Biopharma Manufacturers Look For Product Innovation

By Eric Langer, president and managing partner, BioPlan Associates, Inc.

Biopharma manufacturers are increasingly vocal about the new product development (NPD) areas they need to increase productivity and improve quality. The top three areas of NPD interest among biomanufacturers and CMOs this year were related to single-use solutions. This was led by "disposable product: purification," cited by almost two in five respondents, according to our 8th Annual Report and Survey of Biopharmaceutical Manufacturers. Within this area, slightly more CMOs are demanding new products. Of the 21 new product areas we measured, the next hottest, with more than 1/3 of the 350 qualified respondents, were improved disposable products: bags, connects, etc., and disposable product: probes, sensors, etc.

But, single-use devices are not the only hot items. Also on the list of nearly two dozen opportunities, and showing up in fourth position, was "analytical assays." This is partly due to increased interest in monitoring process improvements, but also as a means to develop biosimilars and demonstrate biologic comparability at different facilities. Disposable bioprocessing equipment is in high demand partly because innovation in these products has been slow in coming. For example, 29.2% also noted a desire for improvements in bioreactors. By comparison, only 6% sought innovations in fixed stainless steel bioprocessing equipment.

Looking at trends in demands for new products from vendors, we found some significant shifts from last year. Interest in better innovation in disposable, single-use devices for measuring and monitoring (probes, sensors, etc) grew from 29.3% of respondents to 37% over the past year. Further, interest in assays increased from 24.5% of respondents to 31.1%.

Areas that declined in interest included: chromatography products (36.7% down to 29.7%) and process development services, both downstream and upstream (down by as much as 10 percentage points). Cell culture media also dropped roughly 5 percentage points.

Biopharma Vendors Doing Their Part
The annual survey also separately evaluates spending and new technology development among hundreds of biopharma suppliers. When we match up where vendors are investing their R&D efforts in 2012, we find, from preliminary survey data, that most vendors' budgets are growing significantly and are aimed at the very areas that biomanufacturers demand. This year, of the 38 new product areas that vendors are developing, the top areas are included in figure 2.

We note that the 2012 data is preliminary and may change with additional data collection. It is clear that, although the overall percentage of vendors working on specific new product areas has declined slightly, the overall efforts remain substantial. The top groupings continue to align with the industry's explicit demands, including areas associated with downstream processing, chromatography, and single-use downstream devices.

Biopharma's Budget Trends
Budgets are a good indicator of industry strength. And budget estimates for 2012 are, once again, up strongly for acquisition of new technologies, capital equipment, and training. In fact, early returns from respondents to BioPlan's 9th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production are projecting increases in all 12 areas measured in 2012, except for outsourcing. This budget bump clearly indicates a healthy continuation of investment and spending trends seen over the previous three to four years. Spending this year, in particular, is occurring in:

• new technology
• capital equipment
• process development and optimization
• personnel training and development.

Across all departments, both budget trends and R&D/NPD efforts are leading indicators of economic constraints loosening. This is especially evident in areas of expenditures that improve process performance. Our annual survey documents and analyzes how the rebounding and maturing biopharmaceutical industry is moving forward despite recent global economic challenges.