Several medical treatments, particularly for genetic ailments, rely on symptomatic management instead of correcting the causative issue. Precision biotherapeutics bring together genetic science, molecular biology, and data analytics to design therapies that identify and rectify the cause of illness.
What are precision biotherapeutics?
Precision biotherapeutics refers to medical interventions—drugs, therapies, or biological products—that are designed and optimised based on a patient’s unique genetic, molecular, or cellular profile.
The field draws on multiple cutting-edge technologies:
Genomic and proteomic analysis — decoding a person’s genetic and protein signatures to identify mutations or dysfunctions causing disease.
Gene editing therapies — directly modifying genes to correct underlying problems (e.g., CRISPR-based treatments for blood disorders).
mRNA and nucleic acid therapeutics — using RNA molecules to instruct cells to produce specific proteins or suppress harmful ones.
Monoclonal antibodies and biologics — laboratory-engineered molecules that bind to precise disease targets, such as cancer cells or viral proteins.
AI-driven drug discovery — leveraging big data and machine learning to predict how molecules interact within the body.
Why does India need precision biotherapeutics?
Non-communicable diseases such as diabetes, cardiovascular illness, and cancers account for nearly 65% of deaths in the country. At the same time, the genetic diversity of India’s population makes it one of the most complex testing grounds for new therapies.
Traditional pharmaceutical interventions might not have cures for such diseases. Sometimes, pharmaceuticals made and tested in foreign countries might not work effectively in the Indian context. By leveraging India’s growing genomic research base, such as the IndiGen programme and GenomeIndia, treatments could be customised for local genetic profiles. Moreover, precision biotherapeutics also hold the promise of shifting care from hospital-based interventions to predictive, preventive, and personalised models.
Where does India stand today?
The Department of Biotechnology (DBT) and its funding arm BIRAC have identified Precision Biotherapeutics as one of the six focus areas under the BioE³ Policy (Biotechnology for Economy, Environment, and Employment).
Indian research institutions such as the Institute of Genomics and Integrative Biology (IGIB), National Institute of Biomedical Genomics (NIBMG), and the Translational Health Science and Technology Institute (THSTI) are leading efforts to map genetic diversity and disease susceptibility across populations.
In the private sector, several biopharma companies are exploring precision therapies. For example, Biocon Biologics and Dr. Reddy’s Laboratories are investing in biosimilars and monoclonal antibodies. Zydus LifeSciences is working on gene therapies for rare diseases.
Other companies exploring precision biotherapeutics include Immuneel Therapeutics, focused on immuno-oncology; Bugworks Research, developing novel antibiotics; Akrivia Biosciences, providing precision diagnostics for cancer; miBiome Therapeutics, working on patient-centric healthcare solutions; 4baseCare, a precision oncology firm with AI-driven tools; and ImmunoACT, the first Indian company to bring CAR-T technology to India.
However, challenges persist. India lacks a clear regulatory framework for the different technologies that form the basis of gene and cell therapies. Most guidelines limit the use of emerging technologies for therapeutic purposes, but the scope of therapy is not defined. For example, is aging a disease? Further, there is limited local manufacturing capacity for biologics and advanced therapies. The cost of precision drugs also remains prohibitive, restricting access to affluent urban patients.
What are other countries doing?
The United States and the European Union dominate research and regulatory leadership, while countries like China, Japan, and Singapore are rapidly catching up.
In the United States, the FDA has approved over 30 gene and cell therapies, including landmark treatments such as Zolgensma (for spinal muscular atrophy) and Casgevy (the world’s first CRISPR-based therapy for sickle cell disease and thalassemia, approved in 2023). The US government’s Precision Medicine Initiative and the NIH’s All of Us programme are advancing large-scale genomic datasets. The EU’s Horizon Europe programme funds precision medicine research and cross-border clinical trials. With massive investments in biomanufacturing, China has over 800 clinical trials in gene and cell therapy underway. Japan and South Korea have simplified approval pathways for regenerative and cell-based therapies, allowing faster clinical translation.
Opportunities and risks ahead
India’s opportunities in precision biotherapeutics are vast.
On the health front, precision therapies can revolutionise treatment for genetic, metabolic, and oncological diseases, reducing both cost and suffering in the long term. On the economy front, the global precision medicine market is projected to exceed $22 billion by 2027. India’s skilled workforce, data analytics strength, and cost advantage position it as a potential hub for affordable precision therapies.
Yet, risks loom large. Ethical and privacy concerns around genetic data remain unresolved. Without strict data protection and consent frameworks, genomic information could be misused. High costs and limited infrastructure may worsen healthcare inequity, with cutting-edge treatments remaining out of reach for most Indians. Inadequate investment in research could lead to dependence on foreign players for healthcare access.
The way forward
For India to fully harness precision biotherapeutics, it must act on several fronts:
First, establish a dedicated framework for gene and cell therapy approvals under the Central Drugs Standard Control Organisation (CDSCO). Second, a biobanking law that safeguards privacy and donor autonomy while expediting research is required. Third, integrate precision medicine into public health through cost-sharing models and inclusion in national health insurance schemes till the costs of production are reduced. Finally, establish national bioethics committees to oversee genetic data use, consent, and therapy access.
Shambhavi Naik is chairperson, Takshashila Institution’s Health & Life Sciences Policy, and CEO at CloudKrate.
Published – November 17, 2025 08:30 am IST
