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Industry Insight – Clinical Trials in India Product Image

Industry Insight – Clinical Trials in India

  • ID: 2017844
  • September 2011
  • Region: India
  • 304 Pages
  • Cygnus Research

FEATURED COMPANIES

  • Cadila healthcare
  • GlaxoSmithKline
  • Johnson & Johnson, India
  • Lupin Limited
  • Merck Limited
  • Pfizer Limited
  • MORE

In view of the growth potential and India's strength in pharmaceuticals to qualify for clinical trials, Cygnus has launched the latest edition (7th edition) of Industry Insight – Clinical Trials in India.

The Clinical Trial industry in India touched US$400 million in 2010 and is expected to touch US$1.09 billion by 2014.

The Clinical Trials market in India has shown significant growth in the recent past. Clinical Trial industry in India touched US$400 million in 2010, up from US$230 million in 2008 and is expected to touch US$1.09 billion by 2014. The cost of conducting clinical trials in developing countries like India and China is far lower when compared to their developed counterparts. The simple reasons are: Due to the multitude of benefits it offers, India has huge patient base, low cost advantage; can complete clinical trials on time; is improving its infrastructure with a strong government support.

SCOPE OF THE REPORT
The report mostly captures secondary information collected from various reliable sources and covers market information, company specific information, regulatory framework, issues and challenges, growth drivers and future outlook.

REASONS READ MORE >

FEATURED COMPANIES

  • Cadila healthcare
  • GlaxoSmithKline
  • Johnson & Johnson, India
  • Lupin Limited
  • Merck Limited
  • Pfizer Limited
  • MORE

EXECUTIVE SUMMARY
HIGHLIGHTS
1. INTRODUCTION
1.1 A Brief History
1.2 Effectiveness and Safety
1.3 Benefits galore
1.3.1 Research and Innovation
1.3.2 Indian companies increase their R&D spending
1.3.3 Investigational New Drug (IND)
1.4 Global Scenario
1.5 Indian Scenario
1.5.1 Rising tide of research and clinical trials
1.5.2 India as a destination for CROs
1.5.3 Potential of CRO industry
1.5.4 Field Trials (Clinical Trials)
1.5.5 Major Diseases
1.5.6 Infrastructure facilities
1.5.7 Competitors in the sector
1.5.8 Laboratory Trials (Pre-clinical trials)
1.5.9 Recent Trends
1.5.10 Trends in Drug Development
1.5.11 Regulatory Developments
1.5.12 Ethical Review Boards
2. MARKET SCENARIO
2.1 Global Scenario
2.1.1 Laboratory-developed Tests
2.1.2 Inspections
2.1.3 Education and Training Requirements
2.1.4 Quality Control
2.2 R&D Expenditure
2.3 Drug withdrawals/Clinical Trial failures
2.4 Research on Drug Price Controls
2.4.1 Loss of Future Drug Therapy
2.4.2 Slowdown in Drug Availability
2.5 Indian Scenario
2.5.1 Indian Companies
2.5.2 Multinational Companies
2.5.3 Business model (Models of clinical trials outsourcing)
2.5.4 Target customers
2.5.5 R&D Budget Break up
2.5.6. Advantages offered by India in Clinical trials domain
2.5.7 Outsourcing Clinical trials
2.5.8 Clinical Trial components
2.5.9 Market related factors
3. MAJOR PLAYERS
3.1 The Players
3.1.1 Dr. Reddy's Laboratories Limited
3.1.2 GlaxoSmithKline
3.1.3 Lupin Limited
3.1.4 Novartis
3.1.5 Pfizer Limited
3.1.6 Torrent Pharmaceuticals Limited
3.1.7 Vimta Labs Limited
3.1.8 Cadila healthcare
3.1.9 Asian Clinical Trials Limited
3.1.10 Bioserve Clinical Research Pvt. Ltd
3.1.11 Clininvent Research Pvt. Ltd
3.1.12 ClinTech International
3.1.13 Eli Lilly and Company (India) Pvt. Ltd
3.1.14 iGATE Clinical Research International
3.1.15 Intas Pharmaceuticals
3.1.16 Johnson & Johnson, India
3.1.17 Lambda Therapeutic Research Ltd
3.1.18 Lotus Labs Pvt. Ltd
3.1.19 Matrix Laboratories Ltd
3.1.20 Merck Limited
3.1.21 Novo Nordisk India Private Ltd
3.1.22 Pharmanet
3.1.23 Quintiles Research (India) Private Limited
3.1.24 Reliance Clinical Research Services
3.1.25 Roche India Ltd
3.1.26 Sanofi-Aventis (Aventis Pharma Limited)
3.1.27 Siro Clinpharm Pvt Ltd
3.1.28 Supper Religare Laboratories Ltd
3.1.29 Sristek
3.1.30 Synchron Research Pvt. Ltd
3.2 Support services
3.2.1 Companies entering into support services
3.2.2 IT-pharma ventures
3.2.3 Other IT/ITES companies' bio-initiatives
3.2.4 Future of support services
4. TECHNOLOGY
4.1 Drug Development
4.2 Biochemistry of the Drugs
4.3 Drug Design
4.3.1 The challenges in drug design
4.3.2 Computers in drug design
4.3.3 RACHEL Software Package
4.4 Animal Studies
4.5 Field Studies
4.6 Bioavailability (BA) / Bioequivalence (BE) studies
4.6.1 Types of studies
4.6.2 Facilities for Conducting Bioavailability and/Or Bioequivalence Studies
4.7 Recent Trends in Technology
5. GROWTH DRIVERS
5.1 Claims of Superiority
5.2 Availability of Patients
5.3 Infrastructure Facilities
5.3.1 Availability of Animal Houses
5.3.2 Hospitals
5.3.3 Facilities for Clinical Trials
5.3.4 Biotechnology Laboratories
5.4 Drug development and price control
5.5 Reduction in R&D expenses
5.6 Decrease in Time-to-Market Clinical Trials
5.7 Regulations and Support from Local Bodies
5.8 FDA Approval
5.8.1 Clinical Trials and FDA
5.8.2 Clinical Trial Process
6. CRITICAL SUCCESS FACTORS
6.1 Infrastructure
6.2 Research Design
6.3 Speed and Quality of Trials
6.4 Professionally Trained Manpower
6.5 Hospitals
6.6 Role of Radiology
6.7 Product Pricing and Market Analysis
6.8 Drug Imports
6.9 Multiple tasks in approvals
6.10 Government Procedures/Sanctions
6.11 Obstacles for Indian Biosimilar players
6.12 Capacity Planning for Drug Developers
7. REGULATORY ISSUES
7.1 Government Regulations
7.1.1 FDA
7.2 Patent Regime
7.2.1 Importance of IPR
7.3 Customs Duty
7.4 GATT / TRIPS / WTO
7.5 Clinical Evaluation of Herbal Remedies and Medicinal Plants
7.5.1 Categories of Herbal Products
7.5.2 Guidelines
7.6 Unsafe Drugs
7.7 Industry's Growing Influence over Research
7.8 Academia & Industry – Eroding Boundaries
7.9 Regulatory System in India
7.9.1 Exemption of Customs Duty
7.9.2 Tax benefit
7.9.3 Role of IACUC
7.9.4 India Exempts Some Clinical Research from Service Tax
7.10 Regulation of Ethical Issues
7.10.1 Ethics of Patenting DNA
7.10.2 Mental Disorders and Genetics
7.10.3 Animal-to-Human Transplants: Ethics of Xenotransplantation
7.10.4 Human Tissue: Ethical and Legal Issues
7.10.5 Clinical Trials without Ethical Review
7.11 The Fair Prescription Drug Competition Act of 2007
7.12 Relationships With Hospitals for Trial Sponsors
7.13 CLINICAL Trials with Controlled drugs
7.14 Conclusion
8. ISSUES AND CHALLENGES
8.1 Training for Clinical Trials
8.1.1 Training Opportunities
8.2 Clinical Trials - Design & Management
8.2.1 Good Clinical Practices (GCP)
8.3 Quality of Clinical Trial Data
8.4 Finding people for trials is always difficult
8.5 Segmenting Physicians
8.6 Protecting Research and Research Participants
8.7 Ethical Problems
8.7.1 The role of ethics in clinical trials
8.7.2 Three major ethical problems
8.7.3 Scientific and Ethical Standards
8.8 Illegal Clinical Trials
8.9 Studies in the Developing World
8.10 Data Protection
8.11 Assessing Risks and Benefits
8.12 Host Country's Capacity to Review and Conduct Clinical Trials
8.13 Additional FDA guidelines for conducting trials
8.13.1 Clinical Trials Conducted Outside United States
8.13.2 Clinical Trial Registration
8.13.3 Computerized Clinical Research Systems
8.14 Clinical Trials in India - Challenges
8.14.1 Shortage of trained manpower
8.14.2 Segmenting Physicians
8.14.3 Addressing the challenges
9. FUTURE OUTLOOK
Annexure 1
BIBLIOGRAPHY
Annexure 2
Glossary
Annexure 3
Good Clinical Practices (GCP)
Annexure 4
A Comparison of FDA versus ICH Regulations
Annexure 5
Good Manufacturing Practices
Annexure 6
A New Chapter Opens
Annexure 7
Annexure 8

LIST OF FIGURES
Figure 1.1: Global clinical trials expected growth
Figure 1.2: Global CRO market-2010
Figure 1.3: India Clinical trials Market (2006-10)
Figure 1.4: Phase wise Distribution of Outsourced Clinical Trials in India-2010
Figure 1.5: Clinical Studies in India till July 2009
Figure 2.1: New molecular Entities (NMEs) Approvals
Figure 2.2: NME Application Filed
Figure 2.3: Percentage Share of Clinical Trials-2010
Figure 2.4: Allocation of R&D Investment-2010
Figure 2.5: R&D budget break up in percentage-2010
Figure 5.1: Transition probabilities for clinical phase
Figure 9.1: India clinical trials market projections (2010-14)
Figure 9.2: Demand-Supply Gap 2011 in India

LIST OF TABLES
Table 1.1: R&D Expenditure (2008-10) Rs in billion
Table 1.2: Change in number of new trials registration for selected countries
Table 1.3: Cost of clinical trials in US vis-a-vis India
Table 1.4: Clinical Trials without volunteers' concern (illegal clinical trials in India) 2009
Table 2.1: Ranking by disease-wise in drug development-2010
Table 2.2: R&D Expenditure in 2009& 2010
Table 2.3: Major private equity funding in clinical research
Table 2.4: strength and weakness of services offered by CRO in India and china
Table 2.5: Advantages offered by India in clinical trials
Table 2.6: Leading Indian contract research organizations
Table 3.1: Educational qualifications of personnel employed in the Chemicals and Pharmaceuticals Segments
Table 5.1: Key Therapeutic Areas
Table 5.2: Top R&D spenders-2010
Table 5.3: Stages of Trials
Table 7.1: List of drugs withdrawn from commercial activities
Table 7.2: Targeted Timelines for Approvals

FEATURED COMPANIES

  • Cadila healthcare
  • GlaxoSmithKline
  • Johnson & Johnson, India
  • Lupin Limited
  • Merck Limited
  • Pfizer Limited
  • MORE

The clinical trials environment has changed significantly in the past few years. An increased emphasis has been put on pharmaceutical research cost-effectiveness. The pharmaceutical industry has been witnessing a rapid expansion of outsourced services from developing countries. Outsourcing is not limited to the fact that clinical trials are being conducted in economically beneficial developing countries, but pharmaceutical companies are increasingly delegating the responsibility of clinical trials to contract research organisations.

In the next five years, the major challenge for the pharmaceutical companies would be to maintain high growth rates. Major drugs going off patent, generic competition and a relatively thin pipeline will all apply considerable pressure to the branded pharmaceutical industries. Because of the nature of the clinical trials industry, it will, in turn be under increasing pressure. The market is clearly shifting away from the traditional one-fits all model of drug discovery as patients and healthcare professionals increase the demand for targeted therapies.

The global clinical trials market is expected to be worth US$66 billion by 2021, up from US$21 billion in 2010 with a CAGR of 12%. The Indian Clinical Trial industry touched US$400 million in 2010, up from US$230 million in 2008 and has been estimated to touch US$1.09 billion by 2014.

Pharmaceutical R&D can be broadly classified into three types: development of new chemical entities, modification of existing NCEs (New chemical derivatives, new formulation and new combinations), and development of new process for manufacturing drugs. The research and development in India has developed tremendous strength in developing cost efficient process for manufacturing drugs satisfying international quality norms.

Due to financial crisis more and more companies are entering into collaboration or alliance or tie-up with multinational companies in the field of R&D, marketing and manufacturing, to reduce costs and consolidate their business.

The leading Indian pharmaceutical companies such as Dr. Reddy’s Laboratories, Nicholas Piramal, Cipla, Lupin and Wockhardt are increasingly focusing on R&D. The R&D activities of Indian companies are targeted both at New Drug Development (NDD) as well as Novel Drug Delivery Systems (NDDS). The R&D expenditure of leading Indian pharmaceutical companies has leaped significantly during the financial year 2010-11. The R&D expenditure for 2010-11 of Lupin went up to Rs.5.30 billion from Rs.4.12 billion in the previous year. Dr Reddy’s stepped up its R&D activities and invested Rs.5.13 billion during the same period as against Rs.3.64 billion in the previous year. Cipla increased its R&D expenditure to Rs.2.84 billion from Rs.2.51 billion. Cadila Healthcare also increased R&D expenditure to Rs.2.54 billion from Rs.1.76 billion.

Currently, there are more than 150 CROs in India, out of which 20 comply with ICH-GCP guidelines. The leading players in India include Clinigene International, Vimta Labs Ltd, and Lotus labs, besides multinationals like Quintiles Spectral, Pharmanet, SIRO Clinpharm and Clintec, who take up multi centre trials in India.

The pharmaceutical industry is using latest technology tools to speed up clinical trials. The analysis of clinical trials data is a major step in the drug development process. The industry is growing due to factors such as the availability of infrastructure facilities, which facilitate all possible trials, product pricing, reduction in R&D expenses, decrease in Time-to-Market Clinical Trials, regulation and support from local bodies.

The regulation support from local bodies makes the trials possible without having legal issues and constraints. The technology support for these trials is equally important and it is required during drug development, drug design, analysis of data (using software), animal studies, and field studies. The current and emerging trends including collaboration for drug discovery, Phase 0 trials, combination of trials, medical writing and phase IV trials will lead to save the time taken for the completion of clinical trials.

The critical success factors for clinical trials segment in India are infrastructure for the trials, trained manpower, drug imports, multiple tasks in approval process, speed and quality of trials, and government procedures and sanctions.

Clinical trials are conducted in a standard regulatory environment. The key regulatory issues are FDA regulations, patent regime, customs duty, tax benefits and regulation of ethical issues. The major issues and challenges in the clinical trials segment in India are: finding the volunteers for the trials, training for trials, quality of the data, segmenting physicians, protection of the research, ethical problems and issues in adhering to the new FDA guidelines for conducting trials.

The opportunities remain largely untapped, in relation to the growth in the global clinical research scenario. Much is being discussed at all levels by stakeholders - government, industry and academia on the infrastructure and regulations to give momentum to the wave of clinical trials in India.

Costs of conducting clinical trials in the developed countries have increased over the years, leaving research-based multinationals with little choice, but to outsource stages of clinical trials to the developing countries such as India and China. Nearly 30% of the clinical trials will be outsourced to developing countries in the near future. India will play an increasingly important role in this segment, due to the genetically-diverse population, abundant technical talent, low costs and sound infrastructure, among other reasons. India has a huge potential for clinical trials. The success rates of clinical trials by phases in India are Phase I: 70%, Phase II: 35%, Phase III: 27%. Particularly for phase 3 trials, appears to differ on the basis of the time frame and therapeutic area in question, but most importantly on the basis of the source.

In the next five years, 1,500 to 2,000 GCP studies will be conducted in India per year, requiring 10,000 to 15,000 GCP-trained investigators, and supported by 50,000 clinical research professionals. Cygnus estimates that during 2010 -2015 clinical trials market will grow at a CAGR of 28%. India has substantial capacity to meet the rapidly growing demand for clinical trials. It has 300 universities, over 750 graduate and post-graduate programmes, and about 50 million college graduates. The industry will need approximately 50,000 recruits. India has a huge pool of scientific, pharmaceutical, and medical talent, but the supply of trained professionals in India is approximately one-tenth of its demand.

- Dr. Reddy's Laboratories Limited
- GlaxoSmithKline
- Lupin Limited
- Novartis
- Pfizer Limited
- Torrent Pharmaceuticals Limited
- Vimta Labs Limited
- Cadila healthcare
- Asian Clinical Trials Limited
- Bioserve Clinical Research Pvt. Ltd
- Clininvent Research Pvt. Ltd
- ClinTech International
- Eli Lilly and Company (India) Pvt. Ltd
- iGATE Clinical Research International
- Intas Pharmaceuticals
- Johnson & Johnson, India
- Lambda Therapeutic Research Ltd
- Lotus Labs Pvt. Ltd
- Matrix Laboratories Ltd
- Merck Limited
- Novo Nordisk India Private Ltd
- Pharmanet
- Quintiles Research (India) Private Limited
- Reliance Clinical Research Services
- Roche India Ltd
- Sanofi-Aventis (Aventis Pharma Limited)
- Siro Clinpharm Pvt Ltd
- Supper Religare Laboratories Ltd
- Sristek
- Synchron Research Pvt. Ltd

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