USD 30.59 billion
Global Biopharmaceutical CMO & CRO Market Size, Share, Growth Analysis, By Source(Mammalian, Non-mammalian), By Service(Contract Manufacturing (Process Development, Downstream), By Product(Biologics (Monoclonal antibodies (MAbs), Recombinant Proteins) - Industry Forecast 2023-2030
Report ID:
SQSG35H2018 |
Region:
Global |
Published Date: February, 2024
Pages:
157
|
Tables:
102 |
Figures:
76
Global Biopharmaceutical CMO & CRO Market Insights
Biopharmaceutical CMO & CRO Market size was valued at USD 30.59 billion in 2019 and is poised to grow from USD 32.4 billion in 2023 to USD 54.27 billion by 2031, growing at a CAGR of 5.9% in the forecast period (2024-2031).
The acronyms for biopharmaceutical contract manufacturing companies and contract research organisations, respectively, are biopharmaceutical CMO and CRO. A contract manufacturing organisation (CMO) is a company that works with other pharmaceutical companies to provide full-service drug manufacturing in order to create new medications. Contract research organisations (CROs) provide research services to the pharmaceutical, biotechnology, and medical device sectors on a contract basis. This encompasses biopharmaceutical development, the creation and marketing of biological assays, preclinical testing, and clinical trials. The CMO and CRO of the biopharmaceutical sector are critical to the industry's success. The biopharmaceutical business directly affects the CMO and CRO. The biopharmaceutical industry's spectacular growth has been fueled by rising consumer demand for biopharmaceutical therapies. Globally, the biopharmaceutical sector is rapidly developing and already accounts for more than 20% of the overall pharmaceutical industry.
The COVID-19 epidemic caused tremendous growth in 2019. Rising investments in the biopharmaceutical business by key participants to improve productivity and efficiency have prompted bio producers to place a greater emphasis on outsourcing operations. Currently, biopharma businesses are beginning to outsource resource and capital-intensive processes, and in some cases, the whole biomanufacturing chain, increasing demand for contract-based services. The Australian government has partnered with Sandoz to invest approximately 50 million euros in integrated antibiotic manufacturing in Europe. CMOs can now provide integrated bioprocessing services to their clients as a result of mergers and acquisitions, making CMOs/CROs an appealing and practical choice for quick product launches.
US Biopharmaceutical CMO & CRO Market is poised to grow at a sustainable CAGR for the next forecast year.
Market snapshot - 2024-2031
Global Market Size
Largest Segment
Mammalian
Fastest Growth
Non-Mammalian
Growth Rate
5.9% CAGR
Global Biopharmaceutical CMO & CRO Market, 2021-2028 ($ Bn)
Country Share for North America Region- 2021 (%)
Global Biopharmaceutical CMO & CRO Market By Source, 2021-2028 (%)
Global Biopharmaceutical CMO & CRO Market By Source 2021-2028 (%)
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Global Biopharmaceutical CMO & CRO Market Segmental Analysis
Global Biopharmaceutical CMO and CRO Market is segmented based on the source, service, product, and region. Based source, the market is segmented into mammalian, and non-mammalian. Based on service, the market is segmented into contract manufacturing (process development, downstream, upstream, fill & finish operations, analytical & QC studies, and packaging), contract research (oncology, inflammation & immunology, cardiology, neuroscience, and others). Based on product, the market is categorized into biologics (monoclonal antibodies (MAbs), recombinant proteins, vaccines, antisense, RNAI, & molecular therapy, and others), biosimilars. By region, the market is segmented into North America, Europe, Asia Pacific, Latin America, and MEA.
Biopharmaceutical CMO & CRO Market Analysis by Source
Due to a lack of internal competence in the sector, the mammalian category retained the largest market share of more than 55% in 2021. This is due to their ability to incorporate human-like post-translational changes into complicated protein therapies. Furthermore, the emergence of innovative and better expression systems, improved process monitoring solutions, cell line engineering tools, automated screening methodologies, and disposable equipment has considerably benefitted the industry. This is attributed to the growing importance of the mammalian cell culture for research and development of various antibodies, vaccines, and proteins in the biopharma industry. Cell lines originated from creatures other than humans, such as microbes, are recognised as capable of operating as factories. Cutting-edge technologies are now being used to discover unique microorganisms and evaluate their potential. This is projected to add to the non-mammalian organisms segment of the biopharmaceutical manufacturing industry.
Non-mammalian cell lines, such as microbial cell lines, are known to be powerful manufacturers. Innovative approaches are being used to discover and investigate the potential of diverse microorganisms. This is expected to benefit the non-mammalian biopharmaceutical production industry.
Biopharmaceutical CMO & CRO Market Analysis by Service
As biopharmaceutical firms are increasingly outsourcing research efforts, the contract research category is predicted to grow at the quickest rate of 7.5% over the projection period. A significant number of CMOs and opportunistic CMOs in the field are involved in delivering a wide range of services to biopharma organisations, including end-to-end coverage from cell culture through fill/finish services. Furthermore, companies are substantially investing in outsourcing the manufacturing component of their product development programme. As a result of these reasons, this category has the biggest share. CROs, on the other hand, are attempting to profit on the industry's potential. Novel market entrants and small-scale firms focused on biopharmaceutical development are expected to adopt contract research services for their new candidate discovery initiatives, increasing sector growth.
Global Biopharmaceutical CMO & CRO Market By Source, 2021 (%), 2023 (%)
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Global Biopharmaceutical CMO & CRO Market Regional Insights
North America had the greatest revenue share in 2021, accounting for almost 35% of overall sales. This might be attributed to the fact that there are several local service providers in the region. CMOs are in charge of producing a sizable portion of the authorised goods marketed in the United States. The creation of a number of small and mid-sized biopharmaceutical businesses (SMEs) that lack the capabilities and funds to build well-equipped facilities is troublesome. As a result, CMOs and SMEs in the United States have become increasingly dependent on one another, resulting in the United States market becoming the most dominating internationally.
The Asia Pacific region is expected to increase at a significant compound annual growth rate throughout the projection period. The key reason for the growth in outsourcing in Asian countries is cost-related benefits such as cheaper labour rates and operating costs throughout the region. This is the fundamental cause for the surge in Asian outsourcing. It is expected that India would see great development as a result of the massive quantity of big molecule manufacturing that takes place in the nation. The lack of worldwide regulatory standardisation for biosimilar product approval is a critical element driving the Indian industry ahead.
Global Biopharmaceutical CMO & CRO Market By Region, 2021-2028, 2024-2031
- Largest
- Fastest
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Global Biopharmaceutical CMO & CRO Market Dynamics
Biopharmaceutical CMO & CRO Market Driver
- Integration of New Bioprocessing Technologies and Single-Use Systems
- In recent years, the biopharmaceutical business has seen a significant number of consolidations. The biopharmaceutical contract manufacturing and service industries aspire to expand their operations and remain competitive through these mergers. New medicines, new bioprocessing processes, and a significant shift in the bio/pharmaceutical market in terms of commodities are likely to put more pressure on contract bio producers. Alternative business models are increasingly being established as a result of these concerns in order to suit the demands of their diverse stakeholders and consumers. Given these factors, the biopharmaceutical CMO and CRO market is projected to expand rapidly in the near future. The introduction of single-use systems in these production facilities is projected to boost the market, increasing manufacturing capacity. This is predicted to provide new chances for growth in the worldwide market throughout the forecast period.
Biopharmaceutical CMO & CRO Market Restraint
- High Initial Investments and Limited Outsourcing are Impeding Market Growth
- In comparison to the pharmaceutical CMO market for biopharmaceuticals, which has profit margins of 5% to 10%, the biopharmaceutical CMO industry has profit margins of more than 30%. The primary constraints restricting the market's growth to some extent are investments in manufacturing facilities and new equipment to enhance biomanufacturing at a quicker rate. The market's development is further impeded by well-established biopharmaceutical businesses' limited use of outsourcing. Contract talks between CMOs and consumers have also been reported to be challenging due to the regulatory landscape and the complexity of the service itself. Client-CMO negotiations are difficult due to problems such as intellectual property rights, warranties, and confidentiality.
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Global Biopharmaceutical CMO & CRO Market Competitive Landscape
Because of the presence of a significant number of established as well as medium- to small-sized CMOs and CROs, the market is fragmented. Several market players are privately held or are part of the portfolios of private equity companies. CMOs are incorporating automation and cutting-edge technology into their factories to boost project productivity and product quality. This has fueled big molecule producers' interest in CMOs to address the increased demand for biologics. Charles River Laboratories International, Inc.; PRA Health Sciences; ICON plc. Pharmaceutical Product Development, LLC; LabCorp; and Parexel International Corporation are engaged in offering contract research services for large molecule production. Market players focus on various business strategies including mergers, acquisitions, product launches, etc. For instance, in December 2021, Discovery Life Sciences completed and announced the acquisition of In Vitro ADMET Laboratories (IVAL). With this move, the company aims to expand its skilled workforce allowing them to competently cater to the rising outsourcing of research activities. Cerba HealthCare made a public statement in December 2021 on its acquisition of the Viroclinics-DDL company. With this, it has joined the CRO industry, with a focus on precision medicine for auto-immune illnesses. Lonza issued a news statement in November 2021 announcing the acquisition of the Exosomics Service Unit. This will increase its future potential to generate and manufacture exosomes.
Biopharmaceutical CMO & CRO Market Top Player's Company Profiles
- Lonza Group AG
- Catalent, Inc.
- Thermo Fisher Scientific Inc.
- Patheon N.V.
- WuXi AppTec Co., Ltd.
- Samsung Biologics
- Boehringer Ingelheim GmbH
- Cytovance Biologics, Inc.
- AbbVie Contract Manufacturing
- Fujifilm Diosynth Biotechnologies
- AGC Biologics
- AMRI Global
- Charles River Laboratories International, Inc.
- Evotec SE
- PAREXEL International Corporation
- Syneos Health, Inc.
- ICON plc
- PRA Health Sciences, Inc.
- IQVIA Holdings Inc.
- LabCorp
Biopharmaceutical CMO & CRO Market Recent Developments
- In May 2022 - Boehringer Ingelheim (BI) of Germany announced that it received approval from the Central Drugs Standard Control Organization (CDSCO) to market Jardiance (empagliflozin) in India for the treatment of all types of heart failure, regardless of ejection fraction.
- In January 2022, Fujifilm Corporation announced a USD 100 million agreement to acquire a cell treatment manufacturing facility from Atara Biotherapeutics, Inc. This facility, which is conveniently located in Thousand Oaks, California, can produce clinical and commercial cell treatments such as allogeneic T-cells and CAR T immunotherapies.
Global Biopharmaceutical CMO & CRO Key Market Trends
- New Product Development to Positively Impact the Market
- The key participants in the biopharmaceutical CMO and CRO businesses are using novel growth strategies. Expanding R&D activity and investment in R&D is one of the most essential approaches to enhance market growth. Other growth strategies include geographical expansions, new product development, collaboration with other industry players, distribution network expansion, and mergers and acquisitions to get a competitive edge in the global market. Lonza and Moderna will collaborate on commercial manufacture of the COVID-19 vaccine over a ten-year period. These discoveries compensated for some clinical trial delays in the first half of 2020. The contract manufacturing organisation business is expected to show significant development potential in the near future. Given the increasing pressure on biopharmaceutical businesses' short-term revenues and profit margins as a result of deteriorating R&D efficiency and growing development costs, this has created appealing prospects for CMOs and CROs to accelerate their commercial operations.
Global Biopharmaceutical CMO & CRO Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Co-relates, and Analyses the Data collected utilizing Primary Exploratory Research backed by the robust Secondary Desk research.
According to our Global Biopharmaceutical CMO And CRO Market analysis, over the projection period, the non-mammalian cell line-based bioproduction system is predicted to be the fastest-growing category. Innovative approaches are being used to discover and investigate the potential of diverse microorganisms. This is due to increased spending in research initiatives aimed at developing innovative treatments. North America market is renowned as a pioneer in biopharmaceutical advances, resulting in a substantial share of 33.97%. Furthermore, the existence of many service providers, as well as a larger concentration and quantity of biopharmaceutical enterprises in the region, helps market expansion. The leading companies are forming mutually advantageous agreements with other rising CMOs in order to scale up their manufacturing capacity.
| Report Metric | Details |
|---|---|
| Market size value in 2023 | USD 30.59 billion |
| Market size value in 2031 | USD 54.27 billion |
| Growth Rate | 5.9% |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
|
| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
| Historical Year | 2019 |
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Global Biopharmaceutical CMO & CRO Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Global Biopharmaceutical CMO & CRO Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Global Biopharmaceutical CMO & CRO Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Global Biopharmaceutical CMO & CRO Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Global Biopharmaceutical CMO & CRO Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Global Biopharmaceutical CMO & CRO Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
Global Biopharmaceutical CMO & CRO Market Report Snapshots
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