生物製剤受託製造の世界市場- 提供されるサービスの種類別、製造される生物製剤の種類別、使用される発現系の種類別、事業規模別、企業規模別、主要地域別：産業動向と世界予測 (2022年～2035年)

世界の生物製剤受託製造市場は、2023年に190億米ドルと評価され、予測期間中 (2023年～2035年) に9%のCAGRで成長します。

バイオ医薬品CMO (受託製造業者) セクターとして認識されている生物製剤受託製造市場は、強固なダイナミズムと急速な拡大を示しており、新しい治療法を開拓するための研究開発に投資する数多くの事業体を惹きつけています。こうしたイノベーションには、抗体薬物複合体、バイオシミラー、細胞・遺伝子治療などが含まれます。長年にわたり、この急成長する市場では、世界中で250以上の生物学的療法とワクチンが登場しています。特筆すべきは、生物学的製剤は従来の低分子医薬品に比べ、低分子医薬品開発の挫折の原因である標的外毒性が少ないため、成功率が高いことです。

生物製剤への関心が高まるにつれ、医薬品業界では低分子医薬品から生物製剤への投資シフトが顕著になっています。この転換は、絶え間ない科学の進歩とFDA承認の生物製剤の急増と相まって、生物製剤の時代の幕開けを告げるものです。バイオ医薬品は製薬業界を根本的に形成し、従来の医療に不可欠な要素になりつつあると予想されます。

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関連する法外なコストを軽減することを目指しています。メーカーによっては、最先端の設備や専門知識を活用するため、特定の業務を外注化することもあります。特に、製造委託先がソフトウェア主導のロボット工学のような最先端技術を採用して製造プロセスを強化し、手作業に関連するリスクを軽減している場合はなおさらです。この分野で外注化が実行可能で有利なビジネスモデルとして普及するにつれ、世界の生物製剤受託製造の市場は予測期間中に著しい成長を遂げるものと思われます。

当レポートでは、世界の生物製剤受託製造の市場について分析し、技術・サービスの概要や生産される生物製剤の種類、全体的な市場規模の動向見通し、セグメント別・地域別の詳細動向、昨今の市場における資本取引・事業提携などの動向、主なBCMO (バイオ医薬品CMO) の概略、といった情報を取りまとめてお届けいたします。

市場の主要企業

目次

第1章 序論

第2章 分析手法

第3章 経済およびその他のプロジェクト特有の考慮事項

第4章 エグゼクティブサマリー

第5章 イントロダクション

• 分析概要
• バイオ医薬品の概要
• バイオ医薬品の発現系
• バイオ医薬品の製造プロセス
• 受託製造の概要
• バイオ医薬品製造業務の外注化の必要性
• 受託製造パートナーを選択する際の重要な考慮事項
• 将来の展望

第6章 市場情勢

• 分析概要
• バイオ医薬品受託製造業者：全体的な市場情勢

第7章 地域別の生産能力の分析

• 分析概要
• 主要な前提条件とパラメーター
• バイオ医薬品受託製造施設の概要
• 地域別の生産能力の分析：北米のバイオ医薬品受託製造施設
• 地域別の生産能力の分析：欧州のバイオ医薬品受託製造施設
• 地域別の生産能力の分析：アジア太平洋のバイオ医薬品受託製造施設
• 地域別の生産能力の分析：世界のその他の地域のバイオ医薬品受託製造施設

第8章 北米におけるバイオ医薬品受託製造

• 分析概要
• 米国のバイオ医薬品受託製造：規制シナリオ
• 北米の大手バイオ医薬品CMO
• 北米のその他の大手バイオ医薬品CMO

第9章 欧州におけるバイオ医薬品受託製造

• 分析概要
• 欧州のバイオ医薬品受託製造：規制シナリオ
• 欧州の大手バイオ医薬品CMO
• 欧州のその他の大手バイオ医薬品CMO

第10章 アジア太平洋・その他の地域におけるバイオ医薬品受託製造

• 分析概要
• 中国におけるバイオ医薬品受託製造
• 中国の大手バイオ医薬品CMO
• インドにおけるバイオ医薬品受託製造
• インドの大手バイオ医薬品CMO
• 日本におけるバイオ医薬品受託製造
• 日本の大手バイオ医薬品CMO
• 韓国におけるバイオ医薬品受託製造
• 韓国の大手バイオ医薬品CMO
• オーストラリアにおけるバイオ医薬品受託製造
• オーストラリアの大手バイオ医薬品CMO
• アジア太平洋・その他の地域 (ROW) の大手バイオ医薬品CMO

第11章 ニッチなバイオ医薬の分野

• 分析概要
• 二重特異性抗体
• 抗体薬物複合体 (ADC)
• 細胞療法
• 遺伝子治療
• ウイルスベクター
• プラスミドDNA

第12章 ケーススタディ：バイオシミラーの受託製造

• 分析概要
• バイオシミラーの概要
• バイオシミラーの開発段階
• バイオシミラーのライセンシングに関する規制要件
• 製造業務の外注化の必要性
• バイオシミラーが世界の受託製造市場に与える影響
• バイオシミラー受託製造サービスプロバイダー
• バイオシミラー製造業務の外注化に伴う課題

第13章 ケーススタディ：低分子薬と高分子薬/治療法の比較

• 分析概要
• 低分子および高分子の薬物/治療法

第14章 ケーススタディ：内製化

• 分析概要
• 内製化
• バイオ医薬品業界における外注化の動向
• 承認された生物製剤に使用される製造アプローチ (2016年～2022年)
• 適切な戦略の選択：内製化と外注化

第15章 製造か、購入か：意思決定の枠組み

• 分析概要
• 主要な前提条件とパラメーター
• バイオ医薬品受託製造業者：「製造か、購入か」の意思決定
• 結論

第16章 大手製薬企業の取り組み

• 分析概要
• 製薬大手によるバイオ医薬品関連の取り組み

第17章 事業提携・協力

• 分析概要
• 事業提携モデル
• バイオ医薬品の受託製造：事業提携・協力

第18章 企業合併・買収 (M&A)

• 分析概要
• M&Aのモデル
• バイオ医薬品の受託製造：M&A
• 主な買収：取引倍率

第19章 最近の拡張

• 分析概要
• バイオ医薬品受託製造：最近の拡張

第20章 最近の動向

• 分析概要
• 資金の種類
• バイオ医薬品の受託製造：資金調達・投資の分析
• 技術進歩

第21章 生産能力の分析

• 分析概要
• 重要な前提と分析手法
• バイオ医薬品受託製造：世界の設置済み生産能力
• 結論

第22章 需要分析

• 分析概要
• 重要な前提と分析手法
• 世界のバイオ医薬品の需要
• 新興の新規生物製剤に対する世界の需要

第23章 バイオ医薬品受託製造組織の総所有コスト

• 分析概要
• 主要なパラメーター
• 前提と分析手法
• 総所有コスト (サンプルデータセット)
• 中規模バイオ医薬品受託製造組織の総所有コスト (2000年～2020年)
• 大規模/超大規模バイオ医薬品受託製造組織の総所有コスト (2000年～2020年)

第24章 世界のバイオ医薬品受託製造市場

• 分析概要
• 前提と分析手法
• 世界のバイオ医薬品受託製造市場、過去の動向 (2018年～2022年) と予測 (2023年～2035年)
• 主要な市場セグメンテーション

第25章 バイオ医薬品受託製造市場：提供されるサービスの種類別

• 分析概要
• 重要な前提と分析手法
• バイオ医薬品受託製造市場：提供されるサービスの種類別 (2018年、2023年、2035年)
• データの計測と検証

第26章 バイオ医薬品受託製造市場：製造される生物製剤の種類別

• 分析概要
• 重要な前提と分析手法
• バイオ医薬品受託製造市場：製造されるバイオ医薬品の種類別 (2018年、2023年、2035年)
• データの計測と検証

第27章 バイオ医薬品受託製造市場：使用される発現系の種類別

• 分析概要
• 重要な前提と分析手法
• バイオ医薬品受託製造市場：使用される発現系の種類別 (2018年、2023年、2035年)
• データの計測と検証

第28章 バイオ医薬品受託製造市場：事業規模別

• 分析概要
• 重要な前提と分析手法
• バイオ医薬品受託製造市場：事業規模別 (2018年、2023年、2035年)
• データの計測と検証

第29章 バイオ医薬品受託製造市場：企業規模別

• 分析概要
• 重要な前提と分析手法
• バイオ医薬品受託製造市場：企業規模別 (2018年、2023年、2035年)
• データの計測と検証

第30章 バイオ医薬品受託製造市場：地域別

• 分析概要
• 重要な前提と分析手法
• バイオ医薬品受託製造市場：地域別 (2018年、2023年、2035年)
• データの計測と検証

第31章 バイオ医薬品受託製造市場：主要企業別

• 分析概要
• 重要な前提と分析手法
• バイオ医薬品受託製造市場：主要企業別
• データの計測と検証

第32章 ケーススタディ：仮想製薬企業

• 分析概要
• 仮想ビジネスモデルの歴史的進化
• バイオ医薬品業界全体の一部としての仮想製薬企業
• 仮想サービスプロバイダーへの運用アウトソーシングのメリット
• 仮想サービスプロバイダーへの運用のアウトソーシングに関連する主な課題

第33章 SWOT分析

• 分析概要
• 強み
• 弱点
• 機会
• 脅威
• SWOT要素の比較
• 結論

第34章 バイオ医薬品CMO市場の将来性

• 分析概要
• 外注化活動：今後数年間で大幅な成長の見通し
• 単発契約から戦略的パートナーシップへの移行
• 新しい革新的技術の統合/採用
• ニッチな治療領域に焦点を当てる
• 成長するバイオシミラー市場が受託製造サービス部門の成長に貢献
• ワンストップ・ショップ化に向けたCMOの機能拡充
• 利益の最大化と既存能力の拡大を目的としたオフショア外注化活動
• 資金流入と外部委託予算の増加
• スポンサーとサービスプロバイダーが直面する課題
• 結論

第35章 結論

第36章 経営陣の分析

• 分析概要
• RoslinCT
• JAFRAL Biosolutions
• Discovery Life Sciences
• Bioworkshops
• Aldevron
• Resilience
• Minaris Regenerative Medicine
• 53Biologics
• Richter-Helm BioLogics

第37章 付録I：表形式のデータ

第38章 付録II：企業・組織の一覧

第39章 付録III：事業提携・協力の詳細

The global biologics contract manufacturing market is valued at USD 19 billion in 2023 growing at a CAGR of 9% during the forecast period 2023-2035.

The biologics contract manufacturing market, recognized as the biopharmaceutical CMO sector, demonstrates robust dynamism and rapid expansion, attracting numerous entities investing in research and development for pioneering new therapeutic modalities. These innovations encompass antibody drug conjugates, biosimilars, and cell and gene therapies. Over the years, this burgeoning market has seen the emergence of more than 250 biologic therapies and vaccines worldwide. Notably, biologics exhibit higher success rates compared to traditional small-molecule drugs due to their reduced off-target toxicity, a prevalent cause of setbacks in small molecule drug development.

The escalating interest in biologics has prompted a notable shift in investment within the pharmaceutical landscape, transitioning from small molecule drugs to biologics. This shift, coupled with continuous scientific advancements and the proliferation of FDA-approved biologics, heralds the dawn of the biologic's era. Biopharmaceuticals are anticipated to fundamentally shape the pharmaceutical industry, progressively becoming an indispensable component of conventional medical treatments.

These service providers offer comprehensive solutions encompassing bioprocess development and optimization, aiming to expedite operational timelines and mitigate the exorbitant costs associated with producing complex biologic drugs. Some manufacturers opt to outsource specific operations to leverage state-of-the-art facilities and expertise, especially when contract manufacturing firms employ cutting-edge technologies like software-driven robotics to enhance manufacturing processes and mitigate risks linked to manual methods. As outsourcing gains traction as a viable and advantageous business model within this sphere, the global market for biologics contract manufacturing is poised to witness remarkable growth in the forecast period.

Key Market Segments:

Type of Service Offered

• API Manufacturing
• FDF Manufacturing

Type of Biologic Manufactured

• Antibodies
• Cell Therapies
• Vaccines
• Other Biologics

Type of Expression System

• Mammalian
• Microbial
• Others

Scale of Operation

• Preclinical / Clinical
• Commercial

Company Size

• Small
• Mid-sized
• Large
• Very Large

Key Geographical Region

• North America
• Europe
• Asia
• Latin America
• Middle East and North Africa

Research Coverage:

• The report studies the biologics contract manufacturing market based on type of services offered, type of biologic manufactured, type of expression system used, scale of operation, company size and key geographical regions
• The report analyzes factors (such as drivers, restraints, opportunities, and challenges) affecting the market growth
• The report assesses the potential advantages and obstacles within the market for those involved and offers information on the competitive environment for top players in the market.
• The report forecasts the revenue of market segments with respect to five major regions
• Executive summary of biologics contract manufacturing market key research insights on the current state and expected evolution of the biologics contract manufacturing market in the short to long term.
• Introduction to biopharmaceuticals, manufacturing processes, expression systems used, and the significance of outsourcing in this industry.
• Current market landscape of contract manufacturing companies analyzing companies offering biologics contract manufacturing services based on various parameters like services offered, biologic types, scale of operation, expression systems, and geographic locations.
• Elaborated profiles of key contract manufacturing organizations in each region, highlighting their services, facilities, recent developments, and future outlook.
• Case studies on biosimilars market examining opportunities for CMOs in the biosimilars market and comparing small and large molecule drug characteristics and manufacturing processes.
• Big pharma manufacturing initiatives and collaborations reviewing initiatives by top pharma companies, collaborations, trends, and activities impacting biologics contract manufacturing.
• Examining recent partnerships, mergers, acquisitions, and their impact on the biologics contract manufacturing industry.
• Reviewing expansion initiatives, funding investments, and technological advancements in biomanufacturing.
• Estimating manufacturing capacity and annual demand for top biologics based on patient population, dosing, and strength.
• Analyzing the total cost of ownership for CMOs based on company size between 2023-2043.
• Examining industry trends, drivers, challenges through a SWOT analysis and their relative impact on the biopharmaceutical industry.
• Exploring the role of the virtual business model in biopharmaceuticals, its advantages, risks, and its impact on outsourcing operations.
• Discussing anticipated market growth, opportunities, and trends expected to influence the biologics contract manufacturing industry in the forecast period.

Key Benefits of Buying this Report:

• The report offers market leaders and newcomers valuable insights into revenue estimations for both the overall market and its sub-segments.
• Stakeholders can utilize the report to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.
• The report provides stakeholders with a pulse on biologics contract manufacturing market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.

Key Market Companies:

TABLE OF CONTENTS

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