생균치료제 및 미생물 CDMO 시장 : 세계 산업 규모, 점유율, 동향, 기회, 예측 - 용도별, 제품 유형별, 사업 규모별, 지역별, 경쟁별(2020-2030년)
Live Biotherapeutics Products and Microbe CDMO Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Application, By Product, By Type of Formulation, By Scale of Operation, By Region and Competition, 2020-2030F
상품코드:1719133
리서치사:TechSci Research
발행일:2025년 04월
페이지 정보:영문 184 Pages
라이선스 & 가격 (부가세 별도)
ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
한글목차
세계 생균치료제 및 미생물 CDMO 시장은 2024년 321억 2,000만 달러로 평가되며, 2030년에는 2,184억 5,000만 달러에 달할 것으로 예상되며, 예측 기간 동안 37.62%의 CAGR로 성장할 것으로 예상됩니다.
제약사 및 생명공학 기업들이 만성질환 및 감염성 질환의 치료 및 예방을 위해 미생물을 이용한 치료법을 채택하는 사례가 증가함에 따라, 이 시장은 강력한 견인차 역할을 하고 있습니다. 살아있는 미생물을 치료제로 사용하는 생균치료제(LBP)는 소화기 질환, 암, 대사성 질환, 면역 관련 질환에 대한 치료 가능성을 모색하고 있습니다. 인간 마이크로바이옴과 건강 전반의 연관성에 대한 과학적 이해가 깊어지면서 헬스케어 제공자, 투자자, 규제기관의 관심이 급증하고 있습니다. 미국 FDA와 유럽의약품청(European Medicines Agency)과 같은 기관은 LBP에 대한 규제 경로를 적극적으로 수립하고 있으며, 이는 시장의 성숙도를 보여주며 더 많은 투자를 유치하고 있습니다. 동시에 미생물 개발 및 제조를 위한 개발 및 제조 수탁기관(CDMO)에 대한 의존도가 높아짐에 따라, 특히 생물의약품의 기술적 복잡성으로 인해 아웃소싱의 상황이 재편되고 있습니다.
시장 개요
예측 기간
2026-2030년
시장 규모 : 2024년
321억 2,000만 달러
시장 규모 : 2030년
2,184억 5,000만 달러
CAGR : 2025-2030년
37.62%
급성장 부문
임상 규모 운영
최대 시장
북미
시장 촉진요인
만성질환 증가
주요 시장 과제
규제 불확실성과 가이드라인의 진화
주요 시장 동향
미생물 기반 치료제에 대한 관심 증가
목차
제1장 개요
제2장 조사 방법
제3장 주요 요약
제4장 고객의 소리
제5장 세계의 생균치료제 및 미생물 CDMO 시장 전망
시장 규모 및 예측
금액별
시장 점유율과 예측
용도별(클로스트리듐 디피실, 크론병, 과민성대장증후군, 당뇨병, 기타)
제품별(API, FDF)
제제 종류별(고형 제제, 경구 액제, 주사제, 기타)
사업 규모별(전임상 규모 사업, 임상 규모 사업, 상업 규모 사업)
기업별(2024)
지역별
시장 맵
제6장 북미의 생균치료제 및 미생물 CDMO 시장 전망
시장 규모 및 예측
시장 점유율과 예측
북미 : 국가별 분석
미국
멕시코
캐나다
제7장 유럽의 생균치료제 및 미생물 CDMO 시장 전망
시장 규모 및 예측
시장 점유율과 예측
유럽 : 국가별 분석
프랑스
독일
영국
이탈리아
스페인
제8장 아시아태평양의 생균치료제 및 미생물 CDMO 시장 전망
시장 규모 및 예측
시장 점유율과 예측
아시아태평양 : 국가별 분석
중국
인도
한국
일본
호주
제9장 남미의 생균치료제 및 미생물 CDMO 시장 전망
시장 규모 및 예측
시장 점유율과 예측
남미 : 국가별 분석
브라질
아르헨티나
콜롬비아
제10장 중동 및 아프리카의 생균치료제 및 미생물 CDMO 시장 전망
시장 규모 및 예측
시장 점유율과 예측
중동 및 아프리카 : 국가별 분석
남아프리카공화국
사우디아라비아
아랍에미리트
제11장 시장 역학
성장 촉진요인
과제
제12장 시장 동향과 발전
인수합병
제품 출시
최근 동향
제13장 Porter's Five Forces 분석
업계내 경쟁
신규 참여의 가능성
공급업체의 능력
고객의 능력
대체품의 위협
제14장 경쟁 구도
Arrant Bio
4D Pharma
Cerbios
Biose Industrie
Assembly Biosciences, Inc.
Wacker Chemie AG
Quay Pharmaceuticals
NIZO
Lonza
Inpac Probiotics
제15장 전략적 제안
제16장 조사 회사 소개 및 면책사항
ksm
영문 목차
영문목차
The Global Live Biotherapeutics Products and Microbe CDMO Market was valued at USD 32.12 Billion in 2024 and is projected to reach USD 218.45 Billion by 2030, growing at a CAGR of 37.62% during the forecast period. The market is gaining strong traction as pharmaceutical and biotechnology companies increasingly embrace microbiome-based therapies for the treatment and prevention of chronic and infectious diseases. Live Biotherapeutic Products (LBPs), which involve live microorganisms as therapeutic agents, are being explored for their potential to address gastrointestinal disorders, cancer, metabolic conditions, and immune-related diseases. Enhanced scientific understanding of the human microbiome and its connection to overall health has triggered a surge in interest from healthcare providers, investors, and regulatory bodies. Agencies like the U.S. FDA and European Medicines Agency are actively establishing regulatory pathways for LBPs, signaling a maturing market and drawing further investment. Simultaneously, the growing reliance on Contract Development and Manufacturing Organizations (CDMOs) for microbial development and production is reshaping the outsourcing landscape, particularly due to the technical complexity of live biotherapeutics.
Market Overview
Forecast Period
2026-2030
Market Size 2024
USD 32.12 Billion
Market Size 2030
USD 218.45 Billion
CAGR 2025-2030
37.62%
Fastest Growing Segment
Clinical Scale Operations
Largest Market
North America
Key Market Drivers
Increasing Prevalence of Chronic Diseases
The rising global burden of chronic diseases is a major factor fueling growth in the Live Biotherapeutics Products and Microbe CDMO Market. Non-communicable diseases such as cardiovascular disorders, cancer, and diabetes are among the leading causes of mortality worldwide. Contributing factors include poor diet, sedentary lifestyles, smoking, and alcohol use. According to the Pan American Health Organization (2019), ischemic heart disease alone accounted for 73.6 deaths per 100,000 globally, with stroke and other circulatory diseases also contributing significantly to mortality. Similarly, the World Health Organization (2022) reported lung cancer as the deadliest cancer worldwide, causing 1.8 million deaths, followed by colorectal, liver, stomach, and breast cancers. Live biotherapeutic products, which aim to regulate the gut microbiome-a key modulator of immunity and metabolic function-are gaining recognition for their potential to prevent or manage chronic conditions. Microbe-focused CDMOs offer tailored development, manufacturing, and scale-up services to support clinical research and commercialization of such therapies. As the incidence of chronic illness increases, demand for microbiome-driven solutions is expected to accelerate, supporting market expansion.
Key Market Challenges
Regulatory Uncertainty and Evolving Guidelines
One of the core challenges confronting the Live Biotherapeutics Products and Microbe CDMO Market is the evolving regulatory landscape. LBPs are biologically complex and often composed of novel microbial strains, which do not conform easily to conventional pharmaceutical classification systems. Regulatory agencies such as the FDA and EMA are still developing dedicated frameworks for assessing the safety, efficacy, and quality of LBPs. This regulatory ambiguity can cause delays in product approvals, increased development costs, and uncertainty in commercial planning. Additionally, navigating varied global regulatory requirements complicates efforts to launch products in multiple markets, adding operational and compliance burdens. The absence of harmonized international guidelines creates further complications for companies with global ambitions, particularly smaller firms that lack dedicated regulatory teams. Ongoing monitoring, documentation updates, and real-time compliance with changing regulations are resource-intensive and may slow down product pipelines, creating a significant barrier for innovation and commercialization.
Key Market Trends
Rising Interest in Microbiome-Based Therapeutics
There is a growing emphasis on microbiome-based therapies, significantly influencing the direction of the global Live Biotherapeutics Products and Microbe CDMO Market. As scientific research increasingly links the gut microbiota to immune regulation, metabolic health, and chronic disease development, pharmaceutical companies are intensifying efforts to develop live biotherapeutic products targeting the microbiome. Innovations in sequencing technologies and microbial identification have accelerated the discovery of beneficial strains, while AI integration is enabling faster optimization of formulations and development pathways. Clinical trials in this space are on the rise, and regulatory support is gradually evolving to accommodate these novel products. Personalized microbiome therapies tailored to individual microbial profiles are also gaining momentum, offering a promising frontier for precision medicine. These advancements are creating new opportunities for CDMOs with specialized capabilities in anaerobic fermentation, formulation, and encapsulation. As industry focus shifts from conventional small molecules to microbiome-centered strategies, the demand for microbial CDMO services is expected to surge.
Key Market Players
Arrant Bio
4D Pharma
Cerbios
Biose Industrie
Assembly Biosciences, Inc.
Wacker Chemie AG
Quay Pharmaceuticals
NIZO
Lonza
Inpac Probiotics
Report Scope
In this report, the Global Live Biotherapeutics Products and Microbe CDMO Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Live Biotherapeutics Products and Microbe CDMO Market, By Application:
C. difficile
Crohn's Disease
IBS
Diabetes
Others
Live Biotherapeutics Products and Microbe CDMO Market, By Product:
APIs
FDFs
Live Biotherapeutics Products and Microbe CDMO Market, By Type of Formulation:
Solid Formulations
Oral Liquids
Injectables
Others
Live Biotherapeutics Products and Microbe CDMO Market, By Scale of Operation:
Preclinical Scale Operations
Clinical Scale Operations
Commercial Scale Operations
Live Biotherapeutics Products and Microbe CDMO Market, By Region:
North America
United States
Canada
Mexico
Europe
France
United Kingdom
Italy
Germany
Spain
Asia-Pacific
China
India
Japan
Australia
South Korea
South America
Brazil
Argentina
Colombia
Middle East & Africa
South Africa
Saudi Arabia
UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the Global Live Biotherapeutics Products and Microbe CDMO Market.
Available Customizations
Global Live Biotherapeutics Products and Microbe CDMO Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:
Company Information
Detailed analysis and profiling of additional market players (up to five).
Table of Contents
1. Product Overview
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2. Research Methodology
2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations
3. Executive Summary
3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, and Trends
4. Voice of Customer
5. Global Live Biotherapeutics Products and Microbe CDMO Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Application (C.difficle, Crohns disease, IBS, Diabetes, Others)
5.2.2. By Product (APIs, FDFs)
5.2.3. By Type of Formulation (Solid Formulations, Oral Liquids, Injectables, Others)
5.2.4. By Scale of Operation (Preclinical Scale Operations, Clinical Scale Operations, Commercial Scale Operations)
5.2.5. By Company (2024)
5.2.6. By Region
5.3. Market Map
6. North America Live Biotherapeutics Products and Microbe CDMO Market Outlook
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Application
6.2.2. By Product
6.2.3. By Type of Formulation
6.2.4. By Scale of Operation
6.2.5. By Country
6.3. North America: Country Analysis
6.3.1. United States Live Biotherapeutics Products and Microbe CDMO Market Outlook
6.3.1.1. Market Size & Forecast
6.3.1.1.1. By Value
6.3.1.2. Market Share & Forecast
6.3.1.2.1. By Application
6.3.1.2.2. By Product
6.3.1.2.3. By Type of Formulation
6.3.1.2.4. By Scale of Operation
6.3.2. Mexico Live Biotherapeutics Products and Microbe CDMO Market Outlook
6.3.2.1. Market Size & Forecast
6.3.2.1.1. By Value
6.3.2.2. Market Share & Forecast
6.3.2.2.1. By Application
6.3.2.2.2. By Product
6.3.2.2.3. By Type of Formulation
6.3.2.2.4. By Scale of Operation
6.3.3. Canada Live Biotherapeutics Products and Microbe CDMO Market Outlook
6.3.3.1. Market Size & Forecast
6.3.3.1.1. By Value
6.3.3.2. Market Share & Forecast
6.3.3.2.1. By Application
6.3.3.2.2. By Product
6.3.3.2.3. By Type of Formulation
6.3.3.2.4. By Scale of Operation
7. Europe Live Biotherapeutics Products and Microbe CDMO Market Outlook
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Application
7.2.2. By Product
7.2.3. By Type of Formulation
7.2.4. By Scale of Operation
7.2.5. By Country
7.3. Europe: Country Analysis
7.3.1. France Live Biotherapeutics Products and Microbe CDMO Market Outlook
7.3.1.1. Market Size & Forecast
7.3.1.1.1. By Value
7.3.1.2. Market Share & Forecast
7.3.1.2.1. By Application
7.3.1.2.2. By Product
7.3.1.2.3. By Type of Formulation
7.3.1.2.4. By Scale of Operation
7.3.2. Germany Live Biotherapeutics Products and Microbe CDMO Market Outlook
7.3.2.1. Market Size & Forecast
7.3.2.1.1. By Value
7.3.2.2. Market Share & Forecast
7.3.2.2.1. By Application
7.3.2.2.2. By Product
7.3.2.2.3. By Type of Formulation
7.3.2.2.4. By Scale of Operation
7.3.3. United Kingdom Live Biotherapeutics Products and Microbe CDMO Market Outlook
7.3.3.1. Market Size & Forecast
7.3.3.1.1. By Value
7.3.3.2. Market Share & Forecast
7.3.3.2.1. By Application
7.3.3.2.2. By Product
7.3.3.2.3. By Type of Formulation
7.3.3.2.4. By Scale of Operation
7.3.4. Italy Live Biotherapeutics Products and Microbe CDMO Market Outlook
7.3.4.1. Market Size & Forecast
7.3.4.1.1. By Value
7.3.4.2. Market Share & Forecast
7.3.4.2.1. By Application
7.3.4.2.2. By Product
7.3.4.2.3. By Type of Formulation
7.3.4.2.4. By Scale of Operation
7.3.5. Spain Live Biotherapeutics Products and Microbe CDMO Market Outlook
7.3.5.1. Market Size & Forecast
7.3.5.1.1. By Value
7.3.5.2. Market Share & Forecast
7.3.5.2.1. By Application
7.3.5.2.2. By Product
7.3.5.2.3. By Type of Formulation
7.3.5.2.4. By Scale of Operation
8. Asia-Pacific Live Biotherapeutics Products and Microbe CDMO Market Outlook
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Application
8.2.2. By Product
8.2.3. By Type of Formulation
8.2.4. By Scale of Operation
8.2.5. By Country
8.3. Asia-Pacific: Country Analysis
8.3.1. China Live Biotherapeutics Products and Microbe CDMO Market Outlook
8.3.1.1. Market Size & Forecast
8.3.1.1.1. By Value
8.3.1.2. Market Share & Forecast
8.3.1.2.1. By Application
8.3.1.2.2. By Product
8.3.1.2.3. By Type of Formulation
8.3.1.2.4. By Scale of Operation
8.3.2. India Live Biotherapeutics Products and Microbe CDMO Market Outlook
8.3.2.1. Market Size & Forecast
8.3.2.1.1. By Value
8.3.2.2. Market Share & Forecast
8.3.2.2.1. By Application
8.3.2.2.2. By Product
8.3.2.2.3. By Type of Formulation
8.3.2.2.4. By Scale of Operation
8.3.3. South Korea Live Biotherapeutics Products and Microbe CDMO Market Outlook
8.3.3.1. Market Size & Forecast
8.3.3.1.1. By Value
8.3.3.2. Market Share & Forecast
8.3.3.2.1. By Application
8.3.3.2.2. By Product
8.3.3.2.3. By Type of Formulation
8.3.3.2.4. By Scale of Operation
8.3.4. Japan Live Biotherapeutics Products and Microbe CDMO Market Outlook
8.3.4.1. Market Size & Forecast
8.3.4.1.1. By Value
8.3.4.2. Market Share & Forecast
8.3.4.2.1. By Application
8.3.4.2.2. By Product
8.3.4.2.3. By Type of Formulation
8.3.4.2.4. By Scale of Operation
8.3.5. Australia Live Biotherapeutics Products and Microbe CDMO Market Outlook
8.3.5.1. Market Size & Forecast
8.3.5.1.1. By Value
8.3.5.2. Market Share & Forecast
8.3.5.2.1. By Application
8.3.5.2.2. By Product
8.3.5.2.3. By Type of Formulation
8.3.5.2.4. By Scale of Operation
9. South America Live Biotherapeutics Products and Microbe CDMO Market Outlook
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Application
9.2.2. By Product
9.2.3. By Type of Formulation
9.2.4. By Scale of Operation
9.2.5. By Country
9.3. South America: Country Analysis
9.3.1. Brazil Live Biotherapeutics Products and Microbe CDMO Market Outlook
9.3.1.1. Market Size & Forecast
9.3.1.1.1. By Value
9.3.1.2. Market Share & Forecast
9.3.1.2.1. By Application
9.3.1.2.2. By Product
9.3.1.2.3. By Type of Formulation
9.3.1.2.4. By Scale of Operation
9.3.2. Argentina Live Biotherapeutics Products and Microbe CDMO Market Outlook
9.3.2.1. Market Size & Forecast
9.3.2.1.1. By Value
9.3.2.2. Market Share & Forecast
9.3.2.2.1. By Application
9.3.2.2.2. By Product
9.3.2.2.3. By Type of Formulation
9.3.2.2.4. By Scale of Operation
9.3.3. Colombia Live Biotherapeutics Products and Microbe CDMO Market Outlook
9.3.3.1. Market Size & Forecast
9.3.3.1.1. By Value
9.3.3.2. Market Share & Forecast
9.3.3.2.1. By Application
9.3.3.2.2. By Product
9.3.3.2.3. By Type of Formulation
9.3.3.2.4. By Scale of Operation
10. Middle East and Africa Live Biotherapeutics Products and Microbe CDMO Market Outlook
10.1. Market Size & Forecast
10.1.1. By Value
10.2. Market Share & Forecast
10.2.1. By Application
10.2.2. By Product
10.2.3. By Type of Formulation
10.2.4. By Scale of Operation
10.2.5. By Country
10.3. MEA: Country Analysis
10.3.1. South Africa Live Biotherapeutics Products and Microbe CDMO Market Outlook
10.3.1.1. Market Size & Forecast
10.3.1.1.1. By Value
10.3.1.2. Market Share & Forecast
10.3.1.2.1. By Application
10.3.1.2.2. By Product
10.3.1.2.3. By Type of Formulation
10.3.1.2.4. By Scale of Operation
10.3.2. Saudi Arabia Live Biotherapeutics Products and Microbe CDMO Market Outlook
10.3.2.1. Market Size & Forecast
10.3.2.1.1. By Value
10.3.2.2. Market Share & Forecast
10.3.2.2.1. By Application
10.3.2.2.2. By Product
10.3.2.2.3. By Type of Formulation
10.3.2.2.4. By Scale of Operation
10.3.3. UAE Live Biotherapeutics Products and Microbe CDMO Market Outlook
