Biologics Outsourcing Market
Biologics Outsourcing Market Forecasts to 2030 - Global Analysis By Product (Antibodies, Vaccines, Recombinant Proteins and Other Products), Type (Instruments and Kits & Reagents), Source, Service, Application, End User and By Geography
Years Covered |
2021-2030 |
Estimated Year Value (2023) |
US $23.78 BN |
Projected Year Value (2030) |
US $62.20 BN |
CAGR (2023 - 2030) |
16.0% |
Regions Covered |
North America, Europe, Asia Pacific, South America, and Middle East & Africa |
Countries Covered |
US, Canada, Mexico, Germany, UK, Italy, France, Spain, Japan, China, India, Australia, New Zealand, South Korea, Rest of Asia Pacific, South America, Argentina, Brazil, Chile, Middle East & Africa, Saudi Arabia, UAE, Qatar, and South Africa |
Largest Market |
Asia Pacific |
Highest Growing Market |
North America |
According to Stratistics MRC, the Global Biologics Outsourcing Market is accounted for $23.78 billion in 2023 and is expected to reach $62.20 billion by 2030 growing at a CAGR of 16.0% during the forecast period. Biologics Outsourcing refers to the practice of contracting specialized services in the biopharmaceutical industry to external partners, such as contract research organizations (CROs) and contract manufacturing organizations (CMOs), for various stages of biologic drug development, manufacturing, or research. It aims to streamline operations, reduce costs, accelerate timelines, access specialized resources, and expand the portfolio of biologic therapies available in the market.
According to the World Health Organisation (WHO), coronavirus disease 2019 (COVID-19) is a highly contagious infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As of February 15, 2023, about 756,291,327 people are affected worldwide.
Market Dynamics:
Driver:
Increasing biologics development
Pharmaceutical companies increasingly focus on biologic drug development for various ailments, like cancer and autoimmune disorders. This heightened development necessitates specialised expertise and infrastructure, driving the outsourcing of research, development, and manufacturing to contract research organisations (CROs) and contract manufacturing organisations (CMOs). Moreover, outsourcing allows for leveraging external capabilities, accelerating drug development timelines, and accessing specialised resources, thereby fostering innovation and expanding the array of available biologic therapies.
Restraint:
Quality control and assurance
Ensuring consistent and stringent quality standards across diverse outsourcing partners poses challenges. Harmonising quality control measures and maintaining uniformity in production processes, especially for biologic drugs with complex manufacturing requirements, can be demanding. Variability in quality assurance practices among different partners might impact the reliability and consistency of biologics, raising concerns about product efficacy and safety.
Opportunity:
Advanced technologies and innovation
The rapid evolution of bioprocessing technologies, such as single-use systems, continuous manufacturing, and gene editing tools, offers outsourcing partners the chance to adopt and integrate cutting-edge innovations into their service offerings. By embracing these advancements, outsourcing firms can enhance their capabilities in biologics development, production, and quality control. Furthermore, investing in and utilising these cutting-edge technologies allows outsourcing partners to provide unique and competitive services that draw in clients looking for cutting-edge technologies and provide growth prospects in the ever-changing biologics development and manufacturing market.
Threat:
Dependency on external expertise
Dependency on external expertise poses a significant threat in the Biologics Outsourcing market. Relying extensively on outsourcing partners for critical functions like research, development, and manufacturing might limit in-house knowledge and control over the biologics production process. Overreliance on external expertise could potentially result in a lack of flexibility, increased vulnerability to disruptions, and reduced agility in responding to dynamic market needs.
Covid-19 Impact
The COVID-19 pandemic had a significant impact on the biologics outsourcing market. The pandemic's primary impact has been a rise in the demand for biologics and the ensuing requirement for outsourcing services. Many pharmaceutical companies are outsourcing to specialised contract development and manufacturing organisations (CDMOs) to handle their biologics manufacturing and development needs due to the emerge to develop effective vaccines and therapies against the virus. In order to guarantee a steady supply of biologics products, this disruption compelled numerous pharmaceutical corporations to search for other outsourcing possibilities.
The antibodies segment is expected to be the largest during the forecast period
The antibodies segment is estimated to hold the largest share. Antibodies are used as therapeutic agents to target particular molecules that cause disease, assisting with the treatment of a variety of diseases such as infectious diseases, autoimmune diseases, and cancer. Antibodies are extensively employed in drug discovery, development, and many other fields for target validation, protein characterization, and quantification. In addition, outsourcing antibodies ensures regulatory compliance and lowers regulatory risks for the companies, allowing them to concentrate on their core strengths, which include drug discovery, pre-clinical and clinical research, and other R&D operations.
The oncology segment is expected to have the highest CAGR during the forecast period
The oncology segment is anticipated to have lucrative growth during the forecast period. Biologics offer targeted and personalised approaches to cancer treatment, making them highly effective in combating various types of malignancies. Contract research organisations (CROs) and contract manufacturing organisations (CMOs) offer specialised support for oncology-related biologics, including monoclonal antibodies, immunotherapies, and targeted therapies. Moreover, with an increasing number of pharmaceutical companies focusing on oncology drug development, the need for outsourcing services in this segment is expected to surge.
Region with largest share:
Asia Pacific commanded the largest market share during the extrapolated period. The region's growing biopharmaceutical industry, favourable regulatory frameworks, and increasing investments in research and development fuel the market's expansion. Furthermore, outsourcing biologics production, including contract research, development, and manufacturing services, thrives in Asia-Pacific due to its competitive advantages in cost-efficiency, innovation, and access to a diverse patient pool. This region continues to play a pivotal role in the global biologics outsourcing landscape, fostering growth and innovation within the industry.
Region with highest CAGR:
North America is expected to witness profitable growth over the projection period due to robust healthcare infrastructure, cutting-edge research and development facilities, and a strong emphasis on innovation. Furthermore, the growing need for biologics, such as vaccines, cell treatments, and monoclonal antibodies, has encouraged pharmaceutical and biotechnology companies to outsource their biologic production processes due to the high expense of internal manufacture. North America has become a popular destination for biologics outsourcing due to its advantageous geographic position and plenty of highly skilled labour.
Key players in the market
Some of the key players in the Biologics Outsourcing Market include Thermo Fisher Scientific Inc, Adimab LLC, Abzena Ltd., KBI Biopharma, Curia Global, Inc., EirGenix, Inc., Bionova Scientific, Inc., Boehringer Ingelheim International GmbH., Abbvie Inc., STC Biologics, Avid Bioservices, Inc., Catalent Inc., Genentech, Inc., Eurofins Scientific, Genscript Biotech Corporation, Lonza, JSR Corporation, Merck KGaA, Rentschler Biopharma SE and Emergent.
Key Developments:
In December 2022, AbbVie partnered with AbCellera Biologics Inc. The partnership leverage AbCellera’s antibody discovery and development engine to deliver optimized development candidates for up to five targets selected by AbbVie across multiple indications. This helped the company to enhance its service offerings.
In December 2022, Thermo Fisher expanded its biologics and steriles manufacturing capabilities in China. The facility offers integrated clinical and commercial drug substance and drug product capabilities. This includes process development, cell line development, biologics drug substance manufacturing, and sterile fill-finish. This helped the company expand its geographic presence.
Products Covered:
• Antibodies
• Vaccines
• Recombinant Proteins
• Other Products
Types Covered:
• Instruments
• Kits & Reagents
Sources Covered:
• Microbial
• Mammalian
Services Covered:
• Cell Development
• Analytical Testing
• Process Development
• CGMP Manufacturing
• Other Services
Applications Covered:
• Oncology
• Blood & Blood-Related Products Development
• Cellular and Gene Therapy
• Stem Cell Research
• Vaccine and Therapeutics Development
• Other Applications
End Users Covered:
• Pharmaceutical Industries
• CDMO
• Biotechnology Industries
Regions Covered:
• North America
o US
o Canada
o Mexico
• Europe
o Germany
o UK
o Italy
o France
o Spain
o Rest of Europe
• Asia Pacific
o Japan
o China
o India
o Australia
o New Zealand
o South Korea
o Rest of Asia Pacific
• South America
o Argentina
o Brazil
o Chile
o Rest of South America
• Middle East & Africa
o Saudi Arabia
o UAE
o Qatar
o South Africa
o Rest of Middle East & Africa
What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements
Free Customization Offerings:
All the customers of this report will be entitled to receive one of the following free customization options:
• Company Profiling
o Comprehensive profiling of additional market players (up to 3)
o SWOT Analysis of key players (up to 3)
• Regional Segmentation
o Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances
Table of Contents
1 Executive Summary
2 Preface
2.1 Abstract
2.2 Stake Holders
2.3 Research Scope
2.4 Research Methodology
2.4.1 Data Mining
2.4.2 Data Analysis
2.4.3 Data Validation
2.4.4 Research Approach
2.5 Research Sources
2.5.1 Primary Research Sources
2.5.2 Secondary Research Sources
2.5.3 Assumptions
3 Market Trend Analysis
3.1 Introduction
3.2 Drivers
3.3 Restraints
3.4 Opportunities
3.5 Threats
3.6 Product Analysis
3.7 Application Analysis
3.8 End User Analysis
3.9 Emerging Markets
3.10 Impact of Covid-19
4 Porters Five Force Analysis
4.1 Bargaining power of suppliers
4.2 Bargaining power of buyers
4.3 Threat of substitutes
4.4 Threat of new entrants
4.5 Competitive rivalry
5 Global Biologics Outsourcing Market, By Product
5.1 Introduction
5.2 Antibodies
5.3 Vaccines
5.4 Recombinant Proteins
5.5 Other Products
6 Global Biologics Outsourcing Market, By Type
6.1 Introduction
6.2 Instruments
6.3 Kits & Reagents
7 Global Biologics Outsourcing Market, By Source
7.1 Introduction
7.2 Microbial
7.3 Mammalian
8 Global Biologics Outsourcing Market, By Service
8.1 Introduction
8.2 Cell Development
8.3 Analytical Testing
8.4 Process Development
8.5 cGMP Manufacturing
8.6 Other Services
9 Global Biologics Outsourcing Market, By Application
9.1 Introduction
9.2 Oncology
9.3 Blood & Blood-Related Products Development
9.4 Cellular and Gene Therapy
9.5 Stem Cell Research
9.6 Vaccine and Therapeutics Development
9.7 Other Applications
10 Global Biologics Outsourcing Market, By End User
10.1 Introduction
10.2 Pharmaceutical Industries
10.3 CDMO
10.4 Biotechnology Industries
11 Global Biologics Outsourcing Market, By Geography
11.1 Introduction
11.2 North America
11.2.1 US
11.2.2 Canada
11.2.3 Mexico
11.3 Europe
11.3.1 Germany
11.3.2 UK
11.3.3 Italy
11.3.4 France
11.3.5 Spain
11.3.6 Rest of Europe
11.4 Asia Pacific
11.4.1 Japan
11.4.2 China
11.4.3 India
11.4.4 Australia
11.4.5 New Zealand
11.4.6 South Korea
11.4.7 Rest of Asia Pacific
11.5 South America
11.5.1 Argentina
11.5.2 Brazil
11.5.3 Chile
11.5.4 Rest of South America
11.6 Middle East & Africa
11.6.1 Saudi Arabia
11.6.2 UAE
11.6.3 Qatar
11.6.4 South Africa
11.6.5 Rest of Middle East & Africa
12 Key Developments
12.1 Agreements, Partnerships, Collaborations and Joint Ventures
12.2 Acquisitions & Mergers
12.3 New Product Launch
12.4 Expansions
12.5 Other Key Strategies
13 Company Profiling
13.1 Thermo Fisher Scientific Inc
13.2 Adimab LLC
13.3 Abzena Ltd.
13.4 KBI Biopharma
13.5 Curia Global, Inc.
13.6 EirGenix, Inc.
13.7 Bionova Scientific, Inc.
13.8 Boehringer Ingelheim International GmbH.
13.9 Abbvie Inc.
13.10 STC Biologics
13.11 Avid Bioservices, Inc.
13.12 Catalent Inc.
13.13 Genentech, Inc.
13.14 Eurofins Scientific
13.15 Genscript Biotech Corporation
13.16 Lonza
13.17 JSR Corporation
13.18 Merck KGaA
13.19 Rentschler Biopharma SE
13.20 Emergent
List of Tables
1 Global Biologics Outsourcing Market Outlook, By Region (2021-2030) ($MN)
2 Global Biologics Outsourcing Market Outlook, By Product (2021-2030) ($MN)
3 Global Biologics Outsourcing Market Outlook, By Antibodies (2021-2030) ($MN)
4 Global Biologics Outsourcing Market Outlook, By Vaccines (2021-2030) ($MN)
5 Global Biologics Outsourcing Market Outlook, By Recombinant Proteins (2021-2030) ($MN)
6 Global Biologics Outsourcing Market Outlook, By Other Products (2021-2030) ($MN)
7 Global Biologics Outsourcing Market Outlook, By Type (2021-2030) ($MN)
8 Global Biologics Outsourcing Market Outlook, By Instruments (2021-2030) ($MN)
9 Global Biologics Outsourcing Market Outlook, By Kits & Reagents (2021-2030) ($MN)
10 Global Biologics Outsourcing Market Outlook, By Source (2021-2030) ($MN)
11 Global Biologics Outsourcing Market Outlook, By Microbial (2021-2030) ($MN)
12 Global Biologics Outsourcing Market Outlook, By Mammalian (2021-2030) ($MN)
13 Global Biologics Outsourcing Market Outlook, By Service (2021-2030) ($MN)
14 Global Biologics Outsourcing Market Outlook, By Cell Development (2021-2030) ($MN)
15 Global Biologics Outsourcing Market Outlook, By Analytical Testing (2021-2030) ($MN)
16 Global Biologics Outsourcing Market Outlook, By Process Development (2021-2030) ($MN)
17 Global Biologics Outsourcing Market Outlook, By cGMP Manufacturing (2021-2030) ($MN)
18 Global Biologics Outsourcing Market Outlook, By Other Services (2021-2030) ($MN)
19 Global Biologics Outsourcing Market Outlook, By Application (2021-2030) ($MN)
20 Global Biologics Outsourcing Market Outlook, By Oncology (2021-2030) ($MN)
21 Global Biologics Outsourcing Market Outlook, By Blood & Blood-Related Products Development (2021-2030) ($MN)
22 Global Biologics Outsourcing Market Outlook, By Cellular and Gene Therapy (2021-2030) ($MN)
23 Global Biologics Outsourcing Market Outlook, By Stem Cell Research (2021-2030) ($MN)
24 Global Biologics Outsourcing Market Outlook, By Vaccine and Therapeutics Development (2021-2030) ($MN)
25 Global Biologics Outsourcing Market Outlook, By Other Applications (2021-2030) ($MN)
26 Global Biologics Outsourcing Market Outlook, By End User (2021-2030) ($MN)
27 Global Biologics Outsourcing Market Outlook, By Pharmaceutical Industries (2021-2030) ($MN)
28 Global Biologics Outsourcing Market Outlook, By CDMO (2021-2030) ($MN)
29 Global Biologics Outsourcing Market Outlook, By Biotechnology Industries (2021-2030) ($MN)
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.
List of Figures
RESEARCH METHODOLOGY
We at ‘Stratistics’ opt for an extensive research approach which involves data mining, data validation, and data analysis. The various research sources include in-house repository, secondary research, competitor’s sources, social media research, client internal data, and primary research.
Our team of analysts prefers the most reliable and authenticated data sources in order to perform the comprehensive literature search. With access to most of the authenticated data bases our team highly considers the best mix of information through various sources to obtain extensive and accurate analysis.
Each report takes an average time of a month and a team of 4 industry analysts. The time may vary depending on the scope and data availability of the desired market report. The various parameters used in the market assessment are standardized in order to enhance the data accuracy.
Data Mining
The data is collected from several authenticated, reliable, paid and unpaid sources and is filtered depending on the scope & objective of the research. Our reports repository acts as an added advantage in this procedure. Data gathering from the raw material suppliers, distributors and the manufacturers is performed on a regular basis, this helps in the comprehensive understanding of the products value chain. Apart from the above mentioned sources the data is also collected from the industry consultants to ensure the objective of the study is in the right direction.
Market trends such as technological advancements, regulatory affairs, market dynamics (Drivers, Restraints, Opportunities and Challenges) are obtained from scientific journals, market related national & international associations and organizations.
Data Analysis
From the data that is collected depending on the scope & objective of the research the data is subjected for the analysis. The critical steps that we follow for the data analysis include:
- Product Lifecycle Analysis
- Competitor analysis
- Risk analysis
- Porters Analysis
- PESTEL Analysis
- SWOT Analysis
The data engineering is performed by the core industry experts considering both the Marketing Mix Modeling and the Demand Forecasting. The marketing mix modeling makes use of multiple-regression techniques to predict the optimal mix of marketing variables. Regression factor is based on a number of variables and how they relate to an outcome such as sales or profits.
Data Validation
The data validation is performed by the exhaustive primary research from the expert interviews. This includes telephonic interviews, focus groups, face to face interviews, and questionnaires to validate our research from all aspects. The industry experts we approach come from the leading firms, involved in the supply chain ranging from the suppliers, distributors to the manufacturers and consumers so as to ensure an unbiased analysis.
We are in touch with more than 15,000 industry experts with the right mix of consultants, CEO's, presidents, vice presidents, managers, experts from both supply side and demand side, executives and so on.
The data validation involves the primary research from the industry experts belonging to:
- Leading Companies
- Suppliers & Distributors
- Manufacturers
- Consumers
- Industry/Strategic Consultants
Apart from the data validation the primary research also helps in performing the fill gap research, i.e. providing solutions for the unmet needs of the research which helps in enhancing the reports quality.
For more details about research methodology, kindly write to us at info@strategymrc.com
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