Pharmaceutical Grade Lactose Market Size

Global Pharmaceutical Grade Lactose Market Overview

Pharmaceutical Grade Lactose Market Valued at USD 1.8 billion in 2023, projected to grow from USD 1.9 billion in 2024 to USD 3.14 billion by 2032, with a CAGR of 5.20% during the forecast period (2023 - 2032). The expansion in awareness about the advantages of consuming pharmaceutical grade lactose products and growing awareness regarding the importance of infant nutrition are the key market drivers enhancing the market growth. 

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

In May 2024, after initiating a probe into the violation of rules by branded spices, food regulator FSSAI decided to extend surveillance to other food items such as fortified rice, dairy products, and spices sold in the market. The Food Safety and Standards Authority of India (FSSAI) will conduct a check on fruit and vegetables, salmonella in fish products, spice and culinary herbs, fortified rice, milk, and milk products; that’s what our sources say. As per quality concerns raised by Singapore and Hong Kong, FSSAI is already collecting powdered samples from all brands, like MDH and Everest, throughout the country.

Lately, the food business has experienced an important shift toward healthier and more sustainable alternatives with changes in consumer tastes. One interesting development is the growing popularity of lactose-free dairy products since they allow people with special dietary needs to consume them. Lactose intolerance, which affects a significant proportion of the global population, necessitated the development and innovation of lactose-free dairy products. A considerable portion of the world population suffers from lactose intolerance or inability to digest lactose (natural sugar found in milk). Dairy-free from this sugar has been sought after due to the increased number of people suffering from ill effects by taking it with lactose intolerant bodies, as the Research & Markets report emphasizes on this point. 

In November 2023, Danone introduced its first adult Foods for Special Medical Purposes (aFSMP) in China as part of its strategic focus on accelerating growth in adult medical nutrition. Fortimel is a “newcomer” specifically designed for patients recovering from surgeries or other non-communicable diseases like cancer or stroke. This move adds value to Danone’s existing portfolio of adult medical nutrition ranges intended for tube feeding. With the increasing prevalence of chronic conditions coupled with an aging Chinese population, this launch carries strategic importance, too. In this regard, providing comprehensive nutritional care after discharge becomes even more crucial.

Increases in healthcare spending around the world are expected to boost economies everywhere. Several companies compete in the pharmaceutical grade lactose market, providing the market and its many different consumers. Gaining an edge over the competition requires more than just doing well in the market. Key market drivers boosting market growth include expanding awareness of the benefits of ingesting pharmaceutical grade lactose products and growing understanding of the importance of baby nutrition.

The rising demand for food and infant-grade lactose is the primary factor in the market's CAGR for pharmaceutical grade lactose. The demand for infant formula has increased dramatically, especially in the developed countries of the United States and Europe. One of the world's largest consumers of baby formula, China has long had to rely on imports to meet its needs. China's newfound preference for domestically produced goods has helped the country's major manufacturers.

In addition, the market for pharma grade lactose has been given a boost by the participation of a number of regional firms. Pharmaceutical grade lactose is highly sought after because of its excellent qualities for use in the production of oral medicines. The rise of the tablet market can be directly attributed to the widespread adoption of pharmaceutical-grade lactose in their production. The pharmaceutical business relies on high-quality lactose since it imparts notable curative effects.

Foreign and domestic investors' increasing interest in the pharmaceutical manufacturing sector in emerging markets like India and Brazil bodes well for the future of the sector. Additionally, the expansion of the drug manufacturing business has contributed to rising product demand because of increased accessibility to medication as a result of generic drug production and novel therapies for chronic diseases.

In July 2023, GSK of the United Kingdom established sustainable sourcing criteria for ingredients such lactose, gelatin, palm oil, paper, and sugar to mitigate the negative effects of its operations on the environment and biodiversity. As part of the Science Based Targets Network's (SBTN) pilot of science-based targets for nature, major pharmaceutical firm GSK is assessing its supply chain and formulating a mitigation plan in light of these nature-based impacts. Only GSK, out of the total of 17, is a pharmaceutical business involved in the pilot.

Pharmaceutical Grade Lactose Market Trends

• Increasing demand for food and infant-grade lactose is driving market growth.

Market CAGR for pharmaceutical grade lactose is driven by the increasing demand for food and infant-grade lactose. Infant formula has seen a significant increase in demand, particularly from industrialised nations like the US and major European nations. For a long time, China, one of the world's biggest users of baby formula, was reliant on imports. The largest domestic manufacturers in the nation have benefited from China's change in emphasis towards homegrown brands. Among the market leaders in China for baby formula are China Feihe and Inner Mongolia Yili Industrial Group Co. Due to the high demand for its infant formula brands in China during the 2019–2020 fiscal year, China Feihe saw a 38% rise in sales.

Additionally, pharma grade lactose has gathered traction from several regional players, which has given a thrust to the growth of the market. The popularity of the pharmaceutical grade lactose market owes to its splendid properties for manufacturing oral medications. The use of pharmaceutical grade lactose in the manufacture of tablets has played a vital role in the growth of the market. Grade lactose endows commendable healing properties, the primary reason behind its use in the pharmaceutical industry. Moreover, grad lactose is also present in milk, with a total content percentage of around 8%. The utility of pharmaceutical grade lactose in multiple areas within healthcare shall aid market growth.

Growing investments by local and foreign players in the pharmaceutical manufacturing sector, particularly in developing economies such as India and Brazil, are anticipated to influence industry growth positively. Furthermore, improved access to medication through generic drug production and the development of creative treatments for chronic diseases has resulted in the development of the drug manufacturing industry, thereby driving product demand. According to the WHO and Centers for Disease Control and Prevention, 30% of the entire world population does not have access to lactose nutrients, and another 15% of the people are incompetent to digest lactose and utilize substitute variants for nutrition.

The rising need from the dairy industry will also aid in expanding the market for pharmaceutical grade lactose in the coming years. The plentiful accessibility of milk across numerous provincial pockets has assumed a fundamental part in the development of the worldwide pharmaceutical grade lactose market lately. Test meds' readiness also includes utilizing the pharmaceutical grade lactose market. Steady unofficial laws and low costs offered by item makers are expected to be the key variables impacting item interest in pharmaceutical applications in the coming years, driving the pharmaceutical grade lactose market revenue.

Pharmaceutical grade lactose Market Segment Insights

Pharmaceutical Grade Lactose Type Insights

The pharmaceutical grade lactose market segmentation, based on type, includes crystalline monohydrate lactose, inhalation lactose, granulated lactose, and spray dried lactose. The granulated lactose segment dominated the market, accounting for 35% of market revenue (0.07 Billion). In developing economies, category growth is driven by rising demand from infant formula and pharmaceutical industries for refined-edible grade lactose combined with innovative product offerings, such as dry-blend infant-grade lactose, by the market players. However, crystalline monohydrate lactose is the fastest-growing category over the forecast period due to the rising applications in feed manufacturing and fermentation applications driving the market growth over the forecast period.

Pharmaceutical Grade Lactose Application Insights

The pharmaceutical grade lactose market segmentation, based on application, includes tablet manufacturing and capsule manufacturing. The capsule manufacturing category generated the most income (70.4%). Capsules are a widely known oral dosage formulation common among pharmaceutical companies and consumers. While buyers comprehend the tasteless and easy-to-take capsules, the pharmaceutical industry appreciates the streamlined development timelines and manufacturing simplicity. However, tablet manufacturing is the fastest-growing category due to the product's ease of absorption, cost-effectiveness, and disintegration driving the market growth.

Figure 1: Pharmaceutical Grade Lactose Market, by Application, 2022 & 2032 (USD Billion) 

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

November 2022: Because of the significant maintenance costs associated with transporting and storing ethanol, Fonterra decided in November 2022 to transform their Trau milk processing plant into a high-value lactose production hub. The cooperative has spent $40 million on concentrating whey permeate so that it may be more easily transported to its other locations where lactose is produced. The co-op sees a higher return on its investment in lactose production than in the production of ethanol, which was previously done at Tirau.

Pharmaceutical Grade Lactose Regional Insights

By region, the study provides market insights into North America, Europe, Asia-Pacific and the Rest of the World. The North America pharmaceutical grade lactose market will dominate this market, owing to the favorable business policies regarding the dairy sector and the higher demand for refined-edible grade lactose from the pharmaceutical industry. Further, the US pharmaceutical grade lactose market held the largest market share, and the Canada pharmaceutical grade lactose market was the fastest-growing market in the North America region.

Further, the major countries studied in the market report are The US, Canada, German, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 2: PHARMACEUTICAL GRADE LACTOSE MARKET SHARE BY REGION 2022 (USD Billion) 

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe pharmaceutical grade lactose market accounts for the second-largest market share due to the increased trend of outsourcing pharmaceutical products in the region, coupled with the existence of a well-established healthcare sector in this region. Further, the German pharmaceutical grade lactose market held the largest market share, and the UK pharmaceutical grade lactose market was the fastest-growing market in the European region.

The Asia-Pacific pharmaceutical grade lactose market is expected to grow at the fastest CAGR from 2023 to 2032. This is owing to the increasing birth rate in emerging economies, including China and India, leading to growth in product demand for infant formulations. Moreover, the China pharmaceutical grade lactose market held the largest market share, and the Indian pharmaceutical grade lactose market was the fastest-growing market in the Asia-Pacific region.

Pharmaceutical Grade Lactose Key Market Players & Competitive Insights

Leading market players are investing heavily in research and development to expand their product lines, which will help the pharmaceutical grade lactose market grow even more. Market participants are also undertaking various strategic activities to expand their footprint, with important market developments including new product launches, contractual agreements, mergers and acquisitions, higher investments, and collaboration with other organizations. To expand and survive in a more competitive and rising market climate, the pharmaceutical grade lactose industry must offer cost-effective items.

Manufacturing locally to minimize operational costs is one of the key business tactics manufacturers use in the pharmaceutical grade lactose industry to benefit clients and increase the market sector. Major players in the pharmaceutical grade lactose market, including Kerry Inc. (Ireland), DFE Pharma (Germany), Meggle Excipients & Technology (Germany), Merck KGaA (Germany), Armor Pharma (France), and others, are attempting to increase market demand by investing in research and development operations.

Royal FrieslandCampina NV, a subsidiary of Zuivelcooperatie FrieslandCampina UA, produces and sells dairy products. The company's product portfolio includes dairy-based beverages, condensed milk, cream, nutrition products, yogurt, butter, milk powders, cheese, desserts and functional ingredients. FrieslandCampina markets its products under Edam, Gouda, Maasdam, Dutch Lady, Frico and Milli brands. It provides dairy products to professional customers such as pastry chefs, bakers, chefs, caterers and chocolate confectioners and sells ingredients to manufacturers of infant nutrition, the pharmaceutical sector and the food industry worldwide. The company has a business presence across Europe, Asia and Oceania, North and South America, Africa and the Middle East. In September 2021, FrieslandCampina Ingredients relaunched its infant nutrition brand Friso in the Netherlands market to expand its brand presence there.

Molkerei MEGGLE Wasserburg GmbH & Co KG provides dairy products. The Company offers yogurt, butter, cream, and other related products. Molkerei MEGGLE Wasserburg operates in Germany. In April 2023, Pharmaceutical lactose specialist MEGGLE launched a platform for its latest inhalable lactose grade, InhaLac® 180. InhaLac® 180 is tailored to dry powder inhalation (DPI) applications with a highly uniform particle size distribution (PSD) of X10=5-15µm, X50=50-100µm, and X90=120-160µm and characterized by the typical flow and surface characteristics of milled lactose.

Key Companies in the pharmaceutical grade lactose market include

• Cargill Incorporated


• General Mills Inc.


• Amway


• Conagra Brands Inc.


• Abbott Laboratories


• Kraft Foods Group Inc.


• The Coca-Cola Company


• PepsiCo Inc.


• Atkins Nutritionals Inc.


• Brunswick Corporation

Pharmaceutical Grade Lactose Industry Developments

July 2022: DFE Pharma, a leader in pharma- and nutraceutical excipient solutions, announces the expansion of its dry powder inhalation (DPI) portfolio with the launch of Lactohale 400. Adding Lactohale 400 further enhances the completeness of DFE Pharma's portfolio of inhalation grade lactose.

 July 2022: Danone launched the first ever Dairy and Plants Blend baby formula in response to parents' desire for vegetarian and flexitarian options for their babies. Plant-based consumption is growing substantially, with over one-third [37%] of EU consumers choosing a vegan, vegetarian or flexitarian diet, and almost 70% [69%] of parents now preferring their children to eat more plant-based foods. Until now, there have been rare options for parents if they choose to move on from breastmilk and want to create healthier, more plant-based food choices and good for the planet.

Pharmaceutical grade lactose Market Segmentation

Pharmaceutical Grade Lactose Type Outlook

• Crystalline Monohydrate Lactose


• Inhalation Lactose


• Granulated Lactose


• Spray Dried Lactose

Pharmaceutical Grade Lactose Application Outlook

• Tablets Manufacturing


• Capsule Manufacturing

Pharmaceutical Grade Lactose Regional Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America