A year in review
Mark Shriner is the strategic sales director for memoQ, leading the company’s market growth in the regulated industries. He has previously worked in several leadership roles in the localization industry including CEO Asia Pacific for CLS Communication.
Mark Shriner is the Strategic Sales Director for memoQ, leading the company’s market growth in the regulated industries. He has previously worked in several leadership roles in the localization industry including CEO Asia Pacific for CLS Communication.
Welcome back to The Lab, where we take a look at what’s cooking in life sciences localization. As we are approaching the end of 2022, I thought it might make sense to review some of the major trends in the life sciences industry and talk about how these trends will affect those of us involved with life sciences-related localization.
Before we get started on the trends in life sciences, let’s take a moment to explain all the different types of businesses that fall under the umbrella term of “life sciences.” At a high level, all companies and organizations that are concerned with the research and development of technologies, products, or services, for the study or betterment of living organisms can be classified as a life sciences organization. In practice, the term “life sciences” is used to cover various industry branches such as biotechnology, pharmaceuticals, nutraceuticals, environmental sciences, medical devices, and more.
Discussing trends in each of these areas of life sciences would require way more space than my usual allotment or capacity. So, in the name of saving space and keeping relevant to our readership, I’ll be focusing this outlook on the industries that have traditionally been strong consumers of localization services: the pharmaceutical industry, which also includes clinical trials and contract research organizations (CROs), and the medical device industry.
The good news for those of us involved in these industries is that, despite the global economic slowdown, supply chain shortages, and exchange rate challenges that are currently plaguing other industries, the growth outlook for CROs and medical device companies looks very positive. Primary drivers of this growth include record levels of clinical trials and aging populations that increasingly suffer from chronic diseases which require both medical devices for diagnosing and monitoring, and pharmaceuticals for treatments.
The market for CROs is expected to maintain a compound annual growth rate (CAGR) of 7-9% until 2027. This impressive rate of growth is partially being fueled by the large number of mRNA products that are being developed. As of April 2022, the top 31 life sciences companies had over 180 mRNA products in clinical pipelines. At the same time, the cell and gene therapy (CGT) market is expected to reach $50 billion by 2027.
On the medical device side, huge growth is expected in wearable medical devices (WMDs) which make treatment more accessible for patients and can provide data to caregivers via cloud technology. This sector is expected to have a CAGR of a whopping 26.8% through 2028 increasing from the current market value of approximately $22 billion to over $110 billion in the next six years.
Two leading indicators for the future growth of an industry is the amount of investment coming into the sector and if there is an increase in the investment in research and development (R&D). In the first half of 2021, PE firms invested $47 billion into biopharma. And from 2010-2019, there was a 41% increase in R&D spending by the largest pharmaceutical companies in the United States.
On the other hand, M&A and IPO activity has dropped dramatically in 2022 and isn’t expected to improve in 2023. However, since the top 30 largest biopharma companies have a combined $87 billion in cash, there is hope that M&A activities will pick up as soon as the economy stabilizes.
The above-mentioned trends point to strong continued growth over the next three to five years in life sciences. That said, there are challenges that need to be addressed in order for the growth to be realized. These challenges include shortening drug development times, recruiting enough participants for trials, ensuring that trials are inclusive, protecting participant and patient data, and adhering to industry and national regulatory requirements. All of these challenges bring opportunities to us in the localization industry.
As an example, according to RSM’s Life Sciences Services and Trends: Fall 2022 report, there is currently a gap of almost 1.4 million participants needed to meet the enrollment requirements for all active phase-three studies that are actively enrolling participants. To meet that challenge, there is a growing trend towards decentralized clinical trials which don’t require participants to be in a central location. Additionally, there’s the movement of retailers like CVS and Walgreens entering the clinical trials business, using their large number of locations to recruit a greater number of participants.
Alongside this movement is the commitment by many large pharmaceutical companies to improve inclusiveness and diversity amongst trial participants. In the report, Five Key Strategies for Enhancing Diversity in Clinical Trials, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Deloitte US Center for Health Solutions (CFHS) recommend key strategies for improving diversity in clinical trials: the establishment of clinical trial sites in underserved communities, developing a racially and ethnically diverse pool of investigators and staff, and improved communications between sponsors and the community.
The underlying need and the above recommendations all point to opportunities for language service and technology providers. For example, voice tech is being used to facilitate communications between trial participants and trial sponsors and uses natural language processing (NLP) to process, evaluate, and analyze each patient’s response. Already, many LSPs are providing machine translation services so that trial sponsors can quickly gain insights into participant feedback and identify potential issues.
One of the challenges of using digital systems and handling patient data is that it needs to be protected and handled in alignment with various regulatory agencies. Decentralized trials and wearable devices often require telemedicine systems that collect and share data in real time and allow treatment providers to monitor treatment progress, make adjustments to treatment, and personalize the treatment for each patient. A byproduct of this approach and of using these systems is the massive amount of personal data that is collected. For example, in 2020 over 2,314 exabytes of healthcare data was collected. That’s the equivalent to the amount of data that could be stored on 2.3 billion MacBook Pros.
It is clear that securely storing and providing access to this amount of data poses technical- and security-related challenges. Additionally, there are an increasing number of data privacy laws that need to be adhered to by CROs, medical device users, and even those of us in the localization industry that are involved with the translation of any patient-related information. Some LSPs have become ISO 13485 certified which is a quality management system for medical devices. Many more LSPs have already been ISO 9001 and ISO 27001 certified, which demonstrate that they adhere to best practices related to general quality management and information and security management. HIPAA compliance is a must have for service providers in the United States.
Another trend that will bring changes to LSPs serving the life sciences industry is the increasing use of rolling submissions. This sees regulators receiving key portions of a drug application as it becomes available, as opposed the traditional practice of submitting the complete application and data at once. Receiving and reviewing applications and data in portions helps to reduce completion times and allows regulators to request clarifications or additional information when needed. LSPs need to align their translation practices with this trend.
One key strategy that most life sciences organizations are adopting to meet the challenges for developing and releasing more products in a shorter amount of time is digital transformation. According to a report issued by Deloitte and Fortune, 77% of queried CEOs expected the digital transformation trend will accelerate and spread into more areas of the supply chain. For LSPs, this is a signal that adopting platforms with automated workflows, machine translation and voice recognition systems, and other digital tools that can connect with their customers in the life sciences space will become increasingly important.
In summary, if you are providing language services to the life sciences industry, the outlook is very strong for the next five to seven years. That said, you should be prepared to adopt the appropriate tools, processes, and security practices to ensure that you are in alignment with your customer’s requirements and have the operational capacity and ability to keep up with the expected growth in language service needs.
While attending a localization conference in Warsaw a few years back, I heard the chief technology officer of a well-known machine translation (MT) company refer…→ Continue Reading
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