Clinical Trials Market - India - Sample


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India is fast emerging as the most preferred destination for clinical trials. Clinical trial is the final step in drug development process after preliminary laboratory research and animal testing. The process of drug discovery is quite long and expensive and trials for any drug are usually conducted in phases which might last for many years. Indian clinical trials market has witnessed tremendous growth with revenues from clinical trials expected to reach USD 500 mn by 2010.

The report provides a brief overview of the clinical trials market in India including market size, number of trials and phase-wise breakup of trials. Analysis of drivers reveals that low cost of trials, disease prevalence, sound medical infrastructure and adherence to international quality standards in India have made India an ideal destination for clinical trials. The key challenges identified include shortage of research professionals, lack of data exclusivity, delays in trial approval and instances of unethical trials in India. Government regulations outlines legal and regulatory framework for conduct of clinical trials in India

The competitive landscape identifies and profiles major Clinical Research organizations and Research Institutes taking part in clinical trials in India. The report also provides details of the private equity investments and key developments in Clinical Trials Market in India.

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Clinical Trials Market - India - Sample

  1. 1. Clinical Trials Market - India July 2009
  2. 2. Executive Summary Revenues from clinical trials were USD XX mn in 20--; Expected to reach USD YY mn by 20-- Market Total A clinical trials were conducted in India in 20-- India’s share in global clinical trial market in 20 -- was a% and is likely to reach b% in 20-- c% of clinical trials conducted in India in 20 -- were Phase III trials Drivers: Challenges: LE Drivers & Cost competitiveness Shortage of research professionals P Disease prevalence in India Lack of data exclusivity Challenges Sound medical infrastructure Delays in trial approval Government SAM International quality standards Challenges of unethical trials Clinical trial can be initiated only after approval from Drugs Controller General of India (DCGI) Clinical trials are governed by Scheduled Y of Drugs and Cosmetics act and Indian Council of Regulations Medical Research (ICMR) guidelines Registration of trials involving humans has been made mandatory starting in June 2009 on the Clinical Trials Registry-India (CTRI) website International pharmaceuticals companies are the major sponsors of clinical trials Many Indian and foreign pharmaceutical companies have tied up with other specialist clinical Competition research companies for development of new drugs Internationally certified central laboratories and research institutes also conduct clinical trials in India Some of the leading CROs in India include Company 1, Company 2, Company 3 CLINICAL TRIALS MARKET – INDIA . PPT 2
  3. 3. •Introduction •Overview •Drivers & Challenges •Government Regulations •Competition •PE Investments •Key Developments CLINICAL TRIALS MARKET – INDIA . PPT 3
  4. 4. India is fast emerging as the most preferred destination for clinical trials Overview Revenues from Clinical Trials •Clinical trial research constitutes 2/3rd of R&D spending USD mn •Low cost and speedy trials have made 600 w India a preferred destination for clinical p% LE 400 trials v •India’s share in global clinical trials 200 P u market is expected to increase from a% 0 in 20-- to b% in 20-- S Clinical trials phase wise India -2008 AM 2002 Number of Clinical Trials 2007 2010 Phase 2 Total = A c% 600 y q% 400 d% Phase 4 x f% e% 200 g% Phase 1/2 Phase 3 Phase 1 0 2007 2008 Source: CLINICAL TRIALS MARKET – INDIA . PPT 4
  5. 5. Drivers & Challenges Challenges Shortage of research professionals Drivers Lack of data exclusivity Cost competitiveness Delays in trial approval Vast patient population with diverse number of diseases Challenges of unethical trials Sound medical infrastructure International quality standards CLINICAL TRIALS MARKET – INDIA . PPT 5
  6. 6. Trials can be initiated only after approval from Drugs Controller General of India (DCGI) For Approval purpose clinical trials are classified into two types Category A Category B • Includes clinical trials whose protocols have been LE • Includes clinical trials whose protocols have been approved in other countries which are not listed in approved by countries like AA, BB and CC category A MP • Regulatory (DCGI) approval time is within x-y weeks • Regulatory (DCGI) turnaround time will be u-v weeks A • India has well-defined guidelines for carrying out various phases of clinical trials S • These guidelines are in line with the global guidelines on clinical research (ICH-GCP) • First time exposure of new drugs (of other countries) in Indian healthy volunteers is not allowed as per the regulations in India • Clinical research organizations (CROs) have to obtain 'no objection' letter from Drugs Controller General of India (DCGI) and import license to import the research drug • In case samples are exported outside the country an export license is required from Directorate General of Foreign Trade (DGFT) • Registration of trials involving humans has been made mandatory starting in June 2009 on the Clinical Trials Registry-India (CTRI) website Source: CLINICAL TRIALS MARKET – INDIA . PPT 6
  7. 7. Clinical Research Organizations (1/7) Company Locations Business Description Bangalore, • Provides end-to-end services for Phase I - IV clinical research, including Clinical Company 1 Manipal and Trial Management, Clinical Data Management, PK/PD services and Central Lab Mangalore • Offers services in drug discovery, medicinal chemistry, toxicology studies Pune and • It entered into Joint venture with A subsidiary, B in September 2008 Company 2 Bangalore • It has alliances for neglected diseases with Geneva based Drugs for Neglected Diseases initiative (DNDi), for tropical disease kala azar and anti-malarial drugs with Genzyme Corp and Medicines • Offers lead generation and optimization and early computational chemistry Bangalore aided and design, mining and screening of novel chemical entities. Company 3 • Has worked on collaborative discovery programmes with Novo Nordisk on Diabetes and discovery services with Rheosciences, Denmark • Has a pipeline of X discovery programs at various stages • Works in product chemistry, organic synthesis, chiral synthesis technology Hyderabad • Company is focusing on high-end contract research, custom synthesis of Company 4 complex chemicals and difficult to manufacture intermediates and APIs Source: SAMPLE CLINICAL TRIALS MARKET – INDIA . PPT 7
  8. 8. Thank you for the attention The Clinical Trial Market - India report is a part of Netscribes’ Healthcare Industry Series. For more detailed information or customized research requirements please contact: Natasha Mehta, CFA Gagan Uppal Phone: +65 9651 6382 Phone: +91 98364 71499 E-Mail: E-Mail: About Netscribes Netscribes is a knowledge-consulting and solutions firm with clientele across the globe. The company’s expertise spans areas of investment & business research, business & corporate intelligence, content-management services, and knowledge-software services. At its core lies a true value proposition that draws upon a vast knowledge base. Netscribes is a one-stop shop designed to fulfil clients’ profitability and growth objectives. This report is published for general information only. Although high standards have been used in preparing this report, Netscribes (India) Pvt. Ltd. or Netscribes is not responsible for any loss or damage arising from use of this document. This document is the sole property of Netscribes (India) Pvt. Ltd. and no part may be reproduced without prior written permission. CLINICAL TRIALS MARKET – INDIA . PPT 8