Canada Pharma Market

Canada

2nd largest country in the world in area (after Russia), occupying roughly the northern two-fifths of the continent of North America. Despite Canada’s great size, it is one of the world’s most sparsely populated countries

Capital

Ottawa

Language

English but government services are available in French in many regions.

Major Cities

• Toronto
• Montréal
• Vancouver
• Calgary
• Edmonton

International Borders

The Canada–United States border is the longest international border in the world.

Population

38.93 Mn

GDP

USD 2.326 Trillion; GDP Per Capita USD 54,966 (approx.)

Currency ?

Canadian Dollar 1 Canadian Dollar = 0.74 US Dollar

Ports in Canada

Canada has the longest coastline in the world, spanning 243,042 KM so that is why Canada has over 900 ports & harbours.

Vancouver is the largest port in Canada and the busiest port in North America.

Healthcare in Canada

Canada has one of the highest health expenditures as a percentage of GDP among developed countries. Healthcare spending in Canada is around USD 344Bn which is 15% of the GDP, or USD 8740 per capita.

Canada has highest & fastest-growing spending of per-capita on drug in the world, only behind to the US. Pharmaceuticals are the second largest component of health care expenditures, representing 15% of total expenditures. Public share is 37.2% on drugs expenditures where as private payers share is 62.8%.

Canada Pharma Market

It is around USD 35 Bn which is 2.1% share of the global market and it ranks 9th in the world is terms of value. Canada generic drug market size is approx. USD 8.90 Bn in 2023.

Domestic pharma manufacturing is around 50% and import is also around 50%. The US is the main trading partner, accounting for 64% of exports and 29% followed by EU imports.

CAGR

5.25%

Market Share

Branded Drugs account for to 75% to 80% of Canadian sales by value and 26.5% of the market by Prescription whereas Generic 73.5% of the Market as per Prescriptions.

Leading Therapeutic Classes in Retail & Hospital Segment

·?????? Oncology

·?????? Antiarthritics

·?????? Diabetes Therapy

·?????? Psychotherapeutics

·?????? Immunologic Agents

·?????? Respiratory Therapy

·?????? Cardiovascular

·?????? Ophthalmic

·?????? Neurological Disorders

·?????? Anti-Viral

?These are among the top most common segments among Canadians.

Top Selling Molecules in Terms of Volume

·?????? Rosuvastatin

·?????? Pantoprazole

·?????? Levothyroxine

·?????? Atorvastatin

·?????? Cholecalciferol

·?????? Amlodipine

·?????? Metformin

·?????? Acetylsalicylic acid

·?????? Methadone

·?????? Bisoprolol

Top Drug Manufacturers—Specialty & Generic Companies from Canada as of Jan. 01, 2024

·?????? Bausch Health Companies Inc.

·?????? Plus Products,

·?????? Inc Tilray, Inc.

·?????? Cronos Group Inc

·?????? TerrAscend Corp

·?????? Knight Therapeutics Inc

·?????? Sundial Growers Inc

·?????? Canopy Growth Corporation

·?????? Aurora Cannabis Inc

·?????? Gage Growth Corp

Leading Market Players

·?????? Sun Pharma Canada Inc,

·?????? Abbott Products Canada Inc, T

·?????? akeda Canada Inc,

·?????? GlaxoSmithKline Inc/Canada,

·?????? Pfizer Canada Inc,

·?????? Novartis Pharmaceuticals Canada Inc,

·?????? AstraZeneca Canada Inc,

·?????? Bristol-Myers Squibb Canada Inc,

·?????? Sanofi-Aventis Canada Inc

These are some of the leading players operating in the Canada pharmaceutical market.

FDA

Health Products and Food Branch (HPFB) of is the FDA of Canada.

Health Canada's HPFB is the national authority that regulates, evaluates, and monitors the safety, efficacy, and quality of therapeutic and diagnostic products. These products include drugs, medical devices, disinfectants, and sanitizers with disinfectant claims.

Registration Process

Dossier

Health Canada only accepts submissions/applications in the electronic common technical document (eCTD) electronic formats and in the non-eCTD electronic-only format. Paper documents are no longer accepted by Health Canada for any type of submission/application.

All generic drugs bioequivalent or pharmaceutically equivalent is must to the Canadian Reference Product. No manufacturer can sell a drug in Canada unless a Drug Identification Number (DIN) have been issued by Health Canada, which grants market authorization for that product.

The submission of generic drug is called an Abbreviated New Drug Submission (ANDS).

?Plant Inspection

Yes

Inspections at foreign sites is must in non-Mutual Recognition Agreement countries where Canada does not have standing agreements. Health Canada sends inspection team to the manufacturing plants.

Fees

• For New Active Substance - USD 442,877
• Chemistry & manufacturing data to support a generic single dosage form – USD 13,166
• Comparative (pharmacodynamic, clinical or bioavailability) data to support a single route of administration and dosage form – USD 7,889
• Variations like (change in the manufacturer's name or brand name)- USD 975
• Fabrication - sterile dosage form -USD 48,255
• Importation License USD 37,259
• Fabrication - non-sterile dosage form USD 35,774
• Distribution License USD 19,017
• Wholesaling License USD 11,098
• Packaging/labelling License USD 6,975
• Testing License USD 5,757
• New Master File Registration USD 1,379

?Approval Time

?Generic the average time for approval was approximately 15 months. Health Canada cannot approve a generic copy of innovative drugs for at least 8 years. After 8 years data protection ends.

Faster review provision is available for promising drug products like life-threatening or severely debilitating conditions, such as cancer, AIDS, or Parkinson's Disease?

Medical device Fees

A Medical Device Establishment License (MDEL) is issued for importing or distributing (selling) medical devices for human.

Applications for Class II medical device license -USD 615

Applications for Class III medical device license – USD 13,559

Applications for Class IV medical device license?– USD 29,405

Patent

Innovative Drugs - an 8 year period of market exclusivity for innovative drugs. In addition, a subsequent-entry manufacturer is prevented from filing a submission for a copy of that innovative drug for the first six years of the eight-year period.

The term of a patent is 20 years from date of filing for patent applications filed on or after October 1, 1989.

The Canada-European Union Comprehensive Economic and Trade Agreement (CETA) has introduced another protection, called a Certificate of Supplementary Protection . This provides up to two years of additional protection to a drug product, after the patent expires.

?Prices

Canada has some of the highest prices for generics medicines in the world. Canada's drug prices are now the 3rd highest among the Organization for Economic Co-operation and Development (OECD) countries - that is about 25% above the OECD median.

Different province has different price structure for the same molecule. Each Provinces currently set limits on generic prices, as a percentage of branded drugs, ranging from 18 – 40% across provinces.? Each province in Canada maintains a public drug plan formulary, which lists the drugs and conditions for which the province will reimburse prescription drugs for an eligible insured person under the public plan.

Thus, a pharma company who wants to distribute its products will need to apply to each province. This is a complex process thus for pricing & reimbursement specialists advise is required.

There is no price control as such on innovative drugs, but still Health Canda monitor the price of innovative drugs in other reference countries.

The Patented Medicine Prices Review Board (PMPRB) determines the maximum price of a brand-name drug by comparing it to the prices of other similar drugs. If there are no similar drugs, they compare the prices internationally in France, Germany, Italy, Sweden, Switzerland, the United Kingdom and the USA to determine if the price is excessive.

For a branded drugs, the price is set by the manufacturer, and the federal government have limited role in the same. ?

Prices of Generic Medicines

Set as a percentage of the brand reference price by pCPA (The pan-Canadian Pharmaceutical Alliance)

• Generic product with single source supply (i.e. only one manufacturer of a generic product in Canadian market) - Priced at 85% of brand reference price,
• Generic Product - When two generics in Canadian market - Priced at 50% of brand reference price
• Generic Products when three or more generic products in Canadian market - Priced at 25% of brand reference price for oral solids and at 35% for all dosage forms other than oral solids (e.g. liquids, patches, injectables, inhalers, etc.)

Distribution Network

?Direct client marketing is prohibited is Canada and can lead significant fines. The product monograph primary document that will be the deciding factor in marketing and selling aspects. Thus, product monograph must be reviewed with a professional expert prior to submissions.

Three main ways to distribute the drugs in Canada – (1) IPD (2) drugstore group self?distribution (3) direct distribution by manufacturers.

Independent pharmacy distributors (IPDs) are the third-party companies which distribute generic & brand drugs, as well as other products to retail pharmacies and hospitals.?IPD’s are the independent intermediaries between the manufacturers and suppliers of drug store products, and pharmacies. IPD plays an increasingly important role in the supply and management of prescription pharmaceuticals. Over 50% of all prescribed pharmaceuticals are distributed to pharmacies through?IPD with this share increasing.

Canadian Pharmaceutical Distribution Network (CPDN) is an independent network of drug manufacturer comprising 19 of the major pharmaceutical companies serving the Canadian hospital market.

Approximately 80% of Canadian hospitals use the CPDN program to consolidate orders and shipments of pharmaceutical products.

Under self?distribution, distribution centres are maintained by pharmacy chain, banner and franchise groups, for supply to pharmacies within the group. Self?distribution involves similar roles and activities to those of IPD, but within a group of pharmacies.

?McKesson Canada - The largest pharmacy distributor in Canada. Amerisource Bergen Canada - The 2nd largest distributor in Canada. Other major self?distributors include, Shoppers Drug Mart,?Groupe Jean Coutu(PJC),?Familiprix?Inc., Lawton's Drugstore, and London Drugs.

?In direct distribution, as the name implies, manufacturers ship directly to drugstores.

?Tender Process

The Buyandsell.gc.ca?is the official government on-line website that publish government tenders opportunities.

Health Canada publishes Advanced Contract Award Notices (ACAN) through the?Buyandsell.gc.ca?website to notify suppliers of the intent to award a contract directly to a supplier and to consider statements of qualifications from any suppliers capable of fulfilling the requirement.

Insurance coverage

Public and private drug plans cover about 98% of all Canadians but still one-fifth of drug spending is out-of-pocket. Here, government covers about 42% of the cost of medicines, private insurance another 36%, and the rest comes out of people’s pockets,

Many Canadians have private health insurance, which can provide a variety of drug coverage plans. Some plans may cover 100% of drug costs — others cover a percentage. This is called a co-pay.

Strengths

One of the leading locations for clinical trials.

Well established domestic production capacity.

Weakness?

Stringent regulatory and approval systems- time and resource demanding.

Expensive cost of medicines.

Market is highly competitive & consists of several major players. A few of the major players are currently dominating the market, making acquisitions and JV with other companies to consolidate their market positions in the country.

Opportunities:

An increase in the geriatric population – Increasing demand for chronic diseases and Oncology products.

Enhance domestic pharma manufacturing capacity & Incentive domestic pharma production.

Emerging fields of biopharmaceuticals include gene and cell therapies, and nanomedicines.

R&D opportunities to develop new or improved patented therapies, bio-equivalent copies of innovative drugs once patents expire.

Threat

For generic products around 80% of the API’s and Excipients imported from China and India.

Thanks and Regards,

Dr Palak Gupta

+91 9971140354

[email protected]

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