According to the Centers for Disease Control and Prevention (CDC), six in 10 adults have a chronic disease (defined as a condition that lasts one year or more and either requires ongoing medical attention or limits daily life, or both) and four in 10 adults have two or more of these conditions.[41] Chronic diseases are the most significant cause of deaths worldwide, and the number is growing every year. According to an NIH report, in 2023, the number of people aged 50 and older in the United States with at least one chronic illness is predicted to rise by 99.5%, from 71.5 million in 2020 to 142.7 million in 2050. Additionally, the number of people with multimorbidity would rise by 91% from 7.8 million in 2020 to 15.0 million in 2050.[42] The rising incidence of chronic diseases is driving the growth of the small molecule drug discovery market.
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In the United States, a “rare disease” is defined as a disease that affects fewer than 200,000 people. According to the National Institutes of Health (NIH), over 30 million Americans have one of the nearly 7,000 rare diseases that have been identified to date.
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The advances in technology mentioned above are also providing greater insight into the individual aspects of smaller subsets of diseases previously considered to be similar among all patients. For instance, there is much greater knowledge about the impact of specific genetic mutations regarding the responsiveness of different cancers to specific types of treatments. New diagnostic tools are allowing physicians to identify medical intervention strategies with higher probabilities of success and thus provide patients with improved quality of life and better survival rates.
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A growing percentage of all approved drug products and pipeline candidates — both small molecule and biologic therapies — fall under the classification of potent or highly potent. The focus of the industry on cancer indications is an important driver, as a large percentage of oncology treatments are formulated using highly potent cytotoxic compounds. These drugs include those based on chemical APIs and increasingly those based on antibody–drug conjugates (ADCs), which comprise an antibody linked to a small molecule or biologic cytotoxic agent.
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Controlled substances in the United States are regulated under the Controlled Substances Act (CSA). Classification as a controlled substance is largely based on the potential for abuse, but other criteria include currently accepted medical use in treatment in the United States and international treaties.
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Dramatic advances in research tools for uncovering the mechanisms of diseases has led not only to precision medicines, but to the discovery of novel drug targets and new approaches to developing treatments for known targets that were previously considered to be undruggable. This trend is reflected in the fact that, from 2020 to 2023, the fraction of novel drugs approved by the FDA that were identified by the agency as first-in-class — drugs that have new mechanisms of action increased from 40% to 54%.[40][51][52] While several were biologics, many were drugs formulated with small molecule APIs. In 2021, the latter included antifungal, antiviral, and anticancer agents, as well as treatments for kidney disease and numerous other diseases.
Notable examples of novel first-in-class approvals in 2022 include:
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