Spinal Fusion: Implanted Instrumentation/media/informa...Spinal Fusion: Implanted Instrumentation...

Spinal Fusion: Implanted InstrumentationUS, five major European markets, Japan, and Rest of World

August 2020

REPORT EXTRACT

2 / November 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)

©2020 Meddevicetracker i #MDT20010

Spinal Fusion: Implanted Instrumentation Table of Contents

Executive Summary ..................................................................................... ES-1

i. Spinal fusion implanted instrumentation market .................................................................... ES-1

a. Selected market drivers and limiters ................................................................... ES-4

b. Market leaders ..................................................................................................... ES-4

ii. Methodology ........................................................................................................................... ES-5

Exhibit ES-1: Spinal fusion instrumentation, combined market forecast, by segment,

2019-24 ......................................................................................................................... ES-2

Exhibit ES-2: Spinal fusion instrumentation, combined market forecast, by region ($m),

2019-24 ......................................................................................................................... ES-3

1. Clinical Overview ...................................................................................... 1-1

1.1 Spinal anatomy ....................................................................................................................... 1-3

1.2 Selected spinal disorders ........................................................................................................ 1-7

1.2.1 Disc herniation ................................................................................................. 1-7

1.2.2 Degenerative disc disease ................................................................................ 1-8

1.2.3 Abnormal curvature of the spine ................................................................... 1-12

1.2.4 Spondylolisthesis............................................................................................ 1-13

1.2.5 Stenosis .......................................................................................................... 1-14

1.2.6 Spinal tumors ................................................................................................. 1-14

1.2.7 Traumatic spinal injuries ................................................................................ 1-15

1.3 Spinal fusion ......................................................................................................................... 1-15

1.3.1 Procedure volumes ........................................................................................ 1-16

1.4 Bibliography .......................................................................................................................... 1-20

Exhibit 1-1: Low back pain prevalence in the US, Japan, and five major European markets,

2010 and 2017 ................................................................................................................. 1-1

Exhibit 1-2: Low back pain, disability-adjusted life years, in the US, Japan, and five major

European markets, 2017.................................................................................................. 1-2

Exhibit 1-3: Neck pain prevalence in the US, Japan, and five major European markets,

2010 and 2017 ................................................................................................................. 1-3

Exhibit 1-4: The human spine .............................................................................................................. 1-6

Exhibit 1-5: Osteoarthritis prevalence in the US, Japan, and five major European markets,

2010 and 2017 ................................................................................................................ 1-10

Exhibit 1-6: Forecast for prevalent cases of osteoporosis in the US, Japan, and five major

European markets, by country, 2019–24 ....................................................................... 1-12


©2020 Meddevicetracker ii #MDT20010


Exhibit 1-7: Spinal fusion, procedure volumes forecast, in the US, Japan, and five major

European markets, 2019–24 .......................................................................................... 1-17

2. Spinal Fusion: Implanted Instrumentation Market.................................... 2-1

2.1 Spinal fusion implanted instrumentation, combined market analysis ................................... 2-1

2.2 Spinal plating systems ............................................................................................................ 2-5

2.2.1 Products ........................................................................................................... 2-6

2.2.2 Market analysis ................................................................................................ 2-9

2.2.3 Competitive analysis ...................................................................................... 2-12

2.3 Interbody fusion devices ...................................................................................................... 2-14

2.3.1 Products ......................................................................................................... 2-15

2.3.2 Market analysis .............................................................................................. 2-21


2.4 Pedicle screws/posterior spinal fixation devices .................................................................. 2-25

2.4.1 Products ......................................................................................................... 2-26

2.4.2 Market analysis .............................................................................................. 2-31


2.5 Spinal fusion implanted instrumentation market, competitive analysis ............................. 2-34

2.5.1 Medtronic ...................................................................................................... 2-34

2.5.2 DePuy Synthes/Johnson & Johnson ............................................................... 2-37

2.5.3 Stryker ............................................................................................................ 2-38

2.5.4 Other leading competitors ............................................................................. 2-39

2.6 Bibliography .......................................................................................................................... 2-43

Exhibit 2-1: Spinal fusion instrumentation, combined market forecast, by segment, 2019–24 ......... 2-4

Exhibit 2-2: Classification of anterior column plates ........................................................................... 2-5

Exhibit 2-3: Selected spinal plating systems ........................................................................................ 2-6

Exhibit 2-4: Medtronic’s Atlantis Vision Elite anterior cervical plate system ...................................... 2-9

Exhibit 2-5: Spinal plating systems, market forecast ($m), by region, 2019–24 ............................... 2-11

Exhibit 2-6: Spinal plating systems, share by supplier, 2019 ............................................................. 2-13

Exhibit 2-7: DePuy Synthes’ BENGAL stackable cage system ............................................................ 2-14

Exhibit 2-8: Selected minimally invasive interbody fusion systems .................................................. 2-17

Exhibit 2-9: Selected interbody fusion and spacer devices ............................................................... 2-18

Exhibit 2-10: Interbody fusion devices, market forecast ($m), by region, 2019–24 ......................... 2-22

Exhibit 2-11: Intervertebral body fusion devices, share by supplier, 2019 ....................................... 2-24


©2020 Meddevicetracker iii #MDT20010


Exhibit 2-12: Selected thoracolumbar fixation/pedicle screw systems ............................................ 2-26

Exhibit 2-13: ATEC Spine’s Arsenal spinal fixation system ................................................................ 2-29

Exhibit 2-14: Selected posterior cervicothoracic fixation and pedicle screw systems ...................... 2-30

Exhibit 2-15: Pedicle screw/posterior fixation systems, market forecast ($m), by region,

2019–24 ....................................................................................................................... 2-32

Exhibit 2-16: Pedicle screw/posterior fixation systems, share by supplier, 2019 ............................. 2-33

Exhibit 2-17: Medtronic net sales ($m), by product category and geography, FY2018–20 .............. 2-35

Exhibit 2-18: Johnson & Johnson net sales ($m), by product category and geography, 2017–19 .... 2-37

Exhibit 2-19: Stryker net sales ($m), by product category and geography, 2017–19 ....................... 2-39

Exhibit 2-20: Zimmer Biomet net sales ($m), by product category and geography, 2017–19 .......... 2-40

Exhibit 2-21: NuVasive net sales ($m), by product category and geography, 2017–19 .................... 2-41

Exhibit 2-22: Globus Medical net sales ($m), by product category and geography, 2017–19 .......... 2-42

APPENDIX: COMPANY LISTING ................................................................................................ A-1


©2020 Meddevicetracker ES-1 #MDT20010

Spinal Fusion: Implanted Instrumentation Market Executive Summary

Executive Summary This medical market and technology report provides a comprehensive discussion of implanted instrumentation for spinal fusion. This market consists of:

• spinal plating systems • intervertebral body fusion devices (IBFDs) • pedicle screw/posterior spinal fixation systems.

Markets covered by this analysis comprise the US, Japan, the five major European markets (France, Germany, Italy, Spain, and the UK), and the rest of world (RoW) markets, which includes all other countries. This report provides the following useful information:

• back pain prevalence data • osteoporosis prevalence data • spinal fusion procedure volumes • an overview of spinal fusion implanted instrumentation technology • related product portfolios offered by leading manufacturers • in-depth market and competitive analyses.

i. Spinal fusion implanted instrumentation market Spinal instrumentation is used by surgeons to stabilize the spine during the bone fusion process. Spinal plating systems and screws are used in conjunction with bone graft material to reduce the motion between the graft and vertebral body endplate, and to facilitate fusion. IBFDs are hollow, threaded cylinders that are placed into the space created between the bodies of adjacent vertebrae following a fusion-related discectomy. These devices are used in conjunction with allograft, autograft, or synthetic bone material, and provide mechanical support and spacing during the fusion healing process. Pedicle screw/posterior fixation systems are multicomponent devices (consisting of hooks, rods, connectors, bridges, and screws) made of cobalt chrome, polyetheretherketone (PEEK), stainless steel, titanium, or titanium alloy. Pedicle screws are designed and sized to anchor in the intraosteal space of the pedicles. Pedicle screw/posterior fixation systems are indicated for the treatment of degenerative disease, spinal deformities, and trauma, to immobilize and stabilize the spine in skeletally mature patients, and for use in conjunction with a spinal fusion procedure. In 2019, global sales of implanted instrumentation for spinal fusion procedures were estimated at $4.4bn (or $4,426.4m); of this, 49% was attributed to pedicle screw systems, 30% was attributed to IBFDs, and the remaining 21% to spinal plating systems. Over the forecast period covered by this analysis, total sales are expected to increase at a compound annual growth rate (CAGR) of 2.2%, reaching $4.9bn (or $4,933.3m) in 2024. Exhibit ES-1 presents the global spinal fusion implanted instrumentation market forecast, by segment, for 2019–24.




Exhibit ES-1: Spinal fusion instrumentation, combined market forecast ($m), by segment, 2019–24

Year Plating systems

IBFDs Pedicle screw systems

Total sales ($m)

2019 948.5 1,322.8 2,155.1 4,426.4

2020 781.0 1,102.6 1,800.8 3,684.4

2021 973.0 1,358.7 2,211.8 4,543.5

2022 991.6 1,403.8 2,272.2 4,667.6

2023 1,010.9 1,450.4 2,336.2 4,797.5

2024 1,033.4 1,498.7 2,401.2 4,933.3

CAGR (2019–24)

1.7% 2.5% 2.2% 2.2%

Note: CAGR = compound annual growth rate; IBFD = intervertebral body fusion device Source: Meddevicetracker; company financials

Geographically, the US accounted for 57% of the market in 2019 (or $2,531.3m), the five major European markets accounted for 16% of sales (or $696.8m), the RoW markets for 18% ($802.2m), and Japan for 9% ($396.1m). Over the forecast period covered by this analysis, the RoW market is projected to grow at a 3.1% CAGR, followed by Japan (2.8% CAGR), the US (2.0% CAGR), and the five major European markets (1.6% CAGR). Exhibit ES-2 presents the global spinal fusion implanted instrumentation market forecast, by region, for 2019–24.

0500

1,0001,5002,0002,5003,0003,5004,0004,5005,000

2019 2020 2021 2022 2023 2024

Sale

s ($m

)

Spinal plating systems IBFDs Pedicle screw systems




Exhibit ES-2: Spinal fusion instrumentation, combined market forecast ($m), by region, 2019–24

Year US 5 Euro Japan RoW Total sales

($m) 2019 2,531.3 696.8 396.1 802.2 4,426.4

2020 2,063.0 599.2 352.5 669.7 3,684.4

2021 2,594.5 710.8 408.0 830.2 4,543.5

2022 2,658.0 724.5 420.9 864.2 4,667.6

2023 2,723.2 738.6 436.2 899.5 4,797.5

2024 2,790.2 753.0 453.8 936.3 4,933.3

CAGR (2019–24) 2.0% 1.6% 2.8% 3.1% 2.2%

Notes: 5 Euro = five major European markets (France, Germany, Italy, Spain, and the UK); CAGR = compound annual growth rate; RoW = rest of world Source: Meddevicetracker; company financials

0

1,000

2,000

3,000

4,000

5,000

6,000

2019 2020 2021 2022 2023 2024

Sale

s ($m

)

US 5 Euro Japan RoW




a. Selected market drivers and limiters The global market for spinal fusion instrumentation has been significantly affected by the COVID-19 pandemic, which led to a severe decline in spinal fusion procedure volumes in 2020 as many hospitals stopped performing deferrable procedures. Meddevicetracker projects that spinal fusion procedure volumes will increase at a 1.3% CAGR during the 2019–24 forecast period, significantly declining in 2020, but rebounding in 2021 and increasing in the low single digits thereafter. The aging of the population and rising prevalence of degenerative disc disease will drive spinal fusion procedure volume growth. Other factors that will contribute to growth of the spinal fusion implanted instrumentation market during the forecast period include the increasing use of minimally invasive surgery; the launch of new enabling technology, such as diagnostic, nerve monitoring, and navigation systems (including robotic-assisted surgery); and new surgical techniques and associated instrumentation that have expanded the range of product indications. Future growth of the global market for spinal fusion instrumentation may be limited, however, by pricing pressures (exacerbated by a gradual shift of spinal fusion procedures to the ambulatory surgery center setting), competition from motion-preserving implants such as artificial intervertebral discs, and improved treatment of osteoporosis through medications. b. Market leaders The global market for implanted instrumentation for spinal fusion is highly fragmented among several companies, including pure play spine companies, spine and orthopedics manufacturers, and multinational device conglomerates. In 2019, Medtronic was the leading competitor in the market, with estimated sales of $823m, holding a leading spot in the pedicle screws market (with $556.9m in sales and a 26% share), a leading spot in spinal plating (with $97.5m in sales and a 10% share), and fourth position in the IBFDs market (with $168.3m in sales and a 13% share). The second-leading competitor in the combined market for spinal fusion implanted instrumentation in 2019 was Stryker, with an estimated $636.2m in sales. Stryker was the leading competitor in the IBFDs market (with $279m in sales and a 21% share), the second-leading competitor in spinal plating (with $82m in sales and an 8.6% share), and the third-leading competitor in the pedicle screws market (with $275.2m in sales and a 13% share). DePuy Synthes/Johnson & Johnson was the third-leading competitor in the market in 2019, with approximately $246.5m in pedicle screw sales and an 11.4% share, $210.7m in IBFD sales and a 16% share, and $54.2m in spinal plating system sales and a 6% share. Other leading competitors included Zimmer Biomet, NuVasive, ATEC Spine, Orthofix, and B. Braun Melsungen, among others.

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