Over the years, the biopharmaceutical industry has evolved tremendously and it has shifted the focus from recombinant proteins and antibodies toward more complex cell and gene therapies.
India is among the leading players in the global generics market. On the contrary, similar achievements for novel and biosimilar biotherapeutic products have yet to be realised.
According to a 2021 study published in the Journal of Pharmaceutical Innovation, the reasons that India is still trailing in this segment are biotherapeutics, particularly monoclonal antibodies, are challenging to manufacture and unlike generic drugs, whose price tags typically reflect a 90 percent reduction from their branded counterparts, a biosimilar is generally sold at a modest 20–30 percent reduction in cost relative to the innovator drug.
The study also pointed out that Indian companies tend to stick with the same or similar manufacturing platforms as global innovator companies, the study revealed.
One of the key biopharma players, Meteoric Biopharmaceuticals, has been catering to the manufacturing and marketing of Enzymes and Enzymatic Preparations, Probiotics, Nutraceuticals and Animal Healthcare for a wide range of industries. The biopharma major exports to 70 countries across the globe including the United States, Japan, Brazil, the United Kingdom, Germany, South Korea, Canada among other countries.
Financial Express.com reached out to Gaurav Kaushik, Managing Director & CEO, Meteoric Biopharmaceuticals and he highlighted the recent trends in the biopharmaceutical industry, upcoming product launches and patents among others. Exerpts:
What are the current trends in the Bio-pharma industry in India? According to you, how this segment will look like in 2023?
With the world looking beyond the pandemic, the bio-pharma industry has worked relentlessly throughout the crisis and is now gearing up for the new normal. In today’s fast-changing landscape, business models are undergoing paradigm shifts shaped by emerging trends transforming the biopharma industry – the rise of curative therapies, digital therapeutics, new methods of diagnosis, treatment, and prevention of diseases, and precision intervention, amongst others.
Growing awareness among patients about biopharma’s health benefits and efficacies drives the demand for biopharma products worldwide. The biopharma market, which accounts for nearly 20% of the global pharmaceuticals industry, is growing faster amid a growing global aging population, rising incidence of various chronic diseases, and increasing government thrust towards policy reforms and research & development of new and innovative treatments.
Bio-pharma industry, albeit slow in adopting digital intervention, is now opening up to new-age automation technologies. Digital interventions such as robotics, virtual clinical trial, data analytics, data visualization, cognitive agents, and language processing can help to weed out inefficiencies, reduce costs and promote innovation.
A highly-regulated industry, bio-pharma manufacturing involves many levels of regulatory compliance and documentation. Automation can also help reduce these administrative tasks and the associated costs.
End-to-end automation is helping biopharma manufacturers and research companies conduct drug discovery experiments with exceptional accuracy and precision, data-driven decisions, and absolute transparency and reproducibility. Robotics are also being deployed to liquid handling equipment in laboratories to conduct experiments more safely and efficiently.
Digital microfluidics is another field that is gaining widespread interest in the field of laboratory automation.
Turning to Greener Options
Plant-based biologics are primarily produced through molecular farming. Their advantages include low costs, high scalability, and the ability to conduct protein modification. There are also lesser risks of contamination while producing biologics using plant-based systems. In contrast, mammalian cell cultures carry high risks of hazardous contamination such as viruses and must be conducted in stringent conditions and in compliance with regulatory requirements. Thus, animal-free cell cultures offer a viable solution for a more consistent, safe, and secure supply for the production of biopharmaceuticals.
2023 will see a further augmentation and adaption of these trends. As a result, biopharma manufacturers will need to evolve, keeping these disruptive changes in mind, and build bioprocess models for the future.
What are your expectations and business plan for the India market?
Innovation and reinventing will drive our biopharma expectation and plan for years to come. Pharmacovigilance, data analysis, early detection of disease, personalised medicine – alternative medicine and expanding Biotanical extract and ways of extraction would be major focus for us.
Apart from biopharmaceuticals, we are targeting more industries in the field of bio-agriculture, biosimilars, crop science, and bioenergy in the upcoming years.
With respect to specific plans for the India market, our new production facility will go live in the next year, adding considerably to our expansion. Research and academic tie-ups are another area that we are consciously working on strengthening. Expanding our presence in the animal healthcare segment further, will be our third priority for the domestic market.
With over 100 products, the company has a stronghold in manufacturing and marketing of Enzymes and Enzymatic Preparations, Probiotics, Nutraceuticals, and Animal Healthcare for a wide range of industries. Are you to diversify into other segments?
At Meteoric, we plan to develop more biological processes, optimize our fermentation capabilities, and launch more innovative and new strains of probiotics that we are actively working on right now. In addition, we have been isolating and describing different cultures from nature, and we are trying to explore their health benefits.
In Probiotics, we shall be diversifying in PostBiotics, Biogenics, and Metabolics.
Finally, we are also trying to expand on animal healthcare. Although animal healthcare is a significant source of livelihood for the rural and semi-urban poor in India, it has unnecessarily witnessed the maximum abuse of antibiotics and chemicals. We are actively working to provide more biological solutions in a biological manner for animal healthcare as well, so the animal healthcare segment will be another major line of progress for our company. In addition, we want to expand on the recombinant set of enzymes and enzymatic formulations and are actively working on this.
What are the key products that you are planning to launch in the upcoming financial year?
Our vegan-Pancreatin was successful in domestic as we all as high end regulated market. We have already developed some more vegan forms of some more animal-based enzymes which would be launched. Some basic metabolites in Postbiotics are also ready for launch in the coming financial year.
The prices of biopharmaceutical drugs have increased tremendously in the last decade. According to you, what are the possible causes?
Rising inflation is having a significant impact on the pharmaceutical industry. The majority of pharmaceutical companies are seeing high costs for raw materials and already experiencing a decline in profit margins. Massive increases in freight rates, transportation and packaging costs are another major contributor. Huge import duty on raw material and medical devices are eroding the profit margin and posing challenges on sustainability of biopharmaceuticals industry.
What are the current challenges that the Indian bio-pharma industry is facing? What are the possible reasons for it, according to you?
As biopharmaceuticals shift from volume to value, this significant transformation can only occur in the laboratory, strategy, technology, and operations driven by high commercials and regulatory scrutiny.
There is a lengthy period of development when money is invested in R&D. The expenses to develop a drug, for instance, could go as high as a billion dollars. The cost of recovering from the market is becoming a challenge for companies. Biopharmaceutical companies have to get approval for their drugs from the FDA, which is an onerous and lengthy process.
There’s a whole series of trials along with human testing, with the FDA keeping a close watch at every stage. And sometimes, during the course of these trials, the product may turn out to be not a viable option. As a result, the entire process could take as long as a decade, during which the firm is not making any profit on the product.
Furthermore, there could be significant technological changes during the R&D phase that could have a negative impact on the product, and the entire Biopharmaceuticals industry has to absorb these challenges. It is observed that 36% of drugs fail to make it to the preliminary stage of drug development. 68% don’t make it past the intermediate stage, while 40% get knocked out in the final stage. At this point, much money and time have been invested in R&D.
This self-funded R & D is a major challenge and moving away from reach.
Imports are sometimes good when they are yet to start in-house production capabilities; meanwhile, the import duty of key essential APIs should be lower for the industry to stay competitive in the finished formulation in the international market.
A disruptive supply chain is still at its highest level after the pandemic. As a result, inflation and high irregular freight charges are bleeding the industry.
Ahead of the upcoming budget, what are your expectations?
India is on the cusp of a massive leap toward being the global biopharma leader. The industry has grown consistently both in terms of production as well as innovation. The Covid pandemic has shown the Indian biopharma industry rise to the unprecedented challenge faced by the world and support it.
As an industry, we are hopeful for a positive Union Budget to integrate public-private partnerships, provide an incentive for R&D, and smoothen supply chain and freight cost challenges.
Indian biopharma companies must ramp up new product and technology capabilities for the next phase of expansion. As learnt from the pandemic, de-risking supply chains, and manufacturing operations while expanding capacity in sensitive APIs and intermediates is critical.
The Government has already taken various positive and concrete steps to achieve the vision of ‘AatmaNirbhar Bharat.’ The upcoming budget needs to augment them further to garner greater momentum. As an industry, we stand ready.
In summation, focus on capacity expansion with a better definition of units, support for innovation, clarification, and smoothening of processes is what we will look forward to from the upcoming budget.