OSTEOGENESIS IMPERFECTA TREATMENT MARKET ANALYSIS

Global osteogenesis imperfecta treatment market is estimated to be valued at US$ 722.8 million in 2023 and is expected to exhibit a CAGR of 2.4% during the forecast period (2023-2030).

Analysts’ Views on Global Osteogenesis Imperfecta Treatment Market:

The osteogenesis imperfecta (OI) treatment market major players are engaged in research & development to create innovative drugs and cutting-edge therapies. During the projected period, it is anticipated that the market strategic collaborative research and medication designation approvals would considerably fuel market expansion and generate vast development potential. For instance, on June 05 2023, Ultragenyx Pharmaceutical Inc., a biopharmaceutical company focused on the development and commercialization of novel products, and Mereo BioPharma Group plc, a clinical stage biopharmaceutical company focused on oncology and rare diseases, announced data from the dose-selection Phase 2 portion of the Phase 2/3 Orbit study showing that setrusumab rapidly induced bone production in OI-affected patients. Across all patients evaluated setrusumab demonstrated statistically significant increases in levels of serum P1NP (the N-terminal propeptide of type I procollagen), a sensitive marker of bone formation, and a substantial and significant improvement in bone mineral density (BMD) by 3 months.

Figure 1. Global Osteogenesis Imperfecta Treatment Market Share (%), By Route of Administration, 2023

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Global Osteogenesis Imperfecta Treatment Market– Drivers

Rising demand for novel therapies for osteogenesis imperfecta treatment

Rising demand for novel therapies for osteogenesis imperfecta treatment is expected to the growth of global osteogenesis imperfecta market over the forecast period. For instance, in January 2020, Oncologie, Inc., an innovative biopharmaceutical company and Mereo BioPharma Group plc, a clinical-stage company focused on developing & commercializing rare disease & oncology treatments, entered into a license agreement to develop and commercialize ‘Navicixizumab.’ It is an anti-DLL4/VEGF bi-specific antibody for osteogenesis imperfecta treatment.

Strategic acquisition by the key market players

Strategic acquisition by the key market players to enhance the product portfolio by developing novel therapies is expected to drive the global osteogenesis imperfecta market over the forecast period. For instance, in February 2020, The Brittle Bone Disorders Consortium (BBDC) brings together physicians, researchers, and educators to learn more about osteogenesis imperfecta. The goal is to develop new and better treatments for patients with the disorder. Through research, the BBDC is discovering new biomarkers of the disease that will lead to a deeper understanding of underlying pathophysiology of osteogenesis imperfecta (OI) as well as assessing response to therapies. The BBDC also established a patient registry and helps to connect those who wish to get involved with support groups, research, and clinical trials. The partnership with the Osteogenesis Imperfecta Foundation and all of the families with OI is a critical component of the BBDC mission.

Figure 2. Global Osteogenesis Imperfecta Treatment Market Value (US$ Million), By Region, 2023

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 Global Osteogenesis Imperfecta Treatment Market- Regional Analysis

Among region, North America is estimated to hold a dominant position in the global osteogenesis imperfecta treatment market over the forecast period owing to the increase in prevalence of osteogenesis imperfecta cases and increasing strategic collaboration. For instance, in November 2021, The OI Foundation (OIF) and Children's Brittle Bone Foundation (CBBF) committed to establishing and funding a network of linked clinical research centers. The goal was to advance care and research in OI by establishing a collaborative network across North America. The OIF Linked Clinical Research Centers conducted a four-year longitudinal study of OI and this established the basis and framework, collaborations, and structure for the RDCRN (Rare Diseases Clinical Research Network application).

Global Osteogenesis Imperfecta Treatment Market– Impact of Coronavirus (COVID-19) Pandemic

Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe, and the World Health Organization declared it a public health emergency on January 30, 2020.

COVID-19 affected the economy in three main ways: by directly affecting the production and demand of drugs, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries such as China, India, Saudi Arabia, the U.A.E., Egypt, and others faced problems regarding transportation of drugs from one place to another.

COVID-19 had a negative impact on the global osteogenesis imperfecta treatment market due to the delayed in the treatment of osteogenesis imperfecta. The COVID-19 pandemic resulted in the cancellation or delay of all osteogenesis imperfecta treatment procedures. For instance, in January 2021, according to a study published in the Journal of Frontiers in Endocrinology, Osteogenesis imperfecta (OI) is a rare genetic disorder of collagen resulting in fractures and skeletal deformities, the hospitalization and screening for the osteogenesis imperfecta is reduced in 2020. Whereas, it is anticipated to increase after COVID-19 pandemic restriction.

Global Osteogenesis Imperfecta Treatment Market- Segmentation

The global osteogenesis imperfecta treatment market report is segmented into drugs, route of administration, and region.

Among Drugs, the global osteogenesis imperfecta treatment market is segmented into teriparatide, denosumab, and others. Out of which, the denosumab segment is expected to dominate the market during the forecast period and this is because it has become a crucial treatment for cancer and other skeletal problems, including children skeletal diseases like OI.

Among Route of Administration, the global osteogenesis imperfecta treatment market is segmented into subcutaneous, intravenous, oral, and others. The intravenous segment is expected to dominate the market over the forecast period and this is attributed due to its faster onset of action and ability to reduce the incidence of fracture and increases bone mineral density (BMD).

Among Region, the global osteogenesis imperfecta treatment market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. Out of which, the North America is expected to dominate the market over the forecast period owing to the increase in inorganic growth strategies by market key players for the growth of novel treatment methods for osteogenesis imperfecta.

Among all segmentation, the intravenous segment has the highest potential to its faster onset of action and ability to reduce the incidence of fracture and increases bone mineral density (BMD). For instance, in In May 2022, Cortexyme, Inc., a clinical-stage biopharmaceutical company developing therapeutic approaches, announced the completion of its acquisition of Novosteo, a privately-held biotech company focused on targeted therapeutics to treat rare skeletal diseases, bone cancer, and injury. With this acquisition, Cortexyme, Inc. will try to improving the lives of patients diagnosed with degenerative diseases such as osteogenesis imperfecta.

Global Osteogenesis Imperfecta Treatment Market- Cross Sectional Analysis

Among route of administration, the intravenous segment held a dominant position in North America region over the forecast period due to market players are focused on inorganic growth strategies such as acquisition as well as collaboration for the growth of osteogenesis imperfecta treatment in North America. For instance, in October 2021, Ultragenyx Pharmaceutical Inc., a biopharmaceutical company focused on the development and commercialization of novel products, and Mereo BioPharma Group plc, a clinical stage biopharmaceutical company focused on oncology and rare diseases, presented secondary endpoint data on UX143 (setrusumab) from the Phase 2b ASTEROID study for the Treatment of Osteogenesis Imperfecta (OI). Data were presented at the American Society for Bone and Mineral Research (ASBMR) 2021 Annual Meeting held in U.S.

Global Osteogenesis Imperfecta Treatment Market- Key Developments

On July 06 2023, Ultragenyx Pharmaceutical Inc., a biopharmaceutical company focused on the development and commercialization of novel products, announced that the first patients have been dosed in both of its late-stage clinical trials evaluating setrusumab in pediatric and young adult patients with OI sub-types I, III, and IV. The Phase 3 portion of the pivotal Phase 2/3 Orbit study is evaluating the effect of setrusumab compared to placebo on annualized clinical fracture rate in patients aged 5 to <26 years. The newly initiated Phase 3 Cosmic study is an active-controlled study evaluating setrusumab compared to intravenous bisphosphonate (IV-BP) therapy on annualized total fracture rate in patients aged 2 to <5 years.

In October 2022, Osteogenesis Imperfecta Federation Europe (OIFE) announced the re-establishing Osteogenesis Imperfecta Federation Europe (OIFE) in Belgium. OIFE is re-established as a new legal entity in Belgium and dissolved as a legal entity in the Netherlands.

In October 2021, Mereo BioPharma Group plc, a clinical stage biopharmaceutical company, focused on oncology and rare diseases, the Osteogenesis Imperfecta Federation Europe (OIFE), an association for organizations dealing with the rare disease Osteogenesis Imperfecta (OI) and the Osteogenesis Imperfecta Foundation (OIF), a voluntary national health organization helping people cope with the problems associated with osteogenesis imperfect, announced completion of enrollment in the largest global gathering of data-to-date about the impact that OI has on people with OI, their families, and caregivers. The IMPACT Survey closed with more than 2200 individual responses collected over a 3-month period from some 65 countries. The survey results will be used to support future collaborative work on better diagnosis, treatment, and care and to support the timely evaluation and availability of potential new treatments for OI.

In December 2022, Sanofi, an innovative global healthcare company, initiated a Phase I study to evaluate the safety, tolerability, and activity of a single dose of SAR439459 in adult participants with Osteogenesis imperfecta. Orphan Drug Designation was granted by the FDA for this indication.

Global Osteogenesis Imperfecta Treatment Market- Key Trends

Increase in number of patients with (OI) Osteogenesis Imperfecta

Increase in number of patients with (OI) osteogenesis imperfecta is likely to drive the market during the forecast period.  For instance, in June 2021, According to National Organization for Rare Disorders, OI type I is estimated to occur in one in 30,000 live births. OI type II is estimated to occur in one in 60,000 live births by 2025. The overall prevalence of all types of OI is estimated at 1 per 10,000 individuals in the U.S. and approximately 20,000 to 50,000 individuals in the U.S. have OI in 2020.

Global Osteogenesis Imperfecta Treatment Market: Restraints

Non-availability of effective treatment for osteogenesis imperfecta

Non-availability of effective treatment for osteogenesis imperfecta is expected to hinder the market growth over the forecast period. To avoid this, various innovation in the therapies is to be carried out for the effective treatment of OI. For instance, in March 2022, according to an article published in the Journal of British Orthopaedic Association by the Medscape, Bisphosphonates are drugs that have been used off label for the treatment of osteogenesis imperfecta (OI). Drugs in this class may slow the loss of existing bones and may reduce long bone fractures and vertebral compression. These drugs only reduces the bone fractures, but can’t treat the osteogenesis imperfecta and therefore, as such no cure is available for the OI.

Global Osteogenesis Imperfecta Treatment Market- Key Players

Major players operating in the global osteogenesis imperfecta treatment market include BioSenic SA, Inc., Mereo Biopharma Group PLC, CELGENE CORPORATION, Eli Lilly and Company, Cipla Inc., Amgen Inc., Sun Pharmaceutical Industries Ltd., Viatris Inc., Teva Pharmaceutical Industries Ltd., Merck & Co., Inc., Jubilant Pharmova Limited, Aurobindo Pharma, Quince, Ultragenyx Pharmaceutical Inc. and OrthoPediatrics Corp.

*Definition: Osteogenesis imperfecta (OI) is a type of orphan disease characterized by varying degrees of skeletal fragility, such as low bone mass and a propensity to fracture. This condition is caused  by mutations in the COL1A1 or COL1A2 genes that encode the alpha chains of collagen produced by osteoblasts. These genes are susceptible to different mutations for the production of fibrils.