Investigating Growth in Clinical Trials (Part 2: Growth by Therapeutic Area)

 

The clinical research industry is shifting and changing. Researchers in certain areas of the industry are seeing a surge of growth and opportunity, owing to numerous factors. In Medrio’s second installment of our three-part eBook series on growth in clinical trials, we’re diving into three therapeutic areas currently experiencing major growth, investigating the factors behind that growth, and lending insight into how researchers can take advantage of this exciting moment.

 

Growth in Oncology Research

 

More pharmaceutical research and development is currently taking place in oncology than in any other therapeutic area. Oncology also commands the biggest share of the clinical trials market, and its compound annual growth rate (CAGR) is outpacing other therapeutic areas.

 

 

 

Growth Drivers in the Oncology Clinical Trials Market

 

1. Personalized Medicine

 

The industry is diving deep into personalized medicine, exploring the use of genetic biomarkers to maximize a treatment’s effectiveness in individual patients.

 

Personalized treatments as a share of all new FDA-approved

molecular entities:

 

Personalized treatment approvals by therapeutic area:

 

 

Why is oncology driving growth in personalized medicine?

 

  • High Unmet Needs: Traditional treatments often yield poor clinical responses and high rates of adverse effects.
  • Biomarkers: Genetic biomarkers are better understood in cancer than in other diseases, enabling more effective drug targeting.
  • Cost Concerns: The high costs of traditional treatments present a big opportunity for personalized medicine.

 

 

2. Advancements in Immunotherapy

 

By harnessing the body’s own immune system to fight cancer cells, immunotherapy represents one of the most exciting and talked-about innovations in oncology today. High-profile initiatives such as the Cancer Moonshot, which aims to cure cancer with a specific focus on immunotherapy, are helping to drive immunotherapy even further.

 

  1. A surge of development:
  2. Immuno-oncology drugs in 2017

 

 

A wide reach:

 

 

Key advantages of immunotherapy:

 

  Can be combined with additional therapy

  Less toxic and resistance-prone than traditional treatments like chemotherapy

  Can be produced for widespread use

 

Growth in Infectious Disease Research

 

Infectious diseases represent a major public health challenge. Their easy communicability makes them particularly susceptible to dangerous outbreaks, as the world saw in the Ebola and Zika crises of the last several years. This lends great urgency to infectious disease clinical trials, as researchers work to find cures and vaccinations.

 

 

 

Growth in Infectious Disease Trials by Condition

                                                        2010                                2017

 

 

Why is Hepatitis leading infectious disease research?

 

1. Regulatory initiatives
Through its Global Health Sector Strategy on viral Hepatitis, the World Health Organization (WHO) aims to diagnose 90%, and treat 80%, of the people suffering from Hepatitis B and C by 2030.

 

2. Rising prevalence
WHO estimated 325 million people globally living with chronic Hepatitis at the end of 2015. By comparison, that’s almost 10 times the number who had HIV as of 2017. As Hepatitis becomes more common, there’s more urgency to find new treatments.

 

3. Limited treatment coverage
In 2015, only 9% of people living with Hepatitis B were diagnosed. Of those, only 8% had treatment coverage. A lack of diagnosis increases the risk of transmission.

 

Growth in Pain Management Research

 

Pain management is one of the largest and fastest-growing segments in the clinical research industry. Driven in large part by the mandate to respond to the opioid addiction epidemic, the number of clinical trials in pain management has grown faster than many other therapeutic areas in recent years.

 

Pain management trials as a share of total clinical trial market:

 

Number of pain management clinical trials by year

 

 

Drivers of Growth in Pain Management Research

 

1. Chronic Pain and Associated Costs

    • More than 100 million Americans suffer from chronic pain.
    • The direct healthcare costs for treating pain in the U.S. are estimated at about $260 billion annually.

 

2. The Opioid Crisis

    • In 2016, there were over 42,000 opioid overdose deaths in the US – a five-fold increase from 1999.
    • 40% of those overdoses involved prescription opioids.

 

3. Need for Non-Opioid Analgesics

    • Existing alternatives to opioids are often labeled “experimental” and not covered by insurance companies.
    • A growing body of evidence points to cannabis as an alternative to opioids for the treatment of chronic pain.

 

4. Regulatory Initiatives

    • 2016: CDC recommends increased use of non-opioid drugs, creating an incentive for increased development.
    • 2017: The U.S. Department of Health and Human Services outlines its Opioid Strategy, which includes support for research into pain and addiction..

 

 

A Smart Technology Strategy for Researchers in 

Growing Therapeutic Areas

 

The growth in oncology, infectious disease, and pain management 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. An EDC platform that requires extensive back-and-forth with programming staff, for example, can end up extending study timelines – and in a field like infectious disease, in which the mandate to deliver new treatments to market is especially urgent, this is unacceptable. For oncology studies, any EDC platform in use must be flexible enough to handle the increasingly complex study designs and frequent protocol changes
in that field.

 

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

 

  • Keep processes such as study build and mid-study changes in the researchers’ control, eliminating reliance on programmers.
  • Are cloud-based, so that researchers can get up and running quickly without spending valuable time on on-premise installation.
  • Have the flexibility to seamlessly manage unforeseen changes and an increasingly wide variety of study designs.

 

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

 

 

 

Sources:
1. PERSONALIZED MEDICINE AT FDA, 2017 Progress Report, Personalized Medicine Coalition (PMC)
2. The Evolving Role of Biomarkers in Oncology Clinical Trial Design, Clinical Leader, July 5, 2018
3. Comprehensive analysis of the clinical immuno-oncology landscape, Oxford Academic, December 7, 2017
4. Immuno-Oncology Drug Development — Too Much of a Good Thing? Forbes, Dec 12, 2017
5. The Cancer Moonshot 2020: Then, Now & the Future, Technology Networks, December 08, 2017
6. Global Immuno-oncology Therapy Market Will Reach USD 42.97 Billion by 2022, Zion Market Research, January 17, 2018
7. WHO International Clinical Trials Registry Platform (ICTRP), January 2018
8. www.who.int/hepatitis/GRSH-training_presentation.pdf
9. Health Resources and Services Administration (HRSA)
10. www.bio.org/sites/default/files/BIO_HPCP_Series-Pain_Addiction_2018-02-08.pdf
11. www.cdc.gov/drugoverdose/data/index.html
12. www.drugabuse.gov/about-nida/legislative-activities/testimony-to-congress/2017/federal-response-to-opioid-crisis
13. www.va.gov/PAINMANAGEMENT/Opioid_Safety_Initiative_OSI.asp
14. www.webmd.com/special-reports/opioids-pain/20180314/opioid-alternatives