Global Biologics CDMO Market Size, Trends & Forecast I BIS Research

Market Research Report

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1.1       Market Definition
1.2       Key Questions Answered in the Report
1.3       Analyst and Forecast Note

2.1       Trends: Current and Future Impact Assessment
2.1.1           Trend 1 – Increasing Biomanufacturing Capacity
2.1.2           Trend 2 – Single-use Bioprocessing Equipment
2.1.3           Trend 3 – Trend Toward Personalized Medicine
2.2       Market Footprint
2.3       Supply Chain Overview
2.4       Patent Analysis
2.5       Regulatory Landscape
2.6       Factors Considered While Outsourcing To CDMO
2.7       Market Dynamics Overview
2.8       Market Drivers
2.9       Market Restraints
2.10       Market Opportunities

3.1       Cell Type Summary
3.2       Mammalian
3.3       Microbial and Others

4.1       Indication Summary
4.2       Oncology
4.3       Auto-Immune Diseases
4.4       Infectious Diseases
4.5       Neurology
4.6       Others

5.1       Molecule Type Summary
5.2       Monoclonal Antibodies
5.3       Recombinant Proteins
5.4       Vaccines
5.5       Hormones
5.6       Others

6.1       Regional Summary
6.2       Drivers and Restraints
6.3       North America
6.3.1           North America Biologics CDMO Market, by Cell Type
6.3.2           North America Biologics CDMO Market, by Molecule Type
6.3.3           North America (by Country)
6.3.3.1               U.S.
6.3.3.1.1                   U.S. Biologics CDMO Market, by Cell Type
6.3.3.1.2                   U.S. Biologics CDMO Market, by Molecule Type
6.3.3.2               Canada
6.3.3.2.1                   Canada Biologics CDMO Market, by Cell Type
6.3.3.2.2                   Canada Biologics CDMO Market, by Molecule Type
6.4       Europe
6.4.1           Europe Biologics CDMO Market, by Cell Type
6.4.2           Europe Biologics CDMO Market, by Molecule Type
6.4.3           Europe (by Country)
6.4.3.1               Germany
6.4.3.1.1                   Germany Biologics CDMO Market, by Cell Type
6.4.3.1.2                   Germany Biologics CDMO Market, by Molecule Type
6.4.3.2               U.K.
6.4.3.2.1                   U.K. Biologics CDMO Market, by Cell Type
6.4.3.2.2                   U.K. Biologics CDMO Market, by Molecule Type
6.4.3.3               France
6.4.3.3.1                   France Biologics CDMO Market, by Cell Type
6.4.3.3.2                   France Biologics CDMO Market, by Molecule Type
6.4.3.4               Italy
6.4.3.4.1                   Italy Biologics CDMO Market, by Cell Type
6.4.3.4.2                   Italy Biologics CDMO Market, by Molecule Type
6.4.3.5               Spain
6.4.3.5.1                   Spain Biologics CDMO Market, by Cell Type
6.4.3.5.2                   Spain Biologics CDMO Market, by Molecule Type
6.4.3.6               Rest-of-Europe
6.4.3.6.1                   Rest-of-Europe Biologics CDMO Market, by Cell Type
6.4.3.6.2                   Rest-of-Europe Biologics CDMO Market, by Molecule Type
6.5       Asia-Pacific
6.5.1           Asia-Pacific Biologics CDMO Market, by Cell Type
6.5.2           Asia-Pacific Biologics CDMO Market, by Molecule Type
6.5.3           Asia-Pacific (by Country)
6.5.3.1               China
6.5.3.1.1                   China Biologics CDMO Market, by Cell Type
6.5.3.1.2                   China Biologics CDMO Market, by Molecule Type
6.5.3.2               Japan
6.5.3.2.1                   Japan Biologics CDMO Market, by Cell Type
6.5.3.2.2                   Japan Biologics CDMO Market, by Molecule Type
6.5.3.3               India
6.5.3.3.1                   India Biologics CDMO Market, by Cell Type
6.5.3.3.2                   India Biologics CDMO Market, by Molecule Type
6.5.3.4               Australia
6.5.3.4.1                   Australia Biologics CDMO Market, by Cell Type
6.5.3.4.2                   Australia Biologics CDMO Market, by Molecule Type
6.5.3.5               Rest-of-Asia-Pacific
6.5.3.5.1                   Rest-of-Asia-Pacific Biologics CDMO Market, by Cell Type
6.5.3.5.2                   Rest-of-Asia-Pacific Biologics CDMO Market, by Molecule Type
6.6       Latin America
6.6.1           Latin America Biologics CDMO Market, by Cell Type
6.6.2           Latin America Biologics CDMO Market, by Molecule Type
6.6.3           Latin America (by Country)
6.6.3.1               Brazil
6.6.3.1.1                   Brazil Biologics CDMO Market, by Cell Type
6.6.3.1.2                   Brazil Biologics CDMO Market, by Molecule Type
6.6.3.2               Mexico
6.6.3.2.1                   Mexico Biologics CDMO Market, by Cell Type
6.6.3.2.2                   Mexico Biologics CDMO Market, by Molecule Type
6.6.3.3               Rest-of-Latin America
6.6.3.3.1                   Rest-of-Latin America Biologics CDMO Market, by Cell Type
6.6.3.3.2                   Rest-of-Latin America Biologics CDMO Market, by Molecule Type
6.7       Middle East and Africa
6.7.1           Middle East and Africa Biologics CDMO Market, by Cell Type
6.7.2           Middle East and Africa Biologics CDMO Market, by Molecule Type
6.7.3           Middle East and Africa (by Country)
6.7.3.1               K.S.A.
6.7.3.1.1                   K.S.A. Biologics CDMO Market, by Cell Type
6.7.3.1.2                   K.S.A. Biologics CDMO Market, by Molecule Type
6.7.3.2               U.A.E.
6.7.3.2.1                   U.A.E. Biologics CDMO Market, by Cell Type
6.7.3.2.2                   U.A.E. Biologics CDMO Market, by Molecule Type
6.7.3.3               Rest-of-Middle East and Africa
6.7.3.3.1                   Rest-of-Middle East and Arica Biologics CDMO Market, by Cell Type
6.7.3.3.2                   Rest-of-Middle East and Arica Biologics CDMO Market, by Molecule Type

7.1       Competitive Landscape
7.2       AbbVie Inc.
7.3       AGC Biologics
7.4       Binex Co. Limited
7.5       Boehringer Ingelheim International GmbH
7.6       Catalent, Inc
7.7       Lonza
7.8       Novartis AG
7.9       Parexel International Corporation
7.10       Samsung Biologics
7.11       Toyobo Co., Ltd.

Biologics CDMO Market Report Coverage

Biologics CDMO Market
Base Year	2022	Market Size in 2022	$19.00 Billion
Forecast Period	2023-2032	Value Projection and Estimation by 2032	$80.05 Billion
CAGR During Forecast Period	15.43%

Key Market Players and Competition Synopsis

The biologics CDMO market is experiencing robust growth and evolving as a critical component of the biopharmaceutical industry. This dynamic market is characterized by an increasing demand for outsourcing services in the development and manufacturing of biologic drugs. Biologics, including monoclonal antibodies, recombinant proteins, and gene therapies, represent a significant and expanding segment of the pharmaceutical landscape. As pharmaceutical and biotech companies seek to bring innovative biologics to market, they often turn to CDMOs to leverage specialized expertise, state-of-the-art technologies, and cost-effective solutions. The market is marked by a diverse range of CDMOs, each offering distinct capabilities across the biologics' development and manufacturing value chain.

With a global footprint, these CDMOs are positioned to address the industry's increasing demand for flexible, high-quality, and efficient solutions in biologics development and manufacturing. As the biopharmaceutical market continues to expand, the biologics CDMO market is poised to play a pivotal role in facilitating the translation of innovative therapies from concept to commercialization.

Some of the prominent companies in this market are:

•   AbbVie Inc.
•   AGC Biologics
•   Binex Co. Limited
•   Boehringer Ingelheim International GmbH
•   Catalent, Inc
•   Lonza
•   Novartis AG
•   Parexel International Corporation
•   Samsung Biologics
•   Toyobo Co., Ltd.

Companies that are not a part of the aforementioned pool have been well-represented across different sections of the report (wherever applicable).

How can this report add value to an organization?

Workflow/Innovation Strategy: The biologics CDMO market (by molecule type) has been segmented into different types of molecules used in developing biologics. Moreover, the study provides the reader with a detailed understanding of the different cell types and indications as well.

Growth/Marketing Strategy: The market growth and marketing strategy of biologics CDMO market revolves around a combination of technical excellence, strategic collaborations, and global market positioning. CDMOs leverage their specialized expertise in bioprocessing and manufacturing to offer comprehensive solutions to biopharmaceutical companies.

Competitive Strategy: Key players in the global biologics CDMO market have been analyzed and profiled in the study, including CDMOs involved in new product launches, acquisitions, expansions, and strategic collaborations. Moreover, a detailed competitive benchmarking of the players operating in the global biologics CDMO market has been done to help the reader understand how players stack against each other, presenting a clear market landscape. Additionally, comprehensive competitive strategies such as partnerships, agreements, and collaborations will aid the reader in understanding the untapped revenue pockets in the market.

Methodology

Key Considerations and Assumptions in Market Engineering and Validation

•   The scope of this report focuses on various cell types, molecule types, and indications in the global biologics CDMO market.
•   The base currency considered for the market analysis is US$. Currencies other than the US$ have been converted to the US$ for all statistical calculations, considering the average conversion rate for that particular year.
•   The currency conversion rate has been taken from the historical exchange rate of the Oanda website.
•   The information rendered in the report is a result of in-depth primary interviews, surveys, and secondary analysis.
•   Where relevant information was not available, proxy indicators and extrapolation were employed.
•   Any economic downturn in the future has not been taken into consideration for the market estimation and forecast.
•   Technologies currently used are expected to persist through the forecast with no major breakthroughs in technology.

Primary Research

The primary sources involve industry experts from the biologics CDMO stakeholders. Respondents such as CEOs, vice presidents, marketing directors, and technology and innovation directors have been interviewed to obtain and verify both qualitative and quantitative aspects of this research study.

Secondary Research

This research study involves the usage of extensive secondary research, directories, company websites, and annual reports. It also makes use of databases, such as Hoovers, Bloomberg, Businessweek, and Factiva, to collect useful and effective information for an extensive, technical, market-oriented, and commercial study of the global market. In addition to the aforementioned data sources, the study has been undertaken with the help of other data sources and websites, such as the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), World Health Organization (WHO), National Center for Biotechnology Information, and others.

The key data points taken from the secondary sources include:

•   Segmentations, split-ups, and percentage shares
•   Data for market value
•   Key industry trends of the top players in the market
•   Qualitative insights into various aspects of the market, key trends, and emerging areas of innovation
•   Quantitative data for mathematical and statistical calculations

Global Biologics CDMO Market Overview

As of 2022, the global biologics CDMO market held a value of $19.00 billion. The market is expected to grow at a CAGR of 15.43% during the forecast period 2023-2032 and attain a value of $80.05 billion by 2032. The market's trajectory suggests a transformative impact on pharmaceutical care, with companies adept at addressing regulatory complexities and embracing technological innovations poised for significant success.

Market Lifecycle Stage

The biologics CDMO market is in the growth stage of its lifecycle, which can be characterized by increasing adoption of biologics, rising demand for outsourced manufacturing services, and growing investments in CDMO capacity.

The growth of the biologics CDMO market is being driven by several factors, including the increasing prevalence of chronic diseases, the development of new and innovative biologics therapies, and the aging of the population. This growth is expected to drive demand for outsourced manufacturing services as pharmaceutical companies increasingly focus on their core competencies of research and development.

CDMOs are well-positioned to capitalize on this growth, as they offer a range of services that can help pharmaceutical companies bring their biologics products to market quickly and efficiently. These services include upstream processing, downstream processing, and analytical services. The biologics CDMO market has also been benefiting from increasing investments in CDMO capacity, which is being driven by the need to meet the growing demand for biologics manufacturing services. In addition, CDMOs are investing in new technologies, such as single-use bioreactors and continuous manufacturing, which can help to improve efficiency and reduce costs.

Industry Impact

The emergence and growth of the biologics CDMO market have significantly transformed the biopharmaceutical industry. Biologics CDMOs play a pivotal role in expediting drug development and manufacturing processes, offering specialized expertise, state-of-the-art technologies, and scalable solutions. This market has not only provided cost-efficient alternatives for companies, particularly startups and smaller enterprises, by reducing the need for substantial capital investment but has also facilitated risk mitigation through its adept handling of regulatory complexities. Moreover, the global reach and diverse capabilities of biologics CDMOs contribute to the globalization of biomanufacturing, enabling pharmaceutical companies to navigate regional regulatory landscapes seamlessly. The competitive landscape spurred by a thriving CDMO sector fosters innovation and technological advancements, benefiting the entire biopharmaceutical ecosystem. As strategic partners, biologics CDMOs continue to enhance the industry's capacity, flexibility, and efficiency, playing a crucial role in meeting the rising demand for biologic drugs.

Market Segmentation:

Segmentation 1: by Cell Type
• Mammalian
• Microbial and Others

Mammalian Segment to Dominate the Global Biologics CDMO Market (by Cell Type)

The mammalian segment dominated the global biologics CDMO market (by cell type) in FY2022. Mammalian cell lines are widely preferred in biopharmaceutical production due to their ability to replicate complex proteins accurately, ensuring high bioactivity and minimal post-translational modifications. This cell type is particularly well-suited for the manufacturing of monoclonal antibodies, which constitute a substantial portion of biologic drugs. Mammalian cell cultures offer scalability, robust performance, and compatibility with the intricate requirements of therapeutic protein production. As the biologics CDMO market continues to expand, the dominance of mammalian cell culture technology underscores its pivotal role in meeting the growing demand for advanced biopharmaceuticals on a global scale.

Segmentation 2: by Indication
•   Oncology
•   Auto-Immune Diseases
•   Infectious Diseases
•   Neurology
•   Others

Oncology Segment to Dominate the Global Biologics CDMO Market (by Indication)

The oncology segment dominated the global biologics CDMO market (by indication) in FY2022. The surge in cancer research and the development of targeted therapies and immunotherapies have driven a substantial portion of biopharmaceutical innovations toward addressing various types of cancer. As a result, CDMOs specializing in biologics production are increasingly engaged in manufacturing processes for oncology-related biologic drugs, such as monoclonal antibodies and cell-based therapies. This trend reflects the growing emphasis on personalized medicine and the need for specialized manufacturing capabilities to cater to the complexities of oncology treatments.

Segmentation 3: by Molecule Type
•   Monoclonal Antibodies
•   Recombinant Proteins
•   Vaccines
•   Hormones
•   Others

Monoclonal Antibodies Segment to Dominate the Global Biologics CDMO Market (by Molecule Type)

The global biologics CDMO market (by molecule type) was dominated by the monoclonal antibodies segment in FY2022. The widespread adoption of monoclonal antibodies (mAbs) in therapeutic applications, particularly for treating various diseases such as cancer, autoimmune disorders, and infectious diseases, has fueled their prominence in the biopharmaceutical landscape. As precision medicine gains traction, mAbs offer targeted and specific treatment approaches, contributing to their increasing demand. Biologics CDMOs are witnessing a surge in requests for the development and manufacturing of monoclonal antibodies, owing to their critical role in the evolving paradigm of biologic drug development.

Segmentation 4: by Region
•   North America
•   Europe
•   Asia-Pacific
•   Latin America
•   Middle East and Africa

China dominated the Asia-Pacific market in 2022 with a share of 40.18%. Moreover, Asia-Pacific is expected to register the highest CAGR of 17.46% during the forecast period 2023-2032. The biologics CDMO market in the Asia-Pacific (APAC) region is witnessing significant growth, marked by increasing demand, technological advancements, and a rising burden of chronic disease.

Recent Developments in the Global Biologics CDMO Market

•   In November 2023, Boehringer Ingelheim Internation GmbH expanded the usage of gene data biologics to DMPK operations.
•   In November 2023, Lonza introduced the new GS Effex cell line with the intention of assisting biotech firms in developing more advanced therapeutic antibodies.
•   In October 2023, Lonza signed a new commercial agreement with Vaxcyte for the global manufacturing of broad-spectrum pneumococcal conjugate vaccines (PCVs).
•   In August 2023, AGC Biologics completed the expansion of the cell and gene therapy (CGT) manufacturing site in Milan.
•   In August 2023, AGC Biologics announced a new agreement with Asahi Kasei Pharma Corporation to produce clinical drug substances for antibody-based therapies.
•   In July 2023, Boehringer Ingelheim Internation GmbH announced the commercial availability of its adalimumab (Humira) biosimilar, adalimumab-adbm (Cyltezo), in the U.S.
•   In July 2023, Biocon Biologics launched a biosimilar version of AbbVie’s rheumatoid arthritis drug Humira in the U.S.
•   In March 2023, Catalent, Inc. licensed Bhami Research Laboratory Technology for biologics formulation development.

Demand - Drivers, Restraints, and Opportunities

Market Drivers:

•   Growing Biologics Approvals and Development
•   Rising Prevalence of Chronic Infectious Diseases
•   Advantages of Investment in Contract Manufacturing Facilities

Market Restraints:

• Stringent Regulatory Requirements
• Shortage of Skilled Professionals in Bioprocessing and Biomanufacturing

Market Opportunities:

• New Outsourcing Opportunities in China
• Potential for Additional CDMO and Big Pharma Alliances

Analyst View

According to Swati Sood, Principal Analyst at BIS Research, “The global biologics CDMO market is experiencing significant growth driven by a confluence of factors. One of the primary drivers is the growing number of biologics approvals and developments, as the surge in approvals reflects the growing significance of biopharmaceuticals in treating various medical conditions and the expanding pipeline of innovative biologic drugs.”

Biologics CDMO Market - A Global and Regional Analysis, 2023-2032

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Some Faq's

Frequently Asked Questions

Biologics CDMOs are specialized service providers in the pharmaceutical industry that offer comprehensive support for the development and manufacturing of biologic drugs. Biologics are complex therapeutic products derived from living cells or organisms, including monoclonal antibodies, vaccines, gene therapies, and cell-based therapies. CDMOs play a crucial role by providing expertise and services throughout the biopharmaceutical development process.

The biologics CDMO market witnessed several trends driven by technological advancements, increased research and development, and broader applications in various sectors. Here are some key trends observed in this market:

•   Increasing Demand for Biologics: The global demand for biologic drugs continues to rise, driven by advancements in biotechnology and an expanding list of therapeutic indications. This trend fuels the need for specialized CDMOs to support biologics development and manufacturing.
•   Biosimilar Development: The growth of biosimilars, which are biologic drugs similar to existing innovator products, has led to increased collaboration between CDMOs and pharmaceutical companies aiming to enter the biosimilars market.
•   Cell and Gene Therapies: The emergence of cell and gene therapies represents a significant trend. CDMOs are adapting their capabilities to support the unique manufacturing requirements of these advanced therapies, including personalized medicine approaches.
•   Single-Use Technologies: The adoption of single-use technologies in bioprocessing is on the rise. CDMOs are incorporating disposable systems to enhance flexibility, reduce contamination risks, and expedite manufacturing processes.

These are only a few illustrations of the major trends in the industry.

The global biologics CDMO market is currently witnessing several developments, primarily aimed at entering into collaborations and partnerships. Major CDMOs of products are actively undertaking significant business strategies to translate success in the market. Companies such as AbbVie Inc., AGC Biologics, and Catalent, Inc., among others, have majorly adopted partnerships, collaborations, and joint venture strategies.

A new entrant in the market can focus on investing in cutting-edge technologies and state-of-the-art facilities for bioprocessing and analytics, which are crucial to ensure efficient and high-quality production. Additionally, focusing on flexibility and scalability in manufacturing processes will appeal to clients with diverse needs. Developing expertise in emerging areas, such as cell and gene therapies, biosimilars, and personalized medicine, can position the company as an industry leader.

•   Market growth potential
•   Patent analysis
•   Regulatory landscape
•   Market dynamics
•   Market opportunities
•   Detailed segmentation, such as cell type, molecule type, and indication
•   Region and country level market size and forecast for cell type and molecule type segments.
•   Competitive landscape

The following can buy this report:

• Companies such as CDMOs/CROs/CMOs producing biologics, manufacturers of biologics, and pharmaceutical companies
• Any new entrant who wants to know where the opportunities lie in the biologics CDMO market

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Global Biologics CDMO Market Overview

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Table of Contents

1 Scope and Definition

2 Markets: Industry Outlook

3 Global Biologics CDMO Market (by Cell Type), 2022-2032

4 Global Biologics CDMO Market (by Indication), 2022-2032

5 Global Biologics CDMO Market (by Molecule Type), 2022-2032

6 Global Biologics CDMO Market, by Region, 2022-2032

7 Markets - Competitive Benchmarking & Company Profiles

Biologics CDMO Market Report Coverage

How can this report add value to an organization?

Global Biologics CDMO Market Overview

Biologics CDMO Market - A Global and Regional Analysis, 2023-2032

Frequently Asked Questions

Q: What are biologics CDMO?

Q: What are the key trends in the biologics CDMO market?

Q: What kinds of new strategies are being adopted by the existing market players to strengthen their market positions in the industry?

Q: For a new company looking to enter the global biologics CDMO market, which areas could it focus on to stay ahead of the competition?

Q: What is the USP of this report?

Q: Who should buy this report?

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