Postmenopausal Osteoporosis - Pipeline Insight, 2025

DelveInsight’s, “Postmenopausal Osteoporosis - Pipeline Insight, 2025” report provides comprehensive insights about 8+ companies and 10+ pipeline drugs in Postmenopausal Osteoporosis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

Global coverage

Postmenopausal Osteoporosis: Understanding

Postmenopausal Osteoporosis: Overview

The World Health Organization (WHO) defines menopause as the complete cessation of menstruation in a woman for one year or more. Perimenopause is irregular menstruation before menopause. Its duration is variable. The average age of Indian women is 46.2 years at menopause. Postmenopausal osteoporosis (PMO) is defined as a generalized skeletal disorder in which because of decreased bone density or deteriorating bone quality there is increased risk of fracture. The bone turnover is increased in early peri menopausal period leading to a net bone loss. Postmenopausal osteoporosis is linked with the deficiency of estrogen that occurs with the cessation of the function of the ovaries as age progresses. The function of estrogen in the bone remodeling process is very well understood after years of research; estrogen plays a part in both the formation of bone as well as the prevention of the resorption of bone. A diagnosis can be made by dual-energy X-ray absorptiometry (DEXA). It is the gold standard and can spot low bone density at particular sites. The treatment options are selected according to the severity and rate of progression and factors pertaining to each patient.

At menopause the normal bone turnover cycle is impaired by estrogen deficiency. This may be due to the presence of estrogen receptors in osteoclast progenitor cells and multi-nucleated osteoclasts. The osteoclastic resorption activity increases while the osteoblastic activity decreases. As a result, the amount of bone resorbed exceeds the amount deposited, which leads to a net loss of bone. The increase of overall bone resorption is due to a weakened inhibition effect due to the reduction of available estrogen on both osteoclastogenesis and osteoclast activity. The enhanced expression of cytokines known to stimulate osteoclastogenesis, such as IL-1, IL-6, and TNF, or enhanced expression of M-CSF (macrophage colony-stimulating factor) and RANKL in osteoblasts/stromal cells may also play an important role. The stimulatory effect of estrogen on bone formation is less-well-understood, but may be mediated by estrogen-receptor-responsive elements on promoters for genes involved in bone matrix biosynthesis, including type I collagen, or cytokines believed to be important for coupling of bone resorption and bone formation. During the first phase of menopausal bone loss women are in marked negative calcium balance.

The symptoms of postmenopausal osteoporosis usually aren't obvious. Osteoporosis tends to develop slowly and silently, and many people don't realize they have the condition until a bone fractures, or breaks, suddenly. It is characterized by a decrease in bone density and quality, which can lead to an increased risk of fractures. The condition often develops without noticeable symptoms until a fracture occurs. Common symptoms and signs of postmenopausal osteoporosis may include Bone Fractures, Back Pain, Loss of Height, Stooped Posture, Decreased Grip Strength and Joint pain.

Osteoporosis is an incurable chronic condition, like heart disease, diabetes, or hypertension. In postmenopausal women at high risk of fractures, initial treatment is recommend with bisphosphonates (alendronate, risedronate, zoledronic acid, and ibandronate) or denosumab as an alternative initial treatment, to reduce fracture risk. In postmenopausal women with osteoporosis at very high risk of fracture, such as those with severe or multiple vertebral fractures, Physicians recommend teriparatide treatment for up to 2 years for the reduction of vertebral and nonvertebral fractures. Preventive no pharmacological treatment includes adequate dietary intakes of key bone nutrients such as calcium, vitamin D and protein contribute to bone health and reduce thereby the risk of osteoporosis and of fracture later in life. Dietary sources of calcium are the preferred option and calcium supplementation should only be targeted to those who do not get sufficient calcium from their diet and who are at high risk for osteoporosis.

""Postmenopausal Osteoporosis- Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Postmenopausal Osteoporosis pipeline landscape is provided which includes the disease overview and Postmenopausal Osteoporosis treatment guidelines. The assessment part of the report embraces, in depth Postmenopausal Osteoporosis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Postmenopausal Osteoporosis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Postmenopausal Osteoporosis R&D. The therapies under development are focused on novel approaches to treat/improve Postmenopausal Osteoporosis.

Postmenopausal Osteoporosis Emerging Drugs Chapters

This segment of the Postmenopausal Osteoporosis report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Postmenopausal Osteoporosis Emerging Drugs

RGB-14-P: Gedeon Richter

RGB-14-P is a biosimilar to the reference products Prolia® (60 mg/ml solution for injection in PFS) and Xgeva® (120 mg/1,7 ml solution for injection in vial), a human monoclonal antibody for the treatment of osteoporosis and fractures due to bone metastasis. RGB-14-P is a RANKL inhibitor which works by preventing the development of osteoclasts, which are cells that break down bone. It is used for patients with osteoporosis at high risk for fractures, bone loss due to certain medications, and in cancer patients with bone metastases or giant cell tumors of the bone. The U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Applications (BLA) for RGB-14, a Denosumab biosimilar candidate comprising two biosimilar products referencing Prolia® and Xgeva® (“Products”), a human monoclonal antibody for the treatment of osteoporosis and fractures due to bone metastasis. Currently, the drug is in Registration stage of its development for the treatment of Postmenopausal Osteoporosis.

Bmab 1000: Biocon Biologics

Bmab 1000 is a biosimilar to denosumab, developed by Biocon for the treatment of postmenopausal osteoporosis. This innovative monoclonal antibody is designed to inhibit receptor activator of nuclear factor kappa-B ligand (RANKL), a key factor involved in the formation, function, and survival of osteoclasts, which are the cells responsible for bone resorption. By effectively blocking RANKL, Bmab 1000 aims to decrease bone resorption and increase bone mineral density, thereby reducing the risk of fractures in postmenopausal women who are particularly vulnerable to osteoporosis. Currently, the drug is in Phase III stage of its development for the treatment of Postmenopausal Osteoporosis.

AGA2118: Angitia Biopharmaceuticals

AGA2118 is a Sclerostin x DKK1 bispecific antibody in clinical development for the treatment of osteoporosis. Sclerostin and DKK1 are two critical, negative regulators of WNT signaling in osteoblasts and bone metabolism. By targeting both proteins, AGA2118 is thought to prevent compensatory increase of either agent, aiming to improve magnitude of bone mineral density gains in osteoporotic patients. Angitia wholly owns the bispecific antibody. Currently, the drug is in Phase II stage of its development for the treatment of Postmenopausal Osteoporosis.

Further product details are provided in the report……..

Postmenopausal Osteoporosis: Therapeutic Assessment

This segment of the report provides insights about the different Postmenopausal Osteoporosis drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Postmenopausal Osteoporosis

There are approx. 8+ key companies which are developing the therapies for Postmenopausal Osteoporosis. The companies which have their Postmenopausal Osteoporosis drug candidates in the most advanced stage, i.e. Registration include, Gedeon Richter.

Phases

DelveInsight’s report covers around 10+ products under different phases of clinical development like

Late stage products (Phase III)

Mid-stage products (Phase II)

Early-stage product (Phase I) along with the details of

Pre-clinical and Discovery stage candidates

Discontinued & Inactive candidates

Route of Administration

Postmenopausal Osteoporosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

Oral

Intravenous

Subcutaneous

Parenteral

Topical

Molecule Type

Products have been categorized under various Molecule types such as

Recombinant fusion proteins

Small molecule

Monoclonal antibody

Peptide

Polymer

Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Postmenopausal Osteoporosis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Postmenopausal Osteoporosis therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Postmenopausal Osteoporosis drugs.

Postmenopausal Osteoporosis Report Insights

Postmenopausal Osteoporosis Pipeline Analysis

Therapeutic Assessment

Unmet Needs

Impact of Drugs

Postmenopausal Osteoporosis Report Assessment

Pipeline Product Profiles

Therapeutic Assessment

Pipeline Assessment

Inactive drugs assessment

Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

How many companies are developing Postmenopausal Osteoporosis drugs?

How many Postmenopausal Osteoporosis drugs are developed by each company?

How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Postmenopausal Osteoporosis?

What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Postmenopausal Osteoporosis therapeutics?

What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?

What are the clinical studies going on for Postmenopausal Osteoporosis and their status?

What are the key designations that have been granted to the emerging drugs?

Key Players

Gedeon Richter

Biocon Biologics

Angitia Biopharmaceuticals

HJB (Hangzhou) Co., Ltd.

Celltrion

Samsung Bioepis Co., Ltd.

Key Products

RGB-14-P

Bmab 1000

AGA2118

TST002

CT-P41

SB16

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