Biotherapeutics Production Market: The Pillar of Medical Industry

It is apparent that the Covid-19 wave has tossed the world fiercely, making it difficult for businesses and households to get back to normalcy. During such stressful situations, the medical industry was the only one to keep the crippled world running. However, it too faced many hurdles due to a slowed production of drugs and vaccines. Nevertheless, as per a report from Research Dive, the global  biotherapeutics cell line development market is estimated to surpass $10,776.2 million by 2027 at a CAGR of 12.5% from 2020.

Now we know that the biotherapeutics production market is not diminishing and would flourish by 2027, let us take a brief look at what the term “biotherapeutics” mean, the challenges faced by this industry, and the future of biotherapeutics in India.

What are Biotherapeutics?

Biotherapeutics are drugs, diagnostics, and vaccines that contain an active element produced in living cells like eggs, tobacco plants, turnips, and potatoes. The living cells act as a miniature factory that grows and replicates the active element. Besides this active ingredient, the living cells also consist of micro-organisms like bacteria, yeast, living cell lines- insect, mammalian, plant, and human cell lines.

Protein therapeutics are a new class of drugs whose first product was introduced in the 1980s to cure diabetes. Other than diabetes, protein therapeutics have also provided new treatment options in areas like infectious diseases, cancers, and auto-immune diseases. This class of therapeutics include many antibodies like Herceptin (useful for cancer treatment), Humira (used in arthritis treatment), and BnAbs- broadly neutralizing antibodies (used in experimental HIV treatments). These antibodies are largely inaccessible in many developing nations because of their high prices.

Protein-based vaccines, which is an advanced approach in biotherapeutics, are built in bioreactors of micro-organisms and have a great contribution to the treatment of hepatitis B. Moreover, Novovax, a leading vaccine manufacturing company, recently launched a protein-based vaccine, that is generated in moth cells, to treat Covid-19.

Challenges for Biotherapeutics Industry in Producing Plant-Based Vaccines

Although the situation is now under control and many countries seem worry-free, there were several challenges faced by the biotherapeutics market. Here are a few listed below.

• The goal of the biotherapeutics market is to produce stable protein-based therapeutic vaccines that are safe for human consumption and have reduced production costs. However, it is nearly impossible to attain lower production cost levels due to the requirement of several processes like proper growth of transgenic plants, purification of plant-based therapeutic vaccines, and completing all phases of clinical trials before the marketable stage.
   
• Another great challenge for the protein-based vaccine production industry is to maintain the GMP (Good Manufacturing Practice) standard published by the World Health Organization (WHO). According to the GMP standard, certain precautions must be taken during manufacture, control, and administration processes to ensure less variation in the quality of protein-based vaccines.
   
• Lack of skillful and trained staff for manufacturing biotherapeutic products is another challenge for the protein-based vaccine production industry. Although it was a blurred challenge for the market during the outbreak of Coronavirus and didn’t affect the consumers directly, it slowed down the production rate immensely. To avoid the undesired delay, some biomanufacturing agencies decided to provide training which was rather a time-consuming approach in a global tensed environment.
   
• Lack of proper architecture to carry out biotherapeutic vaccine production is also one of the challenges. According to the GMP protocol, a special design must be adopted for plant vaccine production where the seed lots are stored separately from other materials.
   
• Despite vaccine purification, there are some risks of transferring allergens from transgenic plants to humans and animals due to the sudden reactivation of pathogens.

Future of Plant-Based Biotherapeutics Market in India

Despite the challenges in the production and application of biotherapeutic vaccines, the development and research for the same remain intact. Unlike synthesized vaccines, plant-based, or biotherapeutic vaccines hold higher value in treating human and animal diseases. Since India is one of the significant biotherapeutic protein sellers to developed nations like the US, the market holds a strong future in the country.

About the Author(s)

Princy A. J

Princy holds a bachelor’s degree in Civil Engineering from the prestigious Tamil Nadu Dr. M.G.R. University at Chennai, India. After a successful academic record, she pursued her passion for writing. A thorough professional and enthusiastic writer, she enjoys writing on various categories and advancements in the global industries. She plays an instrumental role in writing about current updates, news, blogs, and trends.