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Biologics are complex drugs derived from living organisms, such as proteins, antibodies, or nucleic acids. They are used to treat a wide range of diseases, including cancer, autoimmune disorders, and inflammatory conditions.
Biosimilars, on the other hand, are biologic drugs that are similar to an already approved reference biologic drug, also known as the originator. Biosimilars are not identical to the originator, but they are highly similar in terms of quality, safety, and efficacy.
Biosimilars are developed using a rigorous scientific process that involves comparing them to the reference biologic drug in terms of their structure, function, and clinical outcomes. They undergo extensive testing and evaluation before they are approved for use by regulatory agencies.
Biosimilars can offer significant benefits to patients and healthcare systems by increasing access to biologic therapies and reducing healthcare costs. They also promote competition in the biologics market, which can lead to lower prices and increased innovation.
However, it's important to note that biosimilars are not interchangeable with their reference biologic drugs. Interchangeability means that the biosimilar can be substituted for the reference biologic drug without the involvement of the prescribing healthcare provider. Interchangeability is determined by regulatory agencies based on specific criteria, and currently, there are very few biosimilars that have been granted interchangeable status.
Biologics and biosimilars are an important and growing segment of the pharmaceutical industry, representing a range of innovative drugs and therapies for the treatment of various diseases and conditions. Biologics are complex molecules produced using living cells, while biosimilars are highly similar copies of biologics that have been approved for use by regulatory authorities.
The global biologics and biosimilars market is expected to grow significantly in the coming years, driven by factors such as the increasing prevalence of chronic diseases, the growing demand for biologics and biosimilars, and advancements in biotechnology and manufacturing processes.
According to a report by Grand View Research, the global biologics and biosimilars market was valued at USD 255.1 billion in 2020 and is expected to reach USD 523.0 billion by 2028, at a compound annual growth rate (CAGR) of 9.5% during the forecast period. The market is segmented based on product type, application, and region.
Based on product type, the market is segmented into monoclonal antibodies, vaccines, recombinant hormones, growth factors, and others. Monoclonal antibodies dominated the market in 2020, accounting for the largest share of the global biologics and biosimilars market. The segment is driven by the increasing use of monoclonal antibodies in the treatment of cancer and autoimmune diseases.
Based on application, the market is segmented into oncology, immunology, diabetes, infectious diseases, and others. Oncology dominated the market in 2020, accounting for the largest share of the global biologics and biosimilars market. The segment is driven by the increasing use of biologics and biosimilars in the treatment of various types of cancer.
North America dominated the global biologics and biosimilars market in 2020, followed by Europe and the Asia Pacific. The dominance of North America is attributed to the presence of a large number of biotechnology and pharmaceutical companies, the high healthcare expenditure, and the favorable regulatory environment.
The key players operating in the global biologics and biosimilars market include AbbVie Inc., Amgen Inc., Biogen Inc., Pfizer Inc., and Roche Holding AG, among others. These companies are investing heavily in research and development activities to develop new and innovative biologics and biosimilars and gain a competitive edge.
Overall, the biologics and biosimilars market is expected to experience significant growth in the coming years, driven by the increasing prevalence of chronic diseases, the growing demand for biologics and biosimilars, and advancements in biotechnology and manufacturing processes.
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