제품 설계 및 개발 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the product design and development market size is expected to increase from USD 13.49 billion in 2025 to USD 14.27 billion in 2026 and reach USD 18.61 billion by 2031, growing at a CAGR of 5.45% over 2026-2031.

This report is Segmented by Service Type (Research, Strategy & Concept Generation, Concept & Requirements Development, and More), Application (Diagnostic Equipment, Therapeutic Equipment, Clinical Laboratory Equipment, and More), End User (Medical-Device Manufacturer, and More), and Geography (North America, Europe, Asia-Pacific, MEA, South America). The Market Forecasts are in Value (USD).

Global Product Design And Development Market Trends and Insights

AI-Enabled Design-Automation Platforms Reduce Concept-to-Prototype Cycle Time

Generative algorithms iterate thousands of geometries in hours, optimizing for strength, biocompatibility, and manufacturability that once required weeks of manual CAD effort. Hospitals seeking faster 510(k) clearances favor suppliers who slash first-article lead times by up to 35%. Smaller startups are now entering the product design and development market with cloud simulations rather than establishing whole internal engineering departments. The approach also cuts material waste by more than 20% and supports early verification under ISO 14971 risk management. Regulators have yet to codify how AI-generated design rationale must be documented, adding uncertainty to Design History File requirements.

Miniaturization of Implantable & Wearable Devices Demands Advanced Systems Engineering

Continuous glucose monitors, loop recorders, and neurostimulators now package multisensor arrays, antennas, and rechargeable batteries into sub-10 g footprints. Precision micro-assembly combines semiconductor techniques with medical-grade encapsulation, prompting design houses to recruit RF engineers, materials scientists, and human factors specialists. Demand is amplified by patch-based biosensors that support remote patient monitoring reimbursement models. ISO 14708 active-implant standards add electromagnetic compatibility and battery safety layers that most OEMs prefer to outsource. As payers reimburse earlier interventions, wearable volumes expand, fortifying a long-term tailwind for the product design and development market.

Rising Cybersecurity Liability Drives Reluctance to Share Design IP

Health-sector ransomware attacks increased by 19% year-over-year in 2025, with several incidents attributed to vulnerabilities in third-party firmware. OEMs now require air-gapped development environments and prohibit contractors from retaining code, which adds weeks to each iteration. Liability insurance premiums for design houses have increased by 30-40%, and underwriters now require ISO 27001 certification, as well as annual penetration testing. Compliance costs strain small consultancies and delay collaborations, tempering growth in the product design and development market. Draft FDA guidance mandates a software bill of materials and vulnerability disclosure protocols, heightening documentation overhead for all parties.

Other drivers and restraints analyzed in the detailed report include:

1. Med-Tech Venture Capital Funding Surge in Robotics & Cardiovascular Devices
2. OEM Pivot to Asset-Light Models Outsourcing Design to Control R&D Burn
3. Talent Deficit in ISO 13485 Systems Engineers Inflates Project Cost

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

The service-mix continues to pivot toward verification as regulators intensify scrutiny of usability, software validation, and real-world evidence. Design & process verification is projected to grow at a 6.96% CAGR through 2031. FDA human-factors guidance now mandates formative and summative studies with representative users, adding USD 150,000-USD 300,000 to typical verification budgets. In parallel, the design community embeds AI-driven test automation, lowering per-iteration costs while increasing the number of iterations within fixed timelines. The product design and development market size for verification services is therefore set to expand as software-heavy devices require continuous risk monitoring even after commercial launch.

The design & process verification segment accounted for 34.81% of revenue in 2025, reflecting robust demand for early-stage ideation, feasibility, and initial architecture definition. However, OEMs often postpone large-scale concept programs until financing is secured, introducing revenue lumpiness that design houses offset by engaging in post-launch lifecycle optimization. Jabil, for example, reported that lifecycle services accounted for 18% of its medical device revenue in 2025. Pilot-to-volume manufacturing transfer remains crucial when clients shift production to low-cost regions; process validation under ISO 14644 cleanroom standards commands premium fees. As regulatory expectations intensify, service providers with integrated quality management systems can close verification and transfer loops more efficiently, thereby strengthening their competitive position within the product design and development market.

Complete Report Scope:

• By Service Type
  • Research, Strategy & Concept Generation
  • Concept & Requirements Development
  • Design & Process Development
  • Design & Process Verification
  • Pilot-to-Volume Manufacturing Transfer
  • Post-Launch Lifecycle Optimisation
• By Application
  • Diagnostic Equipment
  • Therapeutic Equipment
  • Clinical Laboratory Equipment
  • Surgical Equipment
  • Consumables & Disposables
  • Digital & Connected Health Solutions
• By End User
  • Medical-Device Manufacturer
  • Pharmaceutical & Biopharmaceutical Firms
  • Contract Research & Manufacturing Organisations
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America accounted for 39.24% of 2025 revenue, supported by a dense ecosystem of OEM headquarters, venture funding, and a transparent FDA path that design partners navigate efficiently. Clients prize local design support for high-complexity implants and Class III robotics, leading to average project values 25% above global norms. The product design and development market size in the United States also benefits from Medicare reimbursement that accelerates adoption of remote-monitoring devices and stimulates design refresh projects directed at home use.

Asia-Pacific is projected to grow at 8.73% CAGR through 2031, the highest regional pace. China's regulator approved 87 innovative Class III devices in 2025, aided by expedited pathways for domestic intellectual property. India's Production-Linked Incentive scheme offers 5% rebates on incremental sales, prompting multinationals to establish engineering hubs in Bangalore and Hyderabad. South Korea's fast-track review program for AI-driven diagnostics further boosts regional demand. Design firms with ISO 13485 certificates across multiple APAC sites gain a structural edge as clients seek simultaneous U.S., EU, and China submissions without redundant documentation.

Europe faces growth headwinds from Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) bottlenecks. Notified-body queues stretched CE-marking lead times to 24 months in 2025, causing some OEMs to prioritize U.S. or APAC launches. Nevertheless, specialist consultancies with pre-certified quality management systems win share by navigating MDR rigor efficiently. In the Middle East & Africa and South America, hospital capacity expansion drives modest demand for diagnostic and surgical instrumentation. Brazil's ANVISA alignment with FDA and EU standards simplifies dossier reuse, fostering cross-border design engagements. GCC countries fund medical-device industrial zones that reward local-content design partnerships, broadening the long-term addressable base for the product design and development market.

1. Aran Biomedical
2. Cambridge Consultants
3. Cambridge Design Partnership
4. Celestica
5. Cirtec Medical
6. Delve
7. Devicelab
8. Donatelle
9. Exponent Inc.
10. Flex
11. Integer Holdings Corp.
12. Jabil
13. Nordson Medical
14. Planet Innovation
15. Plexus Corp.
16. StarFish Medical
17. Sterling Medical Devices
18. TE Connectivity
19. TTP plc
20. Viant
21. Ximedica (Veranex)

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 AI-Enabled Design-Automation Platforms Reduce Concept-To-Prototype Cycle-Time
  • 4.2.2 Miniaturisation of Implantable & Wearable Devices Demands Advanced Systems-Engineering
  • 4.2.3 Med-Tech VC Funding Surge in Robotics & Cardiovascular Devices
  • 4.2.4 OEM Pivot to Asset-Light Models Outsourcing Design to Control R&D Burn
  • 4.2.5 Regulatory Harmonisation Favours Specialist Design Partners
  • 4.2.6 Sustainability Mandates Push Eco-Design & Circular-Economy Services
• 4.3 Market Restraints
  • 4.3.1 Rising Cybersecurity Liability Drives Reluctance to Share Design IP
  • 4.3.2 Talent Deficit in ISO 13485 Systems-Engineers Inflates Project Cost
  • 4.3.3 Fragmented Data Interoperability Standards Slow Software-Heavy Device Programmes
  • 4.3.4 Inflationary Metals & Electronics Pricing Erodes Design-To-Value Gains
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Bargaining Power of Suppliers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts

• 5.1 By Service Type
  • 5.1.1 Research, Strategy & Concept Generation
  • 5.1.2 Concept & Requirements Development
  • 5.1.3 Design & Process Development
  • 5.1.4 Design & Process Verification
  • 5.1.5 Pilot-to-Volume Manufacturing Transfer
  • 5.1.6 Post-Launch Lifecycle Optimisation
• 5.2 By Application
  • 5.2.1 Diagnostic Equipment
  • 5.2.2 Therapeutic Equipment
  • 5.2.3 Clinical Laboratory Equipment
  • 5.2.4 Surgical Equipment
  • 5.2.5 Consumables & Disposables
  • 5.2.6 Digital & Connected Health Solutions
• 5.3 By End User
  • 5.3.1 Medical-Device Manufacturer
  • 5.3.2 Pharmaceutical & Biopharmaceutical Firms
  • 5.3.3 Contract Research & Manufacturing Organisations
• 5.4 By Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East & Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East & Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 Aran Biomedical
  • 6.3.2 Cambridge Consultants
  • 6.3.3 Cambridge Design Partnership
  • 6.3.4 Celestica Inc.
  • 6.3.5 Cirtec Medical
  • 6.3.6 Delve
  • 6.3.7 DeviceLab Inc.
  • 6.3.8 Donatelle
  • 6.3.9 Exponent Inc.
  • 6.3.10 Flex Ltd.
  • 6.3.11 Integer Holdings Corp.
  • 6.3.12 Jabil Inc.
  • 6.3.13 Nordson Medical
  • 6.3.14 Planet Innovation
  • 6.3.15 Plexus Corp.
  • 6.3.16 StarFish Medical
  • 6.3.17 Sterling Medical Devices
  • 6.3.18 TE Connectivity
  • 6.3.19 TTP plc
  • 6.3.20 Viant
  • 6.3.21 Ximedica (Veranex)

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment