23, May 2023
As per IDF Diabetes Atlas 10th edition, around 537 million adults are diagnosed with diabetes globally; this number is anticipated to surge to 643 million by 2030. Type 1 diabetes is among the most common autoimmune diseases, followed by lupus, rheumatoid arthritis, and psoriasis. According to the National Stem Cell Foundation, nearly 4% of the world’s population is distressed by at least 1 out of 80+ diseases. Such high prevalence has increased the adoption of bioengineered protein medications due to high affinity and low toxicity. Based on our estimates, the global bioengineered protein drugs market is predicted to witness progress with a CAGR of 7.7% during the forecast period 2023-2030.
The burden of diseases due to the rising aging population has elevated the demand for advanced medications. As per the World Population Prospects 2019, 1 in 6 people will be over 65 globally by 2050. This has prompted advancements in biotechnology and protein engineering, resulting in the availability of various drugs, including monoclonal antibodies, peptide hormones, vaccines, and fusion proteins.
Let’s look deeper into the key trends prompting developments in drug delivery systems, leading to the bioengineered protein drugs market’s expansion.
Over the past decade, the incidence rate of chronic diseases has soared due to unhealthy lifestyles. According to WHO, more than 15 million people between 30-69 years decease from chronic conditions annually. Cardiovascular disease accounts for most non-communicable disease mortality, followed by cancers, diabetes, etc. This has led to a significant shift in the pharmaceutical industry from chemical drugs to protein drug development. For instance, between 2021 and 2022, the US FDA approved 19 mAbs, 6 peptide hormones, 1 fusion protein, 4 therapeutic enzymes, etc.
Protein drugs using recombinant DNA technology have gained significant traction recently, leading to various launches. For instance, in February 2023, Researchers at the Indian Institute of Technology (IIT) Guwahati developed a ‘Recombinant Protein Toolbox’ consisting of six proteins that convert skin cells into heart cells, especially cardiomyocytes. This toolbox regenerates damaged heart tissues using DNA technology.
Earlier, protein drugs were obtained from humans or other resources. For example, vaccines were formulated using egg cultures. However, recombinant DNA technology has enabled manufacturers to produce bioengineered protein drugs like vaccines, monoclonal antibodies, and blood factors using genetically modified organisms. To elucidate, blood products can be manufactured using DNA technology in bacterial expression or mammalian cell culture systems. The prominence of protein engineering platform technologies is mainly owing to their ability to enhance medications’ functionality, purity, and circulating half-life. Protein conjugation and derivatization are among the major approaches that elevate circulating half-life.
Advancements in protein engineering have led to further R&D investments in protein-based drug manufacturing. For instance, in March 2023, Eli Lilly and Company invested $1.5 billion to expand its manufacturing footprint with new facilities in North Carolina, Indiana, and Ireland. Its facility in Ireland is set to be the most technically advanced manufacturing site for existing monoclonal antibodies, producing existing and pipeline clinical products by 2026. Hence, drug manufacturing and delivery advancements create opportunities for the bioengineered protein drugs market.
Considering the rising demand for effective therapies and high unmet needs, healthcare companies are surpassing research boundaries to improve treatments. This has led the pharmaceutical industry to move towards novel molecular formats to deliver breakthrough therapies. Moreover, rare diseases with few or no treatment drugs have influenced players to expand research capabilities and launch new drugs. Since numerous factors drive many complex conditions, constraining one target may not prosper in achieving efficiency. In such a scenario, developing multi-specific antibody formats treats multi-layered diseases by engaging two or more targets with one molecule. Therefore, rising research and development activities are expected to boost the bioengineered protein drugs market.
North America holds the highest share of the global market.
Q2) Which are the major bioengineered protein drug types?Monoclonal antibodies, peptide hormones, vaccines, blood factors & peptide antibiotics, fusion proteins, cytokines, and therapeutic enzymes are major drug types.
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