Vishal Pratap Singh | Friday, 18 February 2022
The Biopharmaceutical Industry is evolving with a shift in focus from recombinant proteins and antibodies towards more complex cell and gene therapies. To be competitive globally, bio manufacturers need to focus on aligning with global standards with regard to drug quality, reducing manufacturing failures and delivering drugs to market quickly.
Building these capabilities requires a multifaceted approach that includes improvements in operations, quality compliance and control strategies. The biopharmaceuticals market was valued at approximately USD 325.17 billion in 2020, and it is expected to witness a growth of USD 496.71 billion in 2026, with a CAGR of 7.32 per cent over the forecast period, 2021-2026.
“Biopharmaceutical companies in India lead the global generics market and their contributions have enabled accessibility to affordable quality medicines, especially to the emerging and developed markets”, says Dilip Shanghvi, CEO, Sun Pharmaceutical Industries.
Skilled Human Resources
The Indian biopharmaceutical industry is emerging with high quality, affordable biosimilars entering the developed market. The Indian biosimilar manufacturing companies also focus on emerging therapeutics sectors, such as cell and gene therapies and personalised medicines.
A focus on innovation driven research and development to promote the growth of the biotherapeutics industry requires the availability of highly and diversely skilled human talent. Specifically, training needs to be directed towards problem solving, knowledge of current, cutting edge technologies that that meet global standards, and know-how of quality processes and products.
Generates High Profit
The opportunity in biopharmaceuticals is big and growing too rapidly in the country. Today, biopharmaceuticals generate global revenues of $163 billion, making up about 20 per cent of the pharmaceutical market.
It’s by far the fastest growing part of the industry. Biopharmaceutical’s current annual growth rate of more than 8 per cent is double than that of conventional pharma, and growth is expected to continue to that rate for the foreseeable future.
Providing Safe Products with Higher Efficacy
Industry experts believe that the efficacy and safety of biopharmaceutical products, combined with their ability to address previously untreatable conditions, allows pharmaceutical companies to command high prices for innovative drugs. Strong demand has driven significant profits, despite the high cost of goods sold. Biopharmaceuticals have set new standards for blockbuster drugs as well. Blockbuster drugs can be defined as drugs that have $1 billion or more in annual sales. There are top 15 biopharmaceutical products each of which enjoys annual revenue of more than $2 billion.
On the other hand, for some players the biggest challenge has been simply making enough products to sell. It’s no surprise that major pharmaceutical companies around the country are increasingly shifting their research & development and sourcing focus to large module products.
Shift of Pharmaceutical Companies towards Biopharma
Investing in biotech research & development has yielded better returns than the pharmaceutical industry average. The current biologics development pipeline supports an outlook of continued healthy growth. According to a study, the number of biotech patents applied for every year has been growing at 25 per cent annually since 1995.
At present, there are more than 1,500 biomolecules undergoing clinical trials and the success rate for biologics has so far been over twice that of small molecule products. Biopharmaceutical looks poised to transform the industry once more, as increasing understanding of the interaction between drugs and the genetic makeup of patients helps to improve the targeting of therapies.
Combined with robust, low cost genetic profiling, this knowledge will improve treatment outcomes and serve to accelerate and improve the outcomes of clinical trials, helping to reduce the cost of drug development.
Challenges in the Way Demand Cost Pressure
As biopharmaceutical moves from the scientific frontier to the business mainstream, the industry will increasingly be forced to confront the same challenges faced by other businesses, maintaining competitiveness by ensuring affordability, quality and delivery performance. Demand cost pressure will intensify as healthcare systems struggle to balance rising demand with flat or declining budgets.
Complexity of Biopharmaceutical Supply Chain
As the number of products rises and new process technologies such as continuous manufacturing are introduced, the complexity of biopharmaceutical operations and supply chain will increase. Evidence indicates that current production programs are already stretching the industry, with several players failing to deliver to the market.
This challenge will further increase as sites move from the current “one line, one product” setup towards nimble and flexible multiple product operations and are required to manage both current and future technologies under one roof.
What’s Next Evolving in a Booming Industry
Global innovators will have to drive product innovation in order to continue to command premium prices, shifting the frontier of technology and exploring new operational setups such as the design and deployment of their future network. Biopharmaceuticals players will have to focus on cost, quality and scale. The biopharmaceutical companies that are best positioned to succeed in tomorrow’s market will be those that master a broad set of technical and operational capabilities.
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