インドのバイオシミラー市場：製品クラス別、適応症別、流通チャネル別、地域別、機会、予測、2019年～2033年

インドのバイオシミラーの市場規模は、2026年～2033年の予測期間中に19.89％のCAGRで拡大し、2025年の15億1,000万米ドルから2033年には64億4,000万米ドルに成長すると予測されています。インドのバイオシミラー市場は、慢性疾患や自己免疫疾患の罹患率の上昇に加え、手頃な価格の生物学的製剤に対する需要の高まりが後押ししています。有利な規制経路や奨励制度による政府の支援が、国内製造と研究開発を後押ししています。さらに、戦略的投資や世界の提携により、インドはバイオシミラー医薬品の世界の生産・輸出拠点としての地位を強化しています。

例えば、2025年4月、Biocon Ltdの子会社であるBiocon Biologics Ltd（BBL）は、米国食品医薬品局が静脈内投与を目的としたベバシズマブのバイオシミラーであるJobevne（TM）（bevacizumab-nwgd）を承認したと発表しました。JOBEVNEは、様々ながんの治療に使用される遺伝子組換えヒト化モノクローナル抗体であり、先発品であるアバスチン（R）（一般名：ベバシズマブ）のバイオシミラーです。

当レポートでは、インドのバイオシミラー市場について調査し、市場の概要とともに、製品クラス別、適応症別、流通チャネル別、地域別動向、および市場に参入する企業のプロファイル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 インドのバイオシミラー市場の見通し、2019年～2033年

• 市場規模分析と予測
• 市場シェア分析と予測
  • 製品クラス別
    • モノクローナル抗体
    • 組み換えホルモン
    • 免疫調節薬
    • 抗炎症剤
    • その他
  • 適応症別
    • 腫瘍学
    • 成長ホルモン欠乏症
    • 血液疾患
    • 慢性疾患および自己免疫疾患
    • 感染症
    • その他
  • 流通チャネル別
    • 病院
    • がんケアセンター
    • その他
  • 地域別
    • 北部
    • 東部
    • 西部と中央部
    • 南部
  • 企業別市場シェア分析（上位5社およびその他- 金額ベース、2025年）
• 2025年の市場マップ分析

第5章 需要供給分析

第6章 バリューチェーン分析

第7章 ポーターのファイブフォース分析

第8章 PESTLE分析

第9章 価格分析

第10章 市場力学

• 市場の促進要因
• 市場の課題

第11章 市場動向と発展

第12章 規制枠組みとイノベーション

• 規制当局の承認
• 臨床試験

第13章 特許の情勢

第14章 ケーススタディ

第15章 競合情勢

• 市場リーダートップ5の競合マトリックス
• 参入企業トップ5のSWOT分析
• 市場の主要企業トップ10の情勢
  • Novartis Healthcare Private Limited
  • Pfizer India Inc.
  • Mylan Pharmaceuticals Private Limited (Subsidiary of Viatris Inc.)
  • Teva India Private Limited
  • Eli Lilly and Company (India) Pvt. Ltd.
  • Bristol Myers Squibb India Pvt Ltd
  • Samsung Bioepis Co., Ltd.
  • Celltrion Healthcare India Private Limited
  • Intas Pharmaceutical Ltd.
  • LG Life Sciences Inc.

第16章 戦略的提言

第17章 調査会社について・免責事項

List of Tables

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

List of Figures

• Figure 1. India Biosimilars Market, By Value, In USD Billion, FY2019-FY2033F
• Figure 2. India Biosimilars Market Share (%), By Product Class, FY2019-FY2033F
• Figure 3. India Biosimilars Market Share (%), By Indication, FY2019-FY2033F
• Figure 4. India Biosimilars Market Share (%), By Distribution Channel, FY2019-FY2033F
• Figure 5. India Biosimilars Market Share (%), By Region, FY2019-FY2033F
• Figure 6. By Product Class Map-Market Size (USD Billion) & Growth Rate (%), FY2025
• Figure 7. By Indication Map-Market Size (USD Billion) & Growth Rate (%), FY2025
• Figure 8. By Distribution Channel Map-Market Size (USD Billion) & Growth Rate (%), FY2025
• Figure 9. By Region Map-Market Size (USD Billion) & Growth Rate (%), FY2025

India biosimilars market is projected to witness a CAGR of 19.89% during the forecast period FY2026-FY2033, growing from USD 1.51 billion in FY2025 to USD 6.44 billion in FY2033. The Indian biosimilars market is being propelled by the rising incidence of chronic and autoimmune diseases, coupled with increasing demand for affordable biologic therapies. Government support through favorable regulatory pathways and incentive schemes is encouraging domestic manufacturing and R&D. Additionally, strategic investments and global collaborations are strengthening India's position as a global biosimilar production and export hub.

For example, in April 2025, Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, announced that the U.S. Food and Drug Administration had granted approval for Jobevne(TM) (bevacizumab-nwgd), a biosimilar version of Bevacizumab intended for intravenous administration. JOBEVNE is a recombinant humanized monoclonal antibody utilized in the treatment of various cancer types and is a biosimilar to the original product Avastin(R) (bevacizumab).

Growing Burden of Chronic and Autoimmune Diseases in India

India is witnessing a steep rise in the prevalence of chronic diseases such as cancer, chronic kidney disease, and cardiovascular ailments, along with infections requiring frequent hospitalizations. These conditions often demand long-term administration of medications, IV fluids, and blood transfusions, significantly increasing the demand for biosimilars. Conditions such as cancer, rheumatoid arthritis, diabetes, and inflammatory bowel disease are becoming more prevalent due to lifestyle changes, aging population, and genetic factors. Biosimilars provide a cost-effective alternative to biologics, improving accessibility for the Indian population, especially within the public healthcare system. With the rising financial burden of chronic illnesses, biosimilars offer sustainable treatment pathways for both patients and healthcare providers. This trend is prompting Indian pharmaceutical companies to invest heavily in biosimilar R&D and manufacturing. This broad healthcare push, combined with higher patient volumes and increasing disease burden, is driving consistent growth in the demand for biosimilars across India. The burden of noncommunicable diseases (NCDs) has overtaken that of infectious diseases in India. An estimated 5.8 million Indians lose their lives to NCDs annually, and one in four Indians are at danger of passing away before turning 70. The World Health Organization (WHO) estimates that NCDs cause nine million deaths a year in Southeast Asia, or 62% of all deaths. The high rate of premature fatalities, or deaths that happen before the age of 70, associated with NCDs is a serious concern.

Supportive Government Regulations and Policies for Biosimilar Development

The Indian government's favorable regulatory framework is a critical enabler of biosimilar market growth. India was among the first countries to implement specific guidelines for biosimilars (2012, updated in 2016), ensuring a streamlined pathway for clinical trials, approvals, and commercialization. The regulatory clarity and cost advantages attract both domestic and international pharmaceutical players to invest in the Indian biosimilar space. Moreover, initiatives such as the 'Pharma Vision 2020' and production-linked incentives (PLI) schemes encourage indigenous manufacturing and R&D in biosimilars. These frameworks foster innovation and improve affordability for the local population, enhancing market penetration and competition. In December 2024, the Department of Pharmaceuticals (DoP) announced an extension of its PLI scheme to include biosimilar manufacturers under its funding umbrella, offering financial incentives to boost domestic capabilities and global competitiveness.

Increasing Investments and Collaborations in Indian Biosimilar Landscape

India's biosimilar market is rapidly expanding due to rising domestic and foreign investments, joint ventures, and strategic collaborations. Global companies are partnering with Indian manufacturers to capitalize on cost-efficient production, skilled workforce, and a strong distribution network. These collaborations foster technology transfer, accelerate clinical development, and improve product availability. Local players are also scaling up manufacturing facilities and enhancing their biologics portfolios. Moreover, biosimilars developed in India are increasingly being approved and marketed in international markets, establishing India as a global hub for biosimilar production. CuraTeq Biologics, a division of Aurobindo Pharma, intends to introduce a minimum of 10 biosimilar products by the year 2031, as stated by the company's chief executive. 'Achieving the launch of four products, which will enter the commercial phase in the July quarter, marks a significant milestone for us during this six-year journey,' remarked Satakarni Makkapati, CEO of biologics, vaccines, and peptides at Aurobindo Pharma, in an exclusive interview with ET NOW at the company's facility located near Hyderabad. 'Curateq and Aurobindo are set to release at least 10 products into the market by 2031.'

Future Market Scenario (FY2026 - FY2033F)

The India biosimilars market is poised for robust growth over the coming years, driven by a confluence of rising chronic disease prevalence, increased healthcare spending, and supportive regulatory policies. As demand for cost-effective biologic therapies grows, biosimilars are expected to play a pivotal role in enhancing treatment accessibility, especially for oncology and autoimmune diseases. Domestic pharmaceutical firms are expanding manufacturing capacities and pursuing global regulatory approvals, reinforcing India's role as a major biosimilar hub. Additionally, international collaborations, government-backed incentives, and the evolving biologics pipeline will continue to fuel innovation. With improving awareness and affordability, biosimilars are set to become a mainstream component of India's therapeutic landscape, especially in public healthcare settings.

Key Players Landscape and Outlook

Key players in the biosimilars industry utilize strategies such as mergers, acquisitions, partnerships, and new product launches to improve their services and competitiveness. Such efforts will propel significant growth in the market, allowing big-cap industry players to increase their presence and, therefore, find new opportunities in this market.

For instance, the pharmaceutical company USV, in collaboration with the biotechnology firm Biogenomics, introduced INSUQUICK, the first biosimilar Insulin Aspart in India, aimed at enhancing accessibility for individuals with diabetes. InsuQuick is a product of the 'Make in India' initiative, developed and produced utilizing entirely domestic technology, and has completed a comprehensive clinical program to meet international quality standards.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. India Biosimilars Market Outlook, FY2019-FY2033F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Product Class
    • 4.2.1.1. Monoclonal Antibodies
      • 4.2.1.1.1. Adalimumab
      • 4.2.1.1.2. Infliximab
      • 4.2.1.1.3. Rituximab
      • 4.2.1.1.4. Trastuzumab
      • 4.2.1.1.5. Others
    • 4.2.1.2. Recombinant Hormones
      • 4.2.1.2.1. Insulin
      • 4.2.1.2.2. Erythropoietin
      • 4.2.1.2.3. Others
    • 4.2.1.3. Immunomodulators
    • 4.2.1.4. Anti-Inflammatory Agents
    • 4.2.1.5. Others
  • 4.2.2. By Indication
    • 4.2.2.1. Oncology
    • 4.2.2.2. Growth Hormone Deficiency
    • 4.2.2.3. Blood Disorders
    • 4.2.2.4. Chronic and Autoimmune Disorders
    • 4.2.2.5. Infectious Diseases
    • 4.2.2.6. Others
  • 4.2.3. By Distribution Channel
    • 4.2.3.1. Hospitals
    • 4.2.3.2. Cancer Care Centers
    • 4.2.3.3. Others
  • 4.2.4. By Region
    • 4.2.4.1. North
    • 4.2.4.2. East
    • 4.2.4.3. West and Central
    • 4.2.4.4. South
  • 4.2.5. By Company Market Share Analysis (Top 5 Companies and Others - By Value, FY2025)
• 4.3. Market Map Analysis, FY2025
  • 4.3.1. By Product Class
  • 4.3.2. By Indication
  • 4.3.3. By Distribution Channel
  • 4.3.4. By Region

5. Demand Supply Analysis

6. Value Chain Analysis

7. Porter's Five Forces Analysis

8. PESTLE Analysis

9. Pricing Analysis

10. Market Dynamics

• 10.1. Market Drivers
• 10.2. Market Challenges

11. Market Trends and Developments

12. Regulatory Framework and Innovation

• 12.1. Regulatory Approvals
• 12.2. Clinical Trials

13. Patent Landscape

14. Case Studies

15. Competitive Landscape

• 15.1. Competition Matrix of Top 5 Market Leaders
• 15.2. SWOT Analysis for Top 5 Players
• 15.3. Key Players Landscape for Top 10 Market Players
  • 15.3.1. Novartis Healthcare Private Limited
    • 15.3.1.1. Company Details
    • 15.3.1.2. Key Management Personnel
    • 15.3.1.3. Products and Services
    • 15.3.1.4. Financials (As Reported)
    • 15.3.1.5. Key Market Focus and Geographical Presence
    • 15.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisition
  • 15.3.2. Pfizer India Inc.
  • 15.3.3. Mylan Pharmaceuticals Private Limited (Subsidiary of Viatris Inc.)
  • 15.3.4. Teva India Private Limited
  • 15.3.5. Eli Lilly and Company (India) Pvt. Ltd.
  • 15.3.6. Bristol Myers Squibb India Pvt Ltd
  • 15.3.7. Samsung Bioepis Co., Ltd.
  • 15.3.8. Celltrion Healthcare India Private Limited
  • 15.3.9. Intas Pharmaceutical Ltd.
  • 15.3.10. LG Life Sciences Inc.

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

16. Strategic Recommendations

17. About Us and Disclaimer