USD 217.6 billion
Report ID: SQSG35J2008 | Region: Global | Published Date: December, 2022 | Pages: 283 | Tables: 35 | Figures: 74
Global Contract Development And Manufacturing Organization (CDMO) Outsourcing Market size was valued at USD 217.6 billion in 2021 and is poised to grow from USD 237.62 billion in 2022 to USD 524.67 billion by 2030, growing at a CAGR of 9.2% in the forecast period (2023-2030).
A CDMO, or contract development and manufacturing organization, is a company that manages both the discovery and invention of new pharmacological compounds as well as their outsourced manufacture. Pharmaceutical firms no longer need to construct and staff specialized innovation and manufacturing facilities. In order to shorten the timetables involved in the drug development process, many small and big pharmaceutical firms throughout the globe are strategically partnering with several contract development and manufacturing organizations (CDMO). This is due to the increased need for innovative therapeutics. Currently, many CDMOs provide services such as drug research, preclinical and clinical trials, manufacturing API and finished products, dosage form development, etc. From medication research to commercialization, these services span the whole value chain. During the projection period, it is projected that the increased complexity of medicines and the lack of internal manufacturing capabilities in many small pharmaceutical businesses would drive the expansion of the global contract development and manufacturing organization (CDMO) outsourcing market.
US Contract Development And Manufacturing Organization (CDMO) Outsourcing Market is poised to grow at a sustainable CAGR for the next forecast year.
Global Market Size
USD 217.6 billion
Contract Manufacturing Organization (CMO)
Contract Research Organization (CRO) Services
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Global contract development and manufacturing organization (CDMO) outsourcing market is segmented based on the service, product, and region. Based on the service, the market is segmented as contract manufacturing organization (CMO) and contract research organization (CRO) services. By product the market is segmented into small molecules and biologics. Based on Region it is categorized into North America, Europe, Asia-Pacific, Latin America, and MEA.
Contract Development And Manufacturing Organization (CDMO) Outsourcing Market Analysis by Service
Further divisions of the contract manufacturing organization (CMO) include packaging, completed products, and API. The largest proportion of the CMO category was accounted for by the active pharmaceutical (API) manufacturing services in the global contract development and manufacturing organization (CDMO) outsourcing market. Growing pipelines of biologic APIs are anticipated to fuel the API manufacturing segment's growth throughout the projected period.
Investments in the API industry have increased three-fold in 2021 compared to the previous year. According to bankers and fund managers, three private equity-led investment platforms have been developed particularly to target the API area, and at least six transactions are reportedly in various stages of negotiation. These include the $300 million platform from Carlyle Group with former Mylan India CEO Hari Babu, the $400 million platform from Advent with RA Chem, and the $200 million platform from Asia-focused PE firm PAG with Samara Capital and CX Partners. According to data gathered by EY, M&A and PE transactions in the API area more than quadrupled during 2021 to $795 million from $293 million in 2020 and barely $30 million in 2019. According to EY, more than one-third of all M&A activity in the pharmaceutical industry will use API in 2021. Compared to $2.86 billion in 2020, the pharmaceutical industry has (so far) witnessed deals totaling $2.57 billion.
Due to the rising demand for injectables and preference for injectable delivery systems like prefilled syringes and auto-injectors for the administration of biologics and biosimilars, the injectables segment in the finished product manufacturing segment is predicted to experience significant growth during the forecast period. With a total of 44,924 injections administered in 2019, the number of injections has grown by almost 11 times since 2009. Most of the injections were administered to treat neovascular age-related macular degeneration. 87 percent of injections given in 2019 contained aflibercept. The number of injections is anticipated to keep rising every year, reaching an estimated 83,000 doses in 2029.
Discovery, preclinical, clinical, and laboratory services make up the clinical research organization (CRO) category. The CRO category is expected to be dominated by clinical trial services throughout the projected period. The increased demand for efficient treatments and the growing number of goods under development are related to this. The need for clinical trial services is also projected to increase due to rising R&D spending and expanding cooperation among top pharmaceutical firms for the outsourcing of clinical trials, which will further boost the growth of the global contract development and manufacturing organization (CDMO) outsourcing market. Clinical studies that have been registered have grown dramatically in recent years. Over 420 thousand clinical investigations have been registered internationally as of March 28, 2022. Since just 2,119 clinical investigations were recorded in 2000, there have been a large number more. Currently, ClinicalTrials.gov offers 422,060 trials with sites in 221 nations and all 50 states.
During the projection period, a moderate rise in the packaging industry is predicted. By including dosage monitoring elements in packaging, the adoption of patient-centric packaging innovations by several pharmaceutical contract manufacturing businesses has emerged as a critical element in enhancing patient adherence. During the projection period, the quick partnerships among various CDMOs to offer creative packaging solutions are also projected to increase demand for the packaging segment.
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The market in North America is distinguished by the region's long-standing CDMO presence. Along with this element, expanding partnerships between pharmaceutical firms and CDMOs providing a wide variety of services are to blame for the region's leading market share globally. The pharmaceutical business is supported by an estimated 300 pharmaceutical contract development and manufacturing companies (CDMOs). The industry is still incredibly fragmented despite rising merger and acquisition (M&A) activity; the top five CDMOs account for only 15% of the market as a whole.
For example, in order to further the research and development of iSTAR Medical's MINIject device, a minimally invasive glaucoma surgery (MIGS) tool for glaucoma patients, AbbVie and iSTAR Medical SA today announced a strategic transaction. This beneficial partnership will aid in iSTAR Medical's research, development, and marketing efforts for MINIject and give AbbVie the chance to grow its eye care division by enhancing its range of glaucoma products, which already includes stents, sustained release implants, and drops. In the fourth quarter of 2021, MINIject got clearance for the Conformité Européenne (CE) marking, allowing it to be on sale in several European nations as early as 2022. To facilitate commercialization in the U.S., iSTAR Medical is presently recruiting participants in the STAR-V U.S. Premarket Approval study.
Due to the region's cheap manufacturing and R&D costs as well as its highly qualified workforce, the Asia Pacific market is anticipated to grow at a much higher CAGR over the forecast period. Furthermore, the policies set up by the government are also expected to boost the growth of the global contract development and manufacturing organization (CDMO) outsourcing market in the forecast period. For example, in India, the Union Cabinet approved yet another production-linked incentive program for pharmaceuticals at its meeting on November 11, 2020. The program's goal is to improve India's manufacturing capabilities by boosting investment and production in the industry and promoting product diversification to high-value goods in the pharmaceutical sector. One of the goals of the program is to develop Indian companies into global leaders with the capacity to scale up by utilizing cutting-edge technology and so enter global value chains. Three kinds of pharmaceutical products would be rewarded under the plan depending on their increased sales, with a budget of Rs 15,000 crore. It is suggested that the program run from 2021–2022 through 2028–2029 in duration.
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Contract Development And Manufacturing Organization (CDMO) Outsourcing Market Driver
Contract Development And Manufacturing Organization (CDMO) Outsourcing Market Restraint
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Global contract development and manufacturing organization (CDMO) outsourcing market is relatively fragmented, with a high level of competition. The prominent players operating in the market are constantly adopting various growth strategies to stay afloat in the market. Product launches, innovations, mergers, and acquisitions, collaborations and partnerships, and intensive R&D are some of the growth strategies that are adopted by these key players to thrive in the competitive market. The key market players are also constantly focused on R&D to supply industries with the most efficient and cost-effective solutions.
Top Players in the Global CDMO Outsourcing Market
CDMO Outsourcing Market Recent Developments
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According to our Global Contract Development and Manufacturing Organization (CDMO) Outsourcing Market Analysis, in terms of Service, The API segment held the largest share in the global contract development and manufacturing organization (CDMO) outsourcing market in 2021. Growing pipelines of biologic APIs are anticipated to fuel the API manufacturing segment's growth throughout the projected period. Investments in the API industry have increased three-fold in 2021 compared to the previous year. And by region, the largest share of the global contract development and manufacturing organization (CDMO) outsourcing market was held by North America due to the expanding partnerships between pharmaceutical firms and CDMOs providing a wide variety of services are to blame for the region's leading market share globally.
|Market size value in 2021||USD 217.6 billion|
|Market size value in 2030||USD 237.62 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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For the Global Contract Development And Manufacturing Organization (CDMO) Outsourcing 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 Contract Development And Manufacturing Organization (CDMO) Outsourcing Market.
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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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