大幅节省成本的潜力。例如，根据印度政府智库 2021 年的资料，印度拥有 60 个治疗类别的 60,000 个仿製药品牌，是世界上最大的仿製药供应国，占全球仿製药出口量的 20%。

主要市场驱动因素

技术进步

主要市场挑战

智慧财产权和专利诉讼

主要市场趋势

专注于专科治疗

目录

第 1 章：产品概述

第 2 章：研究方法

第 3 章：执行摘要

第 4 章：顾客之声

第五章：全球特种仿製药市场展望

• 市场规模和预测
  • 按价值
• 市场占有率和预测
  • 依给药途径（注射、口服、其他）
  • 依适应症分类（肿瘤科、自体免疫疾病、传染病等）
  • 按配销通路（零售药局、专科药局、医院药局）
  • 按地区
  • 按公司分类（2024）
• 市场地图

第六章：亚太地区特种仿製药市场展望

• 市场规模和预测
• 市场占有率和预测
• 亚太地区：国家分析
  • 印度
  • 澳洲
  • 日本
  • 韩国

第 7 章：欧洲特种仿製药市场展望

• 市场规模和预测
• 市场占有率和预测
• 欧洲：国家分析
  • 德国
  • 西班牙
  • 义大利
  • 英国

第 8 章：北美特种仿製药市场展望

• 市场规模和预测
• 市场占有率和预测
• 北美：国家分析
  • 墨西哥
  • 加拿大

第 9 章：南美洲特种仿製药市场展望

• 市场规模和预测
• 市场占有率和预测
• 南美洲：国家分析
  • 阿根廷
  • 哥伦比亚

第 10 章：中东和非洲特种仿製药市场展望

• 市场规模和预测
• 市场占有率和预测
• MEA：国家分析
  • 沙乌地阿拉伯
  • 阿联酋

第 11 章：市场动态

• 驱动程式
• 挑战

第 12 章：市场趋势与发展

• 最新动态
• 产品发布
• 合併与收购

第 13 章：全球特种仿製药市场：SWOT 分析

第 14 章：波特五力分析

• 产业竞争
• 新进入者的潜力
• 供应商的力量
• 顾客的力量
• 替代产品的威胁

第 15 章： 大环境分析

第 16 章：竞争格局

• 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

第 17 章：策略建议

第18章调查会社について・免责事项

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.

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

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Product

15. PESTLE Analysis

16. Competitive Landscape

• 16.1. Teva Pharmaceuticals Industries Ltd
  • 16.1.1. Business Overview
  • 16.1.2. Company Snapshot
  • 16.1.3. Products & Services
  • 16.1.4. Financials (In case of listed companies)
  • 16.1.5. Recent Developments
  • 16.1.6. SWOT Analysis
• 16.2. Viatris Inc.
  • 16.2.1. Business Overview
  • 16.2.2. Company Snapshot
  • 16.2.3. Products & Services
  • 16.2.4. Financials (In case of listed companies)
  • 16.2.5. Recent Developments
  • 16.2.6. SWOT Analysis
• 16.3. Novartis AG
  • 16.3.1. Business Overview
  • 16.3.2. Company Snapshot
  • 16.3.3. Products & Services
  • 16.3.4. Financials (In case of listed companies)
  • 16.3.5. Recent Developments
  • 16.3.6. SWOT Analysis
• 16.4. Hikma Pharmaceuticals PLC
  • 16.4.1. Business Overview
  • 16.4.2. Company Snapshot
  • 16.4.3. Products & Services
  • 16.4.4. Financials (In case of listed companies)
  • 16.4.5. Recent Developments
  • 16.4.6. SWOT Analysis
• 16.5. Bausch Health Companies Inc.
  • 16.5.1. Business Overview
  • 16.5.2. Company Snapshot
  • 16.5.3. Products & Services
  • 16.5.4. Financials (In case of listed companies)
  • 16.5.5. Recent Developments
  • 16.5.6. SWOT Analysis
• 16.6. Dr. Reddy's Laboratories Ltd.
  • 16.6.1. Business Overview
  • 16.6.2. Company Snapshot
  • 16.6.3. Products & Services
  • 16.6.4. Financials (In case of listed companies)
  • 16.6.5. Recent Developments
  • 16.6.6. SWOT Analysis
• 16.7. Endo Pharmaceuticals Inc.
  • 16.7.1. Business Overview
  • 16.7.2. Company Snapshot
  • 16.7.3. Products & Services
  • 16.7.4. Financials (In case of listed companies)
  • 16.7.5. Recent Developments
  • 16.7.6. SWOT Analysis
• 16.8. Apotex Corp.
  • 16.8.1. Business Overview
  • 16.8.2. Company Snapshot
  • 16.8.3. Products & Services
  • 16.8.4. Financials (In case of listed companies)
  • 16.8.5. Recent Developments
  • 16.8.6. SWOT Analysis
• 16.9. Sun Pharmaceutical Industries Ltd
  • 16.9.1. Business Overview
  • 16.9.2. Company Snapshot
  • 16.9.3. Products & Services
  • 16.9.4. Financials (In case of listed companies)
  • 16.9.5. Recent Developments
  • 16.9.6. SWOT Analysis
• 16.10.STADA Arzneimittel AG
  • 16.10.1. Business Overview
  • 16.10.2. Company Snapshot
  • 16.10.3. Products & Services
  • 16.10.4. Financials (In case of listed companies)
  • 16.10.5. Recent Developments
  • 16.10.6. SWOT Analysis

17. Strategic Recommendations

18. About Us & Disclaimer