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.
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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.
Pharmaceutical Grade Lactose Market – Key Players
BASF SE, Merck KGaA, Kerry Inc. DFE Pharma, Meggle, Armor Pharma, ALPAVIT, and others are some of the prominent players at the forefront of competition in the pharmaceutical grade lactose market and are profiled in MRFR Analysis.
Pharmaceutical Grade Lactose Market – Overview
The pharmaceutical grade lactose market is growing mainly due to efficient compatibility of lactose with active ingredients. According to a recent study report published by the Market Research Future, the pharmaceutical grade lactose market is booming and expected to gain prominence over the forecast period.
The market is forecast to demonstrate a spectacular growth by 2023, surpassing its previous growth records in terms of value with a striking CAGR during the anticipated period (2017 – 2023). 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. Rising approval from government bodies to use pharmaceutical grade lactose as an excipient is the primary driver for pharmaceutical grade lactose market.
Due to broad availability and cost effectiveness, lactose is getting great acceptance across the world. According 2017 updated inactive ingredient database by FDA, lactose is approved to use as an excipient for different dosage forms. Other push factors such as, compatibility with active ingredients and other excipients, and increasing demand for dry powder inhalers (DPI) products are also fuelling the growth of the market. With the increasing advancement, the usage of dry powder inhalers is also expanding for the delivery of different drugs.
Using DPI technique an effective plasma concentration of levonorgestrel drug can be exceeded over a period of 16-60 hours in comparison to the oral delivery. According to FDA, lactose along with glucose and mannitol can be used as carriers in DPIs.
Despite these drivers, lactose-induced problems, stringent government regulations, and lack of compatibility with amine-based drugs are expected to hinder the growth of the market. Although lactose has been widely accepted for inhalation products, but it is not compatible with proteins. 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.
Pharmaceutical Grade Lactose Market – Competitive Analysis
Due to rising research and development expenditure various existing and new marketers are continuously coming up with more advanced products. The global pharmaceutical grade lactose market is currently dominated by very few players.
Kerry Inc. is one among them, by holding a strong position globally. It has a global presence, however more than 60% of its share come from European region. This shows strong grip on the European market, however, only 40% of the share comes from the rest of the world, which includes countries like India, China, etc. The strategic alliance of Foremost Farms, Sheffield Bio-Science, and Kerry Group is expected to promote the pharmaceutical grade lactose products. The lactose is sold internationally under the Fast Flo trademarks and foremost trademarks. Acquiring Lactose (India) Limited, was also a part of strategy.
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BASF SE is another renowned player in the pharmaceutical grade lactose market. The company’s stronghold is largely attributed to its innovative and sustainable products. The company provides customized products to make drug formation processes more efficient. Pharmaceutical grade lactose products are covered under “Nutrition & Health” segment of the company. In 2016, the “Nutrition & Health” was having revenue of USD 2251.39 million.
DFE Pharma is well-known for its broad range of lactose offerings in the pharmaceutical industry. Its position among the key pharmaceutical grade lactose manufacturers is due to its global footprint through distributors and agents. In October 2014, the company opened a new sales office in Shanghai, China to effectively meet the escalating demand for excipients products in China. In April 2014, the company has also opened a new sales office in São Paulo, Brazil to strengthen its position in South and Central American countries.
Over the past years, Merck KGaA has also transformed from a supplier of pharmaceutical and chemicals into a global science & technology company with the acquisition of various companies such as Sigma Aldrich in the year 2015. The company has portfolio in three business sectors, Life Science, Healthcare, and Performance materials.
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