Vitamin D Testing Market To Expand US$ 860 Million By 2032

Introduction

Global Vitamin D Testing Market size is expected to be worth around US$ 1,786.0 Million by 2032 from US$ 918 Million in 2023, growing at a CAGR of 7.90% during the forecast period from 2023 to 2032. In 2022, North America led the market, achieving revenue of US$ 365 Million.

Market growth is driven by increasing awareness about vitamin D deficiency, advancements in diagnostic technologies, and a rising focus on preventive healthcare measures. Factors such as the growing prevalence of conditions like osteoporosis and thyroid disorders, which are closely linked to insufficient vitamin D levels, underscore the necessity for accurate testing solutions. Technological progress, particularly in liquid chromatography-mass spectrometry (LC-MS), has significantly improved the precision and reliability of vitamin D tests, making them highly preferred in clinical settings. Among these, the 25-hydroxy vitamin D test remains the most commonly used method due to its high accuracy in assessing vitamin D levels.

Despite its growth, the market faces challenges, including variability in test results, especially with methods such as radioimmunoassay and ELISA, which can complicate the determination of vitamin D levels. Additionally, the COVID-19 pandemic temporarily disrupted healthcare services, including routine vitamin D testing. However, with increasing recognition of immune health’s importance, the market is expected to recover post-pandemic.

Danaher Corporation, a key player in the life sciences sector, has advanced its strategic growth through acquisitions. Recently, Danaher announced its intention to acquire Abcam plc, a leading provider of protein consumables, in a deal valued at approximately USD 5.7 billion. This acquisition is anticipated to conclude by mid-2024, pending regulatory and shareholder approvals.

In the Vitamin D testing segment, bioMérieux strengthened its position with the launch of the VIDAS® 25 OH Vitamin D Total assay in 2013. This diagnostic tool measures total vitamin D levels in human serum and plasma, delivering results in 40 minutes using ELFA technology. The VIDAS platform, known for its reliability, is widely installed in clinical laboratories worldwide, enabling in-house Vitamin D testing and reducing reliance on external reference labs.

Key Takeaways

• The Global Vitamin D Testing Market is expanding, with a projected CAGR of 7.90%, driven by increased awareness and a rising incidence of vitamin D deficiencies.
• The 25-hydroxy vitamin D test, as the primary method for assessing vitamin D levels, captures the largest share of the market.
• Clinical testing dominates the vitamin D testing applications, with diagnostic laboratories emerging as the primary end-users.
• Vitamin D testing is crucial for diagnosing osteoporosis and rickets, diseases directly linked to vitamin D deficiency.
• Liquid Chromatography-Mass Spectrometry (LC-MS) leads in testing accuracy for vitamin D metabolites, making it the preferred technique.
• North America is at the forefront of the vitamin D testing market, propelled by robust awareness campaigns and FDA-approved testing kits.
• Major industry players include F. Hoffmann-La Roche Ltd., DiaSorin S.p.A., and Abbott, with opportunities for market leadership through technological innovations.
• DiaSorin S.p.A. saw a 25.9% drop in sales for vitamin D testing products in 2022.
• Abbott reported a 3.9% decrease in core laboratory revenue in 2022, a downturn attributed to disruptions caused by COVID-19.

Vitamin D Testing Market Statistics

• Global Prevalence of Vitamin D Deficiency:
  • An estimated 1 billion people globally are affected by vitamin D deficiency.
  • Approximately 50% of the world population has insufficient levels of vitamin D.
• High-Risk Populations:
  • In the United States, 50% to 60% of nursing home residents and hospitalized patients are vitamin D deficient.
  • Among U.S. adults, 35% experience vitamin D deficiency, while the rate increases to 61% among the elderly population.
• Prevalence in Different Ethnic Groups:
  • In the United States, vitamin D deficiency affects 47% of African American infants and 56% of Caucasian infants.
  • In Iran, Turkey, and India, more than 90% of infants have vitamin D deficiency.
  • Over 80% of adults in Pakistan, India, and Bangladesh are vitamin D deficient.
• Recommended Serum Levels:
  • Optimal serum levels of 25-hydroxyvitamin D are still debated. However, the International Society for Clinical Densitometry and the International Osteoporosis Foundation suggest a minimum of 30 ng/mL.
  • Serum levels exceeding 100 ng/mL may increase the risk of toxicity due to secondary hypercalcemia.
• Treatment and Management:
  • Adults with vitamin D deficiency may start with 6,000 IU of vitamin D3 daily or 50,000 IU weekly for b weeks. Maintenance doses of 1,000–2,000 IU daily are recommended once levels surpass 30 ng/mL.
  • Children with deficiency require either 2,000 IU daily or 50,000 IU weekly for six weeks.
• Serum 25-Hydroxy-Vitamin D (25OH-D) Levels:
  • Ideal levels for skeletal health are at least 50 nmol/L, with experts recommending 75 nmol/L or higher for optimal musculoskeletal function.
  • A minimum of 100 nmol/L is associated with reducing the risk of cancers, cardiovascular diseases, infectious diseases, and COVID-19.
  • The normal range is 75–150 nmol/L, while levels above 150 nmol/L indicate increased vitamin D levels and may lead to overdose or intoxication.
• Categories of Vitamin D Status by 25OH-D Levels:
  • Severe deficiency: <25 nmol/L
  • Moderate deficiency: 25–<50 nmol/L
  • Insufficiency: 50–<75 nmol/L
  • Sufficiency: 75–<100 nmol/L
  • Optimal levels: 100–<150 nmol/L
  • Increased levels: 150–<250 nmol/L
  • Overdose: ≥250 nmol/L
  • Intoxication: ≥375 nmol/L (or lower levels with hypercalcemia from supplements)
• Recommended Vitamin D Doses for Prevention and Treatment:
  • Prophylactic doses:
    • Infants: 400–800 IU/day
    • Children: 600–2,000 IU/day
    • Teens: 800–2,000 IU/day
    • Adults: 1,000–4,000 IU/day
  • Therapeutic doses:
    • Infants to adults: 1,000–6,000 IU/day for three months, adjusted based on initial levels and risk factors.
    • High-risk groups, including obese individuals or those with malabsorption syndromes, may require doses two to three times higher.

Vitamin D Testing Product Analysis

• 25-Hydroxyvitamin D Testing: 25-Hydroxyvitamin D [25(OH)D] is the predominant circulating form of vitamin D and serves as the best indicator of vitamin D status in individuals. It reflects total vitamin D obtained from sunlight exposure, food intake, and supplements. The Centers for Disease Control and Prevention (CDC) utilizes high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS) for precise quantification of 25(OH)D2 and 25(OH)D3, ensuring high specificity unaffected by other vitamin D isomers.
• 1,25-Dihydroxyvitamin D Testing: 1,25-Dihydroxyvitamin D [1,25(OH)₂D], the biologically active form of vitamin D, is crucial for calcium absorption and bone health. However, its serum concentration is much lower compared to 25(OH)D and can be influenced by parathyroid hormone levels, making it a less reliable marker for overall vitamin D status. Testing for 1,25(OH)₂D is typically reserved for specific medical conditions affecting vitamin D metabolism, such as certain kidney disorders.
• 24,25-Dihydroxyvitamin D Testing: 24,25-Dihydroxyvitamin D [24,25(OH)₂D] is a catabolic product of 25(OH)D metabolism. Its measurement can provide insights into vitamin D metabolism and is sometimes used to assess certain genetic disorders affecting vitamin D hydroxylation. However, routine testing for 24,25(OH)₂D is not commonly performed in clinical practice.
• Analytical Methods: The CDC’s Vitamin D Standardization-Certification Program (VDSCP) emphasizes the importance of standardized and accurate measurement of these vitamin D metabolites. Certified assays are required to demonstrate a mean bias within ±5% compared to the CDC reference measurement procedure and an overall imprecision of less than 10%. This standardization ensures consistency and reliability across different laboratories and testing methods.
• Clinical Implications: Accurate assessment of vitamin D status is essential for diagnosing and managing conditions related to bone health and calcium metabolism. While 25(OH)D remains the primary marker for evaluating vitamin D sufficiency, measurements of 1,25(OH)₂D and 24,25(OH)₂D can provide additional information in specific clinical scenarios. Standardized testing methods, as promoted by the CDC, are vital for ensuring precise and reliable results, thereby supporting effective clinical decision-making.

Emerging Trends in Vitamin D Testing

• Rising Health Consciousness and Preventive Healthcare: The growing focus on preventive healthcare is driving an increased demand for vitamin D testing. Greater awareness of vitamin D’s critical role in overall health, fueled by educational campaigns and media coverage, is encouraging people to monitor their levels regularly. This shift is aimed at preventing health issues linked to vitamin D deficiency.
• Advancements in Testing Technologies: Innovations in diagnostic technologies are transforming vitamin D testing. New methods, such as Liquid Chromatography-Mass Spectrometry (LC-MS), and point-of-care testing kits offer quick, precise, and reliable results. These advancements enable healthcare providers to diagnose and treat vitamin D deficiencies more efficiently.
• Integration into Routine Health Assessments: Vitamin D testing is increasingly becoming a standard component of regular health checkups, particularly for at-risk populations such as older adults and individuals living in low-sunlight regions. Healthcare providers now recommend these tests as part of comprehensive health evaluations, emphasizing their importance in preventive care.
• Educational Campaigns and Health Initiatives: In regions like North America, health organizations are promoting vitamin D’s benefits through targeted educational campaigns. These efforts have significantly raised public awareness about vitamin D deficiency, driving the adoption of testing services and encouraging proactive health management.
• Expansion in Emerging Markets: The vitamin D testing market is witnessing substantial growth in emerging regions such as Asia-Pacific. Improved healthcare infrastructure, increased accessibility to health services, and a rising health-conscious middle class are key factors driving adoption. This trend is expected to bolster the market in these regions significantly.

Use Cases of Vitamin D Testing

• Assessment of Nutritional Status: Vitamin D testing evaluates an individual’s nutritional status by measuring their vitamin D levels. Deficiency or insufficiency, affecting approximately 40% of U.S. adults, can have adverse impacts on bone health and overall well-being.
• Bone Health Evaluation: Testing is vital for identifying individuals at risk of osteoporosis or fractures due to low vitamin D levels. Adequate vitamin D is essential for bone mineralization, with research indicating a 30% higher risk of cardiovascular disease in those with the lowest levels.
• Monitoring Treatment Efficacy: Regular testing allows healthcare providers to track the effectiveness of vitamin D supplementation or lifestyle modifications. Ensuring optimal vitamin D levels through testing contributes to better health outcomes.
• Risk Assessment for Chronic Diseases: Low vitamin D levels are linked to increased risks of chronic diseases, including cardiovascular conditions, diabetes, and certain cancers. Testing helps identify at-risk individuals, enabling early interventions and tailored health strategies.
• Monitoring Sunlight Exposure: Vitamin D synthesis depends on sunlight exposure. Testing aids in evaluating whether individuals are receiving adequate sunlight or need supplementation. Globally, 1 billion people suffer from vitamin D deficiency or insufficiency, often due to limited sun exposure.
• Athlete Performance Optimization: Athletes benefit from vitamin D testing to optimize performance and reduce injury risk. Studies reveal that higher vitamin D levels enhance muscle function and lower the likelihood of stress fractures, supporting peak athletic performance.

Key Players in the Vitamin D Testing Market

• Abbott Laboratories: Abbott, in collaboration with BP Healthcare, launched a non-invasive Vitamin D deficiency testing service addressing conditions like osteoporosis and rickets. The company leverages LC-MS technology for accurate diagnostics, driving global market growth.
• Beckman Coulter, Inc.: Beckman Coulter offers the Access 25(OH) Vitamin D Total assay, detecting both D2 and D3 forms. Compatible with Access and UniCel DxI systems, it ensures precise, reliable bone health assessments.
• F. Hoffmann-La Roche Ltd: Roche’s Elecsys Vitamin D Total II assay provides high precision and consistency, directly traceable to official standards. The company’s innovative diagnostics support global disease management and preventive care.
• Danaher Corporation: Danaher delivers advanced diagnostic solutions for Vitamin D testing, addressing rising deficiencies. Its technologies align with the market’s focus on preventive healthcare and accurate testing.
• Siemens Healthcare GmbH: Siemens offers reliable Vitamin D diagnostic solutions, meeting growing demands for deficiency detection. Its advanced testing kits enhance health outcomes, solidifying its role as a market leader.
• BIOMÉRIEUX: BIOMÉRIEUX focuses on innovations in Vitamin D testing, catering to the rising global demand. Its VIDAS® assay strengthens its position among industry leaders like Abbott and Thermo Fisher Scientific.
• DiaSorin S.p.A.: DiaSorin specializes in immunodiagnostics, particularly Vitamin D testing. Despite a 2022 sales decline, its strategic launches, like the CLIA 25 OH Vitamin D test in Japan, maintain its global leadership.
• Quest Diagnostics Incorporated: Quest Diagnostics offers targeted Vitamin D tests like QuestAssureD™, critical for detecting deficiencies and ensuring optimal health, strengthening its comprehensive diagnostic portfolio.
• Thermo Fisher Scientific Inc.: Thermo Fisher’s Cascadion SM Clinical Analyzer simplifies Vitamin D testing by automating processes with LC-MS technology. Its FDA-listed system ensures accuracy and reliability in clinical use.
• Tosoh Bioscience, Inc.: Tosoh’s ST AIA-PACK 25-OH Vitamin D assay provides efficient, cost-effective testing with 90-day calibration stability, positioning it as a key player in medical laboratory diagnostics.

Conclusion

The global Vitamin D testing market is experiencing robust growth, driven by rising awareness of vitamin D deficiency, advancements in diagnostic technologies, and the increasing focus on preventive healthcare. The 25-hydroxy vitamin D test, known for its high accuracy, continues to dominate the market, with Liquid Chromatography-Mass Spectrometry (LC-MS) emerging as the preferred method for precision testing.

The market faces challenges, such as test result variability and the COVID-19 pandemic’s disruption, but is poised for recovery. Key players, including Danaher Corporation and bioMérieux, are leading with innovations that enhance testing efficiency. The market is projected to grow at a CAGR of 7.90%, driven by rising health consciousness and expanding testing services, particularly in emerging markets.

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