India CRO Market Information, by Services Type (Clinical trials, Product Development, Process Development, Post-Marketing Surveillance, Quality Monitoring and Others); by Therapeutic Application (Oncology, Cardiovascular, Neurology, Nephrology and Urology, and Others) and by End Users (Pharmaceutical/biopharmaceutical Companies, Medical devices Companies and Academic Institutes) – Forecast to 2025
Published:
May 2020
Report Code:
BWC2070
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india cro market information bwc2070

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India CRO Market Information:  Forecast and Trends

The India CRO (Contract Research Organization) Market was valued USD 970 million and is expected to reach by USD 1962 million with a CAGR of 12.7% during the forecast period. Presence of diverse climatic conditions and acceptance of international guidelines and intellectual property rights are the key factors that fuel the market. Availability of largest pool of patients and large number of hospitals, educated and accessible human resources, and low operational cost due to cheap human resources are some of the other factors that boost the market to reach its target during the forecast period.

Continuous positive efforts by the regulatory authorities such as Director Controller General of India (DCGI), Indian Council of Medical Research (ICMR), and Directorate General of Foreign Trade (DGFT) are creating favorable conditions for the research in India and thus making a positive impact for the boost of market.

India CRO Market Information:  Overview

A CRO provides its support to the pharmaceutical, biotechnology, and health companies. These services include clinical research, product development, and process development, post-marketing surveillance, quality monitoring and others. CRO also provide management services for clinical trials and pharmacovigilance.

Recently Indian Government has removed some clauses in the clinical trial rules that mandate the sponsor to compensate up to 60 percent of amount to the patient family in case of death or permanent disability during a clinical trial.

Beside this, the drug companies also consider India as a market for running local clinical trials and get additional benefits in marketing in Europe, UK, US, Australia and other countries once the drug is approved.

 

India CRO Market Information:  Service Type

India CRO Market is segmented into clinical Trials, product development, process development, post marketing surveillance, quality monitoring and others on the basis of service type.

Clinical trials : Clinical trials are conducted for the evaluation of effectiveness and safety of medications and medical devices by monitoring their effects on large group of people.

Product development : Product development generally consists of 3 phases of testing. The first phase includes trial on small group of healthy people where the drug is tested on few people for the effectiveness, safety and right dose to use in people  to continue with the trial. Successful completion of phase one, the trial moved to second phase where large numbers of people, between 100 to 500, are enrolled for the trial. These people are suffering from the diseases that is targeting in the clinical trials. After the successful completion of second phase of trial, third phase starts with the group of several thousand people. If the third phase trial shows that the drug is effective and safe, then the drug developing company applies for a license to a regulatory agency such as the U.S. Food and Drug Administrator or the European Medicines Agency to produce the product for sale.

Process development  : A Drug development process involves 9 steps. In the first step, drug discovery and target selection takes place. After testing multiple molecules the drug development company chooses the most effective molecule for the development. 2nd step includes Preclinical testing that involves testing in laboratories. Efficacy and safety is a major concern in this step as without extensive data on safety, the FDA will not give any permission for human trials. 3rd stage involves submitting of New Drug Investigational application to FDA prior to beginning of human clinical trials. In this point, FDA will scrutinize the result, look at the side effects and other safety features of the developing drug. After FDA approval, the drug moves to clinical trials. 4th step involves the 1st phase of clinical trial where few numbers of healthy people involve for the effectiveness, safety and right dose to use. Step 5 involves 2nd phase of clinical trial where large numbers of people, between 100 to 500, are enrolled for the trial. These people are suffering from the diseases that is targeting in the clinical trials. 6th step involves 3rd phase of clinical trial where the drug is tested on few thousands of people for the final trial. If the drug passes all the safety methods and effective in treating the disease, the next step is to file for its approval. 7th step involves New Drug Application filing to a regulatory agency. Step 8 includes the PDUFA Date in which the drug regularity agency releases its decision over the drug.  In this stage, the agency can deny the drug or approve a drug or can request additional information by sending a complete response letter to the drug company. If the drug is approved by the regularity agency, the drug is available for commercial production. Step 9 involves further clinical trials even it is approved by the regularity agency for commercial production. The total steps (step 1 to step 8) generally takes about 8 to 10 years.

Post marketing surveillance: Monitoring of safety of a drug or medical device after its release in the market, comes under the post marketing surveillance.

Quality monitoring: Drug manufacturing companies are responsible for protection of human subject from the research risk, the integrity of data generated by the third party vendors. Clinical trials accounted for the largest share in this market.

India CRO Market Information:  Application

CRO plays important role in the treatment of various therapeutic diseases like Oncology, Cardiovascular, Neurology, Nephrology and Urology with the help of cell and gene therapy. Currently more than 25 advanced therapies are available in the market in which Alofisel (2018), LUXTURNA™ (2017), YESCARTA™ (2017), Kymriah™ (2017) are world famous. A recent study reveals that more than 1000 clinical trials have been conducted in the last five years for the evaluation of potential of these therapies.  Oncology segment shares the largest share in the market.

India CRO Market Information:  End User

On the basis of end users, the market is segmented into Pharmaceutical/biopharmaceutical Companies, Medical devices Companies and Academic Institutes. Pharmaceutical/biopharmaceutical Companies accounted for the largest share in the market.

India CRO Market Information:  Regional Analysis

Due to different geographical regions and states the India CRO Market is divided into North, East, West and South region. South and West regions are accounted for largest share in the market. But due to more diverse genetic pool and presence of different regulatory agency, the CRO industry is shifting its focus in the North region.

India CRO Market Information:  Key Players

Some of the prominent key players in the India CRO Market are Quintiles IMS Holdings, Inc, Syngene, Pharmaceutical Product Development, LLC, Siro Clinpharm, Clininvent Research Pvt. Ltd., VIMTA, Bilcare Limited, Aizant Drug Research Solutions Private Limited, Piramal Pharma Solutions, Synapse Labs Pvt Limited, Eurofins Scientific, Laurus Labs, Neuland Laboratories Ltd, PAREXEL International Corporation.

Recent development by the Industries

Ø  Asian Clinical Trials linked with VPSCRO, a China based company, to perform clinical trial services in India and China.

Ø  Veeda Clinical Research launched the Global Oncological CRO that will provide its services to the biopharmaceutical firms.

Ø  Siro Clinpharm acquired mid-sized German CRO Omega Mediation Group.

 

India CRO Market Information: Report Objective

Ø  To provide detail analysis of the market structure during the forecast period.

Ø  To provide country level analysis of the market.

Ø  Detail analysis of the factors that affect the market growth.

Ø  Detail analysis of top key player companies and their strategies.

Ø  Comprehensive study of recent developments in the field


Scope of the report

·         By Services Type

Ø  Clinical trials

Ø  Product Development

Ø  Process Development

Ø  Post-Marketing Surveillance

Ø  Quality Monitoring

Ø   Others

·         By Therapeutic Application

Ø  Oncology

Ø  Cardiovascular

Ø  Neurology

Ø  Nephrology and Urology

Ø  Others

·         by End Users

Ø  Pharmaceutical/biopharmaceutical Companies

Ø   Medical devices Companies

Ø   and Academic Institutes

·         by Region

Ø  North India

Ø  East India

Ø  West India

Ø  South India

 

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