Why Indian pharma cos are investing in biologics

Indian pharmaceutical companies are investing in biologics considering the demand for effective and safe treatments especially for cancer.  

Traditionally dominated by small molecules, biologics are now emerging as the predominant molecule type in cancer treatment, a trend that experts observed during the Convention on Pharmaceutical Ingredients (CPHI) that concluded on Thursday.  

“There is a rising global demand for biologic drugs, particularly in the treatment of complex diseases like cancer, autoimmune disorders, and chronic conditions. Indian companies aim to tap into this expanding market and provide advanced treatment options,” said Dr Sanjay Chaturvedi, CEO of Aurobindo Pharma’s arm Apitoria Pharma.  

As projected at $120 billion by data and analytics firm GlobalData, the shift highlights a new era of personalised medicine and signals that biologics are set to surpass innovative small molecules in sales revenue by 2027.  

“Similar to how generics have reduced costs and increased accessibility to conventional pharmaceuticals, biosimilars hold the same potential for biopharmaceutical products,” said Mahesh Bhalgat, COO at Syngene International.  

Small molecules, characterised by their simplicity, chemical synthesis, diverse mechanisms of action, versatile administration routes, and cost-effectiveness, have historically held an 80% share in the pharmaceutical landscape, as per GlobalData's Drugs Database.  

In contrast, biologic drugs, derived from living organisms through advanced biotechnological methods, encompass various molecule types, including monoclonal antibodies and cell therapies. These biologics offer diverse modalities for addressing once-untreatable diseases and conditions lacking alternative therapies. Since the advent of genetic engineering in the early 1980s, biologics have steadily gained prominence in production and development.  

Biologics target specific cancer-related molecules and pathways, growing more effective due to research and development breakthroughs.  

“Innovations like CAR T-cell therapy and checkpoint inhibitors use the immune system to combat cancer. While biologics can be pricier than traditional chemotherapy, their higher efficacy and safety with fewer side effects make them the preferred choice for many cancer types. This leads to the expectation of continued biologics dominance in India's cancer treatment market,” said Dr. Poonam Patil, Consultant - Medical Oncology, Manipal Hospital, Bangalore.  

“Biologics' precision and customization make them the top choice for cancer treatment. High demand for efficient and safe treatments has led to substantial pharmaceutical investments in biologics, solidifying their leading role in cancer care,” said Dr C S Madhu, Senior Consultant and HOD Oncology at Lourdes Hospital, Cochin.  

While biologics account for 51% of oncological drugs, they notably dominate the solid tumor indication, constituting 64% of treatments, compared to 34% for small molecules. This marked difference becomes even more evident when compared to all drugs in the database, where biologics make up less than 20%, GlobalData said.

Solid tumors present unique treatment challenges, such as abnormal vasculature hindering drug delivery. "Advancements in cancer research have enabled the development of biologics to overcome such obstacles associated with solid tumors, paving the way for the dominance of this molecule type in this indication,” Jasper Morley, Drugs Intelligence Analyst at GlobalData said.

Biologics employ various mechanisms to precisely target cancer cells, allowing for tailored treatment that penetrates solid tumors more effectively than small molecules. For instance, chimeric antigen receptor (CAR) T cell therapies genetically modify a patient's T cells to target cancer-specific antigens, offering a more precise approach compared to traditional small molecules. An example of successful CAR T immunotherapy is Gilead Sciences' Yescarta (axicabtagene ciloleucel), projected to generate nearly $2.5 billion in sales in 2029.

Continued research advancements are likely to yield even more promising and effective biologic modalities, further establishing their dominance in solid tumor treatment "As research progresses, even more promising and effective biologic modalities are likely to emerge, shifting the balance further in favor of this molecule type,” said Morley.  

Experts claim that biologics derived from living systems, emphasise patient safety and call for a regulatory framework.“Their journey to dominance in cancer therapy requires rigorous testing to maintain high safety and efficacy standards. While affordable access is crucial, patient well-being should never be compromised. Strengthening India's regulatory framework is urgently needed to strike a delicate balance between innovation and patient safety,said Professor Bejon Kumar Misra, Founder Director, Patient Safety and Access Initiative of India Foundation.