While it might not make headlines the way cancer, obesity or heart disease do, osteoporosis has become a major public health threat for an estimated 44 million Americans, or 55% of people over the age of 50, according to the National Osteoporosis Foundation (NOF).

In the U.S., this disease affects about 10 million people (80% of them women), and nearly 34 million more have low bone mass, placing them at increased risk for this common bone pathology, which relates to an imbalance between bone formation and bone resorption.

Globally, osteoporosis affects 200 million men and women, according to the International Osteoporosis Foundation, and the associated cost is considerable—with osteoporosis-related fractures costing about $50 billion.

According to the World Health Organization, the prevalence of osteoporosis has increased all over the world since 2003, and will continue to grow by about 3% per year. This reality has led to greater awareness of preventative measures, especially in light of spiraling healthcare costs.

“Consumers are now becoming more concerned about preventing potential health problems than treating them once they have occurred,” said Caroline Nègre, marketing manager with The Netherlands-based Rousselot. “Nutraceuticals are giving them the opportunity to feel good about their general wellness levels on a day-to-day basis. Claims that products ‘guard against’ certain aliments are growing in prominence.”

An Attractive Market

According to a recent Frost & Sullivan report titled “U.S. Bone and Joint Health Ingredients Market,” ingredients in this area earned revenues of more than $178 million in 2008 and are expected to reach $246 million by 2015. The report cited prominent competitive factors in the U.S. market, which include “price, quality, distribution efficiency, ability to provide a point of differentiation through novel ingredient combinations and value-added services that include assistance in product formulation and regulatory support.”

Greater emphasis on prevention and management of chronic diseases related to aging would have a favorable impact on growth, the report added. Interestingly, the report also suggested that concern for other health issues—like cancer, obesity and heart health—undermine the importance of bone and joint health, which are often perceived to be nonfatal health issues.

However, consumer awareness has grown alongside clinical research that details the risks of bone-related disease across different demographics, according to Lorraine Niba, PhD, regional marketing manager, Americas, FrieslandCampina Domo, Paramus, NJ.

“Epidemiological research highlighting some of the population groups that are most at risk for bone-related illnesses and diseases has escalated consumer interest in products and ingredients that help to support and promote bone health,” she said. “Caucasian and Asian women, for instance, are susceptible to osteoporosis and bone fractures as they age and are among the most vulnerable groups.”

These discoveries have led to an increase in the number of products in the marketplace that target bone health and calcium absorption, she added. “In recent years especially, there has clearly been an effort by the food, pharmaceutical and supplement industries to educate consumers on bone health and bone-related disease prevention. With increasing consumer awareness and understanding of the role of diet in bone health, the category is poised to continue to grow. The Baby Boomer generation in particular is more affluent and active than preceding generations of retirees, and is therefore a dependable market segment for products aimed at bone health.”

According to a HealthFocus study from 2008, bone health/strength is a top health concern for 61% of survey respondents. This figure compares with retaining mental sharpness (65%), cardiovascular disease (62%) and cancer (61%).

Concern and awareness is reflected in sales figures. The bone health condition-specific market grew by 16% in 2008 to about $1.7 billon, according to Nutrition Business Journal (NBJ), Boulder, CO. Calcium represents 60% of the market, multivitamins 19%, vitamin D 14% and magnesium 5%. NBJ estimated that U.S. consumer sales of calcium reached $1.1 billion in 2008 on 6% growth, while magnesium grew 14% to $310 million and vitamin D sales grew 117% to $230 million. In comparison, the prescription drug market for this category grew at a slower rate of 5.5%, but still brought in more than $6 billion in 2007.

Changing Demographics

When speaking of bone health, most people think of the elderly, as well as the aging Baby Boomer population. However, Todd Sitkowski, senior marketing manager, DSM Nutritional Products, Parsippany, NJ, said it’s imperative “to build and maximize bone capital before the bones reach their peak strength and density, which takes place around 30 years of age.”

Vanessa Teter, associate food scientist at Watson, Inc., West Haven, CT, agreed, saying the market for dietary ingredients continues to evolve, encompassing both the old and the young alike. About 85-90% of adult bone mass is acquired by age 18 in girls and age 20 in boys. Building strong bones during childhood and adolescence can help to prevent osteoporosis later in life, according to the NOF.

“Bone health concerns used to focus primarily on the elderly, but studies have shown that you can prevent the loss of bone density starting at a young age,” said Ms. Teter. “The U.S. Department of Health & Human Services (HHS) has taken large steps in helping the younger generation pay more attention to their calcium intake, especially young girls. The government has come out with tools to give these young women the information they need to help develop stronger bones through both nutrition and exercise.” For example, the HHS-sponsored website www.bestbonesforever.gov is specifically targeted toward young girls.

Frost & Sullivan’s report also recognized the trend toward a broader audience when discussing bone health, creating greater market opportunities. “A large number of bone health products are targeted at menopausal women and the elderly; however, it has been found that men and women of all ages and ethnicities could develop osteoporosis. The need for bone and joint supplements for children and men as well considerably expands the scope of the market.”

Sam Wright, president & CEO, The Wright Group, Crowley, LA, said bone and joint health “have become mainstays of the supplement and functional foods market as a function of changing age demographics and the proliferation of scientific information on the subject. It is one of the few areas where strong claims can be made to an interested market segment. The products involved also happen to be relatively inexpensive when compared to other supplement products. For these reasons, we feel the future of this category is bright.”

Calcium

Undoubtedly, calcium is a key micronutrient with an established role in protecting and enhancing bone health, according to FrieslandCampina Domo’s Ms. Niba. “Because calcium is easily identifiable in foods and beverages like milk and vegetables, and also in supplements, it is an extremely popular ingredient for consumers as well as manufacturers.”

According to the National Institutes of Health, “calcium is needed for our heart, muscles and nerves to function properly and for blood to clot. Inadequate calcium significantly contributes to the development of osteoporosis. Many published studies show that low calcium intake throughout life is associated with low bone mass and high fracture rates. National nutrition surveys have shown that most people are not getting the calcium they need to grow and maintain healthy bones.”

Chris Haynes, director of sales, ESM Technologies, Carthage, MO, said his company’s most popular form of calcium comes from eggshells via its trademarked ESC (eggshell calcium). “Eggshells are a 100% natural form of calcium providing their own ‘transport proteins’ to enhance absorption,” he said. “Studies have shown that as the body begins to digest these naturally occurring proteins, they transport the calcium into the blood stream. ESC contains nearly non-detectable [levels of] heavy metals and testing has proven that ESC is California Proposition 65 compliant.”

One study from Europe showed that chickens deposit a transporter protein in eggshell calcium, which significantly enhanced its bioavailability. Multiple human clinical trials have also shown the effectiveness of eggshell calcium in improving bone mineral density, Mr. Haynes said.

The Wright Group’s Mr. Wright said the scientific findings around calcium, vitamin D and bone health are “voluminous.” An article published in the Journal of Clinical Nutrition in June 2008 reported that daily supplementation of calcium in healthy patients reduced bone fractures by 72%. Another study from the Women’s Health Initiative involving 36,282 post-menopausal women aged 50-79, published in the February 2010 issue of the New England Journal of Medicine showed significant improvement in bone strength after taking 1000 mg/day of calcium carbonate and 400 IU of vitamin D3 daily for seven years.

Vitamin D

Jim Currie, business development manager, Premium Ingredients, Carol Stream, IL, said the importance of calcium is undeniable, and that product manufacturers have been focused on increasing absorption. For example, “calcium uptake is dependent on vitamin D,” he said. “A good balanced diet of products with calcium such as milk, cheese and of course sunlight are adequate sources. Food fortification and supplements can provide people of all ages with these essential ingredients. Premium Ingredients stocks a variety of products with calcium and can provide vitamin D for various applications either as vitamin D3 or as vitamin D2.”

While calcium is the key mineral in bone, it needs vitamin D to be absorbed by the body and incorporated into bone, said DSM’s Mr. Sitkowski. “The combination of these two nutrients is essential for strong bones.”

Based on the most recent scientific conclusions, it takes a daily dose of at least 800 IU—two to four times higher than current recommendations—to bring vitamin D levels into an effective range, Mr. Sitkowski noted. New research also suggests that 1000-2000 IU may be the optimum daily dose for bone health. Vitamin D also helps reduce fall-related fractures by boosting muscle function. Specifically, it plays a role in initiating protein synthesis in muscles, reversing the breakdown of fibers related to speed and strength. Additionally, vitamin D maintains calcium levels in the blood, which is necessary for normal muscle functioning.

Opening a door for product manufacturers and marketers, FDA approved a petition from Coca-Cola for an osteoporosis risk reduction claim for juice-based beverages fortified with calcium and vitamin D. “The emergence of calcium citrate malate, a highly soluble calcium salt, has allowed orange juice manufacturers to fortify their products in recent years,” said Mr. Wright.

However, Watson’s Ms. Teter said it can be difficult to develop this type of product due to calcium’s natural buffering capabilities. “The addition of many calcium sources can raise the pH of a product, making a typical acidified product lose its acidic bite characteristic. Tropicana has overcome this and has thus created a product fortified with calcium while still retaining the quality of a natural Florida orange juice.”

Beverages aren’t the only products on the market that help promote healthy and strong bone development, she added. Dreyer’s ice cream and Nature’s Valley granola bars both have products on the market targeting similar claims.

Danone has also introduced a yogurt product in Spain that claims to increase bone density. Densia contains twice the calcium of standard yogurt in addition to added vitamin D, according to Mr. Wright. “If it performs well, it will be rolled out to other markets,” he said.

Fonterra Dairy, Rosemont, IL, has also introduced Anlene, a high calcium/vitamin D milk in Asian markets. “As part of their promotional activity, they set up bone scanning machines in supermarkets to make consumers aware of [bone health issues],” Mr. Wright added. “Another trend we have seen is the growth of soft chews which contain calcium, vitamin D and other ingredients targeted at bone health.”

Ms. Teter noted that “as children continue to grow and as the Baby Boom population continues to get older, there is a need for healthy bone supplementation in the diet. And the food industry will continue to fortify a wide variety of products while maintaining high quality finished goods. In the near future, there is no reason to see why this trend wouldn’t simply continue to gain speed and grow on the shelves of supermarkets worldwide.”

Credible Contributions

While calcium and vitamin D dominate the category, there are many other nutrients that have demonstrated a positive impact on bone health, including magnesium, zinc and phosphorus, which are all essential for building healthy bones. DSM’s Mr. Sitkowski noted that half of all bone mineral is made of phosphorus. Vitamins B6, B12 and folic acid also may reduce the risk of osteoporosis by reducing the concentration of homocysteine in the blood, which is associated with poor bone health, he said.

In addition, DSM offers geniVida genistein, the principal isoflavone found in soybeans and soy foods. Human bone is constantly being dissolved and then reformed by a process called “remodeling,” which is carried out by two types of bone cells: osteoclasts, which dissolve bone (resorption) and osteoblasts, which build bone with calcium (formation).

Until menopause, the osteoclasts and osteoblasts are in equilibrium in most women due to the presence and activity of estrogen. During and after menopause—with the loss of estrogen—excessive remodeling occurs as osteoclast activity is no longer restricted, reducing the mineral content of bone and resulting in bones becoming less dense, more fragile and more susceptible to fracture. According to DSM, “The bottom line for post-menopausal women concerned about bone health: without geniVida, extra calcium and vitamin D don’t have the opportunity to provide the optimal level of bone-building benefits.”

The ingredient can selectively activate the estrogen receptors in different tissues. Genistein promotes osteoblast growth and differentiation, stimulating bone formation in vitro. Thus, genistein has the potential to attenuate bone loss by reducing bone resorption and increasing bone formation.

Vitamin K has also been recognized for its ability to activate proteins that function in bone mineralization. Blue California, Rancho Santa Margarita, CA, produces Natural Vitamin K2 1% (menaquinone), which meets EU requirements for a novel ingredient. “The health benefits of natural vitamin K2 (menaquinone) for bone structure, bone density and cardiovascular health benefits are supported by a solid body of science and clinical research,” according to Cecilia McCollum, executive vice president, Blue California. “In brief, vitamin K2 helps remove the calcium from the arteries, thus helping prevent calcification of the arteries, and moves the calcium to the bones where it helps increase production of healthy bone cells, thus increasing bone density and helping prevent osteoporosis and bone fractures in women.”

Blue California’s material is produced by fermentation, and it offers a high concentration (1% rather than 0.1%) at a competitive price, she added. “We want consumers to have the benefit of this vitamin that is notoriously absent in most multivitamin formulations.”

FrieslandCampina Domo’s Ms. Niba said that scientific advances have elucidated the mechanisms by which other ingredients could promote mineral uptake and absorption. “Various prebiotics (fermentable non-digestible carbohydrates), probiotics and minerals, for instance, have been shown to improve calcium absorption,” she noted. “While most of these studies have only been published in the peer-reviewed literature in the last decade or so, there is no evidence that these products may be unsafe or ineffective.”

Certain prebiotics are thought to enhance calcium absorption, and therefore could play a role in bone health, she added. The company’s Vivinal GOS, a prebiotic galacto-oligosaccharide, helps to improve mineral absorption, primarily through the effects of colonic fermentation. “It is fermented by colonic bacteria in the colon, resulting in a decreased intestinal pH. Clinical studies with Vivinal GOS have shown a statistically significant improvement in calcium absorption. It is thought that this is because the lowered pH in the colon facilitates the solubilization of minerals, and therefore enhances their absorption. While many different factors influence bone health, Vivinal GOS is one ingredient that could augment the absorption and utilization of calcium, a critical factor in maintaining overall bone health.”

According to Rousselot’s Ms. Nègre, the company’s Peptan hydrolyzed collagen positively impacts bone mineral density and strength. The effect of Peptan on osteoblasts and osteoclasts was analyzed through in vitro studies, which demonstrate that Peptan increases osteoblast activity, as measured by an increase of markers such as alkaline phosphatase, in cell cultures. The study confirms the effect of Peptan on the prevention of bone loss, and it can work synergistically with calcium and vitamin D to prevent osteoporosis, she said.

Jennifer Gu, PhD, director of research and development, AIDP, Inc., City of Industry, CA, said most bone health products in today’s market work to increase calcium intake. “However, an important ingredient in bone health is missing: bone collagen,” she said. “Bone collagen is the most important organic matrix protein (over 90%) in our bone.” The company’s KoAct, a patented calcium collagen chelate, is designed with this in mind, and provides both calcium and collagen.

In an animal study performed at Tokyo University of Agriculture and Technology, KoAct dose-dependently increased femur bone strength by nearly 10% and bone mineral density by 3.5%, compared to a group fed an equal amount of calcium.

Alongside a growing range of positive health attributes, omega 3 fatty acids have been associated with enhancing bone strength, according to Premium Ingredients’ Mr. Currie. He cited a recent cohort study involving 78 healthy young men conducted by researchers from Umea University in Sweden. A positive association was found between serum levels of omega 3 fatty acids with peak bone mineral density. The bone mineral density of the hip and spine were measured at baseline at the mean age of 16.7 years, as well as 22 and 24 years. The measurement of fatty acid concentration along with bone mineral density led authors to the conclusion that omega 3 fatty acids, especially DHA, are positively associated with bone mineral accrual and with peak bone mineral density in young men.

As the market for these bone health ingredients advances, product manufacturers, marketers and researchers will all be challenged to provide real results to consumers who are eager to obtain lasting health benefits.