Table of Contents
Overview
New York, NY – June 17, 2025 – Global Orthopedic Contract Manufacturing Market size is expected to be worth around US$ 17.6 Billion by 2034 from US$ 8.3 Billion in 2024, growing at a CAGR of 7.8% during the forecast period 2025 to 2034. In 2024, North America led the market, achieving over 38.4% share with a revenue of US$ 3.2 Billion.
In 2024, the orthopedic contract manufacturing market continues to witness stable expansion, driven by the increasing demand for joint reconstruction, spinal implants, and trauma fixation devices. Contract manufacturers play a critical role in supporting orthopedic OEMs by offering services such as precision machining, additive manufacturing, forging, packaging, and regulatory support. As healthcare systems worldwide face growing orthopedic caseloads due to aging populations and a rise in sports-related injuries, outsourcing has become a strategic necessity for medical device companies seeking cost efficiency and faster time-to-market.
The market is segmented by service type into design & development, manufacturing, quality assurance, and packaging. Among these, manufacturing services remain dominant due to the complexity and customization required in producing orthopedic implants. Material-wise, titanium and stainless steel alloys continue to be widely used, while interest in bioresorbable materials and PEEK (polyether ether ketone) is rising.
North America holds the largest share of the market, supported by advanced healthcare infrastructure, high surgical volume, and a strong base of orthopedic OEMs. Meanwhile, Asia Pacific is emerging as a high-growth region, driven by increasing medical tourism, cost-effective manufacturing capabilities, and favorable government policies to support the medtech sector. As innovation in minimally invasive techniques and smart implants accelerates, contract manufacturers are expected to adopt advanced automation and digital manufacturing technologies to stay competitive.
Key Takeaways
- In 2024, the orthopedic contract manufacturing market generated revenue of US$ 8.3 billion and is projected to reach US$ 17.6 billion by 2033, growing at a CAGR of 7.8% during the forecast period.
- By product type, the market is segmented into implants, trays, instruments, and cases. Among these, implants dominated in 2023, accounting for a market share of 52.3%.
- Based on services, the segmentation includes forging/casting, spine & trauma, knee machining & finishing, instrument machining & finishing, hip machining & finishing, and others. Forging/casting held the largest share at 48.7%.
- Regionally, North America led the global market in 2023 with a market share of 38.4%, supported by a robust orthopedic manufacturing ecosystem.
Segmentation Analysis
- Product Type Analysis: In 2023, the implants segment led the orthopedic contract manufacturing market with a 52.3% share. This dominance is driven by the rising demand for joint replacements due to an aging population and increasing musculoskeletal disorders. Implants such as hip and knee replacements require advanced, precise manufacturing. With growing investments in R\&D for new implant materials and designs, the segment is expected to continue expanding as healthcare systems seek cost-effective surgical solutions.
- Service Analysis: The forging/casting segment accounted for 48.7% of the market in 2023. These techniques are essential for producing strong, complex orthopedic components with high material integrity. As demand grows for custom, high-performance implants and instruments, forging and casting services remain critical. Advancements in these processes enhance product strength and precision, supporting the increasing need for durable, efficient orthopedic devices. This trend is expected to drive sustained growth in the forging/casting segment through the forecast period.
Market Segments
By Product Type
- Implants
- Trays
- Instruments
- Cases
By Service
- Forging/Casting
- Spine & Trauma
- Knee Machining & Finishing
- Instrument Machining & Finishing
- Hip Machining & Finishing
- Others
Regional Analysis
In 2023, North America led the orthopedic contract manufacturing market, capturing a 38.4% revenue share. The growth is driven by rising demand for joint replacements, trauma implants, and advanced surgical instruments. According to the U.S. Food and Drug Administration (FDA), there was a 12% increase in 510(k) clearances for orthopedic devices, reflecting greater manufacturing activity.
The Centers for Medicare & Medicaid Services (CMS) also recorded an 8% rise in orthopedic procedure volumes, reinforcing the need for outsourced production. Major companies like Stryker and Zimmer Biomet increased reliance on contract manufacturers, with Stryker reporting a 15% rise in such expenditures. Additionally, the American Academy of Orthopaedic Surgeons (AAOS) reported a 20% increase in robotic-assisted surgeries, boosting demand for precision-made components.
Asia Pacific is projected to register the highest CAGR during the forecast period, supported by improved healthcare infrastructure, cost efficiencies, and favorable policies. India saw a 22% increase in medical device output under its PLI scheme, while China recorded an 18% rise in orthopedic implant approvals. Japan, Thailand, Vietnam, and Australia also saw significant growth in orthopedic surgeries, exports, and regulatory approvals. These factors collectively position Asia Pacific as a high-potential growth region for orthopedic manufacturing.
Emerging Trends
The adoption of additive manufacturing has accelerated the production of patient-specific implants and surgical tools. Three-dimensional (3D) printing enables complex geometries and porous structures that support bone ingrowth, reducing lead times and waste in component fabrication. Regulatory requirements under the FDA’s Quality System (QS) Regulation (21 CFR Part 820) have intensified. In FY 2023, the Center for Devices and Radiological Health (CDRH) accepted 3,276 510(k) submissions upholding strict design control and process validation standards that many original equipment manufacturers are now outsourcing to specialized contract manufacturers.
Supply chain resilience has been prioritized in response to past disruptions. Domestic and near-shore contract manufacturing arrangements are being re-evaluated to ensure continuity of critical device production. Partnerships between OEMs and CMOs are increasingly formalized through long-term agreements. This shift is supported by government programs such as the Medicare Comprehensive Care for Joint Replacement (CJR) Model, which incentivizes cost control and quality, prompting providers to seek manufacturing partners who can guarantee compliance and rapid scalability.
Use Cases
Total knee replacements represent a key driver of manufacturing demand. According to the CDC’s National Hospital Discharge Survey, 719,000 total knee replacement procedures were performed in the United States in 2010, underscoring the ongoing need for precision-engineered femoral and tibial components. Contract manufacturers produce these high-volume implant parts under strict clean-room conditions and adhere to sterilization protocols mandated by the FDA.
Spinal implant instrumentation provides another prominent use case. In December 2024, the FDA cleared a Titanium Niobium Nitride (TiNbN) coated version of a stemmed femoral component for total disc replacement devices under traditional 510(k) number K242869. This clearance reflects the specialized machining and coating expertise required services often outsourced to CMOs with dedicated regulatory and quality assurance teams.
Additionally, more than 671,000 fracture reduction procedures were reported in 2010, driving demand for contract-manufactured plates, screws, and fixation systems designed to exacting biomechanical specifications.
Conclusion
The orthopedic contract manufacturing market is poised for continued growth, driven by increasing surgical volumes, aging populations, and demand for advanced orthopedic solutions. Contract manufacturers play a crucial role in providing specialized services such as forging, additive manufacturing, and regulatory support, enabling OEMs to meet rising clinical and regulatory demands.
North America leads in revenue share, while Asia Pacific emerges as a high-growth region. The shift toward personalized implants, digital manufacturing, and resilient supply chains further reinforces the strategic importance of contract manufacturing in orthopedics, supporting cost-efficiency, innovation, and scalability across global healthcare systems.
Discuss your needs with our analyst
Please share your requirements with more details so our analyst can check if they can solve your problem(s)
