Chapter 1. Research Background
1.1 Research Objectives
1.2 Market Definition
1.3 Analysis Period
1.4 Market Data Reporting Unit
1.4.1 Value
1.5 Market Size Breakdown by Segment
1.5.1 Market Segmentation by Product Type
1.5.2 Market Segmentation by Cell Line Type
1.5.3 Market Segmentation by Service Type
1.5.4 Market Segmentation by Region
1.6 Key Stakeholders
Chapter 2. Research Methodology
2.1 Secondary Research
2.1.1 Paid
2.1.2 Unpaid
2.1.3 P&S Intelligence Database
2.2 Primary Research
2.2.1 Breakdown of Primary Research, by Region
2.2.2 Breakdown of Primary Research, by Industry Participant
2.2.3 Breakdown of Primary Research, by Designation
2.2.4 Breakdown of Primary Research, by Company Type
2.3 Market Size Estimation
2.4 Data Triangulation
2.5 Currency Conversion Rates
2.6 Notes and Caveats
Chapter 3. Executive Summary
Chapter 4. Definition of Market Segments
4.1 By Product Type
4.1.1 Drug Substance
4.1.2 Drug Product
4.2 By Cell Line Type
4.2.1 Microbial
4.2.2 Mammalian
4.2.3 Viral Vector & Other Modalities
4.3 By Service Type
4.3.1 Clinical
4.3.2 Commercial
Chapter 5. Industry Outlook
5.1 Market Dynamics
5.1.1 Trends
5.1.1.1 Partnerships and mergers & acquisitions
5.1.1.2 Expansion of healthcare facilities
5.1.1.3 Shift in preference toward CDMOs
5.1.2 Drivers
5.1.2.1 Surging incidence of chronic diseases
5.1.2.2 Rising outsourcing of R&D activities
5.1.2.3 Companies involve in partnerships with biologics CDMOs to introduce novel products
5.1.2.4 Rising geriatric population
5.1.3 Impact Analysis of Drivers on Market Forecast
5.1.4 Restraints
5.1.4.1 Issue regarding intellectual property
5.1.4.2 Product recall
5.1.4.3 Stringent regulations
5.1.4.4 Unfavorable drug price control policies
5.1.5 Impact Analysis of Restraints on Market Forecast
5.1.6 Growth Opportunities and Their Impact
5.2 Impact of Covid-19
5.3 Porter’s Five Forces Analysis
5.3.1 Bargaining Power of Buyers
5.3.2 Bargaining Power of Suppliers
5.3.3 Intensity of Rivalry
5.3.4 Threat of New Entrants
5.3.5 Threat of Substitutes
Chapter 6. Global Market Size and Forecast
6.1 Overview
6.2 Market Revenue, by Product Type (2017–2030)
6.3 Market Revenue, by Cell Line Type (2017–2030)
6.4 Market Revenue, by Service Type (2017–2030)
6.5 Market Revenue, by Region (2017–2030)
Chapter 7. North America Market Size and Forecast
7.1 Overview
7.2 Market Revenue, by Product Type (2017–2030)
7.3 Market Revenue, by Cell Line Type (2017–2030)
7.4 Market Revenue, by Service Type (2017–2030)
7.5 Market Revenue, by Country (2017–2030)
Chapter 8. Europe Market Size and Forecast
8.1 Overview
8.2 Market Revenue, by Product Type (2017–2030)
8.3 Market Revenue, by Cell Line Type (2017–2030)
8.4 Market Revenue, by Service Type (2017–2030)
8.5 Market Revenue, by Country (2017–2030)
Chapter 9. APAC Market Size and Forecast
9.1 Overview
9.2 Market Revenue, by Product Type (2017–2030)
9.3 Market Revenue, by Cell Line Type (2017–2030)
9.4 Market Revenue, by Service Type (2017–2030)
9.5 Market Revenue, by Country (2017–2030)
Chapter 10. LATAM Market Size and Forecast
10.1 Overview
10.2 Market Revenue, by Product Type (2017–2030)
10.3 Market Revenue, by Cell Line Type (2017–2030)
10.4 Market Revenue, by Service Type (2017–2030)
10.5 Market Revenue, by Country (2017–2030)
Chapter 11. MEA Market Size and Forecast
11.1 Overview
11.2 Market Revenue, by Product Type (2017–2030)
11.3 Market Revenue, by Cell Line Type (2017–2030)
11.4 Market Revenue, by Service Type (2017–2030)
11.5 Market Revenue, by Country (2017–2030)
Chapter 12. Competitive Landscape
12.1 List of Major Players
12.2 Market Share Analysis of Key Players
12.3 Recent Strategic Developments of Key Players
12.3.1 Expansions
12.3.2 Partnerships & Collaborations
12.3.3 Acquisitions
Chapter 13. Company Profiles
13.1 Catalent Inc.
13.1.1 Business Overview
13.1.2 Product and Service Offerings
13.1.3 Key Financial Summary
13.2 Rentschler Biopharma SE
13.2.1 Business Overview
13.2.2 Product and Service Offerings
13.3 Emergent BioSolutions Inc.
13.3.1 Business Overview
13.3.2 Product and Service Offerings
13.3.3 Key Financial Summary
13.4 JRS PHARMA LP
13.4.1 Business Overview
13.4.2 Product and Service Offerings
13.5 Boehringer Ingelheim International GmbH
13.5.1 Business Overview
13.5.2 Product and Service Offerings
13.5.3 Key Financial Summary
13.6 WuXi Biologics (Cayman) Inc.
13.6.1 Business Overview
13.6.2 Product and Service Offerings
13.6.3 Key Financial Summary
13.7 Samsung Biologics Co. Ltd.
13.7.1 Business Overview
13.7.2 Product and Service Offerings
13.7.3 Key Financial Summary
13.8 Lonza Group Ltd.
13.8.1 Business Overview
13.8.2 Product and Service Offerings
13.8.3 Key Financial Summary
13.9 FUJIFILM Diosynth Biotechnologies U.S.A. Inc.
13.9.1 Business Overview
13.9.2 Product and Service Offerings
13.10 Binex Co. Ltd.
13.10.1 Business Overview
13.10.2 Product and Service Offerings
13.11 Novartis AG
13.11.1 Business Overview
13.11.2 Product and Service Offerings
13.11.3 Key Financial Summary
13.12 AbbVie Inc.
13.12.1 Business Overview
13.12.2 Product and Service Offerings
13.12.3 Key Financial Summary
13.13 Thermo Fisher Scientific Inc.
13.13.1 Business Overview
13.13.2 Product and Service Offerings
13.13.3 Key Financial Summary
Chapter 14. Appendix
14.1 Sources and References
14.2 Related Reports
LIST OF TABLES
TABLE 1 ANALYSIS PERIOD OF THE STUDY
TABLE 2 DRIVERS FOR THE MARKET: IMPACT ANALYSIS
TABLE 3 RESTRAINTS FOR THE MARKET: IMPACT ANALYSIS
TABLE 4 GROWTH OPPORTUNITIES AND THEIR IMPACT
TABLE 5 MAJOR COVID-19 VACCINE DEALS SIGNED BY CDMO IN 2020
TABLE 6 GLOBAL BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2017–2022)
TABLE 7 GLOBAL BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2023–2026)
TABLE 8 GLOBAL BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2027–2030)
TABLE 9 GLOBAL BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2017–2022)
TABLE 10 GLOBAL BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2023–2026)
TABLE 11 GLOBAL BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2027–2030)
TABLE 12 GLOBAL BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2017–2022)
TABLE 13 GLOBAL BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2023–2026)
TABLE 14 GLOBAL BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2027–2030)
TABLE 15 GLOBAL BIOLOGICS CDMO MARKET REVENUE, BY REGION, $M (2017–2022)
TABLE 16 GLOBAL BIOLOGICS CDMO MARKET REVENUE, BY REGION, $M (2023–2026)
TABLE 17 GLOBAL BIOLOGICS CDMO MARKET REVENUE, BY REGION, $M (2027–2030)
TABLE 18 NORTH AMERICA BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2017–2022)
TABLE 19 NORTH AMERICA BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2023–2026)
TABLE 20 NORTH AMERICA BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2027–2030)
TABLE 21 NORTH AMERICA BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2017–2022)
TABLE 22 NORTH AMERICA BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2023–2026)
TABLE 23 NORTH AMERICA BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2027–2030)
TABLE 24 NORTH AMERICA BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2017–2022)
TABLE 25 NORTH AMERICA BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2023–2026)
TABLE 26 NORTH AMERICA BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2027–2030)
TABLE 27 NORTH AMERICA BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2017–2022)
TABLE 28 NORTH AMERICA BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2023–2026)
TABLE 29 NORTH AMERICA BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2027–2030)
TABLE 30 EUROPE BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2017–2022)
TABLE 31 EUROPE BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2023–2026)
TABLE 32 EUROPE BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2027–2030)
TABLE 33 EUROPE BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2017–2022)
TABLE 34 EUROPE BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2023–2026)
TABLE 35 EUROPE BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2027–2030)
TABLE 36 EUROPE BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2017–2022)
TABLE 37 EUROPE BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2023–2026)
TABLE 38 EUROPE BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2027–2030)
TABLE 39 EUROPE BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2017–2022)
TABLE 40 EUROPE BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2023–2026)
TABLE 41 EUROPE BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2027–2030)
TABLE 42 BIOLOGICS APPROVED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION, CHINA, 2019–2020
TABLE 43 APAC BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2017–2022)
TABLE 44 APAC BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2023–2026)
TABLE 45 APAC BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2027–2030)
TABLE 46 APAC BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2017–2022)
TABLE 47 APAC BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2023–2026)
TABLE 48 APAC BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2027–2030)
TABLE 49 APAC BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2017–2022)
TABLE 50 APAC BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2023–2026)
TABLE 51 APAC BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2027–2030)
TABLE 52 APAC BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2017–2022)
TABLE 53 APAC BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2023–2026)
TABLE 54 APAC BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2027–2030)
TABLE 55 LATAM BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2017–2022)
TABLE 56 LATAM BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2023–2026)
TABLE 57 LATAM BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2027–2030)
TABLE 58 LATAM BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2017–2022)
TABLE 59 LATAM BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2023–2026)
TABLE 60 LATAM BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2027–2030)
TABLE 61 LATAM BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2017–2022)
TABLE 62 LATAM BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2023–2026)
TABLE 63 LATAM BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2027–2030)
TABLE 64 LATAM BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2017–2022)
TABLE 65 LATAM BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2023–2026)
TABLE 66 LATAM BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2027–2030)
TABLE 67 MEA BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2017–2022)
TABLE 68 MEA BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2023–2026)
TABLE 69 MEA BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2027–2030)
TABLE 70 MEA BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2017–2022)
TABLE 71 MEA BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2023–2026)
TABLE 72 MEA BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2027–2030)
TABLE 73 MEA BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2017–2022)
TABLE 74 MEA BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2023–2026)
TABLE 75 MEA BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2027–2030)
TABLE 76 MEA BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2017–2022)
TABLE 77 MEA BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2023–2026)
TABLE 78 MEA BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2027–2030)
TABLE 79 LIST OF MAJOR PLAYERS
TABLE 80 CATALENT INC. – AT A GLANCE
TABLE 81 CATALENT INC. – KEY FINANCIAL SUMMARY
TABLE 82 RENTSCHLER BIOPHARMA SE – AT A GLANCE
TABLE 83 EMERGENT BIOSOLUTIONS INC. – AT A GLANCE
TABLE 84 EMERGENT BIOSOLUTIONS INC. – KEY FINANCIAL SUMMARY
TABLE 85 JRS PHARMA LP – AT A GLANCE
TABLE 86 BOEHRINGER INGELHEIM INTERNATIONAL GMBH – AT A GLANCE
TABLE 87 BOEHRINGER INGELHEIM INTERNATIONAL GMBH – KEY FINANCIAL SUMMARY
TABLE 88 WUXI BIOLOGICS (CAYMAN) INC. – AT A GLANCE
TABLE 89 WUXI BIOLOGICS (CAYMAN) INC. – KEY FINANCIAL SUMMARY
TABLE 90 SAMSUNG BIOLOGICS CO. LTD. – AT A GLANCE
TABLE 91 SAMSUNG BIOLOGICS CO. LTD. – KEY FINANCIAL SUMMARY
TABLE 92 LONZA GROUP LTD. – AT A GLANCE
TABLE 93 LONZA GROUP LTD. – KEY FINANCIAL SUMMARY
TABLE 94 FUJIFILM DIOSYNTH BIOTECHNOLOGIES U.S.A. INC. – AT A GLANCE
TABLE 95 BINEX CO. LTD. – AT A GLANCE
TABLE 96 NOVARTIS AG – AT A GLANCE
TABLE 97 NOVARTIS AG – KEY FINANCIAL SUMMARY
TABLE 98 ABBVIE INC. – AT A GLANCE
TABLE 99 ABBVIE INC. – KEY FINANCIAL SUMMARY
TABLE 100 THERMO FISHER SCIENTIFIC INC. – AT A GLANCE
TABLE 101 THERMO FISHER SCIENTIFIC INC. – KEY FINANCIAL SUMMARY
LIST OF FIGURES
FIG 1 MARKET SIZE BREAKDOWN BY SEGMENT
FIG 2 RESEARCH METHODOLOGY
FIG 3 BREAKDOWN OF PRIMARY RESEARCH, BY REGION
FIG 4 BREAKDOWN OF PRIMARY RESEARCH, BY INDUSTRY PARTICIPANT
FIG 5 BREAKDOWN OF PRIMARY RESEARCH, BY DESIGNATION
FIG 6 BREAKDOWN OF PRIMARY RESEARCH, BY COMPANY TYPE
FIG 7 DATA TRIANGULATION APPROACH
FIG 8 CURRENCY CONVERSION RATES FOR USD (2022)
FIG 9 GLOBAL BIOLOGICS CDMO MARKET SUMMARY
FIG 11 AGING POPULATION IN MAJOR REGIONS (2000–2050)
FIG 12 BARGAINING POWER OF BUYERS
FIG 13 BARGAINING POWER OF SUPPLIERS
FIG 14 INTENSITY OF RIVALRY
FIG 15 THREAT OF NEW ENTRANTS
FIG 16 THREAT OF SUBSTITUTES
FIG 17 GLOBAL BIOLOGICS CDMO MARKET SNAPSHOT
FIG 18 GLOBAL BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2017–2030)
FIG 19 GLOBAL BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2017–2030)
FIG 20 GLOBAL BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2017–2030)
FIG 21 MAJOR WORLDWIDE MARKETS FOR BIOLOGICS CDMO SERVICES, $M
FIG 22 NORTH AMERICA BIOLOGICS CDMO MARKET SNAPSHOT
FIG 23 NORTH AMERICA BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2017–2030)
FIG 24 NORTH AMERICA BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2017–2030)
FIG 25 NORTH AMERICA BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2017–2030)
FIG 26 NORTH AMERICA BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2017–2030)
FIG 27 EUROPE BIOLOGICS CDMO MARKET SNAPSHOT
FIG 28 EUROPE BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2017–2030)
FIG 29 EUROPE BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2017–2030)
FIG 30 EUROPE BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2017–2030)
FIG 31 EUROPE BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2017–2030)
FIG 32 APAC BIOLOGICS CDMO MARKET SNAPSHOT
FIG 33 APAC BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2017–2030)
FIG 34 APAC BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2017–2030)
FIG 35 APAC BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2017–2030)
FIG 36 APAC BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2017–2030)
FIG 37 LATAM BIOLOGICS CDMO MARKET SNAPSHOT
FIG 38 LATAM BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2017–2030)
FIG 39 LATAM BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2017–2030)
FIG 40 LATAM BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2017–2030)
FIG 41 LATAM BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2017–2030)
FIG 42 MEA BIOLOGICS CDMO MARKET SNAPSHOT
FIG 43 MEA BIOLOGICS CDMO MARKET REVENUE, BY PRODUCT TYPE, $M (2017–2030)
FIG 44 MEA BIOLOGICS CDMO MARKET REVENUE, BY CELL LINE TYPE, $M (2017–2030)
FIG 45 MEA BIOLOGICS CDMO MARKET REVENUE, BY SERVICE TYPE, $M (2017–2030)
FIG 46 MEA BIOLOGICS CDMO MARKET REVENUE, BY COUNTRY, $M (2017–2030)
FIG 47 GLOBAL BIOLOGICS CDMO MARKET SHARE OF KEY PLAYERS (2022)
FIG 48 CATALENT INC. – REVENUE SPLIT BY SEGMENT AND GEOGRAPHY (2022)
FIG 49 EMERGENT BIOSOLUTIONS INC. – REVENUE SPLIT BY SEGMENT (2022)
FIG 50 BOEHRINGER INGELHEIM INTERNATIONAL GMBH – REVENUE SPLIT BY SEGMENT AND GEOGRAPHY (2021)
FIG 51 WUXI BIOLOGICS (CAYMAN) INC. – REVENUE SPLIT BY SEGMENT AND GEOGRAPHY (2022)
FIG 52 SAMSUNG BIOLOGICS CO. LTD. – REVENUE SPLIT BY SEGMENT AND GEOGRAPHY (2022)
FIG 53 LONZA GROUP LTD. – REVENUE SPLIT BY SEGMENT AND GEOGRAPHY (2022)
FIG 54 NOVARTIS AG – REVENUE SPLIT BY SEGMENT AND GEOGRAPHY (2022)
FIG 55 ABBVIE INC. – REVENUE SPLIT BY PRODUCT CATEGORY AND GEOGRAPHY (2022)
FIG 56 THERMO FISHER SCIENTIFIC INC. – REVENUE SPLIT BY SEGMENT AND GEOGRAPHY (2022)
| ※参考情報 生物製剤CDMO(Contract Development and Manufacturing Organization)は、生物製剤の開発と製造を専門とする契約受託機関のことを指します。生物製剤とは、抗体、ワクチン、遺伝子治療薬、細胞治療薬など、生物由来の製品であり、従来の化学合成による医薬品とは異なります。CDMOは、製薬企業がお自身の製品の開発や製造を外部に委託する際に利用されます。 生物製剤CDMOの主な種類には、開発CDMOと製造CDMOがあります。開発CDMOは、製品の初期の研究開発段階をサポートすることに特化しています。これには、実験室でのスクリーニング、前臨床試験用のバイオ製品のプロトタイプ作成、さらには臨床試験のプロセスまでが含まれます。一方、製造CDMOは、開発が完了した製品の大規模生産を行います。この段階では、GMP(Good Manufacturing Practice)に準拠した生産が求められ、品質管理や規制対応が重要なポイントとなります。 生物製剤CDMOの用途は多岐にわたります。例えば、製薬企業が新しい治療法を開発する際には、専門的な知識や設備が必要となりますが、CDMOはそれを提供することにより、製薬企業が自社のリソースを集中させることを可能にします。これにより、製薬企業は製品の市場投入までの期間を短縮でき、リスクを分散することもできます。 生物製剤CDMOの関連技術には、細胞培養技術や発酵技術があります。細胞培養技術は、生物製剤の製造に不可欠な基盤技術です。細胞培養を通じて、ターゲットとするタンパク質を大量に生産することが可能です。また、発酵技術は微生物を利用して metabolite(代謝物)を生成する手法であり、高効率の生産を実現します。 さらに、分析技術もCDMOにおいて重要です。製品の品質を保証するために、様々な分析方法が用いられます。例えば、高度な質量分析やクロマトグラフィ技術を用いて、製品の純度や活性を確認することが求められます。特にタンパク質製剤の場合、折りたたみの状態や構造が製品の効果に大きく影響するため、これらを正確に分析する技術が重要です。 また、最近ではAIや機械学習の活用も進んでおり、これにより製品開発のプロセスが効率化されています。データ解析によって、より良い製品設計やプロトタイプの選定が行われ、研究の初期段階から速度と精度を向上させることが可能となります。 生物製剤CDMOは、製薬業界のサプライチェーンにおいて重要な役割を担っています。製薬企業は開発や製造のアウトソーシングによって、リソースの最適化を図り、ビジネスモデルを柔軟に変えることができるようになります。特に、現在の医療ニーズに応じた新たな生物医薬品の開発が進む中で、CDMOの重要性はますます高まっています。 最後に、生物製剤CDMOは、規制要件の厳しい環境下で運営されているため、高度な専門知識と経験が求められます。製品が市場に投入されるまでの過程すべてにおいて、品質と安全性が確保されなければなりません。このように、CDMOは製薬企業と密接に連携し、高品質な生物製剤の供給を支える重要な存在です。 |
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