PUBLISHER: The Business Research Company | PRODUCT CODE: 1815735
PUBLISHER: The Business Research Company | PRODUCT CODE: 1815735
A small-molecule Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) is a business entity that offers services to pharmaceutical companies on a contractual basis. These services encompass various aspects of the pharmaceutical development lifecycle, including contract development, manufacturing, and packaging of small-molecule drugs. Small-molecule CMOs/CDMOs play a crucial role in assisting other companies in the pharmaceutical industry to complete projects and navigate through the regulatory submission process.
Small-molecule Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) are primarily classified into two categories, small-molecule drug products and small-molecule Active Pharmaceutical Ingredient (API). The term small-molecule drug product denotes the final form of a medicinal product that incorporates an active pharmaceutical ingredient composed of small molecules. This involves comprehensive stages, including clinical, commercial, and preclinical development. These drug products find applications in therapeutic areas such as oncology, neurology, infectious diseases, cardiovascular diseases, respiratory disorders, metabolic disorders, among others. The end-users of these services are entities specializing in cardiovascular, oncology, diabetes, and immunological disorders.
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 resulting trade tensions in spring 2025 are having a significant impact on the pharmaceutical sector. Companies are grappling with higher costs on imported active pharmaceutical ingredients (APIs), glass vials, and laboratory equipment-many of which have limited alternative sources. Generic drug manufacturers, already operating with minimal profit margins, are particularly affected, with some scaling back production of low-margin medications. Biotech firms are also experiencing delays in clinical trials due to shortages of specialized reagents linked to tariffs. In response, the industry is shifting API production to regions like India and Europe, building up inventory reserves, and advocating for tariff exemptions on essential medicines.
The small-molecule CMO/CDMO market research report is one of a series of new reports from The Business Research Company that provides small-molecule CMO/CDMO market statistics, including small-molecule CMO/CDMO industry global market size, regional shares, competitors with a small-molecule CMO/CDMO market share, detailed small-molecule CMO/CDMO market segments, market trends and opportunities, and any further data you may need to thrive in the small-molecule CMO/CDMO industry. This small-molecule CMO/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 small molecule CMO/CDMO market size has grown strongly in recent years. It will grow from $50.58 billion in 2024 to $54.42 billion in 2025 at a compound annual growth rate (CAGR) of 7.6%. The growth in the historic period can be attributed to favorable government support, cost-effective solutions, growing complexity in drug development, industry consolidation, focus on core competencies.
The small molecule CMO/CDMO market size is expected to see strong growth in the next few years. It will grow to $72.9 billion in 2029 at a compound annual growth rate (CAGR) of 7.6%. The growth in the forecast period can be attributed to rise in drug pipelines, globalization of pharmaceutical operations, demand for flexible manufacturing, regulatory compliance expertise, biopharmaceutical convergence. Major trends in the forecast period include sustainable and green manufacturing practices, increased collaboration and partnerships, personalized medicine and niche therapies, rise in virtual and virtual-to-reality companies, integration of digital technologies, rapid response manufacturing.
The forecast of 7.6% growth over the next five years reflects a slight reduction of 0.1% from the previous projection. This reduction is primarily due to the impact of tariffs between the US and other countries. The imposition of trade restrictions may challenge U.S. biotech firms by increasing costs of contract manufacturing services and specialized crystallization technologies imported from Singapore and Ireland, potentially slowing clinical trial material production and raising development costs. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.
The increasing demand for pharmaceuticals is anticipated to drive the growth of the small-molecule CMO/CDMO market in the future. The pharmaceutical industry encompasses the discovery, development, and production of drugs and medicines by both government and private sectors. Small-molecule CMO/CDMO services are utilized in the pharmaceutical industry to outsource various functions, such as the development, manufacturing, and packaging of small-molecule drugs. This outsourcing enables pharmaceutical companies to reduce costs, save time, and streamline their processes. For example, in August 2024, the Government of Canada, a national government agency, reported that domestic exports in the pharmaceutical sector rose to $9.59 billion USD (12.79 billion CAD) in 2022, an increase from 10.71 billion CAD in 2021. Additionally, imports rose to 30.21 billion CAD, up from 26.63 billion CAD in 2021. Thus, the growing demand for pharmaceuticals is a key factor driving the expansion of the small-molecule CMO/CDMO market.
Major companies in the small-molecule CMO/CDMO market are focusing on innovative technologies to enhance CDMO services, such as the state-of-the-art small-molecule platform in Shanghai. This platform represents cutting-edge technological innovations aimed at developing and producing small-molecule drugs more efficiently. In June 2023, Porton Pharma Solutions Ltd., a China-based pharmaceutical company, launched a state-of-the-art small-molecule platform in Shanghai. This platform adopts a holistic approach by combining advanced technologies and methodologies to advance the entire lifecycle of small-molecule pharmaceuticals. It offers one-stop-shop solutions, flexibility, availability, and digital transformation.
In March 2023, Catalent Inc., a US-based pharmaceutical company, entered into a partnership with Grunentha GmbH, a Germany-based pharmaceutical company. This partnership is focused on expediting clinical development timelines for an orally dosed small molecule in Grunenthal's pipeline. The collaboration aims to improve the bioavailability of the small molecule and reduce the Phase 1 development timeline. Grunenthal GmbH is actively engaged in partnerships and agreements with contract development and manufacturing organizations (CDMOs).
Major companies operating in the small molecule CMO/CDMO market report are Patheon NV (Thermo Fisher Scientific), GlaxoSmithKline, Johnson Matthey PLC, Lonza Group Ltd., WuXi AppTec, Catalent Inc., Aurobindo Pharma, Fareva, Aesica Pharmaceuticals Limited, Siegfried holdings AG, Recipharm AB, Jubilant Life Sciences Limited, Almac Group, Piramal Pharma Solutions, Oxford Chemicals Inc., Syngene International Limited, Novasep, Pfizer CentreOne, GVK Biosciences, ChemPartner, Avid Bioservices Inc., Dishman Carbogen Amcis Ltd., ProChem Inc., Metrics Contract Services
North America was the largest region in the Small Molecule CMO/CDMO market in 2024. The regions covered in the Small Molecule CMO/CDMO market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
The countries covered in the Small Molecule CMO/CDMO market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The small-molecule contract manufacturing organization (CMO) or contract development and manufacturing organization (CDMO) market consists of revenues earned by entities by providing services such as drug development services, process scale-up, quality control and testing, technology transfer, and clinical trial support. The market value includes the value of related goods sold by the service provider or included within the service offering. The small-molecule contract manufacturing organization (CMO) or contract development and manufacturing organization (CDMO) market also includes sales of active pharmaceutical ingredients, drug intermediates, and drug formulation. Values in this market are 'factory gate' values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
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 that 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.
Small Molecule CMO/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 small molecule cmo/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 small molecule cmo/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 small molecule cmo/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.