Biomolecular separation is an important technique used in many industries. Biomolecular products such as proteins and DNA have become an integral part of the healthcare industry. These biomolecular products are widely used in the diagnosis and treatment of various life-threatening diseases. Separation systems for commercial biotechnology include chromatography, centrifugation, electrophoresis, membrane filtration, flow cytometry, magnetic separation, microarrays, biochips, and lab-on-a-chip. These techniques are widely used to separate biomolecular products.
Fast-moving developments in 3D cell culture tools and technologies are accelerating cancer research and its clinical applications, as well as other areas of medical research and safety applications. BCC Research forecasts some segments of the global 3D cell culture market to have five-year compound annual growth rates as high as 44% through 2021 (e.g., 3D applications in toxicology for pharmaceutical development). In another example, neurological safety testing could grow from being a $5 million segment in 2015 to $95 million by 2021, according to BCC Research’s study, 3D Cell Cultures: Technologies and Global Markets.
The global market for drugs that fall under the Breakthrough Therapy Designation (BTD) is forecast to grow from $48.8 billion in 2017 to $99.2 billion by 2022, according to a comprehensive market analysis by BCC Research. In 2012, the US FDA launched the BTD pathway to expedite the approval of drug candidates that are intended to treat serious or life-threatening diseases and that outperform existing therapies. The European Medicines Agency introduced a similar fast-track program, called PRIME (PRIority MEdicines), in March 2016.
“Our analysis of the breakthrough drug market shows that companies have an opportunity to leapfrog the lengthy drug approval process by up to three years, generating hundreds of millions of dollars in revenue and maximizing the length of time their drug is on the market before their patent expires,” says Kevin Fitzgerald, BCC Research Editorial Director.
OPPORTUNITY AND CHALLENGES OF A BREAKTHROUGH STATUS
Continuous research and innovations in drug discovery are driving modest growth in the global market for bioengineered protein therapeutics. According to an analysis by BCC Research, other growth factors include more sedentary lifestyles, the rising incidence of chronic illnesses, and an increasing awareness of enzymatic and other disorders. Bioengineered proteins are widely used as therapeutics because of their high potency and reduced side effects. They are created by genetically modifying living cells using recombinant DNA technology. The model organisms for these include Escherichia coli bacteria, yeast, and mammalian cell cultures. Protein drugs can help treat chronic diseases such as asthma, rheumatoid arthritis, cancer, and diabetes.
The global market for bioengineered protein drugs is expected to reach $228.4 billion by 2021 from $172.5 billion in 2016, growing at a five-year compound annual growth rate (CAGR) of 5.8%. The United States, which is the largest market, should attain $148.7 billion in 2021, demonstrating a five-year CAGR of 9.7%. The European market could reach $39.5 billion at a CAGR of 0.3% from 2016 through 2021. The emerging markets are predicted to total $40.2 billion in 2021, up from $39.8 billion in 2016, representing a five-year CAGR of 0.2%.
GLOBAL MARKET FOR BIOENGINEERED PROTEIN DRUGS BY REGION, 2014–2021
A rise in revenues from monoclonal antibodies, peptide hormones, blood products, and therapeutic enzymes has boosted the US market. In Europe, competition from the entry of biosimilars and Brexit (the exiting of Britain from the European Union in 2016) have had adverse effects on the market. The emerging markets have shrunk slightly due to lack of awareness and facilities to market bioengineered products in countries such as India and Brazil. These regions are unfamiliar with protein therapeutics and prefer chemical drugs. Also, many of these products are marketed in a limited number of countries; thus people do not have convenient access to the drugs nor to information about them.
The therapeutic use of monoclonal antibodies is expected to increase during BCC Research’s forecast period. Other protein therapies, including some vaccines and therapeutic enzymes, are in demand as the result of the increasing incidence of hormonal disorders, diabetes, and infertility. Increased research and development spending, growing competition, patent expiries, and changing lifestyles are factors shaping the protein therapeutics market. “Global market growth has been favorably affected by the rapid increase in new medical technologies, heightened awareness, the rise in patent approvals, improved diagnosis of diseases, and expansion of healthcare in emerging markets,” says BCC Research analyst Shalini S. Dewan.
USING ENGINEERED PROTEINS TO COMBAT VIRAL THREATS