Medical Equipment Industry Overview

Anesthesia And Respiratory Devices Market Characteristics

The global anesthesia and respiratory devices market is segmented into respiratory devices and anesthesia devices. The respiratory devices segment accounts for a major share in the market due to its wide usage in healthcare institutions, home healthcare and ambulances. Rising incidence of obstructive sleep apnea, chronic obstructive pulmonary diseases among aging population are the driving factors in the global anesthesia and respiratory devices market. Rising healthcare expenditure, medical tourism, and emerging economies provide growth opportunities for these devices in the market.

The point-of-care diagnostics devices and equipment market consists of sales of point-of-care (POC) diagnostics devices and equipment and related services. Point-of-care diagnostics devices and equipment are designed to aid physicians in performing medical diagnostic testing at or near the point of care, for immediate knowledge on diseases or conditions. Point-of-care diagnostics are segmented into cardio metabolic monitoring kits, infectious diseases testing kits, cardiac and cancer markers excluding blood glucose monitoring kits. The global point-of-care diagnostics devices and equipment market was valued at about $9.3 billion in 2018 and is expected to grow to $11.35 billion at a CAGR of 5.1% through 2022. The point-of-care diagnostic devices and equipment market has been geographically segmented into North America, Western Europe, APAC, Eastern Europe, South America and Middle East & Africa. The North America is the largest market for point-of-care diagnostic devices and equipment and is expected to continue to be the largest market during the forecast period. An increase in the incidence of target diseases is driving the POC devices and equipment market globally. The rising incidence of chronic diseases, like diabetes, rheumatism, or cancer is increasing steadily worldwide due to poor lifestyle choices and increasing obesity, thus driving the growth of POC devices and equipment market. For example, according to American Heart Association cardiovascular disease is listed as the underlying cause of death for 0.84 million deaths in the US in 2016, approximately 1 of every 3 deaths. The POC diagnostics devices and equipment market is expected to slow down due to stringent regulatory policies, which increases the gestational period before the product enters market. POC devices and equipment manufacturers are required to obtain multiple FDA clearances before launching their product into the market. The entire process of approval consumes a lot of time, thereby restraining the market growth. Over-the-Counter (OTC) testing is being termed as an important trend driving the growth of point of care diagnostics market. FDA has approved OTC test kits for cholesterol, fecal occult blood, pregnancy and HIV/HCV. This method would improve the access to testing and early detection of the disease. These testing kits may generate more revenue than prescription tests over the forecast period due to ease of using the kits, increased home care and self-testing, and rise in availability and adoption rate. Point of care devices are regulated by the U.S. Food and Drug Administration (FDA) and all the diagnostic laboratory tests regulated by the clinical laboratory improvement amendments of 1988 (CLIA) that is administered by the centers for Medicare & Medicaid services (CMS). As these devices measure the biomarker levels in the body they are classified as class II (requiring 510[k] approval), or III devices (requiring the more tedious premarket approval). On the contrary, to the stringent approvals by FDA, China has a moderately lenient approval mechanism. Therefore, the top companies are using partnership approach with local vendors and distributors to expand their market share. Major players in the market are Abbott, F. Hoffmann-La Roche, Siemens Healthineers, Danaher and Beckman Coulter.

The microbiology diagnostics devices and equipment market consists of sales of microbiology diagnostics devices and equipment and related services. Microbiology diagnostics devices and equipment are used to diagnose infectious diseases by examining pathogens. These instruments include incubators, autoclave sterilizers, anaerobic culture systems, blood culture systems, gram strainers, microscopes, mass spectrometers, molecular diagnostic instruments, reagents pathogen specific kits and general reagents. The global microbiology diagnostic devices and equipment market was valued at about $4.4 billion in 2018 and is expected to grow to $4.52 billion at a CAGR of 0.7% through 2022. The microbiology diagnostic devices and equipment market has been geographically segmented into North America, Western Europe, Asia-Pacific, Eastern Europe, South America and Middle East & Africa. The North American market is the largest market for microbiology diagnostic devices and equipment and is expected to continue to be the largest market during the forecast period. Increasing funding of public and private investments in the medical devices is driving the growth of microbiology diagnostic devices market. Increasing Investments indicates rising confidence of various private and public players on microbiology diagnostic devices thereby indicating a progressive increase and stimulating growth. For instance, the global medical device funding accounted for $4,804 million in 2014 and has raised to $6,133 million in 2017. The increasing investments on digital health technologies, artificial intelligence and non-invasive monitoring capability, delivery of gene therapy and regenerative medicines technologies, customized 3D printing of medical devices are expected to drive the microbiology diagnostic devices market. Unfavorable regulatory scenarios is one of the major restraints in the microbiology diagnosis devices market. In the US, section 510(k) of the Food, Drug and Cosmetic Act states that every device manufacturer must register with FDA and notify their intent to market a medical device at least 90 days in advance. These pre-market notifications are considered to be lengthy, rigorous and time-consuming processes for the approval of medical devices. If in case the submission fails due to some uncertainty, the company has to reperform all the tests and resubmit the premarket approval application. For instance, a 'Verticle Autoclave', a microbiology diagnostic device, complies with the strict international directives and standards such as capacity of 80-120 litre autoclave chamber volume, low sensitivity loads, restrictions on temperature calibration and a certificate from ISO17025 accreditation lab for temperature, pressure gauges & timer. Next Generation Sequencing (NGS) technologies are increasing their prevalence in the microbiology diagnostic devices market due to its cost effectiveness, sensitivity to detect low-frequency variants and comprehensive genomic coverage. Next Generation Sequencing (NGS) or high throughput sequencing or Massively Parallel Sequencing (MPS) is a method of sequencing genomes with an ability to sequence hundreds to thousands of genes or gene regions and capability to detect novel resistance genes (ARG) in bacteria. In 2015, bioMérieux partnered with Illumina to develop bioMérieux EpiSeq™, a NGS service which will facilitate epidemiological monitoring of bacterial infections and monitor outbreaks in hospitals. Some of the modern next generation sequencing technologies that help to sequence DNA and RNA include Illumina (Solexa) sequencing, Roche 454 sequencing, Ion torrent Proton / PGM sequencing, and SOLiD sequencing. In April 2017, the European parliament approved the 2012 proposal of European Commission for regulations on in-vitro diagnostic Medical Devices (IVD) and other medical devices. The two new regulations replace the three existing directives on medical devices in order to enhance patient safety. These changes by the EU legislation aids in the development of microbiology diagnostic devices, as they focus on providing transparency of information through EUDAMED (the new European database of medical devices), allowing manufacturers to monitor products, stronger clinical evidence, post-market surveillance, and enhance safety improvements. In February 2019, Biomerieux, biotechnology company specialized in in vitro diagnostics, acquired Invisible Sentinel, a US-based company, for $75 million. This acquisition enables bioMérieux’s to expand its customer segments, innovative alternatives to deliver accurate results by rare pathogen testing and challenging food matrices. Invisible Sentinel provides microbial detection tools and devices for food and beverage molecular testing in order to improve safety, quality and productivity. These provide bioMérieux’s molecular food testing solution, 'GENE-UP®', an opportunity to adapt Invisible Sentinel assays to process high volumes of samples. Major players in the market are Becton, Dickinnson and Company, Biomerieux , Danaher, Thermo Fisher Scientific and Abbott Laboratories.

The cardiovascular surgery devices and equipment market consists of sales of cardiovascular surgery devices and related services. Cardiovascular surgery devices and equipment are used in cardiac surgery and other cardiovascular procedures performed to repair structural defects of the cardiovascular system of the heart and its damaged or blocked valves and vessels. Cardiovascular surgery devices are divided into perfusion disposables, beating heart surgery systems, cardiopulmonary bypass equipment and cardiac ablation devices. The global cardiovascular surgery devices and equipment market was valued at about $27.23 billion in 2018 and is expected to grow to $35.69 billion at a CAGR of 7.0% through 2022. North America was the largest region in the cardiovascular surgery devices and equipment market in 2018. This region is expected to remain the largest during the next five years. The cardiovascular surgery devices and equipment market in Asia Pacific is forecasted to register the highest CAGR during 2018-2023. Rising geriatric population along with the rising deaths related to cardiovascular disorders is driving the cardiovascular surgical devices market. According to American Heart Association (AHA), in the US, approximately 43.7 million aged above 60 suffered from cardiovascular disorders. It is also reported by AHA that death related to cardiac diseases amount to 17.3 million per year and is expected to rise to more than 23.6 million by 2030, world-wide. Due to these factors, higher number of surgeries are being performed, thereby driving the market. The cardiovascular surgical devices market may be restrained due to stringent and longer approval process by the regulatory authorities. According to a researcher from Harvard Business School, innovative first-mover products such as implantable defibrillators or trans-catheter heart valves are delayed for approvals by FDA, thereby adding to the development cost to the manufacturer. For new cardiovascular devices (first-entrants), the innovator spends 7.2 months longer than the first follow-on innovator. For example, Edwards Lifesciences trans-catheter heart valve, was approved in Europe 4 years before it was approved in the USA. The study also estimated the financial loss associated with the delay in getting the approval. The delay may cost firms an average of $6.7 million to the already existing $94 million average price to introduce a new medical device to market, thereby hampering companies’ pursuit on new innovations. Companies in the cardiovascular surgery devices and equipment market are investing in second generation bioresorbable stents and as well rectifying the glitches which occurred in the earlier version of bioresorbable stents. This advancing segment is poised to garner $247 million by 2025. Due to the all-new device features such as thinner strut thicknesses, faster resorption times, and better radial force, these are expected to grow at a higher growth rate. A higher elective procedure volume due to the less-invasive nature of PCIs when compared to coronary artery bypass grafting is expected to drive bioresorbable stents adoption. For instance, Amaranth Medical has developed three medical devices with thinner strut thickness, latest bearing a magnitude of 100 microns. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) made public, its priority list for medical device guidance documents for the fiscal year 2017. This would allow the companies in promoting innovation and as well save them from the stringent consequences of non-approval of any product. Thus, a clearer and transparent approval method would drive the cardiovascular surgical devices market in the future. Major players in the market are Abbott Laboratories, Boston Scientific Corporation, Cook Medical, C.R.Bard and Abiomed.

The therapeutic dental equipment market consists of sales of therapeutic dental equipment and related services. Therapeutic dental equipment is used for the treatment of dental diseases. The key products include dental lasers, soft-tissue laser systems, diode lasers systems, CO2 lasers systems, YAG laser systems, and all-tissue (hard/soft) laser systems. The global therapeutic dental equipment market was valued at about $0.1 billion in 2018 and is expected to grow to $0.12 billion at a CAGR of 4.9% through 2022. The therapeutic dental equipment market has been geographically segmented into North America, Western Europe, Asia-Pacific, Eastern Europe, South America and Middle East & Africa. The North American market is the largest market for therapeutic dental equipment and is expected to continue to be the largest segment during the forecast period. The changing lifestyles and unhealthy habits of people has increased the instances of oral disease & has increased the demand for dental and oral care. The major lifestyle changes that has stimulated periodontal diseases include smoking, inadequate oral hygiene, and unawareness about dental health. Diabetes is also one of the major reason for oral diseases. With increasing diabetic population, which is estimated to rise by 154% (415 million in 2015 to 642 million in 2040), the need for periodontal care is expected to rise. These lifestyle change along with rising diabetes prevalence are expected to increase the demand for dental care and surgeries thereby driving the therapeutic dental market. The painless procedure using dental lasers have complications that affect the tooth and the surrounding dental region. Tooth surface, dental pulp, subcutaneous and submucosal layers are some of the regions prone to adverse effects during the use of dental lasers. Necrosis of the pulp, bone resorption, hypo/hyperpigmentation, scarring among others are the complications associated with dental lasers. In addition to this, the micro-hardness of the tooth walls is also affected, resulting in surface cracks of the tooth. Due to these effects, the growth of the therapeutic dental market is expected to be restrained in the future. There have been continuous technological advancements in dental lasers that is resulting in a positive impact on the growth of the dental laser industry. For instance, UltraDent Products, Inc. in 2016 launched the first dual-wavelength soft tissue diode laser named the Gemini 810 + 980 diode laser, this tool is used in intraoral and soft tissue procedures. Development of such new technologically advanced devices will augment industry growth. In the USA, manufacturers of laser devices in the medical device industry must comply with Title 21 Code of Federal Regulations (CFR). As per the Title 21 Code of Federal Regulation, the performance standard and specific purpose of the laser product must also be mentioned along with other records on calibration that are provided to the customers. Daheng Group Inc. recalled its Diode Laser Therapy System and Dental Laser Therapy System as it failed to comply with 21 CFR 1040.11 and did not provide calibration procedures to purchasers. In the UK, institutions employing laser for dental surgeries must register with the Care Quality Commission and the National Minimum Standards and Regulations for Independent Health Care 2002 states all the standards (C1 to C32) that are a mandate to all hospitals and dental clinics that use lasers. According to the core standards, the operators must have patient guide explaining the benefits and risk of laser, statement of treatment policy, management and personnel, a complaints procedure, premises, facilities and equipment management, risk management procedure and research strategy in place. Major players in the market are AMD LASERS LLC, BIOLASE Technology, Inc, Danaher Corporation, Dentsply Sirona and Planmeca Group.

The dental diagnostic imaging devices and equipment market consists of sales of dental diagnostic imaging devices and equipment. The dental diagnostic imaging devices use technology that creates visual representation of the inner body of tooth for clinical analysis. These devices are used for better analysis of dental problems such as tooth decay, tooth erosion and gum disease. The global dental diagnostic imaging devices and equipment market was valued at about $1.9 billion in 2018 and is expected to grow to $2.45 billion at a CAGR of 6.6% through 2022. The dental diagnostic imaging devices and equipment market has been geographically segmented into North America, Western Europe, Asia-Pacific, Eastern Europe, South America and Middle East & Africa. The North American market is the largest market for dental diagnostic imaging devices and equipment and is expected to continue to be the largest market during the forecast period. The growing awareness on dental health care has led to demand for proper healthcare system with upgraded devices. The dental diagnostic imaging devices help to meet the oral healthcare demands of people and will drive the market growth. These imaging devices helps to reduce shorten the recovery time for a patient and also result in less pain when compared to earlier methods of diagnosing dental problems. According to Adults Oral Health & Well-being Survey, 85% Americans believe that oral health is extremely important among which only 15% were satisfied with their current oral health. This indicates that people look for better dental care now and are aware of the importance of oral healthcare. The lack consumer awareness on the available dental diagnostic imaging devices in many developing economies is restraining the dental diagnostic imaging market growth. People in many developing countries tend to neglect dental problems due to lack of awareness. This attitude affects the health and also the growth of dental diagnostic imaging device market as the use and procurement of these devices is affected negatively. For example, WHO has provided technical and financial support to the Ministry of Public Health and Education in conducting a series of workshops and campaigns on oral health for school teachers in Kabul city. The aim of these workshops is to raise awareness of oral health and prevention of negligence towards the dental problems. The need for precise diagnostic tools has given rise to innovation in dental imaging technology such as cone beam computed tomography (CBCT) and magnetic resonance imaging and others. These new techniques have helped in better examination of complex facial structures and early diagnosis of dental diseases. For example, on 19 January 2018, The All India Institute of Medical Sciences (AIIMS) started use of Cone Beam CT (CBCT) scan facility that would help dental surgeons in increasing the efficiency of their dental surgeries. These devices provide a 3D image of the patient's jaw to get precise knowledge of the problem before the surgery is performed and helps in safe and better treatment outcome. Various government reforms and organizations are currently focusing on dental care safety and aim to reduce oral health care problems. For example, FDA's Center for devices and radiological health is responsible for regulating firms who manufacture, repackage or import medical devices sold in the United States. Also, CDRH regulates medical devices such as radiation-emitting electronic products such as lasers, x-ray systems, and ultrasound equipment. Major players in the market are Carestream Health, Inc. (US), Fujifilm Holdings Corporation (Japan), Hitachi Medical Corporation (Japan), Siemens Healthcare (Germany) and GE Healthcare (U.S.).

The dental surgical devices and equipment market consists of sales of dental surgical devices and equipment. Dental surgical devices and equipment are used for the treatment of problems related to dental caries, cavities, tooth decay, periodontitis, gingivitis, oral candidiasis, xerostomia, and other forms of oral cancers and injury. This includes examination instruments, retractors, dental hand-pieces, dental lasers and others. This market does not include therapeutic dental equipment, general dental devices and equipment and dental diagnostic imaging devices and equipment. The global dental surgical devices and equipment market was valued at about $4.6 billion in 2018 and is expected to grow to $5.81 billion at a CAGR of 6.0% through 2022. The dental diagnostic surgical devices and equipment market has been geographically segmented into North America, Western Europe, Asia-Pacific, Eastern Europe, South America and Middle East & Africa. The rise in dental diseases is the driving force in the dental surgical devices Market. Oral diseases are the most common non-communicable diseases (NCDs) and affect people throughout their lifetime, causing pain, discomfort, disfigurement and even death. According to WHO, in 2016, an estimated half of the world’s population (3.58 billion people) were found to be affected with dental caries. The periodontal (gum) disease, which may result in tooth loss, was estimated to be the 11th most prevalent disease globally. All these diseases require suitable surgical procedures involving various dental surgical instruments. The rise in dental diseases coupled with the rising demand for cosmetic dentistry is expected to drive the market in the forecast period. High costs associated with dental surgical procedures such as implants, periodontal surgery, root canal, laser whitening along with less favorable reimbursement policies are the factors which may hinder the growth of dental surgical devices market. The dental implants on an average costs around $2000 to $34,000. The additional costs associated with X-ray, scans, tests and consultation fee increases the total cost of the surgical procedure. Due to these high costs, the surgical devices market may find the growth to be challenging. Increasing number of companies are investing in 3D Printing technology in dental surgical devices and Instrument market. 3D printing technology is process of making complex 3-D structures by laying down thin layers of raw material in succession. In this market, 3D Printing technology is used for the production of drill guides for dental implants, the preparation of physical models for prosthodontics, orthodontics and surgery, the production of dental, craniomaxillofacial and orthopedic implants, and the fabrication of copings and frameworks for implant and dental restorations. The major players are using 3D Printing technology to produce devices like 3D printed braces, dental crowns and implants as well. For example, ArchForm, a teeth-aligner software startup allows the orthodontists to create, design and 3D print aligners within their own offices. According to the company’s customer base, approximately 75% of orthodontists already have 3D printers with software. The US FDA regulates material that is being used in manufacturing of dental devices and instruments apart from regulating the devices in USA. The dental materials cleared by the FDA fall into one of two classes: Class I which signifies minimum to no risk, and Class II that indicates some risk. Materials in class II include alloys, ceramic and polymers, all those that take final form in the hands of a practitioner or lab. Carbon’s new 3D printable DENTCA resins have been approved by the FDA. However, the material approval process takes extra time in overall launch of the product in the market. Major players in the market are Sirona, Planmeca, DentalEZ, KaVo Group and LM Dental.

The cataract surgery devices and equipment market consists of sales of cataract surgery devices and equipment and related services. Cataract surgery devices and equipment include instruments used for performing cataract surgeries such as small incision cataract surgery and extra capsular surgery in the treatment of cataract, a condition in which the lens of the eye becomes progressively opaque, resulting in blurred vision. This market does not include vision care devices and equipment, refractive surgery devices and equipment and diagnostic & monitoring ophthalmic devices and equipment. Femtosecond Lasers used in cataract surgery are included in this market. The global cataract surgery devices and equipment market was valued at about $3.4 billion in 2018 and is expected to grow to $4.15 billion at a CAGR of 5.1% through 2022. In 2018, North America was the largest region in the cataract surgery devices and equipment market. During the forecast period, Asia Pacific cataract surgery devices and equipment market is forecasted to register a CAGR of 5.5%. The major growth driver for this industry has been the global ageing population. The world population recorded an estimate of 962 million people aged 60 or above in the year 2017. This estimate is expected to show an upward trend and is expected to double by 2050. The cases of cataract in the geriatric population also expected to increase in the same proportion. According to World Health Organization, the number of cataract cases are expected to increase by 78% by 2050 in the U.S. alone. This presents a huge market for the cataract surgery equipment manufacturers in the near future by expanding the customer base due to the fast growing geriatric population. For instance, the population of China is getting older faster than anywhere else in the world, this presents a huge market for the cataract surgery device manufacturers in China. Major challenge that is faced by this industry is the low level of awareness about eye disorders, especially cataract. Many people do not have proper knowledge about the symptoms of cataract and do not get the treatment done. This leads to potential revenue loss for the cataract surgery device manufacturers because of low number of end users. For example, as per a study done by NCBI, out of 1552 respondents 89.9% had heard of cataract but only 42% were aware of any symptom of cataract, low awareness of cataract symptoms acts as a major restraint for the cataract surgery equipment industry. The cataract surgery devices and equipment industry has witnessed many positive changes introduced by the market players, the most prominent one being the introduction of laser technology. The laser assisted cataract surgery is used to gather information about the lens, to make the corneal incision and for the opening in the lens capsule. The advent of laser technology has caused a significant impact over this industry by bringing in new levels of safety and accuracy and advancing cataract surgery. Femtosecond laser platforms have significantly contributed to the precision of cataract surgeries being performed and may soon surpass the traditional hand-held surgeries. For example, Abbott laboratories which lacked this technology, acquired Optimedica for $250 million to enter laser cataract surgery devices market after witnessing the huge demand and benefits of laser technology. The ophthalmology and medical equipment industry is subject to numerous stringent regulations and the cataract surgery device equipment manufacturers are no exception. These manufacturers need to comply with several regulations of which the European Medical Device Directives and the U.S. Health Care Compliance are the most prominent ones. The European Medical Device Directive requires a manufacturer to meet the harmonized standards for placing their devices in the European market. Similarly the U.S. Health Care Compliance has laid down certain guidelines related to standards of business conduct to be followed by the Pharmaceutical manufacturers. The Medicines and Healthcare products Regulatory Agency (MHRA), which regulates the safety of medical devices in the UK, has issued an urgent notice to Carl Zeiss Meditec, for voluntarily recalling a small batch of its intraocular lenses (IOL). The recall was initiated after the manufacturer detected mislabeling of its IOL, Aaren Scienfific EC-3 hydrophobic lens with a wrong dioptric power. Therefore, the manufacturers need to comply strictly with correct labelling of dioptric power on the IOLs. In 2018, Carl Zeiss Meditec acquired IanTECH for an undisclosed amount. The acquisition would strengthen Carl Zeiss’ position in the cataract surgery portfolio as IanTECH focuses on technology solutions for micro-interventional cataract surgery. IanTECH is expected to complement Zeiss’ leading portfolio of equipment and consumables in cataract surgery. IanTECH specializes in endocapsular lens fragmentation and micro-interventional technology for cataract removal and eye treatment. It is headquartered in Reno, Nevada, USA. Major players in the market are Alcon, Inc., Abbott Laboratories, Carl Zeiss Meditech AG, Essilor International S.A. and Opcon Corporation.