• The Government of India introduced the 'BioE3' policy to promote innovation in the biotechnology sector through the creation of biomanufacturing plants, bio-AI hubs, and bio-foundries.
• A primary goal of the policy is to advance precision therapeutics, which involves tailoring drugs to meet individual patient needs. Additionally, it aims to foster the growth of biologics, including gene and cell therapies.
• Recent breakthroughs in human-relevant 3D culture models, also known as 'new approach methods' (NAMs), have shown promise in precision therapeutics. These include technologies such as 3D spheroids, organoids, bioprinting, and organ-on-chip systems.
• The global organ-on-chip market is projected to reach $1.4 billion by 2032, driven by increased investment in NAMs, particularly organ-on-chip technology. Since its inception, organ-on-chip technology has gained significant traction, poised to transform healthcare by creating lab-based environments that simulate human body conditions using cells from the body.
• One of the main reasons for the organ-on-chip market's growth is the rising demand for alternatives to animal-based drug testing.
• In recent developments, the UK company CN Bio raised $21 million to further its R&D efforts in organ-on-chip technology, while the U.S. firm Vivodyne secured $38 million in funding to incorporate AI and automation into this technology. These examples reflect the growing commercial interest in this area.

Drug testing and development

• The traditional drug development process typically takes around 10 years and costs approximately $2.3 billion, with many drugs failing in the final stages of clinical trials. A key reason is that drugs are often tested on genetically modified animals, which may not accurately predict human responses.
• Organ-on-chip technology offers a solution by providing a more precise and efficient platform for preclinical drug testing without the need for animals or human subjects. These small devices replicate the functioning of human organs in a controlled environment and are expected to outperform current cell culture and animal models, offering better insights into a drug's effectiveness and safety.
• This technology could also cut drug development time and costs, leading to faster and potentially more affordable drug availability.

Investment in technology

• The first report on the potential of organ-on-chip models emerged in 2010. By 2012, the U.S. National Institutes of Health had allocated $100 million to develop devices simulating organs such as the kidneys, intestines, and heart, as well as multi-organ systems.
• The technology’s potential quickly became evident, prompting the formation of several organ-on-chip companies worldwide. Today, chips exist for organs like the liver and lungs.
• In 2022, the U.S. passed the FDA Modernization Act 2.0, allowing the use of organ-on-chip devices as alternatives in drug testing. The European Union has also moved towards phasing out animal testing for cosmetics and is developing a regulatory framework for NAMs, including organ-on-chips.
• Major pharmaceutical companies are also exploring the use of these devices. For instance, Bayer has collaborated with TissUse to develop liver and multi-organ-on-chip models, while Roche is using Mimetas chips to study diseases like hepatitis B and inflammatory bowel disease. AstraZeneca and Johnson & Johnson are leveraging chips created by Emulate Bio for research. It is estimated that around 30 pharmaceutical companies globally are evaluating organ-on-chip models in an effort to move away from animal testing.

Challenges for India

• India has made strides by amending the New Drugs and Clinical Trials Rules 2019 to allow the use of organ-on-chips and other NAMs, alongside animal testing, for evaluating new drugs.
• In July, the CSIR-Centre for Cellular and Molecular Biology in Hyderabad and the Central Drugs Standard Control Organisation held a workshop on the latest scientific and regulatory developments in NAMs.
• Developing organ-on-chip technology requires collaboration across diverse fields like bioengineering, biotechnology, computer science, pharmacology, and clinical medicine.
• Currently, over 80 labs in India are working on NAMs, including 3D culture models. To fully leverage this technology, the country needs specialized centres that can foster interdisciplinary collaboration.
• Such centres could also enhance communication between academia and industry, particularly for personalized medicine, which requires NAMs to account for the genetic diversity of the Indian population. Additionally, researchers must navigate regulatory requirements for developing and standardizing organ-on-chip devices. These centres could streamline the process and help bring devices from the lab to the market.
• Establishing these centres would also help build a skilled workforce, preparing the next generation of scientists and engineers. Industry-linked doctoral programs could further bridge the gap between academia and industry.
• As medical research advances, it is crucial for the Indian government, businesses, and policymakers to support the development of organ-on-chip centres. These centres could improve healthcare and bolster the economy while enhancing the country’s self-reliance in a strategically important area.