ZYDUS LIFESCIENCES LIMITED

In 2024, India's CDSCO approved 19 new drugs, including next-gen therapies for chronic diseases by global majors. Eli Lilly's Mounjaro for diabetes/obesity, Orchid Pharma's Enmetazobactam for resistant bacteria, Cipla's plazomicin for UTIs, Sun Pharma's Etifoxine for anxiety, Dr Reddy's Elobixibat for constipation, and Zydus/Lupin's Vonoprazan for stomach ulcers were notable. New cancer drugs like Eli Lilly's Retevmo and Zydus's nelarabine were also approved.

Dr. Reddy's launched Toripalimab in India on Nov 28, 2024, an immune oncology drug for rare head and neck cancer. India is the third country to access this next-gen PD-1 inhibitor. Dr. Reddy's R&D increased at 8% CAGR over FY19-FY24, with FY24 R&D growth at 18%. Revenues grew 17% YoY to INR80.2bn in 2QFY25, driven by Global Generics and new product launches. Dr. Reddy's trades at a P/E of 18.0x, lower than peers Cipla and Zydus.

The generic pharmaceuticals market was valued at USD 424.98 billion in 2024 and is projected to reach USD 874.63 billion by 2033, driven by cost-effective medications, rising chronic disease prevalence, government support, and advancements in manufacturing technologies.

India has approved 2 vaccines for emergency use.

Zydus Lifesciences plans to acquire commercial assets via M&A or licensing for a specialty portfolio, including potential US launch of liver therapy saroglitazar. The company aims to diversify into medical devices, expand diagnostics and nutrition businesses, and build a specialty play in the US, particularly in orphan and rare diseases. Zydus also targets Europe for M&A, focusing on profitable growth and innovation in unmet medical needs, including orphan and rare diseases. The company is bullish on biologics and globalizing its biosimilars portfolio, with a new facility set to commission in 2025. Zydus received WHO approval for a typhoid conjugate vaccine and expects significant supply orders from UNICEF. The company remains committed to the US market despite potential pricing pressures and political changes.

CVS Caremark adjusts diabetes drug coverage for 2025, removing older therapies like V-go Infusion Pump and Merck's Janumet/Janumet XR, in favor of newer products and generics. Notable additions include Twiist infusion system, Zituvimet, and biosimilars to Lantus. CVS also adds HIV, cancer, and mental health treatments to its formulary.

NLRP3 protein inhibitors show promise in treating autoimmune, inflammatory, neurodegenerative, and metabolic diseases. Over 20 pharma companies are developing 25+ inhibitors, with notable progress in clinical trials by Halia Therapeutics, Ventus Therapeutics, and Novo Nordisk.

SEC recommends market authorisation for MSN Laboratories' generic Pitolisant tablets for narcolepsy, with conditions including a phase-IV trial. The drug, a generic of Harmony Biosciences' Wakix, addresses EDS and cataplexy, with a novel mechanism and unmet need. MSN must include CYP2D6 Genotype determination in prescribing info. Harmony Biosciences holds a US patent until 2029 and sued MSN for patent infringement.

The global liposomal doxorubicin market is expanding due to rising cancer prevalence and advanced drug delivery technologies. Key segments include lyophilized powder and doxorubicin injection, with applications in various cancers like breast, liver, and leukemia. Hospitals dominate the end-user segment, while North America leads in regional markets. Major players include Pfizer, Sun Pharmaceutical, and Johnson & Johnson. The market is expected to grow from $1.3 billion in 2024 to $2 billion by 2032 at a CAGR of 5.1%.

The global liposomal doxorubicin market reached USD 1.3 billion in 2023 and is projected to grow at a CAGR of 5.1% to exceed USD 2 billion by 2032, driven by rising cancer incidence, advancements in nanotechnology, and favorable regulatory approvals. Key challenges include high treatment costs, adverse effects, and stringent regulatory requirements. Opportunities lie in emerging markets, ongoing R&D, and collaborations. Market segmentation includes drug formulations, applications, end users, and regions.