The cell and gene industry considers the Trump agenda in the midst of positivity on growth

Krishna Kakkaiyadi de Pinent Masons said that an approach to the patient first ‘will help the industry to rely on the growth opportunities it sees for CGTs and meet major challenges that still exist taking CGTS throughout the life cycle of development and marketing.

Kakkaiyadi commented on the consequences of The recent cell and gene state of the briefing industry Hosted by the Alliance for Regenerative Medicine (ARM). The discussion during the event went from: the growing pipeline of the CGT “ blockbuster ” at the level of interest of investors in the CGT, how the political agenda of American president Donald Trump will have an impact on market growth and The important CGT marketing opportunities in the external countries of the United States.

The United States Briefing is an annual event assisted by nearly 2,000 of the main stakeholders in the CGT sector and takes place in parallel with the largest annual JP Morgan health conference in San Francisco. In addition to updating the widely awaited industry of Tim Hunt, the director general of Arm, this year’s event included a session on updates on the efforts of the American Food and Drug Administration to accelerate The progress of the CGT sector, which was provided by Peter Marks, director of the Center for Biologics Evaluation and Research of the FDA (CBER), as well as a panel session on opportunities and challenges of navigation in the sector.

“There is a global positive perspective for the CGT sector, despite various challenges and” opposite winds “,” said Kakkaiyadi. “Analysts compare the current climate in the CGT sector to that of the development of monoclonal antibodies in the years 1990, when there were periods when the interest of investors in the sector has decreased due to the setbacks. However, the space of monoclonal antibodies is a mature and flourishing sector drawing significant investments and income. There was a general consensus among those in the briefing of a similar perspective for the CGT space in the middle, with some, going so far as to say that we are at a “inflection point”.

Kakkaiyadi said that real scientific progress, in particular in publishing / genetic platform technologies like CRISPR, which will also propel the development of in vivo cell therapies and drug delivery methods, coupled with data on trends Shared at the ARM event, supports this positive perspective in industry.

According to this data, while only two CGTs with an estimated global sales value of more than $ 1 billion has been put on the market in the past six years, this number should reach more than 10 by 2030. Other data shared with the delegates underlined how 13 of the 15 largest biopharmaceutical companies in the world have invested in the development or marketing of CGTS. Kakkaiyadi said that this reflected the purchase of large pharmace products The range of diseases, blood disorders to muscular dystrophy, is now emerging in a greater number.

The American market is by far the largest CGTS market, worldwide – 62% of $ 5.9 billion spent in CGTS by payers worldwide in 2023 have been spent in the United States, and additional data show that the proportion of new products approved by American foods and the administration of drugs (FDA) constituting the CGT has increased in constant increase in recent years.

The Peter Marks session underlined certain initiatives in which the agency is committed to supporting the development of the CGTS, referring to the center of rare diseases which promotes collaboration between two national bodies – the Center for Drug Evaluation and Research and CBER – as well as methods to accelerate regulatory approvals.

On the American market, there was also an emphasis on the ARM event on how the agenda of the new Trump administration will have an impact on the sector.

Some of the measures that President Trump seem to continue to continue that have been discussed include his broad objective of fighting the deep cause of the disease and reducing the need for treatment of chronic conditions; its support for regulatory flexibility, accelerated approvals and the activation of genetic publishing platforms; and strengthening manufacturing capacity in the United States, which may well align and present real opportunities for the development and maturation of the CGT sector

Part of the positive perspectives of the industry are also reflected in the scope of CGT growth outside the United States, as in Europe and the Asia-Pacific region, Kakkaiyadi said. Only 35% of CGTS revenues worldwide in 2024 were generated in non -American markets, but the data presented during the briefing suggested strong annual growth in all regions.

Speaking during the ARM event, Marks highlighted an international pilot in which the FDA participates – the collaboration on the Global Pilot Genic Therapies (Cogent) in which he works with other authorities around the world to explore how A CGT review by several regulators could work simultaneously. The FDA has worked with the World Health Organization (WHO), among other things, on the initiative. However, Trump published a decree little executive shortly after his arrival at the post for the second time to point out that the United States would withdraw from membership, throwing the future of the pilot project in doubt.

Kakkaiyadi said: “It is clear that the CGT arm and industry in general see how certain developments expected under the Trump administration could support the sector, but it remains to be seen how its program“ initially American ” will see The head of the United States or will participate in larger global initiatives to develop and develop the CGT sector on other markets. »»

“There are real opportunities for all countries to collaborate and take advantage of the developments and breakthroughs that occur around the world. For example, recently approved T Cor cell therapy (Qartemi, Varnimcabtagene Autoleucel) in India, for non-Hodgkin’s lymphoma for adult B cells, came out of collaboration between Immuneel, a start-up CGT in India and the clinic of the ‘Barcelona hospital. It could be manufactured using an automated platform that has been approved by the American FDA and the European Medicines Agency. It is all the more interesting since The price of the medication would be a fraction of other therapies by T cells“He said.

“Although there is optimism and positivity on what the future contains for CGTs, industry is not blind with real challenges and obstacles to which it faces, to attract it from investments to management Regulatory charges, prices and manufacturing scale, “said Kakkaiyadi. “Concerted policy and regulatory action in the United States and other major markets, such as the EU and the United Kingdom, and collaboration will support industry in the maximization of growth possibilities.”

“In the end, the industry is better served by putting patients at the heart of what it does – during the ARM event, there was a message of optimism and a call for arms ” for Investors and stakeholders, especially when there is a chance to think about the CGT transformative capacities for patients, to help advance CGT to become a “first line” treatment for large populations of patients to through appropriate diseases, “he added.