Orthobiologics Market Size and Share
Market Definition
Biologic and biochemical products with application across orthopedics.
November 2023
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, so I’ll have plenty of updates in late November as we build our year-end projections. See you soon!
The Market at a Glance
Orthobiologics sales surpassed $5.3 billion in 2022 and account for 9.6% of the $55 billion global orthopedics market. A return to normal surgical volumes helped the orthobiologics segment rebound toward its historical growth rate.
While the situation remains dynamic, we believe volumes in this portion of the market have largely stabilized. However, disrupted ordering patterns and reimbursement changes offset some of the procedure volume recovery.
Market Forecast
We’re cautiously optimistic that the orthobiologics market can maintain 2% growth in the coming years. We project that the market will reach $5.4 billion in 2023 and $5.7 billion in 2026.
Exhibit 1: Worldwide Orthobiologics Sales by Year ($millions)
Get More Orthopedic Market Data. Download the Orthopedic Revenue Matrix for our most complete and granular numbers. It contains worldwide orthopedic sales for 67 public and private companies by segment from 2016 through 2022.
Patient demographics, new regenerative treatments and volume-based procurement (VBP) in China are among the factors we considered in our orthobiologics forecast.
Highly Favorable Demographics
Orthobiologics benefit from highly favorable patient demographics. According to Bioventus, 50 million people in the U.S. live with chronic pain. By 2040 more than 78 million people will suffer from osteoarthritis, and the number of Americans older than 65 will increase by 50% to 81 million. Orthobiologics are used to treat various stages of osteoarthritis.
While there have been minor modifications in the implant space, I do not foresee any drastic improvements in the immediate future. Therefore, we need to focus on fracture augmentation, and I believe orthobiologics are the next step.
Philipp Leucht, M.D., Ph.D, NYU Langone Health Associate Professor of Orthopedic Surgery and Cell Biology
Regenerative Treatments
Regenerative products that focus on healing and augmentation represent a fast-growing, high-margin market with underserved patients. Companies from global corporations to small-team startups are investing in the regenerative space.
While orthopedic M&A slowed in 2022, orthobiologics was the most active segment thanks in part to regenerative products, as indicated by CONMED’s purchase of Biorez. Smith+Nephew CEO Deepak Nath said, “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.”
Spine National VBP Tender in China
Medtronic’s sales in China were disrupted in advance of a potential spine national VBP tender, as customer ordering patterns led to midteen declines in orthobiologics sales in the middle of 2022.
Previous tenders drastically reduced implant prices, which overwhelmingly shifted volume to domestic companies and forced some large players like Smith+Nephew and ZimVie out of the Chinese market. VBP significantly changes the economics of the Chinese market and makes it far more difficult for international players to thrive there.
Other Segment Reports
Orthopedic Market Overview
October 26, 2023
Joint Replacement Implant Market
October 26, 2023
Spine Implant Market
October 26, 2023
Trauma Implant Market
October 26, 2023
Sports Medicine Market
October 26, 2023
Enabling Technology Market
October 26, 2023
Sales by Region
Surgical volumes were pressured in early 2022 from lingering COVID surges from the year before. Those surges significantly impacted APAC markets. Players like Medtronic, NuVasive and Orthofix cited disruption in international ordering patterns.
Additionally, a national VBP tender in China is likely for spinal implants and could further alter traditional ordering patterns of biologics. Highly globalized players also experienced mid-single-digit currency headwinds in 2022 due to the strengthening U.S. dollar.
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.
Geoffrey Martha, Medtronic CEO
The U.S. accounted for 70% of orthobiologics market sales and surpassed $3.7 billion in 2022, while OUS markets amassed $1.6 billion in orthobiologics sales.
Exhibit 2: Orthobiologics Sales by Region ($millions)
| Region | FY22 | FY21 | $ Chg | % Chg |
|---|---|---|---|---|
| US | $3,706.6 | $3,596.7 | $109.9 | 3.1% |
| OUS | $1,611.3 | $1,615.9 | ($4.6) | (0.3%) |
| EMEA | $866.8 | $860.1 | $6.7 | 0.8% |
| APAC | $600.9 | $609.9 | ($9.0) | (1.5%) |
| ROW | $143.6 | $146.0 | ($2.4) | (1.6%) |
| Total | $5,317.9 | $5,212.6 | $105.3 | 2% |
Exhibit 3: Orthobiologics Market Share by Region ($millions)
Top Companies
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 $50 million in annual sales make up 44% of the market.
While it can be a challenging space to penetrate, the clinical promise and virtually untapped opportunity of regenerative medicine makes it an attractive segment for innovative startups.
Exhibit 4: Top 10 Orthobiologics Players and All Others ($millions)
| Company | FY22 | FY21 | $ Chg | % Chg |
|---|---|---|---|---|
| Medtronic | $493.8 | $529.0 | ($35.2) | (6.7%) |
| MTF Biologics | $388.9 | $375.0 | $13.9 | 3.7% |
| Bioventus | $331.1 | $300.1 | $31.1 | 10.4% |
| Stryker | $308.7 | $295.1 | $13.6 | 4.6% |
| Sanofi | $299.8 | $295.9 | $3.8 | 1.3% |
| DePuy Synthes | $289.6 | $298.3 | ($8.8) | (2.9%) |
| Arthrex | $262.3 | $251.0 | $11.3 | 4.5% |
| Zimmer Biomet | $232.4 | $235.4 | ($3.1) | (1.3%) |
| Heraeus | $179.2 | $168.8 | $10.5 | 6.2% |
| LifeNet Health | $175.6 | $166.6 | $9.0 | 5.4% |
| All Others | $2,356.6 | $2,297.3 | $59.3 | 2.6% |
| Total | $5,317.9 | $5,212.6 | $105.3 | 2% |
Exhibit 5: Orthobiologics Market Share by Company ($millions)
We estimate that the orthobiologics market grew +2% in 2022 as improved procedure volumes offset macro headwinds. Medtronic’s orthobiologics sales declined due to 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. Vericel won an accelerated regulatory pathway for arthroscopic delivery of MACI, while the merger of SeaSpine and Orthofix created a wide-ranging biologics portfolio.
Important Developments in the Orthobiologics Market
Bioventus Struggles to Finance CartiHeal Acquisition
In mid-2022, Bioventus amended its agreement with CartiHeal to reduce upfront cash consideration to $50 million, with the remaining $215 million payable upon certain dates or milestones. Bioventus completed the acquisition in July 2022.
After recording a $189 million goodwill impairment on its third-quarter earnings, Bioventus announced that it had entered into a settlement agreement and release from future claims with the former CartiHeal shareholders in February 2023. CartiHeal’s Agili-C received Premarket Approval in 2022 and is expected to be a disruptive technology for the cartilage repair market.
Reimbursement Changes for Viscosupplements
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. The company weathered volatility through the first half of 2023.
Other players like Anika Therapeutics weren’t impacted by the change, as they already operated under average selling price, thanks to the pharmaceutical company roots of its sales partner J&J Mitek.
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.
Dr. Cheryl Blanchard, Anika Therapeutics CEO
SeaSpine and Orthofix Merger Creates Diverse Biologics Portfolio
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.
Further Reading
Thanks for visiting! Need more insight into the orthobiologics market? Questions and comments are always welcome. You can reach me by email. I’ll be back soon with updates to this page as we complete our projections for the 2023 finish.
Until then, check out this selection of orthobiologics-related posts from recent months.
September 19, 2023
,
Julie A. Vetalice
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. Orthobiologics sales surpassed $5.3 billion in 2022 and account for 9.6% of the $55 billion global orthopedics market. A return to normal surgical volumes helped the orthobiologics segment rebound toward its historical growth rate in 2023.
Market Definition
Biologic and biochemical products with application across orthopedics.
November 2023
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, so I’ll have plenty of updates in late November as we build our year-end projections. See you soon!
The Market at a Glance
Orthobiologics sales surpassed $5.3 billion in 2022 and account for 9.6% of the $55 billion global orthopedics market. A return to normal surgical volumes helped the orthobiologics segment rebound toward its historical growth rate.
While the situation remains dynamic, we believe volumes in this portion of the market have largely stabilized. However, disrupted ordering patterns and reimbursement changes offset some of the procedure volume recovery.
Market Forecast
We’re cautiously optimistic that the orthobiologics market can maintain 2% growth in the coming years. We project that the market will reach $5.4 billion in 2023 and $5.7 billion in 2026.
Exhibit 1: Worldwide Orthobiologics Sales by Year ($millions)
Get More Orthopedic Market Data. Download the Orthopedic Revenue Matrix for our most complete and granular numbers. It contains worldwide orthopedic sales for 67 public and private companies by segment from 2016 through 2022.
Patient demographics, new regenerative treatments and volume-based procurement (VBP) in China are among the factors we considered in our orthobiologics forecast.
Highly Favorable Demographics
Orthobiologics benefit from highly favorable patient demographics. According to Bioventus, 50 million people in the U.S. live with chronic pain. By 2040 more than 78 million people will suffer from osteoarthritis, and the number of Americans older than 65 will increase by 50% to 81 million. Orthobiologics are used to treat various stages of osteoarthritis.
While there have been minor modifications in the implant space, I do not foresee any drastic improvements in the immediate future. Therefore, we need to focus on fracture augmentation, and I believe orthobiologics are the next step.
Philipp Leucht, M.D., Ph.D, NYU Langone Health Associate Professor of Orthopedic Surgery and Cell Biology
Regenerative Treatments
Regenerative products that focus on healing and augmentation represent a fast-growing, high-margin market with underserved patients. Companies from global corporations to small-team startups are investing in the regenerative space.
While orthopedic M&A slowed in 2022, orthobiologics was the most active segment thanks in part to regenerative products, as indicated by CONMED’s purchase of Biorez. Smith+Nephew CEO Deepak Nath said, “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.”
Spine National VBP Tender in China
Medtronic’s sales in China were disrupted in advance of a potential spine national VBP tender, as customer ordering patterns led to midteen declines in orthobiologics sales in the middle of 2022.
Previous tenders drastically reduced implant prices, which overwhelmingly shifted volume to domestic companies and forced some large players like Smith+Nephew and ZimVie out of the Chinese market. VBP significantly changes the economics of the Chinese market and makes it far more difficult for international players to thrive there.
Other Segment Reports
Orthopedic Market Overview
October 26, 2023
Joint Replacement Implant Market
October 26, 2023
Spine Implant Market
October 26, 2023
Trauma Implant Market
October 26, 2023
Sports Medicine Market
October 26, 2023
Enabling Technology Market
October 26, 2023
Sales by Region
Surgical volumes were pressured in early 2022 from lingering COVID surges from the year before. Those surges significantly impacted APAC markets. Players like Medtronic, NuVasive and Orthofix cited disruption in international ordering patterns.
Additionally, a national VBP tender in China is likely for spinal implants and could further alter traditional ordering patterns of biologics. Highly globalized players also experienced mid-single-digit currency headwinds in 2022 due to the strengthening U.S. dollar.
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.
Geoffrey Martha, Medtronic CEO
The U.S. accounted for 70% of orthobiologics market sales and surpassed $3.7 billion in 2022, while OUS markets amassed $1.6 billion in orthobiologics sales.
Exhibit 2: Orthobiologics Sales by Region ($millions)
| Region | FY22 | FY21 | $ Chg | % Chg |
|---|---|---|---|---|
| US | $3,706.6 | $3,596.7 | $109.9 | 3.1% |
| OUS | $1,611.3 | $1,615.9 | ($4.6) | (0.3%) |
| EMEA | $866.8 | $860.1 | $6.7 | 0.8% |
| APAC | $600.9 | $609.9 | ($9.0) | (1.5%) |
| ROW | $143.6 | $146.0 | ($2.4) | (1.6%) |
| Total | $5,317.9 | $5,212.6 | $105.3 | 2% |
Exhibit 3: Orthobiologics Market Share by Region ($millions)
Top Companies
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 $50 million in annual sales make up 44% of the market.
While it can be a challenging space to penetrate, the clinical promise and virtually untapped opportunity of regenerative medicine makes it an attractive segment for innovative startups.
Exhibit 4: Top 10 Orthobiologics Players and All Others ($millions)
| Company | FY22 | FY21 | $ Chg | % Chg |
|---|---|---|---|---|
| Medtronic | $493.8 | $529.0 | ($35.2) | (6.7%) |
| MTF Biologics | $388.9 | $375.0 | $13.9 | 3.7% |
| Bioventus | $331.1 | $300.1 | $31.1 | 10.4% |
| Stryker | $308.7 | $295.1 | $13.6 | 4.6% |
| Sanofi | $299.8 | $295.9 | $3.8 | 1.3% |
| DePuy Synthes | $289.6 | $298.3 | ($8.8) | (2.9%) |
| Arthrex | $262.3 | $251.0 | $11.3 | 4.5% |
| Zimmer Biomet | $232.4 | $235.4 | ($3.1) | (1.3%) |
| Heraeus | $179.2 | $168.8 | $10.5 | 6.2% |
| LifeNet Health | $175.6 | $166.6 | $9.0 | 5.4% |
| All Others | $2,356.6 | $2,297.3 | $59.3 | 2.6% |
| Total | $5,317.9 | $5,212.6 | $105.3 | 2% |
Exhibit 5: Orthobiologics Market Share by Company ($millions)
We estimate that the orthobiologics market grew +2% in 2022 as improved procedure volumes offset macro headwinds. Medtronic’s orthobiologics sales declined due to 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. Vericel won an accelerated regulatory pathway for arthroscopic delivery of MACI, while the merger of SeaSpine and Orthofix created a wide-ranging biologics portfolio.
Important Developments in the Orthobiologics Market
Bioventus Struggles to Finance CartiHeal Acquisition
In mid-2022, Bioventus amended its agreement with CartiHeal to reduce upfront cash consideration to $50 million, with the remaining $215 million payable upon certain dates or milestones. Bioventus completed the acquisition in July 2022.
After recording a $189 million goodwill impairment on its third-quarter earnings, Bioventus announced that it had entered into a settlement agreement and release from future claims with the former CartiHeal shareholders in February 2023. CartiHeal’s Agili-C received Premarket Approval in 2022 and is expected to be a disruptive technology for the cartilage repair market.
Reimbursement Changes for Viscosupplements
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. The company weathered volatility through the first half of 2023.
Other players like Anika Therapeutics weren’t impacted by the change, as they already operated under average selling price, thanks to the pharmaceutical company roots of its sales partner J&J Mitek.
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.
Dr. Cheryl Blanchard, Anika Therapeutics CEO
SeaSpine and Orthofix Merger Creates Diverse Biologics Portfolio
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.
Further Reading
Thanks for visiting! Need more insight into the orthobiologics market? Questions and comments are always welcome. You can reach me by email. I’ll be back soon with updates to this page as we complete our projections for the 2023 finish.
Until then, check out this selection of orthobiologics-related posts from recent months.
September 19, 2023
,
Julie A. Vetalice
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