Precision Biotherapeutics

Syllabus: GS2/Health

Context

• 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 that are designed and optimised based on a patient’s unique genetic, molecular, or cellular profile. 
• The field draws on multiple technologies such as: 
  • Genomic and Proteomic Analysis: Decoding a person’s genetic and protein signatures to identify mutations or dysfunctions causing the disease.
  • Gene Editing Therapies: Directly modifying genes to correct underlying problems (for example, 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 protein.
  • AI-driven drug discovery: It involves leveraging big data and machine learning to predict how molecules interact within the body.

Need for the Precision Biotherapeutics

• Rising Burden of Complex Diseases: Non-communicable diseases such as diabetes, cardiovascular illness, and cancers account for nearly 65% of deaths in the country. 
• Precision: For cancer especially, conventional therapies (like chemotherapy) often cause significant collateral damage; targeted biologics or gene/cell therapies can be more precise.
• The genetic diversity of India: India has a very genetically diverse population, which means “one-size-fits-all” drugs may not work equally across sub-populations.
• Local Solutions: Pharmaceuticals made and tested in foreign countries might not work effectively in the Indian context. 

Challenges

• Lack of Regulatory Framework: 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. 
• Cost & Affordability: Precision biotherapeutics are expensive to develop and manufacture. This could make them inaccessible to large segments of India’s population.
• Infrastructure & Capacity: There is limited local manufacturing capacity for biologics and advanced therapies. 

India’s Efforts

• The Department of Biotechnology has identified precision biotherapeutics as one of the six focus areas under the Biotechnology for Economy, Environment, and Employment policy. 
• Mapping: Indian research institutions such as the Institute of Genomics and Integrative Biology, the National Institute of Biomedical Genomics, and the Translational Health Science and Technology Institute are leading efforts to map genetic diversity and disease susceptibility across populations. 
• In the private sector, several biopharma companies are exploring precision therapies.

Way Ahead

• 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.
• Without strict data protection and consent frameworks, genomic information could be misused.
• India’s expertise in biologics manufacturing will further support the development of cutting-edge therapies for both domestic and international markets.

Source: TH