The TMF is the official record of the clinical study for Regulatory Authorities, be it…
The Global Clinical Trials Market was valued at $44.3B USD in 2020, and by 2028 is expected to reach $69.3B according to a recent Researchandmarkets.com report.
As in the past oncology research and development continues to lead the sector, with anticancer drugs reportedly contributing the highest to the drug development pipeline in 2020. A trend expected to pick-up in 2022 and continue with the highest development of oncology drugs seen for over a decade.
This is partly due to thousands of compounds that are currently in the latter stages of clinical development, coupled with hundreds of new products with approvals anticipated in 2022 and beyond. (linchpinseo.com - 2021)
Expected Surge of non-COVID-19 Drug Discovery Programs
Through 2022 most COVID-19-related drug discovery projects will have advanced to the clinical research stage, and as pandemic-related restrictions are lifted, a surge is expected as non-COVID-19 drug discovery programs stalled during the pandemic resume full activity.
Overall, we expect that the therapeutic area of oncology will continue to have a meaningful and transformative potential for patient outcomes. Many indications continue to have significant unmet need, both in the United States and globally. There is tremendous potential for innovation as measured both by the number of new medicines being tested and the investment made by the pharmaceutical industry. Precision medicine and novel modalities, including cell therapy, offer huge potential to transform the lives of patients. However, capitalizing on this potential will require pharmaceutical companies to work in new ways as they accelerate development timelines, develop combination therapies, and—critically—find effective routes to bring these therapies to market. (McKinsey - 2020)
North America Continues to Dominate
More than 800,000 people are employed in the biopharmaceutical industry in the U.S. in scientific research and technical support, as well as manufacturing and distribution according to data provider Ampliz.
The growing burden of chronic disease and increasing investments in research and development activities in the United States are the major factors driving the biopharmaceuticals market in North America. The United States has been recognized as the innovation capital of the world for life sciences, and it is involved in global capital investments in the early stages of biopharmaceutical companies. (Mordor Intelligence Forecast 2021-2026)
Oncology Remains the Top Therapeutic Priority
Estimated cancer cases in the U.S. in 2020 is 2,281,658, with 612,390 deaths according to Globocan. This high incidence of cancer is exacerbated by the global pandemic and surges the demand for effective therapeutics.
Almost two-thirds of biopharmaceutical leaders say that oncology is a top therapeutic area priority for the next year, followed by 53% who cite rare diseases and 48% who cite autoimmune/inflammation… Immuno-oncology, precision medicine and gene therapy are still viewed among the top innovative, disruptive technological priorities for the next 12 months, according to biopharmaceutical leaders, followed by RNA-based therapeutics, cell therapy and next-generation antibodies. (lifehealth.com - 2021)
Effects of the Pandemic Will Persist
Healthcare leaders expect the pandemic to continue through 2022 and beyond. 90% of respondents expect baseline caseloads to persist at more than minimal levels in 2022, and 58% expect this to continue in 2023 and beyond. More than 90% expect the same for peak caseloads in 2022, and two thirds expect this trend for peak caseloads to continue in 2023 and beyond. (lifehealth.com - 2021)
Clinical Trial Support Services are Key
To a great extent, the future success of an increasingly more complex clinical trials industry to bring new products to market rests on the ability of sponsors and CROs with their network of sties to work together ever more effectively. Whereby all parties benefit from strong partnership established on a meeting of goals and ‘minds’ to forge win-win-win outcomes for the sponsor, the CRO, and the sites and patients served.
The global clinical trials support services market size is anticipated to reach USD 35.2 billion by 2028, expanding at a CAGR of 7.3% over the forecast period. The factors driving market growth include rising demand for drug development that necessitates clinical trials and an increase in the number of CROs. (Research And Markets Segment Forecasts 2021-2028)
Making the Right Choice
Scimega is a Canadian niche oncology CRO that serves small to mid-size biotech companies in the clinical development of cutting-edge oncology therapies in Canada. We consistently deliver our services with a strategic focus on Sponsor program success, and our team’s ability to engage oncologists and site teams at the highest level is unparalleled. Even under the current pandemic circumstances.
Mobilizing an expert Canadian team significantly enhances study start-up and overall performance. In keeping with KPI targets shared with its Sponsors, the Scimega team delivers consistent clinical trial start-up times 50% faster than the North American average. These same Canadian sites selected and motivated by Scimega very often rank as top enrollers on global studies. In addition, over 90% of sites we select and activate enroll participants across our oncology trials.
U.S. drug developers turn to Scimega and the Canadian trial landscape upon realizing program timelines and targets aren’t being met in other regions of their global trials, and marvel at the timely results achieved by Scimega in Canada.
As can be seen in the table below, for the past four years running Scimega selected and motivated Canadian sites have achieved or surpassed its own KPI targets in 2018, 2019, 2020, & 2021 for an SDV of 96%; eTMF upload of 10 days; enrollment FPI of 6-weeks; site identification & selection of 2-months; and site start-up of 3-months.
These metrics clearly reflect the caliber of combined skill and service the Scimega team of oncology experts consistently deliver. Working hard at working smarter every year for over two decades.
Contributed by: Julie Martin, CEO