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生技药品合约开发市场报告：2030 年趋势、预测与竞争分析

Biologics Contract Development Market Report: Trends, Forecast and Competitive Analysis to 2030

出版日期: 2024年11月29日 | 出版商:

Lucintel | 英文 150 Pages | 商品交期: 3个工作天内

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简介目录

生技药品合约开发趋势及预测

全球合约生技药品开发市场的未来充满希望，癌症、免疫学、心血管和血液学市场充满机会。到 2030 年，全球合约生技药品开发市场预计将达到 409 亿美元，2024 年至 2030 年复合年增长率为 11.5%。该市场的主要驱动因素是製药公司增加药物开发步骤、越来越多地采用先进技术以及开发中国家有利于临床试验的环境。

Lucintel 专注于来源类别中的哺乳动物细胞，因为越来越多地采用哺乳动物细胞进行蛋白质表达，并且透过适当的转译后修饰来开发哺乳动物蛋白质以获得天然结构的显着优势预计将继续成为一个重要领域。
在这种疾病适应症中，肿瘤学仍将是最大的细分市场，因为治疗需求的成长推动了研发和外包的投资。
从地区来看，由于研发投资增加、临床试验需求增加以及大型企业的存在，北美在预测期内可能仍然是最大的地区。

合约生技药品开发的策略性成长机会

技术的改进、新的市场预期和政府支持为生技药品合约开发行业提供了策略性成长机会。应识别并利用这些机会来促进成长和提高竞争力。

新兴市场的出现：向新的地区扩张可以开闢新的收益来源，同时降低产业相关人员的风险。随着这些地区进入国际市场并发展其生物技术产业，他们对合约生技药品开发服务的兴趣日益浓厚。
细胞和基因治疗服务的进步：新细胞和基因疗法的兴起正在创造对开发服务的需求。透过投资这些能力，CDO 可以更好地满足客户对这些专业服务的需求。
经济观点：各地区的经济赋权应促进生物技术的发展。许多客户现在能够追求长期利润，而不必担心立即的投资回报。
先进技术的整合：公司的整体策略对先进技术的开发和整合有正面影响。 CDO 需要共同开发目前的产品，以维持和扩大其市场地位。
利用尖端製造方法：创新製造技术提高生产力并降低製造成本。透过采用这些技术，CDO 可以更好地服务并满足对可扩展且负担得起的生技药品製造不断增长的需求。
采用数位分析和人工智慧整合：人工智慧和进阶分析可改善决策和流程优化。这些技术透过缩短开发时间来提高业务效率并提高竞争力。
建立国际伙伴关係：策略性全球伙伴关係提供进入所需市场、汇集资源并利用内部专业知识的机会。合作促进创新、促进国际扩张并巩固我们的市场地位。

拓展新兴市场、提高细胞和基因治疗服务的复杂性、采用创新製造技术、整合人工智慧以及建立全球伙伴关係等策略性成长机会正在塑造合约生技药品开发市场。抓住这些机会将推动成长、提高竞争力并建立产业。

生技药品合约开发市场的市场推动因素及挑战

生技药品合约开发市场由技术进步、政治支持和私营部门参与等多种因素所驱动。这些因素对于增加需求、吸引投资和製定有效策略至关重要。

推动生技药品合约开发市场的因素包括：

技术进步：技术进步：技术发展提高了生技药品的生产效率和产能。连续製造和製程自动化等新技术提高了安全性并降低了成本，从而推动了市场成长。
对生技药品的需求不断增长：对专业合约开发业务的需求不断增长，这是由于对生技药品的需求不断增长而推动的。随着新治疗方法的出现，CDO 必须调整业务以支援这些复杂治疗方法的开发和生产。
良好的监管环境：支持性的法规环境可以加快核准流程并降低进入障碍。此类监管规定吸引了投资者并促进了新型生物疗法的出现。
成本效率和外包趋势：透过将业务委託给 CDO，公司可以减少开支，同时专注于核心业务。这一趋势将创造对 CDO 服务不断增长的需求并推动市场扩张。
增加研发投入：增加研发投入可以加快新生技药品的开发速度。这项投资将支持市场成长并提高 CDO 能力。

合约生技药品开发市场面临的挑战如下：

法规复杂性：法规复杂性：法规复杂性会延长开发时间并增加成本。公司必须确保审核资源的安全，监控合规政策的变化，并确保必要的变更得到实施。
高开发成本：高开发成本限制了市场进入并影响盈利。克服这项挑战需要有效的成本管理和投资策略。
激烈竞争：激烈竞争会影响市场占有率和定价。为了保持领先地位，CDO 需要透过创新、高品质的工作和卓越的客户服务脱颖而出。

合约生技药品开发市场的驱动因素包括技术进步、生技药品需求增加、法规环境改善、营运成本降低、研发投资增加。然而，成功的市场进入必须克服监管障碍、高昂的开发成本和激烈的竞争等挑战。平衡这些驱动因素和挑战是实现产业成长和创新的关键。

宏观经济趋势（2018-2023）与预测（2024-2030）
全球生技药品合约开发市场（2018-2023）与预测（2024-2030）
全球生技药品合约开发市场：依来源分类
- 微生物
- 哺乳动物的
- 其他的
生技药品合约开发市场：依产品和服务分类
- 细胞株开发
- 製程开发
- 其他的
异世界生技药品合约开发市场：按疾病适应症
- 肿瘤学
- 免疫疾病
- 心血管疾病
- 血液疾病
- 其他的

第四章 2018-2030年区域市场趋势及预测分析

按地区分類的生技药品合约开发市场
北美生技药品合约开发市场
欧洲合约生技药品开发市场
亚太生技药品合约开发市场
其他地区生技药品合约开发市场

第五章竞争分析

产品系列分析
业务整合
波特五力分析

第六章成长机会与策略分析

成长机会分析
- 资料来源：全球生技药品合约开发市场的成长机会
- 按产品服务：全球生技药品合约开发市场的成长机会
- 按疾病适应症分類的全球生技药品合约开发市场的成长机会
- 按地区划分：全球生技药品合约开发市场的成长机会
全球生技药品合约开发市场新趋势
战略分析
- 新产品开发
- 扩大全球合约生技药品开发市场的能力
- 全球生技药品开发市场的合併、收购和合资企业
- 认证和许可

第七章主要企业概况

WuXi Biologics
Abzena
Fujifilm Diosynth Biotechnologies
KBI Biopharma
AGC Biologics
Thermo Fisher Scientific
Curia Global
GenScript
Bionova Scientific
BioXcellence

简介目录

Biologics Contract Development Trends and Forecast

The future of the global biologics contract development market looks promising with opportunities in the oncology, immunological disorder, cardiovascular disorder, and hematological disorder markets. The global biologics contract development market is expected to reach an estimated $40.9 billion by 2030 with a CAGR of 11.5% from 2024 to 2030. The major drivers for this market are the rising number of drug development procedures by pharmaceutical companies, the growing adoption of advanced technologies, and a favorable environment for clinical trials in developing countries.

Lucintel forecasts that, within the source category, mammalian will remain a larger segment over the forecast period due to the increasing adoption of mammalian cells for protein expression, which provides a major advantage by developing mammalian proteins with correct post-translational modifications that deliver a native structure.
Within this disease indication category, oncology will remain the largest segment due to the growing demand for therapy, which encourages more investments in research and development and outsourcing.
In terms of regions, North America will remain the largest region over the forecast period due to growing R&D investments, rising demand for clinical trials, and the presence of major players in the region.

Gain valuable insights for your business decisions with our comprehensive 150+ page report.

Emerging Trends in the Biologics Contract Development Market

The biologics contract development market is consistent with the development of technology, regulatory changes, evolving relationships, and the booming population. These trends are changing the marketplace and affecting how contract development organizations and pharmaceutical companies operate.

Adoption of Advanced Manufacturing Technologies: Advanced manufacturing technologies enhance the efficiency, scalability, and flexibility in the production of biologics. For instance, continuous manufacturing reduces the time required in the production process and significantly reduces operational costs. Modular systems help optimize production by quickly reconfiguring processes.
Growth of Cell and Gene Therapy: The growing popularity of cell and gene therapies creates a need for specialized contract development services. Contract development organizations (CDOs) are establishing competence in this area to offer services that are specific to the complex and regulation-heavy processes involved in manufacturing advanced therapies.
Integration of Artificial Intelligence and Data Analytics: AI and data analytics enhance the quality of decision-making, increase efficiency in R&D processes, and improve production. These technologies help develop biologics by enhancing predictive modeling, adopting significant process control methods, and facilitating the analysis of data to reduce lead time and improve outcomes.
Increasing Focus on Regulatory Compliance: As legal regulations become more complex, compliance has become a focal point for contract development organizations. Emphasizing the fulfillment of legal requirements reduces risks, improves product standards, and accelerates biological approval processes.
International Partnerships and Collaborations: Collaborations allow organizations to develop new territories, pool assets, and capitalize on synergistic skills. Cooperation between contract development organizations and biotechnology companies from different countries promotes innovation, shortens development timelines, and helps distribute products in various regions.

Emerging trends such as innovations in manufacturing technologies increases in cell and gene therapy, AI applications, pressure to adhere to regulatory measures, and international partnerships are revolutionizing the biologics contract development industry. These factors lead to innovation and increased efficiencies, and address the growing demand for biologics, positioning the industry for continued growth and transformation.

Recent Developments in the Biologics Contract Development Market

Recent progress in the biologics contract development market highlights trends in technological advancement, supportive regulations, and market expansion. Key developments include advancements in manufacturing processes, increased R&D funding, and regulations that support the market's growth and evolution.

New Manufacturing Technologies: New manufacturing technologies offer efficient and scalable operations, reducing production costs and time. Continuous manufacturing eliminates nonproductive time by allowing production processes to be altered as needed and increases product uniformity. Modular systems improve adaptability and allow quick responses to changing production requirements.
Broader Cell and Gene Therapy Services: The increasing production of cell and gene therapies has led to more contract development services for these therapies. CDOs are investing in specific technologies and professionals to manage complex regulatory requirements for these specialized facilities.
AI and Data Analytics in Processes: AI and data analytics optimize drug development processes and enhance performance during manufacturing. These technologies provide advanced modeling, system controls, and real-time data analytics to improve efficiency and shorten development timelines.

Recent trends, including advancements in manufacturing technologies, enhanced cell and gene therapies, AI integration, regulatory improvements, and growing international alliances, are greatly influencing the biologics contract development market. These efficiencies lead to technological advancements and international expansion, driving growth in the industry.

Strategic Growth Opportunities for Biologics Contract Development Market

Technological improvements, new market expectations, and government support provide strategic growth opportunities in the biologics contract development industry. These opportunities should be identified and leveraged to enhance growth and competitiveness.

Emergence of Emerging Markets: Expanding into new regions reduces risk for industry players while opening new revenue streams. These areas are increasingly inclined toward biologics contract development services as they enter international markets or develop the biotech industry.
Development of Cell and Gene Therapy Services: The rise of new cell and gene therapies has created a demand for development services. As CDOs invest in these competencies, they empower themselves to meet the needs of clients seeking these specialized services.
Economic Perspectives: Economic empowerment in different regions should enhance biotechnology development. Many clients are now able to look beyond the immediate return on investment and explore long-term benefits.
Integration of Advanced Technologies: Overall company strategies positively impact the development and integration of advanced technologies. CDOs must co-develop current service offerings to maintain or grow their position in the market.
Utilizing Cutting-Edge Manufacturing Practices: Innovative manufacturing technologies increase productivity and reduce production costs. CDOs can adopt these technologies to provide better offerings and meet the increasing demand for scalable and affordable biologics production.
Adoption of Digital Analytics and AI Integration: AI and advanced analytics improve decision-making and process optimization. These technologies enhance competitiveness by increasing operational efficiency and reducing development time.
Entering International Partnerships: Strategic global partnerships provide access to desirable markets, pool resources, and leverage in-house expertise. Collaborations foster innovation, encourage international expansion and strengthen market position.

Strategic growth opportunities such as expanding into emerging markets, advancing cell and gene therapy services, adopting innovative manufacturing technologies, integrating AI, and forming global partnerships are shaping the biologics contract development market. Capturing these opportunities will drive growth, improve competitiveness, and build the industry.

Biologics Contract Development Market Driver and Challenges

The biologics contract development market is driven by various factors, including technological advancements, political support, and private sector involvement. These factors are essential for increasing demand, attracting investment, and formulating effective strategies.

The factors driving the biologics contract development market include:

Advances in Technology: Technological developments improve the efficiency and capacity of biologics production. New technologies, such as continuous manufacturing and process automation, enhance safety and reduce costs, thereby fostering market growth.
Increased Demand for Biologics: The rising demand for specialized contract development services is driven by the growing need for biologics. As new therapies emerge, CDOs must adjust operations to support the development and production of these complex therapies.
Favorable Operating Environment for Regulatory Agencies: Supportive regulatory environments accelerate the approval process and lower entry barriers. Such regulatory provisions attract investors and facilitate the emergence of novel biological therapies.
Cost Efficiency and Outsourcing Trends: Outsourcing operations to CDOs allows companies to reduce expenses while focusing on core activities. This trend creates a growing need for CDO services, driving market expansion.
Rising Investment in R&D: Increased investment in R&D leads to faster development of new biologics. This investment boosts market growth and improves the capabilities of CDOs.

Challenges in the biologics contract development market include:

Regulatory Complexity: Regulatory complexity can extend development timelines and increase costs. Companies must secure auditing resources, monitor changes in compliance policies, and ensure necessary changes are implemented.
High Development Costs: High development costs can limit market entry and affect profitability. Effective cost control and investment strategies are necessary to overcome this challenge.
High Degree of Competition: Intense competition can impact market share and pricing. To stay ahead, CDOs must stand out through technology innovation, quality work, and excellent customer service.

The drivers of the biologics contract development market include technological advancements, increasing demand for biologics, supportive regulatory environments, reduced operational costs, and increased R&D investment. However, challenges such as regulatory hurdles, high development costs, and fierce competition must be overcome for successful market participation. Balancing these drivers and challenges is key to achieving growth and innovation in the industry.

List of Biologics Contract Development Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. With these strategies biologics contract development companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the biologics contract development companies profiled in this report include-

WuXi Biologics
Abzena
Fujifilm Diosynth Biotechnologies
KBI Biopharma
AGC Biologics
Thermo Fisher Scientific
Curia Global
GenScript
Bionova Scientific
BioXcellence

Biologics Contract Development by Segment

The study includes a forecast for the global biologics contract development by source, product service, disease indication, and region.

Biologics Contract Development Market by Source [Analysis by Value from 2018 to 2030]:

Microbial
Mammalian
Others

Biologics Contract Development Market by Product Service [Analysis by Value from 2018 to 2030]:

Cell Line Development
Process Development
Others

Biologics Contract Development Market by Disease Indication [Analysis by Value from 2018 to 2030]:

Oncology
Immunological Disorders
Cardiovascular Disorders
Hematological Disorders
Others

Biologics Contract Development Market by Region [Shipment Analysis by Value from 2018 to 2030]:

North America
Europe
Asia Pacific
The Rest of the World

Country Wise Outlook for the Biologics Contract Development Market

The biologics contract development market is shaped by advancements in technology, investment policies, and increasing demand for biologics. Countries like the United States, China, Germany, India, and Japan are actively participating in these developments and transforming the industry through innovation and investment.

United States: In the U.S., the biologics contract development market is showing healthy growth due to rising investments in advanced manufacturing technologies and synergies between biotechnology companies and contract development organizations (CDOs)/contract manufacturing organizations (CMOs). Increasing process efficiencies and implementing new technologies like continuous manufacturing and cell/gene therapy remain priorities. Moreover, the U.S. regulatory framework continues to encourage innovation, especially in the approval of biologics.
China: China is rapidly expanding its biologics contract development capabilities due to state policies supporting biotechnology and pharmaceutical innovation. Recent developments include new biomanufacturing plants and additional resources to improve the scaling up of biologics. China is positioning itself as a leader in global biologics development with significant investment in R&D and international collaboration.
Germany: Germany is a leader in biologics contract development and production in Europe, supported by favorable policies and regulations. Recent changes include innovations in bioprocessing and increased capacity for high-throughput screening and analysis. As a member of the European Union, Germany benefits from transnational research cooperation and a broad market for biologics.
India: India's biologics contract development market is growing due to improved infrastructure and increased biopharmaceutical capabilities. Modern factories and updated laws are facilitating quicker approvals. India's low-cost manufacturing and experienced labor are attracting offshore clients seeking cost-effective biologics development solutions.
Japan: Japan is advancing its biologics contract development through technological innovations and industry collaboration. Recent developments include enhancements in biomanufacturing processes and the integration of cutting-edge technologies like artificial intelligence in drug development. Japan's supportive regulatory structure continues to drive growth and foster international partnerships.

Features of the Global Biologics Contract Development Market

Market Size Estimates: Biologics contract development market size estimation in terms of value ($B).

Trend and Forecast Analysis: Market trends (2018 to 2023) and forecast (2024 to 2030) by various segments and regions.

Segmentation Analysis: Biologics contract development market size by source, product service, disease indication, and region in terms of value ($B).

Regional Analysis: Biologics contract development market breakdown by North America, Europe, Asia Pacific, and Rest of the World.

Growth Opportunities: Analysis of growth opportunities in different sources, product services, disease indication, and regions for the biologics contract development market.

Strategic Analysis: This includes M&A, new product development, and competitive landscape of the biologics contract development market.

Analysis of competitive intensity of the industry based on Porter's Five Forces model.

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This report answers following 11 key questions:

Q.1. What are some of the most promising, high-growth opportunities for the biologics contract development market by source (microbial, mammalian, and others), product service (cell line development, process development, and others), disease indication (oncology, immunological disorders, cardiovascular disorders, hematological disorders, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
Q.2. Which segments will grow at a faster pace and why?
Q.3. Which region will grow at a faster pace and why?
Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
Q.5. What are the business risks and competitive threats in this market?
Q.6. What are the emerging trends in this market and the reasons behind them?
Q.7. What are some of the changing demands of customers in the market?
Q.8. What are the new developments in the market? Which companies are leading these developments?
Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?

1. Executive Summary

2. Global Biologics Contract Development Market : Market Dynamics

2.1: Introduction, Background, and Classifications
2.2: Supply Chain
2.3: Industry Drivers and Challenges

3. Market Trends and Forecast Analysis from 2018 to 2030

3.1. Macroeconomic Trends (2018-2023) and Forecast (2024-2030)
3.2. Global Biologics Contract Development Market Trends (2018-2023) and Forecast (2024-2030)
3.3: Global Biologics Contract Development Market by Source
- 3.3.1: Microbial
- 3.3.2: Mammalian
- 3.3.3: Others
3.4: Global Biologics Contract Development Market by Product Service
- 3.4.1: Cell Line Development
- 3.4.2: Process Development
- 3.4.3: Others
3.5: Global Biologics Contract Development Market by Disease Indication
- 3.5.1: Oncology
- 3.5.2: Immunological Disorders
- 3.5.3: Cardiovascular Disorders
- 3.5.4: Hematological Disorders
- 3.5.5: Others

4. Market Trends and Forecast Analysis by Region from 2018 to 2030

4.1: Global Biologics Contract Development Market by Region
4.2: North American Biologics Contract Development Market
- 4.2.1: North American Biologics Contract Development Market by Source: Microbial, Mammalian, and Others
- 4.2.2: North American Biologics Contract Development Market by Disease Indication: Oncology, Immunological Disorders, Cardiovascular Disorders, Hematological Disorders, and Others
4.3: European Biologics Contract Development Market
- 4.3.1: European Biologics Contract Development Market by Source: Microbial, Mammalian, and Others
- 4.3.2: European Biologics Contract Development Market by Disease Indication: Oncology, Immunological Disorders, Cardiovascular Disorders, Hematological Disorders, and Others
4.4: APAC Biologics Contract Development Market
- 4.4.1: APAC Biologics Contract Development Market by Source: Microbial, Mammalian, and Others
- 4.4.2: APAC Biologics Contract Development Market by Disease Indication: Oncology, Immunological Disorders, Cardiovascular Disorders, Hematological Disorders, and Others
4.5: ROW Biologics Contract Development Market
- 4.5.1: ROW Biologics Contract Development Market by Source: Microbial, Mammalian, and Others
- 4.5.2: ROW Biologics Contract Development Market by Disease Indication: Oncology, Immunological Disorders, Cardiovascular Disorders, Hematological Disorders, and Others

5. Competitor Analysis

5.1: Product Portfolio Analysis
5.2: Operational Integration
5.3: Porter's Five Forces Analysis

6. Growth Opportunities and Strategic Analysis

6.1: Growth Opportunity Analysis
- 6.1.1: Growth Opportunities for the Global Biologics Contract Development Market by Source
- 6.1.2: Growth Opportunities for the Global Biologics Contract Development Market by Product Service
- 6.1.3: Growth Opportunities for the Global Biologics Contract Development Market by Disease Indication
- 6.1.4: Growth Opportunities for the Global Biologics Contract Development Market by Region
6.2: Emerging Trends in the Global Biologics Contract Development Market
6.3: Strategic Analysis
- 6.3.1: New Product Development
- 6.3.2: Capacity Expansion of the Global Biologics Contract Development Market
- 6.3.3: Mergers, Acquisitions, and Joint Ventures in the Global Biologics Contract Development Market
- 6.3.4: Certification and Licensing