Report Code : CVMI2412313 | Published Date : March 3, 2025
The global biologics market was valued at USD 421.5 billion in 2023 and is projected to reach USD 856.3 billion by 2031, growing at a CAGR of 9.3%. This growth is driven by the increasing demand for targeted therapies, advancements in biotechnology, and the rising prevalence of chronic diseases. Key segments include monoclonal antibodies, vaccines, and cell & gene therapies.
2024 Market Breakthroughs
1. Next-Generation Biologics
- Bispecific Antibodies: Roche’s Glofitamab demonstrates a 75% response rate in lymphoma trials.
- mRNA Vaccines: Moderna’s Personalised Cancer Vaccine enters Phase III trials.
- CRISPR-Based Therapies: Vertex’s Exa-cel achieves 95% efficacy in the treatment of sickle cell disease.
2. Manufacturing Innovations
- Continuous Bioprocessing: Reduces production costs by 40% (Merck’s BioContinuum™ Platform).
- AI-Driven Drug Design: Insilico Medicine’s AI-generated biologic enters clinical trials.
- Single-Use Bioreactors: 50% faster scale-up (Sartorius’ Flexsafe® STR).
3. Regulatory Advancements
- FDA’s Project Orbis: Accelerates approvals for 7 oncology biologics in 2024.
- EU’s ATMP Regulation: Fast-tracks 12 gene therapies.
- WHO Biosimilar Guidelines: Reduce approval timelines to 8 months.
Market Drivers
- Chronic Disease Burden: 60% of biologics target cancer, diabetes, and autoimmune diseases.
- Patent Expiries: USD 120 billion in biologics face biosimilar competition by 2026.
- Personalized Medicine: 45% of pipeline biologics are patient-specific.
Competitive Landscape
Company |
Market Share |
Flagship Product |
2024 Pipeline |
Roche |
22% |
Rituxan® |
15 oncology biologics |
AbbVie |
18% |
Humira® |
8 immunology biosimilars |
Novartis |
15% |
Cosentyx® |
10 cell & gene therapies |
Emerging Disruptors:
- BioNTech: mRNA-based autoimmune disease vaccines.
- CSL Behring: Gene-edited plasma therapies.
- Gritstone Bio: Neoantigen cancer vaccines.
Market Segmentation
- By Product:
- Monoclonal Antibodies (45%)
- Vaccines (XX%)
- Cell & Gene Therapies (XX%)
- Others (XX%)
- By Disease:
- Oncology (40%)
- Autoimmune (XX%)
- Infectious Diseases (XX%)
- By Region:
- North America (50%)
- Europe (XX%)
- Asia-Pacific (XX%)
Recent Developments (2024)
- Q1: FDA approves first CRISPR-based biologic for beta-thalassemia.
- Q2: EU invests €2.1 billion in biologics manufacturing.
- Q3: China’s NMPA fast-tracks 5 biosimilars.
Reasons To Buy

Scope

Key Players
- Biologics Market – Amgen
- Pfizer
- Roche
- Johnson & Johnson
- Novartis
- Merck & Co.
- Sanofi
- Eli Lilly
- Bristol-Myers Squibb
- AstraZeneca.
Global Biologics Market Report
- 1. Global Biologics Market Research Report
- 1.1 Study Objectives
- 1.2 Global Biologics Market - Overview
- 1.3 Reason to Read This Report
- 1.4 Methodology and Forecast Analysis
- 2.1 Global Biologics Market Research Report – Detailed Scope and Definitions
- 2.1.1 By Type
- 2.1.2 By Application
- 2.1.3 By End-user
- 2.1.4 By Region
- 3.1. Drivers - Macro-Economic Based, Supply Side, and Demand Side Drivers
- 3.2. Restraints – By Type, By Application, By End-user, By Country
- 3.3. Opportunities – By Type, By Application, By End-user, By Country
- 3.4. Trends – By Type, By Application, By End-user, By Country
- 3.5. PEST Analysis
- 3.6. Porters Five Rule Analysis
- 3.7. Company’s Share Analysis (CSA) by Region or By Country
- 3.8. Global Biologics Market Research Report – DROTs Impact Analysis
- 4.1. Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 4.2. Annual Market Trend Assessment – Year-on-Year (YoY) Growth Analysis (%)
- 4.3. Incremental Market Value/Volume Opportunity between 2019 - 2023 and 2024 - 2031
- 4.4. Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 5.1 Monoclonal Antibodies
- 5.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 5.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 5.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 5.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 5.2 Vaccines
- 5.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 5.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 5.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 5.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 5.3 Recombinant Proteins
- 5.3.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 5.3.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 5.3.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 5.3.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 5.4 Gene Therapies
- 5.4.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 5.4.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 5.4.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 5.4.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 5.5 Cell Therapies
- 5.5.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 5.5.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 5.5.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 5.5.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 6.1 Cancer
- 6.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 6.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 6.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 6.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 6.2 Cardiovascular Diseases
- 6.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 6.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 6.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 6.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 6.3 Autoimmune Diseases
- 6.3.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 6.3.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 6.3.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 6.3.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 6.4 Infectious Diseases
- 6.4.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 6.4.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 6.4.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 6.4.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 7.1 Hospitals
- 7.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 7.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 7.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 7.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 7.2 Clinics
- 7.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 7.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 7.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 7.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 7.3 Biotech Companies
- 7.3.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 7.3.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 7.3.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 7.3.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 7.4 Pharmaceutical Companies.
- 7.4.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 7.4.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 7.4.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 7.4.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.1 North America
- 8.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.2 Europe
- 8.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.3 Asia-Pacific
- 8.3.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.3.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.3.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.3.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.4 Latin America
- 8.4.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.4.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.4.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.4.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.5 Middle East & Africa
- 8.5.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.5.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.5.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.5.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.6 Global Biologics Market - Opportunity Analysis Index, By Type, By Application, By End-user, and Region, 2024 - 2031
- 9.1 By Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 9.1.1 Monoclonal Antibodies
- 9.1.2 Vaccines
- 9.1.3 Recombinant Proteins
- 9.1.4 Gene Therapies
- 9.1.5 Cell Therapies
- 9.2.1 Cancer
- 9.2.2 Cardiovascular Diseases
- 9.2.3 Autoimmune Diseases
- 9.2.4 Infectious Diseases
- 9.3.1 Hospitals
- 9.3.2 Clinics
- 9.3.3 Biotech Companies
- 9.3.4 Pharmaceutical Companies.
- 9.4.1 United States
- 9.4.2 Canada
9.6 Regional Trends Analysis
9.7 North America Global Biologics Market Research Report - Company Profiles- 9.7.1 Company 1 (United States)
- 9.7.2 Company 2 (Canada)
- 9.7.3 Company 3 (Canada)
- 10.1 By Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 10.1.1 Monoclonal Antibodies
- 10.1.2 Vaccines
- 10.1.3 Recombinant Proteins
- 10.1.4 Gene Therapies
- 10.1.5 Cell Therapies
- 10.2.1 Cancer
- 10.2.2 Cardiovascular Diseases
- 10.2.3 Autoimmune Diseases
- 10.2.4 Infectious Diseases
- 10.3.1 Hospitals
- 10.3.2 Clinics
- 10.3.3 Biotech Companies
- 10.3.4 Pharmaceutical Companies.
- 10.4.1 Germany
- 10.4.2 United Kingdom
- 10.4.3 France
- 10.4.4 Spain
- 10.4.5 Italy
- 10.4.6 Russia
- 10.4.7 Netherlands
- 10.4.8 Poland
- 10.4.9 Rest of Europe
10.6 Regional Trends Analysis
10.7 Europe Global Biologics Market Research Report - Company Profiles- 10.7.1 Company 1 (Germany)
- 10.7.2 Company 2 (United Kingdom)
- 10.7.3 Company 3 (United Kingdom)
- 11.1 By Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 11.1.1 Monoclonal Antibodies
- 11.1.2 Vaccines
- 11.1.3 Recombinant Proteins
- 11.1.4 Gene Therapies
- 11.1.5 Cell Therapies
- 11.2.1 Cancer
- 11.2.2 Cardiovascular Diseases
- 11.2.3 Autoimmune Diseases
- 11.2.4 Infectious Diseases
- 11.3.1 Hospitals
- 11.3.2 Clinics
- 11.3.3 Biotech Companies
- 11.3.4 Pharmaceutical Companies.
- 11.4.1 China
- 11.4.2 Japan
- 11.4.3 India
- 11.4.4 South Korea
- 11.4.5 Australia & NZ
- 11.4.6 ASEAN
- 11.4.7 Rest of Asia-Pacific
11.6 Regional Trends Analysis
11.7 Asia-Pacific Global Biologics Market Research Report - Company Profiles- 11.7.1 Company 1 (China)
- 11.7.2 Company 2 (Japan)
- 11.7.3 Company 3 (Japan)
- 12.1 By Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 12.1.1 Monoclonal Antibodies
- 12.1.2 Vaccines
- 12.1.3 Recombinant Proteins
- 12.1.4 Gene Therapies
- 12.1.5 Cell Therapies
- 12.2.1 Cancer
- 12.2.2 Cardiovascular Diseases
- 12.2.3 Autoimmune Diseases
- 12.2.4 Infectious Diseases
- 12.3.1 Hospitals
- 12.3.2 Clinics
- 12.3.3 Biotech Companies
- 12.3.4 Pharmaceutical Companies.
- 12.4.1 Brazil
- 12.4.2 Mexico
- 12.4.3 Argentina
- 12.4.4 Peru
- 12.4.5 Colombia
- 12.4.6 Rest of Latin America
12.6 Regional Trends Analysis
12.7 Latin America Global Biologics Market Research Report - Company Profiles- 12.7.1 Company 1 (Brazil)
- 12.7.2 Company 2 (Mexico)
- 12.7.3 Company 3 (Mexico)
- 13.1 By Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 13.1.1 Monoclonal Antibodies
- 13.1.2 Vaccines
- 13.1.3 Recombinant Proteins
- 13.1.4 Gene Therapies
- 13.1.5 Cell Therapies
- 13.2.1 Cancer
- 13.2.2 Cardiovascular Diseases
- 13.2.3 Autoimmune Diseases
- 13.2.4 Infectious Diseases
- 13.3.1 Hospitals
- 13.3.2 Clinics
- 13.3.3 Biotech Companies
- 13.3.4 Pharmaceutical Companies.
- 13.4.1 Saudi Arabia
- 13.4.2 UAE
- 13.4.3 South Africa
- 13.4.4 Egypt
- 13.4.5 Israel
- 13.4.6 Rest of Middle East and Africa
13.6 Regional Trends Analysis
13.7 Middle East & Africa Global Biologics Market Research Report - Company Profiles- 13.7.1 Company 1 (Saudi Arabia)
- 13.7.2 Company 2 (UAE)
- 13.7.3 Company 3 (UAE)
- 14.1 Strategic Dashboard of Top Market Players
14.2 Company Profiles (Introduction, Financial Assessments, Portfolio of Offerings, Milestones and Achievements, Strategic Initiative, and SWOT Analysis)- 14.2.1 Biologics Market – Amgen
- 14.2.2 Pfizer
- 14.2.3 Roche
- 14.2.4 Johnson & Johnson
- 14.2.5 Novartis
- 14.2.6 Merck & Co.
- 14.2.7 Sanofi
- 14.2.8 Eli Lilly
- 14.2.9 Bristol-Myers Squibb
- 14.2.10 AstraZeneca.
16. Principal Presumptions and Acronyms