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替代技术对抗生素市场未来影响的评估。

An assessment of the future impact of alternative technologies on antibiotics markets.

作者信息

Nwokoro Ejike, Leach Ross, Årdal Christine, Baraldi Enrico, Ryan Kellie, Plahte Jens

机构信息

Norwegian Institute of Public Health, Oslo, Norway.

Infection Control Program and Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.

出版信息

J Pharm Policy Pract. 2016 Oct 26;9:34. doi: 10.1186/s40545-016-0085-3. eCollection 2016.

Abstract

BACKGROUND

The increasing threat of antimicrobial resistance combined with the paucity of new classes of antibiotics represents a serious public health challenge. New treatment technologies could, in theory, have a significant impact on the future use of traditional antibiotics, be it by facilitating rational and responsible use or by product substitution in the existing antibiotics markets, including by reducing the incidence of bacterial infections through preventative approaches. The aim of this paper is to assess the potential of alternative technologies in reducing clinical use of and demand for antibiotics, and to briefly indicate which segments of the antibiotics market that might be impacted by these technologies.

METHODS

An initial mapping exercise to identify the alternative technologies was followed by a review of relevant published and grey literature ( = 52). We also carried out stakeholder engagement activities by a round-table discussion with infectious disease specialists and a multi-criteria decision analysis exercise with pharmaceutical industry experts.

RESULTS

Ten alternative technologies were identified and analyzed for their potential impact on the antibiotics market. Of these, rapid point-of-care diagnostics, vaccines, fecal microbiota transplantation, and probiotics were considered to have a "high" or "medium" potential impact over a 10-20 year horizon. Therapeutic antibodies, antibiotic biomaterials, bacteriophages, antimicrobial nanoparticles, antimicrobial peptides, and anti-virulence materials were rated as having "low" potential impact.

CONCLUSION

Despite the apparent potential of the most promising alternative technologies to reduce demand, that reduction will likely only happen in limited segments of the antibiotics market or, in the case of preventing community acquired streptococcal infections by vaccination, in a low-price generics market segment. Thus, alternative technologies are not expected to represent any disincentive to antibiotics developers. Finally, it is unlikely that alternative technologies will displace the need for new classes, and sub-classes, of antibiotics in the short and medium terms.

摘要

背景

抗菌药物耐药性的威胁日益增加,同时新型抗生素种类匮乏,这构成了严峻的公共卫生挑战。从理论上讲,新的治疗技术可能会对传统抗生素的未来使用产生重大影响,无论是通过促进合理和负责任的使用,还是通过在现有抗生素市场中进行产品替代,包括通过预防方法降低细菌感染的发生率。本文旨在评估替代技术在减少抗生素临床使用和需求方面的潜力,并简要指出抗生素市场中哪些细分领域可能会受到这些技术的影响。

方法

首先进行了一次初步的映射工作,以识别替代技术,随后对相关的已发表和灰色文献(共52篇)进行了综述。我们还通过与传染病专家进行圆桌讨论以及与制药行业专家进行多标准决策分析活动,开展了利益相关者参与活动。

结果

确定了10种替代技术,并分析了它们对抗生素市场的潜在影响。其中,即时快速诊断、疫苗、粪便微生物群移植和益生菌在10至20年的时间范围内被认为具有“高”或“中”的潜在影响。治疗性抗体、抗生素生物材料、噬菌体、抗菌纳米颗粒、抗菌肽和抗毒力材料的潜在影响被评为“低”。

结论

尽管最有前景的替代技术在减少需求方面具有明显潜力,但这种减少可能只会发生在抗生素市场的有限细分领域,或者在通过接种疫苗预防社区获得性链球菌感染的情况下,发生在低价仿制药市场细分领域。因此,预计替代技术不会对抗生素开发者构成任何抑制因素。最后,在短期和中期内,替代技术不太可能取代对新型抗生素类别和亚类的需求。

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本文引用的文献

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Beyond Antibiotics: New Therapeutic Approaches for Bacterial Infections.超越抗生素:细菌感染的新治疗方法
Clin Infect Dis. 2016 Jul 1;63(1):89-95. doi: 10.1093/cid/ciw200. Epub 2016 Mar 29.
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Alternatives to antibiotics-a pipeline portfolio review.抗生素替代品-管线组合评审。
Lancet Infect Dis. 2016 Feb;16(2):239-51. doi: 10.1016/S1473-3099(15)00466-1. Epub 2016 Jan 13.
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Antibiotics: achieving the balance between access and excess.抗生素:实现可及性与过度使用之间的平衡
Lancet. 2016 Jan 9;387(10014):102-4. doi: 10.1016/S0140-6736(15)00729-1. Epub 2015 Nov 18.
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Understanding the mechanisms and drivers of antimicrobial resistance.理解抗菌药物耐药性的机制和驱动因素。
Lancet. 2016 Jan 9;387(10014):176-87. doi: 10.1016/S0140-6736(15)00473-0. Epub 2015 Nov 18.
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Access to effective antimicrobials: a worldwide challenge.获取有效的抗菌药物:全球性挑战。
Lancet. 2016 Jan 9;387(10014):168-75. doi: 10.1016/S0140-6736(15)00474-2. Epub 2015 Nov 18.

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