Biopharmaceuticals are therapeutic recombinant proteins which are produced through biotechnological processes. Bioprocessing is a significant part of biotechnology. It has been estimated that with the next 5 to 10 years, up to 50% of all drugs in development will be biopharmaceuticals. These processes include recombinant DNA techniques, purification processes, and hybridoma techniques. Biopharmaceuticals are obtained from biological sources such as live organisms, animal fluids, organs, and tissues, or genetically modified cells and organisms.
Biopharmaceuticals target specific diseases and patient groups and are used in the treatment of various chronic diseases, including cancer, metabolic, cardiovascular, neurological, and other rare diseases, for which the treatments are not yet available. It is considered to be the breakthrough in the field of medicine, which has enhanced the quality of treating diseases and improved the quality of life of patients. Monoclonal antibodies, recombinant proteins, erythropoietin (EPO), recombinant human insulin, vaccines, interferon, growth hormones, purified proteins, and other biopharmaceuticals are the different types of biopharmaceuticals that are used for treating diseases.
The use of biopharmaceutical drugs has grown over the last few years. In 2016, the total number of products approved by the Foods and Drugs Administration (FDA) and European Medicines Agency (EMA) reached 1357, out of which, 737 are biosimilars, more than 130 have different formulations, and the remaining 482 are differentiated as biobetters. 73 biopharmaceuticals have approved for use in humans, from 2013 to 2016, out of which, the monoclonal antibodies were widely used in the treatment of inflammatory diseases, neoplastic tumors, and several diagnostic procedures.
The tremendous rise in the geriatric population, strong pipeline of biopharmaceuticals, and less number of marketed generics are some of the factors likely to drive the growth of the global biopharmaceuticals market during the forecast period. Furthermore, the high lobby power of several biopharma companies, the expansion of indicators, and fewer patient expirations are some of the other factors driving the growth of the market. Increase in the FDA-approved biopharma products is expected to create lucrative opportunities for the market throughout the coming years.
Increasing Adoption Of Biopharmaceuticals
Opportunities in the global biopharmaceuticals market have been increasing since the last few years. The adequacy and safety of the drugs are some of the major product features that are propelling the market growth. Over the past few years, biopharmaceuticals have been used in the treatments of various diseases and have been diminishing the mortality rates in patients with HIV/AIDs, cystic fibrosis, malignancy, and rheumatoid joint inflammation, further enhancing personal satisfaction. The adequacy of the drugs and their safety has increased the adoption of biopharmaceuticals.
North Americ To Hold The Largest Market Share
North America is expected to be the largest market for biopharmaceuticals during the forecast period, owing to the technological advancements and high investment and funding in the region, in order to support the support development of biopharmaceuticals. The biopharmaceuticals market in North America was estimated at USD 64,681.3 million in 2014 and is projected to reach USD 111,598.2 million by 2020, expanding at a rate of 9.5% CAGR during the forecast period.
One of the latest trends gaining traction in the market is outsourcing, wherein the biopharma companies enter into partnerships with contract manufacturing organizations (CMOs) to make biopharmaceutical drug substances. In this way, a newly launched product can gain market access with ease, thereby reducing the overall investment required to launch the product in the market.
High-End Manufacturing Requirements
Unlike the regular drugs, biopharmaceuticals are derived using living biological systems. Because of this, biopharmaceutical production requires specialized devices and equipment like incubators that can support these living systems. These devices and equipment are very expensive in comparison to regular and traditional manufacturing devices.
Alongside this, most biopharmaceuticals require custom built manufacturing devices and highly experienced personnel to operate them. Because of these high-grade manufacturing conditions, the resources and time required to set up a biopharmaceutical production office is high, which makes scaling extremely difficult. Hence, these factors are restraining the growth of the biopharmaceuticals market during the forecast period.
Despite the fact that elements like the entry of low-cost biosimilars, risk of side-effects posed by biopharmaceuticals, and cost containment in the well-established markets are probably going to limit the development of this market in the coming years, it is expected that with their high strength and ability to attack targets beyond the reach of small molecule drugs, biopharmaceuticals provide the market with an immense scope for future growth. Additionally, increasing demand in emerging countries and a rich late-stage pipeline are also likely to drive the growth of the market over the coming years.