USD 20.1 billion
Report ID: SQSG35H2018 | Region: Global | Published Date: December, 2022 | Pages: 157
Global Biopharmaceutical CMO and CRO Market was valued at USD 20.1 billion in 2021, and it is expected to reach a value of USD 27.95 billion by 2028, at a CAGR of 4.4 % over the forecast period (2022-2028).
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 2020. 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.
Global Market Size
USD 20.1 billion
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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.
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.
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.
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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.
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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.
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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.
|Market size value in 2021||USD 20.1 billion|
|Market size value in 2028||USD 27.95 billion|
|Forecast Unit (Value)||USD Billion|
|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)|
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Parent Market Analysis
KEY MARKET INSIGHTS
MARKET DYNAMICS & OUTLOOK
Market Size by Region
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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.
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Product ID: SQSG35H2018