Mercado Global de Ortobiológicos – Tendências da Indústria e Previsão para 2031

Análise e dimensão do mercado ortobiológico

O mercado global de ortobiológicos está a assistir a um crescimento significativo impulsionado pelo aumento da incidência de distúrbios musculoesqueléticos, pelos avanços na medicina regenerativa e pelo aumento da procura de cirurgias minimamente invasivas . Os principais fatores incluem a expansão da população geriátrica, as inovações tecnológicas nos tratamentos ortopédicos e a crescente consciencialização dos benefícios dos produtos biológicos nos procedimentos ortopédicos, promovendo a expansão do mercado.

O tamanho do mercado global de ortobiológicos foi avaliado em 8,85 mil milhões de dólares em 2023 e deverá atingir 14,00 mil milhões de dólares até 2031, com um CAGR de 5,9% durante o período de previsão de 2024 a 2031. Para além dos insights sobre cenários de mercado, tais como valor de mercado , taxa de crescimento, segmentação, cobertura geográfica e grandes players, os relatórios de mercado com curadoria da Data Bridge Market Research também incluem análises especializadas aprofundadas, epidemiologia de pacientes, análise de pipeline, análise de preços e a estrutura regulatória.

Âmbito do relatório e segmentação de mercado       

Market Definition

Orthobiologics refers to the use of biological substances, such as cells, growth factors, and other biologically active materials, to help facilitate the healing and regeneration of musculoskeletal tissues, such as bones, cartilage, muscles, ligaments, and tendons. These substances can be derived from natural sources within the body (autologous) or external sources (allogeneic or synthetic). Orthobiologics are used in various orthopedic treatments, including bone grafting, spinal fusion, and cartilage repair.                                     

Orthobiologics Market Dynamics

Drivers

• Rising Demand for Minimally Invasive Surgeries

The preference for minimally invasive surgical procedures is on the rise, driven by their associated benefits such as shorter recovery times, reduced post-operative pain, and lower risk of complications compared to traditional open surgeries. This trend is fueling the demand for bone grafts and substitutes that are compatible with minimally invasive techniques. These grafts and substitutes need to be easily implantable through small incisions and provide adequate support for bone healing and regeneration in minimally invasive procedures, thus driving innovation and development in the orthobiologics market.

• Increasing Prevalence of Orthopedic Conditions

The incidence of orthopedic conditions such as fractures, osteoarthritis, and sports injuries is increasing globally. This rise is attributed to lifestyle changes, including sedentary habits, dietary factors, and the prevalence of sports and recreational activities. As these conditions become more widespread, the demand for bone grafts and substitutes is also growing. Orthobiologics, by enhancing the body's natural healing mechanisms, are playing a crucial role in addressing these conditions, improving patient outcomes, and drive the market growth.

Opportunities

• Growing Adoption of Regenerative Medicine 

The field of regenerative medicine, encompassing therapies such as stem cell therapy and growth factor-based treatments, is experiencing a surge in adoption. These innovative approaches hold immense potential for tissue regeneration and repair, particularly in orthopedic applications. Stem cells, for instance, can differentiate into various cell types, aiding in the regeneration of bone and cartilage tissues. Growth factor-based treatments can stimulate the body's natural healing processes, promoting tissue growth and repair. The increasing acceptance of these regenerative therapies among patients and healthcare providers is creating significant growth opportunities for the orthobiologics market, driving research and development in this field.  

• Rising Aging Population  

The global population is aging at a rapid pace, with a significant portion of the elderly population experiencing musculoskeletal disorders such as osteoarthritis, fractures, and degenerative spine conditions. As individuals age, their bones and joints undergo degenerative changes, leading to an increased need for orthopedic interventions. This demographic trend presents a substantial opportunity for the orthobiologics market, as older individuals often require bone grafts and substitutes to support orthopedic procedures. The development of orthobiologic products tailored to the specific needs of the elderly population, such as enhanced bone healing and reduced recovery times, creates new opportunities for the market.

Restraints/Challenges

• Stringent Regulatory Approval Processes 

Regulatory bodies, such as the FDA in the U.S. and the EMA in Europe, require extensive preclinical and clinical data to demonstrate the safety and efficacy of orthobiologic products. These approval processes can be time-consuming and expensive, delaying market entry and increasing development costs. Furthermore, regulatory requirements may vary across regions, adding complexity for companies seeking to market their products globally. Compliance with these stringent regulations is crucial for ensuring patient safety and product quality but can be a barrier to entry for smaller companies or those with limited resources. The market is subject to rigorous regulatory scrutiny and approval processes, which can pose challenges for market expansion.       

• Limited Availability of Donor Grafts

The availability of donor grafts, particularly autografts sourced from the patient's own body, is limited and can vary depending on factors such as tissue type and quality. This limitation is further exacerbated in regions with strict regulations on tissue donation, where the supply of donor grafts may be insufficient to meet demand. Additionally, the use of allografts (grafts sourced from a donor) is subject to stringent screening and processing requirements to minimize the risk of disease transmission and graft rejection. These factors can pose challenges for healthcare providers and patients seeking access to bone grafts and substitutes, particularly in cases where autografts are preferred but not readily available, creating challenges for market growth.

This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Recent Developments

• In November 2021, three primary FDA approval pathways were identified for bone grafts and substitutes, which are essential for mending nonunions, malunions, and bone defects. Among FDA-approved bioactive molecules for bone regeneration, a notable example is the peptide P-15
• In September 2021, Locate Bio, a company focused on regenerative medicine with a focus on orthobiologics, has secured an oversubscribed £10 million equity investment in a funding round co-led by current shareholder Mercia Asset Management and new investor BGF. The funds will be utilized to further progress Locate Bio’s proprietary pipeline of regenerative orthobiologics products towards patients, with key clinical and regulatory milestones expected to drive growth over the next two years. This investment brings Locate Bio's total funds raised to over £18 million. The company's primary product in development, LDGraft, is a controlled-release rhBMP-2 treatment for degenerative disc disease

Orthobiologics Market Scope

The market is segmented on the basis of product, application, type, and end-user. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Product

• Demineralized Bone Matrix (DBM)
• Allograft
• Bone Morphogenetic Protein (BPM)
• Viscosupplementation Products
• Synthetic Bone Substitutes
• Others

Application

• Osteoartrite e artrite degenerativa
• Recuperação de fratura de fusão espinhal
• Lesões de tecidos moles
• Aplicações Maxilofaciais e Dentárias

Tipo

• Joelho
• Tornozelo
• Anca
• Pulso e ombro
• Coluna
• Outros

Utilizador final

• Hospitais e Centros de Ambulatório
• Instituto Académico e de Investigação
• Clínicas Dentárias

Análise/perspetivas regionais do mercado de ortobiológicos

O mercado é analisado e os insights e tendências do tamanho do mercado são fornecidos por país, produto, aplicação, tipo e utilizador final, como mencionado acima.

Os países abrangidos no mercado são os EUA, Canadá, México, Alemanha, França, Reino Unido, Holanda, Suíça, Bélgica, Rússia, Itália, Espanha, Turquia, resto da Europa, China, Japão, Índia, Coreia do Sul, Singapura, Malásia , Austrália, Tailândia, Indonésia, Filipinas, resto da Ásia-Pacífico, Arábia Saudita, Emirados Árabes Unidos, África do Sul, Egito, Israel, resto do Médio Oriente e África, Brasil, Argentina e resto da América do Sul.

Espera-se que a América do Norte domine o mercado devido à presença de players importantes e à crescente incidência de condições ortopédicas. Além disso, espera-se que o aumento da população idosa impulsione um maior crescimento do mercado.

Espera-se que a Ásia-Pacífico testemunhe um crescimento significativo durante o período de previsão devido à crescente consciencialização entre os médicos. Além disso, prevê-se que o crescimento das despesas com a saúde e do rendimento disponível impulsione o crescimento do mercado.

A secção do país do relatório também fornece fatores individuais de impacto no mercado e alterações na regulamentação do mercado interno que impactam as tendências atuais e futuras do mercado. Pontos de dados como a análise da cadeia de valor a jusante e a montante, tendências técnicas e análise das cinco forças de Porter, estudos de caso são alguns dos indicadores utilizados para prever o cenário de mercado para países individuais. Além disso, são considerados a presença e disponibilidade de marcas globais e os desafios enfrentados devido à grande ou escassa concorrência de marcas locais e nacionais, o impacto das tarifas nacionais e das rotas comerciais, ao mesmo tempo que se fornece uma análise de previsão dos dados do país.

Base instalada de crescimento da infraestrutura de saúde e penetração de novas tecnologias

O mercado também fornece análises de mercado detalhadas para o crescimento de cada país em despesas de saúde para equipamentos de capital, base instalada de diferentes tipos de produtos para o mercado, impacto da tecnologia utilizando curvas de linha de vida e mudanças nos cenários regulamentares de saúde e o seu impacto no mercado. Os dados estão disponíveis para o período histórico 2016-2021.

Análise do cenário competitivo e da quota de mercado ortobiológico

O cenário competitivo do mercado fornece detalhes por concorrente. Os detalhes incluídos são a visão geral da empresa, finanças da empresa, receitas geradas, potencial de mercado, investimento em investigação e desenvolvimento, novas iniciativas de mercado, presença global, localizações e instalações de produção, capacidades de produção, pontos fortes e fracos da empresa , lançamento de produto, largura e amplitude do produto, aplicação domínio. Os dados acima fornecidos estão apenas relacionados com o foco das empresas em relação ao mercado.

Alguns dos principais players que operam no mercado são:

• XTANT MÉDICO (EUA)
• (EUA)
• SeaSpine (EUA)
• (EUA)
• Bioventus (EUA)
• Kuros Biosciences (Suíça)
• (EUA)
• RTI Surgical Holdings, Inc.
• (EUA)
• Globus Medical Inc (EUA)
• Tecnologias de colheita (EUA)
• Zimmer Biomet (EUA)
• Stryker (EUA)
• Medtronic (Irlanda)
• DePuy Synthes (EUA)
• Sanofi (França)
• SEIKAGAKU CORPORATION (Japão)
• Localize Bio Ltd. (Reino Unido)
• MTF Biologics (EUA)
• (EUA)
• (EUA)

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