市场调查报告书
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1466697
抗体契约製造市场:按抗体类型、来源、服务和最终用户划分 - 2024-2030 年全球预测Antibodies Contract Manufacturing Market by Antibody Type (Monoclonal Antibodies, Polyclonal Antibodies), Source (Mammalian, Microbial), Services, End-User - Global Forecast 2024-2030 |
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预计2023年抗体契约製造市场规模为163.4亿美元,预计2024年将达180.4亿美元,2030年将达335.6亿美元,复合年增长率为10.82%。
抗体契约製造涉及将抗体生产和精製过程外包给专业公司。这种方法允许生物技术和製药公司利用外部专业知识和先进设备来生产单株、多株抗体和重组抗体,而无需对基础设施进行大量资本投资。抗体契约製造服务通常涵盖广泛的流程,包括细胞株开发、上游和下游加工、精製和最终製剂。抗体药物在癌症、自体免疫疾病和感染疾病等慢性疾病的治疗中变得越来越重要,增加了对专业製造服务的需求。对创新抗体疗法的监管支持增加,加上生技药品核准的简化,正在推动与受託製造厂商(CMO) 的合作。智慧财产权问题以及与抗体契约製造相关的品质和合规风险不断上升正在限制市场成长。生物加工、基因工程和高通量筛检的技术进步正在加速新型抗体的开发并创造市场成长机会。
主要市场统计 | |
---|---|
基准年[2023] | 163.4亿美元 |
预测年份 [2024] | 180.4亿美元 |
预测年份 [2030] | 335.6亿美元 |
复合年增长率(%) | 10.82% |
抗体类型 由于单株抗体的均一性、特异性和大规模生产能力,对单株抗体的需求不断增加。
单株抗体是针对特定抗原的抗体的相同副本。它们由单一克隆细胞或细胞株产生,具有亲和性,仅与相同表位结合。在契约製造中,单株抗体是使用融合瘤开发、重组 DNA 和噬菌体展示等先进技术生产的。这些抗体有广泛的应用,包括诊断、治疗(针对癌症、自体免疫疾病和感染疾病等疾病)和研究。它们的均匀性、特异性和大量生产的能力使它们成为医学和生物学领域的宝贵工具。多株抗体由不同 B 细胞克隆产生的混合抗体分子群组成。多株抗体可辨识并结合单一抗原上的多个表位。由于这种多样性,多株抗体常用于免疫沉淀分析法和萤光方法中检测各种抗原。生产涉及用抗原免疫合适的哺乳动物,例如兔子、山羊或小鼠。动物的免疫系统产生多种针对抗原的抗体,并且可以从血清中回收抗体。多株抗体因其高灵敏度和捕获天然构象蛋白质的能力而备受讚誉,但批次间的变异性是其生产和使用中的一个重要考虑因素。
最终用户:抗体契约製造越来越多地被生物技术和製药公司采用,以利用抗体生产和精製方面的专业知识。
学术和研究机构是抗体契约製造市场最终用户的重要组成部分。这些机构将先进的抗体开发服务用于各种研究目的,专注于阐明疾病机制、发现新的治疗标靶和开发新型诊断工具。与受託製造厂商(CMO) 合作,无需对基础设施进行大量投资,即可获得尖端技术和专业知识,从而加快科学发现和创新的步伐。生技和製药公司,从新新兴企业到老字型大小企业,都严重依赖抗体契约製造服务来实现各种应用,包括开发治疗性抗体和製造诊断试剂。这些公司通常专注于特定的治疗领域或新颖的生物技术方法,需要高度专业、可扩展且具成本效益的抗体製造解决方案。受託製造合作伙伴关係使生物技术公司能够应对复杂的监管环境,管理与生物製药产品开发週期相关的风险,并加快创新的上市时间。透过与 CMO 合作,製药和生物技术公司可以利用我们在抗体生产和精製的专业知识来优化製造流程并确保产品品质并符合全球监管标准。
区域洞察
美洲是全球市场格局中高度开拓的地区。该地区拥有强大的生物製药研究、高额的医疗保健支出以及完善的法规环境。美国拥有多个重要的合约受託製造厂商(CMO),提供从早期开发到大规模製造的广泛服务。加拿大和巴西在这一领域也出现了成长,但美国在市场规模和技术进步方面继续处于领先地位。生物技术投资的增加、生物相似药需求的增长以及医疗保健基础设施的改善为亚太地区抗体契约製造市场注入了活力。中国、韩国和印度等国家处于领先地位,政府实施了有利于生物技术进步的政策。尤其是中国,由于患者数量众多以及生物技术产业的发展,CMO和合约开发与受託製造厂商(CDMO)的建立迅速增加。该地区的产品具有成本竞争力,加上品质标准的提高,使其成为外包抗体生产的有吸引力的地点。 EMEA(欧洲、中东和非洲)地区在抗体契约製造市场拥有强大的影响力,其中欧洲因其高度发展的生物製药产业而处于领先地位。德国、英国和瑞士等国家以其复杂的生物技术生态系统而闻名,其中包括成熟的生物技术公司和新兴的生物技术公司。严格的监管标准的存在确保了高品质的製造流程和产量。随着对医疗基础设施的投资和对生物技术研究兴趣的增加,中东和非洲正逐渐迎头赶上。
FPNV定位矩阵
FPNV定位矩阵对于评估抗体契约製造市场至关重要。我们检视与业务策略和产品满意度相关的关键指标,以对供应商进行全面评估。这种深入的分析使用户能够根据自己的要求做出明智的决策。根据评估,供应商被分为四个成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市场占有率分析
市场占有率分析是一种综合工具,可以对抗体契约製造市场中供应商的现状进行深入而深入的研究。全面比较和分析供应商在整体收益、基本客群和其他关键指标方面的贡献,以便更好地了解公司的绩效及其在争夺市场占有率时面临的挑战。此外,该分析还提供了对该行业竞争特征的宝贵见解,包括在研究基准年观察到的累积、分散主导地位和合併特征等因素。这种详细程度的提高使供应商能够做出更明智的决策并制定有效的策略,从而在市场上获得竞争优势。
1. 市场渗透率:提供有关主要企业所服务的市场的全面资讯。
2. 市场开拓:我们深入研究利润丰厚的新兴市场,并分析其在成熟细分市场的渗透率。
3. 市场多元化:提供有关新产品发布、开拓地区、最新发展和投资的详细资讯。
4. 竞争评估和情报:对主要企业的市场占有率、策略、产品、认证、监管状况、专利状况和製造能力进行全面评估。
5. 产品开发与创新:提供对未来技术、研发活动和突破性产品开发的见解。
1.抗体契约製造市场的市场规模与预测是多少?
2.抗体契约製造市场预测期内需要考虑投资的产品、细分市场、应用和领域有哪些?
3.抗体契约製造市场的技术趋势和法规结构是什么?
4.抗体契约製造市场主要厂商的市场占有率是多少?
5.进入抗体契约製造市场的合适型态和策略手段是什么?
[198 Pages Report] The Antibodies Contract Manufacturing Market size was estimated at USD 16.34 billion in 2023 and expected to reach USD 18.04 billion in 2024, at a CAGR 10.82% to reach USD 33.56 billion by 2030.
Antibodies contract manufacturing includes the outsourcing of antibody production and purification processes to specialized service providers. This approach allows biotechnology and pharmaceutical companies to leverage external expertise and advanced facilities for the production of monoclonal, polyclonal, and recombinant antibodies without the need for significant capital investments in infrastructure. Antibodies contract manufacturing services typically cover a broad spectrum of processes, including cell line development, upstream and downstream processing, purification, and final formulation. The growing emphasis on antibody-based drugs in the treatment of chronic diseases such as cancer, autoimmune diseases, and infectious diseases significantly fuels the need for specialized manufacturing services. Increasing regulatory support for innovative therapeutic antibodies, combined with streamlined approvals for biologics, promotes partnerships with contract manufacturing organizations (CMOs). Intellectual property concerns with rising quality and compliance risks associated with antibody contract manufacturing is restraining the growth of the market. Technological progress in bioprocessing, genetic engineering, and high-throughput screening accelerates the development of novel antibodies, creating opportunities for market growth.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 16.34 billion |
Estimated Year [2024] | USD 18.04 billion |
Forecast Year [2030] | USD 33.56 billion |
CAGR (%) | 10.82% |
Antibody Type: Growing need for monoclonal antibodies due to their uniformity, specificity, and large-scale production capabilities
Monoclonal antibodies are identical copies of an antibody that targets a specific antigen. They are produced by a single clone of cells or cell lines and have monovalent affinity, binding only to the same epitope. In the context of contract manufacturing, monoclonal antibodies are generated through sophisticated technologies such as hybridoma development, recombinant DNA, or phage display. These antibodies have a broad range of applications in diagnostics, therapeutics (for diseases such as cancer, autoimmune diseases, and infectious diseases), and research. Their uniformity, specificity, and large-scale production capabilities make them invaluable tools in medicine and biology. Polyclonal antibodies consist of a mixed population of antibody molecules that are produced by different clones of B cells. They recognize and bind to multiple epitopes on a single antigen. Due to this diversity, polyclonal antibodies are often used for detecting a wide range of antigens in immunoprecipitation and immunofluorescence assays. Production involves the immunization of a suitable mammal, such as a rabbit, goat, or mouse, with an antigen. The animal's immune system produces a wide array of antibodies against the antigen, which can then be collected from the serum. Polyclonal antibodies are appreciated for their high sensitivity and ability to capture proteins in their native conformation, but variability from batch to batch is a significant consideration in their production and use.
End-User: Rising adoption of antibodies contract manufacturing among biotechnology & pharmaceutical firms to leverage specialized expertise in antibody production and purification
Academics & research institutions constitute a significant segment of the end-users in the antibodies contract manufacturing market. Utilizing advanced antibody development services for diverse research purposes, these entities focus on understanding disease mechanisms, discovering new therapeutic targets, and developing novel diagnostics tools. The partnership with contract manufacturing organizations (CMOs) allows them to access cutting-edge technologies and expertise without the need for substantial investments in infrastructure, thereby accelerating the pace of scientific discoveries and innovations. Biotechnology & pharmaceutical companies, ranging from startups to well-established firms, heavily rely on antibody contract manufacturing services for various applications, including therapeutic antibody development, diagnostic reagent production, and more. These companies often focus on specific therapeutic areas or novel biotechnological approaches, necessitating the need for specialized, scalable, and cost-effective antibody production solutions. Contract manufacturing partnerships enable biotech companies to navigate the complex regulatory landscapes and manage the risks associated with the biopharmaceutical product development cycle, facilitating a quicker time-to-market for their innovations. The collaboration with CMOs allows pharmaceutical & biotechnology firms to leverage specialized expertise in antibody production and purification, optimize manufacturing processes, and ensure product quality and compliance with global regulatory standards, thus supporting their efforts to deliver safe and effective treatments to patients worldwide.
Regional Insights
The Americas represents a highly developing landscape for the global antibodies contract manufacturing market attributed to the region's robust biopharmaceutical research landscape, significant healthcare spending, and supportive regulatory environment. The US houses several significant contract manufacturing organizations (CMOs) that offer a wide range of services, from early-stage development to large-scale production. Canada and Brazil are also witnessing growth in this sector, though the US continues to lead in terms of market size and technological advancements. The antibody contract manufacturing market in Asia-Pacific is fueled by increasing investment in biotechnology, rising demand for biosimilars, and improving healthcare infrastructure. Countries such as China, South Korea, and India are at the forefront, with their governments implementing favorable policies for biotech advancements. China, in particular, has seen a surge in the establishment of CMOs and contract development and manufacturing organizations (CDMOs) owing to its large patient population and growing biotech industry. The region offers cost-competitive services, which, combined with improving quality standards, makes it an attractive location for outsourcing antibody production. The EMEA region exhibits a strong presence in the antibodies contract manufacturing market, with Europe leading the way due to its highly developed biopharmaceutical sector. Countries including Germany, the United Kingdom, and Switzerland are notable for their sophisticated biotech ecosystems, comprising both established players and emerging biotechs. The presence of stringent regulatory standards ensures high-quality manufacturing processes and outputs. The Middle East and Africa are gradually catching up, with investments in healthcare infrastructure and an increasing focus on biotechnology research.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Antibodies Contract Manufacturing Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Antibodies Contract Manufacturing Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Antibodies Contract Manufacturing Market, highlighting leading vendors and their innovative profiles. These include Abeomics, Absolute Antibody by LSBio, Advanced ChemTech, Inc., AGC Biologics, Antibodies, Inc., AstraZeneca, Boehringer Ingelheim Biopharmaceuticals GmbH., Bryllan LLC, Catalent, Inc., CD BioSciences, Charles River Laboratories International, Inc., Eli Lilly and Company, FUJIFILM Holdings Corporation, Fujirebio Inc. by H.U. Group Holdings, Inc., Hycult Biotechnology (H.B.T.) B.V., Labcorp Drug Development, Lonza Group Ltd., Merck KGaA, Molecular Depot LLC, Pierre Fabre S.A, Samsung Biologics, Sapphire Bioscience Pty. Ltd., Scantibodies Laboratory, Inc., Synthon International Holding B.V., The Serum Institute of India, and WuXi Biologics Co., Ltd..
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Antibodies Contract Manufacturing Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Antibodies Contract Manufacturing Market?
3. What are the technology trends and regulatory frameworks in the Antibodies Contract Manufacturing Market?
4. What is the market share of the leading vendors in the Antibodies Contract Manufacturing Market?
5. Which modes and strategic moves are suitable for entering the Antibodies Contract Manufacturing Market?