2.1.1 Growth in demand for biologic drugs is fueled by several factors. Increasing wealth in emerging economies is leading to a rise in diseases once primarily seen in mature markets — such as heart disease and diabetes — as well as a growing ability to afford more advanced treatments. The global population is also aging, leading to greater incidence of chronic diseases best treated with biologic drugs. Biologics also often offer greater target specificity, efficacy, and safety profiles.
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2.2.1 Although projections differ by source, there continues to be consensus that the biopharmaceutical market will experience robust annual growth over the near future at rates higher than projected for the pharmaceutical industry as a whole. As a consequence, biopharmaceuticals will continue to claim a greater share of the overall prescription drug market.
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2.3.1 In the United States, a “rare disease” is defined as a disease that affects fewer than 200,000 people.[44] 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.[44]
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2.4.1 Biologics, which include recombinant proteins, antibodies, growth hormones, vaccines, and cell and gene therapies, among others, have traditionally been developed to treat many complex and chronic diseases, such as rheumatoid arthritis, psoriasis, and Crohn’s disease, for which limited effective treatment options have previously been available.
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2.5.1 A significant fraction of the biopharmaceutical development pipeline comprises not only follow-on biopharmaceuticals — mostly biosimilars — but also many biogenerics (copies of protein products that were not originally approved as biologics and, therefore, not subject to approval as biosimilars but more often via the 505(b)(2) pathway) and biobetters (modified versions of previously approved products, often but not always for the same indication, which typically provide some benefit with respect to delivery, stability, etc.). By the end of 2019, 17% of the biologics market was accessible to biosimilar competition, and biosimilars had achieved a 20% market share.[52] In addition, including approved but not yet launched biosimilars, 50% of the biologics market could ultimately face biosimilar competition. By April 2024, a total of 50 biosimilars had been approved by the FDA (Table 10). And by year’s end, a record total of 18 biosimilars for 8 reference products had been approved in 2024.[53]
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.