Local manufacturing for market access

01Overview and value chain#

Markers EC: FDA cGMP / EU GMP | OECD: Bio-pharmaceuticals | Regulator: FDA (USA), EMA (EU), NMPA (China)

Local manufacturing for market access is the service of establishing biopharmaceutical production inside a target country or region so that a product qualifies for market entry, government procurement preference and supply security, typically through a CDMO, technology transfer or a joint local-build. It is surging because governments are treating domestic drug supply as strategic: Thermo Fisher flags 500 billion US dollars of announced US biomanufacturing investments by big pharma as a structural tailwind and is itself executing a 1 billion US dollar CDMO investment plan. CDMOs with a global footprint convert that demand into capacity, with Lonza citing its available US capacity and global network as a core competitive advantage and WuXi Biologics running roughly 580,000 litres of installed biologic capacity across a network that now extends to Singapore and Qatar. For emerging markets, local manufacturing is also a market-access condition: Biocon Biologics earned EMA approval of a new monoclonal-antibody facility in India alongside GMP renewals for its India and Malaysia sites, turning local build into EU market access.

The key directions of local manufacturing for market access are:

1. Contract development and manufacturing (CDMO services): outsourcing local production to a global CDMO (Catalent, Lonza, Thermo Fisher Patheon) with an existing GMP site in the target market.
2. Technology transfer (Process transfer): transferring a validated process from an originator to a local manufacturer under GMP, including analytical comparability.
3. Modular local build (Modular biomanufacturing): deploying pre-fabricated, modular biologics plants (WuXi Biologics Singapore) to compress time-to-capacity.
4. Multi-site GMP network qualification (Network access): qualifying a network of GMP sites across jurisdictions so one product can be supplied to many markets from different origins.

Sectoral value chain#

[Market-access & site decision] ──> [CDMO selection / local partner] ──> [Technology transfer] ──> [GMP build & qualification]
                                            │
                                  (Regulatory filing)
                                            │
                                            ▼
[Commercial supply] <─── [Inspection & approval] <─────┘

Value chain levels#

Cross-cutting technologies of the sector:

• CDMO multi-site networks: global GMP capacity (Lonza Visp/US, Catalent, Thermo Fisher Patheon) that lets a sponsor manufacture in-region without owning a plant.
• Modular biomanufacturing: pre-fabricated biologics modules (WuXi Biologics Singapore) that cut construction and commissioning time.
• Technology transfer toolkits: standardised process, analytical and comparability packages that move a product between sites with minimal revalidation.

02US#

The United States is the centre of the local-manufacturing-for-access build-out, with hundreds of billions of announced biomanufacturing investment and the largest CDMO networks.

Reshoring wave, big CDMO investment, US capacity advantage#

• Investment tailwind: Thermo Fisher (originating 1956) sees 500 billion US dollars of announced US biomanufacturing investment by big pharma as a tailwind and is executing a 1 billion US dollar CDMO investment plan of its own.
• Reshoring partnerships: Catalent (founded 1957) supports reshoring of US pharmaceutical manufacturing in 2026 and pairs US capacity with late-phase specialist partnerships such as its AAV alliance with Elpida.
• Capacity as advantage: Lonza cites its available US capacity and global footprint as a major competitive advantage in capturing the access-driven build-out.

03CN#

China combines the largest biologics CRDMO with an aggressive global footprint expansion that turns domestic capacity into worldwide market access.

CRDMO scale, global network, modular builds#

• Capacity leader: WuXi Biologics (founded 2010) runs roughly 580,000 litres of installed biologic capacity and has won the CDMO Leadership Award for nine consecutive years.
• Global modular expansion: WuXi Biologics topped out a modular biologics CRDMO plant in Singapore and signed a strategic memorandum with the Qatar Free Zone Authority, extending its access-enabling network.
• Standards recognition: inclusion in the 2026 Dow Jones Sustainability World Index reinforces WuXi Biologics’ qualification as a multi-jurisdiction manufacturing partner.

04EU#

Europe anchors the heritage CDMO industry and the large-scale mammalian capacity that underpins both EU access and exports.

Pure-play CDMO, large-scale mammalian, footprint focus#

• Pure-play CDMO: Lonza (founded 1897, Switzerland) is completing its transformation into a pure-play CDMO and continues ramping its large-scale mammalian site in Visp, with an India hub adding fermentation leadership.
• Sterile and OSD investment: Recipharm (founded 1995, Sweden) is investing multi-million sums in US sterile manufacturing, a new BFS line and high-potency OSD at Leganés, sharpening its access-enabling footprint.
• Footprint focus: Recipharm is actively reshaping its network, divesting an Israel API plant to form a CDMO alliance with Scinai, illustrating how CDMOs reconfigure sites to serve access strategies.

05Leading companies and research institutes#

06Tech stack and innovations#

The local-manufacturing stack is built on multi-site CDMO networks, modular plant design and disciplined technology transfer that make in-region capacity faster and cheaper than greenfield ownership.

1. CDMO multi-site GMP networks:
   • Networks of qualified GMP sites across regions let a sponsor manufacture in-region without owning a plant, satisfying local-content and supply-security rules.
   • Thermo Fisher’s Patheon network and Catalent’s global sites convert the 500-billion-US-dollar US investment wave into immediately bookable capacity.
2. Modular biomanufacturing:
   • Pre-fabricated biologics modules ship as skid-mounted units and commission in months rather than years, the model WuXi Biologics is deploying in Singapore.
   • Modular lines pair naturally with single-use bioreactors, shortening both build and changeover for multi-product access supply.
3. Technology-transfer toolkits:
   • Standardised process, analytical and comparability packages move a product between sites with minimal revalidation, the engineering step that makes local manufacturing viable.
   • Catalent’s Qai quality-assurance platform exemplifies the digital tooling now wrapping technology transfer to shorten the path from transfer to approved supply.

07Value chains and production pipelines#

Industrial pipeline of a local-manufacturing-for-access project (FDA cGMP / EU GMP)#

┌───────────────────────────┐      ┌───────────────────────────┐
│ 1. Access & site decision │ ───> │ 2. CDMO / partner select  │
└───────────────────────────┘      └───────────────────────────┘
                                                  │
                                                  ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 4. GMP build & qualify    │ <─── │ 3. Technology transfer    │
└───────────────────────────┘      └───────────────────────────┘
              │
              ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 5. Inspection & approval  │ ───> │ 6. Commercial supply      │
└───────────────────────────┘      └───────────────────────────┘

Stage 1: Access and site decision

The sponsor maps the target market, its local-content and procurement rules, and the make-vs-partner trade-off, producing an access plan that defines where production must physically sit.

Stage 2: CDMO or partner selection

The sponsor selects a CDMO with a qualifying GMP site (Catalent, Lonza, Thermo Fisher Patheon) or a local manufacturer, evaluating available capacity, technology fit and regulatory track record.

Stage 3: Technology transfer

The validated process, cell line and analytical methods are transferred to the chosen site, with comparability studies demonstrating the local product matches the originator.

Stage 4: GMP build and qualification

The local line is built or fitted out and qualified through installation, operational and performance qualification, often using modular and single-use equipment to compress the timeline.

Stage 5: Inspection and approval

The local site undergoes FDA, EMA or NMPA pre-approval inspection and is named in the market authorisation, which is the legal step that converts local build into market access.

Stage 6: Commercial supply

The site produces and releases commercial product for the target market under the access agreement, with ongoing GMP compliance and lifecycle change control maintaining the access qualification.