세계의 마이크로바이옴 치료제 시장 : 기회, 성장 촉진요인, 산업 동향 분석, 예측(2025-2034년)

The Global Microbiome Therapeutics Market was valued at USD 212.1 million in 2024 and is estimated to grow at a CAGR of 31.1% to reach USD 3.2 billion by 2034. The remarkable growth in this field is largely driven by heightened investment in research and development, increased partnerships targeting advanced drug development, and a broader push toward personalized medicine. Favorable regulatory pathways, including accelerated drug approval mechanisms, have also contributed to this upward trend. In addition, scientific progress in understanding the complex interactions between microbes and the human host has enhanced the development of targeted therapeutic solutions. Technologies allowing for deeper insights into microbial ecosystems are making it possible to develop more precise treatments, which, in turn, have led to better diagnostic capabilities and more refined therapies. As diagnostic methods evolve, the ability to match patients with appropriate microbiome-based solutions becomes more efficient, further boosting the demand for these therapies.

Microbiome therapeutics utilize engineered microorganisms, live biotherapeutics, and microbiome-modulating compounds to address a range of chronic conditions. These approaches include both microbiome drugs and fecal microbiota transplantation (FMT). The therapeutic applications cover immune regulation, gastrointestinal health, metabolic imbalances, and cancer-related conditions. As public awareness grows and the clinical benefits become more evident, these treatment modalities continue to see broader adoption across medical settings.

When broken down by type, the market is categorized into fecal microbiota transplantation (FMT) and microbiome drugs. In 2024, the FMT segment dominated the market by generating USD 158.3 million in revenue. This segment is projected to reach USD 2.3 billion by 2034, maintaining its leading position with an expected CAGR of 30.7% over the forecast period. FMT has earned widespread recognition for its effectiveness, particularly in treating persistent gastrointestinal infections where conventional antibiotics fail to yield lasting results. Its growing credibility in clinical practice has contributed to its increasing usage in both hospital and outpatient settings. With expanding implementation across healthcare institutions, the demand for FMT-based therapeutics continues to climb.

From an application standpoint, the market is segmented into inflammatory bowel disease (IBD), cancer, diabetes, Clostridioides difficile (C. difficile), and other indications. Among these, the C. difficile segment emerged as the top contributor, capturing a 39.4% market share in 2024. This segment is expected to grow at a CAGR of 31.6% between 2025 and 2034. The severity of C. difficile infections often leads to critical health complications such as colitis and sepsis, making it a major concern for healthcare providers. As a common hospital-acquired infection, particularly in long-term care environments, it poses a considerable burden on healthcare systems. Given the high recurrence rates associated with traditional antibiotic treatment-estimated between 25% to 30%-there is a pressing need for more effective and sustainable solutions. Microbiome-based therapies address this need by restoring gut flora and enhancing immune response, which positions them as both cost-effective and clinically valuable alternatives.

In the regional landscape, the United States accounted for USD 85.3 million in microbiome therapeutics revenue in 2024. The US market is forecast to grow at a CAGR of 30.1% from 2025 to 2034. Rising incidences of gastrointestinal and metabolic disorders have significantly contributed to this growth. Infections such as C. difficile remain prevalent, particularly among individuals with compromised immune systems. As a result, demand continues to rise for innovative therapeutic options that can address these issues more effectively than traditional treatments.

The presence of leading biotechnology firms with robust pipelines in microbiome drug development is another key growth driver in the US market. These companies are at the forefront of innovation, investing heavily in clinical trials and forming strategic alliances to bring novel therapies to market. Regulatory approvals are also becoming more streamlined, further enabling companies to introduce cutting-edge solutions with greater efficiency. With a highly competitive landscape marked by continuous advancements and collaborations, the microbiome therapeutics market is poised for sustained expansion in the years ahead.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates and calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360⁰ synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Rising burden of chronic diseases
    • 3.2.1.2 Advancements in microbiome research
    • 3.2.1.3 Increasing investment and partnerships for drug development
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 Regulatory and clinical challenges
    • 3.2.2.2 Limited availability in developing areas
• 3.3 Growth potential analysis
• 3.4 Pipeline analysis
• 3.5 Regulatory landscape
• 3.6 Trump administration tariffs
  • 3.6.1 Impact on trade
    • 3.6.1.1 Trade volume disruptions
    • 3.6.1.2 Retaliatory measures
  • 3.6.2 Impact on the Industry
    • 3.6.2.1 Supply-side impact (raw materials)
      • 3.6.2.1.1 Price volatility in key materials
      • 3.6.2.1.2 Supply chain restructuring
      • 3.6.2.1.3 Production cost implications
    • 3.6.2.2 Demand-side impact (selling price)
      • 3.6.2.2.1 Price transmission to end markets
      • 3.6.2.2.2 Market share dynamics
      • 3.6.2.2.3 Consumer response patterns
  • 3.6.3 Key companies impacted
  • 3.6.4 Strategic industry responses
    • 3.6.4.1 Supply chain reconfiguration
    • 3.6.4.2 Pricing and product strategies
    • 3.6.4.3 Policy engagement
  • 3.6.5 Outlook and future considerations
• 3.7 Porter's analysis
• 3.8 PESTEL analysis

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 4.2 Company matrix analysis
• 4.3 Competitive analysis of major market players
• 4.4 Competitive positioning matrix
• 4.5 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Type, 2021 - 2034 ($ Mn)

• 5.1 Key trends
• 5.2 Fecal microbiota transplantation (FMT)
• 5.3 Microbiome drugs

Chapter 6 Market Estimates and Forecast, By Application, 2021 - 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Inflammatory bowel disease (IBD)
• 6.3 Cancer
• 6.4 Clostridioides difficile (C. difficile)
• 6.5 Diabetes
• 6.6 Other applications

Chapter 7 Market Estimates and Forecast, By Region, 2021 - 2034 ($ Mn)

• 7.1 Key trends
• 7.2 North America
  • 7.2.1 U.S.
  • 7.2.2 Canada
• 7.3 Europe
  • 7.3.1 Germany
  • 7.3.2 UK
  • 7.3.3 France
  • 7.3.4 Spain
  • 7.3.5 Italy
  • 7.3.6 Netherlands
• 7.4 Asia Pacific
  • 7.4.1 China
  • 7.4.2 Japan
  • 7.4.3 India
  • 7.4.4 Australia
  • 7.4.5 South Korea
• 7.5 Latin America
  • 7.5.1 Brazil
  • 7.5.2 Mexico
  • 7.5.3 Argentina
• 7.6 Middle East and Africa
  • 7.6.1 South Africa
  • 7.6.2 Saudi Arabia
  • 7.6.3 UAE

Chapter 8 Company Profiles

• 8.1 Aardvark Therapeutics
• 8.2 AOB Pharma
• 8.3 Enterome
• 8.4 Ferring Pharmaceuticals
• 8.5 Finch
• 8.6 Inlife
• 8.7 Intralytix
• 8.8 LNC Therapeutics
• 8.9 MaaT Pharma
• 8.10 OPENBIOME
• 8.11 Seres Therapeutics
• 8.12 VEDANATA Biosciences