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市場調查報告書

商品編碼

1917898

生技藥品合約開發市場－2026-2031年預測

Biologics Contract Development Market - Forecast from 2026 to 2031

出版日期: 2026年01月08日 | 出版商:

Knowledge Sourcing Intelligence | 英文 147 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

預計生技藥品合約開發市場將從 2025 年的 82.45 億美元成長到 2031 年的 127.58 億美元，複合年成長率為 7.55%。

生技藥品合約開發市場是整個醫藥服務產業中重要且快速成長的細分市場，為包括單株抗體、重組蛋白、細胞和基因療法以及疫苗在內的複雜生物製藥提供外包研發和生產服務。隨著生物製劑開發平臺的複雜性和規模不斷成長，生物製藥公司擴大與合約研發生產力機構（CDMO）合作，以利用其專業知識、先進技術和靈活的生產能力。該市場使企業能夠縮短研發週期、管理風險並應對生物製藥生產過程中固有的技術和監管挑戰。

生物療法研發管線的不斷擴展和日益複雜是推動市場成長的根本動力。包括癌症、自體免疫疾病和神經系統疾病在內的慢性病和罕見疾病在全球範圍內的日益普遍，持續推動對新型生物治療方法的需求。然而，開發這些分子需要細胞株開發、上游和下游製程最佳化、分析表徵和製劑科學等方面的高度專業化能力。極少有生物製藥公司能夠以必要的規模在內部具備所有這些能力，因此，企業對擁有生物製藥開發成熟經驗的合約研發生產機構（CDMO）的依賴程度持續且不斷提高。

生物製藥研發固有的技術複雜性和高成本進一步推動了外包的普及。從細胞株到臨床供應，生物製藥的研發過程涉及複雜的多步驟流程，且每個分子的具體情況都各不特異性。合約研發生產機構（CDMO）在哺乳動物細胞培養、蛋白質純化和病毒載體生產等領域擁有先進的專業知識，而申辦者通常發現從外部獲取這些資源更為高效。這種夥伴關係模式使申辦方能夠將內部資源集中於核心藥物發現活動和臨床策略，同時減輕了建造和維護先進生物製藥設施所需的大量資本投入。

領先的合約研發生產機構 (CDMO) 普遍採用先進且靈活的技術，這已成為一種顯著趨勢，並推動了客戶偏好和市場差異化。一次性生物反應器系統、連續製程、高通量製程開發平台和先進分析技術等創新正逐漸成為標準配備。特別是一次性技術，具有柔軟性、交叉污染風險低、宣傳活動週期切換快等優勢，使其成為擁有多種產品且需求波動較大的合約服務環境的理想選擇。投資這些先進平台的 CDMO 可以提供更有效率、擴充性且可客製化的開發解決方案。

從服務領域來看，上游工程開發是關鍵且高成長的領域。此階段包括細胞株篩選、培養基最佳化和生物反應器製程設計，是實現高效價和穩定產品品質的基礎。 CDMO（合約研發生產機構）正日益提供高度客製化的上游開發服務，利用平台製程和專有技術來加速這一瓶頸階段。上游開發能力是關鍵的差異化因素，因為它直接影響最終生產流程的經濟性和擴充性。

從區域來看，北美仍是規模最大、最成熟的市場。這一主導地位得益於該地區生物製藥創新企業的高度集中、為生物技術Start-Ups公司提供資金支持的強大創業投資生態系統以及完善的法規結構。該地區蓬勃發展的臨床試驗和早期研發活動，催生了從藥物發現到商業化生產的各類合約服務的強勁需求。此外，北美作為許多全球合約研發生產機構（CDMO）的總部所在地，也進一步鞏固了其核心地位。

同時，亞太地區被公認為成長最快的市場。這一成長得益於該地區生物製造基礎設施的大規模投資、龐大的初治患者群體（適合開展臨床試驗）、與西方市場相比更低的運營成本，以及正在與國際標準接軌的不斷完善的監管體系。跨國和區域性合約研發生產力機構（CDMO）都在亞太地區拓展業務，以把握這一成長機遇，從而為申辦方在成本和速度方面提供戰略優勢。

競爭格局的特點是既有大規模的、提供全方位服務的全球性合約研發生產機構（CDMO），也小規模、專注於特定技術或分子類型（例如細胞療法、mRNA）的利基型企業。競爭異常激烈，企業之間的差異化體現在技術能力、品質和法規合規記錄、計劃管理專長以及提供從臨床前開發到商業化供應的端到端一體化服務的能力等方面。為了拓展服務範圍、取得新技術並擴大地域覆蓋，CDMO之間透過策略聯盟、併購等方式合作十分普遍。

總之，生技藥品合約開發市場正在發展成為全球生物製藥產業不可或缺的合作夥伴生態系統。其成長的結構性基礎在於藥物研發管線持續向複雜生物製劑轉型，以及外包專業開發活動的經濟與策略合理性。未來市場發展將取決於CDMO（合約研發生產機構）掌握細胞和基因療法等下一代技術的能力，進一步將數位化和數據驅動方法融入開發流程，並提供靈活且富有韌性的供應鏈解決方案。成功取決於對卓越科學和營運品質的不懈追求，以及與申辦者建立真正的合作夥伴關係，攜手走過從生物製劑概念到核准上市這一充滿挑戰的歷程。

本報告的主要優勢：

深入分析：取得以客戶群、政府政策和社會經濟因素、消費者偏好、垂直產業和其他細分市場為重點的深入市場洞察，涵蓋主要地區和新興地區。
競爭格局：了解主要企業採取的策略舉措，並了解透過正確的策略打入市場的潛力。
市場促進因素與未來趨勢：探索動態因素和關鍵市場趨勢，以及它們將如何塑造未來的市場發展。
可執行的建議：利用洞察力為策略決策提供訊息，從而在動態環境中開拓新的業務管道和收入來源。
受眾範圍廣：對新興企業、研究機構、顧問公司、中小企業和大型企業都有益處且經濟高效。

它是用來做什麼的？

產業與市場洞察、商業機會評估、產品需求預測、打入市場策略、地理擴張、資本投資決策、法律規範及其影響、新產品開發、競爭影響

分析範圍

歷史資料（2021-2025 年）和預測資料（2026-2031 年）
成長機會、挑戰、供應鏈前景、法規結構、客戶行為和趨勢分析
競爭對手定位、策略和市場佔有率分析
按業務板塊和地區（國家）分類的收入成長和預測分析
公司概況（策略、產品、財務資訊、關鍵趨勢等）

The biologics contract development market is a critical and rapidly expanding segment within the broader pharmaceutical services industry, focused on providing outsourced research, development, and manufacturing services for complex biologic drugs. These include monoclonal antibodies, recombinant proteins, cell and gene therapies, and vaccines. As biologic pipelines grow in complexity and volume, biopharmaceutical companies are increasingly partnering with Contract Development and Manufacturing Organizations (CDMOs) to leverage specialized expertise, advanced technologies, and flexible capacity. This market enables innovators to accelerate development timelines, manage risk, and navigate the substantial technical and regulatory challenges inherent in biologic drug creation.

A fundamental driver of market growth is the expanding and increasingly complex pipeline of biologic therapeutics. The rising global prevalence of chronic and rare diseases-including cancers, autoimmune disorders, and neurological conditions-continues to fuel demand for novel biologic treatments. Developing these molecules, however, requires highly specialized capabilities in cell line development, upstream and downstream process optimization, analytical characterization, and formulation science. Few biopharmaceutical companies possess all these capabilities in-house at the scale required, creating a sustained and growing reliance on CDMOs with proven expertise in biologics development.

The intrinsic technical complexity and high cost of biologic development further incentivize outsourcing. The biologics development pathway, from cell line to clinical supply, involves intricate, multi-step processes that are highly molecule-specific. CDMOs offer concentrated knowledge in areas like mammalian cell culture, protein purification, and viral vector production, which is often more efficient for sponsors to access externally. This partnership model allows sponsors to focus internal resources on core discovery and clinical strategy while mitigating the massive capital expenditure required to build and maintain state-of-the-art biologics facilities.

A significant trend is the adoption of advanced and flexible technologies by leading CDMOs, which in turn drives sponsor preference and market differentiation. Innovations such as single-use bioreactor systems, continuous processing, high-throughput process development platforms, and advanced analytics are becoming standard. Single-use technologies, in particular, offer advantages in flexibility, reduced cross-contamination risk, and faster turnaround between campaigns, making them ideal for the multi-product, variable-demand environment of contract services. CDMOs that invest in these advanced platforms can offer more efficient, scalable, and customizable development solutions.

From a service segment perspective, upstream process development represents a critical and high-growth area. This phase, involving cell line selection, media optimization, and bioreactor process design, is foundational to achieving high titers and consistent product quality. CDMOs are increasingly offering highly customized upstream development services, leveraging platform processes and proprietary technologies to accelerate this bottleneck stage. Mastery in upstream development is a key differentiator, as it directly impacts the economic viability and scalability of the eventual manufacturing process.

Geographically, North America remains the largest and most mature market. This dominance is supported by the concentration of major biopharmaceutical innovators, a robust venture capital ecosystem funding biotechnology startups, and a sophisticated regulatory framework. The region sees high volumes of clinical trial activity and early-stage development, creating strong demand for contract services from discovery through to commercial manufacturing. The presence of many global CDMO headquarters also reinforces North America's central role.

Concurrently, the Asia-Pacific region is identified as the fastest-growing market. This growth is propelled by significant investments in regional biomanufacturing infrastructure, a large and treatment-naive patient pool conducive to clinical trials, lower operational costs relative to Western markets, and evolving regulatory systems that are aligning with international standards. Both multinational and regional CDMOs are expanding their footprints in Asia-Pacific to capture this growth, offering sponsors strategic advantages in cost and speed.

The competitive landscape is characterized by a mix of large, full-service global CDMOs and smaller, niche players specializing in specific technologies or molecule types (e.g., cell therapies, mRNA). Competition is intensifying, with differentiation based on technological prowess, quality and regulatory track record, project management expertise, and the ability to offer integrated, end-to-end services from preclinical development through commercial supply. Strategic partnerships, mergers, and acquisitions are common as CDMOs seek to broaden their service portfolios, gain new technologies, and expand geographic reach.

In conclusion, the biologics contract development market is evolving into an indispensable partner ecosystem for the global biopharmaceutical industry. Its growth is structurally supported by the continued shift of the pharmaceutical pipeline toward complex biologics and the economic and strategic logic of outsourcing specialized development work. Future market development will be shaped by the ability of CDMOs to master next-generation modalities like cell and gene therapies, further integrate digital and data-driven approaches into development workflows, and provide resilient and flexible supply chain solutions. Success will depend on a relentless focus on scientific excellence, operational quality, and forming true collaborative partnerships with sponsors to navigate the challenging journey from biologic concept to approved medicine.

Key Benefits of this Report:

Insightful Analysis: Gain detailed market insights covering major as well as emerging geographical regions, focusing on customer segments, government policies and socio-economic factors, consumer preferences, industry verticals, and other sub-segments.
Competitive Landscape: Understand the strategic maneuvers employed by key players globally to understand possible market penetration with the correct strategy.
Market Drivers & Future Trends: Explore the dynamic factors and pivotal market trends and how they will shape future market developments.
Actionable Recommendations: Utilize the insights to exercise strategic decisions to uncover new business streams and revenues in a dynamic environment.
Caters to a Wide Audience: Beneficial and cost-effective for startups, research institutions, consultants, SMEs, and large enterprises.

What do businesses use our reports for?

Industry and Market Insights, Opportunity Assessment, Product Demand Forecasting, Market Entry Strategy, Geographical Expansion, Capital Investment Decisions, Regulatory Framework & Implications, New Product Development, Competitive Intelligence

Report Coverage:

Historical data from 2021 to 2025 & forecast data from 2026 to 2031
Growth Opportunities, Challenges, Supply Chain Outlook, Regulatory Framework, and Trend Analysis
Competitive Positioning, Strategies, and Market Share Analysis
Revenue Growth and Forecast Assessment of segments and regions including countries
Company Profiling (Strategies, Products, Financial Information), and Key Developments among others.

Biologics Contract Development Market Segmentation

By Source
Mammalian
Non-Mammalian
By Service
Upstream Processing
Downstream Processing
Others
By Indication
Oncology
Immunological Disorders
Cardiovascular Disorders
Neurological Disorders
Others
By Application
Vaccines
Gene Therapies
Monoclonal Antibodies
Others
By Geography
North America
USA
Canada
Mexico
South America
Brazil
Argentina
Others
Europe
Germany
France
United Kingdom
Spain
Others
Middle East and Africa
Saudi Arabia
UAE
Others
Asia Pacific
China
India
Japan
South Korea
Indonesia
Thailand
Others

1. EXECUTIVE SUMMARY

2. MARKET SNAPSHOT

2.1. Market Overview
2.2. Market Definition
2.3. Scope of the Study
2.4. Market Segmentation

3. BUSINESS LANDSCAPE

3.1. Market Drivers
3.2. Market Restraints
3.3. Market Opportunities
3.4. Porter's Five Forces Analysis
3.5. Industry Value Chain Analysis
3.6. Policies and Regulations
3.7. Strategic Recommendations

4. TECHNOLOGICAL OUTLOOK

5. BIOLOGICS CONTRACT DEVELOPMENT MARKET BY SOURCE

5.1. Introduction
5.2. Mammalian
5.3. Non-Mammalian

6. BIOLOGICS CONTRACT DEVELOPMENT MARKET BY SERVICE

6.1. Introduction
6.2. Upstream Processing
6.3. Downstream Processing
6.4. Others

7. BIOLOGICS CONTRACT DEVELOPMENT MARKET BY INDICATION

7.1. Introduction
7.2. Oncology
7.3. Immunological Disorders
7.4. Cardiovascular Disorders
7.5. Neurological Disorders
7.6. Others

8. BIOLOGICS CONTRACT DEVELOPMENT MARKET BY APPLICATION

8.1. Introduction
8.2. Vaccines
8.3. Gene Therapies
8.4. Monoclonal Antibodies
8.5. Others

9. BIOLOGICS CONTRACT DEVELOPMENT MARKET BY GEOGRAPHY

9.1. Introduction
9.2. North America
- 9.2.1. USA
- 9.2.2. Canada
- 9.2.3. Mexico
9.3. South America
- 9.3.1. Brazil
- 9.3.2. Argentina
- 9.3.3. Others
9.4. Europe
- 9.4.1. Germany
- 9.4.2. France
- 9.4.3. United Kingdom
- 9.4.4. Spain
- 9.4.5. Others
9.5. Middle East and Africa
- 9.5.1. Saudi Arabia
- 9.5.2. UAE
- 9.5.3. Others
9.6. Asia Pacific
- 9.6.1. China
- 9.6.2. India
- 9.6.3. Japan
- 9.6.4. South Korea
- 9.6.5. Indonesia
- 9.6.6. Thailand
- 9.6.7. Others