norstella-logo-white

Pharma outlook: From uncertainty to predictability

By Andrew Warmington

Manufacturing Editor | Citeline

Change is the only constant in the pharmaceuticals industry. There have been many paradigm shifts driven by specific therapies, like AIDS in the 1990s and the COVID-19 vaccine in 2020, and some believe that the recent rise of obesity and diabetes drugs to be potentially the biggest of all. That said, it may be that the current wave of change may lead to more stability.

Evaluate, a Norstella company, recently published its World Preview 2024. This found that the pharmaceutical industry’s ‘Age of Uncertainty’ in 2023 “has given way to more predictable realities, including the dominance of obesity and other big diseases, a wider range of modalities and an Inflation Reduction Act (IRA) that’s here to stay”. 

Obesity drugs drive growth

Worldwide prescription drug sales are forecast to grow by almost 7.7% per year over the next five years, outpacing the previous five years and reaching a total of $1.7 trillion in 2030. This marks a shift away from drugs for rare diseases and cancer in favor of products that can more quickly fill impending post-patent-expiry gaps.

The top ten will be dominated by drugs for metabolic diseases, most obviously the glucagon-like peptide (GLP)-1 agonists that have turned the industry on its head in recent years. The biggest are: Novo Nordkisk’s Ozempic (semaglutide) and Lilly’s Mounjaro (tirzepatide) in diabetes; their analogs Wegovy and Zepbound for obesity; and Novo’s follow-on combination Cagrisema (semaglutide and cagrilintide). 

Figure 1: Top 10 selling products WW in 2030

Description of Image

Novo and Lilly will be the top two drug companies by sales in 2030, each being forecast to grow at 12%/year. Between them, Ozempic and Wegovy had only $5 billion in sales in 2020 but the whole GLP-1 space is expected to hit $130 billion in 2030. Given the many other benefits being claimed for them, it is hard to find a ceiling for their potential.

Based on Zepbound’s later launch and slightly stronger weight loss data, Evaluate forecasts growth of 90% per year for it. However, much may change in the battle for market share that led to Novo agreeing to acquire the contract development and manufacturing organization (CDMO) Calent in order to ensure security of supply.

Novo is also fighting back with Cagrisema, which combines the long-acting amylin analog cagrilintide with semaglutide. With a net present value of $80 billion, it is the most valuable pipeline candidate, followed by Lilly’s oral GLP-1, orforglipron. Other Big Pharma companies are inevitably piling into the space.

Coming up on the rails are two inflammatory disease blockbusters. Sanofi and Regeneron’s Dupixent (dupilumab) will be second only to Ozempic in 2030 with $22 billion in sales as it gains further approvals for different therapies. AbbVie’s Skyrizi, an interleukin (IL)-23 antibody, will be in sixth place, growing by 14% per year to reach $19.5 billion in sales as further approvals are also secured. However, finding further blockbusters in this increasingly crowded market sector will be hard.

The top ten is completed by oncology drugs: Johnson & Johnson (J&J)’s anti-CD28 antibody Darzalex (daratumumab) and Merck’s checkpoint inhibitor Keytruda (pembrolizumab). The latter’s key patent, however, expires in 2028, which is a peak year for patent expiry, with $100 billion, or 6.6%, of total sales affected.

Dupixent, Skyrizi and Keytruda, among others, will come under the purview of the IRA by 2030, when they will have been on the US market for over ten years. Life-cycle management strategies will become even more important in this context and are already being implemented in some cases. Subcutaneous versions of both Duxipent and Keytruda have been launched with added hyaluronidase.

Three CNS drugs also feature in the top ten, “reflecting significant scientific progress and investor interest in this large under-served category”, Evaluate finds. These comprise BMS’s KarXT, a combination drug that could help up to three million people with schizophrenia; Lilly’s donanemab for early-stage Alzheimer’s, with peak sales forecast at $5 billion; and Vertex’s VX-548, for moderate-to-acute pain, with nearly $3 billion in 2030 sales.

Oncology’s dominance eroded

Despite all this, oncology will remain the most valuable therapy area in 2030, with over $370 billion in forecast sales across all products after a compound an annual growth rate (CAGR) of 9.8% that will slightly slow from the 2016-2023 CAGR. This is still more than twice the totals for obesity and diabetes, immunology and CNS. 

Figure 2: Top 10 therapy areas in 2030 & historic and forecasted sales growth

Description of Image

The decreasing dominance of oncology reflects the difficulty in finding genuinely new large-scale therapies: “pan-cancer targets are rare, and precision medicines chase ever-narrower mutations”, the report finds. However, antibody-drug conjugates (ADCs), bi- and multi-specific antibodies, radiopharmaceuticals and oligonucleotide-based drugs are opening up more targets and targeting mechanisms, which will swell the pipeline.

AstraZeneca and Daiichi Sankyo’s ADC, datopotamab deruxetecan, which is under regulatory review for lung and breast cancer on both sides of the Atlantic, is one of two oncology drugs in the top ten pipeline products. ADCs have also been the subject of several massive deals, most notably Pfizer’s $43 billion acquisition of Seagen. On a smaller scale, BMS, Lilly, AstraZeneca and Novartis have been buying into the radiopharmaceutical market in the last six months. The rapid growth of non-conventional modalities like these are also leading to biotechnology approaching a 50-50 share of the market with small molecules. 

M&A: The biotechs’ lifeline

M&A activity was strong in Q1 2024, with deals totalling $36.6 billion in value, but fell back by 44% to $20.4 billion in Q2, after the report was published. This was largely due to Novo Nordisk’s proposed $16.5 billion acquisition of Catalent. Evaluate forecasts more M&A activity “as patents expire, obesity/diabetes drug revenues pile up, and as innovation continues to flourish”.

Being acquired by Big Pharma has been a lifeline for some of the biotechs, because there has been a long downcycle in the public markets. However, there are some early indications of a recovery, with 132 venture capital investments worth a total of about $8.0 billion in Q2 after 143 deals worth $6.5 billion in Q1.

The pharma R&D spend is forecast to grow significantly more slowly, with a CAGR of 3% in 2023-2030 compared to 9% in 2016-2023. Combined R&D spend will fall from 27% of sales in 2024 to 21% in 2030. This reflects multiple factors: streamlining of pipelines, increased M&A, plus potentially the role played by artificial intelligence (AI) in boosting R&D and operational efficiency, as well as geopolitical tensions making firms act more cautiously in general.

Finally, the IRA will continue to make its impact felt. This has a disproportionate effect on biological drugs, though it is too soon to say that it is definitely having an impact on the industry’s choice of modality and/or indication. Price negotiations are already underway for multiple products to come into effect in January 2026 and Medicare will select up to 15 more drugs for negotiations at the start of 2025.

Evaluate expects semaglutide, the API in Ozempic and Wegovy, to be targeted as well by the end of the decade. If Medicare also starts to include obesity drugs because of their ever-growing list of benefits across related conditions, it could be a game-changer.

For the full report, see World Preview 2024 – Pharma’s Growth Boost – eBook | Evaluate

Work with us

Join our mission

We’re looking for agile, growth-oriented team players who are passionate about client success and helping clients bring life-saving therapies to market quicker—and help patients in need.

Work with us

Get in Touch

Let's connect

Have questions about Norstella or its brands? Or do you want to know more about how to solve your challenges at each stage of the drug life cycle?

We want to hear from you