NEW
YORK, Aug. 22, 2024 /PRNewswire/ -- The global
medical device manufacturing outsourcing market size is estimated
to grow by USD 50.44 billion from
2024-2028, according to Technavio. The market is estimated to grow
at a CAGR of 10.87% during the forecast period. Growing
focus of oems on reducing medical device manufacturing
costs is driving market growth, with a trend
towards increasing m and a activities. However, stringent
regulatory environment poses a challenge. Key market players
include Benchmark Electronics Inc., Cadence Inc., Celestica Inc.,
Cirtec Medical, Eurofins Scientific SE, Flex Ltd., Gerresheimer AG,
Heraeus Holding GmbH, Integer Holdings Corp., Jabil Inc., Kimball
Electronics Inc., NN Inc., Nortech Systems Inc., Plexus Corp.,
Sanmina Corp., Tata Sons Pvt. Ltd., TE Connectivity Ltd., Tecomet
Inc., TRICOR Systems Inc., and West Pharmaceutical Services
Inc..
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Medical Device
Manufacturing Outsourcing Market Scope
|
Report
Coverage
|
Details
|
Base year
|
2023
|
Historic
period
|
2018 - 2022
|
Forecast
period
|
2024-2028
|
Growth momentum &
CAGR
|
Accelerate at a CAGR of
10.87%
|
Market growth
2024-2028
|
USD 50.44
billion
|
Market
structure
|
Fragmented
|
YoY growth 2022-2023
(%)
|
9.53
|
Regional
analysis
|
North America, Asia,
Europe, and Rest of World (ROW)
|
Performing market
contribution
|
North America at
37%
|
Key
countries
|
US, China, Germany,
Japan, and India
|
Key companies
profiled
|
Benchmark Electronics
Inc., Cadence Inc., Celestica Inc., Cirtec Medical, Eurofins
Scientific SE, Flex Ltd., Gerresheimer AG, Heraeus Holding GmbH,
Integer Holdings Corp., Jabil Inc., Kimball Electronics Inc., NN
Inc., Nortech Systems Inc., Plexus Corp., Sanmina Corp., Tata Sons
Pvt. Ltd., TE Connectivity Ltd., Tecomet Inc., TRICOR Systems Inc.,
and West Pharmaceutical Services Inc.
|
Market Driver
The medical device manufacturing outsourcing market is
characterized by a high level of competition among numerous global,
regional, and local players. To gain an advantage through inorganic
growth, companies are actively engaging in mergers and acquisitions
(M&A). The M&A activity in this market is robust, with a
significant number of transactions taking place recently. Buyers
use M&A as a key marketing strategy to expand their product
offerings, enter new markets, and consolidate their businesses.
This approach has led to increased inorganic growth, particularly
for larger players. Major companies view the medical device
industry as an attractive growth sector and are pursuing
acquisition strategies to boost market share. These acquisitions
also facilitate technological advancements among vendors. Companies
employ M&A strategies with long-term goals to expand into new
markets. For instance, in September
2022, Eurofins Scientific SE acquired Inpac Medizintechnik
GmbH, a German firm specializing in cleaning, packaging, and
sterilization services for the medical devices, biotech, and pharma
industries. Similarly, Eurofins Scientific SE completed the
acquisition of WESSLING Hungary in July
2022, extending its presence in the food, environment, and
pharmaceutical testing market. These factors will fuel the growth
of the medical device manufacturing outsourcing market during the
forecast period.
The Medical Device Manufacturing Outsourcing market is
experiencing significant growth, particularly in sectors like
Oncology, Coronary stents, Wound care, and Orthopedic devices.
Companies are focusing on scientific innovation to meet the
increasing demand for advanced medical devices. Quality assurance
services, regulatory affairs, product implementation, upgrade,
maintenance, and contract manufacturing are key areas of
outsourcing. Diagnostic Imaging, Orthopedic, IVD, Ophthalmic,
General & Plastic Surgery, Drug Delivery, Dental, Endoscopy,
Diabetes care, Cardiovascular devices, and Cosmetic surgeries are
major sectors driving outsourcing. Medical practitioners require
finished goods with electronic components, sensors, and polymers
for patient care. Age-related conditions, cardiovascular diseases,
orthopaedic issues, neurological disorders, and cardiac disorders
are major patient epidemiology trends. IT outsourcing is crucial
for productivity, with quality control, logistics, and testing
being essential services. Procurement of raw materials and device
production are also outsourced. The market encompasses various
sectors, including electronics assembly, packaging, and product
maintenance. The future of medical device manufacturing outsourcing
lies in continuous innovation and adherence to regulatory
standards.
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Market Challenges
- Medical device manufacturing outsourcing by Original Equipment
Manufacturers (OEMs) is subject to rigorous regulatory compliance.
For devices manufactured overseas, each country has specific
regulations for medical products. The US Food and Drug
Administration (FDA) and the European Commission have implemented
stringent guidelines for quality control and environmental
requirements. The FDA's 510(k) process for approving certain
medical devices has faced scrutiny, with Class III devices taking
longer approval times in the US. Adherence to regulations includes
testing, quality control, and documentation procedures. Continuous
regulatory reviews and inspections, along with product field
monitoring, ensure compliance. Non-compliance can significantly
impact business operations. Strict regulatory guidelines pose a
significant challenge to the global medical device manufacturing
outsourcing market.
- The Medical Device Manufacturing Outsourcing market encompasses
various sectors including general and plastic surgery, drug
delivery, dental, endoscopy, diabetes care, cardiovascular devices,
and more. Outsourcing medical device production offers benefits
like access to modern technology and state-of-the-art equipment.
However, challenges exist. In sectors like cosmetic surgeries,
physical appearance plays a significant role, necessitating high
product quality. Procurement of electronic components, sensors, and
polymers is crucial. Medical practitioners require finished goods
on time for patient care. IT outsourcing brings in quality control,
logistics, and productivity improvements. Security and privacy,
data confidentiality, and intellectual property protection are
vital concerns. The contract manufacturing segment offers solutions
through advanced technology and adherence to medical device quality
standards. Despite these advantages, challenges persist in areas
like patient epidemiology, testing, age-related conditions,
cardiovascular diseases, orthopaedic issues, neurological
disorders, and cardiac disorders. Effective supply chain
management, adherence to regulatory requirements, and maintaining
product quality are essential.
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challenges - Request a sample report!
Segment Overview
This medical device manufacturing outsourcing market report
extensively covers market segmentation by
- Product
- 1.1 EMS
- 1.2 Raw materials
- 1.3 Finished goods
- Medical Device Regulatory Classification
- 2.1 Class II
- 2.2 Class III
- 2.3 Class I
- Geography
- 3.1 North America
- 3.2 Asia
- 3.3 Europe
- 3.4 Rest of World (ROW)
1.1 EMS- The Electronics Manufacturing
Services (EMS) market in the medical device sector is experiencing
significant growth, driven by various factors. Major product
categories include patient monitoring, diagnostic imaging, in-vitro
diagnostics, and pacemakers. Notable EMS providers include Jabil
Inc., Celestica Inc., Sanmina Corp., and Flex Ltd. The global EMS
market is expected to expand due to rising healthcare expenditures,
the high growth potential in emerging economies like India, China,
and Brazil, and rapid advancements
in medical device technologies. OEMs are under pressure to reduce
costs and focus on growth strategies, leading them to outsource
design and production to EMS providers. Robotics, wireless
products, and advanced medical software are driving the demand for
EMS in the healthcare industry. EMS providers offer cost savings,
increased quality, innovation, and efficiency, enabling OEMs to
bring new products to market faster and manage their supply chains
effectively. Cost pressures and the need to generate profits in
low-to-medium volume manufacturing are key drivers for OEM
outsourcing. In the US, the Affordable Care Act is expected to
boost EMS provider growth by increasing outsourcing to offset
additional cost burdens on OEMs. EMS providers can also help
upgrade older designs and enhance electronic designs within
existing medical devices. These factors will fuel the growth of the
medical device manufacturing outsourcing market during the forecast
period.
For more information on market segmentation with
geographical analysis including forecast (2024-2028) and historic
data (2017-2021) - Download a Sample Report
Research Analysis
The Medical Device Manufacturing Outsourcing Market encompasses
various medical devices and technologies, including Oncology,
Coronary stents, Orthopedic devices, Wound care, and Diagnostic
Imaging. Scientific innovation is a significant driver in this
market, leading to the development of advanced devices such as
electronic components, sensors, and IVD. Quality assurance and
regulatory affairs services are crucial to ensure compliance with
industry standards and regulations. Product implementation,
upgrade, maintenance, and contract manufacturing services enable
OEMs to focus on core competencies while outsourcing production and
assembly. Orthopedic devices, including joint replacements and
spine implants, are major sectors in the market. Wound care,
age-related conditions, and cardiovascular diseases are key
application areas. Procurement of raw materials, such as polymers,
and device production are essential aspects of the outsourcing
process. The market caters to various medical specialties,
including IVD, Ophthalmic, and Cardiovascular. The increasing
prevalence of age-related conditions and cardiovascular diseases
worldwide is driving demand for medical devices in these sectors.
The market is expected to grow significantly due to these factors
and the continuous advancements in technology.
Market Research Overview
The Medical Device Manufacturing Outsourcing Market encompasses
various medical specialties, including Oncology, Cardiovascular
devices (Coronary stents), Orthopedic devices, Wound care, and
Diagnostic Imaging. Scientific innovation is a significant driver,
with companies outsourcing services for Quality Assurance,
Regulatory Affairs, Product Implementation, Upgrade, Maintenance,
and Contract Manufacturing. Devices under this market include
Surgical, Finished Goods, Electronics, Assembly, Packaging, and
Electronic Components, incorporating sensors and polymers.
Procurement, logistics, and IT outsourcing are essential non-core
services. Medical practitioners across General & Plastic
Surgery, Cosmetic Surgeries, Diabetes care, Dental, Endoscopy,
Ophthalmic, IVD, Drug Delivery, and Cardiovascular diseases require
these devices. Modern technology and state-of-the-art equipment
ensure product quality, productivity, and time-to-market.
Outsourcing also addresses age-related conditions, neurological
disorders, and cardiac disorders. Security and privacy, data
confidentiality, intellectual property protection, and supply chain
management are critical considerations. The Contract Manufacturing
segment leverages advanced technology to deliver high-quality
devices while maintaining regulatory compliance.
Table of Contents:
1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation
- Product
-
- EMS
- Raw Materials
- Finished Goods
- Medical Device Regulatory Classification
-
- Class II
- Class III
- Class I
- Geography
-
- North America
- Asia
- Europe
- Rest Of World (ROW)
7 Customer Landscape
8 Geographic Landscape
9 Drivers, Challenges, and Trends
10 Company Landscape
11 Company Analysis
12 Appendix
About Technavio
Technavio is a leading global technology research and advisory
company. Their research and analysis focuses on emerging market
trends and provides actionable insights to help businesses identify
market opportunities and develop effective strategies to optimize
their market positions.
With over 500 specialized analysts, Technavio's report library
consists of more than 17,000 reports and counting, covering 800
technologies, spanning across 50 countries. Their client base
consists of enterprises of all sizes, including more than 100
Fortune 500 companies. This growing client base relies on
Technavio's comprehensive coverage, extensive research, and
actionable market insights to identify opportunities in existing
and potential markets and assess their competitive positions within
changing market scenarios.
Contacts
Technavio Research
Jesse Maida
Media & Marketing Executive
US: +1 844 364 1100
UK: +44 203 893 3200
Email: media@technavio.com
Website: www.technavio.com/
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