Page 169 - CW E-Magazine (24-9-2024)

Special Report

Opportunities for the CRO sector in India

ndia is the largest provider of generic growing demand in the pharmaceutical Depending on the requirements,
drugs globally and is known for sector. However, the modern shape of Pharmaceutical and biotechnology
Iits affordable vaccines and generic the CRO industry began to crystallize companies can partially or full out-
medications. The Indian pharmaceuti- in the late 1970s and early 1980s. This source their R&D activities to these
cal industry is currently ranked third in period witnessed the establishment of CROs. By outsourcing research activi-
pharmaceutical production by volume leading organizations such as Quintiles ties, pharmaceutical and biotechnology
after evolving over time into a thriving (now IQVIA) and Parexel, which diver- companies save time and cost as they
industry growing at a CAGR of 9.43% sified the traditionally confined role of do not need to invest into research in-
since the past nine years. According to preclinical testing to embrace broader frastructure and manpower and there-
a recent EY FICCI report, the Indian areas like clinical trials, data manage- fore, these companies can focus on
pharmaceutical market is estimated to ment, pharmacovigilance and logistics. their core competencies and areas of
touch $130-bn in value by the end of expertise. In newer models, initial inno-
2030. Unlike the CROs which are ser- vation often comes from the CROs,
vice driven, the core area of interest who establish early chemistry and bio-
India has the highest number of for a pharma company is increasing logy entry points into disease and then
pharmaceutical manufacturing facili- its product portfolio and registering its approach potentially interested pharma
ties that are in compliant with the US pharmaceutical products across new companies to collaborate as strategic
Food and Drug Administration (USF- geographies. Registration of a new drug discovery partners. Such projects
DA) and has 500 API producers that pharmaceutical product in new geo- can be structured in different ways,
make for around 8% of the worldwide graphy requires extensive research and including milestone and royalty pay-
API market. The Indian pharmaceuti- regulatory-compliant data, which needs ments, Full-Time Equivalent (FTE)
cal sector supplies over 50% of global to be generated through extensive and payments, and event potentially jointly
demand for various vaccines, 40% of reproducible research. Most pharma owned intellectual property rights com-
generic demand in the US and 25% of companies do not want to invest their mercialized as joint ventures or spin-off
all medicines in the UK. The domestic time and resources in this domain and companies.
pharmaceutical industry itself includes look for professional expertise, which
a network of 3,000+ companies and is offered by the CROs. Mostly, the clinical CROs work on
more that 10,000 manufacturing units. “Fee for Service model” however there
India enjoys an important position in The CRO sector in India has been have been cases where CROs have
the global pharmaceuticals sector and growing at a CAGR 10.75% and is worked on the FTE model, where the
is rightfully called the ‘Pharmacy of expected to reach $2.5-bn by the year pharmaceutical company hires a clini-
World’. 2030. The CRO sector is driven by cal trial project team at CRO premises
specialized R&D service providers, and pays for all the materials and other
One of the key factors contributing which can assist the pharmaceutical project expenses. The FTE model is
to India’s success in the pharmaceuti- and biotechnology companies in over- suitable for the complex projects, where
cal sector is its strong contract research all drug discovery and development flexible continuous work is anticipated.
foundation. The CROs or Contract programmes. These include Discovery
Research Organisations are entities hired CROs, Pre-Clinical CROs, Clinical Business trends in CRO industry
by a pharmaceutical, biotechnology or CROs and the CROs offering bioequiva-
medical device company to conduct lence and bioavailability services. Global Growth Pattern
research and development activities on CROs range from large, international During the years between 2022-
its behalf in a defined geography with full-service organizations to small, 30, the global CRO market is expected
full or partial scope of work. The evo- niche specialty groups and can offer to grow at a CAGR of 7% and reach
lution of CROs stems from the mid- their clients the experience of moving a $90.4-bn by 2030 (Fig. 1) The CRO
20th century. Companies like Hunting- new drug or device from its conception market in US, which was estimated
don Life Sciences and Charles River to marketing approval without the drug to be $20.1-bn in 2022 is expected to
Laboratories came into being during sponsor having to maintain a staff or grow at a CAGR of around 8% and
the 1940s and 1950s, addressing the research centre for these services. reach $37.20-bn by 2030. The US will

Chemical Weekly September 24, 2024 169

Contents Index to Advertisers Index to Products Advertised