Osteogenesis Imperfecta Treatment Market Analysis

Osteogenesis imperfecta (OI) is a type of orphan disease group, characterized by varying degrees of skeletal fragility such as low bone mass and a propensity to fracture. This condition is caused due to the mutations in the COL1A1 or COL1A2 gene that encodes the alpha chains of collagen produced by osteoblasts.These genes are susceptible to different mutations for the production of fibrils. Currently, the available treatment options such as physical therapy, bracing, and medication (Bisphosphonates) do not treat OI condition effectively. Therefore, number of researchers are involved in research & development to develop novel therapies and treatment, which is expected to drive growth of the global osteogenesis imperfecta treatment market. Key players in the market have a lucrative opportunity in the market, as there is no treatment available for osteogenesis imperfecta.

According to a study published in The Indian Journal of Endocrinology and Metabolism, osteogenesis imperfecta (OI) is a common genetic connective tissue disorder. Around 90% are caused due to Type I collagen mutations. The Type I-IV mutations are autosomal dominant, whereas Type VI–XIII are autosomal recessive. On the basis of severity, these types are graded 1-5. The mainstay of OI treatment is bisphosphonate therapy. However, there is no such treatment available for osteogenesis imperfecta.

The rising demand for new developments and novel therapies for OI is expected to drive growth of the global osteogenesis imperfecta treatment market during the forecast period. For instance, in August 2016, the California-based biopharmaceutical company, Amgen Inc. developed denosumab, which is a phase III clinical trial product for OI treatment.

Osteogenesis Imperfecta Treatment Market - Impact of Coronavirus (Covid-19) Pandemic

Osteogenesis imperfecta (OI) treatment market is adversely affected due to the outbreak of COVID-19, as it is becoming difficult for researchers to conduct researches during this pandemic. Though OI does not affect the immune system, lung connective tissue is distorted in all types of OI. The risk of pulmonary problems and severity of symptoms is high in people with abnormal chest shape, short stature, rib or vertebral fractures, and kyphoscoliosis.

The all-inclusive version of the report will include the impact of COVID-19 and the probable changes in the future outlook of the industry, by taking into account the technological, social, political, and economical parameters.

The osteogenesis imperfecta treatment market is estimated to be valued at US$ 684.2 million in 2020 and is expected to rise at a CAGR of 1.90% during the forecast period (2020-2027).

Figure 1. Osteogenesis Imperfecta Treatment Market Share (%) Analysis, By Route of Administration, 2020

An increase in the number of clinical trials and collaborative research for OI treatment is expected to propel growth of the osteogenesis imperfecta treatment market

Key players in the market are involved in research & development to develop advanced drugs and novel therapies in the osteogenesis imperfecta treatment market. The drug designation approvals and strategic collaborative researches in the industry are expected to significantly drive the market growth and create enormous growth opportunities in the overall market during the forecast period.

For instance, in November 2017, Mereo BioPharma Group Plc received PRIME Designation from the Europe Medicines Agency for its BPS-804 (setrusumab). Setrusumabis a monoclonal antibody that targets sclerostin for the osteogenesis imperfecta treatment. This designation has enabled the company to receive health-technology assessment and scientific advice to accelerate the approval to quickly treat patients.

For instance, in October 2019, Recombinetics entered into a collaborative research project with Mayo Clinic. The aim of this collaboration was to advance osteogenesis imperfecta research by developing the first swine models of osteogenesis imperfecta. These models will aid preclinical researchers to better understand the etiology and progression of the disease and thereby, provide a trustworthy preclinical model to establish the safety and efficacy of novel therapies needed by the OI patients.

Osteogenesis Imperfecta Treatment Market - Restraints

The non-availability of effective treatment for osteogenesis imperfecta is expected to hinder the market growth during the forecast period. Moreover, the shortage of trained professionals in some low- and middle-income countries is likely to hamper the market growth.

Osteogenesis Imperfecta Treatment Market Report Coverage

Report Coverage	Details
Base Year:	2019	Market Size in 2019:	US$ 684.2 Mn
Historical Data for:	2016 to 2019	Forecast Period:	2020 to 2027
Forecast Period 2020 to 2027 CAGR:	1.90%	2027 Value Projection:	US$ 780.4 Mn
Geographies covered:	North America: U.S. and Canada Latin America: Brazil, Argentina, Mexico, and Rest of Latin America Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific Middle East: GCC, Israel, and rest of Middle East Africa: South Africa, North Africa, and Central Africa
Segments covered:	By Drugs: Teriparatide, Denosumab, Others. By Route of Administration: Intravenous, Subcutaneous, Oral, Others.
Companies covered:	Bone Therapeutics SA, Mereo BioPharma Group plc, Celgene Corporation, Eli Lilly and Company, Cipla Inc., Amgen Inc, Sun Pharmaceutical Industries Limited, Mylan N.V., Teva Pharmaceutical Industries Ltd, Merck & Co., Inc. Jubilant Life Sciences Ltd., Aurobindo Pharma, and Genzyme Corp.
Growth Drivers:	Rising demand for novel therapies for osteogenesis imperfecta treatment Licensing agreement and strategic collaborations between key industry players
Restraints & Challenges:	Lack of trained professionals Non-availability of effective treatment for osteogenesis imperfecta

Osteogenesis Imperfecta Treatment Market – Regional Analysis

Europe region accounted for the largest share in the osteogenesis imperfecta treatment market in 2019, owing to increasing focus of key players on research & development and rise in the number of clinical trials for the treatment of osteogenesis imperfecta. For instance, Bone Therapeutics SA received an Orphan Drug designation from the Europe Medicines Agency (EMA) as well as the FDA for ALLOB, which is an allogeneic bone cell therapy product for osteogenesis imperfect treatment. A product with Orphan Drug designation recevies certain incentives and benefits along with a period of 10 years market exclusivity, protocol assistance, and reduced regulatory fees upon approval.

For instance, in May 2019, Mereo BioPharma Group plc announced encouraging 6-month data from its phase II-B clinical study in adult patients with Type IV, III, or I osteogenesis imperfecta treated with setursumab (BPS-804). The European Medicines Agency (EMA) had approved the company’s pediatric investigation plan for BPS-804 and with a registration study design, and the drug candidate is now phase III ready for a pediatric population.

Furthermore, Asia Pacific region is expected to witness noteworthy growth in the global osteogenesis imperfecta treatment market, owing to initiatives taken by key players and orphan drug designations for the treatment of osteogenesis imperfecta. For instance, in October 2019, the research team at the Hong Kong Baptist University (HKBU) developed a novel single-stranded piece of DNA i.e. aptamer for osteogenesis imperfecta (OI) treatment with the help of artificial intelligence (AI) technology. The first time ever in Hong Kong, the U.S. Food and Drug Administration (FDA) granted HKBU orphan drug designation. The research team at the School of Chinese Medicine is expecting to conduct clinical trials at the earliest in the next three years.

Figure 2. Osteogenesis Imperfecta Treatment Market Value (US$ Mn) & Y-o-Y Growth (%), 2017-2027

Osteogenesis Imperfecta Treatment Market - Competitive Landscape

Key players operating in the osteogenesis imperfecta treatment market include Bone Therapeutics SA, Mereo BioPharma Group plc, Celgene Corporation, Eli Lilly and Company, Cipla Inc., Amgen Inc, Sun Pharmaceutical Industries Limited, Mylan N.V., Teva Pharmaceutical Industries Ltd, Merck & Co., Inc., Jubilant Life Sciences Ltd., Aurobindo Pharma, and Genzyme Corp.