According to industry sources, the IVD market  in India, which is currently valued at approximately US$330 million is expected to grow at an annual rate of 15 to 20%. Of this, 37% comes from the biochemistry instruments and reagents market in India. Consolidation of diagnostic facilities, rising demand for integrated and fully automated high-throughput systems, an ever-expanding number of diagnostics centres and awareness of accreditation are some of the prime factors driving the growth of this market.

Interestingly, reagents contribute 75% to the total biochemistry market. Placement of high-end analysers under reagent rental schemes has been the trend in the biochemistry business and is expected to be the major growth driver in years to come.

Excepting multinational companies, the Indian biochemistry instruments and reagents market is dominated by  Transasia, Trivitron, Aggape and CPC Diagnostics, among others. Span Diagnostics and Tulip Diagnostics are aggressive in the reagents segment.

Located at Rabale, Navi Mumbai, the new site includes an ISO Class 7 cleanroom, which will be used primarily to produce the DF30 metering valve platform for metered dose inhalers and to assemble spray pumps.

Established in 1999 in Mumbai, Aptar Pharma provides aerosol, spray and dispensing systems to biotechnology, healthcare and pharmaceutical companies in India.

The site was officially inaugurated on 21 January 2012 in the presence of Ajit Singh, chairman of ACG Worldwide; Dr C. Gopalakrishna Murty, President of the Indian Pharmaceutical Association; and business partners and suppliers as well as AptarGroup senior management representatives including CEO Stephen J. Hagge.

Dozens of international experts have been invited to present papers. The use of Raman spectroscopy in nanotechnology and biomedical applications will be explored.

Early-bird registration is available until 30 April.

Processes for fabricating 3-D porous biomaterials from regenerated silk fibroin (RSF) have been developed by India’s NCL Innovations, part of the National Chemical Laboratory. Notably, NCL scientists have been able to accelerate RSF gelation time to produce a porous structure. The process, which typically takes several days, now can be completed in a few hours. The organisation has also been able to create 3-D porous structures by electrospinning RSF from an aqueous solution. Medical applications include tissue engineering, wound care and drug delivery. NCL Innovations is seeking licensing partners for the technologies.

The reduction in RSF gelation time has widened the spectrum of applications for the materials, according to NCL Innovations. The process is less costly and faster than conventional techniques, because an aqueous solution is used in lieu of organic solvents. The resulting implants are reproduced with increased consistency, adds the organisation, and the technology enables pore sizes in the 1 to 10 µm range.

In addition to the production of bioabsorbable scaffolds for tissue engineering, the biomaterials can be used to manufacture controlled drug-delivery devices and bandages that provide a moist environment to promote wound healing.

NCL Innovations notes that the market for biomaterials such as RSF is projected to grow from US$37.6 billion in 2011 to US$64.7 billion by 2015, and that the global market for tissue engineering and regenerative medicine is expected to exceed US$118 billion by 2013, primarily in the wound care and orthopaedics sectors.

Under the terms of the agreement between the two companies, Biocon has worldwide distribution rights to INSUPen for use with Biocon’s insulin and insulin analogues.

“The INSUPen provides diabetic patients with user-friendly features at an affordable cost. Haselmeier is proud to work with Biocon, a premier biotechnology company, on this important programme to develop and supply INSUPen and we look forward to a long and successful partnership,” said Volker Wirth, Director Business Development and Marketing at Haselmeier.

Rakesh Bamzai, President, Marketing at Biocon added: “I am confident that INSUPen will be a delight for patients and a value enhancer for all stakeholders.”

Biocon has recruited a team of 125 Diabetic Care Advisors across India to support its existing helpline for diabetics, which offers complementary wide-ranging support for this device including at-home product demos, counseling on lifestyle changes and answers to product-related queries.

Today, molecular diagnostics makes up just 5% of the IVD market, but it is the fastest growing segment. According to a report titled Global In Vitro Diagnostics (IVD) Market Trends and Future Forecast (2009 – 2014), the market share of molecular diagnostics will reach approximately 18% by 2014.

In India, molecular diagnostics has grown in waves. Molecular diagnostic tools were first used for the detection of infectious diseases such as HIV, hepatitis C, Epstein-Barr virus and so forth. Blood screening was the next phase, while the current generation of tools, enabled by poymerase chain reaction technology, encompasses pharmacogenomic, predictive and genetic testing and companion diagnostics.

DNA diagnostics, in particular, is poised for steady growth.

The conference is jointly organised by the MGM University of Health Sciences, Indian Society for the Study of Reproduction and Fertility and Yashraj Research Foundation, Mumbai.

The diagnostic test that is currently used by the Indian TB programme (RNTCP) for routine cases is sputum smear microscopy, a technique that was developed more than 100 years ago. The private sector uses serological (antibody) tests, which the World Health Organization advises against. While serological tests work well for several infectious diseases, antibody tests for TB are known to be inaccurate, inconsistent and of no clinical value, says the WHO.

A preliminary analysis by McKinsey and Co. estimates the annual TB diagnostics market in India to be worth approximately US$100 million, although the actual market size could could be significantly larger as the private sector does not report cases. The RNTCP screens more than 7.5 million people with suspected active TB every year and a similar number is likely to seek care in the private sector. Thus, at least 15 million people will need to be tested, which should translate into a fairly sizeable market.

India’s current in vitro diagnostics market, particularly molecular tests, is dominated by imported, expensive products. But India has the potential to solve its TB problem with home-grown solutions. Just as Indian pharma and biotech companies revolutionised access to high-quality, affordable AIDS drugs and hepatitis vaccines through generic production methods, Indian diagnostics companies could become the global hub for high-quality generic diagnostic products.

India also has the potential to lead the world in developing new TB products. Indian industry has done well with generic products but the transition to innovation is not an easy one. In fact, easy success with generics has actually made it harder for Indian industry to innovate. Development of new technologies will require changes, such as progressive policies by the government, to increase funding and partnership opportunities among the government, donors, researchers and private industry.

These concerns were the main topic of discussion at a recent conference at St. John’s Research Institute in Bangalore. The TB Diagnostics in India: From Importation and Imitation to Innovation conference was hosted by McGill University and Global Health Strategies. The event brought together for the first time more than 200 representatives from industry, government, donor and civil societies, academia and the media to discuss what it takes to innovate in TB diagnostics in India.

—medtechinsider editors

Last year, SMD won the Harvard Business School competition for new ventures, competing against 70 global contenders to win a cash prize of US$25,000.

Krishna Mahesh, the owner of SMD, comes from the TVS Group, India’s largest manufacturer and distributor of automotive components. According to Mahesh, SMD will be building on the engineering rigour, high standards and cost control of the Indian automotive industry to develop a high-tech, low-cost medical bed that meets the highest standards of quality, safety and usability.

With a population of a billion people and a shortage of more than three million hospital beds, the market for locally manufactured medical beds is dramatically underserved.

Krishna Mahesh describes his vision in the video below.