In a year that has seen significant changes throughout the generics and biosimilars industry ranking, the top 10 has welcomed two Indian off-patent leaders. Meanwhile, companies lower down our ranking have enjoyed mixed fortunes, leading to a number of significant movements in this year’s Generics Bulletin Top 50.

Money may have become too tight to mention for many biotechs and the IPO window in Europe is not just shut but boarded up. However, big pharma’s need to replenish the pipeline has become urgent and the major players are looking to tap into the continent’s early-stage companies which are driving innovation and provide them with much-needed cash.

Novo Nordisk’s Wegovy/Ozempic and Lilly’s Mounjaro were third quarter standouts, but the exploding obesity category was a theme across many of the big pharma company earnings calls.

M&A activity in 2023 began with March’s $43bn mega-deal for Seagen, but only one eight-figure takeout has occurred since. Still, the values are higher overall than seen in 2022 and might indicate a gradual return to larger deals.

Johnson & Johnson and Roche lead the most recent Scrip 100 ranking for R&D spend, but a look beyond investment in internal development highlights a big year for Pfizer and Bristol Myer Squibb.

Using machine learning, PhaseV, an Israeli startup is trying to make adaptive trial design more accessible. It is early days, but the company's approach is attracting investors and partners. 

Novo Nordisk and Eli Lilly are duking it out in the market, but dozens of competitors are waiting in the wings. 

GENinCode’s mission as a clinical-genetic diagnostic company is to apply a combination of polygenics, a proprietary bioinformatics platform and AI to risk-assess and prevent cardiovascular disease. The company set a UK precedent in being the first to have a CVD commercial polygenic test implemented in the NHS and keenly awaits another milestone, US 510k clearance in 2024.

Mads Krogsgaard Thomsen, CEO of the Novo Nordisk Foundation and the man who supervised the development of semaglutide, describes the unprecedented growth of the obesity market and what might come next for Novo.

Industry experts from Norstella, whose data and technologies support decision making from R&D through to market access, shared their worries going into 2024.

Syngene’s CEO discusses its work in ADC development and trends in the CRDMO space as US biotechs navigate a funding squeeze and manufacturing opportunities loom in areas like GLP- 1 receptor agonists.

Due to the unprecedented growth in the development of cell and gene therapies over the past decade, there is now high demand for certain workforce roles, especially in highly specialized areas and entry-level manufacturing positions.

Infographic: One of the more prominent arguments against the Medicare drug price negotiation program is that by limiting the number of years that products can be marketed before price caps are imposed, the scheme discourages development of additional indications.

Will scrutiny by the Centers for Medicare and Medicaid Services eventually lead to shifts in investment away from improving older drugs toward developing new products? 

A scale-up strategy is the missing link in the UK devices industry, claims business research organization CPI. Own brand and contract medical manufacturer and packaging company Pennine Healthcare and longstanding medical device CDMO Renfrew Group International give their take on the environment for manufacturers and the opportunities for strengthening the industry base.

Industry support for a new regional regulator for Latin America and the Caribbean is cautious and experts warn that it could harm competitiveness of the region.

Venture capital and public market fundraising have grown increasingly difficult since 2021, but while there are glimmers of hope, the rules for who can raise venture cash or launch an IPO have changed.

Johnson & Johnson and Roche lead the most recent Scrip 100 ranking for R&D spend, but a look beyond investment in internal development highlights a big year for Pfizer and Bristol Myer Squibb.

Nine $1bn+ alliances were penned in October. Topping the list was a potential $22bn deal between Daiichi Sankyo and Merck for the global development and commercialization of Daiichi’s DXd antibody drug conjugate candidates patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan.  

In a post-pandemic world, the evolving landscape of clinical trials just got more complex. The year 2022 was one of many adjustments given the incidence of lower trial initiations. The health care industry endured the impacts of geopolitical conflicts, curbed growth in China and stagflation in major markets.

Infographic: One of the more prominent arguments against the Medicare drug price negotiation program is that by limiting the number of years that products can be marketed before price caps are imposed, the scheme discourages development of additional indications.

Will scrutiny by the Centers for Medicare and Medicaid Services eventually lead to shifts in investment away from improving older drugs toward developing new products? 

Mads Krogsgaard Thomsen, CEO of the Novo Nordisk Foundation and the man who supervised the development of semaglutide, describes the unprecedented growth of the obesity market and what might come next for Novo.

Industry experts from Norstella, whose data and technologies support decision making from R&D through to market access, shared their worries going into 2024.

“A lot of companies are hurting because of the higher interest rates,” one major CEO observed recently, summing up a year which saw little headline-grabbing news on the M&A front for generic and biosimilar sponsors.

Women’s health startups focusing on areas of high unmet need such as menopause, infertility, preventive care and post-partum care will continue to attract investors in 2024. Meanwhile, machine learning and AI, as well as next-generation treatments such as psychedelic therapy, stand to drive advancements in the space.

In a year that has seen significant changes throughout the generics and biosimilars industry ranking, the top 10 has welcomed two Indian off-patent leaders. Meanwhile, companies lower down our ranking have enjoyed mixed fortunes, leading to a number of significant movements in this year’s Generics Bulletin Top 50.

Money may have become too tight to mention for many biotechs and the IPO window in Europe is not just shut but boarded up. However, big pharma’s need to replenish the pipeline has become urgent and the major players are looking to tap into the continent’s early-stage companies which are driving innovation and provide them with much-needed cash.

Venture capital and public market fundraising have grown increasingly difficult since 2021, but while there are glimmers of hope, the rules for who can raise venture cash or launch an IPO have changed.

Syngene’s CEO discusses its work in ADC development and trends in the CRDMO space as US biotechs navigate a funding squeeze and manufacturing opportunities loom in areas like GLP- 1 receptor agonists.

A scale-up strategy is the missing link in the UK devices industry, claims business research organization CPI. Own brand and contract medical manufacturer and packaging company Pennine Healthcare and longstanding medical device CDMO Renfrew Group International give their take on the environment for manufacturers and the opportunities for strengthening the industry base.

Nine $1bn+ alliances were penned in October. Topping the list was a potential $22bn deal between Daiichi Sankyo and Merck for the global development and commercialization of Daiichi’s DXd antibody drug conjugate candidates patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan.