USD 217.6 billion
Contract Development And Manufacturing Organization (CDMO) Outsourcing Market Size, Share, Growth Analysis, By Service(Contract Manufacturing Organization (CMO), Contract Research Organization (CRO) Services) - Industry Forecast 2024-2031
Report ID:
SQSG35J2008 |
Region:
Global |
Published Date: February, 2024
Pages:
283
|
Tables:
35 |
Figures:
74
Contract Development And Manufacturing Organization (CDMO) Outsourcing Market Insights
Global Contract Development And Manufacturing Organization (CDMO) Outsourcing Market size was valued at USD 217.6 billion in 2019 and is poised to grow from USD 237.62 billion in 2023 to USD 524.67 billion by 2031, growing at a CAGR of 9.2% in the forecast period (2024-2031).
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.
Market snapshot - 2024-2031
Global Market Size
Largest Segment
Contract Manufacturing Organization (CMO)
Fastest Growth
Contract Research Organization (CRO) Services
Growth Rate
9.2% CAGR
Global Contract Development and Manufacturing Organization (CDMO) Outsourcing Market, 2021-2028 ($ Bn)
Country Share for North America Region- 2021 (%)
Global Contract Development and Manufacturing Organization (CDMO) Outsourcing Market By Service, 2021-2028 ($ Bn)
Global Contract Development and Manufacturing Organization (CDMO) Outsourcing Market By Service, 2021-2028 (%)
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Contract Development And Manufacturing Organization (CDMO) Outsourcing Market Segmental Analysis
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.
Global Contract Development and Manufacturing Organization (CDMO) Outsourcing Market By Service, 2021(%), 2019 (%)
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Contract Development And Manufacturing Organization (CDMO) Outsourcing Market Regional Insights
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.
Global Contract Development and Manufacturing Organization (CDMO) Outsourcing Market By Geography, 2021 - 2028, 2024-2031
- Largest
- Fastest
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Contract Development And Manufacturing Organization (CDMO) Outsourcing Market Dynamics
Contract Development And Manufacturing Organization (CDMO) Outsourcing Market Driver
- Owing to expanding acceptance of a westernized lifestyle, rising economic development, and rising population, the burden of chronic illnesses is rising significantly over the world. About 133 million Americans suffer from chronic illnesses, accounting for more than 40% of the nation's population and being typically incurable and continuous. It is anticipated that by 2020, there would be 157 million people worldwide, 81 million of whom will have various illnesses. Around 8% of children aged 5 to 17 reported having limited activities because of at least one chronic illness or impairment, while around 50% of adults report having a chronic condition.
- Many CDMOs are placing a major emphasis on capital investments to create innovative chemicals and broaden their geographic reach. For instance, the global biopharmaceutical giant AbbVie expanded its production capabilities today by launching the Singapore manufacturing site's small molecule active pharmaceutical ingredient (API) facility. The development of AbbVie's cancer and women's health pipeline is supported by and reflected in this facility.
- Additionally, another significant driver projected to fuel the global contract development and manufacturing organization (CDMO) outsourcing market expansion during the forecast period is a rise in the number of new players entering the market through partnerships. For instance, Cugene Inc. and AbbVie announced an exclusive worldwide license option agreement for CUG252, a potential best-in-class Treg-selective IL-2 mutein, and other novel IL-2 muteins, for the potential treatment of autoimmune and inflammatory diseases. Cugene Inc. is a clinical-stage biotechnology company focused on developing next-generation precision immunology and oncology medicines to treat autoimmune diseases and cancer.
Contract Development And Manufacturing Organization (CDMO) Outsourcing Market Restraint
- The primary factors most likely to impede the growth of the CDMO market during the projected period are the existence of stringent government restrictions and the decline in the approval of numerous small molecules and biologics in developed countries. Additionally, small-scale CDMOs without cutting-edge machinery are more likely to have process mistakes, poor quality, and increasing price issues, which are anticipated to restrain the market's expansion.
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Contract Development And Manufacturing Organization (CDMO) Outsourcing Market Competitive Landscape
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
- Lonza Group Ltd.
- Catalent, Inc.
- Thermo Fisher Scientific, Inc.
- Patheon N.V. (a part of Thermo Fisher Scientific, Inc.)
- Cambrex Corporation
- Recipharm AB
- Fujifilm Holdings Corporation
- Samsung Biologics Co., Ltd.
- WuXi AppTec Co., Ltd.
- Boehringer Ingelheim GmbH
- Evonik Industries AG
- Vetter Pharma International GmbH
- AbbVie Contract Manufacturing
- Jubilant Life Sciences Limited
- Piramal Pharma Solutions
- Almac Group Limited
- Cytovance Biologics, Inc.
- Ajinomoto Bio-Pharma Services
- Grifols SA
- Biocon Limited
CDMO Outsourcing Market Recent Developments
- In June 2022, a high-speed blister packaging line has been installed at Catalent's clinical supply facility in Shiga, Japan, to complement its current automated bottling line. Catalent is a global leader in empowering biopharma, cell, gene, and consumer health partners to optimize the development, launch, and supply of better patient treatments across multiple modalities.
- In June 2022, for the treatment of individuals with moderately to highly active Crohn's disease, AbbVie said that the U.S. Food and Drug Administration (FDA) has authorized SKYRIZI (risankizumab-rzaa), the first and only selective interleukin-23 (IL-23) inhibitor (CD). 4 In two induction clinical trials and one maintenance trial, SKYRIZI significantly outperformed placebo in terms of endoscopic response (defined as a decrease of more than 50% from the baseline Simple Endoscopic Score in CD [SES-CD] or for patients with the isolated ileal disease and SES-CD of 4, at least a 2-point reduction from baseline) and clinical remission (defined as a Crohn's Disease Activity Index [CDAI] of less than 150).
Contract Development And Manufacturing Organization (CDMO) Outsourcing Key Market Trends
- Currently, the contract development and manufacturing organization outsourcing market is fragmented. The necessity for quick innovations to provide efficient process solutions to improve the drug development process has increased among pharmaceutical businesses. Many contract development and manufacturing businesses are preferring to combine with small and major pharma & biotech enterprises, along with many life-science corporations, in order to improve their service offerings.
Contract Development And Manufacturing Organization (CDMO) Outsourcing 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 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.
| Report Metric | Details |
|---|---|
| Market size value in 2019 | USD 217.6 billion |
| Market size value in 2031 | USD 524.67 billion |
| Growth Rate | 9.2% |
| Base year | 2023 |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
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| 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:-
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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 Contract Development And Manufacturing Organization (CDMO) Outsourcing 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 Contract Development And Manufacturing Organization (CDMO) Outsourcing 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 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 Contract Development And Manufacturing Organization (CDMO) Outsourcing 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 Contract Development And Manufacturing Organization (CDMO) Outsourcing Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Contract Development And Manufacturing Organization (CDMO) Outsourcing 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.
Contract Development And Manufacturing Organization (CDMO) Outsourcing Market Report Snapshots
- Global Contract Development And Manufacturing Organization (CDMO) Outsourcing Companies
- Global Contract Development And Manufacturing Organization (CDMO) Outsourcing Market Size
- Global Contract Development And Manufacturing Organization (CDMO) Outsourcing Market Analysis
- Global Contract Development And Manufacturing Organization (CDMO) Outsourcing Geographic Analysis
- Global Contract Development And Manufacturing Organization (CDMO) Outsourcing Market News
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