Global Bio CMO Market Size By Type (In-House, CMO), By Manufacturing Process (Downstream, Upstream, Fill, Finish), By Geographic Scope And Forecast

Bio CMO Market Size And Forecast

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Bio CMO Market size was valued at USD 4.47 Billion in 2024 and is projected to reach USD 7.59 Billion by 2031, growing at a CAGR of 6.85 % from 2024 to 2031.

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Growth in pharmaceutical industries, increased usage of biosimilars, prospective biologics blockbusters, the launch of targeted medicines, and increased outsourcing demand from global pharma are all expected to boost the global Bio CMO Market. The Global Bio CMO Market report provides a holistic evaluation of the market. The report offers a comprehensive analysis of key segments, trends, drivers, restraints, competitive landscape, and factors that are playing a substantial role in the market.

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Global Bio CMO Market Definition

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Contract Manufacturing Organization (CMO) is an abbreviation for Contract Manufacturing Organization, which is also known as contract development and manufacturing organization (CDMO). It is a contract-based third-party organization that is engaged by pharmaceutical companies to provide full services ranging from drug discovery to drug manufacture. CMOS is increasingly being viewed as a strategic partner for pharmaceutical businesses, offering a one-stop-shop for formulation development and manufacturing services throughout the drug’s lifespan. Bio CMOs is commonly utilized in the branded pharmaceutical sector to give secondary manufacturing coverage. Typically, a modest laboratory generates a breakthrough cure after resource-intensive input yields promising results and well-preserved records for a fledgling company.

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A CMO can aid in the crystallization of a company’s processes. This is accomplished by assessing each stage with the company, improving and streamlining processes, ensuring that production steps are as efficient and safe as possible, and verifying that methods can be replicated by a third party. A CMO will identify potential concerns and work with a starting company to fix them, whether the issues are related to quality, regulatory, legal, safety, efficacy, cost, or other factors. To complete a project on schedule and on budget, a startup company must collaborate closely with its CMO.

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When opposed to smaller CMOS, large CMOs’ size and established platforms allow for better efficiency and economies of scale, with commercial production delivering larger billing and margins (vs. R&D support) over longer durations. Due to their competencies and track records, large CMOS frequently charge greater costs. Many smaller firms, on the other hand, with more unique goods, are forced to use multiple, smaller CMOS for R&D and clinical needs. The biopharmaceutical sector requires smaller CMOs, of which there are numerous, and mid-sized CMOs, of which there are very few that have not been merged/acquired. Smaller CMOS can provide preclinically and early clinical phase support that is comparable to that of larger CMOS in terms of quality, time, and other factors, despite a lack of facilities and experience in commercial manufacture.

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Global Bio CMO Market Overview

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Growth in pharmaceutical industries, increased usage of biosimilars, prospective biologics blockbusters, the launch of targeted medicines, and increased outsourcing demand from global pharma are all expected to boost the global Bio CMO Market. The increasing investments in the biopharmaceutical industry by major players to improve productivity and efficiency have prompted bio producers to place a greater emphasis on outsourcing activities. A substantial amount of growth in the biologics market is due to cancer therapy. Despite the stronger growth forecast, small molecules outnumber biologics in terms of drug approvals. Despite the growing trend of keeping biologic API synthesis in-house, pharma companies are more comfortable and willing to outsource the secondary manufacturing and packaging phases of their biologic products.

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The shortage of available assets among CDMOs is another important element impacting the expansion of outsourcing biologics to CDMOs. However, the danger of using a CMO, the availability of in-house manufacturing facilities by big pharma companies, and productivity concerns with a mammalian cell system are all factors that could limit the market’s growth. The biopharmaceutical and biotechnology sectors, which have undergone exponential growth in terms of unique technology and applications, can be credited at least in part for the amazing increase in life expectancy and substantial breakthroughs in medical treatment over the past several decades.

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In the development of novel medications, antibodies, recombinant proteins, gene-editing technology, and much more, several revolutionary milestones have been surpassed, with much more to be explored in the future. This enormous development potential in the biopharmaceutical business also means tighter competition, both in terms of launching new, efficient blockbuster treatments and maintaining a healthy price system to secure profitability. Companies have adopted the business strategy of optimizing production capacity through outsourcing as a result of a balanced approach.

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Contract Manufacture Organizations (CMOs) have filled this need by offering competitive services ranging from medication manufacturing to aseptic filling, and have been a key factor in the biopharmaceutical industry’s development. CMOS can be suitable partners for biosimilar development and manufacturing in this scenario. CMOS has a wider range of bioprocess design and execution experience, having worked on a greater variety of products, whereas developers often focus on only a few. Furthermore, most CMOs have created unique in-house expression systems and other technologies that may be used with a variety of products, allowing biosimilars to be plugged into these well-established manufacturing platforms.

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Global Bio CMO Market: Segmentation Analysis

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The Global Bio CMO Market is Segmented on the basis of Type, Manufacturing Process, And Geography.

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Bio CMO Market, By Type

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•  In-House

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•  CMO

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Based on Type, The market is classified into In-House and CMO. In January 2022, Lonza announced the debut of its new bYlok technology platform for bispecific antibody discovery and creation. Bispecific antibodies (bsAbs) have shown promise in terms of precision targeting and efficacy, in addition, several binding sites may help to prevent the development of clinical resistance. Bispecific antibody production presents distinct problems in terms of expression and downstream processing. Multiple combinations are conceivable during assembly in manufacturing since bsAbs are made up of two separate heavy and light chains. Mispairing of light and heavy chains during expression may result in undesired antibody species that are difficult to remove due to their resemblance to the right format.

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Bio CMO Market, By Manufacturing Process

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•  Downstream

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•  Upstream

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•  Fill

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•  Finish

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Based on Manufacturing Process, The market is classified into Downstream, Upstream, Fill, and Finish. The upstream process of producing active pharmaceutical ingredients (API) for biopharmaceuticals usually begins with the creation of the API using living cells, followed by the purification of the target API, or the downstream process. Separating the cells from the medium is the first step in purification. Because the protein is secreted into the media in most mammalian cultures, the supernatant must be collected for further purification. Because the protein can accumulate within the cells during microbial synthesis, the cells must be destroyed and the cell debris removed from the protein of interest. Insoluble products, such as unfolded, pure proteins that clump together and are referred to as inclusion bodies, must be refolded to return to their original and active state.

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Bio CMO Market, By Geography

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•  North America

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•  Europe

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•  Asia Pacific

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•  Rest of the world

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On the basis of Geography, The Global Bio CMO Market is classified into North America, Europe, Asia Pacific, and the Rest of the world. The Asia Pacific region is expected to witness a significant CAGR during the forecast period. This is primarily due to the growth in pharmaceutical industries, increased usage of biosimilars, prospective biologics blockbusters, the launch of targeted medicines, and increased outsourcing demand from global pharma are all expected to boost the global Bio CMO Market.

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Key Players

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The “Global Bio CMO Market” study report will provide a valuable insight with an emphasis on the global market including some of the major players such as Lonza Group, Boehringer Ingelheim, Samsung Electronics (Samsung Biologics), Wuxi Biologics, Almac, Catalent, Dr. Reddy’s Laboratories, Famar, Patheon, and PCI.

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Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with its product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

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Key Developments

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•  In December 2021, Lonza has announced intentions to invest CHF 850 million ($935 million) in two new mammalian drug substance manufacturing facilities at its Visp, Switzerland, and Portsmouth, New Hampshire, locations.

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•  On March 2022, Oasmia and Lonza signed a manufacturing deal for ovarian cancer medication.

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Reasons to Purchase this Report

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• Qualitative and quantitative analysis of the market based on segmentation involving both economic as well as non-economic factors
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• Provision of market value (USD Billion) data for each segment and sub-segment
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• Indicates the region and segment that is expected to witness the fastest growth as well as to dominate the market
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• Analysis by geography highlighting the consumption of the product/service in the region as well as indicating the factors that are affecting the market within each region
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• Competitive landscape which incorporates the market ranking of the major players, along with new service/product launches, partnerships, business expansions and acquisitions in the past five years of companies profiled
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