Biologics Market by Source, Product, Indication, End-user

List of Tables

[180 Pages Report] The Biologics Market size was estimated at USD 405.76 billion in 2023 and expected to reach USD 430.59 billion in 2024, at a CAGR 6.39% to reach USD 626.34 billion by 2030.

Biologics are integral to the biomedical sector, focusing on developing, manufacturing, and distributing biological treatments derived from living organisms to combat various health conditions. Products, including vaccines, gene therapies, and monoclonal antibodies, are pivotal in treating serious ailments such as cancer, autoimmune disorders, and genetic diseases. These treatments are crucial in healthcare facilities and also for patients in need of innovative therapies. The rising prevalence of chronic diseases that can be treated with biologics is driving the growth of the biologics market. Increasing investments in healthcare infrastructure and an increase in healthcare spending are widening the accessibility of advanced biologic treatments, creating a platform for market growth. High manufacturing costs, rising competition from biosimilars, and demanding logistics for distribution, particularly cold chain requirements hampers the market growth. A rising inclination toward personalized medicine that provides tailored therapies based on individual genetic makeup is expected to create opportunities for market growth. Growing partnerships in research and development between biotech companies and academic entities to enhance innovation associated with biologics are anticipated to expand the market scope.

KEY MARKET STATISTICS
Base Year [2023]	USD 405.76 billion
Estimated Year [2024]	USD 430.59 billion
Forecast Year [2030]	USD 626.34 billion
CAGR (%)	6.39%

Regional Insights

The Americas represents a significant region in the biologics market, driven by strong research frameworks, substantial investments, and robust patent laws that encourage innovation. Additionally, America has a well-established biologics market supported by healthcare policies that favor biotechnological advancements. Recent trends include the FDA's accelerated approval of biological treatments for rare diseases, showcasing a significant government endorsement. Key players in the Americas are consistently engaging in mergers and acquisitions, bolstering growth and innovation in this region. The European Union exhibits stringent regulatory standards for biologics, ensuring high safety and efficacy of treatments. Consumers in the EU focus on sustainable and ethically developed products, influencing companies to adopt greener technologies and practices. The European Medicines Agency (EMA) actively coordinates across member states to streamline the approval processes for biologics, fueling rapid market entry of new therapies. The Middle East and Africa region presents a dynamic landscape, with Gulf countries investing heavily in healthcare infrastructure and the biologics sector. There is a growing awareness and acceptance of biological treatments among consumers.

Market Insights

Market Dynamics

The market dynamics represent an ever-changing landscape of the Biologics Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.

Market Drivers
- Rising prevalence of chronic diseases worldwide
- Growing need and preference for minimally invasive procedures

Market Restraints
- High cost of treatment associated with biologics

Market Opportunities
- Ongoing advancements in biomaterials improving the treatment of chronic disorders
- Rising expansion of manufacturing facilities associated with biologics

Market Challenges
- Availability of complex manufacturing of biologics

Market Segmentation Analysis
- Source: Mammalian cells are preferable for producing larger and more complex proteins
- Indication: Ongoing innovations in oncology and infectious diseases driven by the COVID-19 pandemic and cancer research's evolution

Market Disruption Analysis
Porter's Five Forces Analysis
Value Chain & Critical Path Analysis
Pricing Analysis
Technology Analysis
Patent Analysis
Trade Analysis
Regulatory Framework Analysis

FPNV Positioning Matrix

The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Biologics Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Biologics Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Recent Developments

FDA Approves First Tocilizumab Biosimilar, TOFIDENCE, Enhancing Access to Treatment for Autoimmune Diseases

Biogen Inc. announced that TOFIDENCE (tocilizumab-bavi), a biosimilar to the monoclonal antibody ACTEMRA, has received U.S. FDA approval for intravenous use in treating moderately to severely active rheumatoid arthritis, as well as polyarticular and systemic juvenile idiopathic arthritis. This marks the first tocilizumab biosimilar cleared in the United States, potentially offering significant cost savings and wider therapy accessibility. The approval is pivotal, considering the annual 10%-25% increase in spending on autoimmune treatments over the last decade. [Published On: 2023-09-29]

Eli Lilly Expands Investment in Irish Biologics Manufacturing Facility

Eli Lilly invested in its biologics production facility, which is currently under construction in Raheen, Limerick County, Ireland. Eli Lilly injected an additional USD 500 million into the site, elevating its total expenditure to approximately 927 million USD 1 billion. [Published On: 2023-03-26]

Sandoz Announces Major Investment in New Biologics Facility in Slovenia

Sandoz invested over USD 400 million to construct a new biologics production facility in Lendava, Slovenia. This strategic development is aimed at bolstering the company's biosimilar portfolio. The construction underscores Sandoz's commitment to expanding its global presence while significantly contributing to local economic growth. [Published On: 2023-03-10]

Strategy Analysis & Recommendation

The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Biologics Market. This critical assessment involves a thorough analysis of the organization's resources, capabilities, and overall performance to identify its core strengths and areas for improvement.

Key Company Profiles

The report delves into recent significant developments in the Biologics Market, highlighting leading vendors and their innovative profiles. These include AbbVie Inc., Amgen Inc., AstraZeneca PLC, Bayer AG, Becton, Dickinson and Company, Biogen Inc., BioPharm Laboratories, LLC, Bristol Myers Squibb Company, Catalent, Inc., F. Hoffmann-La Roche Ltd., Genentech, Inc., Gilead Sciences, Inc., GlaxoSmithKline PLC, Innovent Biologics, Inc., Johnson & Johnson Services, Inc., Merck KGaA, Novartis AG, Pfizer Inc., Sanofi S.A., Thermo Fisher Scientific Inc., and Vertex Pharmaceuticals Inc..

Market Segmentation & Coverage

This research report categorizes the Biologics Market to forecast the revenues and analyze trends in each of the following sub-markets:

Source
- Mammalian
- Microbial

Product
- Antisense & RNAi Therapeutics
- Monoclonal Antibodies
- Recombinant Hormones or Proteins
- Vaccines

Indication
- Cardiovascular Disorders
- Hematological Disorders
- Immunological Disorders
- Infectious Diseases
- Oncology

End-user
- Ambulatory Surgical Centers
- Hospitals

Region
- Americas
  - Argentina
  - Brazil
  - Canada
  - Mexico
  - United States
    - California
    - Florida
    - Illinois
    - New York
    - Ohio
    - Pennsylvania
    - Texas
- Asia-Pacific
  - Australia
  - China
  - India
  - Indonesia
  - Japan
  - Malaysia
  - Philippines
  - Singapore
  - South Korea
  - Taiwan
  - Thailand
  - Vietnam

Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom

Product Code: MRR-4302AC72200D

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Rising prevalence of chronic diseases worldwide
  - 5.1.1.2. Growing need and preference for minimally invasive procedures
- 5.1.2. Restraints
  - 5.1.2.1. High cost of treatment associated with biologics
- 5.1.3. Opportunities
  - 5.1.3.1. Ongoing advancements in biomaterials improving the treatment of chronic disorders
  - 5.1.3.2. Rising expansion of manufacturing facilities associated with biologics
- 5.1.4. Challenges
  - 5.1.4.1. Availability of complex manufacturing of biologics
5.2. Market Segmentation Analysis
- 5.2.1. Source: Mammalian cells are preferable for producing larger and more complex proteins
- 5.2.2. Indication: Ongoing innovations in oncology and infectious diseases driven by the COVID-19 pandemic and cancer research's evolution
5.3. Market Disruption Analysis
5.4. Porter's Five Forces Analysis
- 5.4.1. Threat of New Entrants
- 5.4.2. Threat of Substitutes
- 5.4.3. Bargaining Power of Customers
- 5.4.4. Bargaining Power of Suppliers
- 5.4.5. Industry Rivalry
5.5. Value Chain & Critical Path Analysis
5.6. Pricing Analysis
5.7. Technology Analysis
5.8. Patent Analysis
5.9. Trade Analysis
5.10. Regulatory Framework Analysis

6. Biologics Market, by Source

6.1. Introduction
6.2. Mammalian
6.3. Microbial

7. Biologics Market, by Product

7.1. Introduction
7.2. Antisense & RNAi Therapeutics
7.3. Monoclonal Antibodies
7.4. Recombinant Hormones or Proteins
7.5. Vaccines

8. Biologics Market, by Indication

8.1. Introduction
8.2. Cardiovascular Disorders
8.3. Hematological Disorders
8.4. Immunological Disorders
8.5. Infectious Diseases
8.6. Oncology

9. Biologics Market, by End-user

9.1. Introduction
9.2. Ambulatory Surgical Centers
9.3. Hospitals

10. Americas Biologics Market

10.1. Introduction
10.2. Argentina
10.3. Brazil
10.4. Canada
10.5. Mexico
10.6. United States

11. Asia-Pacific Biologics Market

11.1. Introduction
11.2. Australia
11.3. China
11.4. India
11.5. Indonesia
11.6. Japan
11.7. Malaysia
11.8. Philippines
11.9. Singapore
11.10. South Korea
11.11. Taiwan
11.12. Thailand
11.13. Vietnam

12. Europe, Middle East & Africa Biologics Market

12.1. Introduction
12.2. Denmark
12.3. Egypt
12.4. Finland
12.5. France
12.6. Germany
12.7. Israel
12.8. Italy
12.9. Netherlands
12.10. Nigeria
12.11. Norway
12.12. Poland
12.13. Qatar
12.14. Russia
12.15. Saudi Arabia
12.16. South Africa
12.17. Spain
12.18. Sweden
12.19. Switzerland
12.20. Turkey
12.21. United Arab Emirates
12.22. United Kingdom

13. Competitive Landscape

13.1. Market Share Analysis, 2023
13.2. FPNV Positioning Matrix, 2023
13.3. Competitive Scenario Analysis
- 13.3.1. FDA Approves First Tocilizumab Biosimilar, TOFIDENCE, Enhancing Access to Treatment for Autoimmune Diseases
- 13.3.2. Eli Lilly Expands Investment in Irish Biologics Manufacturing Facility
- 13.3.3. Sandoz Announces Major Investment in New Biologics Facility in Slovenia
13.4. Strategy Analysis & Recommendation

14. Competitive Portfolio

14.1. Key Company Profiles
14.2. Key Product Portfolio