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生技藥品合約開發市場報告：2030 年趨勢、預測與競爭分析

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個工作天內

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簡介目錄

生技藥品合約開發趨勢及預測

全球合約生技藥品開發市場的未來充滿希望，癌症、免疫學、心血管和血液學市場充滿機會。到 2030 年，全球合約生技藥品開發市場預計將達到 409 億美元，2024 年至 2030 年複合年成長率為 11.5%。該市場的主要促進因素是製藥公司增加藥物開發步驟、擴大採用先進技術以及開發中國家有利於臨床試驗的環境。

Lucintel 專注於來源類別中的哺乳動物細胞，因為擴大採用哺乳動物細胞進行蛋白質表達，並且透過適當的轉譯後修飾來開發哺乳動物蛋白質以獲得天然結構的顯著優勢預計將繼續成為一個重要領域。
在這種疾病適應症中，腫瘤學仍將是最大的細分市場，因為治療需求的成長推動了研發和外包的投資。
從地區來看，由於研發投資增加、臨床試驗需求增加以及大型企業的存在，北美在預測期內可能仍然是最大的地區。

合約生技藥品開發的策略性成長機會

技術的改進、新的市場預期和政府支持為生技藥品合約開發行業提供了策略性成長機會。應識別並利用這些機會來促進成長和提高競爭力。

新興市場的出現：向新的地區擴張可以開闢新的收益來源，同時降低產業相關人員的風險。隨著這些地區進入國際市場並發展其生物技術產業，他們對合約生技藥品開發服務的興趣日益濃厚。
細胞和基因治療服務的進步：新細胞和基因療法的興起正在創造對開發服務的需求。透過投資這些能力，CDO 可以更好地滿足客戶對這些專業服務的需求。
經濟觀點：各地區的經濟賦權應促進生物技術的發展。許多客戶現在能夠追求長期利潤，而不必擔心立即的投資回報。
先進技術的整合：公司的整體策略對先進技術的開發和整合有正面影響。 CDO 需要共同開發目前的產品，以維持和擴大其市場地位。
利用尖端製造方法：創新製造技術提高生產力並降低製造成本。透過採用這些技術，CDO 可以更好地服務並滿足對可擴展且負擔得起的生技藥品製造不斷成長的需求。
採用數位分析和人工智慧整合：人工智慧和進階分析可改善決策和流程最佳化。這些技術透過縮短開發時間來提高業務效率並提高競爭力。
建立國際夥伴關係：策略性全球夥伴關係提供進入所需市場、匯集資源並利用內部專業知識的機會。合作促進創新、促進國際擴張並鞏固我們的市場地位。

拓展新興市場、提高細胞和基因治療服務的複雜性、採用創新製造技術、整合人工智慧以及建立全球夥伴關係等策略性成長機會正在塑造合約生技藥品開發市場。抓住這些機會將推動成長、提高競爭力並建立產業。

生技藥品合約開發市場的市場推動因素及挑戰

生技藥品合約開發市場由技術進步、政治支持和私營部門參與等多種因素所驅動。這些因素對於增加需求、吸引投資和製定有效策略至關重要。

推動生技藥品合約開發市場的因素包括：

技術進步：技術進步：技術發展提高了生技藥品的生產效率和產能。連續製造和製程自動化等新技術提高了安全性並降低了成本，從而推動了市場成長。
對生技藥品的需求不斷成長：對專業合約開發業務的需求不斷成長，這是由於對生技藥品的需求不斷成長而推動的。隨著新治療方法的出現，CDO 必須調整業務以支援這些複雜治療方法的開發和生產。
良好的監管環境：支持性的法規環境可以加快核准流程並降低進入障礙。此類監管規定吸引了投資者並促進了新型生物療法的出現。
成本效率和外包趨勢：透過將業務委託給 CDO，公司可以減少開支，同時專注於核心業務。這一趨勢將創造對 CDO 服務不斷成長的需求並推動市場擴張。
增加研發投入：增加研發投入可以加快新生技藥品的開發速度。這項投資將支持市場成長並提高 CDO 能力。

合約生技藥品開發市場面臨的挑戰如下：

法規複雜性：法規複雜性：法規複雜性會延長開發時間並增加成本。公司必須確保審核資源的安全，監控合規政策的變化，並確保必要的變更得到實施。
高開發成本：高開發成本限制了市場進入並影響盈利。克服這項挑戰需要有效的成本管理和投資策略。
激烈競爭：激烈競爭會影響市場佔有率和定價。為了保持領先地位，CDO 需要透過創新、高品質的工作和卓越的客戶服務脫穎而出。

合約生技藥品開發市場的促進因素包括技術進步、生技藥品需求增加、法規環境改善、營運成本降低、研發投資增加。然而，成功的市場進入必須克服監管障礙、高昂的開發成本和激烈的競爭等挑戰。平衡這些促進因素和挑戰是實現產業成長和創新的關鍵。

宏觀經濟趨勢（2018-2023）與預測（2024-2030）
全球生技藥品合約開發市場（2018-2023）與預測（2024-2030）
全球生技藥品合約開發市場：依來源分類
- 微生物
- 哺乳動物的
- 其他
生技藥品合約開發市場：依產品和服務分類
- 細胞株開發
- 製程開發
- 其他
異世界生技藥品合約開發市場：按疾病適應症
- 腫瘤學
- 免疫疾病
- 心血管疾病
- 血液疾病
- 其他

第4章 2018-2030年區域市場趨勢及預測分析

按地區分類的生技藥品合約開發市場
北美生技藥品合約開發市場
歐洲合約生技藥品開發市場
亞太生技藥品合約開發市場
其他地區生技藥品合約開發市場

第5章競爭分析

產品系列分析
業務整合
波特五力分析

第6章成長機會與策略分析

成長機會分析
- 資料來源：全球生技藥品合約開發市場的成長機會
- 按產品服務：全球生技藥品合約開發市場的成長機會
- 按疾病適應症分類的全球生技藥品合約開發市場的成長機會
- 按地區分類：全球生技藥品合約開發市場的成長機會
全球生技藥品合約開發市場新趨勢
戰略分析
- 新產品開發
- 擴大全球合約生技藥品開發市場的能力
- 全球生技藥品開發市場的合併、收購和合資企業
- 認證和許可

第7章主要企業概況

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

簡介目錄

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.

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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