It is anticipated that the small molecule innovative CDMOs market will be valued US$ 48.09 billion in 2023 and US$ 89.43 billion in 2033. Sales of small molecule pioneer CDMO are anticipated to expand at a compound annual growth rate (CAGR) of 6.4% over the course of the predicted decade.

The contract development and manufacturing organisation (CDO) market for small molecule innovators is a dynamic and quickly expanding industry that offers vital services to the biotech and pharmaceutical sectors. The market is driven by the rising complexity of drug molecules, which calls for specialised knowledge and equipment, as well as the growing need for outsourcing drug research and manufacturing activities.

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The majority of small molecule innovator CDMOs are concentrated in North America and Europe, with a few players in Asia. This is due to the concentration of the pharmaceutical industry in these regions, as well as the regulatory requirements for drug development and manufacturing. The small molecule innovator CDMO market is highly specialized, with players focusing on specific areas such as formulation development, API synthesis, and analytical testing. This allows them to develop deep expertise and offer high-quality services to their clients.

The small molecule innovator CDMO market is adopting new technologies such as continuous manufacturing and automation to increase efficiency and reduce costs. However, the adoption of these technologies is still in its early stages, and many players are still using traditional batch manufacturing methods. Overall, the small molecule innovator CDMO market is a rapidly growing and dynamic sector that provides essential services to the pharmaceutical and biotech industries.

The market is undergoing consolidation, and players are focusing on specialization and technology adoption to stay competitive.

Key Takeaways:

• The small molecule API segment is expected to record a swift growth of 6.7% during the forecast period. This expansion can be attributed primarily to regulatory agencies’ high approval rate of NME small molecules.
• In 2022, the clinical stage segment held a sub-substantial share of the market, accounting for 55.1% of total revenue. During clinical procedures, CDMOs provide specialized expertise, time savings, and cost efficiency. This is expected to boost segmental growth during the forecast period.
• In terms of customer type, pharmaceutical companies had the controllable share (93.9%) in 2022. The growing emphasis on core competencies, such as sales, and the adoption of expansion strategies by CDMOs for manufacturing small molecule drugs, are driving the segment’s market growth.
• The oncology segment acquired a prominent share of the market in 2022, accounting for 41.8% of revenue, and it is expected to grow at the fastest rate of more than 7.0% over the forecast period. One of the major factors supporting the segment’s growth is the large number of oncology drugs in the regulatory approval pipeline.
• Over the forecast period, Asia Pacific is expected to record a healthy growth of 7.2% because of significantly lower manufacturing costs than in North America and Europe, as well as favorable regulations that encourage innovation

Competitive Landscape:

The presence of numerous competitors in the market influences service pricing, making it a direct source of competition, especially for small-scale providers. To gain a competitive advantage, market vendors are expected to focus on providing one-stop-shop services. With access to significant capital, the CMO could engage in these activities, making entry difficult for new players and increasing competition. Partnerships, company expansions, innovations, and acquisitions are among the strategies used by market participants to improve their product offerings and gain a sustainable competitive advantage.

Latest Developments:

• Catalent announced in January 2023 that it had signed a development and license agreement with Ethicann Pharmaceuticals Inc., a Canadian/American specialty pharmaceutical company specializing in developing high-value cannabinoid drug therapies, to advance Ethicann’s clinical drug pipeline using Zydis orally disintegrating tablet (ODT) technology.
• Binding Site Group, a global provider of speciality diagnostics, was acquired by Thermo Fisher Scientific Inc. for US$ 2.8 billion in January 2023. The Binding Site expands Thermo Fisher’s already extensive specialized diagnostics range by adding ground-breaking innovation in multiple myeloma diagnosis and monitoring.

Key Companies:

• Piramal Pharma Solutions
• CordenPharma International
• Wuxi AppTec
• Cambrex Corporation
• Recipharm AB
• Pantheon (Thermo Fisher Scientific)
• Lonza
• Catalent Inc.
• Siegfried Holding AG
• Boehringer Ingelheim
• Labcorp Drug Development

Key Segments:

• Product Outlook
• Small Molecule API
• Small Molecule Drug Product
• Oral solid dose
• Semi-Solid Dose
• Liquid Dose
• Others

Stage Type Outlook:

• Preclinical
• Clinical
• Phase I
• Small
• Medium
• Large
• Phase II
• Small
• Medium
• Large
• Phase III
• Small
• Medium
• Large
• Commercial

Customer Type Outlook:

• Pharmaceutical
• Small
• Medium
• Large
• Biotechnology

Therapeutic Area Outlook:

• Cardiovascular disease
• Oncology
• Respiratory disorders
• Neurology
• Metabolic disorders
• Infectious disease
• Others

By Region:

• North America
• Latin America
• Western Europe
• Eastern Europe
• Asia Pacific Excluding Japan (APEJ)
• Japan
• Middle East Africa (MEA)