サマリー

世界の生物製剤受託製造市場は、2023年には190億米ドルに達すると推定され、予測期間2023-2035年の年平均成長率は9％と予測されている。

バイオ医薬品CMO業界の代名詞である生物製剤受託製造部門は、強固なダイナミズムと急速な拡大を示し、新しい治療法を開拓する研究開発に専念する様々な事業体から大きな関心を集めている。こうした画期的なイノベーションは、抗体薬物複合体、バイオシミラー、細胞・遺伝子治療など、さまざまな進歩を包含している。この急成長する市場には、250を超える生物学的製剤とワクチンが世界中に広まっている。注目すべきは、生物学的製剤は従来の低分子製剤に比べて、低分子製剤開発で陥りがちな標的外毒性が少ないため、成功率が高いということである。

生物学的製剤への熱意の高まりは、医薬品業界における投資トレンドに明らかな変化をもたらし、低分子医薬品から生物学的製剤へと移行している。この転換は、絶え間ない科学の進歩やFDA承認の生物製剤数の増加と相まって、生物製剤時代の到来を意味している。バイオ医薬品は製薬業界を根本的に再定義し、徐々に医療の主流に欠かせない要素へと進化していくと予想される。

これらのサービス・プロバイダーは、バイオプロセスの開発と最適化を含む包括的なソリューションを提供し、業務スケジュールを迅速化し、複雑な生物学的製剤の製造に伴う多額のコストを軽減することを目指している。メーカーによっては、最先端の設備と専門知識を活用するため、特定の業務をアウトソーシングすることを選択する場合もある。特に、製造委託会社がソフトウェア主導のロボット工学などの最先端技術を採用することで、製造プロセスを高度化し、手作業に伴うリスクを最小限に抑えることができる。この分野でアウトソーシングが実行可能で有利なビジネスモデルとして支持されるにつれ、生物製剤の受託製造の世界市場は予測期間中に著しい成長を遂げるものと思われる。

レポート対象範囲
 本レポートでは、提供するサービスの種類、製造する生物製剤の種類、使用する発現系の種類、事業規模、企業規模、主要地域に基づいて生物製剤受託製造市場を掘り下げています。
 市場成長に影響を与える促進要因、阻害要因、機会、課題などの要因を分析します。
 市場内の潜在的な優位性と障害を評価し、トッププレイヤー間の競争状況についての洞察を提供します。
 主要5地域における市場セグメントの収益予測。
 生物製剤受託製造市場の現状と短期的・長期的に予想される進化に関する主要な調査洞察を詳述したエグゼクティブサマリー。
 バイオ医薬品、製造プロセス、発現システム、この業界におけるアウトソーシングの意義について紹介。
 受託製造企業の現在の市場状況を調査し、そのサービス、生物学的製剤の種類、事業規模、発現システム、地理的拠点を評価する。
 各地域の主要受託製造企業の詳細なプロフィールを掲載し、そのサービス、施設、最近の開発、将来の展望にスポットライトを当てている。
 バイオシミラー市場に関するケーススタディでは、製造受託機関（CMO）のビジネスチャンスを探り、低分子医薬品と高分子医薬品の特性や製造プロセスを比較する。
 大手製薬会社の製造イニシアチブと提携の評価。生物製剤の受託製造に影響を与えるトップ企業のイニシアチブ、提携、トレンド、活動をレビュー。
 最近の提携、合併、買収、およびそれらが生物製剤受託製造業界に及ぼす影響の分析。
 生物製剤製造における拡大イニシアチブ、資金投資、技術進歩のレビュー。
 患者数、投与量、強度に基づく主要生物製剤の製造能力および年間需要の推定。
 2023-2043年の企業規模に基づくCMOの総所有コストの評価。
 SWOT分析による業界動向、推進要因、課題、およびそれらがバイオ医薬品業界に与える影響の検討。
 バイオ医薬品における仮想ビジネスモデルの役割について、その利点、リスク、アウトソーシング業務への影響などを探る。
 予測される市場成長、機会、予測期間中に生物製剤受託製造業界を形成すると思われるトレンドについての考察。

主要市場企業
 AGC Biologics
 ベーリンガーインゲルハイム
 キャタレント
 セル セラピー
 チャールズ・リバー・ラボラトリーズ
 富士フイルムジオシンスバイオテクノロジーズ
 KBI バイオファーマ
 ケムウェル・バイオファーマ
 ロンザ
 Miltenyi Biotec
 ミナリス再生医療
 サムスンバイオロジクス
 サンド
 ベッターファーマ
 無錫生物製剤

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目次

1 PREFACE
1.1. Biopharmaceutical Contract Manufacturing Market Overview
1.2. Key Market Insights
1.3. Scope of the Report
1.4. Research Methodology
1.5. Key Questions Answered
1.6. Chapter Outlines

2 RESEARCH METHODOLOGY
2.1. Chapter Overview
2.2. Research Assumptions
2.3. Project Methodology
2.4. Forecast Methodology
2.5. Robust Quality Control
2.6. Key Market Segmentations

2.7. Key Considerations
2.7.1. Demographics
2.7.2. Economic Factors
2.7.3. Government Regulations
2.7.4. Supply Chain
2.7.5. COVID Impact / Related Factors
2.7.6. Market Access
2.7.7. Healthcare Policies
2.7.8. Industry Consolidation

3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS
3.1. Chapter Overview
3.2. Market Dynamics

3.2.1. Time Period
3.2.1.1. Historical Trends
3.2.1.2. Current and Forecasted Estimates

3.2.2. Currency Coverage
3.2.2.1. Overview of Major Currencies Affecting the Market
3.2.2.2. Impact of Currency Fluctuations on the Industry

3.2.3. Foreign Exchange Impact
3.2.3.1. Evaluation of Foreign Exchange Rates and Their Impact on Market
3.2.3.2. Strategies for Mitigating Foreign Exchange Risk

3.2.4. Recession
3.2.4.1. Historical Analysis of Past Recessions and Lessons Learnt
3.2.4.2. Assessment of Current Economic Conditions and Potential Impact on the Market

3.2.5. Inflation
3.2.5.1. Measurement and Analysis of Inflationary Pressures in the Economy
3.2.5.2. Potential Impact of Inflation on the Market Evolution

4 EXECUTIVE SUMMARY

5 INTRODUCTION
5.1. Chapter Overview
5.2. Overview of Biopharmaceuticals
5.3. Expression Systems for Biopharmaceuticals
5.3.1. Insect Expression Systems
5.3.2. Mammalian Expression Systems
5.3.3. Microbial Expression Systems
5.3.3.1. Bacterial Expression Systems
5.3.3.2. Fungal Expression Systems
5.3.3.3. Yeast Expression Systems
5.3.4. Plant Expression Systems
5.3.5. Mammalian versus Microbial Expression Systems

5.4. Manufacturing Process of Biopharmaceuticals
5.4.1. Upstream Processing
5.4.2. Fermentation
5.4.3. Downstream Processing

5.5. Overview of Contract Manufacturing
5.6. Need for Outsourcing Biopharmaceutical Manufacturing Operations
5.6.1. Commonly Outsourced Manufacturing Operations for Biopharmaceuticals
5.6.2. Advantages of Outsourcing Biopharmaceutical Manufacturing Operations
5.6.3. Risks and Challenges Associated with Outsourcing Biopharmaceutical Manufacturing Operations
5.7. Key Considerations While Selecting a Contract Manufacturing Partner
5.8. Future Perspectives

6 MARKET LANDSCAPE
6.1. Chapter Overview
6.2. Biopharmaceutical Contract Manufacturers: Overall Market Landscape
6.2.1. Analysis by Year of Establishment
6.2.2. Analysis by Company Size
6.2.3. Analysis by Location of Headquarters
6.2.4. Analysis by Type of Service Offered
6.2.5. Analysis by Type of Biologic Manufactured
6.2.6. Analysis by Scale of Operation
6.2.7. Analysis by Type of Expression System Used
6.2.8. Analysis by Type of Bioreactor Used
6.2.9. Analysis by Mode of Operation of Bioreactor

7 REGIONAL CAPABILITY ANALYSIS
7.1. Chapter Overview
7.2. Key Assumptions and Parameter
7.3. Overview of Biopharmaceutical Contract Manufacturing Facilities
7.3.1. Analysis by Type of Service Offered
7.3.2. Analysis by Scale of Operation
7.4. Regional Capability Analysis: Biopharmaceutical Contract Manufacturing Facilities in North America
7.5. Regional Capability Analysis: Biopharmaceutical Contract Manufacturing Facilities in Europe
7.6. Regional Capability Analysis: Biopharmaceutical Contract Manufacturing Facilities in Asia-Pacific
7.7. Regional Capability Analysis: Biopharmaceutical Contract Manufacturing Facilities in Rest of the World

8 BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN NORTH AMERICA
8.1. Chapter Overview
8.2. Biopharmaceutical Contract Manufacturing in the US: Regulatory Scenario
8.3. Leading Biopharmaceutical CMOs in North America

8.3.1. AGC Biologics
8.3.1.1. Company Overview
8.3.1.2. Service Portfolio
8.3.1.2.1. Process Development
8.3.1.2.2. cGMP Manufacturing
8.3.1.2.3. Quality and Regulatory Services
8.3.1.2.4. Process Validation
8.3.1.3. Financial Information
8.3.1.4. Manufacturing Facilities
8.3.1.5. Recent Developments and Future Outlook
8.3.2. Catalent
8.3.2.1. Company Overview
8.3.2.2. Service Portfolio
8.3.2.2.1. Cell Line Development
8.3.2.2.2. Biomanufacturing
8.3.2.2.3. ADCs and Bioconjugates Manufacturing
8.3.2.2.4. Biosimilars Development and Manufacturing
8.3.2.2.5. Fill / Finish Solutions and Delivery Services
8.3.2.2.6. Analytical Services
8.3.2.3. Clinical Supply Services
8.3.2.4. Financial Information
8.3.2.5. Manufacturing Facilities
8.3.2.6. Recent Developments and Future Outlook

8.3.3. FUJIFILM Diosynth Biotechnologies
8.3.3.1. Company Overview
8.3.3.2. Service Portfolio
8.3.3.2.1. Strain Development
8.3.3.2.2. Process Development
8.3.3.2.3. cGMP Manufacturing
8.3.3.2.4. Analytical Solutions
8.3.3.3. Financial Information
8.3.3.4. Manufacturing Facilities
8.3.3.5. Recent Developments and Future Outlook

8.3.4. KBI Biopharma
8.3.4.1. Company Overview
8.3.4.2. Service Portfolio
8.3.4.2.1. Process Development
8.3.4.2.2. Analytical Development
8.3.4.2.3. GMP Manufacturing
8.3.4.2.4. Clinical Cell Therapy Support
8.3.4.3. Manufacturing Facilities
8.3.4.4. Recent Developments and Future Outlook

8.3.5. Charles River Laboratories
8.3.5.1 Company Overview
8.3.5.2. Service Portfolio
8.3.5.2.1. Cell Sourcing
8.3.5.2.2. Cell and Gene Therapy Solutions
8.3.5.2.3. Biologics Testing Solutions
8.3.5.2.4. Avian Vaccine Services
8.3.5.2.5. QC Microbial Solutions
8.3.5.2.6. Scientific and Regulatory Advisory Services
8.3.5.3. Financial Information
8.3.5.4. Manufacturing Facilities
8.3.5.5. Recent Developments and Future Outlook

8.4. Other Leading Biopharmaceutical CMOs in North America
8.4.1. Cytiva
8.4.1.1. Company Overview
8.4.2. Patheon
8.4.2.1. Company Overview
8.4.3 Piramal Pharma Solutions
8.4.3.1. Company Overview

9 BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN EUROPE
9.1. Chapter Overview
9.2. Biopharmaceutical Contract Manufacturing in Europe: Regulatory Scenario
9.2.1. EMA’s cGMP Regulations

9.3. Leading Biopharmaceutical CMOs in Europe

9.3.1. Boehringer Ingelheim (BioXcellence)
9.3.1.1. Company Overview
9.3.1.2. Service Portfolio
9.3.1.2.1. Process Development
9.3.1.2.1.1. Expression Systems
9.3.1.2.1.2. Upstream Technology
9.3.1.2.1.3. Downstream Technology
9.3.1.2.1.4. Other Process Development Services
9.3.1.2.2. Quality Assurance
9.3.1.2.3. Fill / Finish Services
9.3.1.3. Financial Information
9.3.1.4. Manufacturing Facilities
9.3.1.5. Recent Developments and Future Outlook

9.3.2. Lonza
9.3.2.1. Company Overview
9.3.2.2. Service Portfolio
9.3.2.3. Manufacturing Services
9.3.2.4. Financial Information
9.3.2.5. Manufacturing Facilities
9.3.2.6. Recent Developments and Future Outlook

9.3.3. Sandoz
9.3.3.1. Company Overview
9.3.3.2. Service Portfolio
9.3.3.3. Financial Information
9.3.3.4. Manufacturing Facilities
9.3.3.5. Recent Developments and Future Outlook

9.3.4. Vetter Pharma
9.3.4.1. Company Overview
9.3.4.2. Service Portfolio
9.3.4.3. Manufacturing Facilities
9.3.4.4. Recent Developments and Future Outlook

9.3.5. Miltenyi Biotec
9.3.5.1. Company Overview
9.3.5.2. Service Portfolio
9.3.5.3. Manufacturing Facilities
9.3.5.4. Recent Developments and Future Outlook
9.4. Other Leading Biopharmaceutical CMOs in Europe
9.4.1 Novasep
9.4.1.1. Company Overview

9.4.2 Olon
9.4.2.1. Company Overview
9.4.3 Rentschler Biopharma
9.4.3.1. Company Overview

10 BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN ASIA-PACIFIC AND REST OF THE WORLD
10.1. Chapter Overview
10.2. Biopharmaceutical Contract Manufacturing in China
10.2.1. Biopharmaceutical Contract Manufacturing in China: Regulatory Scenario
10.3. Leading Biopharmaceutical CMOs in China
10.3.1. WuXi Biologics
10.3.1.1. Company Overview
10.3.1.2. Service Portfolio
10.3.1.2.1. Discovery Services
10.3.1.2.2. Development Services
10.3.1.2.3. Testing Services
10.3.1.2.4. Clinical Manufacturing Services
10.3.1.3. Financial Information
10.3.1.4. Manufacturing Facilities
10.3.1.5. Recent Developments and Future Outlook

10.4. Biopharmaceutical Contract Manufacturing in India
10.4.1. Biopharmaceutical Contract Manufacturing in India: Regulatory Scenario

10.5. Leading Biopharmaceutical CMOs in India
10.5.1. Kemwell Biopharma
10.5.1.1. Company Overview
10.5.1.2. Service Portfolio
10.5.1.2.1. Development Services for Biopharmaceuticals
10.5.1.2.2. Manufacturing Services for Biopharmaceuticals
10.5.1.3. Manufacturing Facilities
10.5.1.4. Recent Developments and Future Outlook
10.6. Biopharmaceutical Contract Manufacturing in Japan
10.6.1. Biopharmaceutical Contract Manufacturing in Japan: Regulatory Scenario
10.7. Leading Biopharmaceutical CMOs in Japan
10.7.1. Minaris Regenerative Medicine
10.7.1.1. Company Overview
10.7.1.2. Service Portfolio
10.7.1.2.1. Manufacturing Development Services
10.7.1.2.2. GMP Manufacturing
10.7.1.3. Manufacturing Facilities
10.7.1.4. Recent Developments and Future Outlook
10.8. Biopharmaceutical Contract Manufacturing in South Korea
10.8.1. Biopharmaceutical Contract Manufacturing in South Korea: Regulatory Scenario

10.9. Leading Biopharmaceutical CMOs in South Korea
10.9.2. Samsung Biologics
10.9.2.1. Company Overview
10.9.2.2. Service Portfolio
10.9.2.2.1. Process Development
10.9.2.2.2. Analytical Services
10.9.2.2.3. cGMP Manufacturing Services
10.9.2.2.4. Aseptic Fill / Finish Services
10.9.2.2.5. Quality Services
10.9.2.3. Financial Information
10.9.2.4. Manufacturing Facilities
10.9.2.5. Recent Developments and Future Outlook

10.10. Biopharmaceutical Contract Manufacturing in Australia
10.10.1. Biopharmaceutical Contract Manufacturing in Australia: Regulatory Scenario

10.11. Leading Biopharmaceutical CMOs in Australia
10.11.1. Cell Therapies
10.11.1.1. Company Overview
10.11.1.2. Service Portfolio
10.11.1.3. Manufacturing Facilities
10.11.1.4. Recent Developments and Future Outlook

10.12. Other Leading Biopharmaceutical CMOs in Asia-Pacific and Rest of the World
10.12.1 AcuraBio (Formerly Known as Luina Bio)
10.12.1.1. Company Overview
10.12.2 Celltrion
10.12.2.1. Company Overview
10.12.3 Takara Bio
10.12.3.1. Company Overview

11 NICHE BIOPHARMACEUTICAL SECTORS
11.1. Chapter Overview
11.2. Bispecific Antibodies
11.2.1. Approved and Clinical Bispecific Antibody Therapeutics: Overall Market Landscape
11.2.2. Bispecific Antibodies: Pipeline Analysis
11.2.2.1. Analysis by Phase of Development
11.2.2.2. Analysis by Target Indication
11.2.3. Bispecific Antibody Therapeutics: Technology Platforms
11.2.4. Key Considerations for Manufacturing and Associated Challenges
11.2.5. Role of CMOs in Offering Services for Bispecific Antibodies
11.2.5.1. CMOs Offering Services for Bispecific Antibodies

11.3. Antibody Drug Conjugates (ADCs)
11.3.1. Components of ADCs
11.3.1.1. Antibody
11.3.1.2. Cytotoxin
11.3.1.3. Linker
11.3.2. Antibody Drug Conjugates (ADCs): Pipeline Analysis
11.3.2.1. Analysis by Status of Development
11.3.2.2. Analysis by Target Disease Indication
11.3.2.3. Most Active Players: Analysis by Number of Therapies
11.3.3. Antibody Drug Conjugate Developers
11.3.4. Manufacturing Process

11.4. Cell Therapies
11.4.5. Technical Challenges Related to Antibody Drug Conjugates Manufacturing
11.4.6. Role of CMOs in Offering Services for ADCs
11.4.6.1. CMOs Offering Services for ADCs
11.4.1. Cell Therapies: Overall Market Landscape
11.4.2. Overview of Cell Therapy Manufacturing
11.4.2.1. Cell Therapy Manufacturing Models
11.4.2.1.1. Centralized Manufacturing
11.4.2.1.2. Decentralized Manufacturing
11.4.3. Key Challenges for Manufacturing Cell Therapies
11.4.4. Key Factors Impacting Cell Therapy Manufacturing
11.4.4.1. Characterization
11.4.4.2. Cost of Goods
11.4.4.3. Automation of Cell Therapy Manufacturing
11.4.5 Cell Therapies: Pipeline Analysis
11.4.5.1 Analysis by Type of Cell Manufactured
11.4.6. Stem Cell Therapies: Analysis by Phase of Development
11.4.7. T-Cell Therapies: Analysis by Phase of Development
11.4.8. Role of CMOs in Offering Services for Cell Therapies
11.4.8.1. CMOs Offering Services for Cell Therapies

11.5. Gene Therapies
11.5.1. Gene Therapies: Pipeline Analysis
11.5.1.1. Analysis by Stage of Development
11.5.1.2. Analysis by Phase of Development
11.5.1.3. Analysis by Type of Vector Used
11.5.1.3.1. Clinical Pipeline
11.5.1.3.2. Preclinical Pipeline
11.5.1.4. Analysis by Therapeutic Area
11.5.1.4.1. Clinical and Commercial Pipeline
11.5.1.4.2. Preclinical Pipeline
11.5.2. Role of CMOs in Offering Services for Gene Therapies
11.5.2.1 CMOs Offering Services for Gene Therapies

11.6. Viral Vectors
11.6.1. Viral Vectors: Pipeline Analysis
11.6.1.1. Analysis by Location of Viral Vectors Manufacturing Facilities
11.6.1.2. Analysis by Type of Viral Vector Manufactured
11.6.2. Role of CMOs in Offering Services for Viral Vectors
11.6.2.1. CMOs Offering Services for Viral Vectors

11.7. Plasmid DNA
11.7.1. Plasmid DNA: Pipeline Analysis
11.7.1.1. Analysis by Location of Manufacturing Facilities
11.7.2. Role of CMOs in Offering Services for Plasmid DNA
11.7.2.1. CMOs Offering Services for Plasmid DNA

12 CASE STUDY: OUTSOURCING OF BIOSIMILARS
12.1. Chapter Overview
12.2. Overview of Biosimilars
12.3. Development Stages of Biosimilars
12.4. Regulatory Requirements for Licensing of Biosimilars
12.5. Need for Outsourcing Manufacturing Operations
12.6. Impact of Biosimilars on the Global Contract Manufacturing Market
12.6.1. Biosimilars: Historical Trend of FDA Approvals
12.7. Biosimilars Contract Manufacturing Service Providers
12.8. Challenges Associated with Outsourcing of Biosimilar Manufacturing Operations

13 CASE STUDY: COMPARISON OF SMALL AND LARGE MOLECULE DRUGS / THERAPIES
13.1. Chapter Overview
13.2. Small Molecule and Large Molecule Drugs / Therapies
13.2.1. Comparison of General Characteristics
13.2.2. Comparison of Key Specifications
13.2.3. Comparison of Manufacturing Process
13.2.4. Comparison of Key Manufacturing Challenges

14 CASE STUDY: IN-HOUSE MANUFACTURING
14.1. Chapter Overview
14.2. In-House Manufacturing
14.2.1. Benefits Associated with In-House Manufacturing
14.2.2. Risks Associated with In-House Manufacturing
14.3. Outsourcing Trends in the Biopharmaceutical Industry
14.3.1. Types of Outsourcing Partners

14.4. Manufacturing Approaches Used for Approved Biologics, 2016-2022
14.5. Choosing the Right Strategy: In-House Manufacturing versus Outsourcing

15 MAKE VERSUS BUY DECISION MAKING FRAMEWORK
15.1. Chapter Overview
15.2. Key Assumptions and Parameters

15.3. Biopharmaceutical Contract Manufacturers: Make versus Buy Decision Making
15.3.1. Scenario 1
15.3.2. Scenario 2
15.3.3. Scenario 3
15.3.4. Scenario 4
15.4. Conclusion

16 BIG PHARMA INITIATIVES
16.1. Chapter Overview
16.2. Biopharmaceutical Related Initiatives by Big Pharmaceutical Players
16.2.1. Analysis by Number of Initiatives
16.2.2. Analysis by Year of Initiative
16.2.3. Analysis by Purpose of Initiative
16.2.4. Analysis by Type of Initiative
16.2.4.1. Analysis by Type of Partnership
16.2.4.2. Analysis by Type of Expansion
16.2.5. Analysis by Scale of Operation
16.2.6. Analysis by Type of Biologic Manufactured
16.2.7. Analysis of Big Pharma Players by Year of Initiative
16.2.8. Analysis of Big Pharma Players by Purpose of Initiative
16.2.9. Analysis by Year and Type of Initiative
16.2.10. Analysis of Big Pharma Players by Region of Expansion
16.2.11. Analysis of Big Pharma Players by Type of Biologic Manufactured

17 PARTNERSHIPS AND COLLABORATIONS
17.1. Chapter Overview
17.2. Partnership Models

17.3. Biopharmaceutical Contract Manufacturing: Partnerships and Collaborations
17.3.1. Analysis by Year of Partnership
17.3.2. Analysis by Type of Partnership
17.3.3. Analysis by Year and Type of Partnership
17.3.4. Analysis by Type of Biologic Manufactured

17.3.5. Analysis by Year of Partnership and Type of Biologic Manufactured
17.3.6. Analysis by Type of Partnership and Type of Biologic Manufactured
17.3.7. Analysis by Scale of Operation
17.3.8. Analysis by Therapeutic Area
17.3.9. Most Active Players: Analysis by Number of Partnerships
17.3.10. Analysis by Geography
17.3.10.1. Local and International Agreements
17.3.10.2. Intracontinental and Intercontinental Agreements

18 MERGERS AND ACQUISITIONS
18.1. Chapter Overview
18.2. Merger and Acquisition Models
18.3. Biopharmaceutical Contract Manufacturing: Mergers and Acquisitions
18.3.1. Cumulative Year-wise Trend of Mergers and Acquisitions
18.3.2. Analysis by Type of Acquisition
18.3.3. Analysis by Geography
18.3.3.1. Local and International Mergers and Acquisitions
18.3.3.2. Intracontinental and Intercontinental Mergers and Acquisitions
18.3.3.3. Year-wise Trend in North America, Europe and Asia-Pacific
18.3.4 Most Active Acquirers: Analysis by Number of Acquisitions
18.3.5 Analysis by Key Value Drivers
18.3.6. Analysis by Year of Acquisition and Key Value Drivers
18.3.7. Analysis by Type of Biologic Manufactured
18.3.8. Analysis by Key Value Drivers and Type of Biologic Manufactured
18.4. Key Acquisitions: Deal Multiples
18.4.1. Year-wise Trend of Deal Multiple Amount

19 RECENT EXPANSIONS
19.1. Chapter Overview
19.2. Biopharmaceutical Contract Manufacturing: Recent Expansions
19.2.1. Analysis by Year of Expansion
19.2.2. Analysis by Purpose of Expansion
19.2.3. Analysis by Year and Purpose of Expansion
19.2.4. Analysis by Type of Biologic Manufactured
19.2.5. Analysis by Purpose of Expansion and Type of Biologic Manufactured
19.2.6. Analysis by Location of Expanded Facility
19.2.7. Most Active Players: Analysis by Number of Recent Expansions
19.2.8. Analysis by Purpose of Expansion and Location of Expanded Facility
19.2.9. Analysis by Amount Invested
19.2.10. Recent Expansions: 2016-2020 and 2021-2023 Scenario

20 RECENT DEVELOPMENTS
20.1. Chapter Overview
20.2. Types of Funding
20.3. Biopharmaceutical Contract Manufacturing: Funding and Investment Analysis
20.3.1. Analysis by Year of Funding
20.3.2. Analysis by Amount Invested
20.3.3. Analysis by Type of Funding
20.3.4. Analysis by Year and Type of Funding
20.3.5. Analysis of Funding Instances and Amount Invested by Geography (Continent)
20.3.6. Analysis of Funding Instances and Amount Invested by Geography (Country)
20.3.7. Most Active Players: Analysis by Number of Funding Instances
20.3.8. Most Active Players: Analysis by Total Amount Raised
20.3.9. Leading Investors: Analysis by Number of Funding Instances
20.3.10. Leading Investors: Analysis by Total Amount Raised
20.4. Technological Advancements
20.4.1. Single-Use Technology
20.4.2. Process Analytical Technology (PAT)
20.4.3. Continuous Processing
20.4.4. Quality by Design (QbD) in Bio-processing
20.4.5. Modular / Podular Biopharma Facilities

21 CAPACITY ANALYSIS
21.1. Chapter Overview
21.2. Key Assumptions and Methodology
21.3. Biopharmaceutical Contract Manufacturing: Global Installed Capacity
21.3.1. Analysis by Company Size
21.3.2. Analysis by Type of Expression System Used
21.3.3. Analysis by Geography
21.3.3.1. Analysis of Biopharmaceutical Contract Manufacturing Capacity in North America

21.3.3.2. Analysis of Biopharmaceutical Contract Manufacturing Capacity in Europe
21.3.3.3. Analysis of Biopharmaceutical Contract Manufacturing Capacity in Asia-Pacific
21.3.3.4. Analysis of Biopharmaceutical Contract Manufacturing Capacity in Rest of the World
21.4. Concluding Remarks

22 DEMAND ANALYSIS
22.1. Chapter Overview
22.2. Key Assumptions and Methodology
22.3. Global Demand for Biopharmaceuticals
22.4. Global Demand for Emerging Novel Biologics
22.4.1. Global Demand for ADC Therapeutics
22.4.2. Global Demand for Cell Therapy Manufacturing

23. TOTAL COST OF OWNERSHIP FOR BIOPHARMACEUTICAL CONTRACT MANUFACTURING ORGANIZATIONS
23.1. Chapter Overview
23.2. Key Parameters
23.3. Assumptions and Methodology
23.4. Total Cost of Ownership (Sample Dataset)
23.5. Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations, Y0-Y20
23.5.1. Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations: Analysis by CAPEX, Y0
23.5.2. Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations: Analysis by OPEX, Y1-Y20

23.7. Total Cost of Ownership for Large / Very Large Biopharmaceutical Contract Manufacturing Organizations, Y0-Y20
23.7.1. Total Cost of Ownership for Large / Very Large Biopharmaceutical Contract Manufacturing Organizations: Analysis by CAPEX, Y0
23.7.2. Total Cost of Ownership for Large / Very Large Biopharmaceutical Contract Manufacturing Organizations: Analysis by OPEX, Y1-Y20

24 GLOBAL BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET
24.1. Chapter Overview
24.2. Assumptions and Methodology
24.3. Global Biopharmaceutical Contract Manufacturing Market, Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
24.3.1. Scenario Analysis
24.3.1.1. Conservative Scenario
24.3.1.2. Optimistic Scenario

24.4. Key Market Segmentations

25 BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY TYPE OF SERVICE OFFERED
25.1. Chapter Overview
25.2. Key Assumptions and Methodology

25.3 Biopharmaceutical Contract Manufacturing Market: Distribution by Type of Service Offered, 2018, 2023 and 2035
25.3.1. API Manufacturing: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
25.3.2. FDF Manufacturing: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)

25.4. Data Triangulation and Validation

26 BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY TYPE OF BIOLOGIC MANUFACTURED
26.1. Chapter Overview
26.2. Key Assumptions and Methodology

26.3 Biopharmaceutical Contract Manufacturing Market: Distribution by Type of Biologic Manufactured, 2018, 2023 and 2035
26.3.1. Antibodies: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
26.3.2. Cell Therapies: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
26.3.3. Vaccines: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
26.3.4. Other Biologics: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)

26.4. Data Triangulation and Validation

27 BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY TYPE OF EXPRESSION SYSTEM USED
27.1. Chapter Overview
27.2. Key Assumptions and Methodology

27.3 Biopharmaceutical Contract Manufacturing Market: Distribution by Type of Expression System Used, 2018, 2023 and 2035
27.3.1. Mammalian Expression Systems: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
27.3.2. Microbial Expression Systems: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
27.3.3. Other Expression Systems: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
27.4. Data Triangulation and Validation

28 BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY SCALE OF OPERATION
28.1. Chapter Overview
28.2. Key Assumptions and Methodology

28.3. Biopharmaceutical Contract Manufacturing Market: Distribution by Scale of Operation, 2018, 2023 and 2035
28.3.1. Preclinical / Clinical Operations: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
28.3.2. Commercial Operations: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)

28.4. Data Triangulation and Validation

29 BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY COMPANY SIZE
29.1. Chapter Overview
29.2. Key Assumptions and Methodology

29.3 Biopharmaceutical Contract Manufacturing Market: Distribution by Company Size, 2018, 2023 and 2035
29.3.1. Small Companies: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
29.3.2. Mid-sized Companies: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
29.3.3. Large and Very Large Companies: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)

29.4. Data Triangulation and Validation

30 BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY GEOGRAPHY
30.1. Chapter Overview
30.2. Key Assumptions and Methodology

30.3 Biopharmaceutical Contract Manufacturing Market: Distribution by Geography, 2018, 2023 and 2035
30.3.1. North America: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
30.3.1.1. US: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
30.3.1.2. Canada: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)

30.3.2. Europe: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
30.3.2.1. Italy: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
30.3.2.2. Germany: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
30.3.2.3. France: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
30.3.2.4. Spain: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
30.3.2.5. UK: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
30.3.2.6. Rest of Europe: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)

30.3.3. Asia-Pacific: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
30.3.3.1. China: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
30.3.3.2. India: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
30.3.3.3. South Korea: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
30.3.3.4. Japan: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
30.3.3.5. Rest of Asia-Pacific: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)

30.3.4. Latin America: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
30.3.5. Middle East and North Africa: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
30.8. Data Triangulation and Validation

31 BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY LEADING PLAYERS
31.1. Chapter Overview
31.2. Key Assumptions and Methodology
31.3 Biopharmaceutical Contract Manufacturing Market: Distribution by Leading Players
31.4. Data Triangulation and Validation

32 CASE STUDY: VIRTUAL PHARMACEUTICAL COMPANIES
32.1. Chapter Overview
32.2. Historical Evolution of the Virtual Business Model
32.3. Virtual Pharmaceutical Companies as a Subset of the Overall Biopharmaceutical Industry
32.4. Advantages Associated with Outsourcing Operations to Virtual Service Providers
32.5. Key Challenges Associated with Outsourcing Operations to Virtual Service Providers

33. SWOT ANALYSIS
33.1 Chapter Overview
33.2. Strengths
33.3. Weaknesses
33.4. Opportunities
33.5. Threats
33.6. Comparison of SWOT Factors
33.7. Conclusion

34 FUTURE OF THE BIOPHARMACEUTICAL CMO MARKET
34.1. Chapter Overview
34.2. Outsourcing Activities to Witness Significant Growth in the Coming Years
34.3. Shift from One-time Contracts to Strategic Partnerships
34.4. Integration / Adoption of New and Innovative Technologies
34.4.1. Single-use Bioreactors
34.4.2. Novel Bioprocess Techniques
34.4.3. Bioprocess Automation

34.5. Focus on Niche Therapeutic Areas
34.6. Growing Biosimilars Market to Contribute to the Growth of the Contract Services Segment
34.7. Capability Expansion by CMOs to become One-Stop-Shops
34.8. Offshoring Outsourcing Activities to Maximize Profits and Expand Existing Capacities
34.9. Increase in Financial Inflow and Outsourcing Budgets
34.10. Challenges Faced by Sponsors and Service Providers
34.10.1. Concerns Related to Single-use Systems
34.10.2. Issues Related to Capacity Fluctuations
34.11. Concluding Remarks

35 CONCLUSION

36 EXECUTIVE INSIGHTS
36.1. Chapter Overview
36.2. RoslinCT
36.2.1. Company Snapshot
36.2.2. Interview Transcript: Peter Coleman, Chief Executive Officer

36.3. Chapter Overview
36.3. JAFRAL Biosolutions
36.3.1. Company Snapshot
36.3.2. Interview Transcript: Frenk Smrekar, Chief Executive Officer And Co-Founder

36.4. Chapter Overview
36.4. Discovery Life Sciences
36.4.1. Company Snapshot
36.4.2. Interview Transcript: Dominic Clarke, Chief Technical Officer, Cell And Gene Therapy

36.5. Chapter Overview
36.5. Bioworkshops
36.5.1. Company Snapshot
36.5.2. Interview Transcript: Nick Kotlarski, President and Chief Operating Officer
36.6. Aldevron
36.6.1. Company Snapshot
36.6.2. Interview Transcript: Jeff Briganti, Senior Director Of Global Strategic Marketing

36.7. Resilience
36.7.1. Company Snapshot
36.7.2. Interview Transcript: Tarek Abdel-Gawad, Senior Director of Commercial Strategy and Market Insights

36.8. Minaris Regenerative Medicine
36.8.1. Company Snapshot
36.8.2. Interview Transcript: Luc St-Onge, Global Head of Sales and Marketing and Head of Business Development (Germany)

36.9. 53Biologics
36.9.1. Company Snapshot
36.9.2. Interview Transcript: Francisco Manuel Reyes Sosa, Business Development Manager

36.10. Richter-Helm BioLogics
36.10.1. Company Snapshot
36.10.2. Interview Transcript Antje Weingarth, Manager Marketing and Sales

37 APPENDIX I: TABULATED DATA

38 APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

39 APPENDIX III: DETAILS OF PARTNERSHIPS AND COLLABORATIONS