Regions
MAIN/REGIONS
regions/
Regions
  1. Americas
  2. Asia & Oceania
  3. Europe
  4. Middle East & Africa
  1. Solutions
  2. Products
  3. Insights
  4. About
  5. Careers
  6. Contact Us
MAIN/search
MAIN/Solutions
Solutions/
SOLUTIONS
  • Research & Development
  • Real World Evidence
  • Commercialization
  • Safety & Regulatory Compliance
  • Technologies
LIFE SCIENCE SEGMENTS
HEALTHCARE SEGMENTS
THERAPEUTIC AREAS

Impacting People's Lives

"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.

LEARN MORE
Harness the power to transform clinical development

Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.

Research & Development Overview
Research & Development Quick Links
Real World Evidence. Real Confidence. Real Results.

Generate and disseminate evidence that answers crucial clinical, regulatory and commercial questions, enabling you to drive smarter decisions and meet your stakeholder needs with confidence.

REAL WORLD EVIDENCE OVERVIEW
Real World Evidence Quick Links
See markets more clearly. Opportunities more often.

Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.

COMMERCIALIZATION OVERVIEW
Commercialization Quick Links
Service driven. Tech-enabled. Integrated compliance.

Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.

COMPLIANCE OVERVIEW
Safety & Regulatory Compliance Quick Links
Intelligence that transforms life sciences end-to-end.

When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.

TECHNOLOGIES OVERVIEW
Technology Quick Links
MAIN/Products
Products/
CLINICAL PRODUCTS
COMMERCIAL PRODUCTS
COMPLIANCE, SAFETY, REG PRODUCTS
REAL WORLD PRODUCTS

CASE STUDY

"Data in a Day

LEARN MORE
MAIN/Insights
Insights/
BLOGS, WHITE PAPERS & CASE STUDIES

Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.

DISCOVER INSIGHTS
THE IQVIA INSTITUTE

An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.

SEE LATEST REPORTS

INSTITUTE REPORT

"Digital Health Trends 2024 - Implications for Research and Patient Care

READ MORE

EMEA Insights

"IQVIA thought leadership with a focus on EMEA.

Learn more

WHITE PAPER

"DCTs Deliver Big ROI

LEARN MORE

WHITE PAPER

"Capturing value at scale: The $4 billion RWE imperative

LEARN MORE
MAIN/About
About/
FEATURED INNOVATIONS
  • IQVIA Connected Intelligence™
  • IQVIA Healthcare-grade AI™
  • Human Data Science Cloud
  • IQVIA Innovation Hub
  • Decentralized Trials
  • Patient Experience Solutions with Apple devices
WHO WE ARE
NEWS & RESOURCES

INVESTOR RELATIONS

"Visit our investor relations site for more information.

LEARN MORE
Unlock your potential to drive healthcare forward

By making intelligent connections between your needs, our capabilities, and the healthcare ecosystem, we can help you be more agile, accelerate results, and improve patient outcomes.

LEARN MORE
IQVIA AI is Healthcare-grade AI

Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. It's what we call Healthcare-grade AI.

LEARN MORE

Your healthcare data deserves more than just a cloud.

The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.

LEARN MORE
Innovations make an impact when bold ideas meet powerful partnerships

The IQVIA Innovation Hub connects start-ups with the extensive IQVIA network of assets, resources, clients, and partners. Together, we can help lead the future of healthcare with the extensive IQVIA network of assets, resources, clients, and partners.

LEARN MORE
Proven, faster DCT solutions

IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are. Our hybrid and fully virtual solutions have been used more than any others.

LEARN MORE
IQVIA Patient Experience Solutions with Apple devices

Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm.

LEARN MORE
MAIN/Careers
Careers/
WORKING AT IQVIA

Our mission is to accelerate innovation for a healthier world. Together, we can solve customer challenges and improve patient lives.

LEARN MORE
LIFE AT IQVIA

Careers, culture and everything in between. Find out what’s going on right here, right now.

LEARN MORE

WE’RE HIRING

"Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.

SEARCH JOBS
MAIN/Contact Us
Contact Us/
White Paper
Global Outlook on the In Vitro Diagnostics Industry
Opportunities and Challenges
Feb 23, 2018
  • Library
  • Global Outlook on the In Vitro Diagnostics Industry
To download files you must give consent to process your personal data by clicking the "Accept" button below.

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.


Introduction

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.


DOWNLOAD TO LEARN MORE
MedTech

Forging a path for MedTech Innovation.

Therapeutic & Specialty Expertise

Specialized expertise and customized solutions across 14 therapeutic centers of excellence, including oncology, GI/NASH, pediatrics, neurology and rare diseases.

Clinical Research & Development Solutions

Explore our end-to-end, full service clinical development capabilities including Therapeutics expertise, Development Planning, Phase I early clinical development, Phase IIb/III and Phase IV Trials, Regulatory Submission and Post-Launch Studies.

Contact Us