Biological Drugs As-supplied Packaging is getting more Patient Friendly. The growth in biological drugs is both a phenomenon and an inflexion point in the practice of patient centered medical care. Not only are biologicals leading the market for new and innovative NCE’s, because they target previously intractable and refractory conditions they are opening up new and underserved areas in clinical pharmacology.
As a technology that was only a decade ago at once both novel and complex to the point of generating batch yields that were marginal at best, recombinant protein and peptide manufacturing has become an indispensable sector in the global drug industry. As the technology has evolved and matured and become easier to implement and manage, the number of companies competing in the recombinant segment has grown dramatically. The listed companies in the chart below represents less than a fifth of the total number of biological drug suppliers with at least one FDA approved biological drug product.
Source: Greystone Research
In addition to process evolution and maturation and the changing competitive landscape, the biologicals market is evolving in other important ways. Because of the chronic nature of the indications they target and the subsequent need for repeated dosing over time, biologicals have become the leading class of non-oral dosage forms to be supplied in primary packaging designed to support patient self administration. Currently, the number of biologicals supplied in prefilled syringes and autoinjectors has reached just under 30% of all drugs in this class, up from 3% in 2005.
Source: Greystone Research
We expect this trend – biological drugs as-supplied packaging – to continue as biosimilars enter the market and seek to compete with first-in-class drugs on an equal footing in the eyes of prescribers and patients.
More information on this market can be found in Greystone’s just-released market analysis – Point-of-Care and Self-administered Biologicals to 2026.
Download the publication brochure HERE,
Point-of-Care and Self-administered Biologicals to 2026 Report Brochure
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JUST PUBLISHED: Point-of-Care and Self-administered Biologicals
Digital health, the healthcare sector that is enabled and provisioned by wireless data and the Internet – which together have become known as the Internet of Things (IoT), is the the most significant force influencing the practice and future course of patient care. Digital health is already impacting such diverse areas as drug delivery, medical imaging, and patient/caregiver relationships.
Examples of connected health include drug injectors and inhalers that communicate with patients about when and how to self-administer therapeutic drugs, and which then collect data on dosing events and pass the information to a Cloud-based repository for caregiver review and response. A well-known example of connected health is the rapid spread and adoption of patient portals that allow patients to log on to their account, request appointments, prescription refills, and report health concerns.
One of the most dynamic areas of digital health is medical imaging. Software-based image processing and analysis – referred to as SaMD (Software as a Medical Device) have been proliferating rapidly. Many of these products employ artificial intelligence, machine learning, and neural networks in their algorithms, endowing them with the ability to evolve over time. There are now more than sixty such products approved by the FDA. Regulators are attempting to adjust approval parameters to reflect this capability. For now, a requirement for approval is that the algorithms be locked. Ultimately, the goal of product developers is to move to unlocked versions that will allow the software to adapt over time to become capable of keeping up with the growth in the imaging market.
More information is available at greystonedigitalhealth.com
Interest in fabrics and textiles that incorporate sensors into the fabric and can detect and measure parameters such as body temperate and heart rate have become the new generation of adult toys, joining ‘smart’ watches and similar gadgets. This generation of smart clothing allows users to view data from the sensors on their smart phones and/or Apple/Fitbit devices. But a separate group of companies is emerging, those who are marketing smart fabrics as FDA 510(k) devices.
There are close to one hundred companies active in this market, a testimonial to the low barrier to entry. As a result, competition for sales can be fierce. A secondary business concern is the inevitable drop off in interest as the novelty factor wears off.
There is, however, another tier of competition – smart fabrics as FDA 510(k) devices – those that have pursued the medical device track, designing and testing their products through the clinical trial process. Market participants that successfully navigate this path can receive marketing authorization – approval to market their products as medical devices for specific indications – under the FDA’s 510(k) authorization.
While the FDA approval process incurs more expense, risk and effort, success represents membership into a rather exclusive club. Of the companies competing for Smart Fabric market share, less than ten percent have at least one FDA approved medical device among their product portfolio.
As the competition continues to intensify for the average consumer/user, we expect the number of players developing and marketing wearables to examine the benefits of FDA approval.
For more information click HERE