ALTEN - Life Science - Information systems - Digitalization

Sectors

Life Sciences & Health

Whether it is investing in a lightning-fast quest to develop drugs and vaccines to combat global pandemics, developing cutting-edge technologies to enhance research possibilities or coping with an everchanging regulated environment, the Life Sciences industry is constantly transforming, adapting, and innovating.

The Life Sciences & Health industries consists of companies operating in the fields of pharmaceuticals, biotechnology, medical devices, biomedical technologies, nutraceuticals, cosmeceuticals, food processing, and others that are dedicated to creating products and solutions to improve the lives of organisms.

Despite being among the most heavily regulated industries in the world, the Life Sciences industry remains one of the most attractive. The overall market is steadily growing because of increases in the worldwide population, access to medicine in developing countries, ageing populations in developed countries, and, circumstantially, the demands of global pandemics on public health.

Transformation and Resilience: Evolving Trends in Life Sciences

The life sciences sector is transforming through enhanced global R&D collaboration, more resilient supply chains, and optimized regulations. Expertise gained from recent health challenges is accelerating drug development via efficient clinical research. The sector is also advancing through digitalization, smart manufacturing, and strong policy support, driving it toward intelligent, high-end growth.

ALTEN: Empowering Innovation in the Life Sciences Industry

Consequently, the Life Science leaders of tomorrow will be those who adapt to the changes, those with a clear vision, ready to grab new opportunities and face challenges, building up collaboration beyond traditional players, and seeking the best available resources and partners on the market.

ALTEN brings value through end-to-end, comprehensive services tailored to client needs. Our technical domains cover quality, biometry, clinical operation, manufacturing and engineering, regulatory affairs, vigilance, and IT services.

What Are the Market Trends in the Life Sciences Industry?

Regulatory pressure

Pharmaceutical and medical device companies in China must comply with continuously evolving regulations. A key example is the nationwide push for full traceability, mandating products (starting with high-risk items) to carry unique identification codes. These codes, verified at critical points in the supply chain, are essential for ensuring safety and combating counterfeiting.

Challenges:

Qualifying and validating impacted production and IT systems.

Navigating complex regulations for new combination products.

Anticipating future requirements like packaging aggregation.

Modernizing processes and systems for efficient, ongoing compliance.

E-health

Medical devices in China are increasingly interconnected through applications, enabling decision support, diagnostics, and treatment management. Key areas include telemedicine and chronic disease care. The market grows over 10% annually, exceeding an estimated RMB 1.5 trillion by 2023.

Challenges:

Regulatory Compliance: Meeting NMPA standards for embedded medical software.

Dual Certification: Navigating combined medical device and software regulations.

Data Security & Trust: Ensuring compliance with PIPL and Cybersecurity Law to protect patient data.

Combined products

A combination product refers to an integrated health product that combines a drug with a medical device. Driven by technological innovation, the development and application of such products are increasing. A well-established example is the antibiotic-coated hip joint prosthesis, designed to inhibit bacterial adhesion and reduce the risk of post-surgical infection. For manufacturers, the primary complexity lies in regulatory classification—such products must be defined as either a "drug" or a "medical device" under China's regulatory framework, each subject to its own distinct registration and supervision system. Consequently, a clear regulatory strategy must be established from the initial design phase.

Challenges:

Mastering the dual regulatory standards for drugs and medical devices to develop a combination product eligible for market registration.

Validating the manufacturing process for the combined product.

Accurately defining and classifying the product to determine its regulatory status and submitting the corresponding registration application.

Health for everyone

Pharmaceutical companies in China must enhance production efficiency and cost competitiveness to address the pressures from national healthcare budget controls, volume-based procurement policies, the expansion of generic drug markets, and growing domestic demand for accessible medicines. In 2023, China's pharmaceutical market size reached approximately RMB 1.8 trillion (about USD 250 billion), maintaining steady growth driven by policy reforms and an aging population.

Challenges:

Share R&D investments to foster collaborative innovation and reduce redundancies.

Modernize production facilities through automation and smart manufacturing upgrades.

Requalify upgraded production sites in accordance with updated national GMP and regulatory standards.

Develop flexible and scalable production methods to support future personalized and precision therapies.

Functional Sectors Covered by ALTEN