![]() |
市場調查報告書
商品編碼
1848367
全球微生物組療法市場:預測至 2032 年—按療法類型、適應症、給藥途徑、最終用戶和地區分類的分析Microbiome Therapeutics Market Forecasts to 2032 - Global Analysis By Therapeutic Type, Indication, Delivery Modes, End User and By Geography |
||||||
根據 Stratistics MRC 的數據,預計到 2025 年,全球微生物組療法市場規模將達到 2,456 億美元,到 2032 年將達到 2,2593 億美元,預測期內複合年成長率為 37.3%。
微生物組療法是指一系列旨在調節或修復人體微生物組(存在於體內外的複雜微生物群落)以改善健康或治療疾病的治療方法方法。這些治療方法針對腸道、皮膚和其他微生物環境,以糾正與發炎性腸道疾病、肥胖、代謝紊亂和感染疾病等相關的失衡。治療方法包括益生菌、益生元、合益素、糞便微生物移植和新一代活體生物療法。透過影響微生物的組成和功能,微生物組療法旨在以精準且個人化的方式增強免疫力、代謝功能和整體健康。
胃腸道疾病發生率上升
醫療保健機構正在探索治療級配方,以應對腸躁症(IBS)、克隆氏症和潰瘍性大腸炎等疾病。研究實驗室正在檢驗菌株特異性抑制發炎和修復腸道屏障的功效。生物技術公司與臨床網路之間的夥伴關係正在加速產品開發。監管機構正在支持對高需求適應症進行快速核准。市場正朝向針對特定疾病的微生物組療法轉變。
高昂的研發成本
微生物組療法的臨床試驗需要耗時較長、通訊協定複雜且需要專門的基礎設施。活體生物療法的生產需要嚴格的品管和低溫運輸物流。中小企業面臨資金短缺和監管障礙。由於菌株變異性和製劑複雜性,智慧財產權保護仍面臨挑戰。這些限制因素阻礙了企業進入市場和產品多樣化。
消費者轉向預防性護理
人們正在尋求非侵入性方法來改善免疫力、消化和代謝健康。治療級益生菌和益生元在臨床和醫療保健領域正日益受到重視。與個人化營養平台的整合正在增強其相關性和用戶參與。零售和數位健康通路正在擴大微生物組產品的可近性。這種趨勢正在重新定義治療和預防保健之間的界限。
臨床證據有限,不足以廣泛應用
許多微生物組療法缺乏在不同人群中進行的廣泛同行評審檢驗。菌株性能和宿主反應的差異性使標準化變得複雜。缺乏統一的指引也延緩了其融入主流治療方案的進程。支付方和醫療服務提供者對報銷和長期療效仍持謹慎態度。這些不足之處凸顯了加強臨床框架和上市後監測的必要性。
新冠疫情凸顯了腸道環境在免疫和復原中的重要作用,推動了人們對微生物組療法的興趣。針對新冠後遺症發炎和長期症狀的研究加速了標靶製劑的研發。醫院和健康機構擴大了益生菌和益生元的使用,以增強免疫力。供應鏈中斷曾一度影響了原料可得性和低溫運輸物流。疫情後的復甦工作正在推動可規模化生產、保存期限長的微生物組產品的投資。這場危機已將微生物組健康從一個邊緣問題提升為一項策略重點。
預計在預測期內,益生元和益生菌(治療級)細分市場將成為最大的細分市場。
由於其臨床相關性、安全性以及擴充性,益生元和益生菌(治療級)預計將在預測期內佔據最大的市場佔有率。這些製劑用於治療胃腸道、代謝和免疫相關疾病。醫院和專科診所正將其納入慢性病和急性病的治療通訊協定中。供應商正在最佳化菌株組合和給藥方式,以實現標靶療效。監管部門的核准和消費者的信任正在鞏固該領域的領先地位。這一類別為微生物組療法的商業性化奠定了基礎。
預計在預測期內,活體生物治療產品(LBP)細分市場將實現最高的複合年成長率。
隨著精準微生物組工程的蓬勃發展,預計在預測期內,活體生物治療產品(LBP)領域將達到最高成長率。這些治療方法利用經過基因鑑定的細菌菌株,旨在達到特定的臨床療效。糞便微生物移植和合成菌叢的研究正在擴大治療範圍。生物技術公司正在開發能夠確保活性並靶向定植的遞送系統。對符合GMP規範的生產和監管合規性的投資正在加速臨床應用。
在預測期內,北美預計將佔據最大的市場佔有率,這主要得益於其先進的研究生態系統、完善的監管體系和較高的消費者認知度。美國和加拿大正在學術界、臨床界和商業界等多個領域拓展微生物組臨床試驗。對生物技術新興企業和轉化研究的投資正在推動創新。領先的益生菌生產商和數位健康平台的存在進一步增強了市場實力。完善的醫保報銷機制和臨床指引正在推動治療方法的普及應用。該地區將繼續引領微生物組商業化的發展。
預計亞太地區在預測期內將實現最高的複合年成長率,這主要得益於醫療保健服務可近性的提高、健康需求的成長以及研發投入的增加。中國、日本、韓國和印度等國家正在臨床和消費領域拓展微生物組舉措。政府支持的健康項目和新興企業生態系統正在加速產品開發。本土製造商正在推出符合當地文化特色的配方和給藥方式。人們對腸道健康和預防性醫療保健日益成長的興趣正在推動各個年齡層對相關產品的接受度。
According to Stratistics MRC, the Global Microbiome Therapeutics Market is accounted for $245.6 billion in 2025 and is expected to reach $2259.3 billion by 2032 growing at a CAGR of 37.3% during the forecast period. Microbiome therapeutics refers to a class of medical treatments designed to modulate or restore the human microbiome-the complex community of microorganisms residing in and on the body-to improve health or treat disease. These therapies target the gut, skin, or other microbial environments to correct imbalances linked to conditions such as inflammatory bowel disease, obesity, metabolic disorders, and infections. Approaches include probiotics, prebiotics, synbiotics, fecal microbiota transplantation, and next-generation live biotherapeutics. By influencing microbial composition and function, microbiome therapeutics aim to enhance immunity, metabolism, and overall well-being in a precise, personalized manner.
Rising prevalence of gastrointestinal disorders
Healthcare providers are exploring therapeutic-grade formulations to address conditions such as IBS, Crohn's disease, and ulcerative colitis. Research institutions are validating strain-specific efficacy for inflammation control and gut barrier restoration. Partnerships between biotech firms and clinical networks are accelerating product development. Regulatory bodies are supporting fast-track approvals for high-need indications. The market is shifting toward condition-specific microbiome therapies.
High research and development costs
Clinical trials for microbiome therapeutics require long timelines, complex protocols, and specialized infrastructure. Manufacturing live biotherapeutics demands stringent quality control and cold-chain logistics. Small and mid-sized players face funding gaps and regulatory hurdles. Intellectual property protection remains challenging due to strain variability and formulation complexity. These constraints are slowing market entry and product diversification.
Consumer shift towards preventive healthcare
Individuals are seeking non-invasive solutions to improve immunity, digestion, and metabolic health. Therapeutic-grade probiotics and prebiotics are gaining traction in clinical and wellness settings. Integration with personalized nutrition platforms is enhancing relevance and engagement. Retail and digital health channels are broadening access to microbiome-based products. This momentum is redefining the boundary between therapeutic and preventive care.
Limited clinical evidence for broad applications
Many microbiome therapies lack large-scale, peer-reviewed validation across diverse populations. Variability in strain performance and host response complicates standardization. Absence of harmonized guidelines is slowing integration into mainstream treatment protocols. Payers and providers remain cautious about reimbursement and long-term efficacy. These gaps are prompting calls for stronger clinical frameworks and post-market surveillance.
The pandemic highlighted the role of gut health in immunity and recovery, boosting interest in microbiome therapeutics. Research into post-Covid inflammation and long-haul symptoms accelerated development of targeted formulations. Hospitals and wellness providers expanded use of probiotics and prebiotics to support immune resilience. Supply chain disruptions temporarily affected raw material availability and cold-chain logistics. Recovery efforts are driving investment in scalable, shelf-stable microbiome products. The crisis elevated microbiome health from niche interest to strategic priority.
The prebiotics & probiotics (Therapeutic-Grade) segment is expected to be the largest during the forecast period
The prebiotics & probiotics (Therapeutic-Grade) segment is expected to account for the largest market share during the forecast period due to their clinical relevance, safety profile, and scalability. These formulations are being used to manage gastrointestinal, metabolic, and immune-related conditions. Hospitals and specialty clinics are integrating them into treatment protocols for chronic and acute disorders. Vendors are optimizing strain combinations and delivery formats for targeted efficacy. Regulatory approvals and consumer trust are reinforcing segment dominance. This category anchors the commercial foundation of microbiome therapeutics.
The live biotherapeutic products (LBPs) segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the live biotherapeutic products (LBPs) segment is predicted to witness the highest growth rate as precision microbiome engineering gains momentum. These therapies involve genetically characterized strains designed for specific clinical outcomes. Research into fecal microbiota transplantation and synthetic consortia is expanding therapeutic scope. Biotech firms are developing delivery systems that ensure viability and targeted colonization. Investment in GMP manufacturing and regulatory alignment is accelerating clinical translation.
During the forecast period, the North America region is expected to hold the largest market share due to its advanced research ecosystem, regulatory support, and consumer awareness. The United States and Canada are scaling microbiome trials across academic, clinical, and commercial settings. Investment in biotech startups and translational research is driving innovation. Presence of leading probiotic manufacturers and digital health platforms is reinforcing market strength. Reimbursement pathways and clinical guidelines are supporting therapeutic adoption. The region remains the benchmark for microbiome commercialization.
Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR as healthcare access, wellness demand, and research investment expand. Countries like China, Japan, South Korea, and India are scaling microbiome initiatives across clinical and consumer domains. Government-backed health programs and startup ecosystems are accelerating product development. Local manufacturers are launching culturally tailored formulations and delivery formats. Rising interest in gut health and preventive care is boosting adoption across demographics.
Key players in the market
Some of the key players in Microbiome Therapeutics Market include Seres Therapeutics, Finch Therapeutics Group, Vedanta Biosciences, Rebiotix Inc., 4D Pharma plc, Evelo Biosciences, Second Genome, Symbiome Inc., BiomX Inc., Axial Therapeutics, Kaleido Biosciences, DayTwo, Viome Life Sciences, LNC Therapeutics and Pendulum Therapeutics.
In June 2024, Seres Therapeutics entered into a Memorandum of Understanding with Nestle Health Science for the sale of its microbiome therapeutic, VOWST. The transaction was finalized, with Nestle acquiring full ownership of VOWST, including all related intellectual property rights.
In March 2022, 4D Pharma entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany, and Pfizer Inc. This partnership aimed to evaluate the combination of 4D Pharma's lead immuno-oncology candidate, MRx0518, with Merck's anti-PD-L1 antibody, avelumab, in patients with advanced solid tumors.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.