PUBLISHER: The Business Research Company | PRODUCT CODE: 1810930
PUBLISHER: The Business Research Company | PRODUCT CODE: 1810930
An investigational new drug contract development and manufacturing organization (CDMO) refers to a service provider that assists in the development and manufacturing of pharmaceutical compounds intended for clinical trial use under an Investigational New Drug (IND) application. These organizations operate in accordance with regulatory standards applicable to early-stage drug development, ensuring adherence to the guidelines necessary for progressing experimental therapies toward regulatory approval.
The primary products offered by investigational new drug CDMOs include small molecules and large molecules. Small molecules are low molecular weight compounds capable of easily penetrating cell membranes and interacting with intracellular targets to affect biological functions. These are developed into various formulations, such as solid, liquid, and injectable forms, and are supported by a range of services including preclinical studies, clinical trial material supply, regulatory support, and manufacturing services. The end users include pharmaceutical companies, biotechnology firms, academic and research institutions, among others.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.
The investigational new drug contract development and manufacturing organization (CDMO) market research report is one of a series of new reports from The Business Research Company that provides investigational new drug contract development and manufacturing organization (CDMO) market statistics, including investigational new drug contract development and manufacturing organization (CDMO) industry global market size, regional shares, competitors with a investigational new drug contract development and manufacturing organization (CDMO) market share, detailed investigational new drug contract development and manufacturing organization (CDMO) market segments, market trends and opportunities, and any further data you may need to thrive in the investigational new drug contract development and manufacturing organization (CDMO) industry. This investigational new drug contract development and manufacturing organization (CDMO) market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The investigational new drug contract development and manufacturing organization (CDMO) market size has grown strongly in recent years. It will grow from $5.53 billion in 2024 to $5.91 billion in 2025 at a compound annual growth rate (CAGR) of 7.0%. The growth during the historic period can be attributed to the increasing demand for early-phase clinical trials, greater outsourcing by pharmaceutical companies, a rise in the development of biologics and complex molecules, enhanced regulatory support for expedited drug approvals, and a heightened emphasis on cost-efficiency and reducing time-to-market.
The investigational new drug contract development and manufacturing organization (CDMO) market size is expected to see strong growth in the next few years. It will grow to $7.67 billion in 2029 at a compound annual growth rate (CAGR) of 6.7%. The growth in the forecast period can be attributed to the expanding emphasis on rare and orphan drug development, the increasing demand for integrated preclinical-to-clinical services, the rising complexity of biologics and gene therapies, growing investments in small molecule innovation, and the wider adoption of virtual pharma business models. Key trends expected during this period include advancements in integrated drug development platforms, the emergence of AI-driven clinical trial designs, innovations in personalized medicine manufacturing, progress in regulatory compliance technologies, and the development of flexible, modular manufacturing facilities.
The increase in clinical trials is expected to drive the growth of the investigational new drug contract development and manufacturing organization (CDMO) market moving forward. Clinical trials are carefully designed studies involving human participants to evaluate the safety and efficacy of medical treatments, procedures, or interventions under controlled conditions. The growth in clinical trials is primarily fueled by the rising demand for innovative treatments, as escalating rates of chronic and complex diseases push pharmaceutical and biotech companies to develop and test new therapies. Investigational new drug CDMOs support clinical trials by streamlining the development and manufacturing of trial-ready drug formulations, ensuring timely and compliant supply of investigational products for each phase of the study. For example, in November 2023, the Association of the British Pharmaceutical Industry, a UK-based trade association, reported a 4.3% increase in the annual number of industry-led clinical trials in the UK, rising from 394 in 2021 to 411 in 2022. Therefore, the rise in clinical trials is driving growth in the investigational new drug CDMO market.
Key players in the investigational new drug CDMO market are focusing on strategic partnerships to enhance development capabilities and accelerate clinical trial entry. Strategic partnerships are formal collaborations between two or more organizations that work together to achieve shared goals, leveraging each other's strengths, resources, or expertise while maintaining independent operations. For instance, in August 2023, Sartorius AG, a Germany-based life sciences company, partnered with Repligen Corporation, a US-based life sciences firm, to introduce an integrated system combining the BIOSTAT STR and XCell ATF technologies for upstream process intensification. This partnership aims to optimize biopharmaceutical production by improving efficiency and scalability. The collaboration highlights Sartorius' ongoing commitment to innovation in bioprocessing solutions and advancing the biomanufacturing industry.
In January 2024, Alcami Corporation, a US-based pharmaceutical contract development and manufacturing organization (CDMO), acquired Pacific Pharmaceutical Services for an undisclosed amount. This acquisition enables Alcami to expand its presence on the West Coast and strengthen its analytical testing and quality control capabilities. Pacific Pharmaceutical Services is a US-based company specializing in pharmaceutical testing and quality assurance services.
Major players in the investigational new drug contract development and manufacturing organization (CDMO) market are Thermo Fisher Scientific Inc., Fresenius Kabi AG, Lonza Group Ltd., Catalent Inc., Samsung Biologics Co. Ltd., Fareva SA, Recipharm AB, PCI Pharma Services, Vetter Pharma, Delpharm, Kindeva Drug Delivery LP, Ajinomoto Bio-Pharma Services, Cenexi SAS, Grand River Aseptic Manufacturing Inc., INCOG BioPharma Services, Aurigene Pharmaceutical Services, Jubilant HollisterStier LLC, Symbiosis Pharmaceutical Services Ltd., Afton Scientific Corp., and Amaran Biotech Inc.
North America was the largest region in the investigational new drug contract development and manufacturing organization (CDMO) market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in investigational new drug contract development and manufacturing organization (CDMO) report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the investigational new drug contract development and manufacturing organization (CDMO) market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The investigational new drug contract development and manufacturing organization (CDMO) market includes revenues earned by entities through analytical method development, clinical trial material manufacturing, process development, and quality control testing. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values and are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on investigational new drug contract development and manufacturing organization (cdmo) market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for investigational new drug contract development and manufacturing organization (cdmo) ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The investigational new drug contract development and manufacturing organization (cdmo) market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.