Investigating Growth in Clinical Trials (Part 1: Growth by Industry)

 

It’s a time of significant growth for the major industries in clinical research, creating exciting opportunities for researchers and investors everywhere. Which industries are experiencing the highest growth? What factors are driving that growth? And how does it change the calculus on eClinical vendor selection?

 

Growth in Pharma

 

Growth in pharmaceutical clinical research is being outpaced by growth in other sectors. But the industry is still growing – particularly in 3 major areas:

 

Oncology

 

Oncology clinical research is outgrowing the rest of the pharma sector in terms of trial volume.

 

Number of Trials, Total Drugs vs Oncology

 

 

 

This trend is expected to continue at least through

theĀ next several years.

 

 

Biotech

 

Share of Biotech in Top 100 Product Sales Worldwide

 

Biotech significantly outgrew the rest of the pharma sector between 2010
and 2017, and is expected to continue to do so through 2024.

 

 

In particular, the biosimilars market is expected to see a surge of activity.

 

 

What’s driving the biosimilars market?

 

Biosimilars can serve as a lower-cost alternative to other biologics, while expanding overall treatment options for life-threatening chronic diseases. And regulators have demonstrated their enthusiasm:

 

 

Orphan Drugs

 

Orphan drugs are another major growth segment in pharmaceutical clinical research.

 

 

For years, the orphan drugs segment has benefitted from various financial incentives.

 

 

Challenges and opportunities

 

As exciting as this surge in pharma clinical research is, it’s important to acknowledge the challenges facing the industry as well. Perhaps the biggest challenge is an economic one: While spending on research and development in pharma is increasing, return on investment has been in decline:

 

 

Behind this trend are several factors, including rising clinical trials costs, increasing competition from generics, and low market-arrival rates. And the consequences are hard to overstate: estimates on the cost of a failed clinical trial range from $800 million to $1.4 billion.

 

Pharma Clinical Research and Technology

 

With these rising cost pressures, efficiency in management of drug trials and patient data is of the utmost importance. eClinical solutions including EDC, eSource, and eConsent can go a long way toward reducing errors and delays in the management of clinical data, ensuring higher return on investment in clinical trials.

 

As researchers evaluate eClinical providers for their pharma trials – especially in the early phases
– several key characteristics should remain top of mind as keys to efficiency and cost reduction:

  • DIY processes: Researchers should be able to build and conduct their studies without reliance on costly programming staff or professional services.
  • Ease of use: Intuitive interfaces and robust training and onboarding resources are key to getting up and running quickly and getting drugs to submission faster.
  • Low cost of ownership: eClinical pricing structures should be simple and transparent, so researchers don’t end up wasting budget on unnecessary features.

 

Growth in Medical Device

 

Medical device trials have grown faster than the overall number of clinical trials worldwide:

 

 

 

Key growth drivers

 

Numerous factors have conspired to set the stage for the growth that the medical device industry is seeing today:

    • Advancements in clinical research, particularly diagnostics research, necessitate more technically sophisticated medical devices.
    • There’s a growing prevalence of virtual trials with the widespread availability of the internet and other technologies including electronic health records (EHR).
    • There’s also a need for products for use in minimally invasive surgeries, essential to improving the quality of healthcare.

 

Growth drivers on the regulatory side

 

    • The Protect Medical Innovation Act of 2018, in the US, is likely to repeal the Medical Device tax, which imposed a 2.3% excise tax on medical device manufacturers.
    • Considering the increasing globalization of clinical trials, the FDA has signalled an openness to accepting clinical trial data collected outside the US.
    • In April 2017, the Medical Device Regulation (MDR) was adopted by the European Union. The MDR is likely to make it easier to conduct clinical trials for medical devices due to the centralized electronic system.

 

Where is the medical device market growing fastest?

 

Driven by economic, regulatory, and cultural forces, Asia has registered growth in medical device trials at a much higher pace compared to the global numbers.

 

 

 

Growth in Diagnostics

 

Diagnostics clinical trials accounted for less than 1 % of the total worldwide clinical trials market in 2010. By 2017, it accounted for almost 4% – and is still growing.

 

 

 

At the heart of growth in diagnostics

 

Companion diagnostics is expected to be the fastest-growing segment of the worldwide diagnostics market, outpacing both in-vitro and in-vivo diagnostics by a wide margin.

 

 

 

There are numerous factors behind this surge of companion diagnostics. But there are also obstacles preventing the market from growing even faster.

 

Growth Drivers

 

    • Growing demand for personalized medicine
    • Improved regulatory guidelines, rising incidence of cancer, and growth in immunotherapy
    • Advances in the use of biomarkers to expand companion diagnostics into a wider range of therapeutic areas

 

 

Restraints

 

    • Increasingly long processes for developing companion diagnostics and consenting clinical trial patients
    • Uncertain reimbursement scenarios in both developed and developing countries
    • Lack of professionals to perform the tests

 

Medical Device and Diagnostics Research:
A Smart Technology Strategy

 

The growth in medical device and diagnostics clinical research has created exciting opportunities for researchers in these sectors. But the wrong technology investments can end up hindering the ability of organizations to capitalize upon that opportunity. Many legacy EDC platforms, for example, are built for large and complex studies in Phase Ill pharmaceutical research.

 

But device and diagnostics trials tend to be short and straightforward in design – and these legacy systems can end up complicating their processes and lengthening their timelines with unnecessary logistical headaches.

 

 

This has significantly raised the stakes of eClinical vendor selection for these studies. The medical device and diagnostics organizations best equipped to capitalize on the growth in their industries will be those who identify eClinical systems that:

 

    • Cater to the needs of studies with straightforward designs and/or small patient populations
    • Empower researchers to handle study build and other processes themselves, without programming or other professional services
    • Offer the intuitiveness, as well as the training and support resources, to get users up and running in the software quickly and seamlessly.

 

With the right clinical trial technology, there’s no limit to what clinical researchers, regardless of their industry, can achieve.

 

 

Sources:

1 WHO International Clinical Trials Registry Platform (ICTRP}, January 2018
2. Evaluate Pharma World Preview 2018, Outlook to 2024
3. Evaluate Pharma World Preview 2018, Outlook to 2024; Biosimilars: Global Markets, BCC Research, 2018.
4. A booming market – looking at the growth of the orphan drug market and its drivers, European Pharmaceutical Manufacturer, June 2018
5. Niche is the new normal: the growth of the orphan drugs market, Pharmaceutical Technology,June 2017
6. www.clinicalleader.com/doc/the-high-price-of-failed-clinical-trials-time-to-rethink-the-model-0001
7. wvvw.outsourci ng-pharma.com/ Article/2018/08/06/I nd ustry-to-refocus-and-rei nvest -in-US-fol lowi ng-potentia I-med ical-device-tax-repeal-say-CRO-execs
8. wvvw.factory-cro.com/news/clinical-investigations-changes-medical-device-regulation/