バイオCDMOの世界市場

Report Overview

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.

Summary:

Contract development and manufacturing organizations serve the pharmaceutical industry and provide clients with services such as drug development, process development, analytical testing, formulation development, scale-up, manufacturing, packaging and distribution. These services can be provided on a standalone basis or as part of an end-to-end service offering.

A biologics contract development and manufacturing organization (CDMO) provides pharmaceutical companies with biological medical product development and manufacturing services. This type of CDMO may either specialize in developing and manufacturing biologics alone, or may offer these same services for biologics and small molecule drugs. Biologics is a general term for drugs manufactured using biotechnology. Unlike small-molecule drugs chemically manufactured, biologics are complex molecules, such as proteins or cells used as medicinal ingredients.

When a pharmaceutical company discovers a new medical biologic, it may choose to partner with a biologics CDMO to outsource one or more steps of the development and manufacturing process. Some biologics CDMOs focus on supporting certain parts of the development process, while full-service biologics CDMOs have the capability to handle each stage of drug development and manufacturing. Biologics CDMOs are valuable resources for pharmaceutical companies, as they have extensive experience navigating everything from pre-formulation to clinical trials and commercial production.

The global biologics CDMO market was valued at nearly $REDACTED billion in 2022. The market is expected to grow at a compound annual growth rate (CAGR) of REDACTED% to reach $REDACTED billion by the end of 2028. Growth in this market is fueled by the increasing R&D activities, prevalence of chronic diseases, rising demand for biologics, increasing aging populations, continuing investment in healthcare infrastructure, and the perpetual parade of new products.
In this report, the global market for biologics CDMO is segmented into product type, cell line type and geographic region. Product types include biologics and biosimilars.

Biologics CDMO companies are concentrating on pharmaceutical and biotechnology companies to provide services for drug development. For instance, in April 2022, ChimeronBio signed a manufacturing agreement with FujiFilm Diosynth Biotechnologies (FDB) to expand its oncology portfolio to include clinics. ChimeronBio selected FDB as its partner for transferring and scaling its drug substance manufacturing process.

The global market for biologics CDMO by cell line type is categorized into mammalian, microbial and other modalities. The mammalian segment is expected to increase from $REDACTED billion in 2022 to $REDACTED billion by the end of 2028, at a CAGR of REDACTED% for the period.

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 Synopsis

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

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