Bone Cement Delivery Systems Market, 2019-2030

Bone Cement Delivery Systems Market, 2019-2030

  • March 2019 •
  • 472 pages •
  • Report ID: 5772431 •
  • Format: PDF
INTRODUCTION
According to a study conducted by the International Osteoporosis Foundation (IOF), more than 200 million individuals around the world suffer from osteoporosis. In fact, a total of 8.9 million fractures per year are attributed to osteoporosis, implying that an osteoporotic fracture (of the hip, knee, spine, shoulder, or wrist) occurs after every three seconds. The annual socioeconomic burden associated with this condition is estimated to be around USD 19 billion and EUR 37 billion, in the US and Europe, respectively. Further estimates suggest that, by 2030, nearly 3.5 million knee replacements and 572,000 hip replacements are likely to be performed every year in the US alone. A recent United Nations’ study projected the global elderly population (aged 60 years and above) to rise to 1.3 billion by 2030; given the susceptibility of this population segment to developing osteoporosis, the global burden related to this particular disease is anticipated to increase significantly in the foreseen future. ,

Over time, bone cement delivery systems have become widely popular in diverse types of orthopedic surgeries / procedures. There are many benefits of using such devices, including ease-of-use, targeted and controlled delivery of bone cements, integrated safety mechanisms, and an almost negligible risk of injury to patients. Companies involved in the development / manufacturing of bone cement delivery systems have also captured the interest of several stakeholders / bone cement developers that are looking for novel ways to deliver various types of bone cements to target sites during surgical procedures. In fact, since 2010, over 6,000 patents have been published in this domain, indicating the rapid pace at which research is being carried out. It is anticipated that such efforts are likely to boost the overall growth of this market in the coming years.

SCOPE OF THE REPORT
The ‘Bone Cement Delivery Systems Market, 2019-2030’ report features an extensive study of the current landscape and the likely future evolution of such systems in the next twelve years. The study features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain, across different global regions. Amongst other elements, the report includes:
A detailed assessment of the current landscape of bone cement delivery systems market, highlighting the contributions of industry players engaged in this domain, along with key system specifications. It features information on the type of surgical procedures (arthroplasty, kyphoplasty and vertebroplasty), compatibility with different types of bone cements (polymethyl methacrylate, calcium phosphate and others), viscosity of bone cements delivered (high, medium and low), system functionality (delivery and mixing), approval date of various products, and maximum capacity.
An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval, including bone cement delivery systems, across different countries. It also includes an insightful multi-dimensional heat map analysis, featuring a review of the contemporary regulatory scenario in key geographies across the globe.
Elaborate profiles of large companies offering bone cement delivery systems (shortlisted on the basis of the number of systems), featuring an overview of the company, its financial information (if available), detailed descriptions of their bone cement delivery systems, and a comprehensive future outlook. In addition, the chapter features tabulated profiles of small-sized and mid-sized bone cement delivery system providers (shortlisted on the basis of number of systems), featuring details on company headquarters, year of establishment, number of employees, executive team, recent developments, along with detailed descriptions of their proprietary bone cement delivery systems.
A detailed analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2014-2018, based on parameters, such as year of acquisition, type of acquisition, geographical location of the acquirer and the acquired company, key value drivers, and financial details of the deal (if available). The analysis also features an ownership change matrix, providing insights on the involvement of private and public sector entities in this domain. In addition, the chapter evaluates the deal multiples of acquisitions specifically focused on bone cement delivery systems, analyzing them based on a number of parameters, namely annual revenues, number of employees and the experience of the acquired company. Moreover, it presents a schematic world map representation of the geographical distribution of this activity, highlighting inter- and intracontinental deals.
An in-depth analysis of the various patents that have been filed / granted related to bone cement delivery systems since 1976. The analysis also highlights the key parameters associated with the patents, including information on patent type (granted patents, patent applications and others), publication year, CPC classification, emerging focus areas (in terms of number of patents filed / granted), type of surgical procedures (arthroplasty, kyphoplasty and vertebroplasty), industry type and leading industry / non-industry players (in terms of size of intellectual property portfolio). It also features a valuation analysis taking into consideration older patents, which have expired, highlighting the upcoming opportunity for generic product developers and manufacturers in this domain.
A comprehensive clinical trial analysis of completed, ongoing and planned studies of different types of bone cements and associated delivery systems for various surgical procedures. For the purpose of this analysis, we considered the clinical studies that started in 1997, and analyzed them on the basis of various parameters, such as trial registration year, current trial status, current trial phase, study design, type of surgical procedure, study focus, leading industry and non-industry players, regional distribution, and enrolled patient population across different geographies. In addition, it features an insightful clinical end-points analysis of ongoing and planned studies.
A detailed study on the various grants that have been awarded to research institutes conducting projects related to different types of bone cements, between 2010 and 2018. The analysis highlights various important parameters associated with grants, such as year of award, support period, amount awarded, type of surgical procedures, grant type, responsible study section, focus area and type of bone cements.
An analysis to estimate the likely demand for bone cement delivery systems across key surgical procedures, including kyphoplasty, vertebroplasty, hip arthroplasty and knee arthroplasty, in different global regions for the period 2019-2030.

One of the key objectives of the report was to estimate the existing market size and potential growth opportunities for bone cement delivery systems over the coming decade. Based on several parameters, such as prices of systems, surgical procedure / region specific adoption trends, and competitive landscape, we have provided an informed estimate on the likely evolution of the market, over the period 2019-2030. The report provides sales forecasts for the overall bone cement delivery systems market with the current and upcoming opportunity segmented across [A] surgical procedure(s) (hip arthroplasty, knee arthroplasty, kyphoplasty and vertebroplasty), [B] type of end-user(s) (ambulatory surgery centers, hospitals and specialty clinics), and [C] key geographies (North America (the US, Canada and Mexico), Europe (EU5 countries), Asia-Pacific and Rest of the World (Australia, China, India, and Japan)). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in this study were also influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of organization names):
Soren Toksvig-Larsen (Associate Professor, Department of Orthopedics, Lund University)
Francesco De Paola (International Product Manager, Medacta International)
Ana Bettencourt (Associate Professor, University of Lisbon)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts’ views

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the present state of the bone cement delivery systems market and its likely evolution in the short-mid and long terms.
Chapter 3 provides a general introduction to the various types of bone cements, including a comprehensive overview of the evolution of such materials, their basic composition, and classification. It also includes an elaborate discussion on the different parameters that impact the physiochemical properties of different types of bone cements. The chapter lays emphasis on the types of bone cement delivery systems, listing their distinguishing features. Subsequently, it provides an overview of the key surgical procedures, including vertebroplasty, kyphoplasty and arthroplasty, for bone cements and affiliated delivery technologies. It also features a brief discussion on the various advantages and limitations related to the use of bone cement delivery systems.

Chapter 4 presents a list of more than 70 delivery systems designed for the administration of bone cements across various types of orthopedic surgeries / procedures. It includes a detailed analysis of the aforementioned products based on the type of surgical procedures (arthroplasty, kyphoplasty and vertebroplasty), compatibility with different types of bone cements (polymethyl methacrylate, calcium phosphate and others), viscosity of bone cements delivered (high, medium and low), system functionality (delivery and mixing), approval date of various products, and maximum capacity. It also provides details of the developer companies, such as year of establishment, company size and location of headquarters. In addition, the chapter features an indicative list of bone cement mixing device providers.

Chapter 5 features a detailed discussion on the various guidelines established by major regulatory bodies, for the evaluation and approval of medical devices, including bone cement delivery systems, across different countries. It also includes an insightful heat map analysis, featuring a review of the contemporary regulatory scenario in key geographies across the globe.

Chapter 6 features detailed profiles of large companies offering bone cement delivery systems (shortlisted on the basis of systems). Each company profile includes a brief overview of the company, financial information (if available), detailed descriptions of their bone cement delivery systems, and a comprehensive future outlook. In addition, the chapter includes tabulated profiles of small-sized and mid-sized bone cement delivery system providers (shortlisted on the basis of number of systems), providing details on company headquarters, year of establishment, number of employees, executive team, recent developments, along with detailed descriptions of their proprietary bone cement delivery systems.

Chapter 7 features a detailed analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2014-2018, based on parameters, such as key value drivers, year of acquisition, type of acquisition, geographical location of the acquirer and the acquired company, and financial details of the deal (if available). The analysis also features an ownership change matrix, providing insights on the involvement of private and public sector entities in this domain. In addition, the chapter evaluates the deal multiples of acquisitions specifically focused on bone cement delivery systems, analyzing them based on a number of parameters, namely annual revenues, number of employees and the experience of the acquired company. Moreover, it presents a schematic world map representation of the geographical distribution of this activity, highlighting inter- and intracontinental deals.

Chapter 8 provides insights from a detailed patent analysis, presenting an overview on the filed / granted patents related to bone cement delivery systems since 1976. For this analysis, we looked at the patents that have been published by various players till November 2018. It also highlights the important information and key trends associated with these patents, including patent type (granted patents, patent applications and others), publication year, CPC classification, emerging focus areas (in terms of number of patents filed / granted), type of surgical procedures (arthroplasty, kyphoplasty and vertebroplasty), patent issuing regions, industry type and leading industry / non-industry players (in terms of size of intellectual property portfolio). The chapter also features a valuation analysis taking into consideration older patents, which have expired, highlighting the upcoming opportunity for generic product developers and manufacturers in this domain.

Chapter 9 presents a comprehensive clinical trial analysis of the completed, ongoing and planned studies related to different types of bone cements and associated delivery systems for various surgical procedures. For the purpose of this analysis, we looked at the clinical studies of bone cements and affiliated delivery systems which started in 1997, and analyzed them on the basis of various parameters, such as trial registration year, current trial status, current trial phase, study design, type of surgical procedure, study focus, leading industry and non-industry players, regional distribution, and enrolled patient population across different geographies. In addition, it features an insightful analysis of key clinical end-points of ongoing and planned studies.

Chapter 10 provides information on the various grants that were awarded to research institutes conducting projects related to different types of bone cements, between 2010 and 2018. The analysis also highlights important parameters associated with grants, such as year of award, support period, amount awarded, type of surgical procedures, grant type, responsible study section, focus area, and type of bone cements.

Chapter 11 provides an overview of the demand for bone cement delivery systems across key surgical procedures, including kyphoplasty, vertebroplasty, hip arthroplasty and knee arthroplasty, in the contemporary market. In order to estimate the aforementioned demand, we considered the number of osteoporosis related fractures reported across different geographies, and the subsequent cemented orthopedic procedures used for treatment, which is indicative of the demand. We have also estimated the likely adoption of such products across key surgical procedures, over the period 2019-2030.

Chapter 12 features a comprehensive market forecast, highlighting the future potential of bone cement delivery systems market till 2030, based on multiple parameters, such as prices of systems, surgical procedure / region specific adoption trends, and competitive landscape. We have segregated the current and upcoming opportunity on the basis of [A] surgical procedure(s) (hip arthroplasty, knee arthroplasty, kyphoplasty and vertebroplasty), [B] type of end-user(s) (ambulatory surgery centers, hospitals and specialty clinics), and [C] key geographies (North America (the US, Canada and Mexico), Europe (EU5 countries), Asia-Pacific and Rest of the World (Australia, China, India, and Japan)). It is worth mentioning that we adopted a bottom up approach for this analysis, backing our claims with relevant datapoints and credible inputs from primary research. Market estimates have been provided both in terms of value (USD billion) and volume (units of systems).

Chapter 13 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the bone cement delivery systems market scenario. Further, it captures the evolutionary trends that are likely to determine the future of this segment of the pharmaceutical industry.

Chapter 14 is a collection of interview transcripts of the discussions that were held with key stakeholders in this market. In this chapter, we have presented the details of interviews held with (in alphabetical order of organization names) Soren Toksvig-Larsen (Associate Professor, Department of Orhopedics, Lund University), Francesco De Paola (International Product Manager, Medacta International), and Ana Bettencourt (Associate Professor, University of Lisbon).

Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 16 is an appendix, which contains the list of companies and organizations mentioned in the report.

EXAMPLE HIGHLIGHTS
1.More than 70 bone cement delivery systems are currently available for use across various surgeries to treat osteoporotic fractures. Of these, 45 are intended for vertebroplasty procedures. Examples include (in alphabetical order, no specific selection criteria) CONFIDENCE SPINAL CEMENT SYSTEM®, HIVAC™7, KMC Bone Cement Delivery System, Kyphon™ Cement Delivery System, SpineJack® System, StabiliT® VP Vertebroplasty System and V-HP GUN™ System. This is followed by delivery systems indicated for use in kyphoplasty (39) and arthroplasty (20) procedures.
2.Close to 52% of such systems are compatible with high viscosity bone cements, while others are designed to deliver either low viscosity (25%), or medium viscosity (21%) bone cements. Examples of delivery systems that can be used for the administration of cements of varying viscosities include (in alphabetical order, no specific selection criteria) APV Synicem Vertebroplasty System, CEMEX® SYSTEM, ClearMix™ Vacuum Mixing and Delivery System, MIXIGUN System, Revolution Cement Mixing & Delivery System, Spider Kyphoplasty and Vertebroplasty System®, and Synicem Vertebroplasty System.
3.Of all the companies developing bone cement delivery systems, nearly 50% are small-sized firms (less than 50 employees), 28% are mid-sized players (50-500 employees), and about 22% are large companies (more than 500 employees). Examples of small-sized companies include (in alphabetical order, established after 2005) Biopsybell, BM Korea, G-21, MEDMIX SYSTEMS, Safe Orthopaedics, Skeletal Kinetics, Spirit Spine and Taeyeon Medical.
4.Several non-profit organizations have extended financial support to research efforts in this industry. Many academic institutes are focused on developing advanced types of bone cements, including variants that are loaded with antibiotics and therapeutic nanoparticles. Majority of research grants awarded in the recent past were under the R01 mechanism to support research projects (44%), however, there were a significant number of Small Business Innovation Research (SBIR) grants (34%), indicating that the research of certain players is at a mature stage and may soon be commercialized.
5.Over 13,000 patents pertaining to the bone cement delivery systems have been filed /granted till November 2018. Stakeholders that have filed / have been granted the maximum number of patents in the last 8-10 years include (in decreasing order of number of patents) DePuy Synthes, Medtronic, Zimmer Biomet, Stryker, ConforMIS, Warsaw Orthopedic, Heraeus Medical, Merit Medical, Smith & Nephew, and Tecres.
6.An analysis of clinical studies that are being / have been conducted to evaluate the performance of various bone cements and affiliated delivery systems revealed Europe to be a major research / innovation hub; about 53% of the total number of patients were enrolled across various centers in this region. It is also important to highlight that device performance and pain relief were observed to be the most important clinical endpoints studied across different phases of clinical trials.
7.Over 25 mergers and acquisitions, during 2014-2018, have taken place amongst various stakeholders working in this domain. Examples of acquisition agreements, wherein companies have acquired capabilities related to bone cement delivery systems, include (in reverse chronological order) acquisition of Vexim by Stryker (October 2017), DFine by Merit Medical Systems (July 2016), Biomet by Zimmer (June 2015), CareFusion by Becton Dickinson (March 2015) and ArthroCare by Smith & Nephew (February 2014). Expansion of product portfolio (primarily related to vertebroplasty and kyphoplasty surgeries) emerged as an important value driver in this domain. Further, geographical consolidation was identified as another prominent value driver across a significant number (78%) of such deals.
8.The current annual global demand for bone cement delivery systems is expected to be around 2.9 million units. Driven by the increasing demand, the market for bone cement delivery systems is expected to grow at an annualized rate of over 6% between 2019 and 2030. Devices intended primarily for use in knee arthroplasty surgeries are expected to capture the majority share (over 60%) in the market; however, the revenues generated by devices intended for kyphoplasty surgeries are anticipated to grow at a relatively faster rate (10%). Additionally, major share (over 70%) of revenues is anticipated to be distributed between North America (primarily the US) and Europe.
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