3.1.1 Growth in demand for biologic drugs and advanced therapies is fueled by several factors. Increasing wealth in emerging economies is resulting in greater levels of diseases previously only observed in mature economies — such as heart disease and diabetes — and the ability to afford more advanced treatments. The global population is aging, leading to greater incidence of chronic diseases best treated with biologic drugs. Biologics often offer greater target specificity, efficacy, and safety profiles.[77] The recent focus on rare diseases is contributing to the growth of next-generation biologics, including multispecific antibodies; cell therapies; and gene, gene-modified cell, and gene-editing therapies, which is another important factor leading to market growth.
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.
3.2.1 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.
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.
3.3.1 As of October 2024, there are now 40 cell and gene therapies approved by the FDA.[3] Since 2021, the FDA has approved an average of five therapies per year, and appear well on their way to the goal of approving an average of 10–20 therapies per year, beginning in 2025.[3]
3.3.2 Of the estimated 7,000 rare diseases (defined by the FDA as diseases affecting fewer than 200,000 people) that are caused by genetic mutations, more than 95% have no approved therapeutic option.[87] The large number of diseases for which advanced therapies could provide a cure — where none currently exists — demonstrates that many potential targets remain for researchers to explore, provided that funding and market opportunities are available. To date, advanced therapies have not proven to be the blockbuster drugs that are as common with antibodies, but the forecasted sales of approved therapies demonstrate this is a fruitful class of therapies for which to develop therapies.[88] Sales forecasts for all gene therapies in 2023 (Table 10) and projected sales for 2029 () are given.
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.
3.4.1 Before the 1983 passage of the Orphan Drug Act (ODA) in the United States,[89] which provides financial incentives to developers of medicines that treat rare diseases in the form of tax breaks and patent exclusivity, only a few orphan drugs had been approved in the United States to treat rare diseases — just 34 from 1967 to 1983.[90] By mid-2018, nearly 7,400 orphan drug designation requests were submitted to the FDA, and as of August 2018, 78% of these had orphan-only indications.[90]
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.
CAR-T
3.5.1 As one would expect from a growing and innovating industry, the patent landscape for cell therapies is very active. A summary of some common categories for CAR-T patents and some examples is given in Table 11. CAR-T therapies can be protected by three general types of intellectual property (IP) strategy. Composition of matter patents are often considered the most valuable by investors, but by no means are the only method of protecting a CAR-T therapy. Because CAR-T are autologous, the manufacturing process is complex and, therefore, is often a critical hurdle in bringing such a therapy to market. For this reason, process inventions and the patents to protect them can be extremely valuable. Contrary to some layman’s discussions in the field, each CAR-T is manufactured by a slightly different process, and has yet to achieve the status of a true platform.[96]
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.