Rising demands for advanced medical products, tightening regulations and, most recently, the effects of a global pandemic, are leading more medical device companies than ever before into outsourcing elements of their production to third parties.
A report released by US market research firm Grand View Research last month indicated that the medical device outsourcing market will more than double in size by 2028 – expanding from a value of $99.9bn in 2020 to $227.1bn over the next eight years.
In the US and Europe in particular, smaller companies are likely to seek third-party assistance from larger, more experienced manufacturers in order to comply with new ISO standards, as well as the upcoming EU MDR and IVDR.
The Covid-19 pandemic has also highlighted the need for OEMs (original equipment manufacturers) to have more versatile, diverse supply chains and production means, leading companies across the medical devices sector to actively seek out ways of offsetting the impact of future crises.
In light of this increased demand for contract manufacturing, product testing, regulatory compliance and other third-party services, we profile seven of the most prominent players in the global medical device outsourcing industry right now – as highlighted by Grand View Research’s 2021 report.
Key medical device outsourcing companies in 2021
1. IQVIA
While many outsourcing companies work across a vast range of industries, North Carolina-based firm IQVIA specialises solely in the life sciences sector.
Its services include technologies like the Human Data Sciences Cloud, which is designed to enable healthcare-grade analytics and data management, as well as tools to aid its customers with R&D, integrated global compliance and product commercialisation.
Alongside pharmaceuticals and consumer health, medtech is one of the main sectors IQVIA currently serves – offering regulatory, clinical and commercial solutions to help companies take their technologies “from concept to market”.
IQVIA is also currently attempting to integrate newer disruptors like AI, machine learning and remote, decentralised ‘virtual’ clinical trials into its services.
The American firm generated a total revenue of $11.4bn in 2020 and employs about 70,000 people across the Americas, Europe, Africa, and the Asia-Pacific.
2. SGS
Swiss firm SGS provides industrial inspection, analysis, testing and verification services across a range of sectors – including transportation, food and crops, chemicals, consumer goods, and production machinery.
Its work in the life sciences sector involves analytical, bioanalytical and clinical trial testing, along with process management capabilities – mainly for more heavily regulated drugs and medical devices, but also for health, beauty and wellness products, and nutraceuticals too.
Within medical devices specifically, SGS’ offerings cover more than 100 different product categories, from cardiac equipment, drug delivery devices, and implantables, to PPE (personal protective equipment) items, in vitro diagnostics (IVDs), and even healthcare-related software tools.
With a total revenue of $5.6bn in 2020 and close to 90,000 global employees, the Geneva-headquartered firm claims to be “the world’s leading inspection, verification, testing and certification company”.
3. Eurofins Scientific
Eurofins Scientific is a Luxembourg-based firm that provides a wide range of analytical testing services to the pharmaceutical, food, environmental and consumer products industries.
The company also engages in medical device testing – offering sterilisation, packaging, biocompatibility, cyber security and electricals validation, as well as materials testing, and various regulatory certification services.
Over the past year, Eurofins Scientific has developed several specific testing solutions relating to PPE, ventilators, infusion pumps, and other devices that are central to the global response to Covid-19 as well.
The company generated total revenues in excess of €4.5bn ($5.3bn) in 2019, and employs more than 50,000 people in 50 different countries.
4. Intertek
UK-based quality and safety consulting firm Intertek operates in numerous different sectors – with food and healthcare featuring alongside chemicals, energy, transportation, construction and engineering, and consumer products as one of many areas it services.
When it comes to medical devices, Intertek provides testing, auditing, and certification – as well as clinical and regulatory support – to enable total quality assurance “throughout the product life-cycle”.
The company also offers “first-in-queue priority” for certain critical care devices, meaning it begins the testing process immediately upon receiving product samples from a customer.
Products covered under this initiative include ventilators, respirators, CPAP (continuous positive airway pressure) machines, telehealth carts and robots, hospital beds and operating tables, IVD testing kits, and more.
Intertek generated a total revenue of more than £2.7bn ($3.7bn) last year and currently has about 44,000 global employees.
5. Charles River Laboratories
Massachusetts-based firm Charles River Laboratories operates across the entire life sciences sector, offering testing, research and other supporting services to pharmaceutical, biotech, cosmetics and medical device companies alike.
These services range from R&D, safety assessments, and preclinical and clinical testing, to regulatory advice and assistance with manufacturing and commercialisation.
In medical devices specifically, this involves biocompatibility analysis, microbial solutions, and safety and efficacy testing to comply with FDA and ISO regulations.
Charles River Laboratories generated a total revenue close to $2.9bn last year – and currently employs more than 17,000 people in at least 20 countries worldwide.
6. WuXi AppTec
China-based WuXi AppTec is currently one of the major companies in the Asia-Pacific – which, according to Grand View Research, was the dominant regional medical device outsourcing market in 2020, owing to the easy availability of skilled human resources there.
WuXi AppTec primarily offers R&D and manufacturing services to aid global pharmaceutical and biotech firms.
But, while the Shanghai-headquartered company specialises in the discovery, development and manufacturing of small molecule drugs and other therapeutic products, it also provides a comprehensive programme of medical device testing capabilities too.
These include various materials, microbiology and biocompatibility analyses, as well as regulatory consulting, risk assessments, and preclinical safety testing at its Suzhou Large Animal Research Facility.
In 2019, WuXi AppTec generated a total revenue of nearly HK$12.9bn ($1.7bn), and the company currently employs 25,000 people across the globe.
7. Toxikon
Toxikon – another specialist in the life sciences sector – provides in vivo, in vitro and analytical testing services for the pharmaceutical, biotech, and medical device industries.
Its medical device testing capabilities range from accelerated ageing, biocompatibility and pathology testing to device cleaning validation, and toxicological risk assessments (TRAs), which evaluate the potential health risks associated with exposure to leachable impurities, contaminants, or other residues found in a product.
Toxikon also claims to have more than 125,000 square feet of state-of-the-art medical device testing facilities at its disposal – including laboratories, vivariums and surgical suites accredited by the FDA and ISO.
The firm, which is based in Massachusetts in the US, reported revenues of $19.4m in 2020 and employs about 125 people globally.
