Non-animal testing can cut drug costs by up to 90%, says report

Dr Reddy's, Biocon and Sun Pharma are exploring human-based testing methods that could halve drug development timelines and sharply reduce costs, while meeting global regulatory standards

India’s pharmaceutical industry is beginning to see a sharp shift in how drugs are tested, as science-led non-animal methods (NAMs) move from theory to real-world use. A new multi-stakeholder report says these approaches can cut drug development timelines by more than half and reduce costs by as much as 70–90 per cent, while still meeting global regulatory standards.

 

The findings are part of the Landscape Analysis on Alternatives to Animal Testing for Drug Development in India, jointly developed by Dr Reddy’s Laboratories (DRL), the Department of Biotechnology–Institute for Stem Cell Science and Regenerative Medicine (inStem), Humane World for Animals India and the Animal Law & Policy Network. The report draws on inputs from regulators, pharmaceutical companies, contract research organisations and academic researchers.

   

For decades, animal testing has been treated as a default step in drug development. However, the report argues that in many cases, especially for generics, biologics and biosimilars, animal studies add little scientific value and mainly increase cost and time. Despite extensive animal testing, only about 10–14 per cent of drugs entering human trials finally get approved.

 

“Scientific advances now allow us to rethink how safety and efficacy are evaluated,” said Rajeev Raghuvanshi, Drugs Controller General of India, in the foreword of the study. “There are clear areas where animal testing is scientifically redundant and can be replaced with more human-relevant approaches without compromising patient safety.”

 

NAMs include lab-grown human tissues, organ-on-chip systems and computer-based models that use artificial intelligence. Because these tools are based on human biology, they often provide a clearer picture of how a drug will behave in people, particularly for organ-specific risks such as liver or heart toxicity. The report says this reduces late-stage failures and avoids repeated testing.

 

The strongest evidence of impact is emerging in biosimilars.

 

Sarfaraz K. Niazi, adjunct professor at the University of Illinois, said global regulatory changes have fundamentally altered the economics of biosimilar development. “Animal studies were mandatory for biosimilars until the end of last year. Those steps are now gone, and frankly, they never made scientific sense,” he said.

 

According to Niazi, removing animal studies and human efficacy trials has cut biosimilar development costs by 70–80 per cent and reduced timelines sharply. “Earlier, biosimilars were quoted at $100–150 million. I just got a product approved for about $8 million end to end, with no animal testing,” he said. For oncology biosimilars, which often struggled with long and impractical clinical trials, products can now be developed within 24 months for around $10 million.

 

“If a molecule, generic, biologic or biosimilar, has already been approved and similarity can be demonstrated, there is no scientific justification for animal testing,” Niazi said. Animal studies, he added, should be limited to new chemical entities with unknown mechanisms.

 

Indian companies are already starting to act on this shift. At DRL, NAMs are being integrated into early toxicology and mechanistic studies, while large datasets from existing studies are being combined to build India-specific models. “We are beginning to see the benefits first-hand,” said Deepak Sapra, Chief Executive Officer, API and Services, Dr Reddy’s. “Other companies such as Biocon and Sun Pharma have also shown early interest, especially where NAMs clearly reduce timelines or lower regulatory risk.”

 

Satish Reddy, Chairman of DRL, said the challenge now is scale and coordination. “There is scattered development across the country. This report is important because it can bring industry, academia and regulators together and avoid siloed efforts,” he said. He noted that the Central Drugs Standard Control Organisation (CDSCO) has already begun accepting NAMs under the 2023 New Drugs and Clinical Trials Rules.

 

The report calls for an industry-led consortium, a central national agency for NAM validation, investment in local infrastructure and close collaboration with regulators. With its strengths in generics, vaccines, data science and manufacturing, India could emerge as a global hub for non-animal drug testing.

 

“As global regulators move faster, this is a chance for India to lead rather than follow,” Raghuvanshi said.

Key Recommendations of the Study:

 

  Set up an industry-led consortium to drive adoption of non-animal methods and coordinate engagement with regulators.

 

  Create a national agency for non-animal testing to validate methods, set standards and support regulatory acceptance.

 

  Phase out outdated animal tests, starting with pyrogen testing, by fast-tracking proven alternatives

 

  Invest in India-made infrastructure—biobanks, reagents, software tools and testing platforms—to lower costs and build scale.

 

  Build skills and confidence across the ecosystem through training, shared data and closer collaboration between industry, academia and CDSCO.