The global next-generation biologics market size is calculated at USD 122.24 billion in 2025 and is forecasted to reach around USD 301.22 billion by 2034, accelerating at a CAGR of 10.54% from 2025 to 2034. The North America market size surpassed USD 48.66 billion in 2024 and is expanding at a CAGR of 10.66% during the forecast period. The market sizing and forecasts are revenue-based (USD Million/Billion), with 2024 as the base year.
1.1. Research Objective
1.2. Scope of the Study
1.3. Definition
2.1. Research Approach
2.2. Data Sources
2.3. Assumptions & Limitations
3.1. Market Snapshot
4.1. Introduction
4.2. Market Classification and Scope
4.3. Industry Value Chain Analysis
4.3.1. Raw Material Procurement Analysis
4.3.2. Sales and Distribution Channel Analysis
4.3.3. Downstream Buyer Analysis
5.1. COVID-19 Landscape: Next-Generation Biologics Industry Impact
5.2. COVID 19 - Impact Assessment for the Industry
5.3. COVID 19 Impact: Global Major Government Policy
5.4. Market Trends and Opportunities in the COVID-19 Landscape
6.1. Market Dynamics
6.1.1. Market Drivers
6.1.2. Market Restraints
6.1.3. Market Opportunities
6.2. Porter’s Five Forces Analysis
6.2.1. Bargaining power of suppliers
6.2.2. Bargaining power of buyers
6.2.3. Threat of substitute
6.2.4. Threat of new entrants
6.2.5. Degree of competition
7.1.1. Company Market Share/Positioning Analysis
7.1.2. Key Strategies Adopted by Players
7.1.3. Vendor Landscape
7.1.3.1. List of Suppliers
7.1.3.2. List of Buyers
8.1. Next-Generation Biologics Market Revenue and Volume, by Product Type
8.1.1. Antibody Drug Conjugates (ADCs)
8.1.1.1. Market Revenue and Volume Forecast
8.1.2. Bispecific Antibodies
8.1.2.1. Market Revenue and Volume Forecast
8.1.3. Fusion Protein Therapeutics
8.1.3.1. Market Revenue and Volume Forecast
8.1.4. Monoclonal Antibody Fragments (e.g., Fab, scFv)
8.1.4.1. Market Revenue and Volume Forecast
8.1.5. Engineered Cytokines
8.1.5.1. Market Revenue and Volume Forecast
8.1.6. Cell-Based Therapies (e.g., CAR-T)
8.1.6.1. Market Revenue and Volume Forecast
8.1.7. Gene Therapies
8.1.7.1. Market Revenue and Volume Forecast
8.1.8. RNA-Based Biologics (e.g., siRNA, mRNA)
8.1.8.1. Market Revenue and Volume Forecast
8.1.9. Nanobodies & Single-Domain Antibodies
8.1.9.1. Market Revenue and Volume Forecast
8.1.10. Others (e.g., Protein Scaffolds, Aptamers)
8.1.10.1. Market Revenue and Volume Forecast
9.1. Next-Generation Biologics Market Revenue and Volume, by Disease Area
9.1.1. Oncology
9.1.1.1. Market Revenue and Volume Forecast
9.1.2. Autoimmune & Inflammatory Disorders
9.1.2.1. Market Revenue and Volume Forecast
9.1.3. Genetic Disorders (e.g., hemophilia, SMA)
9.1.3.1. Market Revenue and Volume Forecast
9.1.4. Infectious Diseases (e.g., HIV, COVID-19)
9.1.4.1. Market Revenue and Volume Forecast
9.1.5. Ophthalmic Diseases (e.g., AMD)
9.1.5.1. Market Revenue and Volume Forecast
9.1.6. Neurological Disorders
9.1.6.1. Market Revenue and Volume Forecast
9.1.7. Others (e.g., metabolic, cardiovascular)
9.1.7.1. Market Revenue and Volume Forecast
10.1. Next-Generation Biologics Market Revenue and Volume, by Manufacturing Platform
10.1.1. Mammalian Cell Culture (CHO, HEK293)
10.1.1.1. Market Revenue and Volume Forecast
10.1.2. Microbial Systems (E. coli, Yeast)
10.1.2.1. Market Revenue and Volume Forecast
10.1.3. Cell-Free Expression Systems
10.1.3.1. Market Revenue and Volume Forecast
10.1.4. Viral Vectors (Lentivirus, AAV)
10.1.4.1. Market Revenue and Volume Forecast
10.1.5. RNA Synthesis Platforms
10.1.5.1. Market Revenue and Volume Forecast
10.1.6. Others (e.g., Plant-based, Insect cell systems)
10.1.6.1. Market Revenue and Volume Forecast
11.1. Next-Generation Biologics Market Revenue and Volume, by Route of Administration
11.1.1. Intravenous (IV)
11.1.1.1. Market Revenue and Volume Forecast
11.1.2. Subcutaneous (SC)
11.1.2.1. Market Revenue and Volume Forecast
11.1.3. Intramuscular (IM)
11.1.3.1. Market Revenue and Volume Forecast
11.1.4. Intrathecal/Intraocular
11.1.4.1. Market Revenue and Volume Forecast
11.1.5. Others (e.g., Inhalation, Topical)
11.1.5.1. Market Revenue and Volume Forecast
12.1. Next-Generation Biologics Market Revenue and Volume, by Distribution Channel
12.1.1. Hospital Pharmacies
12.1.1.1. Market Revenue and Volume Forecast
12.1.2. Specialty Pharmacies
12.1.2.1. Market Revenue and Volume Forecast
12.1.3. Retail Pharmacies
12.1.3.1. Market Revenue and Volume Forecast
12.1.4. Others (e.g., Direct-to-Patient, Clinical Sites)
12.1.4.1. Market Revenue and Volume Forecast
13.1. North America
13.1.1. Market Revenue and Volume Forecast, by Product Type
13.1.2. Market Revenue and Volume Forecast, by Disease Area
13.1.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.1.4. Market Revenue and Volume Forecast, by Route of Administration
13.1.5. Market Revenue and Volume Forecast, by Distribution Channel
13.1.6. U.S.
13.1.6.1. Market Revenue and Volume Forecast, by Product Type
13.1.6.2. Market Revenue and Volume Forecast, by Disease Area
13.1.6.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.1.6.4. Market Revenue and Volume Forecast, by Route of Administration
13.1.6.5. Market Revenue and Volume Forecast, by Distribution Channel
13.1.7. Rest of North America
13.1.7.1. Market Revenue and Volume Forecast, by Product Type
13.1.7.2. Market Revenue and Volume Forecast, by Disease Area
13.1.7.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.1.7.4. Market Revenue and Volume Forecast, by Route of Administration
13.1.7.5. Market Revenue and Volume Forecast, by Distribution Channel
13.2. Europe
13.2.1. Market Revenue and Volume Forecast, by Product Type
13.2.2. Market Revenue and Volume Forecast, by Disease Area
13.2.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.2.4. Market Revenue and Volume Forecast, by Route of Administration
13.2.5. Market Revenue and Volume Forecast, by Distribution Channel
13.2.6. UK
13.2.6.1. Market Revenue and Volume Forecast, by Product Type
13.2.6.2. Market Revenue and Volume Forecast, by Disease Area
13.2.6.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.2.7. Market Revenue and Volume Forecast, by Route of Administration
13.2.8. Market Revenue and Volume Forecast, by Distribution Channel
13.2.9. Germany
13.2.9.1. Market Revenue and Volume Forecast, by Product Type
13.2.9.2. Market Revenue and Volume Forecast, by Disease Area
13.2.9.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.2.10. Market Revenue and Volume Forecast, by Route of Administration
13.2.11. Market Revenue and Volume Forecast, by Distribution Channel
13.2.12. France
13.2.12.1. Market Revenue and Volume Forecast, by Product Type
13.2.12.2. Market Revenue and Volume Forecast, by Disease Area
13.2.12.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.2.12.4. Market Revenue and Volume Forecast, by Route of Administration
13.2.13. Market Revenue and Volume Forecast, by Distribution Channel
13.2.14. Rest of Europe
13.2.14.1. Market Revenue and Volume Forecast, by Product Type
13.2.14.2. Market Revenue and Volume Forecast, by Disease Area
13.2.14.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.2.14.4. Market Revenue and Volume Forecast, by Route of Administration
13.2.15. Market Revenue and Volume Forecast, by Distribution Channel
13.3. APAC
13.3.1. Market Revenue and Volume Forecast, by Product Type
13.3.2. Market Revenue and Volume Forecast, by Disease Area
13.3.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.3.4. Market Revenue and Volume Forecast, by Route of Administration
13.3.5. Market Revenue and Volume Forecast, by Distribution Channel
13.3.6. India
13.3.6.1. Market Revenue and Volume Forecast, by Product Type
13.3.6.2. Market Revenue and Volume Forecast, by Disease Area
13.3.6.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.3.6.4. Market Revenue and Volume Forecast, by Route of Administration
13.3.7. Market Revenue and Volume Forecast, by Distribution Channel
13.3.8. China
13.3.8.1. Market Revenue and Volume Forecast, by Product Type
13.3.8.2. Market Revenue and Volume Forecast, by Disease Area
13.3.8.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.3.8.4. Market Revenue and Volume Forecast, by Route of Administration
13.3.9. Market Revenue and Volume Forecast, by Distribution Channel
13.3.10. Japan
13.3.10.1. Market Revenue and Volume Forecast, by Product Type
13.3.10.2. Market Revenue and Volume Forecast, by Disease Area
13.3.10.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.3.10.4. Market Revenue and Volume Forecast, by Route of Administration
13.3.10.5. Market Revenue and Volume Forecast, by Distribution Channel
13.3.11. Rest of APAC
13.3.11.1. Market Revenue and Volume Forecast, by Product Type
13.3.11.2. Market Revenue and Volume Forecast, by Disease Area
13.3.11.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.3.11.4. Market Revenue and Volume Forecast, by Route of Administration
13.3.11.5. Market Revenue and Volume Forecast, by Distribution Channel
13.4. MEA
13.4.1. Market Revenue and Volume Forecast, by Product Type
13.4.2. Market Revenue and Volume Forecast, by Disease Area
13.4.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.4.4. Market Revenue and Volume Forecast, by Route of Administration
13.4.5. Market Revenue and Volume Forecast, by Distribution Channel
13.4.6. GCC
13.4.6.1. Market Revenue and Volume Forecast, by Product Type
13.4.6.2. Market Revenue and Volume Forecast, by Disease Area
13.4.6.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.4.6.4. Market Revenue and Volume Forecast, by Route of Administration
13.4.7. Market Revenue and Volume Forecast, by Distribution Channel
13.4.8. North Africa
13.4.8.1. Market Revenue and Volume Forecast, by Product Type
13.4.8.2. Market Revenue and Volume Forecast, by Disease Area
13.4.8.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.4.8.4. Market Revenue and Volume Forecast, by Route of Administration
13.4.9. Market Revenue and Volume Forecast, by Distribution Channel
13.4.10. South Africa
13.4.10.1. Market Revenue and Volume Forecast, by Product Type
13.4.10.2. Market Revenue and Volume Forecast, by Disease Area
13.4.10.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.4.10.4. Market Revenue and Volume Forecast, by Route of Administration
13.4.10.5. Market Revenue and Volume Forecast, by Distribution Channel
13.4.11. Rest of MEA
13.4.11.1. Market Revenue and Volume Forecast, by Product Type
13.4.11.2. Market Revenue and Volume Forecast, by Disease Area
13.4.11.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.4.11.4. Market Revenue and Volume Forecast, by Route of Administration
13.4.11.5. Market Revenue and Volume Forecast, by Distribution Channel
13.5. Latin America
13.5.1. Market Revenue and Volume Forecast, by Product Type
13.5.2. Market Revenue and Volume Forecast, by Disease Area
13.5.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.5.4. Market Revenue and Volume Forecast, by Route of Administration
13.5.5. Market Revenue and Volume Forecast, by Distribution Channel
13.5.6. Brazil
13.5.6.1. Market Revenue and Volume Forecast, by Product Type
13.5.6.2. Market Revenue and Volume Forecast, by Disease Area
13.5.6.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.5.6.4. Market Revenue and Volume Forecast, by Route of Administration
13.5.7. Market Revenue and Volume Forecast, by Distribution Channel
13.5.8. Rest of LATAM
13.5.8.1. Market Revenue and Volume Forecast, by Product Type
13.5.8.2. Market Revenue and Volume Forecast, by Disease Area
13.5.8.3. Market Revenue and Volume Forecast, by Manufacturing Platform
13.5.8.4. Market Revenue and Volume Forecast, by Route of Administration
13.5.8.5. Market Revenue and Volume Forecast, by Distribution Channel
14.1. Roche Holding AG
14.1.1. Company Overview
14.1.2. Product Offerings
14.1.3. Financial Performance
14.1.4. Recent Initiatives
14.2. Amgen Inc.
14.2.1. Company Overview
14.2.2. Product Offerings
14.2.3. Financial Performance
14.2.4. Recent Initiatives
14.3. Merck & Co., Inc.
14.3.1. Company Overview
14.3.2. Product Offerings
14.3.3. Financial Performance
14.3.4. Recent Initiatives
14.4. Takeda Pharmaceutical Co. Ltd.
14.4.1. Company Overview
14.4.2. Product Offerings
14.4.3. Financial Performance
14.4.4. Recent Initiatives
14.5. Regeneron Pharmaceuticals
14.5.1. Company Overview
14.5.2. Product Offerings
14.5.3. Financial Performance
14.5.4. Recent Initiatives
14.6. Biogen Inc.
14.6.1. Company Overview
14.6.2. Product Offerings
14.6.3. Financial Performance
14.6.4. Recent Initiatives
14.7. UCB S.A.
14.7.1. Company Overview
14.7.2. Product Offerings
14.7.3. Financial Performance
14.7.4. Recent Initiatives
14.8. Moderna, Inc.
14.8.1. Company Overview
14.8.2. Product Offerings
14.8.3. Financial Performance
14.8.4. Recent Initiatives
14.9. BioNTech SE
14.9.1. Company Overview
14.9.2. Product Offerings
14.9.3. Financial Performance
14.9.4. Recent Initiatives
14.10. Bluebird Bio
14.10.1. Company Overview
14.10.2. Product Offerings
14.10.3. Financial Performance
14.10.4. Recent Initiatives
15.1. Primary Research
15.2. Secondary Research
15.3. Assumptions
16.1. About Us
16.2. Glossary of Terms
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