Global Pharmaceutical-Grade Lactose Market By Product Types: (Granulated Lactose, Spray Dried Lactose) By Applications: (Tablet Manufacturing, Pharmaceuticals, Capsule Manufacturing, Feed and Infant Formula) and by Region and Companies - Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2022-2032

Pharmaceutical-Grade Lactose Market Overview:

The global Pharmaceutical-Grade Lactose Market is projected to reach a valuation of USD 3,401.29 Mn by 2032 at a CAGR of 3.9%, from USD 2,320.00 Mn in 2022.

Lactose is a disaccharide carbohydrate that is only produced as part of the milk of mammals, and as a storage carbohydrate in the seeds of a few plants. It is a carbohydrate that only produces a single molecule of glucose and one of galactose linked together. Lactose is sometimes called milk sugar as it comprises 4–5% of the milk of mammals such as cows, goats, and sheep, and about 7% of human milk. Lactose is an important food source for several types of fermenting bacteria. The bacteria convert lactose into lactic acid, and this process is the basis for several types of dairy products.

Lactose can be prepared from whey, a by-product of the cheese-making process. Fermentation of lactose by microorganisms such as Lactobacillus acidophilus is part of the industrial production of lactic acid. A highly pure form of lactose is used in the pharmaceutical industry as a diluent in tablets and capsules, and to more of an extent, in lyophilized products, infant feed formulas, and as a diluent in dry-powder inhalations. Crystalline a-lactose monohydrate is the most common form of lactose used in pharmaceuticals.

Detailed Segmentation:

The pharmaceutical grade market is segmented on the basis of – product type, application, and region.

By Product Types:

• Granulated Lactose
• Spray Dried Lactose
• Crystalline Monohydrate Lactose
• Inhalation Lactose

By Applications:

• Tablet Manufacturing
• Pharmaceuticals
• Capsule Manufacturing
• Feed and Infant Formula

By Region:

• North America
• Europe
• APAC
• South America
• MEA

Market Dynamics:

The popularity of lactose as an excipient can be attributed to its cost, availability, bland taste, low hygroscopicity, good compatibility with other ingredients, excellent stability, and water solubility. The demand for pharmaceutical-grade lactose is steadily increasing due to its surge in demand as an excipient in the drug manufacturing industry, along with supportive government regulations, as well as low costs offered by product manufacturers. These are factors expected to boost the revenue trajectory of this market.

Anhydrous lactose is generally produced by roller drying a lactose solution, which is then milled and sieved to the desired size range. It is widely used in direct compression tableting processes as well as a capsule or tablet filler/binder, especially with moisture-sensitive compounds where low moisture content is desirable.

Lactose may contain reactive impurities such as glucose, formaldehyde, furfuraldehyde, formic acid, and other aldehydes. The level of the reactive impurities may vary among vendors and lots. The presence of these reactive impurities, even though at trace levels, could be detrimental to the stability, efficacy, and safety of the final drug product. Many individuals cannot properly digest lactose causing lactose intolerance. This can lead to diarrhea, stomach aches, or other gastrointestinal issues.

The requirement for the pharmaceutical-grade lactose market is increasing due to the developments in the pharmaceutical industry. A large number of regional players are establishing themselves in this market, which in turn is fuelling the market growth. Lactose-induced health problems, rigid government regulations, and a lack of compatibility of pharmaceutical-grade lactose with amine-based drugs are elements expected to hamper this market’s economic growth.

Key Players:

• Kerry Inc.
• BASF SE
• Abbott Healthcare Ltd.
• Astra Zeneca Limited
• Wyeth Ltd.
• Bayer
• Cadila Pharmaceutical Ltd.
• GSK Ltd.
• Merck
• Pfizer Ltd.
• Novartis
• Unichem Limited
• USV Ltd.
• Sanofi-Aventis Pharma Ltd.
• Wockhardt Ltd.

Key Developments:

DFE Pharma is well-known for its broad range of lactose offerings in the pharmaceutical industry. Its position among other key pharmaceutical grade lactose manufacturers is due to its global footprint through distributors and agents.

BASF SE is another renowned player in the pharmaceutical-grade lactose market. This company’s stronghold is largely attributed to its innovative and sustainable products. It provides customized products to make drug formation processes more efficient.

For the Pharmaceutical-Grade Lactose Market research study, the following years have been considered to estimate the market size: