Osteoporosis - Pipeline Insight, 2024

DelveInsight's, "Osteoporosis - Pipeline Insight, 2024" report provides comprehensive insights about 30+ companies and 35+ pipeline drugs in 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

Osteoporosis: Understanding

Osteoporosis: Overview

Osteoporosis is a condition characterized by a decrease in the density of bone, decreasing its strength and resulting in fragile bones. Osteoporosis literally leads to the abnormally porous bone that is compressible, like a sponge. This disorder of the skeleton weakens the bone and results in frequent fractures (breaks) in the bones. Osteoporosis can be present without any symptoms for decades because osteoporosis doesn't cause symptoms until bone breaks (fractures). Key risk factors for osteoporosis include genetics, lack of exercise, lack of calcium and vitamin D, personal history of fracture as an adult, cigarette smoking, excessive alcohol consumption, history of rheumatoid arthritis, low body weight, and family history of osteoporosis. The long-term use of corticosteroids (such as prednisone, cortisone, and prednisolone) can lead to osteoporosis.

Osteoporosis is often termed a "silent disease" because it typically does not present noticeable symptoms until significant bone loss has occurred. Early signs may include subtle changes such as receding gums, weakened grip strength, and minor back or neck pain. As the condition progresses, more pronounced symptoms emerge, including a noticeable loss of height, stooped posture, and an increased frequency of fractures, particularly in the wrist, hip, and spine, even from minor falls or stress.

The pathophysiology involves an imbalance between bone resorption by osteoclasts and bone formation by osteoblasts, often exacerbated by factors such as aging, hormonal changes-particularly estrogen deficiency in postmenopausal women-and various medical conditions. The disease is multifactorial, influenced by genetic predisposition, nutritional factors (such as calcium and vitamin D deficiency), lifestyle choices (like physical inactivity and smoking), and certain medications. As a result, bones become porous and weak, making individuals susceptible to fractures even from minor falls or injuries, with common sites including the hip, wrist, and spine.

The diagnosis of osteoporosis can be suggested by X-rays and confirmed by tests to measure bone density. The National Osteoporosis Foundation, the American Medical Association, and other major medical organizations recommend a dual-energy X-ray absorptiometry scan (DXA, formerly known as DEXA) be used for the diagnosis of osteoporosis. DXA typically measures bone density in the hip, the spine, and the forearm. The treatment of osteoporosis aims to prevent bone fractures by reducing bone loss or ideally increasing bone density and strength. Effective measures include lifestyle changes such as quitting smoking, limiting alcohol, exercising regularly, and maintaining a balanced diet with adequate calcium and vitamin D.

"Osteoporosis- Pipeline Insight, 2024" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Osteoporosis pipeline landscape is provided which includes the disease overview and Osteoporosis treatment guidelines. The assessment part of the report embraces, in depth 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, 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 Osteoporosis R&D. The therapies under development are focused on novel approaches to treat/improve Osteoporosis.

Osteoporosis Emerging Drugs Chapters

This segment of the 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.

Osteoporosis Emerging Drugs

• AVT03: Alvotech

AVT03 is a human monoclonal antibody and a biosimilar candidate to Prolia and Xgeva (denosumab). Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, preventing the RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction. AVT03 is an investigational product and has not received regulatory approval in any country. Currently, the drug is in Phase III stage of its development for the treatment of osteoporosis.

• TST002: Transcenta Holding

TST002 (Blosozumab) is a humanized anti-sclerostin monoclonal antibody as a drug candidate for osteoporosis and other bone loss diseases. It has a dual effect possessing both anabolic and anti-resorptive effects, which stimulates bone formation and inhibits bone absorption, resulting in fast increase in bone mineral density and bone strength. Blocking sclerostin activity in human treated with anti-sclerostin antibody or with naturally occurring genetic deletion has been shown to be an effective approach in increasing bone mineral density (BMD) and reducing bone fracture. Currently, the drug is in Phase II stage of its clinical trial for the treatment of osteoporosis.

• Denosumab biosimilar: GlycoNex

GlycoNex, a Taiwanese biotech company, is developing a denosumab biosimilar called SPD8 for the treatment of osteoporosis. Denosumab is a fully human monoclonal antibody that inhibits receptor activator of nuclear factor kappa-B ligand (RANKL), a key regulator of osteoclast formation, function and survival. By blocking RANKL, denosumab reduces bone resorption and increases bone mineral density. GlycoNex recently reported positive results from a Phase I clinical trial of SPD8, which met its primary endpoint of pharmacokinetic equivalence to the reference product. Currently, the drug is in Phase II stage of its clinical trial for the treatment of osteoporosis.

Osteoporosis: Therapeutic Assessment

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

• Major Players in Osteoporosis
• There are approx. 30+ key companies which are developing the therapies for Osteoporosis. The companies which have their Osteoporosis drug candidates in the most advanced stage, i.e. Phase III include, Alvotech.
• Phases

DelveInsight's report covers around 35+ 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

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.

Osteoporosis: Pipeline Development Activities

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

Osteoporosis Report Insights

• Osteoporosis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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 Osteoporosis drugs?
• How many Osteoporosis drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Osteoporosis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the 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 Osteoporosis and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• mAbxience
• Alvotech
• Transcenta Holding
• Suzhou Suncadia Biopharmaceuticals
• GlycoNex
• Cellatoz Therapeutics
• Enzo Biochem
• Surrozen

Key Products

• MB-09
• AVT03
• TST002
• SHR2017
• Denosumab biosimilar
• CLZ 1001
• Research programme: small molecule
• Research programme: regenerative therapeutics