市场调查报告书
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1403507
2030 年生技药品製品外包市场预测:按产品类型、来源、服务、应用、最终用户和地区进行的全球分析Biologics Outsourcing Market Forecasts to 2030 - Global Analysis By Product (Antibodies, Vaccines, Recombinant Proteins and Other Products), Type (Instruments and Kits & Reagents), Source, Service, Application, End User and By Geography |
根据Stratistics MRC的数据,2023年全球生技药品外包市场规模为237.8亿美元,预计2030年将达到622亿美元,预测期内复合年增长率为16.0%。
生技药品外包是指将生技药品产业在生物製品的开发、生产、研究各个阶段向CRO(合约药物委外研发机构)、CMO(业务生产组织)等外部方提供专业化服务。委託给合作伙伴。目标是简化业务、降低成本、加快时间表、获取专业资源并扩大市场上可用的生物製药产品组合。
据世界卫生组织(WHO)称,2019年冠状病毒感染疾病(COVID-19)是由严重急性呼吸症候群冠状病毒2(SARS-CoV-2)引起的一种高度感染疾病。截至 2023 年 2 月 15 日,全球约有 756,291,327 人受到影响。
製药公司越来越注重开发治疗多种疾病的生物製药,包括癌症和自体免疫疾病。随着这种发展的增加,需要专业知识和基础设施,并且委託研发和製造外包给 CRO(合约药物委外研发机构)和 CMO(业务药品製造组织)的趋势正在加速。我是。此外,外包可以利用外部能力,加快药物开发时间表,并获取专业资源,从而促进创新并扩大可用的生物疗法的种类。
确保不同的外包合作伙伴保持一致且严格的品质标准是一项挑战。特别是对于生产要求复杂的生物製药,很难协调品管措施并保持生产过程的一致性。不同合作伙伴之间品质保证实践的差异可能会影响生技药品的可靠性和一致性,引发对产品功效和安全性的担忧。
生物加工技术的快速进步,包括一次性系统、连续製造和基因编辑工具,为外包合作伙伴提供了采用尖端创新并将其整合到其服务产品中的机会。透过整合这些进步,外包公司可以提高其在生技药品开发、生产和品管方面的能力。此外,透过投资和利用这些最尖端科技,外包合作伙伴可以吸引寻求最尖端科技的客户,并开发独特的竞争优势,为不断变化的生技药品开发和製造市场提供一定的成长。
对外部专业知识的依赖是生技药品製剂外包市场的主要威胁。在研究、开发和製造等关键职能方面过度依赖外包合作伙伴可能会限制我们对生技药品製造流程的内部知识和控制。过度依赖外部专业知识可能会导致缺乏弹性、增加破坏的脆弱性以及降低迴应动态市场需求的敏捷性。
COVID-19大流行对生技药品外包市场产生了重大影响。这场流行病的主要影响是对生技药品的需求增加以及由此产生的对外包服务的需求。由于迫切需要开发针对病毒的有效疫苗和治疗方法,许多製药公司将业务外包给专门的受託製造厂商(CDMO)来满足生技药品製造和开发需求。我就是。为了确保生技药品的稳定供应,这种中断导致许多製药公司寻找其他外包的可能性。
预计抗体领域将占最大份额。抗体被用作针对引起疾病的特定分子的治疗剂,并可用于治疗各种疾病,例如感染疾病、自体免疫疾病和癌症。抗体广泛应用于药物研发、药物开发和许多其他领域的标检验、蛋白质表征和定量。此外,外包抗体可以确保公司的监管合规性并降低监管风险,使他们能够专注于自己的核心优势,例如药物研发、临床前和临床研究以及其他可以做的研究业务。
预计肿瘤学领域在预测期内将出现良好的成长。生物製药为癌症治疗提供了有针对性的个体化方法,使其能够非常有效地对抗不同类型的恶性。委外研发机构(CRO) 和业务组织 (CMO) 为癌症相关生技药品提供专门支持,包括单株抗体、免疫疗法和标靶治疗。此外,随着越来越多的製药公司专注于癌症领域的药物开发,该领域的外包服务需求预计将迅速增加。
在估计期间,亚太地区占据最大的市场占有率。该地区不断发展的生物製药行业、有利的法规结构以及不断增加的研发投资正在推动市场扩张。此外,由于成本效率、创新和接触多样化患者群体等竞争优势,生技药品製剂外包(包括研发和受託製造服务)在亚太地区蓬勃发展。该地区继续在全球生技药品外包形势发挥关键作用,推动产业成长和创新。
由于其强大的医疗基础设施、最先进的研发设施以及对技术创新的重视,预计北美在预测期内将实现盈利成长。此外,对疫苗、细胞治疗药物和单株抗体等生技药品的需求不断增长,正促使製药和生物技术公司外包生技药品的製造过程,因为内部製造成本昂贵。我就是。北美因其优越的地理位置和丰富的熟练劳动力而成为生技药品外包的热门目的地。
According to Stratistics MRC, the Global Biologics Outsourcing Market is accounted for $23.78 billion in 2023 and is expected to reach $62.20 billion by 2030 growing at a CAGR of 16.0% during the forecast period. Biologics Outsourcing refers to the practice of contracting specialized services in the biopharmaceutical industry to external partners, such as contract research organizations (CROs) and contract manufacturing organizations (CMOs), for various stages of biologic drug development, manufacturing, or research. It aims to streamline operations, reduce costs, accelerate timelines, access specialized resources, and expand the portfolio of biologic therapies available in the market.
According to the World Health Organisation (WHO), coronavirus disease 2019 (COVID-19) is a highly contagious infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As of February 15, 2023, about 756,291,327 people are affected worldwide.
Pharmaceutical companies increasingly focus on biologic drug development for various ailments, like cancer and autoimmune disorders. This heightened development necessitates specialised expertise and infrastructure, driving the outsourcing of research, development, and manufacturing to contract research organisations (CROs) and contract manufacturing organisations (CMOs). Moreover, outsourcing allows for leveraging external capabilities, accelerating drug development timelines, and accessing specialised resources, thereby fostering innovation and expanding the array of available biologic therapies.
Ensuring consistent and stringent quality standards across diverse outsourcing partners poses challenges. Harmonising quality control measures and maintaining uniformity in production processes, especially for biologic drugs with complex manufacturing requirements, can be demanding. Variability in quality assurance practices among different partners might impact the reliability and consistency of biologics, raising concerns about product efficacy and safety.
The rapid evolution of bioprocessing technologies, such as single-use systems, continuous manufacturing, and gene editing tools, offers outsourcing partners the chance to adopt and integrate cutting-edge innovations into their service offerings. By embracing these advancements, outsourcing firms can enhance their capabilities in biologics development, production, and quality control. Furthermore, investing in and utilising these cutting-edge technologies allows outsourcing partners to provide unique and competitive services that draw in clients looking for cutting-edge technologies and provide growth prospects in the ever-changing biologics development and manufacturing market.
Dependency on external expertise poses a significant threat in the Biologics Outsourcing market. Relying extensively on outsourcing partners for critical functions like research, development, and manufacturing might limit in-house knowledge and control over the biologics production process. Overreliance on external expertise could potentially result in a lack of flexibility, increased vulnerability to disruptions, and reduced agility in responding to dynamic market needs.
The COVID-19 pandemic had a significant impact on the biologics outsourcing market. The pandemic's primary impact has been a rise in the demand for biologics and the ensuing requirement for outsourcing services. Many pharmaceutical companies are outsourcing to specialised contract development and manufacturing organisations (CDMOs) to handle their biologics manufacturing and development needs due to the emerge to develop effective vaccines and therapies against the virus. In order to guarantee a steady supply of biologics products, this disruption compelled numerous pharmaceutical corporations to search for other outsourcing possibilities.
The antibodies segment is estimated to hold the largest share. Antibodies are used as therapeutic agents to target particular molecules that cause disease, assisting with the treatment of a variety of diseases such as infectious diseases, autoimmune diseases, and cancer. Antibodies are extensively employed in drug discovery, development, and many other fields for target validation, protein characterization, and quantification. In addition, outsourcing antibodies ensures regulatory compliance and lowers regulatory risks for the companies, allowing them to concentrate on their core strengths, which include drug discovery, pre-clinical and clinical research, and other R&D operations.
The oncology segment is anticipated to have lucrative growth during the forecast period. Biologics offer targeted and personalised approaches to cancer treatment, making them highly effective in combating various types of malignancies. Contract research organisations (CROs) and contract manufacturing organisations (CMOs) offer specialised support for oncology-related biologics, including monoclonal antibodies, immunotherapies, and targeted therapies. Moreover, with an increasing number of pharmaceutical companies focusing on oncology drug development, the need for outsourcing services in this segment is expected to surge.
Asia Pacific commanded the largest market share during the extrapolated period. The region's growing biopharmaceutical industry, favourable regulatory frameworks, and increasing investments in research and development fuel the market's expansion. Furthermore, outsourcing biologics production, including contract research, development, and manufacturing services, thrives in Asia-Pacific due to its competitive advantages in cost-efficiency, innovation, and access to a diverse patient pool. This region continues to play a pivotal role in the global biologics outsourcing landscape, fostering growth and innovation within the industry.
North America is expected to witness profitable growth over the projection period due to robust healthcare infrastructure, cutting-edge research and development facilities, and a strong emphasis on innovation. Furthermore, the growing need for biologics, such as vaccines, cell treatments, and monoclonal antibodies, has encouraged pharmaceutical and biotechnology companies to outsource their biologic production processes due to the high expense of internal manufacture. North America has become a popular destination for biologics outsourcing due to its advantageous geographic position and plenty of highly skilled labour.
Some of the key players in the Biologics Outsourcing Market include Thermo Fisher Scientific Inc, Adimab LLC, Abzena Ltd., KBI Biopharma, Curia Global, Inc., EirGenix, Inc., Bionova Scientific, Inc., Boehringer Ingelheim International GmbH., Abbvie Inc., STC Biologics, Avid Bioservices, Inc., Catalent Inc., Genentech, Inc., Eurofins Scientific, Genscript Biotech Corporation, Lonza, JSR Corporation, Merck KGaA, Rentschler Biopharma SE and Emergent.
In December 2022, AbbVie partnered with AbCellera Biologics Inc. The partnership leverage AbCellera's antibody discovery and development engine to deliver optimized development candidates for up to five targets selected by AbbVie across multiple indications. This helped the company to enhance its service offerings.
In December 2022, Thermo Fisher expanded its biologics and steriles manufacturing capabilities in China. The facility offers integrated clinical and commercial drug substance and drug product capabilities. This includes process development, cell line development, biologics drug substance manufacturing, and sterile fill-finish. This helped the company expand its geographic presence.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.