Bio Services

The BioServices sector, which accounted for about 11 percent to the total biotechnology industry's revenues of Rs 6,521 crore, has recorded a growth of 69 percent over the previous year. The bioservices revenue for 2005-06 was estimated at Rs 720 crore.

Exports dominate the bioservices sector. Bioservices mainly includes clinical research and contract research organizations (CRO) and to some extent custom manufacturing. We have taken only the confirmed figures for the ranking purpose.

There are over 70 companies doing business in this space by offering services in areas like data management, clinical trials, site management, bio equivalence and bio availability studies toxicology studies, knowledge process outsourcing for pharma industry. The contract research space is also opening up in the country after India entered the patent regime in January 2005. Most of the Indian CROs are actively involved in doing bio equivalence and bioavailability studies with a handful of them into clinical trials (Phase I-IV).

Quintiles India leads the clinical research space in India with sales of Rs 136 crore. The other leading names in this space include Clinigene International, iGATE Clinical Research International, Lambda Therapeutics Research, Lotus Labs, SIRO Clinpharm,

Syngene, and Vimta Labs.
Considering the opportunity and growth in this space, new companies have opened up in the last couple of years. To name a few Ace Biomed, Biogeniux, Kendle India, Pharmaceutical Product Development (PPD) India, Triesta Sciences, and Veeda Clinical Research have set up offices in 2004. During 2005 Chiltern International opened its branch office in India to provide support for clinical operations, project management, data management, biostatistics, medical writing, quality assurance and regulatory and medical affairs services to the pharmaceutical, biotechnology and medical device industries. Manipal AcuNova too started its clinical research operations under Asia Clinical Research Center. Jubilant Organosys, one of largest custom research and manufacturing services (CRAMS) companies, launched its Clinsys India, wholly owned subsidiary in New Delhi and also in the US. Ranbaxy Laboratories too entered the clinical research space by setting up Fortis Clinical Research activities.

RxMD which was instrumental in bringing several innovative compounds to market in the disease areas of Hepatitis B, Hepatitis C, HIV, Influenza, erectile dysfunction and others has opened up its office in 2005 in Chennai. It pioneered Knowledge Process Outsourcing (KPO) by offering value added services in clinical data management, drug safety, medical writing and SAS programming in the pharma domain. In short span of time, with strength of 10 professionals it is on an impressive growth trajectory, having recently bagged contracts to manage data from clinical studies being conducted by North American pharma companies and poised to partner some of them in comprehensive drug development activities.

On the other hand the existing clinical research organizations like SIRO Clinpharm, iGATE Clinical Research International, Lambda Therapeutics Research, ClinInvent, and Clinigene have increased their headcount and are also making investments on infrastructure to undertake more studies.

Even leading healthcare companies with a chain of hospitals like Apollo, Fortis Healthcare, and Max Group are associating with the clinical research activities by offering their space as site management centers. Similarly leading pathology centers like SRL Ranbaxy, Dr Lal's Labs, and Metropolis Health Services too have divisions on clinical research.

Sterling Synergy Systems that has been providing an integrated, comprehensive platform to design, conduct and monitor clinical development services for Phase II – IV trials was acquired by PRA International, one of the world's leading CROs and an ISO 9001:2000 registered company, in 2006. Set up in 2001 Sterling Synergy Systems has about six on going projects in Phase III and IV clinical trails.

Similarly Synchron Research Services has entered into joint venture with the US based Parexel International Corporation. It has a minority stake in the newly formed entity called Parexel International Synchron Private Ltd into which Synchron transferred its clinical trial business operations located in Bangalore. Parexel also acquired a minority equity interest in the clinical pharmacology business of Synchron Research in Ahmedabad.

Since India has many advantages over other developing countries it has become an attractive destination for global pharmaceutical companies to outsource their clinical research operations. Many global companies who had presence in India have been conducting clinical trails in the country. In all 122 clinical trails are being outsourced to India. GlaxoSmithKline, a leading vaccine manufacturer which has set up its clinical research and data management center at Bangalore 10 years ago, is leading the list by carrying out 13 drug trials for treatment of different diseases. The other MNCs that are carrying out clinical trials in India include Astra Zeneca, Eli Lilly, Johnson & Johnson, Pfizer, Sanofi Aventis, Novartis, Bayer, Merck, Wyeth, Novo Nordisk, Bristal Myers Squibb and Roche. These companies have been carrying out clinical trials as a part of global studies for data generation as well as for registration in the local market. These companies have set up their in house teams for clinical research, data management and data mining etc.

Novo Nordisk has outsourced its large IT project during the year to TCS for implementation of offshore clinical operations services. TCS will provide a suite of data management services that include designing, capturing and coding of trial data gathered by Novo Nordisk across the globe from its BPO facility in Mumbai.

During 2005, GEAC has given approval for conducting 27 (includes Phase I, II, III) clinical trails. It has given green signal to Indian Council of Medical Research for conducting phase I trials for TBC –M4 (a preventive recombinant AIDS vaccine) after importing from the US at Tuberculosis Research Centre, Chennai. Pfizer, Biocon Biopharmaceuticals, and Quintiles received approval for conducting Phase II trials for Pegvisomant, EGF-R neutralizing monoclonal antibodies hR3 TheraCIM and with Natrecor R (nesiritide) for management of patient with heart failure respectively during the year.

Indian Immunologicals Ltd (combined Rabies DNA Vaccine (veterinary use)), LG Life Sciences (LG Leucostin Injection (r-human Granulocyte colony Stimulating factor) filgrastim), Wockhardt (r insulin (Glargine), r-Insulin Lispro Cr-DNA origin, r-h GCSF), Merck (anti cancer monoclonal antibody, Cetuximab (Erbitux)), Shantha Biotechnics (r-DTwPHb-Hib Pentavalent Combination Vaccine), Bharat Serum and Vaccine (r-h FSH), Biocon (rh GCSF, r-Streptokinase), Sun Pharmaceuticals (r-human granulocyte colony stimulating factor), GlaxoSmithKline India (Cervarix human Papilloma virus vaccine), Bharat Biotech International (tetravalent vaccine DTPw –r Hep B and pentavalent vaccine DTPw –r Hep B+ Hib) and Virchow Biotech (r-Peg Interferon alpha 2b) received approval fro conducting Phase III trials during the year.

While few companies like Virchow Biotech (VIRKINASE- recombinant Streptokinase),ClinInvent Research (r-human Erythropoietin), Shasun Chemicals & Drugs (r-Streptokinase), Emcure Biotech (r-Mutant Tissue plasminogen Activator (TNK-t- PA) and r-GM-CSF), Serum Institute of India (r-erythropoietin, r-G-CSF and PEG-G-CSF), Reliance Life Sciences (r-human interferon alpha 2b (Reliferon)) too received approval for conducting clinical trails during the year. Biocon received GEAC's approval to conduct large-scale process optimization studies (R& D purpose only) of oral insulin IN –105 precursor, for the production of oral formulation of recombinant human Insulin.

ClinInvent Research and Quintiles, both clinical research organizations, have received approval from GEAC for carrying out clinical trails for recombinant biotech drugs in India.

Custom Manufacturing
With India being a base for large number of USFDA approved plants out side US and low manpower costs, India has become an important destination for many leading pharma companies for both custom manufacturing and contract research. Custom manufacturing is another growing area with slowdown in sales of patented drugs and drying of R&D pipelines. So MNCs are looking for alternatives to reduce the costs on R&D and manufacturing. Companies like Nicholas primal, Shasun Chemicals, Dishman Pharma, Dr Reddy's Labs, Jubilant Organosys, GVK Biosciences, Suven Lifesciences, and Bharat Biotech are leading names in the custom manufacturing business.

Similarly Sun Pharmaceuticals and Torrent Pharmaceuticals are into contract manufacturing of recombinant products for multinationals like Eli Lilly and Novo Nordisk respectively. Chiron Behring Vaccines, a joint venture with Aventis in which Aventis has a 49 percent stake, has been manufacturing Rabipur, anti-rabies vaccines for Aventis Pharma.

Contract Research
In the contract research space US-based Wyeth Pharma has entered into research partnership with GVK Biosciences in 2005. Under the pact GVK Biosciences will establish a dedicated research site to engage over 150 people working exclusively for Wyeth. Syngene, Jubilant Organosys, Nicholas Piramal, Suven Lifesciences are other names in this space. Nicholas Piramal has also been into contract research area through its division Wellspring. All three businesses are on the rise.