市场调查报告书
商品编码
1466473
生物製药契约製造市场:按产品、供应商、服务、业务规模、治疗应用 - 2024-2030 年全球预测Biopharmaceuticals Contract Manufacturing Market by Product (Biologics, Biosimilar), Source (Mammalian, Non-Mammalian), Services, Scale of Operation, Therapeutic Applications - Global Forecast 2024-2030 |
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生物製药契约製造市场规模预计2023年为182.7亿美元,2024年达到191.6亿美元,预计2030年将达259.5亿美元,复合年增长率为5.14%。
生物药品契约製造是指将生物药品的製造过程委託给第三方製造商。这些专业公司拥有生产生质製药所需的专业知识、设备和设施,包括疫苗、单株抗体、重组蛋白和其他生物来源。这种协作方法使生物製药公司能够利用外部能力和资源来提高扩充性、降低成本并加快新治疗方法的上市时间。生物製药契约製造市场是由生物製药管道的不断增长、生物仿製药需求的增加以及生物製药製造过程日益复杂性所推动的。对专业製造能力的需求、严格的监管要求以及缩短时间的愿望正在推动製药公司走向外包。然而,建立生物製药生产设施成本高昂,这可能会阻碍市场成长。然而,生物製药研发和製造的投资不断增加,以及全球对个人化医疗的日益关注,预计将为市场成长创造潜在机会。
主要市场统计 | |
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基准年[2023] | 182.7亿美元 |
预测年份 [2024] | 191.6亿美元 |
预测年份 [2030] | 259.5亿美元 |
复合年增长率(%) | 5.14% |
扩大分析和品质控制测试的使用对于满足服务监管标准至关重要
分析和品管(QC) 测试对于确保生物製药的安全性、有效性和品质至关重要。该服务包括各种活动,包括测试方法开发、验证、稳定性测试和批量发布测试。这些测试对于满足监管标准并确保製造的产品符合规格至关重要。灌装和精加工作业是生物製药製造过程中的关键步骤,其中最终药品被无菌填充到容器中,并进行贴标和包装等精加工操作。该过程需要精确度和高标准的清洁度,以保持产品的无菌性和完整性,使其成为生物製药契约製造的关键要素。生物製药包装服务不仅仅是封装产品。这包括设计和开发包装系统,保护产品免受环境因素的影响,确保储存和运输过程中的稳定性,并满足监管要求。此外,先进的包装解决方案增加了患者的便利性并支持治疗计划的遵守。製程开发是生物製药契约製造中的关键服务,重点是设计、优化和扩大生产工艺,以确保成本效益、效率并符合品质标准。这包括细胞培养製程、精製製程和整合製程分析的开发,以确保商业性製造的製程稳健性和永续性。在下游过程中,上游工程中产生的生物物质被回收和精製。此步骤对于去除杂质和浓缩产品很重要。下游加工涉及的技术包括层析法、过滤和沈淀,所有这些对于确保最终生物製药产品的纯度和品质至关重要。上游工程是指生物製药製造的早期阶段,涉及在受控条件下在反应器中培养细胞以生产所需的生物物质。这项服务需要细胞株开发、培养基製备和反应器操作方面的专业知识,并构成生产可进一步加工和最终形成治疗产品的生物活性物质的基础。
业务规模:生物製药契约製造:不断发展的商业性业务规模
生物药品契约製造中的临床规模是指以临床试验为目的的中小批量生物药品的生产。在这种规模下,弹性、准确性和遵守监管标准是优先考虑的,以确保临床实验产品的有效性和安全性。製造流程旨在适应临床开发过程中不断变化的需求,促进从临床前测试向 I、II 和 III 期临床试验的过渡。这种规模强调适应性以及随着产品接近商业化而扩大流程的能力。受託製造厂商(CMO) 提供临床规模的服务,拥有处理复杂生技药品(包括单株抗体、重组蛋白和基因疗法)的尖端技术和专业知识,确保产品为临床研究做好准备。符合严格的品质标准要求。生物製药契约製造的商业性规模涉及大规模生产,目标是在监管部门核准后进行大量销售。此规模强调效率、成本效益以及满足对核准生物製药的高需求的能力。商业规模的製造需要对基础设施、技术和品管系统进行大量投资,以确保一致的产品品质并符合全球监管要求。商业规模的受託製造公司有能力优化製造流程、高效管理供应链并及时交付大量生物製药。这种规模的企业不断追求卓越营运、流程优化和良好生产规范 (GMP) 合规性,以满足生物製药行业的严格标准并满足世界各地人们的健康需求。
区域洞察
美洲因其先进的技术基础设施、强有力的法律规范以及对生物技术研究的大量投资而成为生物製药契约製造的重要市场。最近的倡议主要集中在精准医学和生技药品上,并在生物加工和基因工程技术领域申请了多项专利。此外,对单株抗体和疫苗研究的关注促使全球合约受託製造厂商(CMO)在该国投资。随着製造能力升级和生技药品产量增加,亚太地区生物製药契约製造製造业正在蓬勃发展,对细胞疗法和重组蛋白药物进行了大量投资。此外,反应器技术和再生医学领域的重要专利,以及对国内和国际市场生物相似药和疫苗的关注,正在推动投资和合作伙伴关係,为 CMO 提供了许多机会。在先进的医疗基础设施和严格的监管标准的支持下,欧盟 (EU) 的生物製药契约製造市场呈现成长态势。最近的趋势包括生技药品的激增以及对个人化药物和细胞疗法的兴趣增加。儘管在中东仍处于起步阶段,但生物製药的契约製造正在逐步进展,投资主要集中在疫苗生产和生物相似药上,以应对不断增长的医疗需求。非洲的生物製药契约製造正在发展,因为该国专注于建立本地製造能力,以减少对进口药品的依赖,并专注于疫苗和一般治疗药物。
FPNV定位矩阵
FPNV定位矩阵对于评估生物製药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,可以对生物製药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.生物製药契约製造市场的市场规模和预测是多少?
2.在生物製药契约製造市场的预测期内,需要考虑投资哪些产品、细分市场、应用和领域?
3.生物製药契约製造市场的技术趋势和法规结构是什么?
4.生物製药契约製造市场主要供应商的市场占有率是多少?
5.进入生物製药契约製造市场的合适型态和策略手段是什么?
[186 Pages Report] The Biopharmaceuticals Contract Manufacturing Market size was estimated at USD 18.27 billion in 2023 and expected to reach USD 19.16 billion in 2024, at a CAGR 5.14% to reach USD 25.95 billion by 2030.
Biopharmaceutical contract manufacturing is the outsourcing of biopharmaceutical production processes to third-party manufacturers. These specialized entities possess the expertise, equipment, and facilities required to manufacture biopharmaceutical products, which include vaccines, monoclonal antibodies, recombinant proteins, and other biologically derived pharmaceuticals. This collaborative approach enables biopharmaceutical companies to leverage external capabilities and resources to enhance scalability, reduce costs, and accelerate the time to market for new therapies. The biopharmaceutical contract manufacturing market is driven by an increasing pipeline of biologic drugs, rising demand for biosimilars, and the complexity of biologic drug production processes. The need for specialized manufacturing capabilities, stringent regulatory requirements, and the desire to reduce costs and time-to-market push pharmaceutical companies toward outsourcing. However, the high price of setting up a production facility for biopharmaceuticals may hinder market growth. Nevertheless, rising investments in biopharmaceutical R&D and manufacturing, coupled with a growing emphasis on personalized medicine globally, are expected to create potential opportunities for market growth.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 18.27 billion |
Estimated Year [2024] | USD 19.16 billion |
Forecast Year [2030] | USD 25.95 billion |
CAGR (%) | 5.14% |
Services: Proliferating utilization of analytical and QC studies critical for meeting regulatory standards
Analytical and quality control (QC) studies are vital in ensuring the safety, efficacy, and quality of biopharmaceutical products. This service encompasses a range of activities, including method development, validation, stability testing, and batch release testing. These studies are critical for meeting regulatory standards and ensuring manufactured products meet specifications. Fill and finish operations are a crucial stage in the manufacturing process of biopharmaceuticals, involving the aseptic filling of the final drug into its container, followed by finishing tasks such as labeling and packaging. This process requires precision and high standards of cleanliness to maintain the sterility and integrity of the product, making it a critical component in the contract manufacturing of biopharmaceuticals. Packaging services for biopharmaceuticals go beyond simply enclosing the product. They involve designing and developing packaging systems that protect the product from environmental factors, ensure its stability during storage and transport, and comply with regulatory requirements. Sophisticated packaging solutions also provide patient convenience and support compliance with treatment regimens. Process development is a critical service in biopharmaceuticals contract manufacturing, focusing on designing, optimizing, and scaling up production processes to ensure cost-effectiveness, efficiency, and compliance with quality standards. This includes the development of cell culture processes, purification processes, and integration process analytics to ensure the process is robust and sustainable for commercial manufacturing. Downstream processing involves recovering and purifying biological substances produced during upstream processing. This phase is critical for removing impurities and concentrating the product. Techniques involved in downstream processes include chromatography, filtration, and precipitation, all of which are essential for ensuring the purity and quality of the final biopharmaceutical product. Upstream Processing refers to the initial phase of biopharmaceutical manufacturing, which involves cultivating cells in bioreactors under controlled conditions to produce the desired biological substance. This service requires expertise in cell line development, media preparation, and bioreactor operation, forming the foundation for producing biologically active substances that can be further processed and finalized as therapeutic products.
Scale of Operation: Evolving commercial scale of operation for biopharmaceuticals contract manufacturing
The clinical scale of operation in biopharmaceutical contract manufacturing refers to producing small to medium batches of biopharmaceutical products intended for clinical trials. This scale prioritizes flexibility, precision, and compliance with regulatory standards to assure the efficacy and safety of products under investigation. The production processes are designed to accommodate the evolving requirements of clinical development stages, facilitating the transition from preclinical studies to Phase I, II, and III clinical trials. At this scale, the focus is on adaptability and the ability to scale up processes as the product moves closer to commercialization. Contract manufacturing organizations (CMOs) offering services at the clinical scale are equipped with cutting-edge technology and expertise to handle complex biologics, including monoclonal antibodies, recombinant proteins, and gene therapies, ensuring that products meet the stringent quality standards required for clinical research. The commercial scale of operation in biopharmaceutical contract manufacturing involves large-scale production intended for the mass market following regulatory approval. This scale focuses on efficiency, cost-effectiveness, and the ability to meet the high demand for approved biopharmaceutical products. Commercial-scale manufacturing requires a significant investment in infrastructure, technology, and quality control systems to assure consistent product quality and compliance with global regulatory requirements. Contract manufacturing organizations serving at the commercial scale have the capabilities to optimize production processes, manage supply chains effectively, and ensure the timely delivery of large quantities of biopharmaceuticals. This scale of operation is characterized by a continuous commitment to operational excellence, process optimization, and adherence to Good Manufacturing Practices (GMP) to meet the stringent standards of the biopharmaceutical industry and address the health needs of populations globally.
Regional Insights
The Americas represent a significant market for biopharmaceuticals contract manufacturing, attributed to its advanced technological infrastructure, robust regulatory framework, and significant investments in biotech research. Recent initiatives focus on precision medicine and biologics, with numerous patents filed in bioprocessing and genetic engineering technologies. In addition, the emphasis on research in monoclonal antibodies and vaccines has attracted global contract manufacturing organizations (CMOs) to invest in the country. The biopharmaceutical contract manufacturing sector in Asia Pacific is booming, owing to the upgrading of manufacturing capabilities and enhancement of biologics production, with considerable investments in cell therapy and recombinant protein drugs. Furthermore, significant patents in bioreactor technologies and regenerative medicine and the focus on biosimilars and vaccines for domestic and international markets propel investments and collaborations, offering numerous opportunities for CMOs. The European Union exhibits growth in the biopharmaceuticals contract manufacturing market, supported by its advanced healthcare infrastructure and strong regulatory standards. Recent trends indicate a surge in biologics production and a growing interest in personalized medicines and cell therapies. Despite being nascent, the Middle East is gradually advancing in biopharmaceutical contract manufacturing, with investments focusing on vaccine production and biosimilars to address the rising healthcare needs. Africa's biopharmaceutical contract manufacturing is developing due to the region's focus on establishing local manufacturing capabilities to reduce dependency on imported drugs, emphasizing vaccines and common therapeutics.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Biopharmaceuticals 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 Biopharmaceuticals 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 Biopharmaceuticals Contract Manufacturing Market, highlighting leading vendors and their innovative profiles. These include 3P Biopharmaceuticals, AbbVie, Inc., Aenova Group GmbH, AGC Biologics, Ajinomoto Co., Inc., Aurobindo Pharma Limited, Boehringer Ingelheim International GmbH, Cambrex Corporation, Catalent, Inc., Celonic AG, FUJIFILM Diosynth Biotechnologies, INCOG BioPharma Services, Inc., JRS PHARMA GmbH + Co. KG, KBI Biopharma Inc, Lonza AG, Merck KGaA, Pressure BioSciences, Inc. by Emergent Health Corp., ProBioGen AG, Rentschler Biopharma SE, Samsung Biologics, Thermo Fisher Scientific Inc., Toyobo Co., Ltd., and WuXi Biologics, Inc..
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 Biopharmaceuticals Contract Manufacturing Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Biopharmaceuticals Contract Manufacturing Market?
3. What are the technology trends and regulatory frameworks in the Biopharmaceuticals Contract Manufacturing Market?
4. What is the market share of the leading vendors in the Biopharmaceuticals Contract Manufacturing Market?
5. Which modes and strategic moves are suitable for entering the Biopharmaceuticals Contract Manufacturing Market?
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