A moderate year for bioprocess segment

The trend towards single-use fluid handling bags, connectors and more critically the bioreactors was quite evident as the industry focused on reducing its capital costs and speed up its expansion and development time.

Filtration
Production technology in biopharmaceutical industry is currently witnessing a paradigm shift. The industry is increasingly switching from stainless steel equipment to single-use products. Even a highly cost-sensitive economy like India is witnessing increasing acceptance of single-use technologies.

While the equipment business slowed down, in-line with the economic scenario in 2009, the consumables and single-use devices registered significant growth. The industry warmed up to the membrane-based chromatography devices which saw it progress from R&D through process development into commercial production with several customers in vaccine industry, as it allowed the users to quickly scale up the process. The trend towards single-use fluid handling bags, connectors and more critically the bioreactors was quite evident as the industry focused on reducing its capital costs and speed up its expansion and development time. The Indian biopharmaceutical industry is exploring the concept seriously—starting from disposable sterile connections on aseptic areas, extending to assemblies for process unit operations, mixing vessels at smaller scale and evaluating the pre-sterilized assemblies.

The total market size for bioprocess equipment is estimated to be Rs 450 crore in 2009, in India, and has been growing at an average rate of 12 percent. Of this, consumables made-up for more than half. The bioprocess and filtration business in India is dominated by four large multinational companies. They are Millipore, which is servicing the biopharmaceutical and research industries, Pall Life Sciences, GE and last but not the least Germany’s Sartorius, which is gaining market share in the hardware business in the same segment. Since the beginning of 2010, Sartorius and Pall Life Sciences have bagged some large orders for core equipments for large biopharmaceutical plants.

Clearly, these few large multinational principal companies dominate the filtration/ bioprocess marketplace with perhaps 10-15 per cent of the remaining sales going to 3M and Nishotech (distributor for Novacep) and other companies.

Millipore leads the market with approximately 30 percent market share followed by Pall Life Sciences with 25 percent share. GE holds another 17 percent of the business, Sartorius has 15 percent and the north-based MDI is at 10 percent. Rest goes to other
players.

All these companies have continued their expansion in India by increasing the number of sales representatives, establishing dedicated CoE/ Validation/ Manufacturing/ Application development facilities to penetrate the market further.

While Pall Life Sciences is relying on biotechnology, specifically—the vaccine segment, to fuel growth of its life sciences division in the coming years the company differentiates itself from competitors by working closely with clients to develop custom-filtration products. Millipore still maintains a large catalog of water filtration devices as well as filtration devices for drug manufacturing that competes directly with Pall Life Sciences. However, Millipore’s filtration and purification devices are used solely for research and drug manufacturing purposes. The company was first to set up India’s first Validation and PDS lab in Bangalore in 2004. Following which Pall Life Sciences too boosted its infrastructure and services in the region by creating a CoE in 2007.

Sartorius, too, is not lagging behind. The company invested nearly Rs 28.52 crore (€5 mn) in India in expanding the competencies, capability and capacity to serve the group and Asian market requirements. The company is one of the largest manufacturers of fermentors.