目次

TABLE OF CONTENTS

1 INTRODUCTION
1.1 STUDY OBJECTIVES
1.2 MARKET DEFINITION
1.3 STUDY SCOPE
1.3.1 MARKET SEGMENTATION & REGIONAL SCOPE
1.3.2 INCLUSIONS & EXCLUSIONS
1.3.3 YEARS CONSIDERED
1.3.4 CURRENCY CONSIDERED
1.4 STAKEHOLDERS
1.5 SUMMARY OF CHANGES

2 RESEARCH METHODOLOGY
2.1 RESEARCH DATA
2.1.1 SECONDARY DATA
2.1.1.1 Objectives of secondary research
2.1.1.2 Key data from secondary sources
2.1.2 PRIMARY DATA
2.1.2.1 Breakdown of primaries
2.1.2.2 Key objective of primary research
2.2 MARKET ESTIMATION
2.2.1 GLOBAL MARKET ESTIMATION
2.2.1.1 Company revenue analysis (bottom-up approach)
2.2.1.1.1 Revenue share analysis of Sandoz Group AG
2.2.1.2 MnM repository analysis
2.2.1.3 Primary interviews
2.2.2 INSIGHTS FROM PRIMARY EXPERTS
2.2.3 SEGMENTAL MARKET SIZE ESTIMATION (TOP-DOWN APPROACH)
2.3 MARKET GROWTH RATE PROJECTIONS
2.4 DATA TRIANGULATION
2.5 STUDY ASSUMPTIONS
2.6 RESEARCH LIMITATIONS
2.7 RISK ANALYSIS

3 EXECUTIVE SUMMARY

4 PREMIUM INSIGHTS
4.1 BIOSIMILARS MARKET OVERVIEW
4.2 NORTH AMERICA: BIOSIMILARS MARKET, BY DRUG CLASS AND COUNTRY
4.3 BIOSIMILARS MARKET: GEOGRAPHIC GROWTH OPPORTUNITIES
4.4 BIOSIMILARS MARKET: EMERGING VS. DEVELOPED MARKETS, 2025 VS. 2035 (USD MILLION)

5 MARKET OVERVIEW
5.1 INTRODUCTION
5.2 MARKET DYNAMICS
5.2.1 DRIVERS
5.2.1.1 Rising global demand for affordable alternatives to expensive biologic therapies
5.2.1.2 Increasing number of biosimilar launches and approvals
5.2.1.3 Impending and ongoing patent expiry of blockbuster biologics
5.2.1.4 Entry of emerging players with cost-efficient manufacturing capabilities
5.2.2 RESTRAINTS
5.2.2.1 Manufacturing complexities and high cost of biosimilars
5.2.2.2 Intense competition and pricing pressure among market players
5.2.3 OPPORTUNITIES
5.2.3.1 Launch of GLP-1 biosimilars
5.2.3.2 Increasing strategic partnerships and collaborations among biosimilar manufacturers
5.2.3.3 Growing focus on advanced R&D operating models
5.2.4 CHALLENGES
5.2.4.1 Increased market competition between biosimilar manufacturers and originator biologic companies
5.3 TECHNOLOGY ANALYSIS
5.3.1 KEY TECHNOLOGIES
5.3.1.1 Advanced bioprocessing & manufacturing technologies
5.3.1.2 Analytical & characterization techniques
5.3.2 COMPLEMENTARY TECHNOLOGIES
5.3.2.1 AI & ML
5.3.2.2 Lab automation & robotics
5.3.3 ADJACENT TECHNOLOGIES
5.3.3.1 Microbial fermentation
5.3.3.2 3D bioprinting & high-density cell culture
5.4 TRENDS/DISRUPTIONS IMPACTING CUSTOMERS' BUSINESSES
5.5 VALUE CHAIN ANALYSIS
5.6 ECOSYSTEM ANALYSIS
5.6.1 ROLE IN ECOSYSTEM
5.7 PATENT ANALYSIS
5.7.1 LIST OF KEY PATENTS
5.8 PIPELINE ANALYSIS
5.8.1 BIOSIMILAR PRODUCTS IN CLINICAL PIPELINE
5.8.2 LIST OF KEY BIOLOGICS TO GO OFF-PATENT
5.9 REGULATORY ANALYSIS
5.9.1 REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS
5.9.2 REGULATORY FRAMEWORK
5.10 REIMBURSEMENT SCENARIO ANALYSIS
5.11 PRICING ANALYSIS
5.11.1 AVERAGE SELLING PRICE TREND OF BIOSIMILAR PRODUCTS, BY KEY PLAYER, 2022-2024
5.11.2 AVERAGE SELLING PRICE TREND OF BIOSIMILAR PRODUCTS, BY REGION, 2022-2024
5.12 KEY CONFERENCES & EVENTS, 2025-2026
5.13 PORTER'S FIVE FORCES ANALYSIS
5.13.1 THREAT OF NEW ENTRANTS
5.13.2 THREAT OF SUBSTITUTES
5.13.3 BARGAINING POWER OF SUPPLIERS
5.13.4 BARGAINING POWER OF BUYERS
5.13.5 INTENSITY OF COMPETITIVE RIVALRY
5.14 KEY STAKEHOLDERS & BUYING CRITERIA
5.14.1 KEY STAKEHOLDERS IN BUYING PROCESS
5.14.2 KEY BUYING CRITERIA
5.15 INVESTMENT & FUNDING SCENARIO
5.16 IMPACT OF AI/GEN AI ON BIOSIMILARS MARKET
5.17 IMPACT OF 2025 US TARIFF ON BIOSIMILARS MARKET
5.17.1 INTRODUCTION
5.17.2 KEY TARIFF RATES
5.17.3 PRICE IMPACT ANALYSIS
5.17.4 IMPACT ON COUNTRY/REGION
5.17.4.1 North America
5.17.4.1.1 US
5.17.4.2 Europe
5.17.4.3 Asia Pacific
5.17.5 IMPACT ON UPSTREAM MANUFACTURING INDUSTRIES

6 BIOSIMILARS MARKET, BY DRUG CLASS
6.1 INTRODUCTION
6.2 MONOCLONAL ANTIBODIES
6.2.1 RITUXIMAB
6.2.1.1 Rising incidences of autoimmune diseases and cancer to boost segment growth
6.2.2 INFLIXIMAB
6.2.2.1 Loss of patent exclusivity to fuel adoption for treating autoimmune diseases
6.2.3 ADALIMUMAB
6.2.3.1 Cost-effectiveness and improved patient access to support segment growth
6.2.4 TRASTUZUMAB
6.2.4.1 Rising incidence of breast cancer to spur market growth
6.2.5 PEMBROLIZUMAB
6.2.5.1 Expansion of immunotherapy in oncology to propel segment growth
6.2.6 DUPILUMAB
6.2.6.1 High cost of originator therapy and ongoing label expansions to increase demand for affordable biosimilars
6.2.7 USTEKINUMAB
6.2.7.1 High annual treatment costs of original drug to augment segment growth
6.2.8 RISANKIZUMAB
6.2.8.1 Increased biologic-naive patient growth and high demand for targeted immunotherapies to fuel adoption
6.2.9 OTHER MONOCLONAL ANTIBODIES
6.3 GRANULOCYTE COLONY-STIMULATING FACTOR
6.3.1 RISING GLOBAL CANCER BURDEN AND INCREASING INVESTMENTS BY PHARMA COMPANIES TO PROPEL MARKET GROWTH
6.4 INSULIN
6.4.1 HIGH PREVALENCE OF DIABETES TO BOOST MARKET GROWTH
6.5 ERYTHROPOIETIN
6.5.1 RISING INCIDENCE OF BLOOD DISEASES TO AUGMENT MARKET GROWTH
6.6 RECOMBINANT HUMAN GROWTH HORMONE
6.6.1 RISING INCIDENCE OF CACHEXIA AND LIVER DISEASES TO FUEL MARKET GROWTH
6.7 ETANERCEPT
6.7.1 RISING INCIDENCE OF AUTOIMMUNE DISEASES TO DRIVE APPROVAL AND COMMERCIALIZATION OF ETANERCEPT BIOSIMILARS
6.8 FOLLITROPIN
6.8.1 POPULARITY OF FOLLITROPIN IN INFERTILITY TREATMENT TO SPUR MARKET GROWTH
6.9 TERIPARATIDE
6.9.1 INCREASING INCIDENCE OF OSTEOPOROSIS TO BOOST MARKET DEMAND
6.10 INTERFERONS
6.10.1 GROWING PREVALENCE OF INFECTIOUS DISEASES TO SUPPORT MARKET GROWTH
6.11 ANTICOAGULANTS
6.11.1 RISING PREVALENCE OF CARDIOVASCULAR DISEASES TO FUEL MARKET GROWTH
6.12 AFLIBERCEPT
6.12.1 HIGH COST OF ORIGINATOR DRUG AND INCREASED PREVALENCE OF AGE-RELATED EYE DISEASES TO DRIVE SEGMENT
6.13 GLP-1 ANTAGONIST
6.13.1 HIGH PREVALENCE OF DIABETES AND OBESITY TO AID MARKET GROWTH
6.14 OTHER DRUG CLASSES

7 BIOSIMILARS MARKET, BY INDICATION
7.1 INTRODUCTION
7.2 ONCOLOGY
7.2.1 HIGH PREVALENCE OF CANCER TO DRIVE MARKET
7.3 INFLAMMATORY & AUTOIMMUNE DISEASES
7.3.1 RISING LIFE EXPECTANCY AND GROWING GERIATRIC POPULATION TO AUGMENT MARKET GROWTH
7.4 CHRONIC DISEASES
7.4.1 HIGH BURDEN OF CARDIOVASCULAR DISEASES TO FUEL UPTAKE OF BIOSIMILARS
7.5 BLOOD DISORDERS
7.5.1 INCREASING INCIDENCE OF BLOOD DISORDERS TO BOOST BIOSIMILAR DEMAND
7.6 GROWTH HORMONE DEFICIENCY
7.6.1 INCREASING CASES OF GROWTH HORMONE DEFICIENCY AMONG ADULTS TO INCREASE DEMAND FOR BIOSIMILARS
7.7 INFECTIOUS DISEASES
7.7.1 HIGH POPULATION DENSITY AND INDUSTRIALIZATION OF FOOD PRODUCTION TO DRIVE PREVALENCE IN EMERGING ECONOMIES
7.8 TYPE II DIABETES
7.8.1 COST-EFFECTIVENESS AND HIGH EFFICACY TO DRIVE BIOSIMILAR ADOPTION FOR DIABETES
7.9 OBESITY
7.9.1 INCREASING SEDENTARY LIFESTYLE AMONG ADULTS TO PROPEL MARKET GROWTH
7.10 OTHER INDICATIONS

8 BIOSIMILARS MARKET, BY REGION
8.1 INTRODUCTION
8.2 EUROPE
8.2.1 MACROECONOMIC OUTLOOK FOR EUROPE
8.2.2 GERMANY
8.2.2.1 Acceptance of biosimilars by physicians over originator products to propel market growth
8.2.3 UK
8.2.3.1 Rising prevalence of life-threatening diseases to fuel demand for low-priced biosimilars
8.2.4 FRANCE
8.2.4.1 Increased government R&D investments for biosimilar drugs to augment market growth
8.2.5 ITALY
8.2.5.1 Favorable government regulations and reimbursement policies to propel market growth
8.2.6 SPAIN
8.2.6.1 Favorable patient incentives and high healthcare R&D expenditure to promote biosimilar use
8.2.7 REST OF EUROPE
8.3 ASIA PACIFIC
8.3.1 MACROECONOMIC OUTLOOK FOR ASIA PACIFIC
8.3.2 JAPAN
8.3.2.1 High demand for affordable biologics and recent patent expiries of blockbuster biologics to drive market
8.3.3 CHINA
8.3.3.1 Increasing investments in pharmaceutical R&D and innovation to augment market growth
8.3.4 INDIA
8.3.4.1 Need for government healthcare expenditure reduction to propel adoption of biosimilars
8.3.5 SOUTH KOREA
8.3.5.1 Favourable government incentives to promote biosimilar use in clinical practice
8.3.6 AUSTRALIA
8.3.6.1 Launch of biosimilar-switching programs in healthcare settings to aid market adoption
8.3.7 REST OF ASIA PACIFIC
8.4 NORTH AMERICA
8.4.1 MACROECONOMIC OUTLOOK FOR NORTH AMERICA
8.4.2 US
8.4.2.1 US to dominate North American biosimilars market during forecast period
8.4.3 CANADA
8.4.3.1 Favorable government initiatives to drive growth in biopharma research and manufacturing facilities
8.5 LATIN AMERICA
8.5.1 MACROECONOMIC OUTLOOK FOR LATIN AMERICA
8.5.2 BRAZIL
8.5.2.1 Increased government pharmaceutical R&D investments for biosimilars to aid market growth
8.5.3 MEXICO
8.5.3.1 Well-developed regulatory landscape and high demand for chronic disease treatment to fuel biosimilar uptake
8.5.4 REST OF LATIN AMERICA
8.6 MIDDLE EAST
8.6.1 MACROECONOMIC OUTLOOK FOR MIDDLE EAST
8.6.2 GCC COUNTRIES
8.6.2.1 Focus on local pharmaceutical R&D to augment market growth
8.6.3 REST OF MIDDLE EAST
8.7 AFRICA
8.7.1 INCREASED CANCER BURDEN AND NEED FOR AFFORDABLE ALTERNATIVES TO HIGH-COST BIOLOGICS TO BOOST ADOPTION
8.7.2 MACROECONOMIC OUTLOOK FOR AFRICA

9 COMPETITIVE LANDSCAPE
9.1 INTRODUCTION
9.2 KEY PLAYER STRATEGIES/RIGHT TO WIN
9.2.1 OVERVIEW OF STRATEGIES ADOPTED BY KEY PLAYERS IN BIOSIMILARS MARKET, 2022-2024
9.3 REVENUE ANALYSIS, 2020-2024
9.4 MARKET SHARE ANALYSIS, 2024
9.5 COMPANY EVALUATION MATRIX: KEY PLAYERS, 2024
9.5.1 STARS
9.5.2 EMERGING LEADERS
9.5.3 PERVASIVE PLAYERS
9.5.4 PARTICIPANTS
9.5.5 COMPETITIVE BENCHMARKING: KEY PLAYERS, 2024
9.5.5.1 Company footprint
9.5.5.2 Region footprint
9.5.5.3 Drug class footprint
9.5.5.4 Indication footprint
9.6 COMPANY EVALUATION MATRIX: STARTUPS/SMES, 2024
9.6.1 PROGRESSIVE COMPANIES
9.6.2 RESPONSIVE COMPANIES
9.6.3 DYNAMIC COMPANIES
9.6.4 STARTING BLOCKS
9.6.5 COMPETITIVE BENCHMARKING: STARTUPS/SMES, 2024
9.6.5.1 Detailed list of key startups/SMEs
9.6.5.2 Competitive benchmarking of key startups/SMEs
9.7 COMPANY VALUATION & FINANCIAL METRICS
9.7.1 FINANCIAL METRICS
9.7.2 COMPANY VALUATION
9.8 BRAND/PRODUCT COMPARISON
9.9 COMPETITIVE SCENARIO
9.9.1 PRODUCT LAUNCHES AND APPROVALS
9.9.2 DEALS
9.9.3 EXPANSIONS

10 COMPANY PROFILES
10.1 KEY PLAYERS
10.1.1 SANDOZ GROUP AG
10.1.1.1 Business overview
10.1.1.2 Products offered
10.1.1.3 Recent developments
10.1.1.3.1 Product launches and approvals
10.1.1.3.2 Deals
10.1.1.3.3 Expansions
10.1.1.3.4 Other developments
10.1.1.4 MnM view
10.1.1.4.1 Key strengths
10.1.1.4.2 Strategic choices
10.1.1.4.3 Weaknesses & competitive threats
10.1.2 PFIZER INC.
10.1.2.1 Business overview
10.1.2.2 Products offered
10.1.2.3 Recent developments
10.1.2.3.1 Product approvals
10.1.2.3.2 Deals
10.1.2.4 MnM view
10.1.2.4.1 Key strengths
10.1.2.4.2 Strategic choices
10.1.2.4.3 Weaknesses & competitive threats
10.1.3 AMGEN INC.
10.1.3.1 Business overview
10.1.3.2 Products offered
10.1.3.3 Products in pipeline
10.1.3.4 Recent developments
10.1.3.4.1 Product launches and approvals
10.1.3.4.2 Deals
10.1.3.4.3 Expansions
10.1.3.5 MnM view
10.1.3.5.1 Key strengths
10.1.3.5.2 Strategic choices
10.1.3.5.3 Weaknesses & competitive threats
10.1.4 CELLTRION INC.
10.1.4.1 Business overview
10.1.4.2 Products offered
10.1.4.3 Recent developments
10.1.4.3.1 Product launches and approvals
10.1.4.3.2 Deals
10.1.4.4 MnM view
10.1.4.4.1 Key strengths
10.1.4.4.2 Strategic choices
10.1.4.4.3 Weaknesses & competitive threats
10.1.5 BIOCON
10.1.5.1 Business overview
10.1.5.2 Products offered
10.1.5.3 Recent developments
10.1.5.3.1 Product approvals
10.1.5.3.2 Deals
10.1.5.3.3 Other developments
10.1.5.4 MnM view
10.1.5.4.1 Key strengths
10.1.5.4.2 Strategic choices
10.1.5.4.3 Weaknesses & competitive threats
10.1.6 DR. REDDY'S LABORATORIES LTD.
10.1.6.1 Business overview
10.1.6.2 Products offered
10.1.6.3 Recent developments
10.1.6.3.1 Product launches
10.1.6.3.2 Deals
10.1.6.3.3 Other developments
10.1.7 ELI LILLY AND COMPANY
10.1.7.1 Business overview
10.1.7.2 Products offered
10.1.7.3 Recent developments
10.1.7.3.1 Product launches
10.1.7.3.2 Deals
10.1.7.3.3 Expansions
10.1.8 TEVA PHARMACEUTICAL INDUSTRIES LTD.
10.1.8.1 Business overview
10.1.8.2 Products offered
10.1.8.3 Recent developments
10.1.8.3.1 Product launches and approvals
10.1.8.3.2 Deals
10.1.8.3.3 Other developments
10.1.9 FRESENIUS KABI AG
10.1.9.1 Business overview
10.1.9.2 Products offered
10.1.9.3 Recent developments
10.1.9.3.1 Product launches and approvals
10.1.9.3.2 Deals
10.1.10 STADA ARZNEIMITTEL AG
10.1.10.1 Business overview
10.1.10.2 Products offered
10.1.10.3 Recent developments
10.1.10.3.1 Product launches
10.1.10.3.2 Deals
10.1.10.3.3 Expansions
10.1.10.3.4 Other developments
10.1.11 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
10.1.11.1 Business overview
10.1.11.2 Products offered
10.1.11.3 Recent developments
10.1.11.3.1 Product approvals
10.1.11.3.2 Deals
10.1.11.3.3 Expansions
10.1.12 SAMSUNG BIOLOGICS
10.1.12.1 Business overview
10.1.12.2 Products offered
10.1.12.3 Recent developments
10.1.12.3.1 Product approvals
10.1.12.3.2 Deals
10.1.12.3.3 Expansions
10.1.13 AMNEAL PHARMACEUTICALS LLC
10.1.13.1 Business overview
10.1.13.2 Products offered
10.1.13.3 Recent developments
10.1.13.3.1 Product approvals
10.1.13.3.2 Deals
10.1.13.3.3 Other developments
10.1.14 COHERUS BIOSCIENCES
10.1.14.1 Business overview
10.1.14.2 Products offered
10.1.14.3 Recent developments
10.1.14.3.1 Deals
10.1.14.3.2 Other developments
10.1.15 BIO THERA SOLUTIONS
10.1.15.1 Business overview
10.1.15.2 Products offered
10.1.15.3 Recent developments
10.1.15.3.1 Product approvals
10.1.15.3.2 Deals
10.1.16 APROGEN
10.1.16.1 Business overview
10.1.16.2 Products offered
10.1.16.3 Recent developments
10.1.16.3.1 Product approvals
10.1.16.4 Products in pipeline
10.1.17 SHANGHAI HENLINUS BIOTECH, INC.
10.1.17.1 Business overview
10.1.17.2 Products offered
10.1.17.3 Products in pipeline
10.1.17.4 Recent developments
10.1.17.4.1 Product approvals
10.1.17.4.2 Deals
10.1.17.4.3 Other developments
10.2 OTHER PLAYERS
10.2.1 ALVOTECH
10.2.2 AMEGA BIOTECH
10.2.3 BIOCAD
10.2.4 PROBIOMED S.A. DE C.V.
10.2.5 FUJIFILM KYOWA KIRIN BIOLOGICS CO., LTD.
10.2.6 POLPHARMA BIOLOGICS GROUP
10.2.7 NEUCLONE
10.2.8 XENTRIA
10.2.9 YL BIOLOGICS
10.2.10 KASHIV BIOSCIENCES, LLC
10.2.11 NANOGEN PHARMACEUTICAL BIOTECHNOLOGY JSC
10.2.12 SYNERMORE BIOLOGICS (SUZHOU) CO., LTD.
10.2.13 CURATEQ BIOLOGICS PVT. LTD.

11 APPENDIX
11.1 DISCUSSION GUIDE
11.2 KNOWLEDGESTORE: MARKETSANDMARKETS' SUBSCRIPTION PORTAL
11.3 CUSTOMIZATION OPTIONS
11.4 RELATED REPORTS
11.5 AUTHOR DETAILS