Pharmaceutical grade lactose is a specialized grade of lactose that meets the rigid pharmaceutical expectations. It is produced by concentrating whey or permeate to over-saturate the lactose, which is then further refined, dried, and milled properly. Pharmaceutical grade lactose is manufactured in different specialty and customized range to use in various oral solid dosage forms (OSDFs) such as tablets, capsules, sachets, dry powder inhalers and others.
In solid form, lactose can either be in an amorphous state or in a crystalline state. The most well-known forms of crystalline lactose are α-lactose monohydrate and β-lactose. Crystallinity of lactose particles is the result of high ordered arrangement of lactose molecules. α-lactose monohydrate is produced by crystallization of highly concentrated lactose solutions at low temperatures, which is then separated from the mother liquor and dried off. α-lactose is mainly used as an excipient in the production of solid dosage forms through wet granulation and direct compression processes.
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Notably increasing approval from government bodies to use pharmaceutical grade lactose as an excipient is the key factor driving the pharmaceutical grade lactose market. According to the 2017 updated inactive ingredient database by FDA, lactose is approved to be used as an excipient for different dosage forms. Many pharmaceutical grade lactose are also included in medicines licensed in the U.K such as, lactose powder manufactured by LFA tablet presses. Due to broad availability and cost effectiveness, lactose is getting great acceptance across the world.
Other factors such as, drug formulation coupled with nanotechnology, efficient compatibility with active ingredients and other excipients, and increasing demand for dry powder inhalers (DPI) products will boost the growth of the market. The advantage of using pharmaceutical grade lactose for DPI products is its low price and broad availability. There are many other drugs in the market for which lactose is used as excipient such as, Alprazolam; in which lactose monohydrate is present as an inactive ingredient. According to the Journal of Thermal Analysis and Calorimetry (2015), lactose is also used as an inactive ingredient in Estradiol drug
However, lactose-induced health complications, stringent government regulations, and lack of compatibility of pharmaceutical grade lactose with amine based drugs may hinder the growth of the market. According to a study published in the Revista Mexicana de Ciencias (Mexican Journal of Sciences) in 2015, lactose has propensity to react with primary and secondary amine drugs through Maillard reaction to produce colored products.
It is estimated that pharmaceutical grade lactose market is expected to grow at a CAGR of 4.1% during the forecast period 2017-2023.
The pharmaceutical grade lactose market is segmented on the basis of type, and application.
On the basis of type, the market is segmented into crystalline monohydrate lactose, inhalation lactose, granulated lactose, spray dried lactose, and others. Crystalline monohydrate lactose is further segmented into α-Lactose monohydrate, and β-Lactose (anhydrous lactose). Sub-segmentation of α-Lactose monohydrate includes milled, and sieved. Inhalation lactose is further segmented into sieved, and milled.
On the basis of application, the market is classified into tablets manufacturing, capsule manufacturing, and others. Tablets manufacturing is further classified into direct compression, wet granulation, and dry granulation. Capsule manufacturing is further classified into capsules, sachets, and others.
- The pharmaceutical grade lactose market is expected to reach USD 229.48 million by 2023 at a CAGR of 4.1%.
- On the basis of application, tablets manufacturing market is expected to command the largest market share of 52.1% over the review period and it is also expected to grow at the fastest CAGR of 4.3% during the forecast period 2017-2023
- Europe hold the largest share of the pharmaceutical grade lactose market and is expected to reach USD 94.289 million by 2023
- Asia Pacific is the fastest growing market, which is expected to grow at a CAGR of 4.4% over the 2017-2023
On the basis of regions, the pharmaceutical grade lactose market is segmented into Europe, Asia Pacific, America, and the Middle East & Africa.
Europe has accounted for the major share of the market. Increasing demand for dry powder inhaler (DPI) products, and rising approval from government bodies are the key drivers for the growth of the market in Europe. Moreover, increasing healthcare expenditure, and rising R&D activities, also supporting the market growth.
Asia Pacific accounts for the second largest and fastest growing pharmaceutical grade lactose market owing to the improving health infrastructure, and developing pharmaceutical industry. According to the Indian Brand Equity Foundation (IBEF), in 2016 the generics market of India stood at USD 26.1 billion. Asia Pacific consists of regions namely Japan, China, India, Australia, Republic of Korea, and rest of Asia Pacific.
Pharmaceutical grade lactose market growth in the Americas is majorly attributed to the approval for the usage of lactose as excipient by FDA. However, high occurrence of lactose induced problems has strongly affected the growth of the market.
The Middle East and Africa holds the least share in the market owing to the presence of poor and slow developing countries, especially, in African region.
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Some of key the players in the market are BASF SE, Merck KGaA, Kerry Inc. DFE Pharma, Meggle, Armor Pharma, ALPAVIT and others.
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