PUBLISHER: Fairfield Market Research | PRODUCT CODE: 1420310
PUBLISHER: Fairfield Market Research | PRODUCT CODE: 1420310
The global oral solid dosage contract manufacturing market is poised for remarkable expansion, as forecasted by Fairfield Market Research. In 2024, this market reached a valuation of US$ 26.3 billion and is expected to surge at a CAGR of 7%, reaching an impressive US$ 41.7 billion by the end of 2031.
Immediate-release mechanisms accounted for over 50% of the market in 2023. The growth can be attributed to increased R&D activities focused on enhancing oral solid dosage forms and the rise in long-term contract manufacturing partnerships between biotechnology companies and Contract Development and Manufacturing Organizations (CDMOs). In 2023, oral solid dosage contract manufacturing revenue made up approximately 12% of the global contract manufacturing market.
During the forecast period, there are abundant opportunities for oral solid dosage contract manufacturing companies worldwide. They can concentrate on technological advancements in oral solid dosage forms to enhance stability, yield, bioavailability, and morphological characteristics. This includes the development of various forms such as enteric-coated, extended-release, and controlled release.
For instance, companies like Catalent are making strides with their GPEx Boost platform for cell-line development, aimed at achieving stable, high-yielding mammalian cell lines for biosimilars.
Despite recent advancements, the market remains fragmented with numerous small CMOs, presenting an opportunity for consolidation. Streamlining and consolidation can lead to better operating margins and higher growth potential. Additionally, firms can adopt flexible business models to attract both large and small pharma and biotech companies.
One of the key challenges facing oral solid dosage contract manufacturers is strict approval criteria imposed by regulatory authorities. Small CDMOs without cutting-edge equipment are more susceptible to process errors, poor quality, and pricing issues. In developed countries, stringent regulations have led to a decline in small molecule approvals, impacting contract development and manufacturing demand.
Oral Solid Dosage Contract Manufacturing is prominent in the U.S. due to the country's advanced healthcare sector. The U.S. holds a significant share in North America's oral solid dosage contract manufacturing market, primarily because of the expansion of manufacturing facilities and a growing focus on drug discovery. Moreover, continuous advancements in the pharmaceutical industry and a rising demand for high-quality products have led many pharmaceutical companies to opt for Contract Manufacturing Organizations (CMOs) in the U.S.
China's Emergence: China is emerging as a prominent market for Oral Solid Dosage Contract Manufacturing due to its cost-effectiveness. The Chinese market for this type of manufacturing held over 50% of the market share in East Asia in 2023. Pharmaceutical manufacturing outsourcing is experiencing rapid growth in Asia, and Chinese CMOs have become preferred outsourcing partners for several reasons.
These include improved regulatory oversight and adherence to Current Good Manufacturing Practices (CGMP) standards, a skilled Chinese workforce, and effective cost containment strategies. These factors are expected to drive the growth of the oral solid dosage contract manufacturing industry in China in the years to come.
Companies are expanding their manufacturing units to meet the growing demand in the pharmaceutical manufacturing sector. Key providers have also pursued acquisitions and expansions to consolidate their market presence.