Despite all the hype surrounding biologic drugs, including monoclonal antibodies and cell and gene therapies, small molecule drugs continue to dominate the pharmaceutical market. Small molecules have always outnumbered advanced therapies in annual approvals, and in the past 10 years (Jan. 2013 to Dec. 2024) small molecules have on average represented 69% of annual new drug approvals (NDAs) issued by the FDA.[9] While the rate of approval of the number of small molecule NDAs during the period has grown annually by 14%, the ratio of small molecules to large molecules has decreased slightly (see Figure 3 and Table 1).[9]
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.
The bulk of APIs — both branded and generic — are produced by pharmaceutical companies for captive use. The demand for contract manufacturing is rising, however, as APIs become increasingly more complex and require specialized skills, expertise, and equipment for their production.
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The reduced number of US-based API suppliers is a key concern for the millions of people that rely on generic medicines, as many of these drugs have no US API source. Among these APIs with no U.S. manufacturer, more than 80% of these medicines defined by the FDA as essential, including 90% of top antibiotics and antivirals.[21] Together, India and China have the greatest number of API facilities supplying the U.S. market. A notable cause for concern is the fact that over 10% of them have received at least one FDA Warning Letter.[22]
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.
Limited capacity is an issue across the board for the Western pharmaceutical market. Beyond limited onshore capacity and the aforementioned logistical difficulties of reshoring production, drug candidates today tend to be more complicated and require more development than the blockbuster drugs of the past. Nowhere is this more apparent than with small, emerging pharmaceutical companies, whose emerging status makes them key drivers of innovation, developing more new drugs than large pharmaceutical companies, but also the most dependent on external services and expertise to perform the development work necessary to bring their compounds to market.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.
The COVID-19 pandemic exacerbated preexisting drug shortages that the United States and other Western countries were already experiencing, turning this problem into a major geopolitical issue. While India’s and China’s restrictions on the export of antiviral and antibacterial products were a major factor driving the United States’ drug shortages during the pandemic, these two countries were not solely responsible for the problem; European countries also restricted the export of some drugs that they determined to be essential for the treatment of COVID-19.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.