Global Market Size, Forecast, and Trend Highlights Over 2025-2037
Pharmaceutical Grade Lactose Market size was over USD 2.6 billion in 2024 and is projected to reach USD 5.3 billion by the end of 2037, escalating at a CAGR of 6.2% during the forecast timeline, i.e., 2025-2037. In 2025, the industry size of pharmaceutical grade lactose is evaluated at USD 2.7 billion.
The pharmaceutical sector makes increasing use of lactose as an excipient owing to its approved flowability and water solubility. In addition, lactose is added as an ingredient to animal feed, pharmaceuticals, and infant formula. As stated in an article published by Drug Discovery Today in September 2023, an estimated 60% to 70% of pharmaceutical preparations comprise lactose which denotes its highest utilization rates. Hence, with progression and advancements in the industry, there is a huge demand for excipient properties, which in turn is a driving factor for the market globally.
Furthermore, the presence of chemical-physical properties is one of the reasons due to which lactose is not only present in milk, but frequently utilized in the drug and food industries. According to the May 2022 NLM article, lactose is easily available owing to its low pricing strategy as a raw material, ranging between USD 794 to USD 992 per ton. Besides, in the case of drug production, the positive effects of lactose include non-toxic, stable, inert, flowable, diluent, compressible, cross-linker, cyro-lipoprtector, and excellent rheological properties. Therefore, all these components denote a positive impact on the market, contributing towards its expansion and upliftment across nations.
Pharmaceutical Grade Lactose Sector: Growth Drivers and Challenges
Growth Drivers
- Increased use of anhydrous lactose: The growth of the market is highly driven by a surge in the utilization of anhydrous lactose. As per the August 2021 MDPI article, the use of anhydrous lactose in the form of the α/β ratio of pollen is suitable as an ingredient carrier for controlling the dissolution rate. This is because the pollen-based lactose is difficult to control, especially in aqueous solutions, and it is unclear whether the product is 100% anhydrous. Therefore, with the use of this particular lactose, the market is surely expected to amplify in the upcoming years.
- Innovation in the pharmaceutical sector: The aspect of technological advancement in the pharma industry is another driver for the pharmaceutical grade lactose market globally. According to an article published by NLM in 2022, inventory management software can ensure 90% accuracy by making reductions in the delivery schedule for obtained products from more than one week to one or two days. This is possible by permitting direct delivery of the product from the supplier to the consumer without having to pass through the warehouse, thus bolstering the market development internationally.
Challenges
- Existence of reactive impurities: The presence of impurities such as aldehydes, formaldehyde, and glucose poses effective risks to health, which causes a hindrance in the market across nations. These risks also negatively impact the safety, efficacy, and overall stability of the ultimate drug products. In addition, there is a delay in diagnosis and treatment solutions since these drugs become harmful to patients when administered. Also, both healthcare providers and patients reduce the adoption of these medical solutions, thereby having a negative impact on the market growth.
- Aspect of lactose intolerance: The evolution of the market is severely impacted owing to the existence of lactose intolerance. As per the March 2023 Medline Plus Government report, an estimated 65% of the human population has a diminished capability to digest lactose post-infancy. In addition, this is quite evident among the East Asia population, wherein 70% to 100% of the population is affected by this condition. Therefore, this results in reduced demand, which creates a barrier in the manufacturing and production processes, thus a challenge for the market development.
Pharmaceutical Grade Lactose Market: Key Insights
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Base Year |
2024 |
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Forecast Year |
2025-2037 |
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CAGR |
6.2% |
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Base Year Market Size (2024) |
USD 2.6 billion |
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Forecast Year Market Size (2037) |
USD 5.3 billion |
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Regional Scope |
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Pharmaceutical Grade Lactose Segmentation
Application (Capsule Manufacturing, Tablet Manufacturing)
Based on the application, the capsule manufacturing segment is expected to garner the highest share of 76.5% in the pharmaceutical grade lactose market at the end of the forecast timeline. The segment plays a pivotal role in the pharma sector, and it is highly preferred due to stability and compatibility which is essential to maintain patient safety as well as drug delivery. In December 2024, Lonza notified the capacity expansion of its sites in India and China. This includes supplementary hard gelatin capsule lines to sustain the manufacture of superior gelatin capsules, including critical and dedicated capsules for the pharmaceutical and nutraceutical industries, thus boosting the segment.
Type (Crystalline Monohydrate Lactose, Inhalation Lactose, Granulated Lactose, Spray Dried Lactose)
Based on the type, the crystalline monohydrate lactose segment is projected to account for a share of 34.8% in the pharmaceutical grade lactose market by the end of the forecast period. This growth depends upon good quality and purity standards that are highly and effectively necessary in pharmaceutical applications, including capsule usage and tablet production. Besides, as per an article published by the Journal of Dairy Science in December 2020, the existence of acid in lactose-based systems such as 0.05% to 1% citric and 1% lactic, can negatively impact the crystallization effect. Therefore, it is crucial to maintain the crystallization effect to enhance the segment’s growth.
Our in-depth analysis of the global market includes the following segments:
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Application |
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Type |
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Customize this ReportPharmaceutical Grade Lactose Industry - Regional Synopsis
North America Market Analysis
The North America region in the pharmaceutical grade lactose market is anticipated to account for the largest share of 49.6% by the end of 2037. This growth is possible due to the availability of cutting-edge medical and health facilities, significant investments to ensure ongoing research and development, as well as strict regulations to maintain quality standards in the region. Besides all these factors, the operational activities carried forward by key companies to enhance the demand for drug formulation are also driving the region’s dominance in the market, thereby amplifying the growth and expansion.
The market in the U.S. is projected to experience a huge opportunity owing to the presence of administrative bodies. For instance, in October 2020, the U.S. FDA and the United States Department of Agriculture (USDA) signed a Memorandum of Understanding (MOU) and outlined an extended collaboration between both the organization’s Agricultural Marketing Service (AMS) and Foreign Agricultural Service (FAS). The purpose was to simplify the exportation of milk and milk products from the U.S. at a valuation of worth USD 6 billion yearly. Therefore, the implementation of such decisions reflects on the market upliftment.
The market in Canada is expected to face excessive growth since the government is inevitably involved in maintaining the overall well-being of the population. As per the September 2023 Government of Canada report, the Minister of Agriculture and Agri-Food declared the unveiling of the latest Dairy Innovation and Investment Fund. The fund will be suitable for the region’s dairy industry with an investment of almost USD 333 million for the upcoming 10 years to enhance its adaptability and competitiveness with the newest market opportunities, thus driving market demand.
APAC Market Statistics
The Asia Pacific region in the pharmaceutical grade lactose market is poised to be the fastest-growing region during the forecast period. Factors attributed to the growth include robust development due to the expansion of pharmaceutical sectors, especially in India and China. In addition, increasing medical investments, rising awareness of generic therapeutic options, standard regulatory policies, and cost-effective manufacturing environments are other factors responsible for driving the market demand and expansion in the region.
India’s pharmaceutical grade lactose market is gaining more exposure owing to service expansions initiated by regional organizations. For instance, in October 2024, Sterling Biotech commenced the development of the world’s original manufacturing facility for dairy proteins by utilizing precise fermentation technology. The facility is located in Bharuch, Gujarat, which is a 27-acre facility slated to become operational by early 2026. Therefore, with such progression by organizations in the country, the market is projected is to expand effectively.
The growth of the market in China is fueled by the increasing demand for pharmaceuticals. This is possible with contributions initiated by international organizations to expand the excipient portfolio in the country. For instance, in June 2023, IFF presented its extensive portfolio of verified and scalable polymer solutions to uplift China’s market demand for revolution and quality standards in oral dosage forms. The purpose was to cater to the country’s pharmaceutical requirements by providing cellulosic-derived excipients to develop progressive delivery formats for dietary and biopharma supplements.
Companies Dominating the Pharmaceutical Grade Lactose Landscape
- Abbott Laboratories
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
- Amway
- Atkins Nutritionals Inc.
- Brunswick Corporation
- Conagra Brands Inc.
- Cargill Incorporated
- General Ills Inc.
- Kraft Foods Group Inc.
- The Coca-Cola Company
- PepsiCo Inc.
- IFF
- Sterling Biotech
- Lonza
- LBB Specialties
- Brenntag Specialties
- Lactalis Ingredients
Key organizations in the pharmaceutical grade lactose market are focusing on augmenting their product range and global existence through agreements and partnerships to ensure the rising demand. For instance, in April 2025, LBB Specialties proclaimed its partnership with Kerry Group. Through this deal, LBB Specialties is striving to become Kerry’s chosen distribution partner in the United States by expanding access to high-quality pharmaceutical lactose ingredients. Besides, Kerry is poised to offer a wide range of pharmaceutical lactose excipients in several grades, forms, and particle sizes to deliver formulators with enhanced solutions for various pharmaceutical applications, thus driving market growth.
Here's the list of some key players:
In the News
- In February 2025, Brenntag Specialties announced its exclusive distribution agreement with MEGGLE Excipients for the availability of pharmaceutical-grade lactose in Benelux and Nordics in Sweden, Finland, Norway, Belgium, and Netherlands.
- In October 2023, Lactalis Ingredients entered the pharmaceutical grade lactose market to achieve excellence and satisfy the requirements of pharmaceutical organizations and manufacturers across nations.
Author Credits: Radhika Pawar
- Report ID: 7585
- Published Date: May 07, 2025
- Report Format: PDF, PPT
