A recent article mentions that in the first decade of the new millennium (2000-2010), there has been less than 1% growth in small molecule new chemical entities (NCEs). Large molecule new biological entities (NBEs) have grown by about 25% during the same period.

The sale of large molecules has also grown at a compound annual growth rate (CAGR) of 10.1% during 2009-2015. Small molecules have sold at a CAGR of only 3.9% during the same period.

Keeping in mind the growing importance of large molecule bioanalysis in the contemporary pharmaceutical industry, this article explores the reasons. It also presents some of the recent trends in the field of large molecule bioanalytics.

Factors Driving The Interest In Large Molecules

Several factors are driving this interest in large molecule bioanalysis, as listed below.

Therapeutic Considerations

  • There is a growing demand for protein therapeutics because of their specificity. The chances of getting healthy cells affected, leading to adverse side effects, is much lower with protein therapeutics or biologics.

Biologics bind to specific receptor cells linked with the disease process. They also have a higher efficacy rate as a result.

  • Protein therapeutics make it possible to develop novel treatment methods for medical conditions that have had limited treatment options so far.
  • Infectious diseases, metabolic disorders, neurology, and oncology are some of the typical areas for biologics-based treatment.

Technological Advances

Our understanding of cell physiology has progressed considerably because of technological advances. Targeting different diseases at the cellular level is now possible. Some of the most remarkable novel treatment options for rare diseases relate to next-generation cell and gene therapies.

Recent Patent Expiries

Biologics estimated to have the annual sales value of US$20 billion have gone off-patent in 2015, an article informs us. This has also created a scope for new initiatives in the development of protein therapeutics.

Economic Factors

This article informs that the average number of years for a large molecule to get approval is nine while that for small molecules is 23. It is natural for the pharmaceutical industry to focus more on biologics, rather than on small molecule bioanalysis.

Some Recent Trends and Challenges

Unlike small molecule bioanalysis, analytical methods for protein therapeutics are far more complex. It is possible to produce the simple and clearly defined structures of small molecule drugs through calculable chemical processes.

Protein therapeutics-base drugs, in contrast, involve manifold heterogeneous molecules. Also, they are produced in living cell culture. Controlling them is far more difficult as a result. A protein therapeutic-based drug development process may involve more than 5000 steps,  for instance.

That is greater by multiple times than small molecule bioanalysis processes. Also, even the slightest change in the manufacturing process of biologics can have a considerable influence on the immunogenicity and safety of a drug. This continues to be the biggest challenge in the development of biologics-based drugs.

Expert Opinion On The Future

Ligand binding assays (LBAs) continue to be the golden rule for large molecule quantification. However, developments in triple quadrupole mass spectrometers in combination with advances in proteomics have made LC-MS/MS a viable technique for large molecule quantification.

Most experts believe that LC-MS/MS will be an additional tool along with LBA, not a substitute. A survey conducted by Bioanalysis-zone had 90% of the respondents emphasize that labs conducting large molecule bioanalysis should have access to both LBA and LC/MS-MS.

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