AstraZeneca

Precision medicine tailors treatment to individual genetic blueprints, with AI and partnerships driving innovation. Key players like Snowflake and BGI Genomics are advancing the field. Challenges include cost, regulatory barriers, and ethical concerns. Strategic insights suggest embracing AI, fostering collaborations, and ensuring ethical compliance for future advancements.

In 2023, FDA's CDER approved 55 new drugs, a five-year high. Key 2024 drug launches include KarXT for schizophrenia, Donanemab for Alzheimer's, Resmetirom for NASH, Sotatercept for PAH, Datopotamab deruxtecan for lung & breast cancer, Acoramidis for ATTR-CM, mRNA-1345 for RSV, Anktiva for NMIBC, Ensifentrine for COPD, and Imetelstat for MDS.

FDA approved AstraZeneca/Ionis' Wainua for ATTRv-PN, issued a CRL to Merck's gefapixant, and approved Pfizer's Padcev with Merck's Keytruda for bladder cancer. Sanofi halted tusamitamab ravtansine development. Keytruda also gained EU approval for two gastrointestinal cancer indications.

Clarivate's 2024 Drugs to Watch report highlights 13 new therapeutics expected to achieve blockbuster status by 2029, targeting conditions like sickle cell disease, RSV, and breast cancer. It also notes the growing chronic disease market in China and the impact of new technologies like CRISPR-Cas9 and AI in drug development.

Johnson & Johnson's Rybrevant showed similar effectiveness to AstraZeneca's Tagrisso in treating advanced EGFR mutant NSCLC, with both drugs shrinking or halting tumor growth in about 75% of patients after a year. Rybrevant, approved in 2021 as a second-line treatment, may now also serve as an initial treatment option alongside Tagrisso, offering more effective choices to extend patient lives.

The rise in chronic diseases is driving the high-throughput screening (HTS) market growth, with HTS enabling rapid drug candidate identification. Major players like PerkinElmer Inc. are innovating with products like the EnVision Nexus system. North America leads the market, with Asia-Pacific expected to grow fastest. PerkinElmer's acquisition of Covaris Inc. aims to expand its life sciences portfolio.

The global digital biomarkers market is projected to grow at a 32.15% CAGR, reaching USD 83.8 billion by 2035, driven by chronic diseases and digital health advancements. Key players include nQ Medical and ActiGraph. Wearables and mHealth apps fuel growth, with North America leading due to Alzheimer's prevalence and Europe due to mHealth app adoption. Neurodegenerative disorders and drug discovery are significant segments.

Phase III trials for Aravive’s batiraxcept in ovarian cancer and Travere’s Filspari in FSGS failed, reducing their LoA. VYNE’s VYN201 showed positive Phase Ib results in vitiligo. Moderna’s MEDI1191, Drug Farm’s DF-006, and Alexion’s ALXN-2220 completed Phase I trials, increasing their PTSR in solid tumors, hepatitis B, and ATTR-CM, respectively.