Several medical therapies, significantly for genetic illnesses, depend on symptomatic administration as a substitute of correcting the causative subject. Precision biotherapeutics carry collectively genetic science, molecular biology, and information analytics to design therapies that establish and rectify the reason for sickness.
What are precision biotherapeutics?
Precision biotherapeutics refers to medical interventions—medication, therapies, or organic merchandise—which might be designed and optimised primarily based on a affected person’s distinctive genetic, molecular, or mobile profile.
The area attracts on a number of chopping-edge applied sciences:
Genomic and proteomic evaluation — decoding an individual’s genetic and protein signatures to establish mutations or dysfunctions inflicting illness.
Gene modifying therapies — straight modifying genes to appropriate underlying issues (e.g., CRISPR-primarily based therapies for blood problems).
mRNA and nucleic acid therapeutics — utilizing RNA molecules to instruct cells to provide particular proteins or suppress dangerous ones.
Monoclonal antibodies and biologics — laboratory-engineered molecules that bind to express illness targets, resembling most cancers cells or viral proteins.
AI-pushed drug discovery — leveraging massive information and machine studying to foretell how molecules work together inside the physique.
Why does India want precision biotherapeutics?
Non-communicable illnesses resembling diabetes, cardiovascular sickness, and cancers account for practically 65% of deaths within the nation. At the identical time, the genetic range of India’s inhabitants makes it some of the advanced testing grounds for brand new therapies.
Traditional pharmaceutical interventions may not have cures for such illnesses. Sometimes, prescribed drugs made and examined in international nations may not work successfully within the Indian context. By leveraging India’s rising genomic analysis base, such because the IndiGen programme and GenomeIndia, therapies may very well be customised for native genetic profiles. Moreover, precision biotherapeutics additionally maintain the promise of shifting care from hospital-primarily based interventions to predictive, preventive, and personalised fashions.
Where does India stand at present?
The Department of Biotechnology (DBT) and its funding arm BIRAC have recognized Precision Biotherapeutics as one of many six focus areas beneath the BioE³ Policy (Biotechnology for Economy, Environment, and Employment).
Indian analysis establishments such because the Institute of Genomics and Integrative Biology (IGIB), National Institute of Biomedical Genomics (NIBMG), and the Translational Health Science and Technology Institute (THSTI) are main efforts to map genetic range and illness susceptibility throughout populations.
In the non-public sector, a number of biopharma firms are exploring precision therapies. For instance, Biocon Biologics and Dr. Reddy’s Laboratories are investing in biosimilars and monoclonal antibodies. Zydus LifeSciences is engaged on gene therapies for uncommon illnesses.
Other firms exploring precision biotherapeutics embody Immuneel Therapeutics, centered on immuno-oncology; Bugworks Research, creating novel antibiotics; Akrivia Biosciences, offering precision diagnostics for most cancers; miBiome Therapeutics, engaged on affected person-centric healthcare options; 4baseCare, a precision oncology agency with AI-pushed instruments; and ImmunoACT, the primary Indian firm to carry CAR-T know-how to India.
However, challenges persist. India lacks a transparent regulatory framework for the completely different applied sciences that kind the idea of gene and cell therapies. Most tips restrict using rising applied sciences for therapeutic functions, however the scope of remedy isn’t outlined. For instance, is ageing a illness? Further, there may be restricted native manufacturing capability for biologics and superior therapies. The value of precision medication additionally stays prohibitive, limiting entry to prosperous city sufferers.
What are different nations doing?
The United States and the European Union dominate analysis and regulatory management, whereas nations like China, Japan, and Singapore are quickly catching up.
In the United States, the FDA has accepted over 30 gene and cell therapies, together with landmark therapies resembling Zolgensma (for spinal muscular atrophy) and Casgevy (the world’s first CRISPR-primarily based remedy for sickle cell illness and thalassemia, accepted in 2023). The US authorities’s Precision Medicine Initiative and the NIH’s All of Us programme are advancing giant-scale genomic datasets. The EU’s Horizon Europe programme funds precision drugs analysis and cross-border scientific trials. With large investments in biomanufacturing, China has over 800 scientific trials in gene and cell remedy underway. Japan and South Korea have simplified approval pathways for regenerative and cell-primarily based therapies, permitting quicker scientific translation.
Opportunities and dangers forward
India’s alternatives in precision biotherapeutics are huge.
On the well being entrance, precision therapies can revolutionise remedy for genetic, metabolic, and oncological illnesses, decreasing each value and struggling in the long run. On the economic system entrance, the worldwide precision drugs market is projected to exceed $22 billion by 2027. India’s expert workforce, information analytics power, and value benefit place it as a possible hub for inexpensive precision therapies.
Yet, dangers loom giant. Ethical and privateness issues round genetic information stay unresolved. Without strict information safety and consent frameworks, genomic data may very well be misused. High prices and restricted infrastructure could worsen healthcare inequity, with chopping-edge therapies remaining out of attain for many Indians. Inadequate funding in analysis may result in dependence on international gamers for healthcare entry.
The approach ahead
For India to completely harness precision biotherapeutics, it should act on a number of fronts:
First, set up a devoted framework for gene and cell remedy approvals beneath the Central Drugs Standard Control Organisation (CDSCO). Second, a biobanking regulation that safeguards privateness and donor autonomy whereas expediting analysis is required. Third, combine precision drugs into public well being by means of value-sharing fashions and inclusion in nationwide medical health insurance schemes until the prices of manufacturing are lowered. Finally, set up nationwide bioethics committees to supervise genetic information use, consent, and remedy entry.
Shambhavi Naik is chairperson, Takshashila Institution’s Health & Life Sciences Policy, and CEO at CloudKrate.
Published – November 17, 2025 08:30 am IST