Biologic and biochemical products with application across orthopedics.
January 2024
Mike Evers, Senior Market Analyst
Welcome to our orthobiologics market report. This page supplements the orthobiologics chapter in THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT®. This segment has a broad reach into many areas of orthopedics that saw elevated growth rates as the market rebounded from a period of disruption.
Orthobiologics sales surpassed $5.5 billion in 2023 and account for 9.4% of the $59 billion global orthopedics market. Rebounding surgical volumes helped the orthobiologics segment surpass its historical growth rate. Reimbursement changes and volume-based procurement in other areas of orthopedics offset some of orthobiologics’ growth potential.
We’re cautiously optimistic that the orthobiologics market has some remaining upside with accelerated growth into early 2025 after which it settles into its normal growth rate just over 2%. We project that the market will reach $5.5 billion in 2023 and $6.2 billion in 2026.
Exhibit 1: Worldwide Orthobiologics Sales by Year ($millions)
Get More Orthopedic Market Data. Download the Orthopedic Revenue Matrix for our most complete and granular numbers. It contains worldwide orthopedic sales for 68 public and private companies by segment from 2016 through 2023.
Patient demographics, short-term market headwinds and volume-based procurement (VBP) in China are among the factors we considered in our orthobiologics forecast.
Osteoarthritis (OA) affects 32.5 million adults in the U.S., with an overall economic burden of $137 billion annually, according to CDC estimates. The economic burden has more than doubled over the last decade. Additionally, research suggests that arthritis-related activity limitations contribute to the lower employment rates of working-age people with OA. The number of impacted adults in the U.S. could double by 2040. Orthobiologics for OA pain will see sustained, robust demand.
Biologics is a significant investment area for us in sports medicine. It is still early innings of what we can do with regenerative in terms of getting it broadly adopted into the market.
Market disruption in 2023 hit orthobiologics directly and indirectly via associated segments like spine and sports medicine. Supply constraints impacted industry-wide allograft availability in the second half of 2023. Major players like Bioventus and Orthofix faced leadership challenges that led to more uncertainty in the market. Ongoing geopolitical instability and inflationary pressures could extend these headwinds through 2024.
The Chinese government will expand its nationalized VBP tender policy to sports medicine in 2024. The competitive dynamics under VBP shift significant market share to domestic Chinese companies. Smith+Nephew initially expected the tender to cover joint repair only but has since said the scope looks wider than it appeared from the initial data request. The company estimates VBP will impact around 2% of its total sales.
Players like Medtronic, NuVasive and Orthofix saw more stable international ordering patterns in 2023 than the previous year. Additionally, a national VBP tender in China for spinal implants could further alter traditional ordering patterns of biologics.
We’re taking out some of our selling and marketing costs in China to offset the lower prices, because this business is now more contracted through VBP. The discounts have gotten lower as they have gone on. So that’s good. We will reset our business and grow from there, but next year will be another where China is a bit of a headwind.
The U.S. accounted for 70% of orthobiologics market sales and surpassed $3.8 billion in 2023, while OUS markets amassed $1.7 billion in orthobiologics sales.
Exhibit 2: Orthobiologics Sales by Region ($millions)
Region | FY23 | FY22 | $ Chg | % Chg |
---|---|---|---|---|
US | $3,859.1 | $3,706.6 | $152.5 | 4.1% |
OUS | $1,669.7 | $1,611.3 | $58.4 | 3.6% |
EMEA | $906.7 | $866.8 | $39.9 | 4.6% |
APAC | $613.7 | $600.9 | $12.8 | 2.1% |
ROW | $149.3 | $143.6 | $5.7 | 4% |
Total | $5,528.8 | $5,317.9 | $210.8 | 4% |
Exhibit 3: Orthobiologics Market Share by Region ($millions)
The orthobiologics market is diverse and fragmented. Unlike other segments in orthopedics, no one player dominates orthobiologics. All players hold a market share position under 10%. Companies that generated less than $50 million in annual sales make up almost 30% of the market.
While it can be a challenging space to penetrate, the clinical promise and virtually untapped opportunity of regenerative medicine make it an attractive segment for innovative startups.
Exhibit 4: Top 10 Orthobiologics Players and All Others ($millions)
Company | FY23E | FY22A | $ Chg | % Chg |
---|---|---|---|---|
Medtronic | $526.0 | $496.7 | $29.3 | 5.9% |
MTF Biologics | $397.1 | $388.9 | $8.2 | 2.1% |
DePuy Synthes | $341.2 | $341.1 | $0.1 | 0% |
Bioventus | $325.8 | $326.3 | ($0.5) | (0.2%) |
Stryker | $321.6 | $308.7 | $12.9 | 4.2% |
Sanofi | $284.2 | $299.8 | ($15.6) | (5.2%) |
Arthrex | $270.4 | $262.3 | $8.1 | 3.1% |
Zimmer Biomet | $216.6 | $232.4 | ($15.8) | (6.8%) |
Globus Medical * | $206.7 | $203.0 | $3.7 | 1.8% |
Heraeus | $188.0 | $179.2 | $8.8 | 4.9% |
All Others | $2,451.2 | $2,279.6 | $171.6 | 7.5% |
Segment Total | $5,528.8 | $5,317.9 | $210.9 | 4% |
Exhibit 5: Orthobiologics Market Share by Company ($millions)
* On a pro forma basis.
We estimate that the orthobiologics market grew +4% in 2023 as improved procedure volumes offset macro headwinds. Medtronic’s orthobiologics sales rebounded after a tough 2022 beset by supply shortages, difficult prior-year comparisons in the U.S. and disrupted customer ordering patterns ahead of a potential spine VBP tender in China.
Bioventus saw its strong sales offset by viscosupplement reimbursement changes, but the company turned a corner toward growth in late 2023. Vericel won an accelerated regulatory pathway for arthroscopic delivery of MACI, while the merger of SeaSpine and Orthofix created a wide-ranging biologics portfolio.
The company’s next-generation Cingal product could potentially double Anika’s already $1 billion market opportunity served by Monovisc and Orthovisc. Cingal continued its strong international performance in 2023, including double-digit growth in the third quarter. While its OA pain revenue stream can be lump quarter-to-quarter, Anika expects above-market growth in the segment for 2024.
Cingal is truly becoming the next-generation non-opioid OA pain product of choice in over 35 markets outside the U.S., and we're looking forward to U.S. market approval. We are pleased to have had a Type C meeting with FDA in the second quarter as we actively engage with them toward U.S. approval.
Reimbursement for hyaluronic acid products shifted from wholesale acquisition cost to average selling price in the second half of 2022. The change particularly impacted Bioventus’ Gelsyn 3-injection product as customers delayed purchases to await lower pricing or shifted to competitive products. However, Bioventus said it loves its position in the market and expects improving price trends and share gain to produce mid-single-digit growth in 2024.
SeaSpine’s messaging over the past two years has been decidedly against expensive biologics like BMP and cellular technologies. The company’s focus on cost-effective demineralized bone matrix products isn’t wholly aligned with Orthofix’s philosophy and portfolio. Since the merger, the combined Orthofix reframed its biologics portfolio as a boon for surgeon preference and reaffirmed the value of its MTF Biologics partnership.
Thanks for visiting! Need more insight into the orthobiologics market? Questions and comments are always welcome. You can reach me by email. Until then, check out this selection of orthobiologics-related posts from recent months.
Our overview of the $5.5 billion orthobiologics market includes up-to-date information on forecasted growth, the top companies and industry-driving trends.
Biologic and biochemical products with application across orthopedics.
January 2024
Mike Evers, Senior Market Analyst
Welcome to our orthobiologics market report. This page supplements the orthobiologics chapter in THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT®. This segment has a broad reach into many areas of orthopedics that saw elevated growth rates as the market rebounded from a period of disruption.
Orthobiologics sales surpassed $5.5 billion in 2023 and account for 9.4% of the $59 billion global orthopedics market. Rebounding surgical volumes helped the orthobiologics segment surpass its historical growth rate. Reimbursement changes and volume-based procurement in other areas of orthopedics offset some of orthobiologics’ growth potential.
We’re cautiously optimistic that the orthobiologics market has some remaining upside with accelerated growth into early 2025 after which it settles into its normal growth rate just over 2%. We project that the market will reach $5.5 billion in 2023 and $6.2 billion in 2026.
Exhibit 1: Worldwide Orthobiologics Sales by Year ($millions)
Get More Orthopedic Market Data. Download the Orthopedic Revenue Matrix for our most complete and granular numbers. It contains worldwide orthopedic sales for 68 public and private companies by segment from 2016 through 2023.
Patient demographics, short-term market headwinds and volume-based procurement (VBP) in China are among the factors we considered in our orthobiologics forecast.
Osteoarthritis (OA) affects 32.5 million adults in the U.S., with an overall economic burden of $137 billion annually, according to CDC estimates. The economic burden has more than doubled over the last decade. Additionally, research suggests that arthritis-related activity limitations contribute to the lower employment rates of working-age people with OA. The number of impacted adults in the U.S. could double by 2040. Orthobiologics for OA pain will see sustained, robust demand.
Biologics is a significant investment area for us in sports medicine. It is still early innings of what we can do with regenerative in terms of getting it broadly adopted into the market.
Market disruption in 2023 hit orthobiologics directly and indirectly via associated segments like spine and sports medicine. Supply constraints impacted industry-wide allograft availability in the second half of 2023. Major players like Bioventus and Orthofix faced leadership challenges that led to more uncertainty in the market. Ongoing geopolitical instability and inflationary pressures could extend these headwinds through 2024.
The Chinese government will expand its nationalized VBP tender policy to sports medicine in 2024. The competitive dynamics under VBP shift significant market share to domestic Chinese companies. Smith+Nephew initially expected the tender to cover joint repair only but has since said the scope looks wider than it appeared from the initial data request. The company estimates VBP will impact around 2% of its total sales.
Players like Medtronic, NuVasive and Orthofix saw more stable international ordering patterns in 2023 than the previous year. Additionally, a national VBP tender in China for spinal implants could further alter traditional ordering patterns of biologics.
We’re taking out some of our selling and marketing costs in China to offset the lower prices, because this business is now more contracted through VBP. The discounts have gotten lower as they have gone on. So that’s good. We will reset our business and grow from there, but next year will be another where China is a bit of a headwind.
The U.S. accounted for 70% of orthobiologics market sales and surpassed $3.8 billion in 2023, while OUS markets amassed $1.7 billion in orthobiologics sales.
Exhibit 2: Orthobiologics Sales by Region ($millions)
Region | FY23 | FY22 | $ Chg | % Chg |
---|---|---|---|---|
US | $3,859.1 | $3,706.6 | $152.5 | 4.1% |
OUS | $1,669.7 | $1,611.3 | $58.4 | 3.6% |
EMEA | $906.7 | $866.8 | $39.9 | 4.6% |
APAC | $613.7 | $600.9 | $12.8 | 2.1% |
ROW | $149.3 | $143.6 | $5.7 | 4% |
Total | $5,528.8 | $5,317.9 | $210.8 | 4% |
Exhibit 3: Orthobiologics Market Share by Region ($millions)
The orthobiologics market is diverse and fragmented. Unlike other segments in orthopedics, no one player dominates orthobiologics. All players hold a market share position under 10%. Companies that generated less than $50 million in annual sales make up almost 30% of the market.
While it can be a challenging space to penetrate, the clinical promise and virtually untapped opportunity of regenerative medicine make it an attractive segment for innovative startups.
Exhibit 4: Top 10 Orthobiologics Players and All Others ($millions)
Company | FY23E | FY22A | $ Chg | % Chg |
---|---|---|---|---|
Medtronic | $526.0 | $496.7 | $29.3 | 5.9% |
MTF Biologics | $397.1 | $388.9 | $8.2 | 2.1% |
DePuy Synthes | $341.2 | $341.1 | $0.1 | 0% |
Bioventus | $325.8 | $326.3 | ($0.5) | (0.2%) |
Stryker | $321.6 | $308.7 | $12.9 | 4.2% |
Sanofi | $284.2 | $299.8 | ($15.6) | (5.2%) |
Arthrex | $270.4 | $262.3 | $8.1 | 3.1% |
Zimmer Biomet | $216.6 | $232.4 | ($15.8) | (6.8%) |
Globus Medical * | $206.7 | $203.0 | $3.7 | 1.8% |
Heraeus | $188.0 | $179.2 | $8.8 | 4.9% |
All Others | $2,451.2 | $2,279.6 | $171.6 | 7.5% |
Segment Total | $5,528.8 | $5,317.9 | $210.9 | 4% |
Exhibit 5: Orthobiologics Market Share by Company ($millions)
* On a pro forma basis.
We estimate that the orthobiologics market grew +4% in 2023 as improved procedure volumes offset macro headwinds. Medtronic’s orthobiologics sales rebounded after a tough 2022 beset by supply shortages, difficult prior-year comparisons in the U.S. and disrupted customer ordering patterns ahead of a potential spine VBP tender in China.
Bioventus saw its strong sales offset by viscosupplement reimbursement changes, but the company turned a corner toward growth in late 2023. Vericel won an accelerated regulatory pathway for arthroscopic delivery of MACI, while the merger of SeaSpine and Orthofix created a wide-ranging biologics portfolio.
The company’s next-generation Cingal product could potentially double Anika’s already $1 billion market opportunity served by Monovisc and Orthovisc. Cingal continued its strong international performance in 2023, including double-digit growth in the third quarter. While its OA pain revenue stream can be lump quarter-to-quarter, Anika expects above-market growth in the segment for 2024.
Cingal is truly becoming the next-generation non-opioid OA pain product of choice in over 35 markets outside the U.S., and we're looking forward to U.S. market approval. We are pleased to have had a Type C meeting with FDA in the second quarter as we actively engage with them toward U.S. approval.
Reimbursement for hyaluronic acid products shifted from wholesale acquisition cost to average selling price in the second half of 2022. The change particularly impacted Bioventus’ Gelsyn 3-injection product as customers delayed purchases to await lower pricing or shifted to competitive products. However, Bioventus said it loves its position in the market and expects improving price trends and share gain to produce mid-single-digit growth in 2024.
SeaSpine’s messaging over the past two years has been decidedly against expensive biologics like BMP and cellular technologies. The company’s focus on cost-effective demineralized bone matrix products isn’t wholly aligned with Orthofix’s philosophy and portfolio. Since the merger, the combined Orthofix reframed its biologics portfolio as a boon for surgeon preference and reaffirmed the value of its MTF Biologics partnership.
Thanks for visiting! Need more insight into the orthobiologics market? Questions and comments are always welcome. You can reach me by email. Until then, check out this selection of orthobiologics-related posts from recent months.
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