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LMWH value & manufacturing

LMWHs, including enoxaparin, are used across a variety of indications.

LMWHs are complex to manufacture given that they are biological medicines derived from porcine heparin, taking several months (9-10 on average) to produce.

As a result, high levels of investment is needed to meet current and future quality and regulatory standards and to continue to supplying high-quality medicines on a global scale.

Market dynamics

Sanofi has observed that some procurement practices aimed at realizing short-term savings may disrupt the market balance leading to long-term market unsustainability.

In some cases, this may unintendedly disincentivise manufacturers to supply in certain markets increasing the risk of challenges in the supply chain and medicines shortages. This situation could lead to an overall increase in healthcare expenditure.

In the past demand was more predictable within the LMWH market; this led to a more sustainable market with manufacturers able to maintain continuity of supply and financial stability. Today this market has been impacted by the following issues: 

  • Increased production costs
  • Covid-19
  • Unsustainable prices
  • African Swine Fever
  • Voluntary scheme for branded medicines pricing and access (VPAS)

Furthermore, with the emergence of biosimilars alongside a continuing pattern of International Non proprietary Names (INN) prescribing, the predictability of demand in this market is becoming ever more complex.

Price-orientated procurement practices also have the potential to increase the availability of parallel imports which could destabilise the supply of LMWHs further.

There is a need for more predictability of demand, particularly considering the long production time and buyer fragmentation observed in the market.

Demand for LMWHs has been increasing over the past 10 years.

Sanofi project the global market to continue growing at approximately 5% per year between 2022-2028.*

Supply resilience

In recent years, the average procurement cost of pure heparin has increased; (for Sanofi this has more than doubled over the past 5 years) with pure heparin accounting for >50% of Clexane (enoxaparin) production costs.

Increased global demand for syringes and component parts has also contributed to difficult market conditions.

Currently, these difficult market conditions are exacerbated by global inflation which also increases procurement costs. At the same time, price-centric tendering practices are contributing to an unsustainable situation by commoditizing the LMWH market.

Due to the length of the supply chain and difficulties in accurately forecasting, the industry faces challenges in responding rapidly to changes in procurement policies and demand. Communication between industry and the NHS is essential in matching supply with demand.

Sanofi believe that if the number of suppliers in each market decrease, vulnerabilities in supply chains can become more exposed which increases the strain on remaining suppliers to deliver consistent volumes.

Investment in high-quality manufacturing supported by sustainable procurement practices can strengthen supply chain resilience.

Sanofi’s commitment

By supplying Clexane (enoxaparin) in more than 100 counties over a 30 year period, Sanofi has become the global leader in the supply of LMWHs.

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Euro API

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Supplying Clexane (enoxaparin) in ~ 100 countries over 30 years

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~ 70 manufacturing sites for a global supply chain

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~ 20 R&D sites committed to improving environmental sustainability

Sanofi also boasts a diversified global supply chain with multiple manufacturing and sourcing sites across Latin America, China and North America, and has the largest EU footprint of any LMWH manufacturer; this diversification, including local manufacturing, helps to support local economies and insulate the market from medicine shortages. 

Furthermore, Sanofi is committed to improving environmental sustainability through improved packaging designs, reinvesting in further life cycle management and providing additional services to patients and healthcare systems. 

Read: Sanofi recognized by S&P as one of the most sustainability-committed companies - Sanofi

Sanofi’s intention to create a new Active Pharmaceutical Ingredient (API) specialist, at a time when around two-thirds of pharma raw materials are sourced from China and India would secure significant API manufacturing and supply capacities that are critical for patients

Paul Hudson

Sanofi CEO

Case for sustainable procurement

As a leading global enoxaparin manufacturer, Sanofi has the expertise to work with authorities across the world. Sanofi is therefore approaching authorities with proposals to overcome the market and supply challenges and ensure patients' access to medicines.

Sanofi believe that the global LMWH market needs greater supply resilience and long-term sustainable market conditions.

Sanofi is calling for all stakeholders involved in LMWH procurement to find the most appropriate conditions and support long-term market sustainability and patient access striking a balance between fair pricing and healthcare cost optimisation

Pricing recommendations should be tailored to the local market and policy environment and should support market sustainability and patient access

National guidance on sustainable tendering practices should be recommended

Tender designs should reflect the complexities of LMWH and safeguard access to medicines

National/Regional

Sanofi asks procurement leads to consider changes to tender structures which increase the emphasis on non-price centric criteria and award multiple suppliers, which will benefit all stakeholders by increasing supply reliability and safeguarding access to these essential medicines. This is in line with the Governments Social Value Model.

Locally

Education is required for a greater understanding of sustainable procurement and local decisions should be communicated to all suppliers of LMWH.

If a locality chooses a single supplier, other suppliers cannot be expected to meet additional demand in the event of a shortage. 

Alternatively, localities could consider choosing multiple suppliers and providing accurate forecasts of their demand to ensure the availability of products.

In assessing the relative benefits of multiple versus single supplier sourcing, procurement teams should look at:

  • The pharmacy workforce impact of out of stock situation
  • The shortages of tackling elective backlogs 
  • The green sustainability commitments of any decisions

Get in touch with the Thrombosis Team

MAT-XU-2205333 (v3.0) Date of Preparation: October 2023