In Vitro Diagnostics (IVD) Market Product (Instruments, Reagents, Services), Technology (Immunoassay, Instruments, Reagents, Services, Hematology, Instruments, Reagents, Services, Clinical Chemistry, Instruments), and Regions Global Forecast 2022 to 2032

POCT is becoming common in emergency rooms, operation theaters, cath laboratories, recovery rooms, and intensive care units due to the increasing need for fast testing. Physician clinics also have a keen interest in POCT owing to the ease of diagnosis, quicker outcomes and growing pool of patients ready to pay for the services. Given the potential of POCT platforms and their capacity to transform healthcare delivery, businesses are reinforcing their focus on POCT tools for improved results in research and development.

Participants in the IVD market also receive good support from industry organizations and activist organizations. These include the Medical Diagnostics Manufacturers Association (MDMA), the Association of Medical Device Manufacturers (AMDM) and the Advanced Medical Technology Association (AdvaMed). The AMDM brings together industry players and regulatory authorities, while the MDMA protects the interests of producers of medical devices by defending the sector from unnecessary or unreasonable regulation.

It was the MDMA that directed political attempts to abolish the 2.3% excise tax on purchases of medical devices introduced through the 2010 Patient Protection and Affordable Care Act that resulted in the tax being suspended until 31st December 2017. AdvaMed is the world's biggest association for medical technology, representing producers of medical devices worldwide, including medical equipment manufacturers, medical software and medical supplies. It operates to foster communication among lawmakers, regulators, and medical communities. AdvaMed also aims to guarantee fast product approval by regulators, sensible policies for reimbursement and coverage and fair access to worldwide markets.

On the one hand, governments in developed countries are adjusting the reimbursement rates to the reimbursement costs and proactively pushing them forward, as can be seen in France. Conversely, the final customer market was expanded by providing the populations with a wide coverage of health insurance. As a consequence of public reforms, more than 800,000 individuals were insured in the United States in January 2014. China is striving to guarantee full demographic coverage through continuing health system reform. Due to widespread regulatory hurdles, entry into the markets of some nations is made even more challenging. China already has an American FDA-like scheme.

Molecular diagnostics have emerged as one of the leading and fastest-growing sectors of the IVD industry. This development is fueled by the introduction of powerful techniques such as real-time polymerase chain reaction (PCR) and next generation sequencing (NGS), which allow the decoding and amplification of genetic and epigenetic information.

Quantitative real-time polymerase chain reaction (qPCR) is a method used to amplify genetic information encoded in RNA and DNA. This method is now used for diagnostics to rapidly detect nucleic acids of pathogens such as viruses and bacteria, cancer mutations and other genetic variations. The diagnosis of infectious diseases has been improved in particular. Quantitative real-time polymerase chain reaction allows the quantification and genotyping of viruses, such as the hepatitis B virus, by a characteristic melting curve without sequencing. Newly emerging pathogens, such as new strains of the influenza virus, can also be quickly discovered.

Advances in DNA sequencing have also revolutionized the industry. Since the first human genome was sequenced in 2001 at a cost of around USD 3 billion, the technology has become much quicker and further economical. Next generation sequencing (NGS) has empowered molecular biologists to sequence a human genome within a day at a cost of approximately USD 1,000. In amalgamation with powerful bioinformatics, genomics is able to diagnose genetic diseases and disorders, particularly when it comes to finding the cause of rare diseases.

North America is a mature market and the largest contributor to the global IVD market. Despite several economic and industry challenges, the IVD market continues to show stable and robust growth in this region. The use of data-driven healthcare, automation and modernization of laboratories, unifying technology investments along with internal and external mergers are currently trending in North America.

The U.S. contributes the largest revenue share in North America. In 2017, the U.S. Food and Drug Administration launched 46 medical devices with premarket approvals as compared to 39 premarket approvals in 2016. The MedTech companies here, are acclimatizing to complex regulatory and reimbursement policies, and are advancing in clinical studies to ascertain the safety and efficacy of their medical devices. An upsurge in the adoption of communication technology in IVD devices in the U.S. also signifies progress in mhealth. The region’s IVD market performance is expected to face strong competition from growth in venture capital investment in emerging economies like China, Brazil and India, alongside growing local investor interest in developing economies. Additionally, implications of the Medical Device Excise Tax (MDET), unfortunate reimbursement procedures and extra fees for grouping of unique medical devices by FDA’s De Novo pathway are evident barriers for companies to enter this market.

The Canadian market is sophisticated and mature, with a robust demand for advanced IVD technologies with superior quality. Its vigorous manufacturing and health industries along with favorable policies for the growth of advanced digital technologies, are the key drivers for IVD market in this country. Approximately, 80% of the Canadian medical device market consists of imported goods, such as diagnostics, orthopedic, prosthetics and dental equipment. This trend is an ideal opportunity to attract foreign investors; however, manufacturers outside North America will face high competitive rivalry from the U.S. companies, which cover more than 50% of the Canadian medical devices market.