The global biologics contract development market was estimated at USD 5.61 billion in 2021 and it is expected to surpass around USD 13.7 billion by 2030, poised to grow at a CAGR of 10.43% from 2022 to 2030
Report Highlights
The market is segmented on the basis of biological source, product service (upstream and downstream), and indication. Factors such as the increasing adoption of advanced technologies for biologic development, a favorable environment for clinical trials in developing countries; and an increase in outsourcing of R&D activities are paving the way for the growth of the market. During the COVID-19 pandemic, a significant number of CROs partnered with biotechnology companies for R&D in COVID-19 vaccines. In 2022, there will be a significant number of companies undergoing research for a potential COVID-19 vaccine owing to the rising cases. This is expected to have a positive impact on the market.
Growing M&A and collaboration activities between biopharma companies and CDOs are yet another factor assisting in market growth, allowing more financial stability and the amalgamation of advanced and specialized technologies. For instance, In September 2021, Curia Global, Inc., formerly AMRI, leading contract research, development, and manufacturing firm, acquired LakePharma Inc., a California-based biologics drug discovery, development, and manufacturing company. Many biopharma and pharma companies are increasingly looking to outsource their activities as it helps accelerate the workflow (speed) of the company, provides unique specialized services, decreases drug manufacturing costs, and provides expertise. These factors are expected to boost the biologics contract development organization market growth in the coming years.
During the COVID-19 pandemic, the majority of clinical trials were focused on developing new therapies for treating COVID-19. However, in the post-pandemic period, research is expected to focus on cancer owing to its rising incidence. Biologics such as monoclonal antibodies have gained significant popularity in treating cancer. According to the IQVIA report Oncology Trends 2022, the number of cancer clinical trials increased significantly in 2021. The high potential of biologics in treating cancer and the growing number of cancer studies are likely to support the growth of the market in the coming years.
Scope of The Report
Report Coverage | Details |
Market Size in 2021 | USD 5.61 billion |
Revenue Forecast by 2030 | USD 13.7 billion |
Growth rate from 2022 to 2030 | CAGR of 10.43% |
Base Year | 2021 |
Forecast Period | 2022 to 2030 |
Segmentation | Source, product service, indication, region |
Companies Covered | WuXi Biologics; Abzena Ltd; Fujifilm Diosynth Biotechnologies; KBI Biopharma; AGC Biologics; Thermo Fisher Scientific Inc.; Curia Global, Inc.; Genscript; Bionova Scientific, Inc.; BioXcellence (Boehringer Ingelheim Biopharmaceuticals GmbH); STC Biologics |
Source Insights
The mammalian source segment accounted for the largest revenue share of 54.96% in 2021 in the market for biologics contract development. The segment is expected to witness a significant CAGR during the forecast period. This is due to the fact that using mammalian cells for protein expression has the major benefit of producing mammalian proteins with correct post-translational modifications that provide a native structure. Mammalian cells like Chinese Hamster Ovary (CHO) cell lines have been among the most preferred and about 70.0% of the protein therapeutics is developed from CHO cells.
The microbial source segment has gained a significant share in 2021. Microbial systems are widely used for producing recombinant protein therapeutics. Around 650 protein drugs have been approved worldwide to date, among which, about 400 were obtained from microbial recombinant technologies. Moreover, approximately 48.0% of biologics approved for manufacturing are produced by microbial sources, which are primarily used by CDMOs to produce cytokines, hormones, enzymes, and MABs. These factors are supporting the segment growth.
Product Services Insights
The process development services accounted for the largest revenue share of 73.5% in 2021 in the biologics contract development market. Biologics process development is characterized by two techniques-upstream process development and downstream process development. Upstream process development mainly includes the selection of the right cell line, culture medium, bioreactor systems, and operating parameters. Upstream process development services are provided by the majority of the biologics manufacturing organizations and are highly specific to the client's business needs, regulatory constraints, and project timeline. Companies, such as AGC Biologics, Curia Global, Inc., and Bionova Scientific, offer upstream process development for mammalian and microbial large-scale manufacturing services.
The cell line development service is expected to hold a significant share in the market in 2021. According to NCBI, cell lines are being rigorously used in, testing vaccine production, drug metabolism & cytotoxicity, generation of artificial tissues (e.g., artificial skin), study of gene function, antibody production, and synthesis of biological compounds. The usage of cell lines has revolutionized scientific research. The development of efficient cell lines is requisite, as they can be used to investigate anticipated clinical results. The production of efficient cell line influences productivity and product quality. Varied characteristics of cell lines also enhance process development to achieve target productivity and quality.
Indication Insights
Oncology accounted for the largest revenue share of 48.93% in 2021 in the market for biologics contract development. As cancers are formed through malfunctioning of the immune system, biologic therapy is stated to repair, stimulate, or enhance the immune response, and hence many pharmaceutical and biopharmaceutical companies are willing to invest in cancer-related novel treatments. Cancer can proliferate in any organ of the body, and thus there is an extensive need for treatment, which in turn is boosting investments in R&D and outsourcing by various companies.
The immunological disorder disease segment is anticipated rise with the fastest growth of 11.2% CAGR during the forecast period. Immunological diseases or conditions caused by dysfunction of the immune system include diseases such as asthma, allergy, autoimmune diseases, and others. According to NCBI, autoimmune inflammatory diseases affect approximately 7.6% to 9.4% of the world’s population, especially young and middle-aged women. Biologics medicines have gained significant importance in treating diseases such as arthritis, rheumatologic diseases, and others. The high efficiency and safety of these medications are likely to improve the demand for biologics for treating immunological disorders which is expected to have a positive impact on the market.
Regional Insights
North America dominated the market for biologics contract development in 2021 and accounted for a revenue share of 37.3% in 2021. The region is expected to showcase a significant CAGR over the forecast period. This is attributed to increasing R&D investments and the local presence of global players and their efforts to obtain new patents. The growth of the contract development organizations (CDO) can be primarily attributed to the increasing outsourcing activities and rise in the number of clinical trials in the region. For instance, as per ClinicalTrial.Gov as of July 2022, over 32% of the global studies were conducted in the U.S. alone. A high number of researches conducted in the U.S. is further supporting the regional market growth.
In Asia Pacific, the market for biologics contract development is expected to witness the highest CAGR of 13.82% over the forecast period. Various regulatory organization amendments to change clinical trial evaluation standards in accordance with global requirements are generating the interest of the biotechnology companies to invest in the Asia Pacific region. Asia Pacific countries have a large patient pool and the potential for advanced medical expertise. In comparison to western countries, the cost of conducting a clinical trial is very low here. These aforementioned factors are expected to contribute to the region's market growth.
Key Players
Market Segmentation
Chapter 1. Introduction
1.1. Research Objective
1.2. Scope of the Study
1.3. Definition
Chapter 2. Research Methodology
2.1. Research Approach
2.2. Data Sources
2.3. Assumptions & Limitations
Chapter 3. Executive Summary
3.1. Market Snapshot
Chapter 4. Market Variables and Scope
4.1. Introduction
4.2. Market Classification and Scope
4.3. Industry Value Chain Analysis
4.3.1. Raw Material Procurement Analysis
4.3.2. Sales and Distribution Channel Analysis
4.3.3. Downstream Buyer Analysis
Chapter 5. COVID 19 Impact on Biologics Contract Development Market
5.1. COVID-19 Landscape: Biologics Contract Development Industry Impact
5.2. COVID 19 - Impact Assessment for the Industry
5.3. COVID 19 Impact: Global Major Government Policy
5.4. Market Trends and Opportunities in the COVID-19 Landscape
Chapter 6. Market Dynamics Analysis and Trends
6.1. Market Dynamics
6.1.1. Market Drivers
6.1.2. Market Restraints
6.1.3. Market Opportunities
6.2. Porter’s Five Forces Analysis
6.2.1. Bargaining power of suppliers
6.2.2. Bargaining power of buyers
6.2.3. Threat of substitute
6.2.4. Threat of new entrants
6.2.5. Degree of competition
Chapter 7. Competitive Landscape
7.1.1. Company Market Share/Positioning Analysis
7.1.2. Key Strategies Adopted by Players
7.1.3. Vendor Landscape
7.1.3.1. List of Suppliers
7.1.3.2. List of Buyers
Chapter 8. Global Biologics Contract Development Market, By Source
8.1. Biologics Contract Development Market, by Source, 2022-2030
8.1.1 Microbial
8.1.1.1. Market Revenue and Forecast (2017-2030)
8.1.2. Mammalian
8.1.2.1. Market Revenue and Forecast (2017-2030)
8.1.3. Others
8.1.3.1. Market Revenue and Forecast (2017-2030)
Chapter 9. Global Biologics Contract Development Market, By Product Service
9.1. Biologics Contract Development Market, by Product Service, 2022-2030
9.1.1. Cell Line Development
9.1.1.1. Market Revenue and Forecast (2017-2030)
9.1.2. Process Development
9.1.2.1. Market Revenue and Forecast (2017-2030)
Chapter 10. Global Biologics Contract Development Market, By Indication
10.1. Biologics Contract Development Market, by Indication, 2022-2030
10.1.1. Oncology
10.1.1.1. Market Revenue and Forecast (2017-2030)
10.1.2. Immunological disorders
10.1.2.1. Market Revenue and Forecast (2017-2030)
10.1.3. Cardiovascular disorders
10.1.3.1. Market Revenue and Forecast (2017-2030)
10.1.4. Hematological disorders
10.1.4.1. Market Revenue and Forecast (2017-2030)
10.1.5. Others
10.1.5.1. Market Revenue and Forecast (2017-2030)
Chapter 11. Global Biologics Contract Development Market, Regional Estimates and Trend Forecast
11.1. North America
11.1.1. Market Revenue and Forecast, by Source (2017-2030)
11.1.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.1.3. Market Revenue and Forecast, by Indication (2017-2030)
11.1.4. U.S.
11.1.4.1. Market Revenue and Forecast, by Source (2017-2030)
11.1.4.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.1.4.3. Market Revenue and Forecast, by Indication (2017-2030)
11.1.5. Rest of North America
11.1.5.1. Market Revenue and Forecast, by Source (2017-2030)
11.1.5.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.1.5.3. Market Revenue and Forecast, by Indication (2017-2030)
11.2. Europe
11.2.1. Market Revenue and Forecast, by Source (2017-2030)
11.2.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.2.3. Market Revenue and Forecast, by Indication (2017-2030)
11.2.4. UK
11.2.4.1. Market Revenue and Forecast, by Source (2017-2030)
11.2.4.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.2.4.3. Market Revenue and Forecast, by Indication (2017-2030)
11.2.5. Germany
11.2.5.1. Market Revenue and Forecast, by Source (2017-2030)
11.2.5.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.2.5.3. Market Revenue and Forecast, by Indication (2017-2030)
11.2.6. France
11.2.6.1. Market Revenue and Forecast, by Source (2017-2030)
11.2.6.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.2.6.3. Market Revenue and Forecast, by Indication (2017-2030)
11.2.7. Rest of Europe
11.2.7.1. Market Revenue and Forecast, by Source (2017-2030)
11.2.7.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.2.7.3. Market Revenue and Forecast, by Indication (2017-2030)
11.3. APAC
11.3.1. Market Revenue and Forecast, by Source (2017-2030)
11.3.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.3.3. Market Revenue and Forecast, by Indication (2017-2030)
11.3.4. India
11.3.4.1. Market Revenue and Forecast, by Source (2017-2030)
11.3.4.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.3.4.3. Market Revenue and Forecast, by Indication (2017-2030)
11.3.5. China
11.3.5.1. Market Revenue and Forecast, by Source (2017-2030)
11.3.5.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.3.5.3. Market Revenue and Forecast, by Indication (2017-2030)
11.3.6. Japan
11.3.6.1. Market Revenue and Forecast, by Source (2017-2030)
11.3.6.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.3.6.3. Market Revenue and Forecast, by Indication (2017-2030)
11.3.7. Rest of APAC
11.3.7.1. Market Revenue and Forecast, by Source (2017-2030)
11.3.7.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.3.7.3. Market Revenue and Forecast, by Indication (2017-2030)
11.4. MEA
11.4.1. Market Revenue and Forecast, by Source (2017-2030)
11.4.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.4.3. Market Revenue and Forecast, by Indication (2017-2030)
11.4.4. GCC
11.4.4.1. Market Revenue and Forecast, by Source (2017-2030)
11.4.4.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.4.4.3. Market Revenue and Forecast, by Indication (2017-2030)
11.4.5. North Africa
11.4.5.1. Market Revenue and Forecast, by Source (2017-2030)
11.4.5.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.4.5.3. Market Revenue and Forecast, by Indication (2017-2030)
11.4.6. South Africa
11.4.6.1. Market Revenue and Forecast, by Source (2017-2030)
11.4.6.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.4.6.3. Market Revenue and Forecast, by Indication (2017-2030)
11.4.7. Rest of MEA
11.4.7.1. Market Revenue and Forecast, by Source (2017-2030)
11.4.7.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.4.7.3. Market Revenue and Forecast, by Indication (2017-2030)
11.5. Latin America
11.5.1. Market Revenue and Forecast, by Source (2017-2030)
11.5.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.5.3. Market Revenue and Forecast, by Indication (2017-2030)
11.5.4. Brazil
11.5.4.1. Market Revenue and Forecast, by Source (2017-2030)
11.5.4.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.5.4.3. Market Revenue and Forecast, by Indication (2017-2030)
11.5.5. Rest of LATAM
11.5.5.1. Market Revenue and Forecast, by Source (2017-2030)
11.5.5.2. Market Revenue and Forecast, by Product Service (2017-2030)
11.5.5.3. Market Revenue and Forecast, by Indication (2017-2030)
Chapter 12. Company Profiles
12.1. WuXi Biologics
12.1.1. Company Overview
12.1.2. Product Offerings
12.1.3. Financial Performance
12.1.4. Recent Initiatives
12.2. Abzena Ltd
12.2.1. Company Overview
12.2.2. Product Offerings
12.2.3. Financial Performance
12.2.4. Recent Initiatives
12.3. Fujifilm Diosynth Biotechnologies
12.3.1. Company Overview
12.3.2. Product Offerings
12.3.3. Financial Performance
12.3.4. Recent Initiatives
12.4. KBI Biopharma
12.4.1. Company Overview
12.4.2. Product Offerings
12.4.3. Financial Performance
12.4.4. Recent Initiatives
12.5. AGC Biologics
12.5.1. Company Overview
12.5.2. Product Offerings
12.5.3. Financial Performance
12.5.4. Recent Initiatives
12.6. Thermo Fisher Scientific Inc.
12.6.1. Company Overview
12.6.2. Product Offerings
12.6.3. Financial Performance
12.6.4. Recent Initiatives
12.7. Curia Global, Inc.
12.7.1. Company Overview
12.7.2. Product Offerings
12.7.3. Financial Performance
12.7.4. Recent Initiatives
12.8. Genscript
12.8.1. Company Overview
12.8.2. Product Offerings
12.8.3. Financial Performance
12.8.4. Recent Initiatives
12.9. Bionova Scientific, Inc.
12.9.1. Company Overview
12.9.2. Product Offerings
12.9.3. Financial Performance
12.9.4. Recent Initiatives
12.10. BioXcellence (Boehringer Ingelheim Biopharmaceuticals GmbH)
12.10.1. Company Overview
12.10.2. Product Offerings
12.10.3. Financial Performance
12.10.4. Recent Initiatives
Chapter 13. Research Methodology
13.1. Primary Research
13.2. Secondary Research
13.3. Assumptions
Chapter 14. Appendix
14.1. About Us
14.2. Glossary of Terms