Pharmaceutical Grade Lactose Market is projected to increase at a 5.41% CAGR, growing from USD 2.006 billion in 2025 to USD 2.752 billion in 2031.
The rising knowledge of the benefits associated with consuming pharmaceutical-grade lactose products, as well as the growing understanding of the necessity of baby nutrition, are the primary market factors boosting market growth. Furthermore, rising healthcare/pharmaceutical spending throughout the world is expected to benefit the worldwide pharmaceutical lactose business. Increased pharmaceutical spending by governments throughout the world is likely to drive demand for pharmaceutical-grade lactose. Additionally, the aging of the worldwide population is a major element driving the growth of the pharmaceutical-grade lactose market. The need for medications to treat chronic illnesses including cancer, diabetes, and cardiovascular disorders is increasing as the world's population ages. When making oral solid dosage forms, such as tablets and capsules, which are frequently used in the treatment of chronic illnesses, lactose is used as an excipient. Therefore, it is anticipated that the growing older population will fuel the need for pharmaceutical-grade lactose.
Introduction:
The global pharmaceutical-grade lactose industry is a subset of the larger lactose market, which is predominantly sourced from cheese production. Pharmaceutical-grade lactose is a segment of Lactose Quality Standards that meet the stringent quality requirements and specifications required for use in pharmaceutical formulations such as tablets, capsule filling with lactose, oral remedies, lactose as a binding agent, and lactose inhalation powdered items. It acts as an excipient, which is an inert material that acts as a conduit or vehicle for the active chemicals in pharmaceuticals. Pharmaceutical-grade lactose is used to improve the flowability, compressibility, stability, and taste of pharmaceutical formulations. Furthermore, lactose serves as a significant supply of carbs and energy in newborn formula, which is essential for child growth and development. Global usage of these products is expected to raise the total demand for lactose, particularly pharmaceutical-grade lactose. Lactose is also used as a diluent and filler in a variety of drugs, notably those taken via injection or inhalation. The growing need for pharmaceutical-grade lactose is being driven by the growing demand for inhalable and injectable drugs, which are recognized for their increased potency and faster beginning of action.
Drivers:
Products offered by key companies:
ARMOR PHARMA lactose monohydrate, ARMOR PROTEINS: ARMOR PHARMATM lactose monohydrate 200M is ?-lactose monohydrate powder that has been finely ground and has good mixing and compaction qualities. The main use of this lactose is in the production of tablets by both wet and dry granulation techniques.
Lactose pharma, Charotar Casein Company: Lactose pharma is delicately processed under the strict supervision of skilled quality controllers. These have a moisture content of 5.10 and an acidity of 0.20 (0.4 ML of 0.1 M naoh/5g). These items are generally acknowledged for their purity and excellent efficacy after being finely processed under the strict supervision of skilled quality controllers. These are clear and colorless (compliant) in terms of solution clarity and color.
Ludipress®, BASF Corporation: Ludipress® is a granulate that makes tableting faster, simpler, and more cost-effective. Ludipress® Polymer is delivered as white, free-flowing, tasteless granules. It contains Lactose monohydrate (93%), Kollidon® 30 (3.5%), and Kollidon® CL (3.5%). This facilitates quick and simple tablet compression, resulting in excellent tablets with rapid disintegration despite optimum hardness, low friability, and rapid active ingredient release.
Prominent growth is anticipated in the ?--lactose sector under the product type segment
The ?--lactose monohydrate sector is expected to hold the lion’s share in the worldwide pharmaceutical lactose business, and it is anticipated to grow substantially over the forecast period. This is due to the increased use of ?--lactose monohydrate as a filler and dilution in a variety of pharmaceutical formulations. ?--lactose monohydrate is commonly utilized as an excipient in the manufacture of solid dosage forms in the pharmaceutical sector. It is also utilized as a carrier in dry powder inhalers. medicinal goods using ?--lactose monohydrate as a major component have a longer shelf life than those containing other medicinal lactose forms.
The North American region is expected to hold a significant share of the Pharmaceutical Grade Lactose market:
The North American region is expected to expand with a healthy CAGR over the forecast period. Since North America is home to many large producers and suppliers of pharmaceutical-grade lactose, the area is anticipated to hold a sizable market share. The expansion of the pharmaceutical sector, particularly in the US, one of the biggest marketplaces for pharmaceutical products worldwide, is what is driving the need for pharmaceutical-grade lactose in this region. Growth in this market is anticipated to be aided by the growing use of lactose as an excipient in a variety of medication formulations, including tablets, lactose-filled capsules, oral solutions, and lactose inhalation powder products. Moreover, using lactose-induced baby formula has also been connected to better digestion and a reduction in gastrointestinal problems in young children. The demand for baby formula is anticipated to rise further as parents and healthcare professionals become more aware of its advantages.
Key developments:
In September 2022, to better service its clients in India, DFE Pharma established a new Center of Excellence. Furthermore, the organization has established strategic alliances and cooperative efforts with prominent industry participants to expedite advancements and provide exceptionally complete solutions for its clientele.
In July 2022, with the introduction of Lactohale® 400 DFE Pharma, a pioneer in pharma- and nutraceutical excipient solutions globally, announced the extension of its Dry Powder Inhalation (DPI) portfolio. The range of inhalation-grade lactose from DFE Pharma is now even more comprehensive with the addition of Lactohale® 400. Like the whole Lactohale® brand, this new grade may be tailored to pharmaceutical firms' unique needs and created in collaboration with formulators to precisely guarantee the appropriate results for patients.
Pharmaceutical Grade Lactose Market Segmentation
By Product Type
?-lactose
?-Lactose monohydrate
Amorphous Lactose
Spray Dried Lactose
By Application
Tablets
Capsules
Dry Powder Inhalers (DPI)
Sachets
Parenteral Formulations (Bulking Agent)
Oral Suspensions
By End-User
Pharmaceutical Companies
Contract Manufacturing Organizations (CMOs)
Contract Development & Manufacturing Organizations (CDMOs)
Nutraceutical Manufacturers
Research & Development Laboratories
By Geography
North America
USA
Canada
Mexico
South America
Brazil
Argentina
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Others
Middle East and Africa
Saudi Arabia
UAE
Others
Asia Pacific
China
India
Japan
South Korea
Taiwan
Indonesia
Thailand
Others