Clinical trials outsourcing to India to top $1000 million by 2010
Clinical trials outsourcing has the potential to touch Rs. 5,000 crore (over $1,241.9 million) by 2010, according to a McKinsey report released in June this year.
India is establishing itself as a hub for clinical trials with more than 10 large multinational pharmaceutical companies and 15 leading CROs (Contract Research Organizations)based here. Indias $100-120 million contract research market is growing at 20-25% each year, driven by the following factors:
The India advantage in clinical trials outsourcing
A vast patient population
A diverse number of diseases that can be studied
Quicker enrollment of patient volunteers
Faster time-to-market for trial, testing and manufacture of critical drugs
Highly affordable R&D costs
IPR protection
World-class facilities to undertake high-quality, cost-effective Phase I Clinical Trials
Facilities to carry out bio-availability (BA) and bio-equivalence (BE) studies on healthy human volunteers
A large pool of trained professionals in the fields of medicine, pharmacology, biosciences, IT and R&D. They also have good English language skills
Outsourcing service providers that are familiar with the global regulatory framework and have in-depth experience in managing the complexity of clinical trials outsourcing
The global contract research market
The research firm Datamonitor places the size of the global contract research market at about $16 billion, with over 1,000 contract research organizations (CROs) globally. The global pharmaceutical industry operates within a rigorous regulatory framework and is squeezed between the pressures of spiraling costs, time investment and complex process of developing an innovative new drug.
CROs help pharmaceutical companies cut clinical trial time by about 30%, says Business Insights, a market research firm.
India with its KPO skills and human capital in biosciences, bio-IT, analytics and medicine, affordable costs and up-to-date infrastructure for drug development research and clinical trials, is well-positioned to seize the huge outsourcing opportunity presented by clinical research.
International drug companies are profiting from the benefits of outsourcing to India as a business strategy in the areas of clinical trial data management, information technology, finance and accounting, data management, payroll, logistics and HR.
Outsourcing drug discovery research to India slashes cuts costs and time-to-market
India has demonstrated its capability in removing the traditional roadblocks to faster drug development.
Patient recruitment
In order to get a few patients for initial screening, companies in developed countries have to reach a huge number of patients first. In India, the availability of a large patient population and a diverse spectrum of diseases, helps reduce lead time for patient recruitment by 30-40%.
The time and cost factor
From the lab to the market and actual usage by patients, the development of an experimental drug costs around $802 and takes between 10 15 years. Every day lost in bringing the drug to market is $1 million lost.
Only five in 5,000 compounds that enter pre-clinical testing will actually progress into human clinical trials, and of these five, only one is likely to be approved by the regulatory authorities.
The rising cost of clinical trials is compounded by other factors. For example, drug testing of degenerative or chronic diseases requires longer trials.
Clinical monitoring
Lab testing and diagnostics is carried out in world-class laboratories by trained professionals in India. This generates huge volumes of data which must be managed.
Data management in clinical trials
Conducting a large number of tests (a few thousands per day) while maintaining data integrity and quality, is a time-consuming and labor-intensive task. Relevant data must be entered into case reports and source documents, data at research centers needs to be reviewed and evaluated for quality.
India offers proven IT and data management skills to deliver quality with quick turnaround in clinical data management and statistical analysis of clinical data. Specialized IT solutions, analytics and new technologies speed the processing of data, routing of documents and management of data collection, storage and retrieval.
Reverse brain drain
Indian scientists are returning to India from foreign shores, bringing with them a wide exposure to the regulatory environment abroad.
A bright future
India is fast emerging as a preferred hub for CROs and CMOs, providing a cost and skill base to support affordable drug development. Transnational business partnerships are also on the rise.
With its ever-growing capabilities in clinical development, acceptance of Indian clinical data by USFDA/EMEA and R&D collaborations with US and EU companies, India is all set to make its mark in the global arena for clinical trials.
India is establishing itself as a hub for clinical trials with more than 10 large multinational pharmaceutical companies and 15 leading CROs (Contract Research Organizations)based here. Indias $100-120 million contract research market is growing at 20-25% each year, driven by the following factors:
The India advantage in clinical trials outsourcing
A vast patient population
A diverse number of diseases that can be studied
Quicker enrollment of patient volunteers
Faster time-to-market for trial, testing and manufacture of critical drugs
Highly affordable R&D costs
IPR protection
World-class facilities to undertake high-quality, cost-effective Phase I Clinical Trials
Facilities to carry out bio-availability (BA) and bio-equivalence (BE) studies on healthy human volunteers
A large pool of trained professionals in the fields of medicine, pharmacology, biosciences, IT and R&D. They also have good English language skills
Outsourcing service providers that are familiar with the global regulatory framework and have in-depth experience in managing the complexity of clinical trials outsourcing
The global contract research market
The research firm Datamonitor places the size of the global contract research market at about $16 billion, with over 1,000 contract research organizations (CROs) globally. The global pharmaceutical industry operates within a rigorous regulatory framework and is squeezed between the pressures of spiraling costs, time investment and complex process of developing an innovative new drug.
CROs help pharmaceutical companies cut clinical trial time by about 30%, says Business Insights, a market research firm.
India with its KPO skills and human capital in biosciences, bio-IT, analytics and medicine, affordable costs and up-to-date infrastructure for drug development research and clinical trials, is well-positioned to seize the huge outsourcing opportunity presented by clinical research.
International drug companies are profiting from the benefits of outsourcing to India as a business strategy in the areas of clinical trial data management, information technology, finance and accounting, data management, payroll, logistics and HR.
Outsourcing drug discovery research to India slashes cuts costs and time-to-market
India has demonstrated its capability in removing the traditional roadblocks to faster drug development.
Patient recruitment
In order to get a few patients for initial screening, companies in developed countries have to reach a huge number of patients first. In India, the availability of a large patient population and a diverse spectrum of diseases, helps reduce lead time for patient recruitment by 30-40%.
The time and cost factor
From the lab to the market and actual usage by patients, the development of an experimental drug costs around $802 and takes between 10 15 years. Every day lost in bringing the drug to market is $1 million lost.
Only five in 5,000 compounds that enter pre-clinical testing will actually progress into human clinical trials, and of these five, only one is likely to be approved by the regulatory authorities.
The rising cost of clinical trials is compounded by other factors. For example, drug testing of degenerative or chronic diseases requires longer trials.
Clinical monitoring
Lab testing and diagnostics is carried out in world-class laboratories by trained professionals in India. This generates huge volumes of data which must be managed.
Data management in clinical trials
Conducting a large number of tests (a few thousands per day) while maintaining data integrity and quality, is a time-consuming and labor-intensive task. Relevant data must be entered into case reports and source documents, data at research centers needs to be reviewed and evaluated for quality.
India offers proven IT and data management skills to deliver quality with quick turnaround in clinical data management and statistical analysis of clinical data. Specialized IT solutions, analytics and new technologies speed the processing of data, routing of documents and management of data collection, storage and retrieval.
Reverse brain drain
Indian scientists are returning to India from foreign shores, bringing with them a wide exposure to the regulatory environment abroad.
A bright future
India is fast emerging as a preferred hub for CROs and CMOs, providing a cost and skill base to support affordable drug development. Transnational business partnerships are also on the rise.
With its ever-growing capabilities in clinical development, acceptance of Indian clinical data by USFDA/EMEA and R&D collaborations with US and EU companies, India is all set to make its mark in the global arena for clinical trials.
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