Market Size of Small Molecules Contract Development And Manufacturing Organization Industry
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Study Period | 2019 - 2029 |
Market Size (2024) | USD 180.52 Billion |
Market Size (2029) | USD 273.70 Billion |
CAGR (2024 - 2029) | 7.27 % |
Fastest Growing Market | North America |
Largest Market | Asia Pacific |
Major Players![]() *Disclaimer: Major Players sorted in no particular order |
Need a report that reflects how COVID-19 has impacted this market and its growth?
Small Molecules Contract Development And Manufacturing Organization Market Analysis
The Small Molecules Contract Development And Manufacturing Organization Market size is estimated at USD 180.52 billion in 2024, and is expected to reach USD 273.70 billion by 2029, growing at a CAGR of 7.27% during the forecast period (2024-2029).
The COVID-19 pandemic significantly impacted the growth of the small molecule CDMO market. Research groups worldwide implemented various strategies to identify small-molecule drugs to treat COVID-19. For instance, according to the article published in the Nature Journal in April 2022, the SARS-CoV2 3CL protease was identified as a critical drug target for small molecule COVID-19 therapy, given its efficacy and essentiality in the viral maturation and replication cycle. The emergence of such active small molecules for the treatment of COVID-19 significantly contributed to the market's growth. Moreover, pharmaceutical companies were continuously engaged in drug development and collaborated with various CDMOs to manufacture COVID-19 therapeutic products. For instance, in March 2023, Samsung Biologics (CDMO) signed on to manufacture COVID-19 vaccines for Moderna. Hence, the small molecule contract development and manufacturing organization market witnessed growth during the pandemic.
The major factors driving the market's growth are increasing pharmaceutical and biotechnology R&D investment, growing demand for small molecules, and rising incidence of chronic diseases.
Small molecule drugs have more demand since they are way more affordable than biological drugs. They have continuously helped to advance medicine and address unmet medical needs. One of the primary factors responsible for the rise in demand for small-molecule medicines is an increase in regulatory approvals. For instance, in December 2022, the FDA's CDER approved 20 new small molecule drugs, or 63% of the total 32 new drugs approved thus far in 2022. Thus, increasing regulatory approval for small molecules is boosting the demand for small molecule development and manufacturing services and is contributing to the market's growth.
The increasing number of small molecules in the pipeline on expedited regulatory pathways being developed by small and emerging pharma companies and a trend toward greater complexity of chemical structures are contributing to the market's growth. Small molecules are likely to continue to represent the majority of prescribed drugs in the coming years, driving the growth of the CDMO market. Accelerating advancement in research and technology is generating opportunities for biopharmaceutical companies to develop innovative small-molecule drugs. Hence, considering the dominance of this type of medicine on the market, around one-third of the CMOs offer commercial-scale small molecule API as well as advanced intermediates manufacturing, compared to 20% that provide biologic API manufacturing.
Besides, the increasing complexity associated with small molecules also contributes to the market's growth. According to Lonza, the complexity of chemical synthesis has almost doubled from eight chemical steps to an average of 14 in 2021. The development of complex generics in an era of increasing costs and increased focus on global developments and manufacturing operations requires a higher level of expertise. It demands more in-depth planning and a deep understanding of the regulatory, quality, and clinical aspects of small molecule development to bring these drugs to the market. Hence, this is likely to create demand for small molecule CDMO services, thereby contributing to the market's growth over the forecast period.
Furthermore, strategic initiatives taken by market players, such as expansion of services portfolios, mergers, collaboration, and partnerships, are likely to increase demand for these services. This is anticipated to boost the demand for small molecules CDMO services over the forecast period. For instance:
- In March 2023, Catalent and Grünenthal announced their successful formulation design and clinical-phase manufacturing collaboration for an orally dosed small molecule in Grünenthal's pipeline.
- In September 2022, Cambrex announced the completion of the first phase of its USD 30 million investment in its small molecule active pharmaceutical ingredient (API) manufacturing facility in High Point, North Carolina.
- In June 2022, Lonza inaugurated a new clinical phase development and manufacturing facility in its small molecules site in Bend, Oregon. It produces bioavailability-enhancing spray-dried dispersion (SDD) finished dosage forms and drug product intermediates.
Hence, increasing demand for small molecule therapeutics, growing R&D investment for the same, and increasing complexity associated with the manufacturing of small molecules are expected to boost the market over the forecast period. However, stringent government regulations and compliance issues with outsourcing are anticipated to restrain the market over the forecast period.
Small Molecules Contract Development And Manufacturing Organization Industry Segmentation
As per the scope of the report, a contract development and manufacturing organization (CDMO) is an organization that provides clients with comprehensive services from drug development through manufacture. In the small molecule manufacturing sector, CDMOs provide expert development and manufacturing services and are now an essential part of the pharmaceutical industry's value chain.
The small molecule contract development and manufacturing organization market is segmented by product (small molecule API, small molecule drug product (oral solid dose, semi-solid dose, liquid dose, and other small molecule drug products), stage type (preclinical, clinical (phase I, phase II, phase III, and phase IV), and commercial), end user (pharmaceutical and biotechnology companies, research institutes and academics), therapeutic area (cardiovascular diseases, oncology, respiratory disorders, neurology, metabolic disorders, infectious diseases, and other therapeutic areas), and geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the market size in value terms in USD for all the abovementioned segments.
By Product | ||||||
Small Molecule API | ||||||
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By Stage | ||||||
Preclinical | ||||||
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Commercial |
By End User | |
Pharmaceutical and Biotechnology Companies | |
Research Institutes and Academics |
By Therapeutic Area | |
Cardiovascular Diseases | |
Oncology | |
Respiratory disorders | |
Neurology | |
Metabolic disorders | |
Infectious diseases | |
Other Therapeutic Areas |
By Geography | ||||||||
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Small Molecules Contract Development And Manufacturing Organization Market Size Summary
The small molecules contract development and manufacturing organization (CDMO) market is poised for significant growth, driven by increasing investments in pharmaceutical and biotechnology research and development, alongside a rising demand for small molecules. These drugs are favored for their affordability compared to biological alternatives and have been pivotal in advancing medical treatments, particularly in addressing chronic diseases. The market's expansion is further supported by a surge in regulatory approvals for small molecule drugs, which has bolstered the demand for development and manufacturing services. The complexity of chemical structures in drug development is also on the rise, necessitating advanced expertise in regulatory and quality aspects, thereby creating additional demand for CDMO services. Strategic initiatives by key market players, including service expansions and collaborations, are expected to further propel market growth over the forecast period.
The market's trajectory is also influenced by the increasing prevalence of cancer, which drives the demand for effective therapeutics and, consequently, small molecule CDMO services. North America is anticipated to be a significant growth region due to its established research facilities and substantial R&D investments. The trend of outsourcing among pharmaceutical companies is expected to contribute to market expansion, as companies seek to leverage the expertise of CDMOs for clinical development and manufacturing. The competitive landscape is characterized by strategic activities such as mergers, acquisitions, and partnerships among major players like Catalent Inc., Lonza, and Thermo Fisher Scientific Inc. These dynamics, coupled with ongoing advancements in research and technology, are set to enhance the market's growth prospects in the coming years.
Small Molecules Contract Development And Manufacturing Organization Market Size - Table of Contents
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1. MARKET DYNAMICS
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1.1 Market Overview
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1.2 Market Drivers
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1.2.1 Increasing Demand for Small Molecule Drugs
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1.2.2 Growing Burden of Chronic Diseases
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1.2.3 Increasing Pharmaceutical R&D Investments
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1.3 Market Restraints
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1.3.1 Stringent Government Regulations
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1.3.2 Compliance Issues with Outsourcing
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1.4 Porter's Five Forces Analysis
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1.4.1 Bargaining Power of Suppliers
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1.4.2 Bargaining Power of Buyers/Consumers
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1.4.3 Threat of New Entrants
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1.4.4 Threat of Substitute Products
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1.4.5 Intensity of Competitive Rivalry
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2. MARKET SEGMENTATION (Market Size by Value - USD)
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2.1 By Product
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2.1.1 Small Molecule API
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2.1.2 Small Molecule Drug Product
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2.1.2.1 Oral Solid dose
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2.1.2.2 Semi-solid Dose
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2.1.2.3 Liquid Dose
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2.1.2.4 Other Small Molecule Drug Products
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2.2 By Stage
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2.2.1 Preclinical
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2.2.2 Clinical
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2.2.2.1 Phase I
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2.2.2.2 Phase II
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2.2.2.3 Phase III
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2.2.2.4 Phase IV
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2.2.3 Commercial
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2.3 By End User
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2.3.1 Pharmaceutical and Biotechnology Companies
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2.3.2 Research Institutes and Academics
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2.4 By Therapeutic Area
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2.4.1 Cardiovascular Diseases
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2.4.2 Oncology
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2.4.3 Respiratory disorders
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2.4.4 Neurology
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2.4.5 Metabolic disorders
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2.4.6 Infectious diseases
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2.4.7 Other Therapeutic Areas
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2.5 By Geography
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2.5.1 North America
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2.5.1.1 United States
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2.5.1.2 Canada
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2.5.1.3 Mexico
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2.5.2 Europe
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2.5.2.1 United Kingdom
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2.5.2.2 Germany
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2.5.2.3 France
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2.5.2.4 Spain
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2.5.2.5 Italy
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2.5.2.6 Rest of Europe
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2.5.3 Asia-Pacific
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2.5.3.1 India
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2.5.3.2 Japan
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2.5.3.3 China
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2.5.3.4 Australia
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2.5.3.5 South Korea
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2.5.3.6 Rest of Asia-Pacific
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2.5.4 Middle East and Africa
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2.5.4.1 GCC
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2.5.4.2 South Africa
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2.5.4.3 Rest of the Middle East and Africa
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2.5.5 South America
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2.5.5.1 Brazil
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2.5.5.2 Argentina
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2.5.5.3 Rest of South America
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Small Molecules Contract Development And Manufacturing Organization Market Size FAQs
How big is the Small Molecules Contract Development And Manufacturing Organization Market?
The Small Molecules Contract Development And Manufacturing Organization Market size is expected to reach USD 180.52 billion in 2024 and grow at a CAGR of 7.27% to reach USD 273.70 billion by 2029.
What is the current Small Molecules Contract Development And Manufacturing Organization Market size?
In 2024, the Small Molecules Contract Development And Manufacturing Organization Market size is expected to reach USD 180.52 billion.
Small Molecules Contract Development and Manufacturing Organization Market Report Snapshots
- Small Molecules Contract Development and Manufacturing Organization Market Size
- Small Molecules Contract Development and Manufacturing Organization Market Share
- Small Molecules Contract Development and Manufacturing Organization Market Trends
- Small Molecules Contract Development and Manufacturing Organization Companies