1.1.1 Biologic drugs have been steadily gaining market share since the first biologic was approved by the U.S. Food and Drug Administration (FDA) in 1982. Historically, small molecule active pharmaceutical ingredients (APIs) held paramount significance within the global pharmaceutical industry, but they now represent only 69% of all new drugs approved by the FDA in the past decade (see Figure 1).[1] The trend continues through 2024. Two-thirds of 2024 new drug applications (NDAs) were for small molecules (Figure 2).[1]
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1.2.1 While the manufacture of pharmaceutically useful products using large-scale fermentation of microbial organisms was widespread by the 1970s (building on pioneering work undertaken in the 1940s by Pfizer, Squibb, Eli Lilly, and others to scale penicillin production to the 10,000-gallon scale), what we think of as modern biomanufacturing emerged in the 1970s and 1980s in response to advances in the recombinant expression of peptides and simple proteins.
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1.3.1 Even as expenditures on human health are increasing, so is the animal health market, and especially the use of biologics for animal therapeutics. The rapid expansion is due to increased animal consumption, rising expectations for assured food security, expanding pet ownership, and increased humanization of pets.[4] The largest animal health companies were previously spun out of pharma companies or remain divisions of large, international biopharmaceutical firms. It is not surprising given the increased demand for animal health products that these companies would seek to translate existing pharma technology to such applications.
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1.4.1 Antibodies have utility outside of therapeutics. They have long been used as critical research reagents for basic assays such as enzyme-linked immunosorbent assays (ELISAs), Western blots, flow blots, and flow cytometry.[5]
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1.5.1 In early 2024, we received many questions regarding the funding outlook for biotech. The following is our answer to these questions. While the text was also published on Pharma’s Almanac in April 2024, we are reproducing it here for the convenience of our readers, along with an update as of this writing in April 2024.
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1.6.1 The pharmaceutical industry, once buoyed by the unprecedented demand and rapid innovation triggered by the COVID-19 pandemic, is currently readjusting to a post-COVID world, which has brought its own challenges, including a wave of layoffs that has swept across the biotech and pharma landscape in the past few years. This undercurrent of job reductions and corporate restructuring echoes the industry’s reflex to recalibrate in response to market pressures and strategic realignments, which appears at odds with forecasts of robust drug sales and potential market growth.
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