Pharmaceutical grade lactose is produced by concentrating whey or permeate to over-saturate the lactose which is further refined, dried, and milled properly. This grade of lactose is prepared to meet rigid pharmaceutical specifications. 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. The general properties offered by lactose such as, cost effectiveness, low hygroscopicity, excellent physical and chemical stability, compatibility with other ingredients, and its bland taste contribute to its acceptance by government bodies as lactose is marked safe according to the regulations of FDA Inactive Ingredients Database and is also ‘GRAS’ (Generally Recognized as Safe) listed. Lactose and its complex are also predominately recommended as filler/diluent in solid dosage forms by European Pharmacopoeia.
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Pharmaceutical Grade Lactose Market Segmentation:
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 grow at a CAGR 4.1% during the forecast period 2017-2023. Increasing approval from government bodies to use pharmaceutical grade lactose as an excipient, drug formulation coupled with nanotechnology, efficient compatibility with active ingredients and other excipients, and increasing demand for dry powder inhalers (DPI) products will propel the growth of the market. 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 market to an extent.
Major Key Players in Global Pharmaceutical Grade Lactose Market:
Some of key the players in the market are BASF SE, Merck KGaA, Kerry Inc. DFE Pharma, Meggle, Armor Pharma, ALPAVIT and others.
Global Pharmaceutical Grade Lactose Market Regional Analysis:
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.
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
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