Technological developments are constantly affecting the global pharmaceuticals market and manipulating trends in point-of-care testing. Practical Patient Care investigates what this means for treating patients and how such progress can bring about positive change.
Technological developments are constantly affecting the global pharmaceuticals market and manipulating trends in point-of-care testing. Practical Patient Care investigates what this means for treating patients and how such progress can bring about positive change.
Expected drivers of growth in the point-of-care (POC) market over the next few years include increased prevalence of lifestyle-related and infectious diseases, faster turnaround times, accelerated decision-making about patient care, and expedited time-to-treatment. There will also be an emphasis on reducing the length of stays in emergency departments, fostering the emergence of more accurate molecular POC technologies to improve infectious-disease testing, increasing adoption of cardiac markers in emergency departments, advancing POC technology and expanding the number of tests available. A growing home-testing market encourages the use of POC devices and the industry’s push for a paradigm shift in treatment to value-based and patient-centred care.
The US and China currently constitute a significant portion of the POC diagnostics market, and will continue to do so until the end of the forecast period of 2015-2021. Together, these two countries represented 64.7% of the total market revenue in 2015, with the US accounting for 52.1%.
Industry estimates suggest the market share will remain relatively stable throughout the forecast period. While all of the major markets are expected to grow in test volume and market revenues, the market penetration of POC tests in France, Germany, Italy, Spain and the UK has been sluggish. Physicians’ limited use for POC testing, reimbursement challenges and stringent regulations continue to negatively impact POC market growth in these countries, and this will be compounded by manufacturers’ focus on the fast-growing US and Asia-Pacific markets. Throughout the forecast period, market share in the global outlook will remain stable, with the emerging markets of China, India, and Brazil providing more opportunities for POC manufacturers seeking faster growth.
Market dynamics
In the US and Europe, expenditures on reforming healthcare have impacted the adoption rate of POC devices in decentralised settings. The driving concept behind POC testing is to bring testing closer to the patient, and bring results swiftly to the physician to accelerate diagnosis and subsequent treatment.
POC testing is convenient, enables faster decision-making in a variety of environments, and can reduce the duration of hospital stays. For these reasons, the popularity of POC testing has risen in developed and developing markets alike.
Among the increasing prevalence of infectious and lifestyle-related diseases, various factors are stimulating the demand for POC testing, such as increased use of home-based POC devices, expansion of the test menu, and technological advancements in molecular testing and lab-on-chip technology. But while it is one of the most active segments within in-vitro diagnostics, the rate of adoption of POC testing will be moderated by regulations, the pressure to control cost and the need to demonstrate the clinical cost benefits of POC testing over central-laboratory testing. With this rising demand, manufacturers are racing to make the next-generation platforms faster, easier to use and more reliable.
Major market players
The market is fragmented: over 100 players are currently marketing POC products. Competition and pricing pressures in the development and marketing of POC diagnostic devices are intense. There are a large number of multinational and regional competitors making investments in competing technologies and products, including several large pharmaceutical and diversified healthcare companies. The competitive factors in the POC market include fast turnaround times for test results, price, reimbursement, data-handling techniques, analytical performance, research and development, distribution, marketing, promotion, and recognition of a company’s brand.
Few companies feature POC products across all areas of therapeutics in their portfolios. Alere and Roche are the two largest players in the POC diagnostics market, and have been pushing the frontier in development, particularly with POC molecular-diagnostics platforms.
Other industry leaders are Beckman Coulter, Siemens Healthcare, Quidel, Meridian Bioscience and Abbott Diagnostics. The current market is congested with small to mid-sized diagnostics companies marketing products in specific POC segments. Although Alere is considered to dominate the market due to the company’s long history in the POC and rapid-testing markets, seizing leadership in the POC arena is still possible, as the molecular-diagnostics market continues to attract new entrants.
The future of diagnostics
With $2 billion in annual worldwide sales, and a compound annual growth rate of 5.3% during the forecast period, the POC diagnostics market represents a major growth opportunity for in-vitro diagnostics companies looking to address the need for faster, more accurate and simpler diagnostic tests at point of care.
The emerging markets mean a promising avenue for growth in volume in the market. China has been undergoing drastic healthcare reforms in recent years, and the entry of POC devices into China will be facilitated by the decentralisation of its healthcare delivery to community hospitals, government investment in in-vitro diagnostics facilities, and a fast-growing middle class. With the spread of clinics and the demand for more effective healthcare delivery in various settings, the US will continue to influence the POC market. However, in the five EU countries previously mentioned, the adoption of POC has been slow due to the poor economic climate and limited clinical use at the point of care.
Ultimately, the trend towards POC diagnostics is a positive one. In the pursuit of improving patient care, the continued development of POC testing can help to support future demands for rapid diagnosis and treatment. Consequently, opportunities to implement successful POC testing facilities have been expanding as technology has improved. The most promising areas of growth within the market include high-sensitivity troponin, hematocrit and HIV testing, where there has been significant focus in pipeline development and the clinical impact of delivering faster turnaround times. Nevertheless, there remain several unmet needs, particularly with regard to accuracy, data management and the establishment of strong clinical data showing improved medical outcomes of POC testing compared with lab testing.
Concerns about testing
POC devices are expected to generate traction, and the volume of tests carried out will increase over the forecast period. However, key opinion leaders are concerned about the reliability, costs and lack of clinical data claiming superior outcomes of POC testing. Presently, POC test results are mostly used to support treatment decisions and are not used to make primary diagnoses.
The tests are convenient, but many within the industry consider them to be unreliable. The high costs may also be a reason why adoption of the tests continues to take a long time.
Several factors are driving the adoption of POC testing in decentralised settings, including the reduction in prescribing antibiotics. Government support in terms of reimbursement will be a major catalyst for adopting POC testing, while management and maintenance of devices are challenging for healthcare providers.
Many see POC testing as being positive for patient care, but it is not without its issues. There seems to be reluctance from physicians to fully endorse the tests, citing insufficient and inconclusive clinical data showing its efficacy as the main reason. Few deny, however, that there is value in using POC tests to speed up results and penetrate more treatment locations. In short, it should not, at this stage, be regarded as sufficient for a primary diagnosis.
Problems will remain for some time as the industry learns to embrace the changes in POC testing and its future – particularly major changes such as handheld analysers – and attempts to modify emergency-department care.