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According to GlobalData’s recent report , a total of five marketed messenger RNA (mRNA) non-vaccine products by 2028 will generate over $2 billion, generated by the approval of pipeline agents. billion during 2028.
This dual-layer certification process can create significant delays, as each framework involves extensive assessments for safety and performance under separate requirements specific to medical device and AI-specific criteria.
Based on the latest report and data, HPAPI market size is expected to reach $32 billion by 2028. Biotechs working with early-stage NCEs must adopt a conservative approach to prioritise safety for their HPAPIs in discussions with contract development and manufacturing organisations (CDMOs) and other scientific partners.
For instance, patent expiries are set to wipe out $300 billion in revenues by 2028. With growing emergence of AI into 2025, the first part of the year saw the US Food and Drug Administration (FDA) issue draft recommendations on AI, which are set to address the safety, effectiveness or quality of drugs or biological products.
The digital health market is being driven by expansion of digital connectivity, declining cost of sensors and other technology components, and an increase in patient engagement, and is predicted to reach a value of $450 billion by 2028, according to the company.
According to GlobalData’s analyst consensus forecast, Yescarta is expected to reach peak sales of $1.8bn in 2028, and Kymriah is expected to reach sales of $686m in the same year. Autologous CAR-T agents are now becoming the standard of care for patients in the third line and later settings, providing lucrative returns for these agents.
Robust analytical methods are needed to establish safety, potency, and purity of mRNA therapeutics in large-scale manufacturing. Sarah Bundra, Pharmaceutical Analyst at GlobalData also warned about patient safety: “introducing mRNA carries the risk of activating the immune system.”
While regulatory support, such as breakthrough therapy designations, can help in this regard, there is a critical need to collaborate with regulatory agencies to agree efficient clinical trial designs that maintain appropriate demonstration of safety and efficacy. AMR has the potential to be just as devastating for the world as COVID-19.
The use of medicines worldwide grew by 14% over the past five years, and is expected to grow an additional 12% by 2028. Some countries require local studies due to different safety and efficacy results. Healthcare expenses in emerging markets are expected to grow and reach parity with developed nations.
Enhertu has already achieved regulatory approval as a second-line therapy for metastatic or recurrent HER2-positive breast cancer, as well as HER2-positive gastric or gastroesophageal junction adenocarcinoma, with annual sales for these indications alone expected to exceed $1.3bn by 2028.
million by 2028. From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. Now, the demand for such equipment is on track to grow exponentially. Development Of New Biotech Coating In Orthopedic Medical Devices.
In the pirtobrutinib safety cohort, only 2.6% GlobalData’s consensus analyst forecast database projects peak sales for pirtobrutinib to reach $892 million by 2028, and $4.8 Only 75 patients were evaluable for response, of which ten underwent a complete response, and 29 a partial response, resulting in a 52% overall response rate (ORR).
GnRH antagonists have an improved safety and efficacy profile compared to the marketed GnRH agonists, which have significant side effects that are unappealing to patients. This therapy is currently in Phase II development and is expected to launch in the US and 5EU in 2027 and 2028, respectively.
Billion by 2028. The pharmaceutical industry globally is realising the growing potential of in vitro tissue models for drug discovery, pathology modelling and validation, safety and toxicity.
When it comes to pharmaceutical, nutritional or cosmeceutical dosing, some of the most crucial parameters are safety, product effectiveness and patient adherence. billion by 2028, at a CAGR of 12.6%. Each formulation is designed with patient adherence, safety and efficiency in mind, offering a range of options for diverse applications.
In addition, the devices must not present an unacceptable risk to patient and user health and safety as established in Articles 94 and 95 of the MDR. Edward helps clients with compliance and safety issues, including in the development, launch and marketing of new products. of the MDR and Article 110.4
Under the pathway, manufacturers can use safety and efficacy data from existing products in their applications for their own products. This increases to 15 Part D drugs in 2026, as well as 15 Part B and D drugs in 2028, and a full 20 Part B and D drugs in 2029. The impact of the IRA’s price negotiations on payers is mixed, he noted.
Subject to planning permission, the site is expected to be opened by 2028. According to Astellas, sustainability measures at the facility will include reducing water consumption by approximately half, a commitment of zero waste to landfill (compared with LEED ® baseline), and onsite renewable technology.
The vaccine demonstrated a similar safety profile to Pfizer’s marketed 20-serotype shot Prevnar 20 at all assessed doses, and showed non-inferior efficacy. billion and $812 million in 2028. According to GlobalData, Pharmaceutical Technology’s parent company, Prevnar 13 and Vaxneuvance are forecasted to have global sales of $7.26
According to the ClinicalTrials.gov trial registry, as of April 2022 3 there were 231 bsAbs in clinical trials and a recent industry report 4 predicts the global market revenue for these products will exceed $20 billion by 2028. Figure 1: Example of bi-specific formats. Labrijn AF, Janmaat ML, Reichert JM, Parren PWHI. Nat Rev Drug Discov.
These high prices are the result of multiple factors: theyre derived from living organisms making them sensitive and complex for both manufacturers and patients, research requires advanced technology to test for safety and effectiveness, and theyre in high demand without much competition. The Cost-Saving Alternative: What are Biosimilars?
GlobalData’s analyst consensus forecast database estimates peak annual sales for ARV-110 of $325 million in 2028. Moreover, off-target effects from conventional BTKis result in a suboptimal safety profile, which the enhanced selectivity of PROTACs can help mitigate. with Calquence, 16% with Imbruvica, NCT02477696).
The dearth of cancer drugs (only blood cancer drug Imbruvica made this first list) stems from CMS only pursuing negotiations for Part D drugs in 2026 and 2027, then expanding to Part B drugs in 2028. Part D cannot cover drugs covered under Part A or Part B , forcing them to be addressed separately.
CAGR between 2020 and 2028. FCM data are used to make clinical decisions around safety, efficacy, and pharmacodynamics. The global immunotherapy market, which includes CAR T-cell therapy, adoptive cell therapies, checkpoint inhibitors, monoclonal antibodies, and other immunotherapies, is expected to grow by 10.1%
According to various market research reports, the global non-invasive medical devices market was valued at approximately USD 45 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of over 6% from 2021 to 2028. This growth is driven by several factors, including: 1.
million by 2028. From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. Now, the demand for such equipment is on track to grow exponentially. Development Of New Biotech Coating In Orthopedic Medical Devices.
In our September 2023 report on the electrophysiology market, Clarivate projected that by 2028, PFA would represent 50% of the U.S. In addition, the improved safety profile of PFA is making the cost-benefit of ablation an easier calculation for many patients. ablation market and would have a total global market value of $3 billion.
In March 2024, New York received approval for a five-year Medicaid expansion through April 1, 2028, extending eligibility to include individuals with incomes up to 250% of the federal poverty level (eligibility was previously capped at 200%).
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