According to industry analysts, in 2026 the pharmaceutical sector is coming to terms with a hard truth: its core challenge is no longer innovation, but industrialization.
After a selectively rebounding 2025—marked by a revival in M&A activity and a biotech sector that proved more resilient than during the 2022–2023 contraction—the industry is entering a phase of enforced maturity. Pressures have not eased; they have stabilized.
According to PwC’s US Deals Outlook 2026, the patent cliff between 2026 and 2029 puts between $47 billion and $176 billion in global sales at risk of erosion. In the United States, the Inflation Reduction Act (IRA) is compressing commercial exclusivity windows. China continues to consolidate its position as a global biotech powerhouse. Europe, meanwhile, faces a structural dilemma between regulatory sophistication and industrial competitiveness.
Global Market Outlook
$2.6 trillion in projected global pharmaceutical spending by 2030
Expected CAGR: 5–8%
(Source: IQVIA – Global Use of Medicines 2026 Outlook)
Patent Cliff Exposure
$47–176 billion in sales at risk between 2026 and 2029
(Source: PwC – US Deals Outlook 2026)
Blockbuster Dominance
Approximately 90% of revenues among the top 20 biopharma companies derived from blockbuster or mega-blockbuster products
(Source: BCG – Biopharma Trends 2026)
AI Adoption Gap
78% of C-level executives identify AI as a central transformation driver
Only 22% have successfully scaled AI beyond pilot programs
(Source: ZS – Pharma Industry Outlook 2026)
U.S. Reshoring Wave
$350 billion in announced investments in manufacturing capacity through 2030
(Source: BCG – Reimagining Business Models 2026)
Global Pipeline Shift
Approximately 30% of the global biotech pipeline originates in China
(Source: Evaluate + BCG 2026 analysis)
The return of scalable therapies
For more than a decade, the dominant narrative in biopharma centered on extreme personalization: CAR-T therapies, gene therapies, and increasingly narrow molecular niches.
In 2026, the pendulum begins to swing back.
According to BCG’s Reimagining Business Models: Biopharma Trends 2026, approximately 90% of revenues among the top 20 biopharma companies will continue to come from blockbusters or mega-blockbusters at least through 2030.
The strategic focus is shifting toward innovative therapies designed for large patient populations:
- Next-generation GLP-1 agonists for obesity and type 2 diabetes
- Monoclonal antibodies targeting Alzheimer’s disease
- New cardiovascular platforms
- Chronic immunology treatments
The drivers behind this shift are structural rather than cyclical:
- Pricing compression in the United States following the Inflation Reduction Act
- The manufacturing and supply chain complexity inherent in ultra-personalized therapies
- A more selective capital environment, with preclinical valuations significantly lower than the 2021 peak
According to IQVIA’s Nine for 2026, immunology, oncology, and cardiometabolic diseases will remain the primary engines of global growth, with obesity in particular acting as a major accelerator.
AI from Promise to GMP Validation
Artificial intelligence is no longer an experimental initiative. It has become a structural investment priority.
According to ZS’s Pharma Industry Outlook 2026, 78% of biopharma leaders identify AI as the primary driver of transformation. Deloitte’s 2026 Life Sciences Outlook reports that nearly half of executives expect measurable returns from AI investments within the next 24 months.
Yet the most telling figure is this: only 22% of companies have successfully scaled AI beyond the pilot stage.
The gap between experimentation and industrial deployment remains wide.
Where AI is being deployed
R&D
- Target identification
- In silico modeling
- Molecular optimization
- Predictive simulations
ZS estimates that AI-enabled approaches could deliver:
- A 40–50% increase in Phase I success rates
- A 40–50% reduction in early-stage development timelines
Clinical Development
- Adaptive trial designs
- Patient digital twins
- Integration of real-world data
Manufacturing
- Predictive maintenance
- Advanced demand planning
- Plant-level digital twins
- Agentic AI to orchestrate workflows
According to BCG (2026), AI-mature companies could generate up to $250 billion in cumulative global value by 2030.
But the real bottleneck is regulatory.
Deploying AI in GMP-regulated environments requires:
- Algorithm validation
- Robust data integrity frameworks
- Full traceability
- Cybersecurity resilience
- Compliance with the EU AI Act
In 2026, the question is no longer “Can we use AI?”
It is “Can we validate it?”
Manufacturing and the rise of resilient smart factories
The transformation of pharmaceutical manufacturing is no less radical.
At the ISPE Facilities of the Future Conference 2026 (San Diego, February 2–3), industry leaders outlined four clear priorities:
- Integrated digital transformation
- Modular facility design
- Advanced sterile automation
- Workforce transformation
Automated cleanrooms are reducing direct human intervention, improving process consistency while lowering contamination risk. The shift is not incremental—it is architectural.
BCG estimates that more than $350 billion will be invested in new U.S. manufacturing capacity by 2030, driven by reshoring strategies and escalating geopolitical tensions.
However, three structural risks are emerging:
- Cybersecurity vulnerabilities, with real production shutdowns already observed between 2023 and 2025
- Talent shortages, particularly hybrid profiles combining pharma expertise, data science, and regulatory compliance
- Manufacturing complexity linked to next-generation modalities such as ADCs, bispecific antibodies, and oligonucleotides
Resilience is no longer optional. It is a competitive requirement.
Drugs to watch 2026 and the platforms that matter
According to Clarivate’s Drugs to Watch 2026, eleven high-impact therapies are expected to shape the competitive landscape. Among the most closely monitored:
- Orforglipron (Eli Lilly) – once-daily oral GLP-1
- Retatrutide (Eli Lilly) – triple agonist targeting GLP-1, GIP, and glucagon
- Mezigdomide (Bristol Myers Squibb) – protein degrader
- BGB-16673 (BeiGene) – BTK degrader
- Depemokimab (GSK) – anti–IL-5 monoclonal antibody
- Tolebrutinib – BTK inhibitor for multiple sclerosis
- Sibeprenlimab – targeting IgA nephropathy
- TAR-200 – intravesical therapy for bladder cancer
The pattern is unmistakable.
Next-generation GLP-1 agents continue to redefine cardiometabolic care at scale.
Protein degraders signal the industrial maturation of targeted protein modulation.
Women’s health and oncology remain priority growth areas.
What stands out, however, is not the individual molecule—but the platform logic behind them.
In 2026, competitive advantage is increasingly built on scalable technology platforms rather than isolated assets. The winners are not those launching a single breakthrough therapy, but those capable of industrializing repeatable innovation engines.
Europe between Advanced Regulation and Fragile Competitiveness
The European Union is moving decisively on regulatory architecture.
The introduction of the AI Act, the European Health Data Space (EHDS), and the Corporate Sustainability Reporting Directive (CSRD) positions Europe at the forefront of rule-setting in health data, artificial intelligence, and ESG accountability.
However, as highlighted in Deloitte’s 2026 Life Sciences Outlook, regulation alone does not translate into industrial leadership. Without faster market access, streamlined approval pathways, and sustained investment attractiveness, regulatory sophistication risks becoming a competitive constraint rather than an advantage.
The structural risk is bifurcation.
The United States and China consolidate their roles as hubs of innovation and scale.
Europe risks becoming a highly regulated ecosystem with comparatively lower dynamism.
For Italy, the operational priorities are increasingly clear:
- AI validation within GMP-regulated environments
- Flexible, modular manufacturing capacity
- Advanced cybersecurity frameworks
- Structured integration of real-world data
- Technical workforce reskilling
Execution speed—not regulatory ambition—will determine competitive positioning.
Industrialization as competitive advantage
2026 is not the year of AI promises. It is the year of proof—proof that AI works in production, in compliance, and in market access.
Industrialization means:
- Scaling innovative therapies without triggering unsustainable cost expansion
- Validating algorithms with the same rigor applied to manufacturing assets
- Embedding sustainability without eroding competitiveness
- Preserving the social contract between innovation and access
Innovation without industrial capability remains a theoretical exercise.
Industry without innovation loses legitimacy.
In 2026, the differentiator will be the ability to do both.
