Calcitriol Market Size, Share, and Industry Analysis, By Dosage Form (Capsules, Injections, Ointment and Creams, and Others), By Route of Administration (Parenteral, Oral, and Topical) By Indication (Hypocalcemia, Hypoparathyroidism, Osteoporosis, and Others), By Distribution Channel (Hospital Pharmacies, Drug Stores & Retail Pharmacies, and Online Pharmacies), and Regional Forecast, 2025-2032

The global calcitriol market is witnessing significant growth due to the increasing prevalence of osteoporosis, osteomalacia, rickets, and hypoparathyroidism across the globe. Calcitriol is a hormonally active, synthetic vitamin D analog and plays a crucial role in maintaining calcium balance in the body and ensures proper bone health. Calcitriol is the active form of vitamin D and which does not require further conversion in the body, unlike other vitamin D analogs. However, the deficiency of vitamin D and calcitriol leads to several health issues, mainly related to bone and mineral metabolism. The deficiency leads to osteomalacia, osteoporosis, hypocalcemia, hyperthyroidism, rickets, cardiovascular issues, and others.

The rising aging population and lifestyle modification lead to the increased prevalence of osteoporosis.

• For instance, the International Osteoporosis Foundation report estimated that around 75.0 million people in Europe, the U.S., and Japan are affected by osteoporosis. Such a rising number of cases related to bone disorders increases the adoption of calcitriol and boosts the growth of the market.

Calcitriol Market Driver

Rising Burden of Bone Disorders to Drive the Market Growth

The increase in deficiency of Vitamin D leads to an increase in a number of bone disorders such as osteoporosis, osteomalacia, and others. Moreover, the rising aging population and prevalence of osteoporosis leads to an increase in the number of fragility fracture cases. Fragility fractures are the breaks that occur from a fall from height in persons with weakened bones due to osteoporosis. This condition occurs due to a decrease in bone density and inadequate calcium levels in the body. Thus, calcitriol, being a hormonally active form of Vitamin D, helps to enhance calcium absorption and improves bone density, reducing the risks of fracture. This is expected to drive the growth of the market.

• For instance, according to the International Osteoporosis Foundation, up to 37.0 million fragility fractures occur annually in individuals aged over 55. Further, 1 in 3 women over age 50 and 1 in 5 men aged over 50 is expected to experience osteoporosis fractures worldwide.
• In addition, according to the International Osteoporosis Foundation, 527,000 new fragility fractures were reported in the U.K. in 2019. Thus, the rising number of osteoporosis-associated fragility fractures is expected to increase the adoption of calcitriol for maintaining bone density, propelling the growth of the market.

According to an article published by the International Osteoporosis Foundation in 2021, in the year 2019, an estimated 3,775,000 people had osteoporosis in the U.K. and 78.3% of women were suffering from it compared to males.

Calcitriol Market Restraint

Alternative Treatment Options to Treat Bone Diseases May Hamper Market Growth

Despite the increasing usage of calcitriol for mineral absorption in osteoporosis conditions, there are rising research and development activities by the pharma and biotech companies to launch alternative advanced therapies for the treatment of bone deformities.

• For instance, in March 2024, Sandoz received the U.S. Food and Drugs Administration (FDA) approval for Wyost/Jubbonti, the first biosimilar to reference Xgeva/Prolia (denosumab). The drugs are used to treat osteoporosis and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors. Such launches and approvals restrict the market growth.

Calcitriol Market Opportunity

Launch of New Formulations to Impel Industry Expansion

In recent years, the advancements in drug delivery systems and the launch of new formulations have enhanced the absorption of vitamin D in the body. An increase in research and development activities and strategic activities amongst government organizations to support and strengthen osteoporosis and fracture prevention is expected to propel the growth of the market during the forecast period.

• In February 2023, the World Health Organization (WHO) and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis, and Musculoskeletal Diseases (ESCEO) signed a collaboration agreement to create a strategic roadmap focused on bone health and aging, as well as to promote a public health strategy aimed at preventing fractures in older adults. This collaboration includes a strategic plan for research and publications, acknowledging osteoporosis as a significant factor in the Global Burden of Disease. Such collaboration agreements are expected to propel the growth of the market during the forecast period.

Segmentation

Key Insights

The report covers the following key insights:

• Prevalence of Key Diseases, By Countries, 2023
• Pipeline Analysis, By Key Players
• Key Industry Developments - Mergers, Acquisitions, Partnerships
• New Product Launches, By Key Players
• Impact of COVID-19 on the Calcitriol Market

Analysis by Dosage Form

Based on dosage form, the market is categorized into capsules, injections, ointment and creams, and others.

The capsules segment held a substantial share of the market. The growth of the segment is augmented by the ease of usage, making it a convenient option for patients by offering precise dosing for managing critical conditions and avoiding complications such as hypercalcemia. The dosage form ensures stability and longer shelf life, is widely available, and is cost-efficient.

Additionally, it increases patients' preference for capsules and oral dosage forms as they are easy to swallow, possess enhanced bioavailability, have better taste masking properties, and are cost-effective.

Furthermore, the presence of key market players with calcitriol capsule offerings and rising prescriptions of calcitriol capsules is expected to boost the segment growth.

Analysis by Route of Administration

Based on the route of administration, the market is divided into parenteral, oral, and topical.

The oral segment held a significant share of the market. The growth of the segment is attributed to the presence of a wide range of calcitriol products in the capsules and tablet forms. Further, calcitriol is taken daily for maintaining bone density in aged population and even during pregnancy. Thus, oral solid dosage forms become the preferred choice of formulations and encourage better patient compliance due to their low cost and ease of availability. Such scenarios boost the growth of the segment in the market.

Analysis by Indication

Based on indication, the market is divided into hypocalcemia, hypoparathyroidism, osteoporosis, and others.

The osteoporosis segment held a prominent share of the market due to the rising prevalence of osteoporosis and increasing fractures associated with it. In addition, rising geriatric population, poor dietary calcium intake, low vitamin D, and lifestyle changes contribute to osteoporosis.

• For instance, in November 2023, according to data published by the National Institute of Health (NIH), in a population capacity of 1.2 billion people in India, various studies revealed an osteoporosis prevalence in Indian women ranging from 8.0% to 62.0%. Such rising cases of osteoporosis require a proper diet, increased calcium uptake, and vitamin D. Thus, it is expected to propel the adoption of calcitriol and boost the segment growth.

Analysis by Distribution Channel

Based on distribution channel, the market is subdivided into hospital pharmacies, drug stores & retail pharmacies, and online pharmacies.

The drug stores & retail pharmacies held a significant share of the market. The growth is attributed to enhanced accessibility, support services, and community engagement initiatives, which help effectively manage the patient's condition. Further, retail pharmacies provide immediate, local access and personalized services, while online pharmacies offer home delivery, competitive pricing, and automatic refills, leading to enhanced patient compliance and easy access to calcitriol.

In addition, the presence of a large number of online and retail pharmacies is expected to boost the segment growth.

• For instance, according to data published by the NHS Business Services Authority (NHS BSA) in October 2023, there were around 11,414 active community pharmacies in England at the end of March 2023. Moreover, the increasing government spending on pharmacies led to the growth of the segment.

Regional Analysis

Based on region, the market has been studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America accounted for a substantial share of the global calcitriol market in 2023. The growth of the market in the region is attributed to the rising prevalence of osteoporosis, osteomalacia, and vitamin D deficiency. Further, the presence of advanced healthcare facilities, key players in the market with advanced product offerings, and rising government initiatives to increase awareness regarding bone deformities and deficiency of vitamins is expected to propel the regional market growth.

• For instance, in May 2023, the Bone Health and Osteoporosis Foundation (BHOF) celebrated Osteoporosis Awareness and Prevention Month with a variety of activities and resources to help people of all ages understand the importance of good bone health. The campaign provides information on bone-healthy foods, exercise, bone density testing, and medications for the treatment of osteoporosis, tips for preventing falls, and much more. Such awareness programs boost the adoption of calcitriol and propel the regional growth.

Europe has a considerable share of the calcitriol market. The strong presence of key players with advanced product offerings and launches augments the growth of the region. Furthermore, the increasing prevalence of osteoporosis and calcium deficiency and rising initiatives by government organizations for reimbursement coverage are expected to propel the growth of the region.

• For instance, in January 2024, the Royal Osteoporosis Society (ROS) joined forces with the Sunday Express for the Better Bones campaign, calling for 100% Fracture Liaison Service (FLS) coverage. Better Bones campaign advocates for a government mandate ensuring that all individuals over 50 have access to a high-quality Fracture Liaison Service (FLS) and an additional USD 37.3 million per year investment in FLS to address gaps in both coverage and quality.

Moreover, the Asia Pacific market is expected to grow owing to the rising geriatric population and lifestyle modification along with poor dietary calcium intake, leading to increased demand for calcitriol and propelling the regional market growth.

Key Players Covered

The global calcitriol market is fragmented, with a large number of established and emerging competitors.

The report includes the profiles of the following key players:

• Pfizer Inc. (U.S.)
• Abbott (U.S.)
• AdvaCare Pharma (U.S.)
• Teva Pharmaceutical Industries Ltd. (Israel)
• Intas Pharmaceuticals Ltd. (India)
• Sun Pharmaceutical Industries Ltd. (India)
• Alembic Limited (India)
• Lupin (India)
• OPKO Health, Inc. (U.S.)

Key Industry Developments

• In February 2024, Cadila Pharma launched the world’s first aqueous formulation of cholecalciferol for vitamin D deficiency. The new formulation holds superior pharmacokinetics (PK) and pharmacodynamics (PD) compared to traditional oil-based cholecalciferol preparations available in the market.
• In February 2022, OPKO Health, Inc. announced that Vifor Fresenius Medical Care Renal Pharma (VFMCRP) initiated the commercial launch of RAYALDEE (extended-release calcifediol) in Germany. These extended-release capsules are indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.