生物製剤CDMO (開発製造受託機関)：世界市場

世界の生物製剤CDMO (開発製造受託機関) の市場規模は、2023年の151億米ドルから、予測期間中は12.3%のCAGRで推移し、2028年末には270億米ドルの規模に成長すると予測されています。

地域別で見ると、北米市場は、2023年の66億米ドルから、同期間中13.2%のCAGRで推移し、2028年末には124億米ドルの規模に成長すると予測されています。また、アジア太平洋市場は、2023年の31億米ドルから、13.7%のCAGRで推移し、2028年には59億米ドルの規模に成長すると予測されています。

当レポートでは、世界の生物製剤CDMO (開発製造受託機関) の市場を調査し、市場および技術の概要、市場影響因子および市場機会の分析、市場規模の推移・予測、各種区分・地域別の詳細分析、技術動向、法規制環境、ESGの展開、競合情勢、主要企業のプロファイルなどをまとめています。

目次

第1章 イントロダクション

第2章 サマリー・ハイライト

第3章 市場概要

• 生物製剤CDMOの利点
• 専門知識
• 設備および製造設備
• スケーラビリティ
• アウトソーシングの利点
• アウトソーシングの欠点
• 受託製造
• 受託製造業者の種類
• 受託製造組織の進化
• アウトソーシング
• 受託製造業者の評価基準
• CMOの中核となる能力
• 常に注意を払う必要がある中核的な機能領域
• アウトソーシングパートナーの選定基準
• 不満の主な原因
• 受託製造における課題
• CMOが提供するサービス
• 受託調査
• CROの選択
• CROが提供するサービス
• CROを選択するためのチェックリスト
• CROを使用する利点
• クライアントとCROの関係

第4章 市場力学

• 市場促進要因
• 癌罹患率の上昇
• 生物製剤の需要の増加
• CDMOの使用の増加
• 高齢者人口の増加
• 市場抑制要因
• 生物製剤のコストと価格管理
• 容量の制約
• 製造コスト
• 市場機会
• バイオシミラーの共同開発

第5章 世界の生物製剤CDMO (開発製造受託機関) 市場：製品タイプ別

• 生物製剤
• バイオシミラー

第6章 世界の生物製剤CDMO (開発製造受託機関) 市場：細胞株タイプ別

• 哺乳類
• 微生物（非哺乳類）
• その他

第7章 世界の生物製剤CDMO (開発製造受託機関) 市場：地域別

• 市場概要・ディスカッション
• 北米
• 欧州
• アジア太平洋
• その他の地域

第8章 生物製剤CDMO (開発製造受託機関) の持続可能性：ESGの観点

• ESG：概要
• 生物製剤のCDMO業界の持続可能性：ESGの観点
• ESGの主な問題
• ESGに対する考え方
• 業界のESGパフォーマンス分析
• ToyoboとESG
• BCCによる総論

第9章 新たな技術と開発

• 概要
• ビッグデータ・AI・ML
• シングルユース技術
• プロセス分析技術（PAT）

第10章 規制状況

第11章 M&Aとベンチャー資金調達の見通し

• M&A分析
• 最近のニュース

第12章 競合情報

第13章 企業プロファイル

• ABBVIE PHARMACEUTICAL CONTRACT MANUFACTURING
• AGC BIOLOGICS
• BOEHRINGER INGELHEIM BIOXCELLENCE
• BINEX CO. LTD.
• BIOVIAN OY
• BORA PHARMACEUTICAL CDMO
• CATALENT INC
• CYTOVANCE BIOLOGICS
• EMERGENT BIOSERVICES
• FUJIFILM DIOSYNTH BIOTECHNOLOGIES
• ICON PLC
• JRS PHARMA GMBH & CO. KG
• KEMWELL
• LONZA GROUP
• LOTTE BIOLOGICS
• PAREXEL INTERNATIONAL CORP.
• RENTSCHLER BIOPHARMA SE
• SAMSUNG BIOLOGICS
• SANDOZ INTERNATIONAL GMBH
• THERMO FISHER SCIENTIFIC INC.
• TOYOBO CO. LTD.
• WUXI XDC

第14章 付録

List of Tables

• Summary Table : Global Market for Biologics CDMOs, by Region, Through 2028
• Table 1 : 65-and Over Population, by Region, 2019 And 2050
• Table 2 : Global Market for Biologics CDMOs, by Product Type, Through 2028
• Table 3 : Global Market for Biologics, by Region, Through 2028
• Table 4 : Global Market for Biosimilars, by Region, Through 2028
• Table 5 : Global Market for Biologics CDMOs, by Cell-Line Type, Through 2028
• Table 6 : Global Market for Mammalian Biologics CDMOs, by Region, Through 2028
• Table 7 : Global Market for Microbial Biologics CDMOs, by Region, Through 2028
• Table 8 : Global Market for Other Modalities for Biologics CDMOs, by Region, Through 2028
• Table 9 : Global Market for Biologics CDMOs, by Region, Through 2028
• Table 10 : North American Market for Biologics CDMOs, by Country, Through 2028
• Table 11 : European Market for Biologics CDMOs, by Country, Through 2028
• Table 12 : Asia-Pacific Market for Biologics CDMOs, by Country, Through 2028
• Table 13 : RoW Market for Biologics CDMOs, Through 2028
• Table 14 : Key Focus Areas in ESG Metrics
• Table 15 : Net-Zero GHG Commitments, by Major Biologics CDMOs
• Table 16 : ESG Rankings for Major Biologics CDMO Companies, 2023*
• Table 17 : CDP's Scope Card for Major Biologics CDMO Companies, 2022
• Table 18 : Ranking of Biologics CDMOs
• Table 19 : Boehringer Ingelheim: Revenue, 2020-2022
• Table 20 : Boehringer Ingelheim: Revenue, by Business, 2020-2022
• Table 21 : Boehringer Ingelheim: Revenue, by Region, 2020-2022
• Table 22 : Bora Pharmaceutical: Revenue, 2021 and 2022
• Table 23 : Bora Pharmaceutical: Revenue, by Product, 2021 and 2022
• Table 24 : Bora Pharmaceutical: Revenue, by Region, 2021 and 2022
• Table 25 : Catalent Inc.: Revenue, 2020 and 2022
• Table 26 : Catalent Inc.: Revenue, by Business Segment, 2020-2022
• Table 27 : Catalent Inc.: Revenue, by Region, 2020-2022
• Table 28 : Emergent Bioservices: Development and Manufacturing Services
• Table 29 : Emergent Biosolutions: Revenue, by Segment, 2021 and 2022
• Table 30 : Emergent Biosolutions: Revenue, by Region, 2021-2022
• Table 31 : FujiFilm Diosynth Biotechnologies: Services
• Table 32 : ICON plc: Revenue, by Region, 2020-2022
• Table 33 : Lonza: Revenue, 2020-2022
• Table 34 : Lonza: Revenue, by Operating Segment, 2020-2022
• Table 35 : Lonza: Revenue Share, by Region, 2020-2022
• Table 36 : Samsung Biologics: Revenue, 2020-2022
• Table 37 : Samsung Biologics: Revenue, by Operating Segment, 2020-2022
• Table 38 : Sandoz: CDMO Services Across Technology Segments
• Table 39 : Sandoz: Revenue, 2020-2022
• Table 40 : Sandoz: Revenue, by Business Segment, 2020-2022
• Table 41 : Sandoz: Revenue, by Region, 2020-2022
• Table 42 : Thermo Fisher Scientific Inc.: Revenue, by Segment
• Table 43 : Thermo Fisher Scientific Inc.: Revenue, by Segment
• Table 44 : Thermo Fisher Scientific Inc.: Revenue, by Region
• Table 45 : Toyobo Co. Ltd.: Revenue, 2020-2022
• Table 46 : WuXi Biologics: Products and Services
• Table 47 : WuXi Biologics: Revenues by Goods and Services, 2020-2022
• Table 48 : WuXi Biologics: Revenue, by Region, 2020-2022
• Table 49 : Acronyms

List of Figures

• Summary Figure A : Global Market for Biologics CDMOs, by Region, 2020-2028
• Summary Figure B : Global Market Shares of Biologics CDMOs, by Region, 2022
• Figure 1 : Role of Contract Service Providers in the Pharmaceutical Value Chain
• Figure 2 : CDMO Services
• Figure 3 : Global Market for Biologics CDMOs, by Product Type, 2020-2028
• Figure 4 : Global Market Shares of Biologics CDMOs, by Product Type, 2022
• Figure 5 : Global Market for Biologics, by Region, 2020-2028
• Figure 6 : Global Market Shares of Biologics, by Region, 2022
• Figure 7 : Global Market for Biosimilars, by Region, 2020-2028
• Figure 8 : Global Market Shares of Biosimilars, by Region, 2022
• Figure 9 : Global Market for Biologics CDMOs, by Cell-Line Type, 2020-2028
• Figure 10 : Global Market Shares of Biologics CDMOs, by Cell-Line Type, 2022
• Figure 11 : Global Market for Mammalian Biologics CDMOs, by Region, 2020-2028
• Figure 12 : Global Market Shares of Mammalian Biologics CDMOs, by Region, 2022
• Figure 13 : Global Market for Microbial Biologics CDMOs, by Region, 2020-2028
• Figure 14 : Global Market Shares of Microbial Biologics CDMOs, by Region, 2022
• Figure 15 : Global Market for Other Modalities for Biologics CDMOs, by Region, 2020-2028
• Figure 16 : Global Market Shares of Other Modalities for Biologics CDMO, by Region, 2022
• Figure 17 : Global Market for Biologics CDMOs, by Region, 2020-2028
• Figure 18 : Global Market Shares of Biologics CDMOs, by Region, 2022
• Figure 19 : North American Market for Biologics CDMOs, by Country, 2020-2028
• Figure 20 : North American Market Shares of Biologics CDMOs, by Country, 2022
• Figure 21 : European Market for Biologics CDMOs, by Country, 2020-2028
• Figure 22 : European Market Shares of Biologics CDMOs, by Country, 2022
• Figure 23 : Asia-Pacific Market for Biologics CDMOs, by Country, 2020-2028
• Figure 24 : Asia-Pacific Market Shares of Biologics CDMOs, by Country, 2022
• Figure 25 : How A Strong ESG Proposition Can Benefit Businesses
• Figure 26 : Level of ESG Adoption across All Industries
• Figure 27 : Business Sustainability Trends
• Figure 28 : Toyobo Co. Ltd. ESG Focus Areas
• Figure 29 : Emerging Technologies in the Biologics CDMO Market
• Figure 30 : FDA cGMP Manufacturing Guidance Documents
• Figure 31 : FDA Site Inspections
• Figure 32 : European cGMP Guideline Documentation
• Figure 33 : European Site Inspection Outcomes
• Figure 34 : Boehringer Ingelheim: Revenue Share, by Business, 2022
• Figure 35 : Boehringer Ingelheim: Revenue Share, by Region, 2022
• Figure 36 : Bora Pharmaceutical: Revenue Share, by Product, 2022
• Figure 37 : Bora Pharmaceutical: Revenue Share, by Region, 2022
• Figure 38 : Catalent Inc.: Revenue Share, by Business Segment, 2022
• Figure 39 : Catalent Inc.: Revenue Share, by Region, 2022
• Figure 40 : Emergent Biosolutions: Revenue Share, by Segment, 2022
• Figure 41 : Emergent Biosolutions: Revenue Share, by Region, 2022
• Figure 42 : ICON plc: Company Revenue, 2020-2022
• Figure 43 : Icon plc: Revenue Share, by Region, 2022
• Figure 44 : Lonza: Revenue Share, by Operating Segment, 2022
• Figure 45 : Lonza: Revenue Share, by Region, 2022
• Figure 46 : Samsung Biologics: Revenue Share, by Operating Segment, 2022
• Figure 47 : Sandoz: Revenue Share, by Business Segment, 2022
• Figure 48 : Sandoz: Revenue Share, by Region, 2022
• Figure 49 : Thermo Fisher Scientific Inc.: Revenue, 2020-2022
• Figure 50 : Thermo Fisher Scientific Inc.: Revenue Share, by Segment, 2022
• Figure 51 : Thermo Fisher Scientific Inc.: Revenue Share, by Segment, 2022
• Figure 52 : Thermo Fisher Scientific Inc.: Revenue Share, by Region, 2022
• Figure 53 : Toyobo Co. Ltd.: Revenue Share, by Operating Segment, 2022
• Figure 54 : WuXi Biologics: Company Revenue, 2020-2022
• Figure 55 : WuXi Biologics: Revenues by Goods and Services, 2020-2022
• Figure 56 : WuXi Biologics: Revenue Share, by Region, 2020-2022

Highlights:

The global market for biologics CDMOs is expected to increase from $15.1 billion in 2023 to $27.0 billion by the end of 2028, with a compound annual growth rate (CAGR) of 12.3% during the forecast period of 2023-2028.

The North American market for biologics CDMOs is expected to increase from $6.6 billion in 2023 to $12.4 billion by the end of 2028, with a CAGR of 13.2% during the forecast period of 2023-2028.

The Asia-Pacific market for biologics CDMOs is projected to increase from $3.1 billion in 2023 to $5.9 billion by the end of 2028, with a CAGR of 13.7% during the forecast period of 2023-2028.

Report Scope:

The scope of the report includes biologics CDMO services, industries, initiatives, patents, and companies. The markets for biologics CDMO are given for 2020, 2021, 2022, 2023 and 2028.

This report explains why biologics CDMO is important in pharmaceutical and biotechnology industry. It then discusses some of the significant research initiatives that are impacting biologics CDMO. The main market-driving forces are also discussed.

The report examines the markets by product type, cell line type and region. The report provides market data and forecasts for biologics CDMO by product type, including biologics and biosimilars. The specific regional markets covered are North America, Europe, Asia-Pacific and the Rest of the World (RoW).

In the report BCC Research summarizes the main industry acquisitions and strategic alliances from January 2020 through December 2022.

Report Includes:

• 40 data tables and 10 additional tables
• An up-to-date overview and industry analysis of the global markets for biologics contract development and manufacturing organizations (CDMO)
• Analyses of the global market trends, with historical market revenue data (sales figures) for 2022, estimates for 2023, forecasts for 2024, and projections of compound annual growth rates (CAGRs) through 2028
• Estimation of the actual market size and revenue forecast for biologics CDMO market in USD million values, and their corresponding market share analysis based on the product type, cell line type, and geographic region
• In-depth information (facts and figures) concerning the market growth drivers, opportunities and challenges, prospects, technologies, regulatory scenarios, and the impact of macroeconomic variables on biologics CDMO marketplace
• Discussion of ESG developments in global CDMO services market, with emphasis on importance of ESG, consumer attitudes, risks and opportunity assessment, and ESG followed practices
• Identification of the pharma companies that are considered as leaders in their field, as well as technological means these companies are using to exploit their markets and dominate the market in their fields
• Market outlook and opportunity assessment of the industry structure for biologics CDMO services, and evaluation of ongoing clinical trials and R&D activities estimating current and future market demand
• Insight into the growth development strategies of the key market players operating within the global market; their key competitive landscape and company share analysis
• Analysis of the company competitive landscape based on recent developments, key financials, and operational integration
• Company profiles of major players within the industry, including Lonza Group, WuXi Biologics, Samsung Biologics, Boehringer Ingelheim, and Catalent Inc.

Table of Contents

Chapter 1 Introduction

• Study Goals and Objectives
• Reasons for Doing This Study
• Scope of Report
• Methodology
• Information Sources
• Geographic Breakdown

Chapter 2 Summary and Highlights

• Market Outlook
• Market Summary

Chapter 3 Market Overview

• Introduction
• Benefits of Biologics CDMOs
• Expertise
• Equipment and Manufacturing Facilities
• Scalability
• Benefits of Outsourcing
• Drawbacks to Outsourcing
• Contract Manufacturing
• Types of Contract Manufacturers
• Evolution of Contract Manufacturing Organizations
• Outsourcing
• Criteria for Evaluating a Contract Manufacturer
• Core Capabilities of CMOs
• Core Functional Areas Requiring Constant Attention
• Criteria for Selecting an Outsourcing Partner
• Top Sources of Dissatisfaction
• Challenges in Contract Manufacturing
• Services Offered by CMOs
• Contract Research
• Selecting a CRO
• Services Offered by CROs
• Checklist for Selecting a CRO
• Benefits of Using a CRO
• Client/CRO Relationship

Chapter 4 Market Dynamics

• Market Drivers
• Rising Prevalence of Cancer
• Increasing Demand for Biologics
• Rising Use of CDMOs
• Increasing Elderly Population
• Market Restraints
• Biologic Product Costs and Price Controls
• Capacity Constraints
• Manufacturing Costs
• Market Opportunities
• Co-development of Biosimilars

Chapter 5 Global Market for Biologics CDMOs by Product Type

• Introduction
• Biologics
• Biosimilars
• Biologics
• Biosimilars

Chapter 6 Global Market for Biologics CDMOs by Cell-Line Type

• Mammalian
• Microbial (Non-mammalian)
• Other Modalities

Chapter 7 Global Market for Biologics CDMOs by Region

• Market Overview and Discussion
• North America
• Europe
• Asia-Pacific
• RoW

Chapter 8 Sustainability in Biologics CDMOs: An ESG Perspective

• Introduction to ESG
• Sustainability in Biologics CDMO Industry: An ESG Perspective
• Key ESG Issues
• Attitudes toward ESG
• Industry ESG Performance Analysis
• Toyobo and ESG
• Concluding Remarks from BCC Research

Chapter 9 Emerging Technologies and Developments

• Overview
• Big Data, AI and ML
• Single-use Technology
• Process Analytical Technology (PAT)

Chapter 10 Regulatory Landscape

• Regulation of Biologics Services
• FDA Regulations
• European Regulations
• Impact of FDA Regulations
• The Declaration of Helsinki
• CDISC Standards

Chapter 11 M&A and Venture Funding Outlook

• M&A Analysis
• Recent News

Chapter 12 Competitive Intelligence

Chapter 13 Company Profiles

• ABBVIE PHARMACEUTICAL CONTRACT MANUFACTURING
• AGC BIOLOGICS
• BOEHRINGER INGELHEIM BIOXCELLENCE
• BINEX CO. LTD.
• BIOVIAN OY
• BORA PHARMACEUTICAL CDMO
• CATALENT INC
• CYTOVANCE BIOLOGICS
• EMERGENT BIOSERVICES
• FUJIFILM DIOSYNTH BIOTECHNOLOGIES
• ICON PLC
• JRS PHARMA GMBH & CO. KG
• KEMWELL
• LONZA GROUP
• LOTTE BIOLOGICS
• PAREXEL INTERNATIONAL CORP.
• RENTSCHLER BIOPHARMA SE
• SAMSUNG BIOLOGICS
• SANDOZ INTERNATIONAL GMBH
• THERMO FISHER SCIENTIFIC INC.
• TOYOBO CO. LTD.
• WUXI XDC

Chapter 14 Appendix