Rapid growth in biopharma: Challenges and opportunities

screenshot_111Large-scale biotech-manufacturing facilities require $200 million to $500 million or more to build, compared with similar-scale small-molecule facilities that may cost just $30 million to $100 million, and they can take four to five years to build. It’s by far the fastest-growing part of the industry: biopharma’s current annual growth rate of more than 8 percent is double that of conventional pharma, and growth is expected to continue at that rate for the foreseeable future.

Blockbusters are traditionally defined as drugs that have $1 billion or more in annual sales; the top 15 biopharma products each enjoy annual revenue of more than $2 billion, with some, such as the antiinflammatory drug Humira, generating sales of more than $10 billion a year.

There are currently more than 1,500 biomolecules undergoing clinical trials, and the success rate for biologics has so far been over twice that of small-molecule products.

The success of the clinical pipeline will lead to an unprecedented number of new molecule launches, rising from a handful a few years ago to 10 to 15 annually, as biopharma products make up an increasing share of new approvals from the US Food and Drug Administration in the future.

If anything, the emerging long-term picture is even more exciting, with disruptive innovations such as immunotherapies, antibody drug conjugates, and gene and cell therapies all making progress toward commercial launch in the next few years.

The new classes of molecules discussed above, from drug conjugates to the cell and gene therapies arriving in the next five years, will each require its own novel manufacturing, supply, and quality-assurance approaches.

Global innovators will have to drive product innovation in order to continue to command premium prices, shifting the frontier of technology and exploring new operational setups (such as the design and deployment of their future network).

Players based in emerging-market nations will have to find their own niches with the right operational and quality performance to make the best use of privileged access to, and knowledge of, their local markets.

ƒ reducing operating costs across manufacturing and quality divisions by methodically adopting lean practices (for example, eliminating waste and improving labor and asset efficiency) and improving process technology (including possible change controls and regulatory approvals), as well as finding new ways to improve the performance of the production process, from increases in expression systems to purification improvement and process stabilization

ƒ Improving operational agility and equipment utilization to increase manufacturing-site capacity for individual molecules by removing bottlenecks from existing assets, introducing the ability to run multiple products in fewer lines, and improving the industry’s readiness to respond quickly to the needs of a volatile market—all without compromising quality.

ƒ expanding capacity, which may encompass decisions on risk taking for postponement of asset deployment, capital-expenditure efficiency, and adoption of new technologies (such as the design of flexible facilities based on stainless steel, disposables, or hybrid systems to suit specific product and market conditions)

ƒ undertaking the right make-or-buy decisions as biopharma contract-manufacturing organizations become increasingly capable and available, forcing companies to reevaluate where their core operational skills should lie and how they will ensure the cost, quality, and availability of those they choose to outsource

ƒ defining the manufacturing footprint—that is, building or acquiring a strong, competitive network with the right suppliers, manufacturing plants, and distribution capabilities to balance cost, service, and customer acceptance—and, in particular, considering a presence in emerging markets and the associated cost, regulatory, and market-access implications with great care

Between these two extremes, companies will need to accelerate the development and commercialization of new molecules to allow a broader range of illnesses to be addressed, and they must reduce manufacturing costs, improve quality, and build capacity to broaden access to the industry’s life-changing products.