Global Outlook on the In Vitro Diagnostics Industry
Opportunities and Challenges
White Paper
Feb 23, 2018

Over the past decade, the healthcare industry has witnessed significant growth and development in the In Vitro Diagnostics (IVD) space. The IVD market continues to be the largest segment within the worldwide medical device industry and while opportunity exists for broader expansion, challenges remain and span across various regions and segments. Regulatory hurdles, reimbursement pressure, healthcare budget constraints, and the ongoing advancement of lower-cost providers represent some of the headwind facing the IVD landscape.

In lieu of regulations followed for other medical devices, regulators have started demanding an evidencebased approval process and are keen on measuring the demonstrable value delivered by high-end diagnostics throughout patient treatment. In light of this opportunity, a vast majority of companies are now eyeing companion diagnostics (CDx) and molecular diagnostics (MDx) as potential new offerings, especially given their high-growth potential.

Oncology has been the major area of focus in the field of CDx, and until now only a few companies are going “beyond oncology” in the CDx space. Other CDx focus areas include endocrinology, infectious diseases and neurodegenerative disorders, all of which are in dire need of breakthrough offerings to enable easy diagnosis and monitoring in follow up care setup.

Advancements in sequencing techniques and molecular biology have dramatically improved treatment outcomes in recent years. Since a majority of drugs tend to fail in clinical trials due to inadequate efficacy, drug manufacturers are currently focusing on exploring treatment options at the molecular level. This has led to deeper partnerships between pharmaceutical and CDx companies.

Regionally, the United States (U.S.) and Europe remain the biggest IVD markets, but recent and pending reimbursement cuts in these regions have resulted in sluggish growth and has dampened the outlook across the developed markets. Leading diagnostic companies are turning toward emerging regions to drive organic gains and to help offset the mature geographies. Citing the importance of these markets, the World Health Organization (WHO) recently stressed the need to improve access to diagnosis facilities in the developing world through technology transfer and local production. In addition to sales and marketing efforts, companies have already begun expanding their R&D infrastructure, technology frameworks and manufacturing in developing markets. The level of R&D efforts as a percent of sales, remain more or less similar across large and small IVD companies, yet larger firms are more aggressive on the Mergers and Acquisitions (M&A) front.

The WHO recently released a draft proposal that focuses on developing a list of essentials to improve access to IVD for the rational use of medicines. This is in line with the global regulatory harmonization effort to eliminate jurisdictional differences. The targeted outcome is decreasing the cost of regulatory compliance and allowing patients earlier access to new technologies and treatments, especially in emerging markets and developing nations. Local production in developing markets is resource-intensive; therefore, small and medium-sized companies should look toward technology transfer and licensing to gain competitive advantages in such high-growth markets.

Despite all the market related challenges, the IVD market will continue to expand due to the rising burden of disease, a global aging population, a greater awareness of healthcare, and an improving infrastructure across the emerging regions. In order for IVD competitors to achieve healthy organic expansion, they need to strengthen their position in high-growth markets, while leveraging their position in the more mature regions and segments within the industry.


IVD is focused on analyzing blood, urine and other specimens derived from the body in order to provide a diagnostic result. They are an essential aspect of the modern healthcare industry and their reach ranges from hospitals and clinics, to self-testing consumers and sophisticated research centers.

According to the U.S. Food and Drug Administration (FDA), “IVD products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are meant to be used for collection, preparation, and examination of specimens taken from the human body.”

IVD test products are useful to diagnose, monitor, screen and assess susceptibilities to diseases, which aids physician decision-making throughout the patient journey. IVD remains pivotal in facilitating early, targeted treatments, reducing hospitals stays, improving healthcare outcomes, and minimizing treatment costs.

The IVD market continues to expand at a steady rate, which is a testimony to its vital role in the healthcare industry. However, in some major markets, like Western Europe, growth has slowed and in some countries, markets have contracted due to the economic downturn and resulting budgetary constraints. Despite the slowdown in developed markets, the global IVD market is likely to maintain its healthy expansion due to the rising demand in emerging markets, such as Latin America (LATAM), Asia Pacific (APAC), and parts of Eastern Europe, Africa, and the Middle East (EEMEA).


IQVIA has leveraged its in-depth industry knowledge with an exhaustive review of medical, business and company literature to author this paper, designed to be a global resource that can give market watchers a clear and factual picture of the business trends.


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