3.1.1 Growth in demand for all classes of biologic drugs 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 also aging, leading to greater incidence of chronic diseases best treated with biologic drugs. IQVIA estimates the total therapeutics market is growing at 2.1%.[32]
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3.2.1 Antibodies and antibody-based therapies represent the majority of the biopharma market and therefore are driving the growth of the overall market. Again the specific projections differ by source; a few examples are given in .
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3.3.1 In the United States, a “rare disease” is defined as a disease that affects fewer than 200,000 people.[48] 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.[48]
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3.4.1 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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3.5.1 Antibody–drug conjugates have been called an “invitation for innovation”[59] and the intellectual property (IP) is complex because of their multiple parts in the drug, along with a maze of third party IP rights. Because these drugs combine IP in biotechnology and organic chemistry, the developer requires counsel with expertise in both backgrounds.[59]
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