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市场调查报告书
商品编码
1938905
噬菌体疗法市场-全球产业规模、份额、趋势、机会及预测(依细菌类型、产品、应用、地区及竞争格局划分,2021-2031年)Phage Therapy Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Bacteria Type, By Product, By Application, By Region & Competition, 2021-2031F |
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全球噬菌体疗法市场预计将从 2025 年的 6,441 万美元成长到 2031 年的 8,173 万美元,复合年增长率为 4.05%。
噬菌体疗法是指利用噬菌体(一种能够标靶、感染并裂解特定致病菌的病毒)进行治疗。推动这一市场发展的主要因素是全球范围内抗菌素抗药性(AMR)的日益普遍,这使得许多传统抗生素对多重抗药性菌株失效,从而促使人们寻求不依赖传统抗菌机制的替代治疗方法。这促进了基于噬菌体的解决方案在临床和农业领域的应用。
| 市场概览 | |
|---|---|
| 预测期 | 2027-2031 |
| 市场规模:2025年 | 6441万美元 |
| 市场规模:2031年 | 8173万美元 |
| 复合年增长率:2026-2031年 | 4.05% |
| 成长最快的细分市场 | 沙门氏菌 |
| 最大的市场 | 北美洲 |
儘管生物製药市场潜力巨大,但缺乏标准化的法规结构是其商业性发展的一大障碍,因为现有的核准流程往往无法适应不断发展的病毒疗法。这种监管的不确定性阻碍了候选药物的临床试验进程。世界卫生组织(WHO)报告称,到2024年,全球处于临床阶段的抗菌药物研发管线共有97种药物,其中40种被归类为非传统治疗方法,例如噬菌体。这项数据表明,业界正致力于开发新型生物疗法以对抗抗药性感染疾病。
基因工程和合成噬菌体开发的技术进步正在从根本上改变市场格局,克服天然噬菌体的限制。 CRISPR-Cas3技术的应用使得人们能够创造出精准设计的噬菌体,这些噬菌体比野生型噬菌体更有效地破坏目标细菌DNA,从而提高了其对抗多重抗药性病原体的疗效。这项变革得益于公共部门的大力支持。例如,2024年1月,Locus Biosciences公司宣布获得美国生物医学高级研究与发展局(BARDA)2,390万美元的资金筹措,用于支持其基于CRISPR技术的噬菌体疗法的第二期临床试验。这项进展旨在应对一项重大的医学挑战:尿道感染每年影响全球约1.5亿人。
策略联盟和创业投资投资为加速临床研发提供了至关重要的资金。随着商业环境的日趋成熟,整合正成为降低研发风险、确保后期临床试验资源的关键策略,近期一些旨在整合临床资产并吸引机构投资者的引人注目的併购案例便印证了这一点。 BiomX公司宣布,该公司于2024年3月与Adaptive Phage Therapeutics签署了合併协议,并同时获得了5000万美元的资金筹措,用于推进合併后公司的二期临床试验项目。这笔资金注入对于将噬菌体疗法从实验性、同情用药阶段转化为商业性化药物至关重要。
生物製药法规结构的缺失严重阻碍了全球噬菌体疗法市场的发展。与传统化学抗生素不同,噬菌体是具有基因进化能力的动态生物实体,而目前的核准流程主要针对静态药物化合物。这种不一致迫使研发人员应对不当的合规要求,导致研发週期延长,且安全性和有效性的评估标准难以预测。此外,缺乏噬菌体特异性特性的统一指南,也使临床试验更加复杂,并导致生产商难以向习惯于固定配方药物的监管机构证明批次间的一致性。
这种监管上的不确定性造成了高风险环境,严重抑制了金融投资,阻碍了商业性扩张。投资人往往不愿将资金投入风险较高、上市核准路径不明朗的研究领域。根据生物技术与创新组织(BIO)统计,截至2024年,专注于感染疾病项目的公司在过去十年中仅获得了生物製药公司总创业投资投资的3.4%,造成了巨大的资金缺口,限制了噬菌体研发者应对复杂监管环境所需的资源。这实际上阻碍了有前景的候选疗法走向商业化。
将人工智慧 (AI) 应用于噬菌体发现领域,正从根本上改变研发格局,加速高特异性病毒候选物的鑑定。研发人员利用机器学习演算法筛检庞大的基因组库并预测噬菌体与宿主的相互作用,显着降低传统湿实验室分离方法所需的时间和成本。这项技术进步能够快速产生优化的噬菌体混合物,比人工匹配方法更有效地绕过细菌抗药性机制,标誌着噬菌体发现正向运算驱动型转变。根据《法国科技杂誌》报道,Phagos 公司于 2025 年 10 月完成 A 轮资金筹措,筹集 2,500 万欧元,用于扩展其人工智慧驱动的平台,以开发不断发展的精准噬菌体药物。
同时,动物健康领域近期监管的成功正推动噬菌体技术向兽医和农业领域扩张,并将市场范围拓展至人类治疗之外。随着全球对畜牧业抗生素使用的限制日益严格,以应对「同一健康」挑战,相关人员正将噬菌体添加剂商业化,以确保食品安全并改善动物福利。该领域目前正取得一系列监管里程碑,为更广泛的商业性应用铺路。例如,Intralytix公司报告称,该公司于2025年9月获得了美国食品药物管理局(FDA)兽药中心对其用于宠物食品加工的沙门氏菌特异性噬菌体核准的正式批准。
The Global Phage Therapy Market is projected to expand from USD 64.41 Million in 2025 to USD 81.73 Million by 2031, reflecting a compound annual growth rate (CAGR) of 4.05%. Phage therapy involves the therapeutic use of bacteriophages, viruses capable of specifically infecting and lysing targeted bacterial pathogens. A primary catalyst for this market is the escalating global prevalence of antimicrobial resistance (AMR), which has rendered many conventional antibiotics ineffective against multi-drug resistant strains; consequently, there is an intensified demand for alternative treatments that function independently of traditional antimicrobial mechanisms, fostering the development of phage-based solutions for both clinical and agricultural applications.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 64.41 Million |
| Market Size 2031 | USD 81.73 Million |
| CAGR 2026-2031 | 4.05% |
| Fastest Growing Segment | Salmonella |
| Largest Market | North America |
Despite the market's potential, the lack of a standardized regulatory framework for biological agents poses a significant barrier to commercial growth, as existing approval pathways are often poorly adapted for evolving viral therapies. This regulatory uncertainty complicates the advancement of candidates through clinical trials. Highlighting the sector's developmental activity, the World Health Organization reported that in 2024, the global clinical antibacterial pipeline included 97 agents, 40 of which were categorized as non-traditional therapeutics including bacteriophages, a statistic that underscores the industry's transition toward novel biological interventions to combat resistant infections.
Market Driver
Technological advancements in genetic engineering and synthetic phage development are fundamentally transforming the market by surmounting the limitations of naturally occurring bacteriophages. The incorporation of CRISPR-Cas3 technologies facilitates the creation of precision-engineered phages that destroy targeted bacterial DNA more effectively than wild-type counterparts, thereby improving efficacy against multidrug-resistant pathogens. This shift is supported by substantial public sector backing; for instance, according to Locus Biosciences, in January 2024, the company announced the receipt of $23.9 million in funding from the Biomedical Advanced Research and Development Authority to support the Phase 2 trial of its CRISPR-engineered bacteriophage therapy, a development that addresses a major medical burden given that an estimated 150 million people worldwide are affected by urinary tract infections annually.
Strategic collaborations and rising venture capital inflows are providing the essential capital to accelerate clinical pipelines. As the commercial landscape matures, consolidation has emerged as a key strategy for mitigating development risks and securing the resources necessary for late-stage trials, a trend illustrated by recent high-profile mergers aimed at pooling clinical assets and attracting institutional investment. According to BiomX Inc., in March 2024, the company finalized a merger agreement with Adaptive Phage Therapeutics while concurrently securing $50 million in financing to advance their combined Phase 2 clinical programs, financial injections that are critical for transitioning phage therapies from experimental compassionate use into commercially viable pharmaceutical products.
Market Challenge
The lack of a standardized regulatory framework for biological agents acts as a critical impediment to the growth of the Global Phage Therapy Market. Unlike traditional chemical antibiotics, bacteriophages are dynamic biological entities capable of genetic evolution, whereas current approval pathways are predominantly designed for static medicinal compounds. This misalignment forces developers to navigate ill-suited compliance requirements, resulting in prolonged development timelines and unpredictable criteria for establishing safety and efficacy, while the absence of harmonized guidelines addressing the unique properties of phages increases the complexity of clinical trials and makes it difficult for manufacturers to prove batch consistency to regulators accustomed to fixed formulations.
This regulatory ambiguity creates a high-risk environment that significantly discourages financial investment, thereby stifling commercial expansion. Investors are frequently hesitant to allocate capital to research sectors where the route to market authorization remains undefined and hazardous. According to the Biotechnology Innovation Organization, in 2024, companies focused on infectious disease programs received only 3.4% of the total venture capital raised for biopharmaceutical companies over the preceding decade, creating a substantial funding gap that limits the resources available for phage developers to navigate the arduous regulatory landscape and effectively stalls the progression of promising therapeutic candidates into the commercial market.
Market Trends
The Integration of Artificial Intelligence for Phage Discovery is fundamentally altering the R&D landscape by accelerating the identification of viral candidates with high specificity. Developers are increasingly utilizing machine learning algorithms to screen vast genomic libraries and predict phage-host interactions, significantly reducing the time and cost associated with traditional wet-lab isolation methods. This technological advancement allows for the rapid generation of optimized cocktails capable of bypassing bacterial resistance mechanisms more efficiently than manual matching methods; validating this shift toward computational discovery, according to French Tech Journal, in October 2025, Phagos raised €25 million in a Series A funding round specifically to scale its AI-driven platform for developing evolving precision phage medicines.
Simultaneously, the Expansion into Veterinary and Agricultural Applications is broadening the market's scope beyond human therapeutics, driven by recent regulatory successes in the animal health sector. As restrictions on antibiotic usage in livestock tighten globally to combat One Health challenges, stakeholders are commercializing phage-based additives to ensure food safety and improve animal welfare. This sector is now witnessing tangible regulatory milestones that establish a pathway for broader commercial adoption; for instance, according to Intralytix, Inc., in September 2025, the company received formal approval from the U.S. Food and Drug Administration's Center for Veterinary Medicine for its Salmonella-specific bacteriophage preparation intended for use in pet food processing.
Report Scope
In this report, the Global Phage Therapy Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global Phage Therapy Market.
Global Phage Therapy 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: