Context: India is emerging as a favourable destination to conduct clinical trials, as per a joint report by PwC India & USAIC (US-India Chamber of Commerce) titled, Clinical trial opportunities in India. 

About Clinical Trial Opportunities in India report

• It is a joint report by PwC India & US-India Chamber of Commerce (USAIC).

• It was released at the USAIC BioPharma & Healthcare Summit.

Key findings

• Regulatory reforms since 2013 and the New Drugs and Clinical Trial Rules of 2019 have streamlined the approval processes, reducing timelines by 30-40%, resulting in India becoming a favorable destination for clinical trials.

• Covid-19 also helped increase awareness about the significance of clinical trials in India.

• Clinical trial activity in India has been increasing steadily since 2014 due to several key regulatory reforms aimed toward global harmonisation, enabling open access to clinical trials in India.

• Private sector is a well-suited channel for the top biopharma to conduct more efficient clinical trials with easier and faster access to investigators and patients.

• Indian states with high disease prevalence (e.g., cancer) also have the most number of tier-1 cities, with advanced medical infrastructure and availability of investigators.

• Targeting these states can provide biopharma companies with faster access to patients, sites, and investigators.

• Total number of investigators has increased by 2x between 2015 and 2020.

• Majority of the increase occurring in the internal medicine and oncology specialisations.

• However, the growth in the number of investigators is largely restricted to tier-1 and 2 cities.

• Top 20 pharma activity has remained largely constant in the last decade, growth opportunities exist across key diseases (e.g., pain, epilepsy, cervical cancer) and orphan diseases (β-thalassemia, Duchenne Muscular Dystrophy).

• India has overall clinical trial participation of ~3% but contributes upwards of 15% to the global burden of most highly prevalent diseases (e.g., respiratory infections, cardiovascular, diabetes, cervical cancer).

• It is less compared to 30% of the US.

• Top biopharma should align their strategy towards tier-1 cities (e.g., Mumbai, Delhi, Bengaluru, Chennai).

• AstraZeneca, Novartis, Eli Lilly, Pfizer, and J&J are the top sponsors of clinical trials in India.