바이오의약품 아웃소싱 시장 예측 : 제품 유형, 유형, 원료, 서비스, 용도, 최종사용자 및 지역별 분석(-2034년)

According to Stratistics MRC, the Global Biologics Outsourcing Market is accounted for $37.1 billion in 2026 and is expected to reach $121.7 billion by 2034 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
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • 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 2023, 2024, 2025, 2026, 2027, 2028, 2030, 2032 and 2034
• 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
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • 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