Over the years, pharmaceutical companies have shifted their priorities from traditional interventions towards more advanced pharmacological strategies, such as protein therapeutics. It is worth highlighting that in 2023 alone, close to 20 protein-based drugs were approved for the treatment of myriad of disease indications including oncological and metabolic disorders. Further, $400 billion is the anticipated sales of protein-based therapeutics in 2023. The growing popularity of this class of drugs can be ascribed to its high specificity, affinity, minimal drug-drug interactions, diverse biological and chemical, proven pharmacological value, and favorable safety profiles. The rising demand for protein therapeutics, such as monoclonal antibodies and vaccines, is driving advancements in protein expression technology to ensure efficient and scalable production.
Protein expression is a potent technology in the field of synthetic biology, that is utilized for the high-throughput production of proteins as well as enzymes and oligonucleotides (DNA / RNA). In the healthcare industry, protein expression technology is primarily used for the production of therapeutic biologics and high-value small molecules. In addition, other industries, such as agriculture, cosmetics, food, environmental sciences, biomedical research and enzyme synthesis industry, are also benefiting from the protein expression process.
General Overview of Protein Expression Process
Protein expression, also referred to as protein production, is a biotechnological process for producing specific proteins for research or commercial use. This process initially involves transcription of DNA to messenger RNA (mRNA). The mRNA is then translated into to form functional proteins. The main components of protein expression are a vector (plasmid) containing the gene of interest, and a host cell, for instance mammalian or prokaryotic cell.
Protein expression process can be divided into following steps:

- Transcription: The DNA sequence of a gene is transcribed into mRNA.
- mRNA Processing: mRNA undergoes splicing to remove introns and add a 5’ cap and poly-A tail.
- Translation: The processed mRNA is then translated by ribosomes to synthesize a polypeptide chain.
- Post-translational Modifications: The polypeptide chain undergoes folding and modifications, including phosphorylation, glycosylation and cleavage, to become a functional protein.
Protein Expression Technology / System
The pharmaceutical industry uses different protein expression technology / system depending on the type of type of protein to be expressed, desired yield, post-translational modifications and capital invested. However, the expression system used must be biocompatible, non-toxic, and able to withstand the stresses of the protein expression process without hampering the quality of the product.

- Algal Expression System: This expression system is used in genetic engineering, biofuel production, botany. It offers excellent experimental control for nutraceuticals and biofuel. However, this is still a nascent protein expression technology and is relatively less developed than other host systems.
- Cell-free Expression System: This expression system is used expressing toxic proteins, high-throughput proteomic studies, translational inhibitor screening. It possess fast and simple format. Further, it is not sustainable for large scale production.
- Insect Expression System: This expression system is used in functional assays, structural analysis, expression of intracellular and complex proteins, and virus production. Interestingly, insect cells offers posttranslational modifications similar to mammalian cells. Further the major drawbacks of this system are longer production time and lacks partial glycosylation.
- Mammalian Expression System: This expression system is used in functional assays, structural analysis, expression of complex proteins and virus production. It is noteworthy that mammalian host cells offer highest level of protein processing. It is worth highlighting that close to 85% of the biopharmaceuticals are produced using mammalian cell cultures. However, these require more demanding culture conditions.
- Prokaryotic Expression System: This expression system is used in structural analysis, antibody generation and functional assays. Prokaryotic cells offer higher scalability and efficiency. However, it requires protein-specific optimization and often results in protein solubilization.
- Yeast Expression System: This expression system is used in structural analysis, antibody generation and functional assays. It has various advantages such as lower production costs, rapid expression and has simple media requirements. However, in yeast cells fermentation is required for very high yields.
Applications of Protein Expression Technology in Healthcare
- The ability to express good quality proteins efficiently has a spectrum of applications across various fields. Protein expression is used in the production of:
- Modified human proteins (includes protein-protein fusion products and PEGylated protein drugs)
- Monoclonal antibodies used in the treatment of various disorders including autoimmune disorders, oncological disorders and infectious diseases.
- Hormones (includes recombinant insulin, erythropoietin and growth hormones)
- Enzyme replacement therapies used in treatment of rare genetic disorders such as Gaucher disease.
- Blood products (includes albumin, blood clotting factors, fibrinolytics and thrombolytics)
- Industrial enzymes used in the biofuels production, food processing and waste management.
Further, protein expression is also used in structural biology and functional genomics to investigate functions, interactions and roles of proteins in different biological pathways.
Challenges With Protein Expression Technologies

Recent Trends in Protein Expression Industry
The field of protein expression continues to evolve, driven by advances in biotechnology and growing demand for recombinant proteins. Some of the key trends and future perspectives include:
- Synthetic Biology: The utilization of synthetic biology techniques to design and engineer improved expression systems with enhanced yield and functionality.
- CRISPR / Cas9: The use of CRISPR/ Cas9 genome editing is being widely used in this field to develop custom host cell lines delivering enhanced protein production capabilities.
- Automation and High-Throughput Screening: The development of automated high throughput techniques for large scale protein production, enabling low cost and reduced time.
- Sustainable Production: Rising efforts to develop more sustainable and environmentally friendly expression systems. One such example is the launch of plant based protein expression systems.
- Cell free Expression Systems: Cell free expression systems have emerged as a promising alternative for the conventional cell-based protein manufacturing process. These are capable of enabling the synthesis of several complex proteins, including toxic proteins, membrane proteins and other post translationally modified proteins.
- Biofuels and Biopolymers: Rising use of protein expression in industrial biotechnology applications to produce biofuels and biopolymers.
- Multi-omics integration: Combining different omics namely genomics, epigenomics proteomics, transcriptomics and metabolomics to better understand protein expression and its impact on diseased cells.
Concluding Remarks
Protein expression is a gold standard in modern biotechnology for the production of vast array of proteins for therapeutic, industrial and research purposes. The choice of expression system and expertise of protein expression providers play a crucial role in the production of high-quality recombinant proteins. The demand for advanced and user-friendly protein expression technology / system has been augmented due to the increase in research and development expenditure in the protein therapeutics domain.
Over the years, protein expression has evolved to incorporate novel types of expression systems that offer several advantages over conventional expression systems. These novel categories include high-throughput cell expression systems, cell-free expression systems and plant based expression systems. These systems can be applied to a wide variety of application areas due to their flexible nature. As the industry continues to evolve, there will likely be a continued focus on improving efficiency and reducing costs even further, paving the way for innovative treatments and biotechnological applications.
For detailed insights about this domain, check out our report on Protein Expression Market, Till 2035.
Author’s Bio
Akarshika Singh is a business research analyst and competitive intelligence professional. She is highly skilled at generating useful insights from unstructured / structured datasets. As an experienced analyst at Roots Analysis, Akarshika has assisted several clients across multiple industry verticals within the healthcare domain. These verticals include, medical devices / technologies, digital healthcare services and various drugs / disease indications. To date, she has contributed to over five full length market research projects.