第23次生物製藥生產能力及產量年度報告及調查（2026年）

調查方法

本報告是我們對生物製藥製造（生物製程）產業現況進行年度評估的第23份報告。該調查方法的優勢在於其廣泛的涵蓋範圍，能夠從最接近行業的受訪者那裡獲得全面的見解。此外，23年的研究經驗、對產業的深刻理解以及高回覆率也是此調查方法的優勢所在。這些因素確保了研究方法的一致性，從而提供可靠的數據和分析。

需要注意的是，此處使用的「生物製藥」一詞遵循基於生物技術的傳統定義，指的是利用生物技術/生物製程生產藥品。該術語並非指整個製藥業或僅指創新領域。目前，「生物製藥」只是先前用於指稱「藥品」或「藥物」的術語的常用替代。

今年，BioPlan Associates, Inc. 對來自 21 個國家的 300 位生物製藥生產商和契約製造組織 (CMO) 的合格負責負責人以及 121 家直接向該行業提供材料、服務和設備的供應商進行了調查。我們使用網路調查工具收集並評估了受訪者關於其當前產能、生產狀況、新技術應用、人員配備、品質和外包問題等方面的各類資訊。我們也評估了受訪者對預期瓶頸原因的看法以及如何解決這些瓶頸。

今年，我們繼續新增問題和章節，包括人工智慧（AI）的應用、連續生物製程和製程改進（第11章）。近年來，技術、平台、表達系統和一次性應用的進步，使得生物程序領域作為創新焦點的重要性日益凸顯。

我們持續與全球媒體和會員組織合作，以確保高回覆率，並提供全球生物製藥產業及其生物加工領域最準確的概覽。我們的產業夥伴名單已在致謝部分列出。我們也要感謝媒體合作夥伴對本次調查的支持。你們的合作使我們能夠接觸到大量高品質的受訪者，這對於本次定量調查和分析至關重要。

目錄

調查方法

第0章 人口統計

• 重點
• 介紹
  • 受訪者的參與領域
  • 受訪者資格
  • 設施位置
  • 生物製藥生產營運領域
  • 生產運營，開發階段
  • 工廠內的員工人數
  • 該工廠的年度批次運作
  • 該設施使用的一次性生物反應器的容量
  • 該設施使用的不銹鋼生物反應器

第1章：引言與討論

• 產業及市場概覽
• 生物製藥產業的現況與市場趨勢
• 製藥業正在向生物製藥轉型。
• 全球生物製藥市場趨勢
• 生物製藥市場（按產品類別分類）
• 動物源性產品和生物製藥
• 生物製藥產業的未來趨勢

第2章：生物程序的未來：專家觀點

• 2025年FDA生物製藥核准：創新與標靶治療驅動的新型生物製藥可望迎來充滿希望的一年
• 近期一些交易將在2025年對CDMO產業產生影響
• 人工智慧在生物製藥的研發、生產和品管的應用
• 靜脈注射生產：為什麼細胞療法需要以病人為中心的依從性模式
• CDMO能否滿足胜肽和寡核苷酸療法的生產能力需求？

第3章 趨勢與新興技術

• 重點
  • 2025年產業趨勢
    • 背景和定義
    • 2026年生物製程改進需求
    • 新冠疫情前後企業營運的變化
    • 與2026年預算相關的挑戰
    • 與生物製程相關的預算支出
    • 開發新型生物製程產品的機會（2026 年）
  • 影響生物製造技術進步的因素
  • 成本削減措施和開發計劃
  • 重組蛋白的平均成本
  • 檢測方法開發
  • 商業規模生物反應器的選擇與購買
  • 討論：產業趨勢與挑戰

第4章 設備運轉率

• 重點
• 設備運轉率趨勢
• 設備運轉率：生物藥廠與CMOS企業對比
• 設備運轉率：美國和西歐製造商的比較。
• 受訪者目前的總生產能力
• 全球生物反應器生產能力
• 單株抗體生產過程中的抗體滴度範圍
• 討論：產能與產業趨勢

第5章 當前及未來的生產能力限制及品質因素

• 重點
• 目前產能限制
• 預計產能限制
• 影響未來產能的因素
• 為避免未來產​​能不足，需要重點關注以下幾個面向。
• 生物製藥生產中的批次失敗
• 供應商造成的生物製造品質問題
• 討論：產業趨勢

第6章：未來產能擴張計劃

• 重點
• 未來產能擴張計劃
• 生物製造商和CMOS系統未來產能擴張計畫（按系統類型分類）
• 美國和西歐未來設施擴建計劃（按系統分類）
• 未來產能擴張計劃
• 討論：產能擴張的未來趨勢

第7章：生物製藥生產外包趨勢

• 重點
• 背景和定義
• 生產系統外包的現狀
• 未來外包
• 生物製藥生產中的外包活動
• 外包的關鍵挑戰
• CMOS面臨的客戶問題
• 生物製造國際外包（境外外包）國家選擇
• 境外外包到低成本地區的趨勢
• 討論：外包和境外外包

第8章 生物製藥生產中的一次性產品和系統

• 重點
• 使用一次性產品和一次性系統
• 可浸出物質和萃取物
• 一次性產品和一次性系統使用日益增多的原因
• 可能限制一次性產品使用的因素
• 與一次性產品採用相關的問題
• 一次性感測器的需求以及生物反應器的特性
• 一次性設備供應商的顧客滿意度（2008-2026 年）
• 8-8 一次性產品的運作與發展趨勢
• 討論 8-9：一次性生物製程

第9章：下游清理

• 重點
• 下游製程對加工能力的影響
• 特定純化步驟中的限制
• 下游清理相關問題
• 估計值的單株抗體純化能力
• 新型下游加工技術
• 下游製程的改進
• 填充和整理的趨勢
• DSP 主製程良率
• 討論：產業趨勢

第10章：生物製藥生產中的招募、就業拓展與培訓

• 重點
• 背景和定義
• 招募趨勢
• 未來五年（至2031年）的招募趨勢
• 當今招募面臨的挑戰
• 生物製藥生產培訓
• 討論：促進就業成長的策略

第11章：新方法：持續製程改良、細胞與基因治療

• 重點
• 創新生物製程導論
• 背景和定義
• 細胞和基因治療的優勢
• 連續生物製程和灌注的優勢
• 未來連續生物製程和製程改進的實施
• 灌注操作和連續生物過程中的操作問題
• 自動化實施
• 人工智慧（AI）活動
• 細胞和基因治療平台
• 討論：生物製造的未來

第12章 生物藥廠生產與生命科學供應商

• 重點
• 人口統計數據
• 供應商銷售成長率
• 產業供應商面臨的預算挑戰與問題
• 客戶與其商業夥伴之間存在的問題
• 新冠疫情對供應商活動的影響
• 供應商的產品和服務
• 銷售人員培訓
• 2026 年前生物製藥供應商的財務前景
• 生物製藥服務中合約生產組織（CMO）定價調整
• 討論：生物製藥供應商

METHODOLOGY

This report is the 23rd in our annual evaluations of the state of the biopharmaceutical manufacturing (bioprocessing) industry. The strength of this study’s methodology remains in its breadth of coverage, which yields a composite view from the respondents closest to the industry, its 23-year longevity, industry familiarity and high response rates. These permit a consistent approach which delivers reliable data and analysis.

Note, “biopharmaceutical” here refers to the classic biotechnology-grounded definition: involving manufacture of pharmaceuticals using biotechnology/bioprocessing. The term does not refer to the entire pharmaceutical industry or just those parts considered innovative, with “biopharmaceutical” now simply commonly substituted where “pharmaceutical” or “drug” were formerly used.

This year, BioPlan Associates, Inc. surveyed 300 qualified and responsible individuals at biopharmaceutical manufacturers and contract manufacturing organizations in 21 countries plus 121 industry vendors and direct suppliers of materials, services, and equipment to this industry segment. Using a web-based survey tool, we obtained and evaluated information including regarding respondents’ current capacity, production, novel technology adoption, human resources, quality, and outsourcing issues. We also assessed respondents’ projected reasons for bottlenecks, and their perception of how these bottlenecks might be resolved.

This year, we continue to include new questions and chapters, including Artificial Intelligence Use and Applications, Continuous Bioprocessing and Process Intensification (Chapter 11.) Over the past few years, advances in technologies, platforms, expression systems, and single-use applications have increasingly made the bioprocessing segment an area of interest for such innovation.

We continue to partner with worldwide media and membership organizations to ensure a high response rate, and the most accurate overview of the worldwide biopharmaceutical industry and its bioprocessing sector. Our industry partners are cited in our acknowledgments section. In addition, to supporting this coverage, we also acknowledge our media partners, whose assistance enables us to reach the many high-quality respondents required for this quantitative survey and analysis.

Further information on methodology, breakouts on specific segments, and data from earlier surveys may be requested by contacting us at the address below. Thank you for your participation and interest in this important research.

Table of Contents

METHODOLOGY

CHAPTER 0: DEMOGRAPHICS

• KEY TAKEAWAYS
• INTRODUCTION
  • 0-1 RESPONDENTS’ AREA OF INVOLVEMENT
  • 0-2 RESPONDENTS’ QUALIFICATIONS
  • 0-3 FACILITY LOCATIONS
  • 0-4 AREAS OF BIOPHARMACEUTICAL MANUFACTURING OPERATIONS
  • 0-5 PRODUCTION OPERATIONS, PHASE OF DEVELOPMENT
  • 0-6 EMPLOYEES AT FACILITY
  • 0-7 BATCHES RUN AT FACILITY PER YEAR
  • 0-8 SINGLE-USE BIOREACTOR CAPACITY IN USE AT SITE
    • Analysis of Average Single-use Bioreactor Size
  • 0-9 STAINLESS STEEL BIOREACTOR CAPACITY IN USE AT SITE
    • Analysis of Average Stainless Steel Bioreactor Size

CHAPTER 1: INTRODUCTION AND DISCUSSION

• 1-1 SECTOR AND MARKET OVERVIEW
  • The Industry Continues to Mature
  • M&A Activities
  • “Biopharmaceutical:” - The Definition Used Here
  • Contract Manufacturing Trends
• 1-2 BIOPHARMACEUTICAL INDUSTRY STATUS AND MARKET TRENDS
  • U.S. Healthcare is Changing
  • Bioprocessing is Increasing Internationally
• 1-3 PHARMA INDUSTRY IS SHIFTING TO BIOPHARMACEUTICALS
  • Pharmaceutical Industry Dependence on Biopharmaceuticals
• 1-4 GLOBAL BIOPHARMACEUTICAL MARKET TRENDS
  • Growth in Biopharmaceutical Product Sales is Increasing the Demand
  • for Bioprocessing
  • Overall Health of the Biopharmaceutical Sector
  • U.S. Industry Leadership Continues
  • Biopharmaceuticals in the Rest-of-the-World
• 1-5 BIOPHARMACEUTICAL MARKETS BY PRODUCT CLASS
  • Monoclonal Antibodies (mAbs) are the Leading Product Class
  • Monoclonals are a Costly Treatment
• 1-6 ANIMAL DERIVED PRODUCTS AND BIOPHARMACEUTICALS
  • Animal Derived Products and Biopharmaceuticals
  • Plant-based Biopharmaceutical Manufacturing
• 1-7 FUTURE TRENDS IN THE BIOPHARMACEUTICAL INDUSTRY
  • Future Trends in Biopharma
  • Conclusion

CHAPTER 2: FUTURE OF BIOPROCESSING: EXPERTS’ PERSPECTIVE

• 2-1 2025 FDA Biopharmaceutical Approvals: Promising Year for Novel Biologics Driven by Innovation and Targeted Therapies
• 2-2 Recent Transactions Affecting the CDMO Landscape in 2025
• 2-3 Artificial Intelligence in Biopharmaceutical Development,Manufacturing, and Quality
• 2-4 Vein-to-Vein Manufacturing: Why Cell Therapy Requires a Patient-Centric Compliance Model
• 2-5 Can CDMOs Meet the Demand for Capacity in Peptide and Oligonucleotide Therapeutics Manufacturing?

CHAPTER 3: TRENDS AND EMERGING TECHNOLOGIES

• KEY TAKEAWAYS
  • 3-1 INDUSTRY TRENDS IN 2025
    • Background and Definitions
    • 3-2 BIOPROCESSING IMPROVEMENTS NEEDED IN 2026
      • Bioprocessing Improvements Most Needed
      • Novel Bioprocessing Systems/Innovations
      • Novel Bioprocessing Systems/Innovations, Biomanufacturers vs. CMOs
    • 3-3 OPERATIONAL CHANGES IN PRE- AND POST-COVID
      • Operational Changes Due to Recent Global Economics
      • Operational Changes (2010 – 2012, 2022-2026)
      • Operational Changes: Biomanufacturers vs. CMOs
      • Operational Changes: U.S. vs. Western Europe
    • 3-4 BUDGET ISSUES IN 2026
      • Biomanufacturers’ Budget Shifts in 2026
      • Budget Change Comparisons (2009-2026)
    • 3-5 TOP BIOPROCESSING BUDGET EXPENDITURES
      • New Expenditures Focus Areas in 2026
      • Top New Bioprocessing Budget Expenditures (2020-2026)
    • 3-6 NEW BIOPROCESSING PRODUCTS DEVELOPMENT OPPORTUNITIES (2026)
      • Upstream New Product Areas of Interest, 2026
      • Trends: Upstream New Product Areas of Interest (2010-2026)
      • Downstream New Product Areas of Interest, 2026
      • Analysis Of Key Finding: Demand for New Product Development in
      • Upstream Bioprocessing
      • Trends: Downstream New Product Areas of Interest (2010-2026)
      • Other General New Product Areas of Interest, 2026
      • Trends: Other General New Product Areas of Interest (2010-2026)
      • New Product Development Areas: Biomanufacturers vs. CMOs
      • New Product Development Areas: U.S. vs. Western Europe and ROW
  • 3-7 FACTORS IN BIOMANUFACTURING CREATING IMPROVEMENTS
    • Factors in Biomanufacturing Performance Creating “Significant” or “Some”Improvements, 2026
    • Factors Improving Biomanufacturing Performance (2010-2015, 2025-2026)
    • Factors Improving Biomanufacturing Performance, Biotherapeutic Developers vs. CMOs
    • Factors Improving Biomanufacturing Performance, U.S. vs. Western Europe vs. ROW
  • 3-8 COST-CUTTING ACTIONS & DEVELOPMENT TIMELINES
    • Cost-Cutting Changes: Actions Undertaken During 2011-2016, 2019-2024
    • Cost-Cutting Changes: Specific to Outsourcing
    • Factors Impacting Reduction in Cost of Goods (2020-2024)
  • 3-9 AVERAGE COST PER GRAM RECOMBINANT PROTEIN
    • Distribution, Average Cost per Gram for PRIMARY Recombinant Protein, 2026
    • Distribution, Average Cost per Gram for PRIMARY Recombinant Protein (2017-2026)
    • Analysis of Key Finding: Some Good from the Pandemic. Cost per Gram in Biomanufacturing Proteins dropped 10% annually during COVID
  • 3-10 ASSAY DEVELOPMENT
    • Biomanufacturing Assay Areas Required; Biomanufacturers vs. CMOs
    • Biomanufacturing Assay Areas Required, U.S. vs Western Europe
  • 3-11 SELECTING AND PURCHASING COMMERCIAL-SCALE BIOREACTORS
    • Largest Commercial-Scale Bioreactor Expected in Next Two Years (2022)
    • Top Options for Bioreactor Platforms at Commercial Scale
    • Top Options for Bioreactor Platforms at Commercial Scale (2021-2024)
    • Largest Single-Use Bioreactor Capacity to Purchase in Next Two Years (2022, 2025-2025)
    • Largest Stainless Steel Bioreactor Capacity Purchase in ‘Next Two Years’,2022, 2025-2026
  • 3-12 DISCUSSION: INDUSTRY TRENDS AND ISSUES
    • Industry Growth and Adaptation
    • Cost Cutting Trends
    • Discussion of Cost per Gram
    • Discussion of Maturity of Single Use

CHAPTER 4: CAPACITY UTILIZATION

• KEY TAKEAWAYS
• 4-1 CAPACITY UTILIZATION TRENDS
  • Capacity Utilization Definitions
  • Relevance of Capacity Utilization
  • Capacity Utilization in Other Industries, 2026: US Federal Reserve Board Comparisons
  • Capacity Utilization in Biomanufacturing by System, 2026
  • Capacity Utilization Changes (2006-2026)
  • Average Growth Rate in Capacity Utilization (2006-2026)
• 4-2 CAPACITY UTILIZATION: BIOMANUFACTURERS VS. CMOS
  • Capacity Utilization By System, Biomanufacturers vs. CMOs, 2026
• 4-3 CAPACITY UTILIZATION: U.S. VS. WESTERN EUROPEAN MANUFACTURERS
  • Capacity Utilization, By System, U.S. vs. Western Europe
  • Historical 14-year US vs. EU Trends in Capacity Utilization
• 4-4 RESPONDENTS’ CURRENT TOTAL PRODUCTION CAPACITY
  • Mammalian Cell Culture Capacity
  • Microbial Fermentation Capacity
  • Cell Therapy Capacity
  • Gene Therapy Capacity
• 4-5 GLOBAL BIOREACTOR CAPACITY
  • The Largest Capacity Facilities
  • Biopharmaceutical Capacity Expansions Continue
  • Biopharmaceutical Developers/Manufacturers as CMOs
  • Major CMOs in Terms of Facilities and Capacity
• 4-6 RANGE OF TITERS WITH MAB PRODUCTION
  • Distribution of mAb Titer Ranges
  • Annual mAb Titer Changes (2008-2026)
• 4-7 DISCUSSION: CAPACITY AND INDUSTRY TRENDS
  • The Risks of Biomanufacturers Seeking to Become a CMO
  • Future Capacity Trends

CHAPTER 5: CURRENT AND FUTURE CAPACITY CONSTRAINTS AND QUALITY FACTORS

• KEY TAKEAWAYS
• 5-1 CURRENT CAPACITY CONSTRAINTS
  • Background & Definitions
  • Current Capacity Constraints
  • Respondents’ Perception of Capacity Constraints (2004-2026)
  • Differences in Capacity Constraints: Biomanufacturers vs. CMOs
  • Capacity Constraints: U.S. vs. Western European Biomanufacturers & CMOs
• 5-2 EXPECTED CAPACITY CONSTRAINTS
  • Respondents’ Expectations of Capacity Constraints in Five Years (2031)
  • Expected Capacity Constraints Five-year Projections (2004-2026)
  • Expected Capacity Constraints in Five Years: Biomanufacturers vs. CMOs (2031).215
  • Expected Capacity Constraints in Five Years: U.S. vs. Western Europe (2031)
• 5-3 FACTORS IMPACTING FUTURE PRODUCTION CAPACITY
  • Factors Creating Future Capacity Constraints in Five Years (2031)
  • Factors Creating Future Capacity Constraints (2008-2026)
  • Factors Creating Future Capacity Constraints: Biomanufacturers vs. CMOs
  • CMO Capacity Bottleneck Projections, in Retrospect
  • Factors Creating Capacity Constraints: U.S. vs. Western Europe Respondents
• 5-4 KEY AREAS TO ADDRESS TO AVOID FUTURE CAPACITY CONSTRAINT
  • Areas to Avoid Capacity Constraints in 2026
  • Areas to Avoid Capacity Constraints: Changing Perspectives (2006-2026)
  • Key areas to Address to Avoid Capacity Constraints; Biomanufacturers vs. CMOs.233
  • Key Areas to Address to Avoid Capacity Constraints: U.S. vs. Western Europe
• 5-5 BATCH FAILURES IN BIOPHARMACEUTICAL MANUFACTURING
  • Background and Definitions
  • Average Time Between Batch Failures (2009-2026)
  • Batch Failure Frequency Distribution (2009-2026)
  • Primary Cause of Batch Failures, Percentages of Failures
  • Primary Cause of Batch Failures, Percentages of Failures for Commercial Manufacturing (2009-2026)
  • Primary Cause of Batch Failures, Percentages of Failures for Clinical Scale Manufacture (2009-2026)
  • Improving Failure Rates
• 5-6 QUALITY PROBLEMS IN BIOMANUFACTURING ATTRIBUTED TO VENDORS
  • Global Quality Supply Management (2011-2013, 2022-2023) – 2023 Data
  • Global Quality Supply Management Biomanufacturers vs. CMOs (2023)
  • U.S. vs. W. Europe Global Quality Supply Management (2023)
  • Addressing Supply Chain Security Post Pandemic
• 5-7 DISCUSSION: INDUSTRY TRENDS
  • Mitigation Strategies for Financial Constraints in Biomanufacturing
  • Automation and Artificial Intelligence to Address Capacity Constraints

CHAPTER 6: PLANNED FUTURE CAPACITY EXPANSIONS

• KEY TAKEAWAYS
• 6-1 PLANNED FUTURE CAPACITY EXPANSIONS
  • Background and Definitions
  • Industry Average Planned Production Increases, Five Years Estimates (2031)
  • Planned Future Capacity Expansions: Five Year Estimates (2009-2031)
  • Planned Future Capacity Expansions of >100%, by Systems
• 6-2 PLANNED FUTURE CAPACITY EXPANSIONS FOR BIOMANUFACTURERS VS CMOS, BY SYSTEM
  • Planned Future Capacity Expansions for Biomanufacturers vs. CMOs, Five Year Estimates (2031)
• 6-3 PLANNED FUTURE CAPACITY EXPANSIONS FOR U.S. VS. WESTERN EUROPE, BY SYSTEM
  • Planned Future Capacity Expansions for U.S. vs. W. Europe Manufacturers, Five Year Estimates (2031)
• 6-4 PLANNED FUTURE CAPACITY EXPANSIONS
  • Biomanufacturing Capacity Under Active Construction in 2026
• 6-5 DISCUSSION: FUTURE OF CAPACITY EXPANSION TRENDS
  • Drivers of Platform-specific Capacity Expansion

CHAPTER 7: OUTSOURCING TRENDS IN BIOPHARMACEUTICAL MANUFACTURING

• KEY TAKEAWAYS
• 7-1 BACKGROUND AND DEFINITIONS
  • Why Outsource?
  • Strategic Manufacturing Planning
  • Future Projections
• 7-2 CURRENT OUTSOURCING BY PRODUCTION SYSTEM
  • Facilities Currently Outsourcing Production by System (2026)
  • Facilities Currently Outsourcing No Production (All Production “In-house”) (2006-2026)
  • Historical Trends in Outsourcing Production
• 7-3 FUTURE OUTSOURCING
  • Biotherapeutic Developers’ Outsourcing, 5-Year Projections, by System (2031)
  • Five Year Projections for Biomanufacturers Outsourcing Some Production
• 7-4 OUTSOURCED ACTIVITIES IN BIOPHARMACEUTICAL MANUFACTURING
  • Biomanufacturers Outsourcing Some Activity Today, 2026
  • Comparison of Biomanufacturers’ Outsourcing, (2010-2026)
  • Increased Outsourced Activities, 24-Month Projections
  • Outsourcing Activities Projected at ‘Significantly Higher Levels’ (2010-2026)
  • Percentage of Activities Outsourced Today, 2026
  • Comparison of Outsourcing Activities (2010-2026)
  • Change in Average Spending on Outsourcing Activities
  • Change in Average Spending on Outsourcing by Facilities (2013-2026)
• 7-5 CRITICAL OUTSOURCING ISSUES
  • Key Attributes CMOs Must Deliver their Clients
  • Selecting a CMO, 2006-2018, 2025-2026
  • Proximity of CMOs to the Client
• 7-6 CMOS’ PROBLEMS WITH THEIR CLIENTS
  • CMOs Problems with Their Clients
• 7-7 COUNTRY SELECTIONS FOR INTERNATIONAL OUTSOURCING (OFFSHORING) OF BIOMANUFACTURING
  • U.S. BioSecure Act Impact on Offshoring (2025 data)
  • USA as Likely for INTERNATIONAL (non-US respondents) Outsourcing
  • Over Next Five Years
  • Possible” Selections for International Outsourcing (Offshoring) of
  • Biomanufacturing, Over Five Years (2016-2026)
  • U.S.-based Companies “Possible” Outsourcing Destinations
  • U.S.-based Companies “Likely” Outsourcing Destinations
  • W. European – based Companies “Possible” Outsourcing Destinations
  • W. European – based Companies “Likely” Outsourcing Destinations
• 7-8 OFFSHORING TRENDS TO LOWER-COST REGIONS
  • 5-Year Projection for Biomanufacturing International Outsourcing /Offshoring to Lower-Cost Regions
  • Five Year Projection for Biomanufacturing International Outsourcing/ Offshoring to Lower-Cost Regions (2011-2026)
  • Five Year Projection for Average Percentages of Biomanufacturing International Outsourcing/Offshoring to Lower-Cost Regions (2011-2026)
  • Outsourcing to New Regions (2020 data)
• 7-9 DISCUSSION: OUTSOURCING AND OFFSHORING
  • Trends and Drivers of Outsourcing
  • Strategic Shifts in Outsourcing
  • Future Projections

CHAPTER 8: DISPOSABLES AND SINGLE-USE SYSTEMS IN BIOPHARMACEUTICAL MANUFACTURING

• KEY TAKEAWAYS
• 8-1 USE OF DISPOSABLES AND SINGLE-USE SYSTEMS
  • Background and Definitions
  • Disposables Applications in Biopharmaceutical Manufacturing
  • Trends in Disposable Applications (2006-2026)
  • Average Annual Growth Rate for Disposables: 20 Years of Market Penetration and Usage
  • 20-Year Average Growth In Disposable Applications, Percentage-Point Gains
  • Disposable Use by Stage of Production/Application
  • Use of Disposables: Biomanufacturers vs. CMOs
• 8-2 LEACHABLES AND EXTRACTABLES
  • Issues Related to Leachables and Extractables (2018 data)
• 8-3 REASONS FOR INCREASING USE OF DISPOSABLES & SINGLE-USE SYSTEMS
  • Single Most Critical Reason for Increasing the Use of Disposables
• 8-4 FACTORS THAT MAY RESTRICT USE OF DISPOSABLES
  • Factors that May Restrict Use of Disposables, 2026
  • Most Important Factors That May Restrict Use of Disposables (2006-2015, 2025-2026)
  • Cell-Culture Problems due to Single-Use Devices (2021 vs. 2022)
  • Recycling of Disposables (2020)
• 8-5 SINGLE-USE ADOPTION ISSUES
  • Evolution of SUS Adoption
  • Single-use Failures by Timeframe and SUS Type
  • Average Weeks Before Failures of Single-use Devices (2023-2026)
• 8-6 NEED FOR SINGLE-USE SENSORS, AND BIOREACTOR ATTRIBUTES
  • Single-Use Sensor Technologies (2012-2017, 2019, 2026)
• 8-7 SATISFACTION WITH SINGLE-USE DEVICE VENDORS (2008-2026)
  • Single-Use Product Vendor Satisfaction Factors (2008-2026)
  • Single-Use Attribute Importance Analysis
  • Single-Use Suppliers’ Issues (2013-2026)
• 8-8 SINGLE-USE OPERATIONS AND TRENDS
  • Percentage of Unit Operations that are Single-Use (2014-2026)
  • Percentage of Single-Use Device Usage in Biomanufacturing
• 8-9 DISCUSSION: SINGLE-USE BIOPROCESSING
  • Single-use Advantages
  • Growth in the Use of Single-use Systems
  • Downstream Single-use Systems Usage
  • CMOs’ Use of Single-use Equipment
  • Modular: The Next Trend after Single-Use?
  • Single-use Equipment Sourcing, Quality Issues, and L&E Testing

CHAPTER 9: DOWNSTREAM PURIFICATION

• KEY TAKEAWAYS
• 9-1 IMPACT OF DOWNSTREAM PROCESSING ON CAPACITY
  • Background and Definitions
  • Impact of Downstream Processing on Overall Capacity
  • Impact of Downstream Processing on Capacity, Biomanufacturers vs. CMOs
  • Impact of Downstream Processing on Capacity, U.S. vs. Western European
  • Biomanufacturers
• 9-2 SPECIFIC PURIFICATION STEP CONSTRAINTS
  • Background on Purification Processes in DSP
  • Changes in Impact on Capacity of Purification Steps (2008-2026)
  • Specific Purification Step Constraints, U.S. vs. Western European Biomanufacturers
• 9-3 DOWNSTREAM PURIFICATION ISSUES
  • Protein A and Alternatives (2022 data)
  • Changes in Perception of Protein A and Alternatives (2009-2017, 2020-2022)
• 9-4 MAB PURIFICATION CAPACITY ESTIMATES
  • Upstream Production Titer vs. Max Capacity
  • Over-building of DSP Capacity to Handle Available Bioreactor Capacity
• 9-5 NEW DOWNSTREAM PROCESSING TECHNOLOGIES
  • New Downstream Processing Solutions (2010-2026)
  • New Downstream Processing Technologies; Biomanufacturers vs. CMOs
  • New Downstream Processing Technologies: U.S. vs. Western Europe
• 9-6 IMPROVEMENTS TO DOWNSTREAM OPERATIONS
  • Drivers of Downstream Processing Bottlenecks
  • Improving Downstream Operations (2011-2019, 2025-2026)
• 9-7 FILL FINISH TRENDS
  • Background and Definitions
  • Fill-Finish Trends (2025)
  • Recent Industry Trends
  • New Technology Implementation in Fill-Finish
  • Outsourcing Fill/Finish
• 9-8 DSP Yield in Primary Process
• 9-9 DISCUSSION: INDUSTRY TRENDS
  • Downstream Processing Solutions
  • Artificial Intelligence
  • Continuous Downstream Bioprocessing
  • Single-use systems
  • Membrane-based Filtration

CHAPTER 10: HIRING, EMPLOYMENT GROWTH, AND TRAINING IN BIOPHARMACEUTICAL MANUFACTURING

• KEY TAKEAWAYS
• Background and Definitions
• 10-1 HIRING TRENDS
  • New Hires in Biopharmaceutical Manufacturing, 2026
  • Trends in New Hires, by Area (2008-2026)
• 10-2 FIVE YEAR TRENDS IN HIRING (2031)
  • New Hires in Biopharmaceutical Manufacturing in Five Years (2031)
• 10-3 HIRING CHALLENGES TODAY
  • Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations, 2026
  • Hiring Difficulties (2010-2026)
  • U.S. and Western Europe Hiring Difficulties
• 10-4 TRAINING IN BIOPHARMACEUTICAL MANUFACTURING
• 10-5 DISCUSSION: STRATEGIES FOR SUCCESSFUL EMPLOYMENT GROWTH
  • Root Causes of the Persistent Talent Gap
  • Rapid Technology Evolution
  • Multidisciplinary Skillset
  • Insufficient Hands-On Training
  • Supply–Demand Mismatch
  • Retention Challenges
  • Strategic Training
  • Attractive Career Paths

CHAPTER 11: NEW METHODS: CONTINUOUS AND PROCESS INTENSIFICATION, CELL AND GENE THERAPIES

• KEY TAKEAWAYS
• INTRODUCTION TO INNOVATIVE BIOPROCESSING
• Background and Definitions
• Benefits of Cell and Gene Therapies
• Benefits of Continuous Bioprocessing and Perfusion
• 11-1 FUTURE ADOPTION OF CONTINUOUS BIOPROCESSING AND PROCESS INTENSIFICATION
  • Future of Continuous Bioprocessing in 2026
  • Future of Continuous Bioprocessing (2018-2025)
• 11-2 PERFUSION OPERATIONS AND CONTINUOUS BIOPROCESSING OPERATIONAL ISSUES
  • Perfusion vs. Batch Fed Bioprocessing – Areas of Much Bigger Concern
  • Perfusion Operation Issues (2010-2014, 2016, 2020, 2023-2025)
  • Evaluating or Considering CBP technologies (Upstream) Over the
  • Next 12 Months (2016-2025)
  • Evaluating or Considering CBP technologies (Downstream) Over the
  • Next 12 Months (2016-2025)
  • Continuous Bioprocessing and Perfusion Trends
• 11-3 AUTOMATION IMPLEMENTATION
  • Demand for Automation
  • Comparison of Implementation Plans (2009-2013, 2022-2026)
  • The Role of Automation in Supporting Continuous Bioprocessing
  • Factor Inhibiting Greater Automation (2026)
• 11-4 ARTIFICIAL INTELLIGENCE (AI) ACTIVITIES
  • Artificial Intelligence in Biomanufacturing
  • Activities Considered Using Artificial Intelligence (AI) in the Next 2 Years (2028)
  • Challenges in Implementation of Artificial Intelligence (2026)
  • Activities Using Artificial Intelligence (AI) Today vs in the Next 2 Years (2028)
• 11-5 CELL AND GENE THERAPY PLATFORMS
  • Cell and Gene Therapy Manufacturing: A Catalyst for Innovation
  • Cell and Gene Therapy Manufacturing Trends
  • Cell Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure (2019-2025)
  • Gene Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure (2019-2025)
  • Advanced Therapy (Cell or Gene Therapy) GMP and Commercial Manufacturing (2020-2025)
  • Cell Therapy Capacity Plans for In-House Bioprocessing Facilities: Five Year Estimates (2023-2025)
  • Cell Therapies Commercial Manufacturing Scales (2021)
  • Gene Therapy Vectors and Products Commercial Manufacturing Scales (2021)
• 11-6 DISCUSSION: FUTURE OF BIOMANUFACTURING
  • Looking Ahead: Industry Considerations and Strategic Imperatives

CHAPTER 12: SUPPLIERS TO BIOPHARMACEUTICAL MANUFACTURING AND LIFE SCIENCES

• KEY TAKEAWAYS
• 12-1 DEMOGRAPHICS
  • Background and Definitions
  • Areas of Involvement
  • Location of Vendor Sales
  • Vendor / Supplier Respondents’ Primary Job
• 12-2 GROWTH RATE OF SALES BY SUPPLIERS
  • Average Annual Vendor Sales Growth Rate
  • Distribution of Growth Rates
  • Average Industry Growth Rate, By Segment
  • Average Industry Growth Rate, By Segment (2007-2026)
  • Supplier Annual Sales, Distribution
• 12-3 BUDGET ISSUES AND PROBLEMS FACED BY INDUSTRY SUPPLIERS
  • Budget planning requires long-term projections for sales, segment growth and other trends
  • Budget Challenges in 2026
  • Vendor Average Pricing Changes
  • Vendor Projected 2026 Pricing Changes
• 12-4 PROBLEMS CLIENTS HAVE WITH THEIR VENDORS
  • Quality of Business Relationships with Suppliers
  • Quality of Business Relationships with Clients
  • Supplier Values:
  • Facility / Customer Values:
  • CMOs Problems with Their Clients (2018 data)
  • Quality Problems Traced to Vendors (2018 data)
• 12-5 IMPACTS OF COVID-19 ON SUPPLIERS’ ACTIVITIES
  • Impact of COVID-19 Pandemic on Vendors, Percent Indicating an INCREASE in COVID-Related Factors (2021-2023)
  • Post COVID Impact on Suppliers: Permanent Changes on Business Operations
  • Biopharma Vendor Business Trends
  • Biopharma Vendor Business Trends (2010-2026)
• 12-6 VENDORS’ PRODUCTS AND SERVICES
  • New Technology Areas in Development by Vendors
  • Suppliers’ R&D Spending/Budgets for New Products/Services
• 12-7 SALES STAFF TRAINING
  • Areas where Training May Help Sales Staff Perform, Trends (2010-2026)
  • Client Demands of Vendors, Service and Support (2012-2026)
• 12-8 BIOPHARMA VENDORS’ FINANCIAL OUTLOOK FOR 2026
• 12-9 CMO PRICING CHANGES FOR BIOPHARMACEUTICAL SERVICES
• 12-10 DISCUSSION: BIOPHARMA SUPPLIERS
  • Vendor and Industry Growth
  • Biopharma Suppliers in Emerging Regions

List of Figures

• Fig 0.1: Area of Primary Involvement in Biopharmaceutical Manufacturing (2010-2026)
• Fig 0.2: Respondents’ Job Responsibilities (2011-2026)
• Fig 0.3: Facility Location, 2026
• Fig 0.4: Facility Location, by Region, 2026
• Fig 0.5: Biopharmaceutical Manufacturing Systems, Trends (2007-2026)
• Fig 0.6: Phase of Development of Surveyed Respondents (2006-2026)
• Fig 0.7: Phase of Development of Surveyed Respondents, U.S. vs. Western Europe (2026)
• Fig 0.8: Distribution of Employees at Facility and Organization, 2026
• Fig 0.9: Distribution of Total Batches Run at Facility in Past 12 Months, by Scale of Production (2026)
• Fig 0.10: Distribution of Largest SINGLE-USE Bioreactor Capacity (2017-2026)
• Fig 0.11: Average SINGLE-USE Bioreactor Volume (Liters) (2017-2026)
• Fig 0.12: Distribution of Largest STAINLESS Bioreactor Capacity (2017-2026)
• Fig 0.13: Average ‘Largest’ Stainless Steel Capacity (L) (2017-2026)
• Fig 1.1: Top 50 Biopharmaceutical Products, Percentage of Total Market Revenue
• Fig 2.1: Numbers of Recombinant and Non-Recombinant Biopharmaceuticals Approved by FDA Since 1982 (1982-2025)
• Fig 2.2: Number of Facilities, both Recombinant and Synthetic (SPPS), Peptide Therapeutics, All Scales, 2026, Percent
• Fig 2.3: Global Capacity for Synthetic (SPPS), Commercial-scale Peptide Therapeutics, 2026, Percent
• Fig 2.4: Factors Creating Future Capacity Constraints, Biomanufacturers vs. CMOs, 2026, Percent
• Fig 3.1: SINGLE Most Important Biomanufacturing Trend or Operational Area (2014-2026)
• Fig 3.2: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months (2018-2026)
• Fig 3.3: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months (Biomanufacturers vs. CMOs), 2026
• Fig 3.4: Operational Changes Due to Recent Global Economics, 2026
• Fig 3.5: Operational Changes Due to Recent Global Economics (2010 - 2012, 2022-2026)
• Fig 3.6: Operational Changes Due to Recent Global Economics; Biomanufacturers vs. CMOs, 2026
• Fig 3.7: Operational Changes Due to Recent Global Economics; U.S. vs. Western Europe, 2026
• Fig 3.8: Biomanufacturers’ Budget Shifts, 2026
• Fig 3.9: Approximate Average Change in Biomanufacturers’ Budgets, 2026
• Fig 3.10: Average Biomanufacturers’ Budget Changes (2009-2026)
• Fig 3.11: New Expenditures Focus Areas, 2026
• Fig 3.12: New Expenditures Focus Areas (2020-2026)
• Fig 3.13: New Product Development-Upstream Focus Areas, 2026
• Fig 3.14: Upstream New Product Development Areas Cited Where Suppliers Should Focus Development Efforts (2010-2026)
• Fig 3.15: Downstream New Product Development Areas Cited Where Suppliers Should Focus Development Efforts, 2026
• Fig 3.16: New Product Development – Downstream Focus Areas (2010-2026)
• Fig 3.17: New Product Development – General Focus Areas, Biomanufacturers & CMOs, 2026
• Fig 3.18: New Product Development – General Focus Areas (2010-2026)
• Fig 3.19: Top 10 New Product Development Areas of Interest: Biomanufacturers vs. CMOs, 2026
• Fig 3.20: Top 10 New Product Development Areas of Interest: U.S. vs. Western Europe vs. ROW, 2026
• Fig 3.21: Factors in Biomanufacturing Performance Creating “Significant” or “Some” Improvements, 2026
• Fig 3.22: Factors in Biomanufacturing Performance Creating “Significant” or “Some” Improvements (2010-2015, 2025-2026)
• Fig 3.23: Factors in Biomanufacturing Performance Creating “Significant” or “Some” Improvements: Biomanufacturers vs. CMOs, 2026
• Fig 3.24: Factors in Biomanufacturing Performance Creating “Significant” or “Some” Improvements: US vs. Western Europe vs. ROW, 2026
• Fig 3.25: Cost-Cutting Changes: Actions Undertaken During “Past 12 Months”Comparing (2011-2016, 2019-2024)
• Fig 3.26: Cost-Cutting Changes, Outsourced Jobs, by Segment, (2011-2016, 2019-2024)
• Fig 3.27: Factors That Will Have the Greatest Impact on REDUCING YOUR COST OF GOODS for Biotherapeutic Products (2020-2024)
• Fig 3.28: Distribution, Average Cost per Gram for PRIMARY Recombinant Protein, 2026
• Fig 3.29: Distribution, Average Cost per Gram for PRIMARY Recombinant Protein (2017-2026)
• Fig 3.30: Biomanufacturing Assay “Areas” Urgently Requiring New, Improved Testing Methods (2011-2015, 2018-2019, 2024, 2026)
• Fig 3.31: Biomanufacturing Assay ‘Areas’ Urgently Requiring New, Improved Testing Methods; Biomanufacturers vs. CMOs, 2026
• Fig 3.32: Biomanufacturing Assay ‘Areas’ Urgently Requiring New, Improved Testing Methods; US vs. Western Europe, 2026
• Fig 3.33: Largest Commercial-Scale Bioreactor Expected in the Next Two Years (2028)
• Fig 3.34: Top Options for Bioreactor Platforms at Commercial Scale, 2024
• Fig 3.35: Top Options for Bioreactor Platforms at Commercial Scale (2021-2024)
• Fig 3.36: Distribution of Largest Single-Use Bioreactor Capacity to Purchase in Next Two Years (2022, 2025-2026)
• Fig 3.37: Distribution of Largest Stainless Steel Bioreactor Capacity to Purchase in Next Two Years (2022, 2025-2026)
• Fig 4.1: Capacity Utilization, By System, 2026
• Fig 4.2: Capacity Utilization, By System (2006-2026)
• Fig 4.3: Change in Capacity Utilization, CAGR (2006-2026)
• Fig 4.4: Capacity Utilization, By System, Biomanufacturers vs. CMOs, 2026
• Fig 4.5: Availability of CMO/CDMO Capacity (2024-2026)
• Fig 4.6: Capacity Utilization, By System, U.S. vs. Western Europe, 2026
• Fig 4.7: Western European vs. US Biomanufacturers’ Average Capacity Utilization (2012-2026)
• Fig 4.8: Current Production Capacity Distribution, Mammalian Cell Culture, 2026
• Fig 4.9: Production Capacity Distribution, Mammalian Cell Culture (2010-2026)
• Fig 4.10: Current Production Capacity Distribution, Microbial Fermentation, 2026
• Fig 4.11: Current Production Capacity Distribution, Microbial Fermentation (2010-2026)
• Fig 4.12: Current Production Capacity Distribution, Cell Therapy, 2026
• Fig 4.13: Production Capacity Distribution, Cell Therapy (2020-2026)
• Fig 4.14: Current Production Capacity Distribution, Gene Therapy, 2026
• Fig 4.15: Production Capacity Distribution, Gene Therapy (2020-2026)
• Fig 4.16: Bioprocessing Concentration, Capacity Data, 2026
• Fig 4.17: Range of Titers for mAbs Obtained at Various Production Scales, Distribution, 2026
• Fig 4.18: Average mAb Titer Trend (2008-2026)
• Fig 5.1: Capacity Constraints, by Stage of Production, 2026
• Fig 5.2: Capacity Constraints ‘Today’ (2004-2026)
• Fig 5.3: Capacity Constraints Trends (2004-2026)
• Fig 5.4: Capacity Constraints, Biomanufacturers vs. CMOs, 2026
• Fig 5.5: Capacity Constraints, U.S. vs. Western Europe, 2026
• Fig 5.6: Expectations of Capacity Constraints by Stage of Production: Five-year Projections (by 2031)
• Fig 5.7: Expectations of Capacity Constraints: Five-year Projections (2004-2026)
• Fig 5.8: Expectations of Capacity Constraints: Five-year Projections (Trend Line) (2004-2026)
• Fig 5.9: Five-year Projections for Capacity Constraints: Biomanufacturers vs. CMOs (2031)
• Fig 5.10: Five-year Projections for Capacity Constraints: U.S. vs. Western Europe (2031)
• Fig 5.11: Factors Creating Future Capacity Constraints in Five Years (2031)
• Fig 5.12A: Factors Creating Future Capacity Constraints in Five Years (2008-2026)
• Fig 5.12B: Factors Creating Future Capacity Constraints in Five Years (2008-2026)
• Fig 5.13: Factors Creating Future Capacity Constraints: Biomanufacturers vs. CMOs, 2026.224
• Fig 5.14: Factors Creating Future Capacity Constraints, U.S. vs. Western Europe Biomanufacturers, 2026
• Fig 5.15: Key Areas to Address to Avoid Capacity Constraints, 2026
• Fig 5.16A: Key Areas to Address to Avoid Capacity Constraints (2006-2026)
• Fig 5.16B: Key areas to Address to Avoid Capacity Constraints (2006-2026)
• Fig 5.17: Key Areas to Address to Avoid Capacity Constraints; Biomanufacturers vs. CMOs, 2026
• Fig 5.18: Key Areas to Address to Avoid Capacity Constraints; U.S. vs. Western Europe, 2026
• Fig 5.19: Average Time (weeks) Between Batch Failures (2009-2026)
• Fig 5.20: Batch Failure Frequency Distribution (2009-2026)
• Fig 5.21: Average Rates of Failure, by Primary Cause, and Phase of Manufacture, 2026
• Fig 5.22: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing (Commercial Manufacture) (2009-2026)
• Fig 5.23: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing (“Clinical” Scale) (2009-2026)
• Fig 5.24: Global Quality Supply Management (2011-2013, 2022-2023)
• Fig 5.25: Global Quality Supply Management, Biomanufacturers vs. CMOs, 2023
• Fig 5.26: Global Quality Supply Management (U.S. vs. W. Europe), 2023
• Fig 5.27: Addressing Supply Chain Security (2023-2026)
• Fig 6.1: Industry Average Planned Production Increase: Five Year Estimates (2031)
• Fig 6.2: Planned Future Capacity Expansion: Five Year Estimates (2009–2031)
• Fig 6.3: Percentage of Respondents Projecting Production Increases over 100%: Five Year Trend (2031)
• Fig 6.4: Average Planned Future Capacity Expansion: Five-Year Estimates, Biomanufacturers vs. CMOs, by 2031
• Fig 6.5: Average Planned Future Capacity Expansion: Five-Year Estimates, U.S. vs. Western Europe, by 2031
• Fig 7.1: Current Percent Production Outsourced; by System, 2026
• Fig 7.2: Biopharmaceutical Manufacturing Facilities Outsourcing NO Production (2006-2026)
• Fig 7.3: Current Percent Respondents Outsourcing up to 50% of Production, by System, 2009-2026
• Fig 7.4: Biomanufacturers’ Outsourcing, Five Year Projections, by System (2031)
• Fig 7.5: Five-year Projections: % Biotherapeutic Manufacturers Planning to Outsource at Least Some Production; Projections made 2007-2026
• Fig 7.6: Biomanufacturers Outsourcing Some Activity Today, 2026
• Fig 7.7A: Percent of Biomanufacturers Outsourcing at Least Some Activity Today (2010-2026)
• Fig 7.7B: Percent of Biomanufacturers Outsourcing at Least Some Activity Today (2010-2026)
• Fig 7.8: Outsourcing Activities Projected to be Done at ‘Significantly Higher Levels’ in 2 Years (2026)
• Fig 7.9A: Outsourcing Activities Projected to be Done at ‘Significantly Higher Levels’ in 2 Years, Trends (2010-2026)
• Fig 7.9B: Outsourcing Activities Projected to be Done at ‘Significantly Higher Levels’ in 2 Years, Trends (2010-2026)
• Fig 7.10: Estimated Average Percentage of Activity Outsourced, by Facilities Today, 2026
• Fig 7.11A: Estimated Average Percent of Activity Outsourced by Facilities (2010-2026)
• Fig 7.11B: Estimated Average Percent of Activity Outsourced by Facilities (2010-2026)
• Fig 7.12: Change in Spending on Outsourcing for R&D or Manufacturing, Next 12 months (2012-2026)
• Fig 7.13: Average Change in Outsourcing Spending by Facilities, (2013-2026), with 2-year moving average
• Fig 7.14: Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations, 2026
• Fig 7.15: ‘Very Important’ Issues for Considering Outsourcing to CMOs, Percentage Point Shifts Over Time (2006-2018, 2025-2026)
• Fig 7.16: U.S. BioSecure Act INFLUENCE Choice of Commercial-scale Contract Manufacturers (CMOs) or Outsourcing Vendors, 2025
• Fig 7.17: Percent Indicating USA as Likely or Strong Likely Selection for INTERNATIONAL (non-US respondents) Outsourcing Over Next Five Years, 2009-2026 (targeting 2031)
• Fig 7.18: Country Selections for International Outsourcing/Capacity Expansion Over Next Five Years, 2031
• Fig 7.19A: Country Selections for “Possible” International Outsourcing/Capacity Expansion Over Next Five Years (2016-2026)
• Fig 7.19B: Country Selections for “Possible” International Outsourcing/Capacity Expansion Over Next Five Years (2016-2026)
• Fig 7.20A: U.S. Respondents Considering International Country as “Possible”International Outsourcing Destination, over Next Five Years (2009-2026)
• Fig 7.20B: U.S. Respondents Considering International Country as “Possible”International Outsourcing Destination, over Next Five Years (2009-2026)
• Fig 7.21: U.S. Respondents Considering Country as “Strong likelihood” or “Likelihood” as Outsourced Capacity Destination, Next Five Years (2031)
• Fig 7.22A: Western European Respondents Considering Country as “Possible”Outsourcing Destination, Next Five Years, (2009-2026)
• Fig 7.22B: Western European Respondents Considering Country as “Possible”Outsourcing Destination, Next Five Years, (2009-2026)
• Fig 7.23: Western European Respondents Considering Country as ‘Strong likelihood’ or ‘Likelihood’ as Outsourced Capacity Destination, over Next Five Years (2031)
• Fig 7.24: Percent of Biomanufacturing Operations Offshored (International Outsourcing) to Lower-Cost Regions Within Five Years (2031)
• Fig 7.25: Percent of Biomanufacturers Performing at Least “Some” International Outsourcing/Offshoring to Lower-Cost Regions Over Next Five Years (2011-2026)
• Fig 7.26: Estimated Average Percentage of Operations to be Done as International Outsourcing/ Offshoring to Lower-Cost Regions During Next Five Years (2011-2026)
• Fig 8.1: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture, 2026
• Fig 8.2A: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture (2006-2026)
• Fig 8.2B: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture (2006-2026)
• Fig 8.3: Average Annual Growth Rate, Disposables (2006-2026)
• Fig 8.4: 20-Year Percentage-Point Increase in First Usage of Disposables (2006-2026)
• Fig 8.5: Usage of Disposables in Biomanufacturing by Stage of Manufacture (R&D–Commercial), 2026
• Fig 8.6: Usage of Disposables in Biopharmaceutical Manufacturing: Biomanufacturers vs. CMOs, 2026
• Fig 8.7: Reasons for Increasing Use of Disposable System Components, 2026
• Fig 8.8: Reasons for Increasing Use of Disposable System Components, 2006-2015, 2026
• Fig 8.9: Reasons for Restricting Use of Disposables, 2026
• Fig 8.10: Factors Restricting Use of Disposables (2006-2015, 2025-2026)
• Fig 8.11: Time Since Facility’s Last Failure of Single-use Devices and Equipment, 2026
• Fig 8.12: Average Weeks Before Failure of Single-use Devices and Equipment (2023-2026)
• Fig 8.13: Need for Improved Single-Use Sensors, 2012-2017, 2019, 2026
• Fig 8.14: Single-Use Product Vendor Satisfaction Factors (2008-2026)
• Fig 8.15: Importance of Single-Use Product Attributes vs. Level of Vendor Satisfaction, 2026
• Fig 8.16: Percentage Point Gap between Importance of SUS Product Attributes and Level of Satisfaction (2013-2026)
• Fig 8.17: Estimated Percentage of Facilities’ Unit Operations that Are “Single-Use”(2014-2026)
• Fig 8.18: Distribution of Responses, % Single-Use Devices in Biomanufacturing, 2026
• Fig 9.1: Impact of Downstream Processing on Overall Capacity (2008-2026)
• Fig 9.2: Impact of Downstream Processing on Overall Capacity; Biomanufacturers vs. CMOs, 2026
• Fig 9.3: Impact of Downstream Processing on Overall Capacity; U.S. vs. Western Europe, 2026
• Fig 9.4: Impact on Capacity of Depth, Chromatography and UF Purification Steps, 2026
• Fig 9.5: Impact on Capacity of Purification Steps: Experiencing at ‘Significant’ or ‘Severe’ Constraints (2008-2026)
• Fig 9.6: Impact on Capacity of Purification Steps, U.S. vs. Western Europe, 2026
• Fig 9.7: Issues Regarding Protein A Usage (2022)
• Fig 9.8: Issues Regarding Protein A Usage (2009-2017, 2020-2022)
• Fig 9.9: mAb Operations: Upstream Production Titer (Distribution of Responses (2014 -2016, 2018-2026)
• Fig 9.10: Bioreactor Output at which DOWNSTREAM Purification Train Becomes Bottlenecked (2014-2016, 2018-2026)
• Fig 9.11: New Downstream Processing Solutions, 2026
• Fig 9.12A: New Downstream Processing Solutions Comparison (2010-2026)
• Fig 9.12B: New Downstream Processing Solutions Comparison (2010-2026)
• Fig 9.13: New Downstream Processing Solutions: Biomanufacturers vs. CMOs, 2026
• Fig 9.14: New Downstream Processing Solutions: U.S. vs. Western Europe, 2026
• Fig 9.15: Improving Downstream Operations, (2011-2019, 2025-2026)
• Fig 9.16: Most Important Fill-Finish Trends (2015-2017, 2025)
• Fig 9.17: Novel Fill-Finish Technology Implementation Plans within 24 Months (2015-2017, 2025)
• Fig 9.18: Average Downstream Processing (DSP) Yield
• Fig 9.19: Percent Point Change in DSP Yield - Past 2 Years vs Today
• Fig 10.1: New Hires in Biopharmaceutical Manufacturing, 2026
• Fig 10.2: Estimated % of Hiring in Biopharmaceutical Manufacturing, by Operational Area, (2008-2026)
• Fig 10.3: New Hires in Biopharmaceutical Manufacturing in Five Years (2031)
• Fig 10.4: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations, 2026
• Fig 10.5A: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations (2010-2026)
• Fig 10.5B: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations (2010-2026)
• Fig 10.6: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations, U.S. vs. Western Europe, 2026
• Fig 10.7: Skills or Hands-On Training Required in NEW HIRES in GMP Bioprocessing (2023-2026)
• Fig 11.1: Future of Continuous Bioprocessing and Process Intensification, 2026
• Fig 11.2: Future of Continuous Bioprocessing and Process Intensification (2018-2025)
• Fig 11.3: Concerns Over Perfusion Processes vs. Batch-fed Processes in Bioprocessing, 2025
• Fig 11.4: Perfusion Operations Issues (2011 – 2014, 2016, 2020, 2023-2025)
• Fig 11.5: Facilities Evaluating CBP Technologies Over the Next 12 Months (Upstream) (2016-2025)
• Fig 11.6: Facilities Evaluating CBP Technologies Over Next 12 months (Downstream) (2016-2025)
• Fig 11.7: Automation Technologies Implemented/to be Implemented in 2026
• Fig 11.8: Automation Technologies to be Implemented; Comparing (2009 - 2013, 2022-2026)
• Fig 11.9: Most Common Factors Inhibiting Greater AUTOMATION of your Facility’s Bioprocessing Today, 2026
• Fig 11.10: Bioprocessing Activities Using AI in Next 2 Years (2028)
• Fig 11.11: Biggest Problems/Hurdles to Facility’s Implementing Artificial Intelligence (AI) tools in Bioprocessing, 2026
• Fig 11.12: Respondents Currently Using or Considering Artificial Intelligence (AI) Application/Approaches at Bioprocessing Facility: TODAY vs 2 YEARS:
• Fig 11.13: Most Needed Cell Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure (2019-2025)
• Fig 11.14: Most Needed Gene Therapy Manufacturing Improvements, Systems, Platforms and Infrastructure (2019-2025)
• Fig 11.15: Cell or Gene Therapy Plans for GMP and Commercial Manufacturing (2020-2025)
• Fig 11.16: Cell Therapy Capacity Plans for In-House Bioprocessing Facilities Next Five Years (2030)
• Fig 12.1: Area of Biopharmaceutical Involvement, Vendor, 2026
• Fig 12.2: Area of Biopharmaceutical Involvement, Vendor (2010-2026)
• Fig 12.3A: In Which Geographic Regions/Countries Does Your Company Currently Actively Sell (2008-2026)
• Fig 12.3B: In Which Geographic Regions/Countries Does Your Company Currently Actively Sell (2008-2026)
• Fig 12.4: Vendor Respondents’ Primary Job Function, 2026
• Fig 12.5: Average Annual Vendor Sales Growth Rate (2007-2026)
• Fig 12.6: Biopharmaceutical Supply Market Segment Sales Growth Distribution, 2026
• Fig 12.7: Average Annual Vendor Segment Sales Growth Rates, 2026
• Fig 12.8: Average Annual Vendor Sales Growth Rate, by Segment (2007-2026)
• Fig 12.9: Vendors’ Approx. Annual Sales to Biopharmaceutical Segment % (2012-2026)
• Fig 12.10: Vendors’ Average Budget Change, 2026
• Fig 12.11: Vendors’ Average Budget Change, Summary (2009-2026)
• Fig 12.12: Vendors’ Average Pricing Changes, Last Year (2026)
• Fig 12.13: Vendors’ Average Pricing Changes, 2009-2025 Actual and 2026 Projected
• Fig 12.14: ‘Most Important’ Factors to Measure The ‘Quality’ of Business Relationships with Suppliers, BIOMANUFACTURERS’ PERSPECTIVE (2022-2026)
• Fig 12.15: ‘Most Important’ Factors to Measure The ‘Quality’ of Business Relationships with Suppliers, SUPPLIERS vs. FACILITIES (2022-2026)
• Fig 12.16: Impact of COVID-19 Pandemic on Vendors, Percent Indicating an INCREASE in COVID- Related Factors (2021-2023)
• Fig 12.17: Permanent Changes caused by Pandemic on Your Business Operations (2024 vs 2025)
• Fig 12.18: Biopharma Business and Marketing Plans, 2026
• Fig 12.19: Biopharma Business and Marketing Plans (2010-2026)
• Fig 12.20A: Top New Technologies or New Product Development Areas (2011-2026)
• Fig 12.20B: Top New Technologies or New Product Development Areas (2011-2026)
• Fig 12.20C: Top New Technologies or New Product Development Areas (2011-2026)
• Fig 12.21: R&D Spending/Budgets for New Products/Services, 2026
• Fig 12.22: Approximate Average Annual R&D Spending/Budget for New Products/Services (2017-2026)
• Fig 12.23: Areas Where Training is Considered as Needed or Very Much Needed, All Vendor Respondents (2010-2026)
• Fig 12.24: Client Demands of Vendors, Service and Support (2012-2026)
• Fig 12.25: Vendors Views of Financial (Sales) Outlook for Next Year (2011-2026)
• Fig 12.26: Average CMOs Service Price Shifts over the “Past 12 Mo.(2010-2012, 2018-2026)
• Fig 12.27: CMOs Service Price Shifts Over Past 12 Months, Distribution, 2026

List of Tables

• Table 0.1: Areas of Biopharmaceutical Manufacturing Operations (2018-2026)
• Table 1.1: Worldwide Revenue of Biopharmaceuticals ($USD billions)
• Table 1.2: Number of Biopharmaceutical Products in U.S. and European Markets, 2025-2026
• Table 1.3: Global Market for Top 50 Biopharma Products in (2024-2025, $USD Million)
• Table 1.4: Top 50 Biopharmaceutical Products vs Total Market Size (%) $million
• Table 1.5: Bioprocess Related Industry Expenditures on Manufacture of Biotherapeutics (estimated $USD, billions)
• Table 1.6: Summary of Worldwide Biopharmaceutical Revenue Growth by Product Class, 2007 and 2025
• Table 2.1: Biopharmaceuticals Approved by FDA, 2025
• Table 2.2: Biopharmaceuticals Approved by FDA in 2026 (Till May’2026)
• Table 2.3: Facility Takeovers Involving CDMOs
• Table 2.4: M&A Transactions Involving CDMOs
• Table 3.1A: Areas of Significant Projected Budget Percentage Increases for Biomanufacturing (2011-2026)
• Table 3.1B: Areas of Significant Projected Budget Percentage Increases for Biomanufacturing (2011-2026)
• Table 4.1: Regional Distribution of Total Worldwide Average Capacity*
• Table 4.2: Leading Biopharma Company Capacity Estimates, 2026
• Table 4.3: Bioprocessing CMOs, Their Number of Facilities Worldwide and Estimated Total Capacity*
• Table 4.4: Compound Annual Change in mAb Titers (2008-2026)
• Table 5.1: Severe or Significant Capacity Constraints, by Stage of Production (2009-2026)
• Table 5.2: Severe and Significant Capacity Constraints Today, U.S. vs. W. Europe (2010-2026)
• Table 5.3: Average Rates of Failure, by Primary Cause, and Phase of Manufacture (2017-2026)
• Table 6.1: U.S. Biomanufacturers’ Five-Year Projected Capacity Increases, by System (2008-2026)
• Table 6.2: Western European Biomanufacturers’ Five-Year Projected Capacity Increases, by System (2008-2026)
• Table 7.1: Percentage of U.S.-based Respondents Indicating Country as a ‘Strong likelihood’ or ‘Likelihood’ as Outsourcing Destination (2009-2026)
• Table 7.2: Percent of Western European-based Respondents Indicating International Countries as a ‘Strong likelihood’ or ‘Likelihood’ as Outsourcing Destination (2011-2026)
• Table 9.1: Percent of Biomanufacturers vs. CMO Facilities Experiencing “Serious” or “Some” Capacity Problems due to Downstream Processing (2008-2026)
• Table 9.2: Percent of U.S. vs. Western Europe Facilities Experiencing ‘Serious’ Capacity Problems due to Downstream Processing (2009-2026)
• Table 9.3: Percent U.S. vs. Western Europe Facilities Not Expecting to see Bottlenecks due to Downstream Processing (2008-2026)
• Table 9.4: Upstream Production Titer vs. Max Capacity (2018-2026)
• Table 12.1: Average Vendor Sales and Technical Training Days (2011-2013, 2019-2021)