Looking Ahead to 2025: Five Key Highlights of the Global Biopharmaceutical Industry

From the historical perspective of the global biopharmaceutical industry development, many changes are happening in 2025.

In terms of new drug development, weight loss drugs are entering the vast fields of cardiovascular and metabolic diseases, becoming a hot topic after traditional specialty drugs such as oncology, immunology, and rare disease therapies. At the same time, the overall industrial environment is also changing - although the funding environment for investment and mergers and acquisitions seems to be warming up, the medical system, which has not fully adapted to the logic of innovative drugs, finds it difficult to support the returns of innovative drugs. As a result, many countries' medical systems are embarking on a path of reform, with increasing patient autonomy. On the other hand, AI in pharmaceuticals, which once left Chinese investors confused, is playing an increasingly important role in global healthcare services, and relevant application regulations are expected to be introduced in 2025...

We are in an environment full of uncertainties, with geopolitical frictions still threatening the globalization trend of the biopharmaceutical industry, but the fundamentals of the biopharmaceutical industry may change in 2025. This article combines a commentary published by Nature to outline the five major changes happening in the pharmaceutical industry in 2025.

Oncology Therapy: The Rise of Bispecific Antibodies and Formulation Innovations

Oncology therapies remain at the forefront of innovation, with significant breakthroughs expected in 2025.

Personalized cancer vaccines may become a reality. This year, the FDA is expected to approve the first personalized cancer vaccine - Moderna's mRNA-4157 in combination with Merck's pembrolizumab (Keytruda) for melanoma treatment.

According to the latest follow-up data released at the 2024 American Society of Clinical Oncology (ASCO) annual meeting, the combination of mRNA-4157 and the PD-1 inhibitor pembrolizumab can reduce the risk of recurrence or death by 49% in high-risk melanoma (stage III/IV) patients who have undergone surgical resection, and reduce the risk of distant metastasis or death by 62%. Moreover, compared to traditional chemotherapy and radiotherapy, mRNA vaccines have higher specificity and lower side effects, promising a safer and more effective treatment option for cancer patients. If this therapy is approved, it may signify the entry of cancer treatment into a personalized era, reshaping the landscape of cancer therapy.

The bispecific antibody field has achieved fruitful results. The PD1 and VEGF-targeting ivonescimab has shown excellent performance in phase III clinical trials for non-small cell lung cancer, becoming the first new therapy to surpass pembrolizumab in head-to-head trials. Although currently only clinical trial data from China is available, global research is already underway, and new treatment standards may soon emerge. Zanidatamab is the first bispecific antibody that can bind to two epitopes on the same target (HER2), which received FDA approval for the treatment of biliary tract cancer in November 2024 and will be officially applied in clinical settings in 2025.

Improvements and innovations in drug formulations are also worth noting. In September 2024, the FDA approved the subcutaneous injection formulation of the PD-L1 inhibitor atezolizumab (Tecentriq). In December, the FDA approved the subcutaneous injection formulation of Bristol Myers Squibb's nivolumab. Additionally, the phase III clinical study of the subcutaneous injection MK-3475A of pembrolizumab achieved success in 2024, and this formulation will soon enter the market. The new formulations will greatly enhance the convenience of medication for patients and improve the treatment experience.

Weight Loss Drugs: New Data and Healthcare Insurance Variables

In recent years, GLP-1 drugs such as Novo Nordisk's semaglutide (Wegovy) and Eli Lilly's tirzepatide (Mounjaro/Zepbound) have driven rapid growth in the weight loss market, with the global weight loss prescription drug market expected to exceed $30 billion in 2024. With the launch of oral semaglutide, this market may continue to grow.

Although there may not be entirely new drugs launched in 2025, key trial results for already marketed and in-development drugs are expected to be announced. For example, the global phase III cardiovascular outcomes trial SURPASS-CVOT for tirzepatide, as well as the clinical trial results of oral semaglutide's EVOKE and EVOKE+ trials, which are assessing the impact of semaglutide on cognitive and functional outcomes in early Alzheimer's disease patients. Currently, GLP-1 drugs have been validated in phases for their remarkable efficacy beyond glycemic control and weight loss, showing effectiveness in conditions such as obstructive sleep apnea (OSA), metabolic-associated fatty liver disease (MASH), and chronic kidney disease (CKD).

New GLP-1 molecules with upcoming phase III trial data include Eli Lilly's orforglipron and Boehringer Ingelheim's GLP-1/GCG receptor dual agonist survodutide. Additionally, the head-to-head phase III study of Novo Nordisk's semaglutide and Cagrilintide's combination product CagriSema with tirzepatide will also be a market focus, with the study expected to be completed in August 2025.

The decisions of healthcare insurance payers regarding weight loss drugs will also have a profound impact on the future development of the market. The funding policy for weight loss drugs by US Medicare faces uncertainties after Trump returns to power - Novo Nordisk's semaglutide combination product is on the second round of "Medicare negotiation" drug list, and its price may face significant reductions. Meanwhile, the UK's National Health Service (NHS) is actively promoting Eli Lilly's Mounjaro, with a five-year real-world study (SURMOUNT-REAL) expected to start in 2025, reflecting the desire of healthcare payers to collect detailed evidence on the cost/benefit of weight loss drugs.

The M&A market is full of potential: urgent demand from buyers and sellers.

Compared to the M&A boom in 2023 after the pandemic, M&A activities have cooled down starting in 2024, with a total transaction value of about $45 billion, a 62% decrease from the previous year.

However, the M&A market in 2025 remains full of potential. From the buyer's market perspective, large pharmaceutical companies have over $1.5 trillion in M&A funds, and by 2030, over $200 billion in revenue from listed products will face patent expiration risks, with nearly 64% of sales from some large pharmaceutical companies potentially affected, making them urgently seek new growth points. Investors are also continuously pressuring pharmaceutical companies to actively engage in emerging hot areas such as weight loss, ADCs, and bispecific antibodies.

From the seller's market perspective, about 70% of clinical stage projects are driven by biotech companies, with 60% of assets still looking for partners. For example, weight loss drugs like Viking's VK2735 and Structure Therapeutics' GSBR-1290 have huge potential.

In terms of funding, although the IPO market has reopened and biotechnology company stock prices have been boosted by falling interest rates, two-thirds of listed biotechnology companies are still facing funding shortages, with cash reserves potentially only sustaining operations for less than 12 months, urgently needing financial support.

Of course, the market still needs to be cautious about the M&A prospects in 2025. The new Trump administration, macroeconomic conditions, geopolitical factors, and changes in the regulatory environment, especially the potential revisions to the U.S. Inflation Reduction Act, have brought uncertainty to M&A activities. However, once these uncertainties gradually dissipate, the M&A market is expected to be reactivated by the demand from buyers and sellers.

AI Pharmaceutical Applications and Regulatory Framework Changes

To ensure the safety and ethics of AI applications, as well as the correctness of their use, governments around the world are working to build a more comprehensive legal framework.

The first global regulation specifically targeting AI—the EU's Artificial Intelligence Act—will take effect on February 2, 2025, setting a precedent for AI governance internationally. In the field of drug development, AI applications involve clinical diagnosis, monitoring, assisted treatment decision-making, or patient interaction. The aim is to ensure the safety, transparency, and fairness of AI technology through strict regulations, but it can be anticipated that this act will also bring new compliance pressures and operational costs for companies.

The U.S. is also working to establish a regulatory system for AI pharmaceutical applications as quickly as possible. On January 6, 2025, the FDA released a draft guidance titled "Considerations for the Use of Artificial Intelligence to Support Drug and Biological Product Regulatory Decisions," which provides a systematic framework for the industry and stakeholders to assess and ensure the credibility of AI models throughout the drug development lifecycle, while encouraging sponsors and other stakeholders to communicate with the FDA early to discuss AI model risks.

In addition to regulatory factors, driven by steady improvements in algorithm efficiency, hardware efficiency, and the availability of training data, AI's computational performance is expected to at least double in the coming year, enhancing its ability to make biological or medical predictions. However, biological systems are extremely complex, and transitioning from molecular-level predictions to cellular or human-level predictions is very challenging. Therefore, it is expected that more molecules discovered by AI will enter clinical trials, but the application process of AI in generating clinical evidence will be relatively slow.

Patient Empowerment and Out-of-Pocket Payment Trends

There is an increasingly evident trend of consumerization in the fields of cardiovascular metabolic diseases and other chronic diseases with high prevalence.

Patients are becoming more willing to pay for private medication consultations and private prescription drugs. Private prescription platforms are continuously developing, and clinical-level diagnostic and monitoring tools are gradually becoming accessible to consumers. The booming development of internet healthcare, with features like heart monitoring and electrocardiograms on smartwatches, is the best example of this trend. The consumerization trend has expanded the drug market but has also raised ethical questions about the fairness of healthcare services.

Behind this phenomenon, healthcare systems in various countries are facing significant financial budget challenges. On one hand, the impact of chronic diseases (such as obesity) is becoming increasingly severe, while on the other hand, the costs of new therapies for treating these diseases are high. As a result, many countries' healthcare systems have limited insurance coverage, further driving the trend of out-of-pocket payments and the transfer of treatment decision-making power to patients.

Commercial factors are also driving the change in medication dominance. Some domestic pharmaceutical companies have already sensed that today's patients have access to many information channels and no longer solely rely on doctors' advice when it comes to medication, wishing to make their own decisions about their treatment. For pharmaceutical companies looking to recoup drug development costs, patients' autonomy in decision-making and willingness to pay out-of-pocket can sometimes mean higher sales and market ceilings.

References:

[1]Rickwood, S., Bayley, H., Lutzmayer, S., Madelung, M., & Gores, M. (2025). Outlook for medicines development and use in 2025. Nature Reviews Drug Discovery.