Fourth-generation biologics, with improved delivery and pharmacokinetics, will continue to drive an overall biologics industry that is already worth over $120 billion, according to a new report from Lux Research. So-called “biobetters” making their way through clinical trials, by and large, target molecules now off-patent with the promise of enabling new players to enter with modifications of proven drugs, the report says.
“With advances in cloning and assay development the therapeutics industry has managed to artificially engineer these molecules to address therapeutically important targets,” said Yan Xiang Yang, Lux Research Analyst and the lead author of the report titled, “Of Biologics and Cells – Are Formulation and Delivery Technologies Keeping Up with the Progression?”
“They are also able to produce them in commercially viable quantities, such that a number of this class of therapeutic molecules has achieved blockbuster status,” she added. “The possibility also exists for positive up-regulation of cellular activity by fifth-generation biomolecular drugs that may be used to activate stem cells or boost immune system functions for diseases such as cancer.”
Lux Research analysts investigated innovations in the biologics industry and the current state of the market. The findings include:
Autoimmune and inflammatory biologics lead. The autoimmune/inflammatory category, followed by hematologic disorders, metabolic disorders (which is dominated by insulin analogs), and cancer together account for over $100 billion in sales. The most lucrative indication is autoimmune diseases, the top four drugs sharing over $25 billion in sales and the next seven adding another $14 billion. The hematologic disorders market, worth $21.5 billion is slightly larger than the $20.5 billion cancer drug market.
Antibodies remain dominant. Several factors place antibodies at the forefront of the biologicals wave – the depth and breadth of knowledge supporting its use, and innate properties such as stability and targeting ability. Blockbuster successes such as Herceptin and Lucentis have also driven others in the industry to follow suit with a likely glut of such therapies on the horizon.
Challenges remain for other biologics. Physical instability, chemically degradable, enzymatically digestible and the inability to penetrate barriers are some key hurdles facing developers of nucleic acid technologies. Also, with only one active cellular therapy trial in the U.S., progress in cell-based therapeutics will remain slow, leaving protein therapeutics the dominant biologic therapy.