In a year-round up preview, Dr. Senthil Sockalingam, Head of IQVIA Biotech in Japan-Asia Pacific and Chief Medical Officer of IQVIA Asia Pacific, offers a comprehensive outlook on the key developments shaping the Biotech and Biopharma industry in 2024. From funding hurdles for Emerging Biotech and Pharma (EBP) companies to the growing impact of India on the sector, Dr. Sockalingam provides valuable insights into the challenges and opportunities that lie ahead. Explore the landscape of drug pricing pressures, the potential resurgence of decentralized clinical trials, and the breakthroughs expected in cell and gene therapies, as the industry navigates through this dynamic year.

Emerging biotech and biopharma (EBP) companies continue to drive global medical innovation, with  Asia Pacific playing a central role. Novel drug discovery processes, advances in preventative care and the leveraging of big data sets make this a truly exciting sector to study. Although it won’t be plain  sailing, 2024 promises to be a crucial year for EBPs and the wider pharmaceutical and healthcare  industries. Here are a few key developments to look out for: 

1. Funding for EBPs remains hard to come by 

Against the backdrop of a tough financing environment, elevated by rising interest rates, the biotech and biopharma sector remains highly competitive, with many new and existing players  competing for a finite pool of funding. Many venture firms are now focused on helping their existing portfolio companies survive the squeeze, resulting in reduced novel investments. HSBC has noted early investment in biotech startups was on pace to fall by 40% in 2023 compared to  20221, and this downward trend is expected to continue into the upcoming year. This challenging  financing environment may force many EBPs to rethink their valuation expectations. 

Aside from venture capital funding, larger pharmaceutical companies, which serve as a significant funding source for EBPs, are also likely to be less interested in deal-making. Ongoing economic pressures may hinder them from investing in small biotech firms and instead focus their capital on their existing pipelines or specific platform-play investments, similar to the trends  observed in 2023.  

2. Drug pricing pressures create ripple effects 

Drug pricing is under increasing scrutiny across markets, including economic powerhouses such  as China and the US. Recent policy enactments, for example, the US’s Inflation Reduction Act to  help reduce out-of-pocket prescription costs for patients2, and price negotiation systems, such as China’s price control system are starting to bite into profit margins, particularly affecting rare disease drugs and precision oncology medicines3.  

Depending on the breadth and effectiveness of these initiatives, multinational pharmaceutical  players may lose their motivation to invest, which in turn can lead to an innovation slowdown. As  a result, we may see more pharmaceutical companies entering strategic partnerships to mitigate the challenges associated with R&D and commercialization. In August 2023, Daiichi Sankyo announced a multi-year, multi-asset partnership with Merck to support the commercialization of  their highly anticipated antibody-drug conjugate (ADC) portfolio. This collaboration supplements their existing partnership with AstraZeneca, and will focus on the launch of their first ADC, 

Enhertu, in diverse markets. There may be a surge in such partnerships in the coming years, especially as the world shifts towards deglobalization. In this environment, the value of local partners with strong market access and commercialization capabilities will be crucial for successful launches. 

3. India’s influence on the biopharma sector continues to grow 

The Indian pharmaceutical industry is primed for exponential growth, with industry experts predicting a US$130 billion valuation by 2030. The current growth trajectory indicates that the  industry will surpass its projected 2045 valuation of US$450 billion4, and there has been a significant 298% jump in pharma-related investment deals during the third quarter of 2023 compared to the previous year5.  

While India is well-established as a global powerhouse for generic medicines, there has been a  gradual shift in R&D activities to other strategic areas such as biosimilars, complex generics, and  new chemical and biological entities. The maturation of India’s regulatory environment coupled  with vast patient populations and lower research costs makes India an attractive proposition for  clinical research. This not only enables broader access to novel therapeutic innovations for Indian  patients but also creates increased commercialization opportunities in what is now the world’s  most populous nation. 

Higher interest rates have resulted in increased operational costs for businesses worldwide. 

Pharmaceutical companies are looking towards shifting a portion of their business operations to  emerging markets such as India to achieve greater cost efficiencies. Several leading pharmaceutical companies have established their presence locally across diverse business   segments, including R&D and commercial operations. A notable example includes Novo Nordisk’s  commitment to doubling its manufacturing capabilities in India by 20256. India’s political and economic ambitions are clear and so it is likely to remain a competitive place for pharmaceutical  players to do business for many years to come. 

4. Decentralized clinical trials, but heavy traffic is slowing down wider implementation  

2023 saw a perhaps predictable slowdown in the adoption of decentralized clinical trials (DCTs) compared to the COVID-19 pandemic years as many countries returned to their pre-pandemic  status quo. Without the strong incentive to perform remote patient monitoring, more traditional  clinical trial models have been favored. That said, legislation in some countries has set the scene  for more decentralized implementation of clinical trials in the future. China, for example, has  recently issued (July 2023) new guidelines supporting the implementation of DCTs through the  use of telemedicine7. Moreover, regions such as Beijing, have also been encouraging local  pharmaceutical players to run DCT pilot projects8. This formal recognition of the value of DCTs in  China, may well pave the way for broader interest in DCTs across APAC in 2024, especially in a  cost-constrained environment. 

5. Cell and gene therapies break into the mainstream 

We are seeing the expansion of chimeric antigen receptor (CAR) T-cell therapy beyond its initial  application to treat hematological malignancies such as myeloma, acute lymphoblastic leukemia and non-Hodgkin’s lymphoma9, and into orthopedics, organ transplantation, and neurology. The  world’s first CRISPR gene-editing therapy was approved in November 2023 in the UK for sickle cell disease and transfusion-dependent β-thalassemia10. This approval is a significant landmark  for the biotech industry, potentially setting the stage for a new generation of gene-editing therapies to be approved for conditions that were previously considered untreatable, as well as injecting a timely boost into the gene editing R&D universe. CRISPR-based therapies face similar  challenges as CAR-T in terms of cost and the substantial healthcare infrastructure needed for  treatment administration, and therefore, 2024 holds potential for innovation beyond the treatment itself.

References 

1. BioPharma Dive (2023). Early-stage biotech funding on pace to drop 40% in 2023, HSBC report  shows. Available from: https://www.biopharmadive.com/news/biotech-venture-capital-hsbc 

report-norris/689313/. 28 Nov 2023. 

2. Greenberg Traurig LLP (2022). China on the Move: Lesson from China’s National Negotiation of  Drug Prices in 2022 | Insights | Available from: https://www.gtlaw.com/en/insights/2023/2/china on-the-move-lesson-from-chinas-national-negotiation-of-drug-prices-in-2022. 28 Nov 2023. 
3. POLITICO (2023). Why Big Pharma might think twice about running away to America. Available  from: https://www.politico.eu/article/eu-drug-price-regulations-big-pharma-think-twice-america/ 28 Nov 2023. 
4. Organization of Pharmaceutical Producers of India. Reimagining pharma and healthcare for India  @100. 2023.  
5. The Pharma Letter (2023). India’s pharma and healthcare sectors maintain investment appeal  despi. Available from: https://www.thepharmaletter.com/article/india-s-pharma-and-healthcare sectors-maintain-investment-appeal-despite-volume-decline. 28 Nov 2023. 
6. Business Standard (2023). Novo Nordisk to double India manufacturing, bring new drugs by 2025.  Available from: https://www.business-standard.com/companies/news/india-part-of-all-global 

clinical-trials-of-danish-drug-major-novo-nordisk-123062000553_1.html. 28 Nov 2023. 

7. Pacific Bridge Medical (2023). China Embraces Decentralized Clinical Trials (DCT), Bethesda  

CHPBM 7315 WAS 400W, Japan, Singapore, Kong H, India affiliate partners in, Indonesia, et al. 

Available from: https://www.pacificbridgemedical.com/news-brief/china-embraces-decentralized clinical-trials-dct/. 28 Nov 2023. 

8. Han Kun Law Offices (2023). China DCT Regulation and Implementation (2023). Available from:  https://www.hankunlaw.com/en/portal/article/index/cid/8/id/13488.html. 28 Nov 2023. 
9. Centre for Clinical Haematology (2023). CAR T-Cell Therapy. Available from:  

https://cfch.com.sg/cellular-therapy/. 28 Nov 2023.  

10. TIME (2023). The World’s First Approved CRISPR Treatment. Available from:  

https://time.com/6336222/crispr-therapy-gets-u-k-approval-the-first-in-the-world/. 28 Nov 2023.