Particle size analysis is one of a number of critical parameters that must be monitored at various stages of pharmaceutical and biopharmaceutical manufacturing. With high single-digit growth, global demand for process particle size analysis instrumentation for the pharmaceutical industry will be more than $30 million by 2012. The vendors that dominate the laboratory particle size analysis market are not necessarily the same as those that lead in the market for pharmaceutical process particle size analysis.

Granulation is a common processing step in drug manufacturing as tablets are the most common dosage forms. Granulation, whether by wet or dry processes, combines primary powders to form larger granules, which enable processing and can affect the performance of the drug. The particle size is typically the primary determinate of the endpoint of the granulation process and is measured on line in real time or off line using a benchtop instrument near the line or in a process lab.

Particle size analyzers are also commonly used in milling and micronization processes, which break down powders, and are occasionally used in crystallization processes. Powder mixing and blending in pharmaceutical manufacturing is typically monitored using NIR spectroscopy, but particle size analyzers are also capable of determining the process endpoint.

The total market for process particle size analyzers used in the pharmaceutical and biopharmaceutical industry was more than $25 million in 2010 and is expected to grow 7%–8% annually over the next several years. Demand is roughly evenly divided between on-line process particle analyzers and off-line benchtop systems.

The FDA and other regulatory agencies have pushed for the adoption of on-line process technologies for a number of years through initiatives such as PAT (Process Analytical Technology) and QbD (Quality by Design). However, pharmaceutical manufacturers continue to be hesitant about transitioning from benchtop instruments to on-line systems due to concerns about disrupting stable and manageable processes and making regulatory validation more challenging. The growth of the pharmaceutical industry, particularly the rise of new generic drug manufacturers, is leading to steady increases in the construction of manufacturing facilities, particularly in India and China, which will help drive demand for process particle size analysis.

Malvern Instruments, a subsidiary of Spectris, is the leader in the market. Malvern supplies both process and lab particle size analyzers. Metler-Toledo’s Autochem group offers the FBRM particle analysis instruments, which are oriented towards process applications. Horiba, a supplier of lab particle size analyzer, also has a strong presence on the process side. There are at least half-a-dozen vendors with more than $1 million in sales of particle size analyzers for use in process analysis for the drug industry.

Particle Size Analysis in Drug Manufacturing at a Glance:

Leading Vendors

• Horiba

• Malvern (Spectris)

• Mettler-Toledo

Leading Applications

• Crystalization

• Granulation

• Mixing/Blending

Instrument Cost

• $10,000–$50,000