세계의 레드 바이오테크놀러지 시장 : 점유율 분석, 산업 동향, 통계, 성장 예측(2025-2030년)

The red biotechnology market size stood at USD 535.68 billion in 2025 and is forecast to reach USD 728.57 billion by 2030, advancing at a 6.34% CAGR.

Growth rests on a transition from pandemic-focused vaccine output toward diversified pipelines that now include cell and gene therapies, next-generation monoclonal antibodies, and precision diagnostics. Faster regulatory reviews underpin momentum, illustrated by 24 biological license approvals issued by the FDA in 2024. Parallel government spending-most notably the USD 79.5 billion Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) allocation through 2027-bolsters domestic capacity for both development and manufacturing. On the industry side, large-scale capital projects such as Merck's USD 1 billion vaccine facility in North Carolina add resilient capacity that can flex between pandemic response and routine commercial production. Together, these factors create a predictable environment for scaling high-complexity biologics, encouraging venture investment and public-private partnerships that shorten time-to-clinic for innovative assets.

Global Red Biotechnology Market Trends and Insights

Rising incidence & prevalence of chronic and rare diseases

Eight novel cell and gene therapies cleared FDA review in 2024, underlining how unmet-need areas convert scientific breakthroughs into commercial assets. Oncology continued to dominate approvals, representing 34% of all new biological products in 2024. Demographic shifts intensify demand; Japan's policy priority on next-generation monoclonal antibodies and gene therapies reflects the challenge of managing a rapidly aging population. Rare-disease pipelines benefit from Orphan Drug incentives, as 88% of 2024 gene-therapy approvals carried that designation. The FDA's Rare Disease Innovation Hub and its START pilot compress development timelines, encouraging companies to target niche diseases once considered commercially unattractive.

Healthcare funding expansion & public-private partnerships

The 2023-2027 PHEMCE allocation set aside USD 79.5 billion for countermeasure R&D and domestic manufacturing, a USD 15.5 billion increase over the earlier planning cycle. BARDA's USD 2 billion BioMaP-Consortium extends this support by co-investing in flexible facilities that can pivot from antibodies to mRNA vaccines within months. Canada's Biologics Manufacturing Centre in Montreal adds 250 million-dose annual capacity for viral-vector and protein subunit vaccines. The European Commission's GenAI4EU programme earmarks EUR 1 billion for AI projects including biologics discovery, reinforcing cross-border knowledge transfer. Emerging economies mirror the model; India's BIO-E3 framework supplies concessional finance and streamlined land acquisition for new bioproduction campuses.

High biomanufacturing & cold-chain costs

Industry losses from cold-chain failures hit USD 35 billion annually, undermining affordability for temperature-sensitive biologics. CAR-T autologous therapies still cost above USD 500,000 per patient due to labor-intensive manufacture and cryogenic distribution. Annex 1 revisions tightened aseptic-processing rules, compelling upgrades to isolator technology and environmental monitoring that inflate capex for greenfield plants. Supply-chain concentration compounds the problem; more than 75% of U.S. API imports originate outside its borders, exposing production to geopolitical shocks. Although AI-enabled route-planning software and digital twins promise 15-25% logistics savings, widespread deployment remains in pilot stages, delaying near-term relief.

Other drivers and restraints analyzed in the detailed report include:

1. Personalized-medicine adoption & companion diagnostics uptake
2. mRNA-platform spill-over fast-tracking new biologics
3. Complex, shifting global biologics regulations

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Therapeutic drugs generated USD 293 billion in 2024, corresponding to a 54.67% share of the Red biotechnology market size, and are forecast to grow at 6.87% CAGR to 2030. Monoclonal antibodies anchor the category, boasting more than 200 approved agents and close to 1,400 active clinical candidates worldwide. Bispecific formats achieve the highest clinical-to-approval conversion, prompting companies such as BioNTech and Bristol Myers Squibb to pursue multi-billion-dollar codevelopment deals. Gene therapies accelerated following the FDA endorsement of eight products in 2024, while CRISPR-modified CAR-T platforms now dominate early-phase haem-oncology trials. mRNA therapeutics move beyond infectious disease into cardiometabolic indications, supported by circular RNA technology that multiplies in vivo protein yield.

Vaccines maintain strategic relevance, supported by BARDA option clauses that guarantee minimum call-off volumes during outbreaks. Diagnostics and research tools expand as sequencing reagents and liquid-biopsy assays gain adoption in decentralized settings. In parallel, therapeutic proteins evolve toward antibody-drug conjugates and fusion cytokines tailored to specific disease microenvironments, reflecting the Red biotechnology market emphasis on precision targeting.

The Red Biotechnology Market Report is Segmented by Product (Vaccines [mRNA Vaccines, Viral Vector Vaccines, and More], Therapeutic Drugs [Monoclonal Antibodies, Recombinant Proteins, and More], and Diagnostics & Research Tools [Sequencing Reagents & Kits and More]), End-User (Biopharmaceutical Companies and More), Aand Geography (North America, Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

Geography Analysis

North America captured 39.13% of the Red biotechnology market size in 2024, and is projected to register a 6.01% CAGR through 2030. The region benefits from a full-spectrum ecosystem that bundles discovery, regulation, and industrial-scale manufacture. BARDA's BioMaP-Consortium and the PHEMCE capital pool safeguard domestic production for both routine and emergency biologics, while the FDA's expedited designations shorten lead times for innovative therapies. Ongoing regulatory restructuring, such as the ACIP membership overhaul, introduces short-term uncertainty for vaccine launch timing. Yet, sizeable Congressional proposals seeking USD 15 billion for biotech competitiveness underscore sustained political commitment.

Europe is projected to grow at 6.24% CAGR to 2030. Policy reforms, including the Clinical Trials Regulation and Horizon Europe funds, facilitate multinational trials and cross-border knowledge sharing. HERA's EUFab infrastructure offers nimble surge capacity, capable of switching among mRNA, viral-vector, and protein vaccines within 100 days, enhancing the bloc's autonomy. Fee increases under new EMA regulations add cost pressure, but simultaneous consultation on streamlined biosimilar dossiers could broaden access to lower-priced biologics for state payers.

Asia-Pacific shows the fastest momentum, expanding at 7.26% CAGR and expected to more than double its segment value by 2030. Japan's national strategy seeks to triple sectoral output to 15 trillion yen by 2030 through tax credits and accelerated review lanes. India's biotech value rocketed from USD 10 billion in 2014 to USD 130 billion in 2024, leveraging cost advantages and a 60% share of global vaccine volume. China deepens AI-enabled discovery, epitomized by AstraZeneca's USD 5.3 billion partnership with CSPC Pharmaceutical that targets autoimmune disorders. Regional governments are synchronizing regulations to ease trans-border clinical trials, accelerating first-in-human studies and subsequent scale-up in nearby contract plants.

List of Companies Covered in this Report:

1. Amgen
2. AstraZeneca
3. Biogen
4. BioNTech
5. Bristol-Myers Squibb
6. CSL Behring
7. Roche
8. Gilead Sciences
9. Illumina
10. Johnson & Johnson
11. Lonza Group
12. Merck
13. Moderna
14. Novartis
15. Pfizer
16. Regeneron Pharmaceuticals
17. Sanofi
18. Sarepta Therapeutics
19. Takeda Pharmaceuticals
20. Thermo Fisher Scientific
21. Vertex Pharmaceuticals

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising incidence & prevalence of chronic and rare diseases
  • 4.2.2 Healthcare funding expansion & public-private partnerships
  • 4.2.3 Personalized-medicine adoption & companion diagnostics uptake
  • 4.2.4 mRNA-platform spill-over fast-tracking new biologics
  • 4.2.5 AI-driven de-risking of early-stage biologics design
  • 4.2.6 Government-led pandemic-preparedness programmes scaling global vaccine manufacturing capacity
• 4.3 Market Restraints
  • 4.3.1 High biomanufacturing & cold-chain costs
  • 4.3.2 Complex, shifting global biologics regulations
  • 4.3.3 Supply-chain fragility for critical raw materials
  • 4.3.4 Immunogenicity risks in next-gen gene therapies
• 4.4 Supply Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers/Consumers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitute Products
  • 4.7.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value)

• 5.1 By Product
  • 5.1.1 Vaccines
    • 5.1.1.1 mRNA Vaccines
    • 5.1.1.2 Viral Vector Vaccines
    • 5.1.1.3 Recombinant-protein Vaccines
    • 5.1.1.4 Conjugate & Subunit Vaccines
    • 5.1.1.5 Live-attenuated & Inactivated Vaccines
  • 5.1.2 Therapeutic Drugs
    • 5.1.2.1 Monoclonal Antibodies
    • 5.1.2.2 Recombinant Proteins
    • 5.1.2.3 Gene Therapies
    • 5.1.2.4 Cell Therapies
    • 5.1.2.5 RNA Therapeutics
  • 5.1.3 Diagnostics & Research Tools
    • 5.1.3.1 Sequencing Reagents & Kits
    • 5.1.3.2 Companion-diagnostic Assays
    • 5.1.3.3 Point-of-care Molecular Tests
• 5.2 By End-User
  • 5.2.1 Biopharmaceutical Companies
  • 5.2.2 Contract Manufacturing Organizations (CMOs)
  • 5.2.3 Contract Research Organizations (CROs)
  • 5.2.4 Academic & Research Institutes
  • 5.2.5 Hospitals & Specialty Clinics
• 5.3 By Geography
  • 5.3.1 North America
    • 5.3.1.1 United States
    • 5.3.1.2 Canada
    • 5.3.1.3 Mexico
  • 5.3.2 Europe
    • 5.3.2.1 Germany
    • 5.3.2.2 United Kingdom
    • 5.3.2.3 France
    • 5.3.2.4 Italy
    • 5.3.2.5 Spain
    • 5.3.2.6 Rest of Europe
  • 5.3.3 Asia-Pacific
    • 5.3.3.1 China
    • 5.3.3.2 India
    • 5.3.3.3 Japan
    • 5.3.3.4 Australia
    • 5.3.3.5 South Korea
    • 5.3.3.6 Rest of Asia-Pacific
  • 5.3.4 Middle East and Africa
    • 5.3.4.1 GCC
    • 5.3.4.2 South Africa
    • 5.3.4.3 Rest of Middle East and Africa
  • 5.3.5 South America
    • 5.3.5.1 Brazil
    • 5.3.5.2 Argentina
    • 5.3.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Competitive Benchmarking
• 6.3 Market Share Analysis
• 6.4 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.4.1 Amgen Inc.
  • 6.4.2 AstraZeneca PLC
  • 6.4.3 Biogen Inc.
  • 6.4.4 BioNTech SE
  • 6.4.5 Bristol Myers Squibb
  • 6.4.6 CSL Limited
  • 6.4.7 F. Hoffmann-La Roche Ltd
  • 6.4.8 Gilead Sciences Inc.
  • 6.4.9 Illumina Inc.
  • 6.4.10 Johnson & Johnson (Janssen)
  • 6.4.11 Lonza Group AG
  • 6.4.12 Merck & Co., Inc.
  • 6.4.13 Moderna Inc.
  • 6.4.14 Novartis AG
  • 6.4.15 Pfizer Inc.
  • 6.4.16 Regeneron Pharmaceuticals
  • 6.4.17 Sanofi
  • 6.4.18 Sarepta Therapeutics
  • 6.4.19 Takeda Pharmaceutical
  • 6.4.20 Thermo Fisher Scientific
  • 6.4.21 Vertex Pharmaceuticals

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-needs Assessment